2010-09-05 | Welcome
Posted by Dave Cavenaugh   12-18-2009 WASHINGTON UPDATE
Vol 11 No. 5

> COTT’S 20TH ANNIVERSARY AND FIRST ANNUAL SURVIVORS GATHERING
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In addition to the brief report on the event which we provided in the previous Update, we wanted to include a strong Statement of Support which we received for the event.  It was necessary to secure written permission, however, to use it in the Update as well as at the Anniversary.  Such permission has now been received, and we are pleased to share with you the following:
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Warm greetings to everyone gathered in our nation's capital to celebrate the 20th anniversary of the Committee of Ten Thousand.

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Since the founding of your organization, your members have joined together to realize a common goal: to ensure a safe national- blood supply and to advocate for those who depend on it. Two decades later, you can take great pride in your record, and I commend you for your unwavering commitment to mutual goals and to one another.

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Your cause has special meaning for me. Before and during my Presidency, I came to know the Ray family, whose three sons contracted AIDS from a contaminated b1ood supply. The two oldest sons, Ricky and Robert, died much too soon, but they did not die in vain. They played an immeasurable role in educating Americans about AIDS and helped lead the journey toward acceptance and understanding. I was honored to sign the Ricky Ray Hemophilia Relief Fund Act to provide assistance to people with hemophilia and their families who, like the Ray brothers, were infected with HIV by blood solids during the 1980s.

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The strides we have made in the past 20 years in the fight against AIDS have been profound. We can be grateful that there now are drugs able to slow the progression of the disease, and people with HIV/AIDS who have access to treatment are living longer and more fulfilling lives. Yet we cannot afford to become complacent. Though new  treatments are effective, they are not available to everyone, and resistant strains of the virus remain a constant threat.

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As new challenges emerge, the hemophilia community, and all  those living with AIDS, can take comfort  in knowing that COTT remains on the front lines in the endeavor to address their concerns and create a healthier future. I salute the many people who have worked over the last 20 years for the success of COTT -- including those present only in spirit -- and send my best wishes for a wonderful celebration.
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                                                     Bill Clinton


Four generations of individuals and families from the hemophilia community gathered together to commemorate, honor and celebrate 20 years of working together in the hemophilia community and the larger bleeding disorders community, We came together to share, remember and recommit ourselves to advocacy on behalf of the younger generations in our community.

