On June 10-11 the Department of Health and Human Services’ Advisory Committee On Blood Safety and Availability

(ACBSA) met in Washington DC to consider change in the blood donor deferral policy regarding “men who have had

sex with men”, or MSM. Currently, a potential male donor who reports having had sex, even once, with another male

at any time since 1977, is permanently deferred from donating blood. In the last Update we reported on the proposal to

lift the ban which came from Gay Mens Health Crisis in New York and was supported by twenty-one Senators in a

joint letter to FDA Commissioner Margaret Hamburg in March of this year. Change in the deferral policy was also

supported by the American Red Cross, the American Association of Blood Banks and Americas Blood Centers. The

ACBSA heard from both experts and community-based organizations regarding the proposed change.

In April, COTT had asked for a meeting of the Plasma Users Coalition (PUC) to discuss this important and potentially

very controversial issue. Simultaneously, in the spirit of better collaboration and communication across the global

community the PUC adopted a new name and logo to bring this coalition more in tune with the European Users

Coalition, which goes by the name PLUS for PLasma USers. A-PLUS was the name adopted: American Plasma

Users.

The first order of business for A-PLUS was to attempt to develop a consensus within the users coalition on the MSM

question and provide coherent and substantive testimony and recommendations on behalf of the users of blood, blood

components and blood products regarding the proposed changes. World Hemophilia Federation (WFH) President Mark

Skinner and COTT President Corey Dubin were tasked to draft the A-PLUS testimony and to establish a dialogue with

Gay Mens Health Crisis before the June meeting of the ACBSA.

For COTT’s Board of Directors, this was a situation that presented a very serious conundrum. During the 1990s COTT

had worked closely with the Gay, Lesbian, Bisexual and Transgender (GLBT) communities on issues of HIV/AIDS,

chairing the Community Constituency Group at the National Institutes of Health, which was the community structure

for what was then called “Trials Without Walls”, a community based clinical trials initiative for HIV/AIDS drug trials.

Through this work and other activities around speeding development of AIDS drugs, COTT worked with many GLBT

organizations.

COTT Board members were concerned that despite the controversial and potentially explosive nature of this issue,

COTT must again work closely with Gay and Bisexual communities to explore what change in the donor deferral

policy for MSM might look like and how we get to that change in a manner that increases the overall safety of our

nation’s blood supply.

Upon gaining the support of the A-PLUS member organizations we began to seek a meeting with Gay Mens Health

Skinner of WFH, Neil Frick of NHF, and Corey Dubin and Dave Cavenaugh of COTT met with the senior policy staff

of GMHC at its offices in New York.

The discussions were substantive and candid and led to a proposal to craft a joint letter between hemophilia

community organizations and leading Gay and Lesbian rights organizations to be presented at the ACBSA. As a result

2

COTT, NHF, HFA and WFH joined with GMHC, Human Rights Campaign, AIDS Action Council, National Gay and

As always COTT views the blood supply in a landscape manner, that is, with an awareness that any changes in policy

or regulation concerning blood almost certainly has impacts and consequences for other elements of the blood system,

thus having an overall effect potentially much larger than the policy change under consideration. It was vital that the

proposals under study here be considered in the context of the overall safety and regulation of that system.

Mark Skinner delivered the A-PLUS testimony to the Advisory Committee at the ACBSA meeting. It included an

acknowledgement that the current policy needs to be changed, and that such changes must be based on existing

science. He then presented a research agenda that would, through a series of studies, further our overall understanding

of the donor deferral landscape, and how previously deferred donors should, if supported by the science, be re-entered

into the donor pool.

A very good presentation was also given by Dr. Ganz of Canadian Blood Services which has been wrestling with this

issue for some time and has decided not to re-enter MSM donors at this time. At the core of the issue for a number of

the members of the ACBSA, were the very high HIV transmission rates in Gay and Bisexual communities and whether

or not the rates of new infections are a marker for unknown threats or pathogens. This is a question that must be

studied if we are going to better understand the risk horizon for re-entering MSM donors.

Hoots, Director of the Division of Blood Resources at the National Heart, Lung and Blood Institute ( NHLBI) of the

NIH , and his staff, concerning plans for studies under review. The meeting was another positive step in moving the

research agenda forward in a timely and deliberate manner.

COTT would like to thank the GMHC Policy team, including Nathan Schaefer and Sean Cahill for their forward

looking vision and their commitment to change that enhances the overall safety of our nation’s blood supply through

more effective policy development and updated and more focused science.

of the A-Plus Coalition paper (Attachment #2), and the final recommendations of the Advisory Committee to DHHS

Secretary Sibelius (Attachment #3).

3

4

5

C o m mi tte e of Te n Tho usa n d, a g r o u p tha t r e p r e s e nts he m o p hilia p ati e nts. … “Ho w this has b e c o m e a n a c c e p t a bl e p a rt of ou r na ti on al bl o o d sup pl y la nd s c a p e is

un c o ns ci o n a bl e,” said C a v e n a u g h. The g r o u p sa ys its na m e ste m s f r o m th e num b e r of he m o p hilia p ati e nts w h o b e c a m e inf e ct e d with HIV.

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

Attachment #1: Joint COTT-MSM Statement

6

The Department of Health & Human Services, Advisory Committee on Blood Safety and Availability will be

reviewing the current Food and Drug Administration (FDA) policy recommending that men who have sex

with another man (MSM) even one time since 1977 should be deferred indefinitely from donating blood. In

the following joint letter advocacy organizations representing both the Gay & Lesbian Communities and the

Plasma User Communities have signed on to demonstrate their past and ongoing ability to work together on

issues surrounding the safety of our nation’s blood and our public health.

“As the Department of Health and Human Services' Advisory Committee on Blood Safety and Availability

(ACBSA) prepares to evaluate the longstanding deferral of all men who have had sex with men (MSM) from

donating blood, the organizations listed below wish to clarify a recently encountered misperception.

Advocates invested in any change of such a policy report a perceived disconnect between the positions of

leading gay rights and hemophilia representatives. We reject this notion.

The communities have more in common than current discourse reflects. Both gay men and people with

hemophilia have been disproportionately impacted by the HIV epidemic. Critical advancements in HIV

prevention, treatment, and research can be linked directly to the years of successful advocacy by both

communities. For most of the past quarter century, these two communities have worked toward shared

goals, including caring for people living with HIV and preventing the virus’s spread.

The organizations listed below continue to share a strong commitment to the safety of our nation's blood

supply and it is with this in mind that we urge the ACBSA to recommend any scientific research that is

necessary to allow for the thoughtful consideration of alternative policies regarding donor deferral. We look

forward to working with the Advisory Committee, and the broader federal government, to critically examine

and evaluate alternative polices for MSM blood donors that maintain or enhance the safety of blood and

blood products.”

AIDS Action Council

AmFAR

Committee of Ten Thousand

Gay Men's Health Crisis

Hemophilia Federation of America

Human RIghts Campaign

National Gay and Lesbian Task Force

National Hemophilia Foundation

World Federation of Hemophilia

7

Attachment #2: Executive Summary of Plasma Users’ Combined Report

of the statement on behalf of the

before the

Advisory Committee on Blood Safety and Availability

Department of Health and Human Services

Thirty-eighth Meeting

June 10-11, 2010

The Universities at Shady Grove, Rockville, MD

The American Plasma Users Coalition (A-PLUS) is a coalition, formerly known as the Plasma User Coalition

(PUC), of national patient organizations created to address the unique needs of patients with rare diseases

that use life-saving plasma protein therapies. The organizations representing these patients share a

common desire to ensure that the patient voice is heard when relevant public polices, regulations,

directives, guidelines and recommendations which have a major impact on their access to safe and

effective therapy and treatment are considered.

Together our coalition represents more than 125,000 Americans living with chronic disorders dependent

upon plasma protein therapies for their daily living. In addition, there are thousands more that remain

undiagnosed.

Partners in our coalition include:

Alpha-1 Association

Alpha-1 Foundation

GBS/CIDP Foundation International

Committee of Ten Thousand

Hemophilia Federation of America

Immune Deficiency Foundation

Jeffrey Modell Foundation

National Hemophilia Foundation

Platelet Disorder Support Association

Patient Services Incorporated

A-PLUS appreciates this opportunity to present our views regarding the Advisory Committee on Blood

Safety and Availability’s (ACBSA) review of the current Food and Drug Administration (FDA) policy

recommending that men who have sex with another man (MSM) even one time since 1977 should be

deferred indefinitely from donating blood.

Both gay men and those in the plasma user community have been disproportionately impacted by the HIV

epidemic. Our communities have a long history of working together on shared goals related to providing HIV

support, research advocacy, treatment access, and prevention programs. We share a historical common

bond. Together, we are committed to ensuring the overall safety of the nation’s blood supply.

At this time, A-PLUS does not believe that the currently available knowledge and data are sufficient to

support a change to the existing donor deferral policy. We acknowledge that the scientific basis for the

permanent deferral requires review. However, we do not currently have enough information to determine if a

8

one-year, five-year, ten-year, or another deferral period is more appropriate than the existing permanent

lifetime deferral. Selection of another interval could also be perceived as arbitrary or lacking scientific

foundation. However, this is not the end of the discussion.

We believe that there are a number of factors which should be fully evaluated before making a revision to

the policy and we support research focused on high risk behaviors of both MSM and heterosexuals. Such

evaluation and research could lead to a policy revision that maintains or enhances the safety of blood and

blood products.

Today we are calling for a research agenda to be undertaken to address several critical areas with the

following goals:

1. Achieving a better understanding of known and emerging pathogens in specific populations including

MSM and heterosexual populations;

2. Developing policy that recognizes societal aspects of the blood system’s safety and risk tolerance;

3. Developing alternate donor deferral strategies and the risk of blood-borne diseases;

4. Establishing a framework for accelerated approval of pathogen reduction, removal and/or inactivation

technologies for fresh components; and

5. Understanding the implications of a revision on the supply and availability of treatment products globally.

If we progress in earnest with such a research strategy, and obtain reassuring answers, we foresee a time

when a revision would be appropriate and donor deferrals could be made on a more individualized,

behavioral-based risk review for both MSM and heterosexual donors.

We urge all stakeholders, including donors and end-users, to aggressively work together to seek answers.

Equally important, is for the government to commit the necessary funding to ensure that this occurs in a

timely manner. Our specific recommendations for research in the context of the research agenda

mentioned above are summarized below.

9

10

Attachment 3: Final Recommendations of

the Advisory Committee on Blood Safety and Availability

HHS Advisory Committee on Blood Safety and Availability

On June 10-11, 2010, the HHS Advisory Committee on Blood Safety and Availability (ACBSA) met to discuss

the current Food and Drug Administration (FDA) policy on men who have sex with other men (MSM). FDA’s

current policy states that men who have had sex with other men at any time since 1977 are currently deferred as

blood donors.

The ACBSA engaged in deliberations and discussed the following: important factors to consider in making a

policy change; scientific information including risk assessments; whether any additional studies are needed before

implementing a policy change or following a policy change; monitoring tools or surveillance activities that could

be implemented, and whether those should be implemented before implementing any policy change; and, whether

additional safety measures, if any, are needed to assure blood safety under a revised deferral policy.

The ACBSA took two votes during the meeting. The first was to vote on whether the current policy should be

changed at the present time. In the second, the Committee was asked to identify studies needed to establish a

basis for a change in policy and to recommend further action needed, if any, to monitor and improve blood safety.

Should the current indefinite deferral for men who have had sex with another man even one time since 1977 be

changed at the present time? Committee Vote: 6 = Yes; 9 = No

The HHS’s Advisory Committee on Blood Safety and Availability (the Committee or ACBSA) is sensitive to the

blood system and broader societal issues related to the current deferral policy for males who have had sex with

another man even (MSM) one time since 1977.

Whereas we believe that the current donor deferral policies are suboptimal in permitting some potentially high

risk donations while preventing some potentially low risk donations, we find that currently available scientific

data are inadequate to support change to a specific alternative policy; therefore, until further evaluation, the

committee recommends that the current indefinite deferral for men who have had sex with another man even one

time since 1977 not be changed at the present time.

To develop and validate candidate alternative policies, we recommend research in the following areas:

1. Validate modifications to the donor questionnaire that would better differentiate low versus high risk MSM

and heterosexuals, including studies to investigate

11

Transfusion Transmitted Infectious Disease (TTID) and Sexual Transmitted Disease (STD) markers in potential

donor subsets;

1. Establish ongoing national hemovigilance program for TTID markers in blood donors linked to analysis of

demographic, behavioral, and other risk factors:

a. Obtain a baseline on prevalence and incidence of TTIDs,

b. Characterize risk in different donor subgroups (e.g., younger age), and

c. Use above characteristics for continuous quality improvement of the donor deferral process;

1. Determine the feasibility of donor pre-testing to limit risk while characterizing donors who might be recruited

under modified eligibility criteria;

1. Investigate the impact of revised donor criteria on the global availability of plasma products;

1. Evaluation of data from other countries that have changed their high risk donor evaluation programs,

including MSM; and

1. Periodic reassessment of transfusion safety including consideration of multiple and cumulative blood product

exposures to recipients.

Additionally, the Committee recommends the following actions.

1. Implement the January 2008 ACBSA recommendation to adopt pathogen reduction technologies for all

transfusible blood components

1. Create a more robust donor education program focusing on high risk behaviors that is more inclusive of all

donor groups, emphasizing the link between safe donation and recipient health

1. The Department should take action to investigate and reduce the risk of Quarantine Release Errors (QREs) in

blood collection establishments

1. Recognizing the relationship between acceptance of risk of transfusion and protection from harms, further

consideration should be given to mechanisms for compensation for blood injuries consistent with the

recommendations of the Institute of Medicine and the U.S. Congress

Committee vote: Unanimous yes (15 votes)

12

Attachment #4: Recent FDA Enforcement Report excerpts

__________

April 14

__________

1) Recovered Plasma. Recall # B-0458-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-0459-10;

3) Plasma Frozen Within 24 hours (FP24). Recall # B-0460-10;

1) Unit: 003LK21499;

2) Units: 03KW26270, 003LK21499;

3) Unit: 03KW26270

The American National Red Cross – Southern Region, Douglasville, GA, by

telephone and facsimile on March 27, 2009 and by letters dated March 27, 2009 and

May 29, 2009. Firm initiated recall is complete.

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob

Disease (vCJD), were distributed.

4 units

GA, AL

Platelets Pheresis- 7d Leukocytes Reduced. Recall # B-0889-10

Unit: 9919347

Florida’s Blood Centers, Inc., Orlando, FL, by letter on March 28, 2008. Firm initiated

recall is complete.

Blood product, found to be contaminated with Corynebacterium species and

Staphylococcus species using the BacT ALERT System, was distributed.

1 unit

FL

1) Red Blood Cells Leukocytes Reduced. Recall # B-0921-10;

2) Cryoprecipitated AHF. Recall # B-0922-10;

3) Fresh Frozen Plasma. Recall # B-0923-10;

4) Plasma Frozen within 24 hours (FP24). Recall # B-0924-10;

5) Red Blood Cells. Recall # B-0925-10;

6) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0926-10;