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We came together to share and heal some of the divisions that have plagued our work in the past. We came together in the spirit of a community reflecting on where it had been and where it is going. We gathered to celebrate the many accomplishments and success that have been the Committee of Ten Thousand and the numerous individuals whose energy and spirit made those successes possible. The Committee of Ten Thousand has always been about the art of the possible: even when the odds were stacked against us, individuals and the organization persevered and stayed on mission. For those of us who continue to survive, it is an honor to have participated with the many COTT board members and community members who have passed into the spirit world, in the many initiatives that in retrospect were successes.
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The celebration opened with very kind and generous praise for COTT from Congresswoman Lois Capps of California who stated that she wished for more public interest organizations like COTT who are always willing to roll up their sleeves and get the job done. She especially singled out COTT Government Relations staff  Dave Cavenaugh for excellent work on behalf of our community. We were then challenged and congratulated by the thoughtful and insightful keynote address of Dr. Don Francis whose work to warn the nation about AIDS was chronicled in the movie, The Band Played On” and the book of the same title from which it was developed.  Dr. Francis was awarded the COTT Lifetime Achievement Award. Dr Francis was followed by Dr. Jay Epstein, the Director of The Office of Blood at the Food & Drug Administration’s Center For Biologics Evaluation and Research. COTT has enjoyed an 18 year working relationship with Dr. Epstein, who received the COTT Guardian of the Blood Supply Award. A long list of awards were presented to the surviving Founders of COTT and we were honored by the presence of Joanne Womboldt and Fran Fahey, two founding Board members, whose husbands were Jonathan Wadleigh and Tom Fahey.
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We all left the Anniversary and Survivors gathering with a renewed commitment to advocacy and support in our community and a sense of closing the circle regarding 20 years of strong community action rooted in social and economic justice for the hemophilia community in the wake of the devastating AIDS/blood epidemic.
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We celebrated and remembered the people and the good that was attained while also sharing the ongoing struggles and challenges for the survivors, both infected with HIV/AIDS and hepatitis C, and the affected family members and friends who have all shared this journey through the nightmare of the AIDS/Blood and HCV epidemics in the hemophilia community. Across four generations the difficult and very personal struggles were shared in the two survivors workshops. It gave COTT a good feel for the degree of physical and psycho-social issues faced by the survivors and their families and certainly deepened our commitment to work to address the issues facing the survivors such as Post Traumatic Stress Disorder and others. It renewed our commitment to not go quietly and to not be the forgotten generations of the hemophilia community.
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While all agreed it was reflective, deepening and moving, there have been consequences for such a small organization to stage such a large event.  COTT is in serious need of some additional funding to cover the closing costs of the Anniversary Celebration.  Any size donation is greatly appreciated and will be recognized.  As always, donations are tax deductible and we certainly will continue to put all raised dollars to strong advocacy for our community. We look forward to your help. As you can imagine pulling off the Anniversary combined with the First Survivors Gathering was and is a heavy lift for COTT. All of our raised monies go to fund Dave Cavenaugh and our Washington office and the projects associated with the federal and state government, and John Rider and our National Advocate program. The Gathering stretched us to the limits and we are in need of some bridging donations to move into next year and grants arriving in January-February. Any size donation is greatly appreciated and as always tax deductible. Please consider COTT in your end of the year giving.
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> CONGRESS
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HEALTH CARE REFORM
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Congress has been in what could be called a vacillating position on health care reform for months and most intensely in the past few weeks.  The House passed its version of the bill late at night just before Thanksgiving, with a last-minute and very strong amendment on abortion added.  The Senate language, derived from two draft bills from the Finance and Health committees, was taken for melding / reformulation into the Office of the Majority Leader, Harry Reid of Nevada a month earlier. 
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Nothing was heard about the results there for weeks. Reid created a panel of members from both parties to review the bills and select the elements for inclusion going forward. Debate continued to rage for and against a Public Option, financing, immigration and abortion provisions, drug importation and more.  Then on December 8th Reid gave the first public description of his bill, which would not include a Public Option (a government-run set of insurance programs, for access by those unable to access private insurance plans.)
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Senate liberals were energized by this bad news, and more stridently began to argue the importance of the Public Option.  Senate conservative Democrats on the other hand realized the savings from dropping the plan were an acceptable downside to the idea, vs. the large number of people who could no longer look to this legislation for coverage.  In fact, for the first time one heard in frequent statements from them and Republicans, ‘many of the uninsured already receive health care.’  Examples of this may be found, but the implication, that everything’s fine so they needn’t be helped, is far from the truth.  Any family which has lost coverage through unemployment knows the difference between being insured and uninsured.  To claim different is heartless.
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Widespread debate over the Reid bill was delayed awaiting analysis of the cost of the bill by the Congressional Budget Office (CBO).  As Christmas approaches, in the latter two weeks of December, a back-up plan was put forward, to cover some of those in need by lowering the age of Medicare eligibility from 65 to 55.  This idea was only on the table for several days before questions arose about the effect this would have on the “regular” (over 65) Medicare program; whether those in the new program could avail themselves of supplemental insurance like the others to help with Medicare’s inflexible 20% co-pay requirement (just what COTT and others were working to obtain relief from in 2007-2008), and other questions. As the program had only been put forward and details not yet addressed, they could not be answered. Finally, perhaps the strongest argument mounted was from health providers, AMA and others, saying they would  lose money given Medicare’s historically low payment rates. Considering however that they would be seeing new patients, that is hard to appreciate.
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However, it became clear that even if this expanded Medicare program was acceptable to all who had favored a Public Option program, the bill would not have enough votes to pass.  One of the most visible liberals to take this position, and one whose vote could have been deciding, was Sen. Joe Lieberman, formerly a Democrat but now Independent. Lieberman represents Connecticut, a state that is the home of many national insurance companies, like Aetna, Travelers, and CIGNA to name a few. (The state government website proudly states that the current Connecticut Insurance Commissioner was employed for over twenty years in the insurance industry.)
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A less-publicized part of the several versions of this bill has been a plan to allow access by those in need to the long-standing program of multiple private insurance plans operated by the government for insuring federal employees (including Members of Congress) called the Federal Employees Health Benefit program (FEHB).  For years, in any discussion of health reform, FEHB has been cited as the real Cadillac of insurance, from the individual’s point of view. It offers a broad range of choices, which means participating insurers must compete for clients, which can keep premium and other costs down.
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This program has been retained in the Reid bill, has engendered little if any opposition, and is expected to have a far more modest effect on the CBO “score” that the other options.  The main reason this program is being allowed, however, is none of these.  It is, simply put, that it will not require creation of a new federal program (The 55-65 Medicare proposal was, once examined, beginning to look like a “new” program.  This plan will s-t-r-e-t-c-h and existing program quite a bit, and may (though is not expected to) impact on the existing federal employees’ plans, but it is far less politically visible than Medicare, being run out of the federal Office of Personnel Management. For more information on the program, as it exist now before the expansion, go to http://www.opm.gov/insure/.
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Visible and less visible pressure was applied by the White House, with Pres. Obama going to the Hill to meet with Democrats, for example.  At this final stage, the watchword became sacrifice your position if needed in order to back enactment of legislation while we have the chance.
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And so, for only a few days now, it has begun looking like we have a bill, and people have been looking around for what that means, including still waiting for CBO (which has had the game changed on them several times during this saga), and at implications for what it leaves out, as well as beginning to think through some of the many new programs it creates.  One cannot forget, however, that the Senate has not voted on any amendment concerning abortion or immigration.
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Sen. Reid’s last most realistic promise for his combined bill (he said three weeks when he took in on in late October) is that the Senate will vote on it by Christmas. Because of procedures to be invoked, to help guard it from obstacles (like the gambit on the 16th when Republicans insisted that a liberal’s proposed 700-page amendment be read in its entirety before moving on), it will take every bit of that time.
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NEEDLE EXCHANGE BAN
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Congress has lifted a federal ban on needle exchanges programs. Federal funds have been unavailable for 20 years and for many cash strapped State’s the lack of any federal funding option has de facto crippled the effort to implement humane needle exchange programs at the state level.
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On December 13 the Senate passed an appropriations bill, which contained needle exchange funding thereby lifting the 20-year ban. The move won immediate approval from AIDS Action in Washington DC, AMFAR, The Foundation For AIDS Research, and many other organizations.
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COTT National Advocate John Rider, a longtime strong voice for the social value of needle exchange programs, was elated stating, “It is about time we treated addiction as a disease and dealt with those confronting it in a humane and effective manner instead of consigning them to hepatitis C and other blood borne transmissible pathogens such as HIV.” Rider went on to add that, “it is a demonstrably efficient public health tool for limiting the transmission of HIV and HCV that has been out of reach due to political and religious concerns.”
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Needle exchange programs are widely used in the European Union countries and elsewhere and have demonstrated a significant reduction in transmission of blood borne pathogens such as hepatitis C and HIV.
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According to the Atlanta based Centers For Disease Control and Prevention, up to 20% of HIV cases stem from needle sharing. In 2004, the World Health organization reported that reductions in HIV cases of up to 18 percent were seen in interventions that included large needle exchange programs.
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However, the House had voted to lift the ban in July although with a problematic provision that restricts the geographic location of needle exchange programs. The provision contained in the July House action would deny federal funding to programs that operate within 1,000 feet of places where children might congregate, schools, parks, day care centers, pools, arcades, and other locales attractive to youth.
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Advocates of needle exchange were outraged at the provision upon its passage in July by the House viewing it as the, “ban all over again.”
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"This 1,000-foot rule is simply instituting the ban in a different form," stated AIDS Action Executive Director, Rebecca Haag in a New York Times Article on November 8, adding that, “clearly the intent of this rule is to nullify the lifting of the ban.”
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According to the Harm Reduction Coalition, “over 8,ooo new HIV infections and 15,000 new hepatitis C infections occur every year due to syringe sharing among people who inject drugs. These infections are preventable through syringe exchange programs, but the ban on federal funding starves programs of resources and curtails their ability to reach people at risk.”
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The appropriations bill to which the legislation lifting the ban was attached increases the budget for the National Institutes of Health (NIH) by over half a billion dollars, as well as providing slight increases in spending for efforts to fight HIV/AIDS around the globe. AMFAR Vice-President and Director of Public Policy Chris Collins stated, “We applaud this historic step to remove the ban on federal funding for syringe exchange, but are disappointed with the relatively minor increases in AIDS and health research and global AIDS programming.”
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COTT President Corey Dubin stated that, “finally we are moving toward a humane and more sane policy regarding injection drugs and the transmission of blood borne pathogens such as HIV and HCV.” Dubin applauded the lifting of the ban while echoing the views expressed by AMFAR’s Chris Collins regarding funding for AIDS programs, domestically and globally. As a 25 year survivor of the AIDS/Blood epidemic, he notes that “ it is appalling that the pandemic continues to grow in communities of color, women, Native Americans and others, yet it is hidden in the shadows again, invisible to the society-at-large and the media that informs it.”
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> AGENCIES
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Both Federal Advisory Committees concerned with blood and blood products met during the same week just before Thanksgiving.  The older of the two, FDA’s Blood Products Advisory Committee (BPAC), addressed first Blood Donor Deferral for Malaria Risk Associated with Travel to Mexico: Eighteen million US residents travel to Mexico annually. Potential blood donors who recently visited Mexico are routinely deferred as Mexico is on the list of countries where malaria is endemic.  However, there is a constant demand for more donors, suggesting re-examination of the whole-country ban. Many US travelers only go to Cancun in the Yucatan Peninsula for holiday. Malaria, while severe in other parts of the country, is almost nonexistent in the Yucatan.  Information was presented by the Red Cross that if deferrals were stopped and these travelers allowed to donate blood, there would be a risk of one case of blood-transmitted malaria every 150 years.  The Committee agreed in concept to relax the ban, and asked FDA to study the effects of doing so, both within the cases of this example, and elsewhere in the world.  Briefly, other topics covered in the meeting included review of a commercial proposal for a new method of pathogen inactivation for human platelets; a discussion of the potential use of blood pressure and/or pulse rate as donor screening criteria; and the demand for a new line of home HIV test kits. Chris Templin, COTT Board Member and member of FDA’s Transmissible Spongiform Encephalopathies (Mad Cow) Advisory Committee, was present as a voting member of the BPAC for this meeting.
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The other Federal advisory committee concerned with blood and blood products by charter, the Secretary-level Advisory Committee on Blood Safety and Availability, once again used the meeting for review of organ transplantation safety issues – which while important are not a subset of blood safety and how it is protected.  The systems for harvesting, logging,, screening, and allocating  organs, tissue, bone and marrow, and the regulatory structure concerning these, generally are not able to conduct such careful screening as is routinely used in whole blood, blood components, and blood products use. The reason is related to the speed with which, for example, an organ must be transplanted after it becomes available, to retain its viability -- usually24  hours  This tight a time limit nevertheless requires contact with donor's family to interview regarding risk and lifestyle; much more difficult in cases of trauma (car accident, etc). We are told that usually only HIV status (from laboratory testing) is possible. Selected other materials used in transplantation, specifically tissue and bone, can be kept viable in storage, and so can receive far more complete screening than organs.
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After an issue overview the Committee heard presentations on US biovigilance efforts, and then heard updates such as on the H1N1 Swine Flu status, and control efforts including but not limited to vaccination programs nationwide.
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In the public hearings portion of the agenda, a union representative provided testimony concerning labor unrest among Red Cross blood collection centers, which led in at least one case to workers going out on strike, essentially closing the centers.
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Our regular feature of excerpts from recent FDA Enforcement Reports can be found at the end of this Update as Attachment #1.
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> INDUSTRY
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LITIGATON AGAINST MANUFACTURERS
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On November 11th COTT learned of a lawsuit against Baxter, CSL and PPTA through an amended filing with the District Court of Eastern Pennsylvania the day before.  The suit, originally filed July 15 against Baxter and CSL only, alleges “a multi-year conspiracy among Defendants and un-named co-conspirators to restrict output and to fix, raise, maintain or stabilize the prices of Blood Plasma Proteins sold in the United States.”  Brought by one small hospital in the Midwest; many other hospitals have joined the lawsuit in the last three months (currently over 20). The case is expected to grow further; it may be converted into a class action. The amendment also expanded the list of Defendants to include PPTA (the fractionators’ trade association).
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The addition of the national association of fractionators has several implications. One is to taint those of its members which are not named in the suit – Grifols, Wyeth, Talecris being the main ones – or at a minimum call for them to issue bulletins distancing themselves from these matters.  Another is to impair PPTA’s effectiveness at working with patient communities, and in lobbying Congress.  Additional issues may unfold with the further passage of time.
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The alleged infractions should be viewed as reflecting company-level actions, rather than product-specific ones.  The product most involved was IVIG, intravenous immune globulin, a blood product which has a far broader demand than hemophilia clotting factor.  If the allegations are proven true, it would echo an earlier time when the risk of viral hepatitis was downplayed  and the response to HIV was unconscionably lacking.
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RED CROSS
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The American Red Cross (ARC) continues to stumble along in the Blood Services arena, apparently unable to right the listing ship over the last 16 years since the imposition of the Consent Decree between the Federal District Court, The Food & Drug Administration and the American Red Cross in 1993.
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As we approach the 2010, ARC is also facing serious issues with components of its work force. Allegations of unfair labor practices have been leveled against Red Cross in the current dispute with unions representing ARC employees. Over the last four years Red Cross has been rocked by labor disputes from Oakland, California to the current situation in Philadelphia and New Jersey. Some workers have expressed concerns regarding ARC labor practices and the impact this can have on safety at a given ARC blood collection facility.
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The ARC has, for sixteen years, showed an apparent lack of will or motivation to put its Blood Services house in order and end the need for an ongoing consent decree. Each year when the Committee of Ten Thousand looks at the upcoming year, we have hoped for serious change at the highest levels of the American Red Cross regarding the operations of its Blood Services. Yet as we speak ARC workers are on strike in New Jersey and Philadelphia are on strike, including bloodmobile drivers and Phlebotomists and according to the AFL is indicative of ongoing unfair labor practices by ARC.