7) Plasma Cryoprecipitate Reduced. Recall # B-0927-10

1) Units: 040FV20572, 040FV20573, 040FV20575, 040FV20576, 040FV20580,

040FV20581, 040FV20583, 040FW42763, 040FY52466, 040FY52467, 040FY52469,

040FY52470, 040FY52471, 040FY52472, 040FY52479, 040FY52480, 040FY52481,

040FY52482, 040FY52483, 040FY52485, 040FY52486, 040FZ37560, 040FZ37767,

040FZ37773, 040FZ37808, 040GE99339, 040GE99342, 040GE99346, 040GE99353,

040GE99374, 040GG09346, 040GJ73393, 040GJ73396, 040GJ73398, 040GJ73399,

040GJ73410, 040GJ73411, 040GJ73415, 040GJ73416, 040GM13796, 040GM13847,

040GS94724, 040GS94726, 040GS94864, 040GS94916, 040GT64381, 040GT64383,

040GT64384, 040GT64385, 040GZ07866, 040GZ07888, 040GZ07892, 040GZ07911,

040GZ07924, 040GZ07975, 040GZ07979, 040GZ08202, 040LE26687, 040LE26692,

040LE26702, 040LE26705, 040LE26710, 040LT35510, 040LT35514, 040LT35515,

040LT35516, 040LT35521, 040LT35527, 040LT35528, 040LT35529, 040LT35531,

040LT35675, 040LZ29379, 040FJ64623, 040FJ64641, 040FJ64648, 040FJ64900,

040FJ64902, 040FJ64910, 040FJ64918, 040FJ64924, 040FL40274, 040FL40278,

040FL40280, 040FL40281, 040FL40289, 040FL40294, 040FN34730, 040FN34732,

040FN34737, 040FN34741, 040FN34744, 040FN34745, 040FN34749, 040FN34752,

040FN34754, 040FN34757, 040FV20425, 040FW42479, 040FW42491, 040FW42500,

040FW42502, 040FW42504, 040FX39040, 040FX39042, 040FX39049, 040FX39055,

040FX39058, 040FX39417, 040FX39421, 040FX39422, 040FX39423, 040FX39428,

040FX39433, 040FX39436, 040FX39438, 040FX39440, 040FY51458, 040FY52128,

040FY52129, 040FY52131, 040FZ37486, 040GE97422, 040GE97426, 040GE97434,

040GE97441, 040GE97485, 040GE97512, 040GE97515, 040GE97947, 040GE97965,

040GE97982, 040GE98007, 040GE98029, 040GE98074, 040GE98099, 040GE99317,

040GF84695, 040GF84696, 040GF84704, 040GF84706, 040GF84715, 040GF84718,

040GF84726, 040GF84730, 040GF84733, 040GF84738, 040GF84745, 040GF84749,

040GF84751, 040GF84757, 040GF84928, 040GF84932, 040GF84958, 040GF84962,

040GF84993, 040GG08094, 040GG08100, 040GG08109, 040GG08115, 040GG08118,

040GG08123, 040GG08449, 040GG08451, 040GG08467, 040GG08468, 040GG08485,

040GG08489, 040GG08499, 040GG08527, 040GG08544, 040GG09242, 040GG09248,

040GG09252, 040GH84565, 040GH84568, 040GH84571, 040GH84573, 040GH84577,

040GH84580, 040GH84584, 040GH84590, 040GH84593, 040GH84598, 040GH84607,

040GH84608, 040GH85239, 040GH85245, 040GH85286, 040GH85299, 040GH85303,

040GH85316, 040GH85321, 040GH85326, 040GH85329, 040GH85343, 040GH85347,

040GH85389, 040GH85417, 040GH85425, 040GH85438, 040GH85446, 040GH85533,

040GH85535, 040GH85536, 040GH85548, 040GH85555, 040GH85561, 040GH85563,

040GH85565, 040GH85568, 040GH85571, 040GH85573, 040GH85575, 040GH85577,

040GH85579, 040GH86093, 040GH86099, 040GH86134, 040GK73527, 040GK73529,

040GK73530, 040GK73536, 040GK73537, 040GK73540, 040GK73544, 040GK73547,

040GK73548, 040GK73968, 040GK73973, 040GK73974, 040GK73980, 040GK73982,

040GK73986, 040GK73989, 040GK73992, 040GK73993, 040GK74007, 040GK74009,

040GK74012, 040GK74016, 040GK74017, 040GK74027, 040GL17893, 040GL17895,

040GL17906, 040GL17914, 040GL17916, 040GL17924, 040GL17926, 040GL17929,

040GL18956, 040GL18959, 040GM12588, 040GM12590, 040GM12591, 040GM12592,

040GM12594, 040GM12595, 040GM12596, 040GM12597, 040GM12600, 040GM12602,

040GM12604, 040GM12606, 040GM12607, 040GM12613, 040GM12614, 040GM12928,

040GM12931, 040GM12934, 040GM12940, 040GM12941, 040GM12949, 040GM12953,

040GM12956, 040GN23504, 040GN23509, 040GN23519, 040GN23523, 040GN23718,

040GN23735, 040GQ11157, 040GQ11170, 040GQ11181, 040GQ11192, 040GQ11194,

040GQ11253, 040GQ11258, 040GQ11259, 040GQ11265, 040GQ11267, 040GQ11277,

040GR90737, 040GR91032, 040GR91035, 040GR91043, 040GR91052, 040GR91053,

040GR91055, 040GR91057, 040GR91434, 040GR91440, 040GR91454, 040GR91462,

040GR91464, 040GR91470, 040GR91481, 040GR91491, 040GR91495, 040GS93365,

040GS93368, 040GS93370, 040GS93374, 040GS93393, 040GS93430, 040GS93456,

040GS93585, 040GS93586, 040GS93591, 040GS93603, 040GS93609, 040GS93615,

040GS93619, 040GS93626, 040GS93945, 040GS93947, 040GS93951, 040GS93953,

040GS93960, 040GS93968, 040GS93969, 040GS93973, 040GS93976, 040GS93977,

040GT63918, 040GV58863, 040GV58866, 040GV58869, 040GV58872, 040GV58877,

040GV58885, 040GV58887, 040GV58892, 040GV59003, 040GV59005, 040GV59024,

040GV59029, 040GV59048, 040GV59052, 040GV59053, 040GV59054, 040GW69176,

040GW69179, 040GW69182, 040GW69185, 040GW69188, 040GW69194, 040GW69200,

040GW69201, 040GW69205, 040GW69208, 040GW69730, 040GW69742, 040GX66515,

040GX66756, 040GX66761, 040GX66763, 040GX66769, 040GX66776, 040GX66779,

040GX66783, 040GX66784, 040GX66788, 040KL07343, 040KL07347, 040KL07350,

040KL07353, 040KL07357, 040KL07359, 040KL07361, 040KL07363, 040KL07367,

040KL07369, 040KL07372, 040KM06703, 040KM06705, 040KM06707, 040KM06711,

040KM06712, 040KM06714, 040KM06717, 040KN04150, 040KN04151, 040KN04155,

040KN04157, 040KN04159, 040KN04170, 040KN04175, 040KN04179, 040KN04180,

040KN04197, 040KN04201, 040KN04204, 040KN04206, 040KN04211, 040KN04214,

040KN04217, 040LE25915, 040LE25917, 040LE25918, 040LE25921, 040LE25923,

040LE25929, 040LE25933, 040LE26473, 040LL06444, 040LL06446, 040LL06451,

040LL06454, 040LL06459, 040LT33409, 040LT33410, 040LT33412, 040LT33415,

040LT33416, 040LT33417, 040LT33418, 040LT33419, 040LT33422, 040LT33521,

040LT33523, 040LT33526, 040LT33527, 040LT33533, 040LT33534, 040LT33539,

040LT33540, 040LT33541, 040LT33542, 040LT33546, 040LT33547, 040LT33550,

040LT33693, 040LT33694, 040LT33695, 040LT33697, 040LT33698, 040LT33701,

040LT33702, 040LT33703, 040LT33704, 040LT33706, 040LT33710, 040LT33711,

040LT33712, 040LT33714, 040LT33715, 040LT33717, 040LT33718, 040LT33719,

040LT33721, 040LT33724, 040LT33725, 040LT34548, 040LT35186, 040LT35517,

040LT35678, 040LV15944, 040LV15946, 040LV15948, 040LV15954, 040LV15955,

040LV15956, 040LW35735, 040LW35737, 040LW35739, 040LW35741, 040LW35746,

040LX14916, 040LX14919, 040LX14922, 040LX14923, 040LX14924, 040LX14926,

040LX15027, 040LX15032, 040LX15038, 040LX15041, 040LX15051, 040LX15054,

040LX15057, 040LX15356, 040LX15365, 040LX15369, 040LX15380, 040LX15388,

040LX15407, 040LY13726, 040LZ28726, 040LZ28743, 040LZ28752, 040LZ28758,

040LZ28775, 040LZ28779, 040LZ28782, 040LZ28792, 040FJ64897, 040FL40285,

040FL40290, 040FW42506, 040FY52468, 040GG09344, 040GH85288, 040GH85332,

040GS93948, 040GX66531, 040LV15949;

2) Units: 040FN34730, 040FN34732, 040FN34737, 040FN34741, 040FN34745,

040FN34749, 040FN34757, 040FV20425, 040FV20446, 040FW42767, 040FZ37556,

040FZ37557, 040FZ37558, 040FZ37560, 040FZ37561, 040FZ37565, 040FZ37767,

040FZ37778, 040FZ37798, 040GE97390, 040GE97410, 040GE97441, 040GE97473,

040GE99317, 040GE99329, 040GE99342, 040GE97391, 040GE97395, 040GE97396,

040GE97397, 040GE97399, 040GE97404, 040GE97420, 040GE97422, 040GE97426,

040GE97429, 040GE97480, 040GE97491, 040GE97499, 040GE97503, 040GE97523,

040GE97525, 040GE97544, 040GE97553, 040GE97556, 040GE99310, 040GE99315,

040GE99325, 040GE99351, 040GF84688, 040GF84696, 040GF84704, 040GF84726,

040GF84733, 040GF84738, 040GF84745, 040GF84757, 040GG08086, 040GG08094,

040GG08101, 040GG08109, 040GG08115, 040GG08121, 040GG08123, 040GG09217,

040GG09242, 040GG09248, 040GG09252, 040GH85387, 040GH85389, 040GH85399,

040GH85401, 040GH85417, 040GH85420, 040GH85425, 040GH85431, 040GH86099,

040GH86134, 040GK73982, 040GK73986, 040GK73989, 040GK74007, 040GK74009,

040GK74016, 040GK74017, 040GK74027, 040GM12931, 040GM12940, 040GM12953,

040GM12928, 040GM12934, 040GM12937, 040GM12941, 040GM12949, 040GM12956,

040GM12959, 040GM13780, 040GM13805, 040GM13842, 040GM13845, 040GN23514,

040GN23519, 040GN23713, 040GN23715, 040GN23723, 040GN23730, 040GN23534,

040GN23735, 040GQ11139, 040GQ11151, 040GQ11157, 040GQ11170, 040GQ11175,

040GQ11183, 040GQ11190, 040GQ11192, 040GQ11194, 040GQ11229, 040GQ11232,

040GQ11249, 040GQ11253, 040GQ11258, 040GQ11259, 040GQ11261, 040GQ11265,

040GQ11267, 040GQ11270, 040GQ11275, 040GR91032, 040GR91033, 040GR91035,

040GR91036, 040GR91039, 040GR91440, 040GR91043, 040GR91044, 040GR91046,

040GR91052, 040GR91055, 040GR91057, 040GR91437, 040GS93365, 040GS93368,

040GS93370, 040GS93374, 040GS93377, 040GS93403, 040GS93405, 040GS93411,

040GS93414, 040GS93422, 040GS93429, 040GS93430, 040GS93433, 040GS93436,

040GS93440, 040GS93442, 040GS93446, 040GS93452, 040GS93612, 040GS93615,

040GS93619, 040GS93626, 040GS94916, 040GT63898, 040GV58863, 040GV58866,

040GV58869, 040GV58872, 040GV58877, 040GV58881, 040GV58885, 040GV58887,

040GV58892, 040GW69176, 040GW69182, 040GW69179, 040GW69188, 040GW69194,

040GW69200, 040GW69201, 040GW69205, 040GW69208, 040GW69893, 040GZ07377,

040GZ07877, 040GZ07880, 040GZ07884, 040GZ07886, 040GZ07888, 040GZ07911,

040GZ07974, 040GZ07979, 040LE25915, 040LE25917, 040LE25918, 040LE25923,

040LE25933, 040LE25935, 040LE26687, 040LE26688, 040LE26692, 040LE26702,

040LT33409, 040LT33410, 040LT33412, 040LT33414, 040LT33415, 040LT33416,

040LT33417, 040LT33418, 040LT33419, 040LT33422, 040LT33527, 040LT33545,

040LT33546, 040LT33547, 040LT33549, 040LT33550, 040LT33693, 040LT33694,

040LT33695, 040LT33698, 040LT33701, 040LT33702, 040LT33703, 040LT33704,

040LT33706, 040LT33710, 040LT33711, 040LT33714, 040LT33715, 040LT33717,

040LT33718, 040LT33719, 040LT33721, 040LT33723, 040LT33724, 040LT33725,

040LT33726, 040LT33727, 040LT34548, 040LT35176, 040LT35186, 040LT35189,

13

040LT35190, 040LT35510, 040LT35515, 040LT35516, 040LT35517, 040LT35521,

040LT35522, 040LT35527, 040LT35529, 040LT35531, 040LT35687, 040LT35175,

040LT35177, 040LT35514, 040LT35528, 040LT35678, 040LT35688, 040LX14916,

040LX14923, 040LX14926, 040LX15032, 040LX15038, 040LX15041, 040LX15051,

040LX15054, 040LX15356, 040LX15357, 040LX15359, 040LX15362, 040LX15364,

040LX15365, 040LX15369, 040LX15374, 040LX15380, 040LX15384, 040LX15386,

040LX15388, 040LX15390, 040LX15392, 040LX15394, 040LX15397, 040LX15400,

040LX15407, 040LX15409, 040LZ28726, 040LZ28743, 040LZ28752, 040LZ28775,

040LZ28779, 040LZ28792, 040GF84740, 040GF84751, 040GH85398, 040GN23718,

040GN23720, 040GS93409, 040GS93456, 040LX15057;