The American Red Cross remains the largest supplier of blood in the United States, collecting over 40 percent of the nation’s blood. According to a recent report on these matters, the sale of donated blood, generating roughly 2 billion dollars in revenues, accounts for more than two-thirds of the Agency/s overall revenues which surpassed 3.2 billion dollars in 2008 (“Labor Relations at the American Red Cross and its Impact on Employee and Donor Safety” by Philip Dine, for the National Workers’ Rights Board).
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The AIDS/Blood epidemic resulted in a higher degree of national attention being focused on the safety of the Nation’s blood supply and those who are tasked to operate and manage the system. The widespread HIV/AIDS infection of the hemophilia community and the unknown numbers of transfusion associated HIV/AIDS transmissions represented a complete breakdown of the federal regulatory structure for blood/blood products.
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By the late 1980 and early 1990s calls for regulatory change and federal government action began to have impact. Yet some sectors of the American blood community have clearly failed to effectively order their procedural and operational house.
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In December of 2001, eight years ago, the FDA petitioned the federal court to hold the American Red Cross in contempt of the consent decree and to increase the potential fines that could be levied in the future.
In September of 2006 the Food & Drug Administration levied an additional $4.2 million in fines for repeated failures of the ARC in handle and collect blood supplies properly. They also cited ARCs ongoing failure to protect the safety of our nation’s blood supply including “failure to ask appropriate questions of potential donors and failure to follow testing procedures.” The additional fines were connected, in part, to the recall of 10.000 units of blood between 2003 and 2005, and the failures in standard operating procedures, SOPs, regarding donor questioning and proper testing.
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In February 2008, the FDA fined the Red Cross $4.6 million for distributing 4,094 unsuitable blood products. In June 2008, the Red Cross was fined $1.7 million for improperly processing six pints of red blood cells that were transfused into three patients, none of whom was believed to be harmed. More broadly, though, there is reportedly no reliable record of whether recipients were harmed by the improperly collected blood. Even before these latter two fines, the FDA commissioner warned Red Cross directors in January 2008 that they could face criminal prosecutions for their continuing inability to bring the organization into compliance with the consent decree.
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While these ongoing compliance failures at the ARC have not resulted in any serious health problems, they are indicative of potential breakdowns that could pose threats to the end users of blood and blood products. From a landscape view of American Red Cross Blood Services, it is indicative of a climate of inaction and a lack of will to ensure compliance at every level of the collection, handling and shipment of blood and blood products. How else do we explain sixteen years of a federal consent decree and no resolution in sight? What will it take for the American Red Cross to move beyond this shameful chapter in its illustrious history of service and support?
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COTT was surprised recently when we began to look at the history of relations between the American Red Cross and its workers. Given that blood collection, processing and handling is not your everyday service or product delivery. It is an undertaking that has national importance and significance, especially when one considers that over 40 percent of the blood collected in the US is done so by the American Red Cross.
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From 1996 through 2007, the American Red Cross was charged with 212 unfair labor practice violations by the National Labor Relations Board. The Federal Mediation and Conciliation Service intervened 152 times in labor- management conflicts at the Red Cross between 1998 and 2007. Those disputes have involved Red Cross management and the various unions representing the organization’s employees, including the International Brotherhood of Teamsters (IBT); Service Employees International Union(SEIU); Communications Workers of America (CWA); American Federation of State, County and Municipal Employees (AFSCME); Office and Professional Employees International Union (OPEIU); United Auto Workers (UAW); United Steelworkers (USW); International Union of Operating Engineers (IUOE); Laborers’ International Union of North America (LIUNA); and the United Food and Commercial Workers (UFCW).
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Several bitter labor-management disputes have rocked the Red Cross in recent years. For example, four East Bay blood centers in the Oakland, California area were closed in late November 2006 because of a strike by nurses and lab technicians, and some East Bay blood drives were canceled. The regional Red Cross spokeswoman acknowledged that blood supplies in the area would be affected, especially because of the difficulty obtaining sufficient amounts of blood between Thanksgiving and New Year’s. The employees involved had been working for nine months without a contract, with a key sticking point being their request for more advance notice for changes in shift scheduling, so they could plan for family responsibilities.
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On the other side of the country, American Red Cross blood collectors serving New Hampshire and southeastern Vermont voted in early November 2007 to go on strike, after the blood collectors’ union had gone 15 months without reaching a contract since its formation in August 2006 and after, according to the union’s spokesman, the workers sought increased personnel to ensure safety at blood drives but the Red Cross “just refused to even discuss it.” Red Cross officials declined at the time to publicly discuss the terms of the proposed contract. The day before the day the strike was to begin, a last-minute ratification vote by workers averted a strike.
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The mix of poor labor relations, high turnover and an inability to meet operating standards leaves us troubled about the ARC and the current situation. We call on the FDA and the federal District Court to ensure that the American Red Cross gets its blood collection and handling house in order. We also call on the American Red Cross to demonstrate the internal will necessary to accomplish the objectives as mandated in the consent decree.
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NEW YORK TIMES ARTICLE ON BORDER BLOOD COLLECTION
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On Saturday November 27, 2009 the New York Times ran a piece in the business section by Andy Pollack. Given the NYTs history of good reporting on blood and blood supply issues we were looking forward to a thoughtful and insightful article. We were sorely disappointed at what appeared. It was generally a whitewash that failed to adequately address the landscape issues surrounding border plasma collection and the range of concerns raised by end user communities such as hemophilia and others.
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The article failed to substantively raise important policy issues such as, does this allowance of border collection ultimately subvert the ban on foreign plasma collection that came in the wake of the AIDS/Blood epidemic of the 1980s. It also failed to address the question of donor health and access to healthcare services separate from those associated with the act of donating plasma, even though these donors come from one of the poorest and most polluted zones in North America.
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Pollack fails to go beyond the HBV, HIV and HCV transmission question to address other known and unknown pathogens of concern to the Committee of Ten Thousand and all those who depend on this nation’s blood supply to retain a modicum of health. By not addressing the transmission of other agents such as Chagas, a parasite, it is as if the reporter failed to see any risks associated with known and unknown pathogens beyond HIV, HBV and HCV. There is also real substantive lack of discussion regarding the question of paid versus unpaid donors in a critical context that goes beyond the surface issues.
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Our role as the largest global supplier of plasma us not a justification for dismissing important safety concerns regarding the issue of paid or unpaid donors. The reasons other nation’s have banned paid donors is not is not somehow made moot by the fact that they may depend on the US for source plasma. We certainly do not share that construction of the global blood and plasma landscape and the importance of the discussion surrounding paid donors.