3) Units: 040FJ64918, 040FX39048, 040FX39058, 040FX39063, 040FX39067,

040GF84984, 040GG09338, 040GL17906, 040GL17916, 040GL17929, 040GR90719,

040GR90726, 040GR90733, 040GW69742, 040GX66776, 040GX66779, 040GX66788,

040KM06703, 040KM06709, 040KM06711, 040KN04151, 040KN04157, 040KN04159,

040KN04197, 040KN04204, 040KN04211, 040KN04214, 040LV15954, 040LV15955,

040LW35735, 040GS93980 (4 units);

4) Units: 040FC22037, 040FJ64621, 040FJ64633, 040FJ64637, 040FJ64658,

040FJ64892, 040FJ64894, 040FJ64902, 040FJ64908, 040FJ64914, 040FJ64915,

040FJ64919, 040FJ64926, 040FJ64927, 040FJ64932, 040FL40280, 040FV20582,

040FW41936, 040FW41939, 040FW41940, 040FW41941, 040FW42479, 040FW42487,

040FW42490, 040FW42500, 040FX39035, 040FX39042, 040FX39049, 040FX39055,

040FX39408, 040FX39417, 040FX39433, 040FY51452, 040FY51456, 040FY51459,

040FY52102, 040FY52104, 040FY52114, 040FY52119, 040FY52125, 040FY52466,

040FY52467, 040FY52469, 040FY52470, 040FY52472, 040FY52473, 040FY52479,

040FY52480, 040GE98073, 040GE98099, 040GE99374, 040GG08499, 040GH84584,

040GH84577, 040GH84590, 040GH84593, 040GH85242, 040GH85282, 040GH85299,

040GH85316, 040GH85535, 040GH85536, 040GH85538, 040GH85544, 040GH85546,

040GH85548, 040GH85553, 040GH85555, 040GH85565, 040GH85568, 040GH85571,

040GH85573, 040GH85575, 040GJ73393, 040GJ73415, 040GK73547, 040GK73548,

040GL18960, 040GM12591, 040GM12592, 040GM12594, 040GM12595, 040GM12596,

040GM12597, 040GM12600, 040GM12604, 040GR90699, 040GR90702, 040GR90705,

040GR90728, 040GS93945, 040GS93947, 040GS93962, 040GS93951, 040GS93960,

040GV59039, 040GW69565, 040GW69568, 040GW69570, 040GW69571, 040GW69730,

040GX66509, 040GX66751, 040GX66761, 040GX66763, 040KL07343, 040KL07347,

040KL07350, 040KL07361, 040KL07363, 040LT35670, 040LZ29379;

5) Units: 040FW42758, 040FY52488, 040FZ37556, 040FZ37561, 040FZ37565,

040GE99310, 040GE99315, 040GE99325, 040GE99329, 040GE99334, 040GJ73405,

040GJ73412, 040GM13773, 040GM13775, 040GM13778, 040GM13780, 040GM13805,

040GM13842, 040GM13845, 040GS93589, 040GS94705, 040GT64550, 040GW69873,

040GW69877, 040GW69879, 040GW69891, 040GW69893, 040GW69896, 040GW69898,

040GZ07974, 040GZ07982, 040GZ07986, 040LT35522, 040LT35670, 040FC22037,

040FC22044, 040FC22047, 040FC22073, 040FC22076, 040FC22078, 040FJ64621,

040FJ64625, 040FJ64633, 040FJ64637, 040FJ64658, 040FJ64892, 040FJ64906,

040FJ64908, 040FJ64914, 040FJ64915, 040FJ64919, 040FJ64926, 040FJ64927,

040FJ64932, 040FV20446, 040FW41936, 040FW41938, 040FW41939, 040FW41940,

040FW41941, 040FW41942, 040FW42490, 040FW42494, 040FW42495, 040FW42499,

040FX39035, 040FX39036, 040FX39048, 040FX39063, 040FX39067, 040FX39408,

040FY51452, 040FY51454, 040FY51456, 040FY51459, 040FY52102, 040FY52104,

040FY52106, 040FY52109, 040FY52114, 040FY52119, 040GE97390, 040GE97391,

040GE97395, 040GE97396, 040GE97397, 040GE97399, 040GE97404, 040GE97410,

040GE97420, 040GE97429, 040GE97473, 040GE97480, 040GE97491, 040GE97503,

040GE97523, 040GE97525, 040GE97544, 040GE97553, 040GE97556, 040GE98073,

040GF84688, 040GF84922, 040GF84972, 040GF84982, 040GG08086, 040GG08121,

040GG08511, 040GG09217, 040GG09222, 040GG09332, 040GG09338, 040GH85237,

040GH85242, 040GH85251, 040GH85387, 040GH85398, 040GH85399, 040GH85401,

040GH85420, 040GH85532, 040GH85538, 040GH85542, 040GH85544, 040GH85546,

040GK73550, 040GN23514, 040GN23531, 040GN23534, 040GN23705, 040GN23708,

040GN23713, 040GN23715, 040GN23720, 040GN23723, 040GN23730, 040GQ11139,

040GQ11151, 040GQ11190, 040GQ11229, 040GQ11232, 040GQ11249, 040GQ11261,

040GQ11275, 040GR90689, 040GR90694, 040GR90698, 040GR90699, 040GR90701,

040GR90702, 040GR90705, 040GR90711, 040GR90717, 040GR90719, 040GR90723,

040GR90726, 040GR90728, 040GR90733, 040GR90734, 040GR90738, 040GR91033,

040GR91039, 040GR91044, 040GR91046, 040GR91834, 040GS93377, 040GS93380,

040GS93391, 040GS93400, 040GS93403, 040GS93405, 040GS93409, 040GS93411,

040GS93414, 040GS93429, 040GS93433, 040GS93436, 040GS93440, 040GS93442,

040GS93446, 040GS93452, 040GS93601, 040GT63898, 040GV59017, 040GX66509,

040GX66520, 040GX66751, 040GX66754, 040GZ07377, 040LT33414, 040LT33727,

040LT35175, 040LT35176, 040LT35177, 040LT35189, 040LX15357, 040LX15359,

040LX15362, 040LX15384, 040LX15386, 040LX15394, 040LX15397, 040LX15400;

6) Units: 040GE99351, 040GS93961, 040GZ07926, 040LX15371, 040FW42760,

040GE99359, 040GZ07877, 040GZ07880, 040GZ07886, 040GZ07910, 040LT35509,

040LT35687, 040LT35688, 040FV20428, 040FY51460, 040FY52125, 040FY52135,

040GE97476, 040GF84984, 040GF84998, 040GG08101, 040GG09334, 040GH85276,

040GH85282, 040GH85291, 040GH85312, 040GM12937, 040GM12959, 040GQ11166,

040GQ11175, 040GQ11183, 040GR91036, 040GS93396, 040GS93962, 040GS93965,

040GV59020, 040GV59031, 040GV59035, 040GV59039, 040LE25935, 040LE26453,

040LE26455, 040LT33545, 040LT33723, 040LT33726, 040LT35190, 040LX15374,

040LX15375, 040LX15390, 040LX15392, 040LX15409;

7) Units: 040LT33695, 040LT33717, 040GH85425, 040GH85431, 040LT33714,

040LX15392, 040LX15409

American National Red Cross Heart of America Region, Peoria IL, by telephone on

February 28, 2009 and letters dated March 6, 2009. Firm initiated recall is complete.

Blood products, collected in a manner that may have compromised the sterility of the

units, were distributed.

1,228 units

CT, GA, IL, KY, MD, MN, MO, NE, NJ, OH, PA, TN, WI, IA, AL

Platelets Pheresis Leukocytes Reduced. Recall # B-0936-10

Unit: 154833198 (2 units)

Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated December 26,

2007.

Manufacturer: Blood Systems, Inc., Lubbock Center, Lubbock, TX. Firm initiated

recall is complete.

Blood products, which were labeled as leukoreduced, but were not tested to verify

white blood cell count, were distributed.

2 units

TX

Red Blood Cells Leukocytes Reduced. Recall # B-0937-10

Unit: 158307101

Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letter dated December

26, 2007.

Manufacturer: Blood Systems, Inc., Lubbock Center, Lubbock, TX. Firm

initiated recall is complete.

Blood product, collected from a donor taking the medication Methotrexate,

was distributed.

1 unit

TX

Source Plasma. Recall # B-0940-10

Units: TA2116335, TA2117150, TA2117722, TA2122331, TA2122648,

TA2122997, TA2123393, TA2123754, TA2124490, TA2124830, TA2125357,

TA2125580, TA2126755, TA2126924, TA2152311, TA2153097, TA2153570,

TA2156097, TA2156360, TA2156841, TA2157014, TA2157741, TA2157989,

TA2158463, TA2158771, TA2159323, TA2159636, TA2160119, TA2160428,

TA2160894, TA2161686, TA2161899, TA2162263, TA2162493, TA2168627,

TA2169090, TA2169350, TA2169804, TA2170153, TA2170506, TA2170817,

TA2172249, TA2172467, TA2172866, TA2173118, TA2173607, TA2173797,

TA2174295, TA2174497

Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM, by e-mail,

facsimile, and letter on July 14, 2008.

Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated

recall is complete.

Blood products, collected from a donor with a history of intravenous (IV) drug

use, were distributed.

49 units

England

Source Plasma. Recall # B-0941-10

Units: TA2096960, TA2097400, TA2097886, TA2098088, TA2098563,

TA2098839, TA2099376, TA2099607, TA2100253, TA2100564, TA2100970,

TA2101419, TA2101865, TA2102055, TA2102483, TA2102892, TA2103425,

TA2103613, TA2104142, TA2104533, TA2105677, TA2106040, TA2106501,

TA2106950, TA2107483, TA2107829, TA2108527, TA2108876, TA2109396,

TA2109644, TA2110222, TA2110414, TA2111039, TA2111361, TA2111798,

TA2112148, TA2112569, TA2112997, TA2113421, TA2113792, TA2114211,

TA2114623, TA2114967, TA2115584, TA2115779, TA2116313, TA2116589,

TA2118202, TA2118606, TA2118984, TA2119342, TA2119569, TA2120063,

TA2120360, TA2120645, TA2121209, TA2121354, TA2121841, TA2122101,

TA2122585, TA2122847, TA2123335, TA2123550, TA2124104, TA2124317,

TA2124801, TA2126217, TA2126523, TA2127038, TA2127206, TA2127786,

TA2128075, TA2128730, TA2129090, TA2129655, TA2129802, TA2130330,

TA2130737, TA2131315, TA2131647, TA2132264, TA2132585

Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM, by e-mail,

facsimile, and letter dated July 16, 2008.

Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated

recall is complete.

82 units

England

14

Source Plasma, Recall # B-0967-10

Units: TA0001771, TA0001853, TA0002016, TA0002191, TA0002541,

TA0002752, TA0003267, TA0003958, TA0004091, TA0005462, TA0005604,

TA0005891, TA0005993, TA0006221, TA0006362, TA0006587, TA0007471,

TA0007571, TA0007802, TA0007907, TA0008243, TA0008354, TA0009535,

TA0009674, TA0009964, TA0010106, TA2082273, TA2082864, TA2082997,

TA2083547, TA2083790, TA2084182, TA2084388, TA2084839, TA2085268,

TA2085681, TA2091101, TA2091651, TA2121282, TA2121504, TA2122082,

TA2122230, TA2122658, TA2122904, TA2123340, TA2123643, TA2124176,

TA2124371, TA2125030, TA2125302, TA2125735, TA2126385, TA2127604,

TA2128014, TA2128863, TA2133032, TA2137021, TA2137865, TA2138788,

TA2139170, TA2139596, TA2140023, TA2140521, TA2140809, TA2141235,

TA2141675, TA2142088, TA2142454, TA2142990, TA2143484, TA2145094,

TA2147140, TA2147759, TA2147982, TA2148541, TA2148809, TA2149347,

TA2149640, TA2150286, TA2150655, TA2151236, TA2151530, TA2152078,

TA2152435, TA2152929, TA2153213, TA2153675, TA2154353, TA2154695,

TA2156102, TA2156386, TA2156937, TA2157019, TA2157554, TA2157691,

TA2158248, TA2158554, TA2159059, TA2159326, TA2159988, TA2161833,

TA2161983, TA2163445, TA2163682, TA2164053, TA2164439, TA2164735,

TA2166498, TA2166673, TA2167524, TA2167951, TA2168236, TA0010463,

TA0010660, TA0010873, TA0011081, TA0011373, TA0011512, TA0011770,

TA0011899, TA0012233, TA0012380, TA0012658, TA2000743, TA2002067,

TA2005366, TA2005456, TA2005739, TA2005865, TA2006117, TA2006262,

TA2006598, TA2006816, TA2006963, TA2007212, TA2007366, TA2007598,

TA2007830, TA2008080, TA2008301, TA2008481, TA2008750, TA2040447,

TA2040773, TA2041012, TA2041327, TA2041669, TA2042024, TA2042376,

TA2042657, TA2043131, TA2043531, TA2043869, TA2044262, TA2044828,

TA2045124, TA2045484, TA2045671, TA2046025, TA2046221, TA2046584,

TA2046827, TA2047125, TA2047419, TA2047755, TA2048060, TA2048410,

TA2048741, TA2049067, TA2049388, TA2049780, TA2049980, TA2050441,

TA2050646, TA2051124, TA2051302, TA2051787, TA2051967, TA2052391,

TA2052610, TA2053081, TA2053236, TA2053754, TA2053986, TA2054428,

TA2054601, TA2055070, TA2055154, TA2055732, TA2055938, TA2056529,

TA2056808, TA2057165, TA2057538, TA2057971, TA2058170, TA2058791,

TA2059048, TA2059555, TA2059756, TA2060185, TA2060480, TA2061078,

TA2061243, TA2061725, TA2061995, TA2062442, TA2062722, TA2063169,

TA2063441, TA2063946, TA2064222, TA2064801, TA2065074, TA2065472,

TA2065757, TA2066223, TA2066559, TA2066976, TA2067271, TA2067886,

TA2068061, TA2068622, TA2068767, TA2069323, TA2069504, TA2069958,

TA2070293, TA2070716, TA2070978, TA2071457, TA2071720, TA2072170,

TA2072418, TA2072916, TA2073156, TA2073711, TA2073917, TA2074364,

TA2074761, TA2077162, TA2077705, TA2078000, TA2078424, TA2078632,

TA2079107, TA2079764, TA2080030, TA2080367, TA2080581, TA2080890,

TA2081735, TA2082014

Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM, by e-mail, facsimile, and

letter on July 9, 2008 and July 14, 2008.

Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated recall is

complete.

Blood products, collected from a donor with a history of high-risk behavior, were

distributed.

253 units

NC, England, Austria

1) Plasma Frozen. Recall # B-0970-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-0971-10

1) Units: 53R41729,

2) Units: 53R41729, 53FN20097

American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore, MD,

by electronic notification on July 18, 2007 and by letter dated July 20, 2007. Firm

initiated recall is complete.

Blood products, collected from a donor for whom donor suitability was not

adequately determined, were distributed.

3 units

D.C., MD

1) Red Blood Cells, Leukocytes Reduced. Recall # B-0976-10;

2) Platelets, Pooled, Leukocytes Reduced. Recall # B-0977-10;

3) Plasma Frozen Within 24 hours (FP24). Recall # B-0978-10

1) and 3) Unit: 13GV90319;

2) Pool #576 (containing units 13GV90319, 13GV90314, 13GV90325, 13KF14788,

13KF14801)

American Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on

August 21, 2008 and by letter dated September 5, 2008. Firm initiated recall is

complete.

Blood products, collected from a donor for whom donor suitability was not

adequately determined, were distributed.

3 units

MI, OH

1) Red Blood Cells Leukocytes Reduced. Recall # B-0993-10;

2) Fresh Frozen Plasma. Recall # B-0994-10;

3) Platelets, Leukocytes Reduced. Recall # B-0995-10

1) Units: 13GV53916 and 13GX96049;

2) and 3) Unit: 13GX96049

American Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on

November 5, 2007 and follow-up letter dated November 21, 2007. Firm initiated

recall is complete.

Blood products, which were collected from a donor who had medical history of

hepatitis A, were distributed.

4 units

MI, OH

Red Blood Cells Leukocytes Reduced. Recall # B-0996-10

Unit: 18GX17549

American National Red Cross Great Lakes Region, Lansing, MI, by telephone on

January 15, 2008 and by follow-up letter dated January 23, 2008. Firm initiated

recall is complete.

Blood product, collected from a donor who did not meet acceptance criteria during

donor screening process, was distributed.

1 unit

MI

Source Plasma. Recall # B-0997-10

Units: 4150064695, 4150065189, 4150063943, 4150063597, 4150069709,

4150067080

CSL Plasma, Inc., Wichita, KS, by letter on October 8, 2009. Firm initiated recall is

complete.

Blood products, collected from a donor who received a tattoo within 12 months of

donating, were distributed.

6 units

Germany, IL

Source Plasma. Recall # B-1000-10

Units: MQ073496, MQ072824

Plasma Biological Services Inc., Columbia, MO, by fax on October 26, 2009. Firm

initiated recall is complete.

Blood products, collected from a donor considered to be at increased risk for variant

Creutzfeldt-Jakob Disease (vCJD), were distributed.

2 units

NC

Red Blood Cells Leukocytes Reduced. Recall # B-1007-10

Unit: 2230346

Suncoast Communities Blood Bank, Inc., Sarasota, FL, by fax on August 25, 2008.

Firm initiated recall is complete.

1 unit

15

FL

1) Red Blood Cells. Recall # B-1031-10;

2) Platelets. Recall # B-1032-10;

3) Fresh Frozen Plasma. Recall # B-1033-10

1), 2), and 3) Unit: W288009006203

Lifesource, Glenview, IL, by facsimile on September 23, 2009. Firm initiated recall is

complete.

were distributed.

3 units

PA, IL

Source Plasma. Recall # B-1048-10

Units: 4070160340, 4070156647, 4070144029, 4070143655

CSL Plasma Inc., Chattanooga, TN, by letter dated November 9, 2009. Firm initiated

recall is complete.

Blood products, collected from a donor who was previously deferred for testing

reactive for the hepatitis C virus (HCV), were distributed.

4 units

Germany, IL

Recovered Plasma. Recall # B-0767-10

Unit: 003E68576

Recalling Firm: The American National Red Cross, Douglasville, GA, by facsimile and

electronic (LOGIC) on November 28, 2007 and by letter on November 29, 2007.

Manufacturer: The American National Red Cross – Southern Region, Douglasville,

GA. Firm initiated recall is complete.

Blood product, collected from a donor for whom donor suitability was not adequately

determined, was distributed.

1 unit

CA

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0670-10

Unit: 017FS61854

The American National Red Cross - North Central Region, Saint Paul, MN, by fax on

March 11, 2009. Firm initiated recall is complete.

Blood product, collected from a previously deferred donor, was distributed.

1 unit

MA

Recovered Plasma. Recall # B-0767-10

Unit: 003E68576

Recalling Firm: The American National Red Cross, Douglasville, GA, by facsimile and

electronic (LOGIC) on November 28, 2007 and by letter on November 29, 2007.

Manufacturer: The American National Red Cross – Southern Region, Douglasville,

GA. Firm initiated recall is complete.

Blood product, collected from a donor for whom donor suitability was not adequately

determined, was distributed.

1 unit

CA

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0945-10

Units: 152026052 (2 units)

Recalling Firm: Blood Systems, Inc., Scottsdale, American Samoa, AZ, by facsimile

on February 18, 2008.

Manufacturer: Blood Systems, Inc - Lubbock Center, Lubbock, TX. Firm initiated

recall is complete.

Blood products, for which the documentation of the apheresis procedure was

incomplete, were distributed.

2 units

TX

1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1077-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1078-10

1) Unit: W230809609236;

2) Units: W230809204317; W230809306667

Coastal Bend Blood Center, Corpus Christi, TX, by fax on August 19, 2009 and

January 21, 2010. Firm initiated recall is complete.

Blood products, with unacceptably high hematocrits, were distributed.

3 units

TX

___________________

April 21

___________________

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0934-10

Units: 004FQ10855P1; 004FQ10855P2; 004FQ10856P1; 004FQ10856P2;

004FQ10857P1; 004FQ10858P1; 004FQ10858P2; 004FQ10859P1;

004FQ10859P2; 004FQ10881P1; 004FQ10881P2; 004FQ10884P1;

004FQ10884P2; 004KG39729P1; 004KG39730P1; 004KG39730P2;

004KG39731P1; and 004KG39731P2

Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by

facsimile and telephone on November 03, 2009 and by facsimile on November 13,

2009.

Manufacturer: ARC/Manchester, NH, Manchester, NH. Firm initiated recall is

complete.

Blood products, collected in a manner that may compromise the sterility of the

product, were distributed

18 units

ME, NY, MA

1) Red Blood Cells Leukocytes Reduced. Recall # B-1040-10;

2) Fresh Frozen Plasma. Recall # B-1041-10;

3) Recovered Plasma. Recall # B-1042-10

1) Units: 2874420, 1645967;

2) Unit: 1645967;

3) Unit: 2874420

Hoxworth Blood Center, University of Cincinnati UC Medical Center, Cincinnati, OH,

by letter dated September 28, 2007. Firm initiated recall is complete.

Blood products, collected from a donor with a history of high risk behavior, were

distributed.

4 units

OH, CA

Platelets Pheresis Leukocytes Reduced. Recall # B-1087-10

Unit: 54KP35450

American National Red Cross, Rio Piedras, PR, by telephone on October 16, 2009

and follow up letters on October 21, 2009 and November 23, 2009. Firm initiated

recall is complete.

Blood product, collected from a donor who had taken aspirin, was distributed.

1 unit

PR

16

1) Fresh Frozen Plasma. Recall # B-1088-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1090-10

1) Unit: 2595901;

2) Units: 2595901; 9189067

Central Kentucky Blood Center Inc., Lexington, KY, by letter dated October 20, 2009.

Blood products, collected from a donor taking the drug Finasteride, were distributed.

3 units

KY

Red Blood Cells Leukocytes Reduced. Recall # B-1091-10

Units: 5030666; 5031177; 5032980; 5033699

Blood Bank of Alaska, Inc., Anchorage, AK, by letter dated September 21, 2009.

Firm initiated recall is complete

Blood products, collected from a donor considered to be at increased risk for variant

Creutzfeldt-Jakob Disease (vCJD), were distributed.

4 units

AK

Red Blood Cells Leukocytes Reduced. Recall # B-1092-10

Units: W036309506746T; W036309535586N

BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on November 13, 2009. Firm

initiated recall is complete.

Blood products, collected from a donor who reported travel to a malarial endemic

area, were distributed.

2 units

WI

Recovered Plasma. Recall # B-1096-10

Unit: W070509321267

Stanford Medical School Blood Center, Palo Alto, CA, by electronic delivery note on

October 29, 2009. Firm initiated recall is complete.

Blood product, collected from a donor considered to be at increased risk for variant

Creutzfeldt-Jakob Disease (vCJD), was distributed.

1 unit

RI

1) Red Blood Cells. Recall # B-1097-10;

2) Fresh Frozen Plasma. Recall # B-1098-10

1) and 2) W010009006247

Department Of The Army, Armed Services Blood Bank Center, Tacoma, WA, by fax

on November 6, 2009. Firm initiated recall is complete.

Blood products, collected from a donor considered to be at increased risk for variant

Creutzfeldt-Jakob Disease (vCJD), were distributed.

2 units

NJ

Source Plasma. Recall # B-1108-10

Unit: 366116208

Talecris Plasma Resources, Inc., Colorado Springs, CO, by Special Investigation

Protocol- Final Report, dated August 15, 2008. Firm initiated recall is complete.

Blood product, collected from a donor considered to be at increased risk for variant

Creutzfeldt-Jakob Disease (vCJD), was distributed.

1 unit

NC

1) Cryoprecipitated AHF. Recall # B-1124-10;

2) Fresh Frozen Plasma. Recall # B-1125-10;

3) Red Blood Cells Leukocytes Reduced. Recall # B-1126-10;

4) Recovered Plasma. Recall # B-1127-10

1) and 4) Unit: KL19746;

2) Unit: KL21504;

3) Units: KL19746 and KL21504;

BloodCenter of Wisconsin, Inc., Milwaukee, WI, by facsimile on April 11, 2007. Firm

initiated recall is complete.

Blood products, that tested negative for hepatitis, but were collected from an

ineligible donor due to a history of jaundice, were distributed.

5 units

WI

Source Plasma. Recall # B-1136-10

Unit: 370084735

Talecris Plasma Resources, Inc., Salem, OR, by fax on May 16, 2008. Firm initiated

recall is complete.

Blood product, collected using an abbreviated screening process, for which the

donor was not eligible, was distributed.

1 unit

NC

Source Plasma. Recall # B-1137-10

Unit: 391051788

Talecris Plasma Resources, Inc., N Las Vegas, NV, by fax on March 06, 2008. Firm

initiated recall is complete.

Blood product, collected using an abbreviated screening process, for which the

donor was not eligible, was distributed.

1 unit

NC

Source Plasma. Recall # B-1141-10

Units: 366121102, 366120336, 366120086, 366122436, 366122238, 366121399

Talecris Plasma Resources, Inc., Colorado Springs, CO, by Special Investigation

Protocol - Final Report dated August 15, 2008. Firm initiated recall is complete.

Blood products, collected from a donor considered to be at increased risk for variant

Creutzfeldt-Jakob Disease (vCJD), were distributed.

6 units

NC

1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0981-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-0982-10;

3) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall # B-0983-10

1) Unit: 53E29469;

2) Units: 53FX31502, 53FL58865, 53FP65544, 53V54812, 53T21073, 53FQ15579;

3) Unit: 53FC81282

American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore,

MD, by telephone on November 3, 2007 and by letter dated November 8, 2007. Firm

initiated recall is complete.

Blood products, tested for red cell antigens using equipment for which the daily

quality control testing was not performed, were distributed.

8 units

17

MD, VA

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1142-10

Units: 8996458 (part 1 and 2), 5817416 (part 1 and 2), 5802144 (part 1 and 2),

8995282 (part 1 and 2), 5817826 (part 1 and 2), 1941878 (part 1 and 2), 1943429

(part 1 and 2), 1944787 (part 1 and 2), 8314196 (part 1 and 2), 1947317 (part 1 and

2), 1944450 (part 1 and 2), 1941930 (part 1 and 2)

Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by letter dated September 06,

2005. Firm initiated recall is complete.

Blood products, for which the quality control testing for total component hemoglobin

was not performed, were distributed.

24 units

FL

April 28

May 5

1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1036-10

2) Platelets Pheresis Leukocytes Reduced. Recall # B-1037-10

1) Unit: W038309117129;

2) Unit: W038309084232 (2 units)

Mississippi Valley Reg Building Center, Davenport, IA, by telephone and facsimile on

November 4, 2009 and by letter dated November 6, 2009. Firm initiated Recall is

complete.

Blood products, which were labeled as leukoreduced, but were not tested to verify

white blood cell count, were distributed.

3 units

NC, MO

Red Blood Cells Leukocytes Reduced. Recall # B-1039-10

Unit: 2008353

Upstate New York Transplant Services, Inc., Buffalo, NY, by telephone and facsimile

on November 12, 2009. Firm initiated recall is complete.

Blood product, collected from a donor with a history of hepatitis B, was distributed.

1 unit

NY

Source plasma. Recall # B-1068-10

Units 0411156741, 0411149824, 0411147516, 0411146603, 0411132985,

0411122483, 0411121510, 0411121015, 0411119855, 0411119141, 0411117883,

0411117172, 0411115511, 0411113286, 0411112530, 0411098824, 0411091243,

0411090486, 0411088698, 0411088255, 0411086884, 0411085937, 0411085285,

0411075986, 0411098014, 0411097229, 0411096314, 0411095439, 0411094704,

0411093698, 0411092841, 0411092039

ZLB Bioplasma, Inc., Oak Park, MI, by facsimile on or about March 18, 2007. Firm

initiated recall is complete.

Blood products, collected from a donor considered to be at increased risk for variant

Creutzfeldt-Jakob Disease (vCJD) were distributed.

32 units

NC, Germany and Switzerland

1) Fresh Frozen Plasma. Recall # B-1116-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1117-10;

3) Platelets Pheresis Leukocytes Reduced. Recall # B-1118-10;

4) Fresh Frozen Plasma Pheresis. Recall # B-1120-10;

5) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1121-10;

6) Red Blood Cells Pheresis Leukocytes Reduced. Recall # B-1122-10;

7) Plasma Frozen Within 24 hours (FP24). Recall # B-1123-10

1) Units: 158322668, 158326591, 158326705, 158327268;

157035112, 157035172, 157035178, 157035185, 157035192, 157035194,

157035241, 157035247, 157035318, 157035328, 157035437, 157035438,

157035440, 157035445, 157035446, 157035449, 157035452, 157037094,

157037097, 157037109, 157037115, 157037177, 157037181, 157037183,

157037189, 157037194, 157037275, 157037277, 157037281, 157037540,

157040402, 157040409, 157040412, 157040414, 157040415, 157040681,

157040697, 157040703, 157041436, 157041479, 157041481, 157041525,

157041546, 157041748, 157041752, 157041756, 157043405, 157043409,

157043416, 157043468, 157043470, 157043486, 157043623, 157043631,

157043633, 157043634, 157043849, 157043870, 157045495, 157045543,

157045546, 157046225, 157046230, 157046233, 157046236, 157046240,

157046243, 157047055, 158327342, 158327347, 158327348, 158327350,

158327352, 158327354, 158327356, 157031202, 157031204, 157031213,

157031214, 157031215, 157031216, 157031261, 157031275, 158322668,

158322761, 158322762, 158325111, 158325116, 158325122, 158325124,

158325126, 158325128, 158325367, 158325368, 158325380, 158325382,

158325860, 158325868, 158325878, 158325890, 158326251, 158326264,

158326277, 158326282, 158326451, 158326517, 158326528, 158326531,

158326537, 158326539, 158326544, 158326546, 158326591, 158326705,

158326719, 158326722, 158326758, 158327017, 158327070, 158327077,

158327080, 158327081, 158327220, 158327225, 158327240, 158327241,

158327244, 158327247, 158327249, 158327255, 158327262, 158327265,

158327268, 157035026, 157035137, 157035182, 157040671, 157040684,

157040689, 157045412, 158327079, 158327132;