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We remain concerned about the economic incentive dangled before populations living in serious poverty conditions with a lack of access to healthcare resources. We find that this easily leads to serious questions regarding the donor questionnaire and the reliability of that tool in effectively screening out high-risk donors. The article does include a statement that whole blood collectors do not pay because “that might induce donors to cover up health problems that could make the blood unsafe.” Why does this not apply to plasma donors? The difference is lost on us – it was prisoners with hepatitis C who lied about it in order to donate (as inmates, to be paid only in cigarettes) that spread the disease among thousands of people with hemophilia in the US, Canada and elsewhere.
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If the United States is the OPEC of plasma as stated by Jim McPherson of Americas Blood Centers, then what are the responsibilities we have regarding the transmission of known and unknown pathogens. We exported tainted plasma derivatives in the 1980s, and people in foreign countries were harmed. It is important to again state that our role as the so-called OPEC of plasma cannot and should not, stand-alone, absolve us of considering this question of how the payment of donors impacts the screening equation. The reasons for banning paid donors in Europe and elsewhere remain relevant to the safety question and are not rendered moot by the US role as the dominant global supplier.
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We also have raised the issue of the exploitation of populations living in serious poverty, and lacking healthcare access yet that remains outside the accepted frame of discussion regarding border collection. We exploited the people of Nicaragua and Haiti in the late 1960 and early 1970s for their plasma. This is not a new question or one lacking in historical controversy.
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After discussing facts and concerns about border area blood and plasma collection, as well as that in major American cities’ low-income and drug-abuse areas, Pollack finds no reports of illness from use of this blood, quoting industry saying it’s safe, legal and besides ‘we don’t pay for the plasma just their time,’ and gives industry a clean bill of health.
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COTT continues to raise ethical questions regarding the practice of border collection. We agree with the statement of Dr. Kobayashi who stated that, “ If you can’t import the plasma, why not import the donor,” adding that “collections on the Mexican border skirt the policy of keeping plasma products safe from pathogens by prohibiting imports of plasma.” .
Many of the donors live and work in the Free-Trade Zone along the US-Mexico border. This is one of the most polluted regions in the Americas and the people living and working there do not generally have access to decent healthcare.
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COTT continues to call for an expanded regulatory framework that is broader in its view of donor screening and donor health issues. We continue to seek a more robust discussion of regulatory policy that is inclusive of all stakeholders in the issue of the safety of our nation’s blood supply.
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ATHN
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The American Thrombosis and Hemostasis Network (ATHN) held its fourth annual community liaison advisory committee meeting in November. Consumer organization representatives present included Mike O’Connor, Board President of NHF; Kimberly Haugstad, Executive Director of HFA; and Dave Cavenaugh, Government Relations staff at COTT.  Among the approximately eight other persons at the table, all were ATHN-affiliated except for Dr. Hani Atrash, the new Director of the Division of Blood Disorders at CDC, and another CDC staff member.  There were several points in the meeting where, considering that the consumer group representatives happened to be seated together, it was "three against the room."
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The first part of the meeting was a review of ATHN projects under way. These include the main data set (yet to obtain any data); a system of portable records called ATHNReady; and a very new project to make use of an offer from Baxter of its in-the-home records collection and HTC-housed data collection system, known for the time being under its Baxter name, Advoy.
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Except for the development of the main database, COTT observed that substantial future development time was needed on each, which should be provided for in their work plan, which also should include a plan for dissemination of information about the project. This would include plans for ATHN persons to present at state organization meetings, so that consumers could hear about ATHN's work directly, rather than only speaking at national and/or ‘leadership’ meetings.
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COTT at several times during this part of the program called on ATHN to work more directly with chapters, other associations, and community members directly.  We have early and vocally expressed concerns about ATHN's original creation and development, out of sight of the consumer groups and in fact the community. The failure to consider the wisdom if not the necessity of meeting directly with consumers is but one more reminder, found frequently in dealing with ATHN,  of this "top level only" view of patient relations. 
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The late-morning discussion of the Advoy system played an interesting if unexpected role in this matter: the system calls for home data entry. Further, the system was implemented worldwide, not just in the US. Therefore, the system was not implemented only through the HTC system, and thus is capable of including many households and patients not getting care primarily through HTCs, by some estimates as much as one-fourth to one-third of the hemophilia population.
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So, for all three projects presented to the ‘committee’ in the morning, major concerns arose as to the degree to which their planning had been thought through.  Accordingly, when in the afternoon consumer input was solicited regarding ATHN’s expansion, COTT raised three points: 1) the three projects under way, and the as-yet-not-plotted development and dissemination work plans, means your plate is full, so at best put this new topic off until the work in hand is well under way; 2) the request for thoughts on expansion, which was a part of the letter of invitation to the meeting, asked for answers to questions about expansion, but were worded only in terms that there should be expansion – not attempting for example to gauge the plusses of expanding, the plusses of not expanding at this time, and the minuses of expanding, and correspondingly the minuses of not expanding now.  Instead they read, as a sample, “How might candidate centers/providers be screened?” 3) The third point was to underscore how much the lack of adequate planning, the lack of considering true consumer workshops, and the willingness to add more work to the plate in sum seem to indicate a project not just out of touch with our community, but out of touch with itself.  We will save repetition of our points about the history and governance of ATHN for another time, but this was a real head-scratcher.  As a final point, the news that slowly came out over the course of the day about ATHN’s no longer being able to house its data at CDC after all (despite a CDC tour given to this committee at last year’s meeting), and other factors, also contributed to this sense of insufficient grounding.
.
.
> COALITIONS
.
COTT Government Relations staff Dave Cavenaugh traveled to New York City on October 20-21 to present to the Executive Board of the Coalition for Safe Blood and Health Care an overview of COTT, including its history and most recent projects, and to describe for them in greater detail our work to date (and plans) on the development of a National Blood Policy. The group is largely comprised of New Yorkers, but, with varying histories with regard to these issues either personally or through family, they are very supportive of these efforts and of COTT.  We look forward to working with them in the future.  A larger meeting, including more consumer organizations and a number of manufacturers, is being planned for March 2010.
.
.
> COTT Operations
.
The COTT Government Relations Working Group met by Conference Call in November. We discussed the then-percolating proposal to lower the eligibility age for Medicare to 55, as an effort to expand health care coverage to those in need without starting a new federal program. Other topics discussed were developments regarding lifetime caps in the health reform bills, the Baxter lawsuit, an Update from the recent ATHN meeting, and the need above all for formalizing a strategic alliance in the face of increasingly restricted access to factor as budgets are cut.  The persistence of the foreclosure ‘epidemic,’ in addition to the ongoing jobs shortage, were both cited as reasons why 2010 cannot be expected to bring us much relief for the economy.  Plans were made for additional calls in the months ahead.
COTT HAS A NEW BLOG!!