3) Units: 157031040, 157031082, 157031139 (2 units), 157037262, 157040661 (2

units), 157040695 (2 units), 157041634, 157041649 (3 units), 157041650 (2 units),

157043841 (3 units), 158322607, 158322621 (2 units), 158322736, 158327012,

158327014 (2 units), 158327124 (2 units), 158327131 (2 units), 158327179,

158327180, 157043838, 158322677;

4) Units: 157037254 (2 units), 157031055, 157035031, 157041634, 158327012,

158327179, 158327180;

5) Units: 157035031, 157043838, 158322677;

6) Units: 157035323 (2 units), 157035329 (2 units), 157035433 (2 units), 157035441

(2 units), 157037254, 157037576 (2 units), 157037591 (2 units), 157040404 (2

units), 157041421 (2 units), 157043403 (2 units), 157043625 (2 units), 157043698 (2

units), 158325370 (2 units), 158326252 (2 units), 158326446 (2 units), 158326513 (2

units), 158326714 (2 units), 157035026, 157035137, 157035182, 157040661,

157040671, 157040684, 157040689, 157045412, 158327014, 158327079,

158327124, 158327126, 158327132, 158327179, 158327180;

7) Units: 157035241, 157037094, 157037097, 157037109, 157037115, 157043409,

157043416, 157043633, 157043634

Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on April 18, 2007

and by letter dated May 18, 2007.

Manufacturer: United Blood Services - San Angelo, San Angelo, TX. Firm initiated

recall is complete.

Blood products, collected from donors for whom donor suitability was not adequately

determined, were distributed.

252 units

NY, NM, TX, MS, AR, England, Switzerland

1) Red Blood Cells Leukocytes Reduced. Recall # B-1131-10;

2) Fresh Frozen Plasma. Recall # B-1132-10

1) and 2) Unit: W04190902807D

Blood Systems, Inc., Reno, NV, by facsimile on November 2, 2009 and by letter

dated December 14, 2009. Firm initiated recall is complete.

Blood products, collected from a donor with a history of hepatitis A, were distributed.

2 units

UK, NV

18

Source Plasma. Recall # B-1133-10

Unit: 09SWIG2570

BioLife Plasma Services LLC, Sheboygan, WI, by facsimile on November 20, 2009.

Firm initiated recall is complete.

Blood product, collected from a donor who did not have a physical exam, was

distributed.

1 unit

Austria

Source Plasma. Recall # B-1134-10

Unit: 09FNCE8448

BioLife Plasma Services L.P., Fayetteville, NC, by facsimile on October 23, 2009.

Firm initiated recall is complete.

Blood product, collected from a donor who did not have a physical exam, was

distributed.

1 unit

CA

Source Plasma. Recall # B-1135-10

Unit: 09SWIA2419

BioLife Plasma Services LLC, Sheboygan, WI, by facsimile on October 27, 2009.

Firm initiated recall is complete.

Blood product, collected from a donor who did not have a physical exam, was

distributed.

1 unit

Austria

Platelets Pheresis Leukocytes Reduced. Recall # B-1051-10

53GK51109 (Parts 1, 2, and 3), 53GK51106 (Parts 1, 2, and 3), 53GK51103 (Part 3)

America National Red Cross-Greater Chesapeake & Potomac Reg., Baltimore, MD,

by telephone on September 4, 2007 and by letter dated November 5, 2007. Firm

initiated recall is complete.

Blood products, which were not tested for platelet yield, were distributed.

7 units

MD

Recovered Plasma. Recall # B-1119-10;

Units: 157031134, 157031135, 157031202, 157031204, 157031213,

157031214, 157031215, 157031216, 157035318, 157037275, 157037277,

157037281, 157037540, 157040402, 157040409, 157040412, 157040415,

157040681, 157041479, 157043405, 157043486, 157043870, 158322762,

158325111, 158325116, 158325122, 158325124, 158325126, 158325128,

158325367, 158325368, 158325380, 158325382, 158325860, 158325868,

158325878, 158325890, 158326251, 158326264, 158326277, 158326282,

158326451, 158326517, 158326528, 158326531, 158326537, 158326539,

158326544, 158326546, 158326719, 158326722, 158326758, 158327017,

158327070, 158327077, 158327080, 158327081, 158327220, 158327225,

158327240, 158327241, 158327244, 158327247, 158327249, 158327255,

158327350, 158327352, 158327354, 157031049, 157031052, 157031057,

157035112, 157035172, 157035178, 157035185, 157035192, 157035194,

157035437, 157035438, 157035440, 157035445, 157035446, 157035449,

157035452, 157037177, 157037181, 157037183, 157037189, 157037194,

157041525, 157041748, 157041752, 157041756, 158327342, 158327347,

158327348, 158327356

Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on April 18, 2007

and by letter dated May 18, 2007.

Manufacturer: United Blood Services - San Angelo, San Angelo, TX. Firm initiated

recall is complete.

Blood products, collected from donors for whom donor suitability was not adequately

determined, were distributed.

97 units

NY, NM, TX, MS, AR, England, Switzerland

May 12

1) Platelets Pheresis Leukocytes Reduced. Recall # B-1144-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1145-10

3) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1146-10;

4) Red Blood Cells. Recall # B-1147-10

1) 9882855 (part b and c), 9876902, 9878395, 9878394 (part a and b), 9884646,

9884642, 5237081, 9885208 (part a, b and c), 9885205, 9882765 (part a, b and c),

9885203, 9932172, 9932227;

4960348, 5233807, 4960359, 4960349, 4960344, 5233827, 4987178, 4987776,

4997524, 4997575, 4997525, 4997578, 4987185, 4997574, 5235495, 4987184,

4994336, 4994314, 4994330, 4993835, 4993831, 4993830, 4994329, 5235498,

5234245, 5234242, 4994328, 4994317, 4981389, 5236688, 4985719, 5238723,

4985859, 4985830, 5237628, 4985858, 5237625, 5237629, 5238731, 5237611,

4982010, 5238711, 4981114, 4982002, 4982001, 5237612, 5237817, 4990801,

5238707, 5238713, 4990798, 7228345, 4994319, 5236297, 5235490, 4994326,

4985835, 5236295, 5236293, 5236296, 5236294, 5232393, 5232402, 5232399,

5232400, 5232395, 5232396, 5232394, 728365, 7228364, 7228393, 7228661;

3) Units: 9884637 (part 1 and 2), 9884038 (part 1 and 2), 9884039 (part 1 and 2);

4) Unit: 9051913

RECALLING FIRM/MANUFACTURER

Florida's Blood Centers, Inc., Orlando, FL, by telephone on June 26, 2006. Firm

initiated recall is complete.

Blood products, not tested for HIV and HCV NAT, were distributed.

105 units

FL

Red Blood Cells Apheresis, Leukocytes Reduced, Irradiated. Recall # B-1150-10

Units: 38C14502, 38C21609, 38C28703, 38FK38377, 38FM66963, 38FV36816,

38KT34643, 38KT40423, 38KT40430, 38KT45599, 38KW00793, 38KW04397,

38KW08996, 38KW09458, 38KW16238, 38LC95517

American National Red Cross Indiana-Ohio Region, Fort Wayne, IN, by telephone on

January 30, 2007 and by follow-up letter dated January 30, 2007. Firm initiated recall

is complete.

Red Blood Cells, mislabeled with an extended expiration date, were distributed.

16 units

IN

Source Plasma. Recall # B-1151-10

Units: LC0516598, LC0516908, LC0517538, LC0517781, LC0518554, LC0518735,

LC0519382, LC0519544, LC0520194, LC0520398, LC0528587, LC0528968,

LC0529253, LC0529769

Las Cruces Biologicals LLC, Las Cruces, NM, by letter dated March 15, 2007. Firm

initiated recall is complete.

Source Plasma, collected from an ineligible donor, was distributed.

8.769 Liters (14 units)

NY, CA

Red Blood Cells, Leukocytes Reduced. B-1152-10

Units 38GZ07400 (split unit)

American National Red Cross Indiana-Ohio Region, Fort Wayne, IN, by telephone on

December 28, 2006. Firm initiated recall is complete.

Blood products, collected from an ineligible donor, were distributed.

2 units

IN

19

1) Red Blood Cells Leukocytes Reduced. Recall # B-1162-10;

2) Recovered Plasma. Recall # B-1163-10;

3) Source Leukocyte. Recall # B-1164-10

1), 2), 3) Unit: 4916905

Gulf Coast Regional Blood Center, Houston, TX, by facsimile on October 21, 2009

and November 3, 2009. Firm initiated recall is complete.

Blood products, collected from a donor who was previously deferred for a history of

hepatitis, were distributed.

3 units

NJ, TX

1) Red Blood Cells Leukocytes Reduced. Recall # B-1166-10;

2) Fresh Frozen Plasma. Recall # B-1167-10;

3) Platelets Leukocytes Reduced, Recall # B-1168-10

19GH76830

American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by

facsimile on November 12, 2009 and by letter dated November 12, 2009. Firm

initiated recall is complete.

Blood products, collected from a donor for whom donor suitability was not adequately

determined, were distributed.