COTT acknowledges the assistance of Hemophilia Health Services and Factor Support Network

in publication of this issue of the COTT Washington Update.

Committee of Ten Thousand  236 Massachusetts Ave., NE Suite 609 Washington, DC  20002
800-488-2688 * 202-543-6720 fax
cott-dc@earthlink.net * WWW.COTT1.ORG

Attachment #1: Recent FDA Enforcement Report excerpts

October 7
___________________________________
PRODUCT 
Source Plasma. Recall # B-1596-09
CODE
Units: GA1249461; GA1249858; GA1250732; GA1251137
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Gallup, NM, by facsimile on February 18, 2009 and February 20, 2009. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
United Kingdom
___________________________________
PRODUCT 
Source Plasma. Recall # B-1598-09
CODE

Units: 0200008011, 0200008116, 0200008414, 0200011782, 0200011931, 0200012546, 0200012713, 0200012914, 0200013077, 0200013300, 0200013462, 0200014077, 0200014214, 0200014579, 0200014821, 0200015065, 0200015305, 0200015737, 0200016634, 0200016734, 0200016986, 0200017195, 0200017420, 0200017664, 0200017929, 0200018150, 0200018409, 0200018734, 0200019204, 0200019305, 0200019731. 0200020245, 0200020344, 0200020696, 0200021104, 0200021560, 0200021928, 0200022294, 0200022482, 0200022715, 0200022924, 0200023174, 0200023710, 0200024030, 0200024325, 0200024658
RECALLING FIRM/MANUFACTURER

Recalling Firm: Biomat USA, Inc., Los Angeles, CA, by letter on December 30, 2004.  
Manufacturer: Biomat USA, Inc., Macon, GA. Firm initiated recall is complete. 
REASON

Blood products, collected from a donor whose physical examination was overdue, were distributed.
VOLUME OF PRODUCT IN COMMERCE

46 units
DISTRIBUTION

Spain
___________________________________

PRODUCT 
Source Plasma. Recall # B-1599-09
CODE

Units: 0200037197, 0200037654, 0200037722, 0200046739, 0200046983, 0200047315, 0200047855, 0200048069, 0200048396, 0200048578, 0200048890, 0200049323, 0200049490, 0200049795, 0200050121, 0200050461, 0200050723, 0200051121, 0200051320, 0200053821, 0200054007, 0200054422, 0200054665, 0200054850, 0200055046, 0200055236, 0200055660, 0200055881, 0200056386
RECALLING FIRM/MANUFACTURER

Biomat USA, Inc., Macon, GA, by letter on June 1, 2006. Firm initiated recall is complete. 
REASON

Blood products, collected from a donor who received tattoos within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE

29 units
DISTRIBUTION

Spain
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-1608-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1609-09
CODE

1) Unit: 007FX24319;
2) Units: 007FH52656, 007FR34317, 007FR34321, 007FR34323, and 007FY80264    
RECALLING FIRM/MANUFACTURER

The American National Red Cross, Arizona Region, Tucson, AZ, by facsimile on January 7, 2009 and letter on January 15, 2009. Firm initiated recall is complete.
REASON

Blood products, collected in a manner that may compromise the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE

6 units
DISTRIBUTION

AZ
___________________________________
PRODUCT 
1) Plasma Frozen. Recall # B-1659-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1660-09   
CODE

1) Unit: W087608022985;
2) Units: W087608820904, W087608022985, W087609020660
RECALLING FIRM/MANUFACTURER

Virginia Blood Service, Inc., Richmond, VA, by telephone or e-mail on May 6, 2009 and by letter dated May 26, 2009. Firm initiated recall is complete.
REASON

Blood products, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE

4 units
DISTRIBUTION

VA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1662-09
CODE

Units: 4590020140, 4590019964, 4590019490, 4590019270, 4590018818, 4590018608, 4590018131, 4590017894, 4590022205, 4590021525, 4590021310, 4590020785, 4590020587
RECALLING FIRM/MANUFACTURER

Life Sera, Jacksonville, FL, by e-mail on March 31, 2009. Firm initiated recall is complete.
REASON

Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE

13 units
DISTRIBUTION

Austria
___________________________________
PRODUCT 
1) Fresh Frozen Plasma (Apheresis), Recall # B-1689-09;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1690-09     
CODE

1) Unit: W087609047378;
2) Unit: W087609047848
RECALLING FIRM/MANUFACTURER

Virginia Blood Service Inc., Richmond, VA, by telephone on May 7, 2009 and by letter dated June 3, 2009. Firm initiated recall is complete.
REASON

Blood products, for which the sterility may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE

2 units
DISTRIBUTION

VA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1691-09;
2) Plasma, Frozen. Recall # B-1692-09
CODE

1) Units: 20M50010, 20M56364, 20M56368;
2) Unit: 20M56364
RECALLING FIRM/MANUFACTURER

The American National Red Cross, Salt Lake City, UT, by telephone on December 4, 2007, by letter dated December 20, 2007, or by electronic notification on December 20, 2007. Firm initiated recall is complete.
REASON

Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE

4 units
DISTRIBUTION

ID, UT
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1589-09
CODE

Unit: 22GG37361
RECALLING FIRM/MANUFACTURER

American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on March 11, 2009 and March 19, 2009. Firm initiated recall is complete.
REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1600-09
CODE

Units: 12GE85971, 12KE02270; 12LV43994
RECALLING FIRM/MANUFACTURER

Recalling Firm: The American National Red Cross, Charlotte, NC, by telephone on November 10, 2007 and letter on November 13, 2007.
Manufacturer: Whole Blood Collections-Mobiles-Carolinas Region, Wilmington, Wilmington, NC. Firm initiated recall is complete.
REASON

Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE

3 units
DISTRIBUTION

CA
___________________________________

PRODUCT 
Source Plasma. Recall # B-1603-09
CODE

Unit: AQ030601
RECALLING FIRM/MANUFACTURER

Plasma Biological Services, Inc., Asheville, NC, by facsimile on October 2, 2007. Firm initiated recall is complete.
REASON

Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

NC
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1661-09   
CODE

Unit: W087609020660
RECALLING FIRM/MANUFACTURER

Virginia Blood Service, Inc., Richmond, VA, by telephone or e-mail on May 6, 2009 and by letter dated May 26, 2009. Firm initiated recall is complete.
REASON

Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

Austria
___________________________________
PRODUCT 
1) Recovered Plasma. Recall # B-1693-09
CODE

Units: 20M50010, 20M56368
RECALLING FIRM/MANUFACTURER

The American National Red Cross, Salt Lake City, UT, by telephone on December 4, 2007, by letter dated December 20, 2007, or by electronic notification on December 20, 2007. Firm initiated recall is complete.
REASON

Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE

2 units
DISTRIBUTION

CA
___________________________________
October 21
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1665-09
CODE

Unit: 6253477
RECALLING FIRM/MANUFACTURER

South Texas Blood & Tissue Center, San Antonio, TX, by fax on March 20, 30, 2009 and April 7, 2009. Firm initiated recall is complete.
REASON

Blood product, collected from a donor taking the drug Evista, was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

TX
___________________________________

PRODUCT 
Fresh Frozen Plasma. Recall # B-1667-09
CODE

Unit: 5166877
RECALLING FIRM/MANUFACTURER

The Blood Center of New Jersey, East Orange, NJ, by letter dated March 1, 2007. Firm initiated recall is complete.
REASON

Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

NJ
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1671-09
CODE

Unit: 5000503
RECALLING FIRM/MANUFACTURER

Atlanta Blood Services, Atlanta, GA, by telephone on June 25, 2009 and by letter dated July 14, 2009. Firm initiated recall is complete.
REASON

Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

GA
___________________________________

PRODUCT 
Source Plasma. Recall # B-1672-09
CODE

Unit: 08MMTE0619
RECALLING FIRM/MANUFACTURER

BioLife Plasma Services, L.P., Missoula, MT, by facsimile on November 7, 2008. Firm initiated recall is complete.
REASON

Blood product, collected from a donor who did not receive a physical examination prior to donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

Austria
___________________________________
PRODUCT 
Source Plasma. Recall # B-1673-09   
CODE

Unit: 08FWIE9698
RECALLING FIRM/MANUFACTURER

BioLife Plasma Services L.P., Fond Du Lac, WI, by facsimile on April 24, 2009. Firm initiated recall is complete.
REASON

Blood product, collected from a donor who did not receive a physical examination prior to donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

CA
___________________________________
PRODUCT 
1) Platelets. Recall # B-1674-09;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1675-09;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1676-09
CODE

1) Unit: 4661542;
2) Unit: 4654007;
3) Units: 4661542, 4648622
RECALLING FIRM/MANUFACTURER

Community Blood Bank, Inc., Rancho Mirage, CA, by facsimile on May 27, 2009 and June 9, 2009. Firm initiated recall is complete.
REASON

Blood products, collected from a donor with a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE

4 units
DISTRIBUTION

CA
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    
CODE
Unit: W226909911123 Part 2
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.
REASON
Blood product, which exhibited signs of hemolysis within its segments, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1721-09
CODE

Unit: 003FR76355
RECALLING FIRM/MANUFACTURER

The American National Red Cross - Southern Region, Douglasville, GA, by telephone on January 23, 2009, by facsimile on March 24, 2009 and May 8, 2009. Firm initiated recall is complete.
REASON

Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

GA
___________________________________
PRODUCT 
1) Platelets. Recall # B-1722-09;
2) Fresh Frozen Plasma. Recall # B-1723-09;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1724-09
CODE

1), 2), and 3) Unit: 6710750
RECALLING FIRM/MANUFACTURER

Blood Bank of Alaska, Inc., Anchorage, AK, by facsimile on December 22, 2004. Firm initiated recall is complete.
REASON

Blood products, collected from a donor who did not speak English, were distributed.
VOLUME OF PRODUCT IN COMMERCE

3 units
DISTRIBUTION

Alaska
___________________________________
PRODUCT 
Platelets. Recall # B-1725-09
CODE

Units: 7422757, 7422758, 7422762, 7422763, 7422765, 7422767, 7121021, 7121022, 7121024, 7121026, and 7121034
RECALLING FIRM/MANUFACTURER

Lane Memorial Blood Bank, Eugene, OR, by fax on February 4, 2005. Firm initiated recall is complete.
REASON

Blood products, which may have been exposed to unacceptable temperatures during processing, were distributed.
VOLUME OF PRODUCT IN COMMERCE

11 units
DISTRIBUTION

OR
__________________________________
November 11
__________________________________
PRODUCT 
Red Blood Cells, Leukocytes Reduced. Recall # B-0030-10
CODE

Unit: 93FK00452
RECALLING FIRM/MANUFACTURER

Cooley Dickinson Hospital, BB, Northampton MA, by telephone on July 10, 2009 and by letter dated August 11, 2009. Firm initiated recall is complete.
REASON

Blood product, which tested negative for the antibodies to human T-lymphotropic virus types I and II (anti-HTLV-I/II), but was collected from a donor who previously tested positive for anti-HTLV-I/II, was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

MA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0068-10;
2) Recovered Plasma. Recall # B-0069-10
CODE

1) and 2) Unit: 5690205
RECALLING FIRM/MANUFACTURER

Recalling Firm: Florida’s Blood Centers, Inc., Ormond Beach, FL, by e-mail and letter dated July 9, 2009.
Manufacturer: Florida’s Blood Centers, Inc., Deland, FL. Firm initiated recall is complete.
REASON

Blood products, collected from a donor with a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE

2 units
DISTRIBUTION

Austria, FL
__________________________________
PRODUCT 
Source Plasma. Recall # B-0116-10
CODE

Units: 365092887; 365080312; 365078372; 65076086; 365072469; 65069292; 365069252
RECALLING FIRM/MANUFACTURER

Telecris Plasma Resources, Roanoke, VA, by facsimile on April 21, 2008. Firm initiated recall is complete.
REASON

Blood products, collected from a donor who was permanently deferred for high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE

7 units
DISTRIBUTION

NC
__________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0001-10;
2) Platelets Leukocytes Reduced. Recall # B-0002-10;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0003-10;
4) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0004-10
CODE

1) Unit: 022FZ67363;
2) Units: 022FQ76103, 022FS80951, 022GC10636, 022GH69205, 022LC65888, 022LC65943, 022LP52492, 022GV28838, 022GV28842, 022GV28857, 022GV28862, 022GV28865;
3) Units: 022FQ76103, 022LC65888;
4) Unit: 022GH68928
RECALLING FIRM/MANUFACTURER

American National Red Cross, Penn Jersey Region, Philadelphia, PA, by telephone on November 1, 2008 and by letter dated November 20, 2008. Firm initiated recall is complete.
REASON

Blood products, which were incorrectly tested for human T lymphotropic virus, types I and II (HTLV-I/II), were distributed.
VOLUME OF PRODUCT IN COMMERCE

16 units
DISTRIBUTION

PA, NJ, VA
_________________________________________
November 25
__________________________________
PRODUCT 
Recovered Plasma. Recall # B-0246-10
CODE

Unit: 041FL15772
RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Birmingham, AL, by telephone or electronic notification on November 19, 2008 and by letter dated November 21, 2008. Firm initiated recall is complete.
REASON

Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

CA
__________________________________________
December 9
__________________________________
PRODUCT 
Recovered Plasma. Recall # B-0279-10
CODE

Unit: 1695326
RECALLING FIRM/MANUFACTURER

Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter on April 26, 2007.  Firm initiated recall is complete.
REASON

Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

OH
__________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0329-10
CODE

Unit: 6328687
RECALLING FIRM/MANUFACTURER

Florida’s Blood Centers, Inc., Orlando, FL, by letter on May 26, 2009. Firm initiated recall is complete.
REASON

Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

FL
__________________________________

PRODUCT 
Source Plasma. Recall # B-0330-10
CODE

Unit: 08CIAK1053
RECALLING FIRM/MANUFACTURER

BioLife Plasma Services LP, Cedar Rapids, IA, by fax on August 6, 2009. Firm initiated recall is complete.
REASON

Blood product, collected from a donor whose scheduled physical exam was not completed, was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

CA
___________________________________

PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0331-10;
2) Platelets. Recall # B-0332-10;
3) Recovered Plasma. Recall # B-0333-10
CODE

1), 2), and 3) Unit: 7037946
RECALLING FIRM/MANUFACTURER

Community Blood Center of the Ozarks, Springfield, MO, by letter on May 21, 2009. Firm initiated recall is complete.
REASON

Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE

3 units
DISTRIBUTION

MO, AR
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;
3) Fresh Frozen Plasma. Recall # B-1054-09;
4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;
5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 
6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09
CODE
1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;
2) Units: W071208008713, W071208008713;
3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;
4) Units: W071208008715, W071208008721;
5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;
6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.
REASON
Blood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.
VOLUME OF PRODUCT IN COMMERCE
110 units
DISTRIBUTION
TN, NY
___________________________________
Red Blood Cells. Recall # B-1142-09
CODE

Unit: W287608002663
RECALLING FIRM/MANUFACTURER

Recalling Firm: LifeSource, Glenview, IL, by telephone on October 20, 2008.
Manufacturer: LifeSource Lincoln Park, Chicago, IL. Firm initiated recall is complete.
REASON

Blood product, with an unacceptable total hemoglobin level, was distributed.
VOLUME OF PRODUCT IN COMMERCE

1 unit
DISTRIBUTION

IL
___________________________________
PRODUCT 

Red Blood Cells Leukocytes Reduced Washed. Recall # B-1547-09
CODE

Units: 24FC65052; 24FC65379; 24GY40848; 24KZ61173
RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Louisville, KY, by fax and letter on February 12, 2009. Firm initiated recall is complete.
REASON

Blood products, with unacceptably low red cell recoveries after washing, were distributed.
VOLUME OF PRODUCT IN COMMERCE

4 units
DISTRIBUTION

KY
___________________________________


1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY

1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY

 

1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY 1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY 1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY 1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYSource Plasma. Recall # B-1596-09Units: GA1249461; GA1249858; GA1250732; GA1251137DCI Biologicals LLC, Gallup, NM, by facsimile on February 18, 2009 and February 20, 2009. Firm initiated recall is complete.Blood products, which were collected from a donor with a history of high risk behavior, were distributed.4 unitsUnited KingdomRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYSource Plasma. Recall # B-1596-09Units: GA1249461; GA1249858; GA1250732; GA1251137DCI Biologicals LLC, Gallup, NM, by facsimile on February 18, 2009 and February 20, 2009. Firm initiated recall is complete.Blood products, which were collected from a donor with a history of high risk behavior, were distributed.4 unitsUnited KingdomRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYSource Plasma. Recall # B-1596-09Units: GA1249461; GA1249858; GA1250732; GA1251137DCI Biologicals LLC, Gallup, NM, by facsimile on February 18, 2009 and February 20, 2009. Firm initiated recall is complete.Blood products, which were collected from a donor with a history of high risk behavior, were distributed.4 unitsUnited KingdomRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYSource Plasma. Recall # B-1596-09Units: GA1249461; GA1249858; GA1250732; GA1251137DCI Biologicals LLC, Gallup, NM, by facsimile on February 18, 2009 and February 20, 2009. Firm initiated recall is complete.Blood products, which were collected from a donor with a history of high risk behavior, were distributed.4 unitsUnited KingdomRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYSource Plasma. Recall # B-1596-09Units: GA1249461; GA1249858; GA1250732; GA1251137DCI Biologicals LLC, Gallup, NM, by facsimile on February 18, 2009 and February 20, 2009. Firm initiated recall is complete.Blood products, which were collected from a donor with a history of high risk behavior, were distributed.4 unitsUnited KingdomRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NYSource Plasma. Recall # B-1596-09Units: GA1249461; GA1249858; GA1250732; GA1251137DCI Biologicals LLC, Gallup, NM, by facsimile on February 18, 2009 and February 20, 2009. Firm initiated recall is complete.Blood products, which were collected from a donor with a history of high risk behavior, were distributed.4 unitsUnited KingdomRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
Source Plasma. Recall # B-1596-09Units: GA1249461; GA1249858; GA1250732; GA1251137DCI Biologicals LLC, Gallup, NM, by facsimile on February 18, 2009 and February 20, 2009. Firm initiated recall is complete.Blood products, which were collected from a donor with a history of high risk behavior, were distributed.4 unitsUnited KingdomRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
Source Plasma. Recall # B-1596-09Units: GA1249461; GA1249858; GA1250732; GA1251137DCI Biologicals LLC, Gallup, NM, by facsimile on February 18, 2009 and February 20, 2009. Firm initiated recall is complete.Blood products, which were collected from a donor with a history of high risk behavior, were distributed.4 unitsUnited KingdomRed Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    Unit: W226909911123 Part 2Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.Blood product, which exhibited signs of hemolysis within its segments, was distributed.1 unitVA1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;3) Fresh Frozen Plasma. Recall # B-1054-09;4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09CODE1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;2) Units: W071208008713, W071208008713;3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;4) Units: W071208008715, W071208008721;5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719RECALLING FIRM/MANUFACTURERMedic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.REASONBlood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.VOLUME OF PRODUCT IN COMMERCE110 unitsDISTRIBUTIONTN, NY
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Washington Update is a bi-monthly primer on government related issues of importance to COTT's constituency. From health care legislation, to regulatory affairs to Administration policy for chronic diseases. A hands-on journal for grass roots health care advocacy in our Nation's capital.

COTT News A range of information, reportage and viewpoints regarding issues and events of importance to grass roots health care advocacy and support. In COTTÂ’s vision information is power and part of the empowered community equation. From Washington D.C. to State capitals to the HIH and the FDA, look to COTT for grass roots health care news.

COTT Canary tracks safety issues in our Nation's blood supply. It provides regular reporting, information and viewpoints from the grass roots end user communities. It is based on the historical practice of taking Canaries into the coalmines to gauge problems with breathable air. If the Canary passed out then it was time to evacuate the mine. Persons with hemophilia and other bleeding disorders are the canaries in the coalmine, the blood supply. If problems are present they will surface first in the hemophilia community.

Treatment Updates: News, information and analysis about living with HIV/AIDS, hepatitis C, and hemophilia and related problems associated with living with multiple life threatening diseases.