3 units

TN, KY, IN

1) Fresh Frozen Plasma. Recall # B-1171-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1172-10;

3) Recovered Plasma. Recall # B-1173-10

1) Unit: W045006099990;

2) Units: W045006099990, W045009075246;

3) Units: W045009029873, W045009075246

by e-mail on October 9, 2009 and by letter dated October 14, 2009. Firm initiated

recall is complete.

Blood products, collected from a donor with a history of exposure to hepatitis B, were

distributed.

5 units

CA, KS, Austria, MO

Source Plasma. Recall # B-1179-10

Units: 377068395, 377068073, 377067522, 377067221, 377058179, 377057309,

377055953, 377054553, 377053631, 377053200, 377052782

Talecris Plasma Resources, Inc., Anderson, IN, by fax on August 20, 2009. Firm

initiated recall is complete.

Blood products, collected using an abbreviated screening process, for which the

donor was not eligible, were distributed

11 units

NC

Source Plasma. Recall # B-1180-10

Units: 3260005168, 3260005420, 3260005774

Talecris Plasma Resources Inc., Lake Charles, LA, by fax on August 20, 2009. Firm

initiated recall is complete.

Blood products, collected from a donor who received a tattoo within 12 months of

3 units

NC

Red Blood Cells. Recall # B-1161-10

Unit: W072109001956

Southern California Permanente Medical Group, San Diego, CA, by telephone on

November 11, 2009 and by letter dated November 11, 2009. Firm initiated recall is

complete.

Blood product, collected from a donor who was at risk for Leishmaniasis, was

distributed.

1 unit

CA

Source Plasma. Recall # B-1177-10

Units: 3250010232, 3250004750

Talecris Plasma Resources, Inc., Sioux Falls, SD, by fax on November 5, 2008. Firm

initiated recall is complete.

Blood products, collected from a donor whose suitability to donate was not

adequately determined, were distributed.

2 units

NC

Source Plasma. Recall # B-1181-10

Units: 351040499, 351040877, 351041338, 351041838, 351042035, 351042594,

351042965, 351044082, 351044443, 351045096, 351036858, 351036892

Talecris Plasma Resources Inc., Louisville, KY, by fax on February 29, 2008. Firm

initiated recall is complete.

Blood products, collected from a donor whose suitability to donate was not

adequately determined, were distributed.

12 units

NC

Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1183-10

Units: 72F955707, 72F663145

Lifesouth Community Blood Centers Inc - Birmingham Region, Birmingham, AL, by

facsimile on July 16, 2008. Firm initiated recall is complete.

2 units

AL

Source Plasma. Recall # B-1188-10

TQ069887, TQ069583, TQ069070, TQ068689, TQ067849, TQ067563, TQ067136,

TQ066875, TQ066289, TQ066013, TQ065366, TQ064958, TQ064363, TQ063712,

TQ063435, TQ062870, TQ062590, TQ062039, TQ060954, TQ060578, TQ059936,

TQ059630, TQ058843 and TQ058522

IBBI dba Knoxville Plasma Corp., Knoxville, TN, by facsimile on 04/08/2009. Firm

initiated recall is complete.

Blood products, collected from a donor in which donor suitability was not adequately

determined, were distributed.

24 units

NC

__________________________________

May 19

20

__________________________________

1) Plasma Frozen within 24 hours (FP24). Recall # B-1155-10;

2) Recovered Plasma. Recall # B-1156-10

1) Unit: W044609220826;

2) Units: W044608211648, W044608322459, W044609340801

Gulf Coast Regional Blood Center, Houston, TX, by facsimile on August 31, 2009

and September 6, 2009. Firm initiated recall is complete.

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob

Disease (vCJD), were distributed.

4 units

TX, NJ

Recovered Plasma. Recall # B-1160-10

Unit: 9651196, 9715661, 5812088

Gulf Coast Regional Blood Center, Houston, TX, by facsimile on October 16, 2009.

Firm initiated recall is complete.

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob

Disease (vCJD), were distributed.

3 units

NJ

Plasma Frozen within 24 hours (FP24). Recall # B-1201-10

Unit: 003LM38428

The American National Red Cross - Southern Region, Douglasville, GA, by email,

fax and letter on October 20, 2009. Firm initiated recall is complete.

Blood product, collected from a donor whose suitability to donate was not adequately

determined, was distributed.

1 unit

AL, GA

1) Red Blood Cells Leukocytes Reduced. Recall # B-1202-10;

2) Liquid Plasma. Recall # B-1203-10;

3) Platelets. Recall # B-1204-10;

4) Source Leukocytes. Recall # B-1205-10

1) Unit: W046609273704;

2), 3) and 4) Unit: W044609273704

Gulf Coast Regional Blood Center, Houston, TX, by fax on August 18 and 21, 2009.

Firm initiated recall is complete.

Blood products, collected from a donor who was previously deferred, were

distributed.

4 units

TX, NJ

1) Red Blood Cells Leukocytes Reduced. Recall # B-1207-10;

2) Fresh Frozen Plasma. Recall # B-1208-10

1) and 2) Units: R41826, R33828, R32312

Blood Center of Northcentral Wisconsin, Inc., Wausau, WI, by e-mail on December

1, 2009 and by letter dated December 3, 2009. Firm initiated recall is complete.

Blood products, collected from a donor taking the medication Avodart, were

distributed.

6 units

WI

Source Plasma. Recall # B-1214-10

Units: SS0016801; SS0017094; SS0017873; SS0018201; SS0018653; SS0018896;

SS0021917

DCI Biologicals San Marcos, LLC, San Marcos, TX, by fax on September 15, 2009

and e-mail on January 22, 2010. Firm initiated recall is complete.

Blood products, collected from a donor with high risk behavior, were distributed

7 units

CA

1) Red Blood Cells. Recall # B-1220-10;

2) Fresh Frozen Plasma. Recall # B-1221-10

1) and 2) Unit: W001306014125

Recalling Firm: Department of the Air Force, Lackland AFB, TX, by fax on April 27,

2007.

Manufacturer: Department of Air Force - BB/HT, Lackland AFB, TX. Firm initiated

recall is complete.

Blood products, collected from a donor considered to be at increased risk for variant

Creutzfeldt-Jakob Disease (vCJD), were distributed.

2 units

TX, NJ

1) Red Blood Cells. Recall # B-1224-10;

2) Platelets Leukocytes Reduced, Recall # B-1225-10

1) Units: 16GR41674, 16KS09109;

2) Unit: 16GR41674

Recalling Firm: The American National Red Cross, Central Ohio Region, Columbus,

OH, by telephone on June 3, 2008 and by follow-up letter on June 6, 2008.

Manufacturer: American Red Cross Blood Services, Central Ohio Region, Columbus,

OH. Firm initiated recall is complete.

Blood products, collected from a donor who reported travel to a malarial endemic

area, were distributed.

3 units

OH

Red Blood Cells Leukocytes Reduced. Recall # B-1231-10

Unit: 03LC47771

The American National Red Cross - Southern Region, Douglasville, GA, by facsimile

on October 6, 2009 and by letter dated October 6, 2009. Firm initiated recall is

complete.

Blood product, collected from a donor for whom donor suitability was not adequately

determined, was distributed.

1 unit

GA

Red Blood Cells Leukocytes Reduced. Recall # B-1233-10

Unit: 003K45761

The American National Red Cross - Southern Region, Douglasville, GA, by facsimile

July 16, 2009 and July 17, 2009 and by letters dated July 16, 2009 and July 17,

2009. Firm initiated recall is complete.

Blood product, collected from a donor for whom donor suitability was not adequately

determined, was distributed.

1 unit

AL, GA

Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1234-10

Unit: 004GK99276

ARC Blood Services, New England Region, Dedham, MA, by facsimile on January 3,

2008 and April 2, 2008. Firm initiated recall is complete.

21

Blood product, which tested positive for syphilis on an invalidated test run, was

distributed

1 unit

NY

Red Blood Cells Leukocytes Reduced. Recall # B-1236-10

Unit: 17KW89860

Recalling Firm: The American National Red Cross, Saint Paul, MN, by letter dated

December 9, 2005 or by electronic notification on December 9, 2005.

Manufacturer: The American National Red Cross - North Central Region, Saint Paul,

MN. Firm initiated recall is complete.

Blood product, collected from a donor who received an accidental needle stick, was

distributed.

1 unit

PA, IL

1) Red Blood Cells. Recall # B-1240-10;

2) Recovered Plasma. Recall # B-1241-10

1) and 2) Unit: 1186066

South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on August 28,

2008 and September 10, 2008. Firm initiated recall is complete.

Blood products, collected from a donor with a history of hepatitis, were distributed

2 units

FL, TX

Fresh Frozen Plasma. Recall # B-1194-10

Unit: W042209010004F

Blood Systems, Inc., Las Vegas, NV, by email on March 05, 2009. Firm initiated

recall is complete.

Blood component, processed from Whole Blood more than 8 hours after collection,

was distributed.

1 unit

NV

Source Plasma. Recall # B-1196-10

Units: 368104648, 368103237, 368102784, 368100746, 368096348

Talecris Plasma Resources Inc dba International BioResources. Glendale, AZ, by fax

on April 23, 2009. Firm initiated recall is complete.

Blood products, collected from a donor who was deferred due to receiving a piercing

within 12 months of donating, were distributed.

5 units

NC

Source Plasma. Recall # B-1197-10

Units: 3600009626, 3600000488, 3600000057, 3600028843, 3600011893,

3600000370, 3600033900, 3600038873, 3600048974, 3600043274, 3600042938,

3600038356, 3600032026, 3600003587, 3600003128, 3600031025, 3600027214

Talecris Plasma Resources, Canton, OH, by fax on April 16, 2009. Firm initiated

recall is complete.

Blood products, collected from a donor whose suitability to donate was not

adequately determined, were distributed.

17 units

NC

Source Plasma. Recall # B-1198-10

Units: 3990013152, 3990020951, 3990022567, 3990022929, 3990023228,

3990023965, 3990024345, 3990024809, 3990025212, 3990025668, 3990026864,

3990027216, 3990027527, 3990028198, 3990028545, 3990028726

International BioResources LLC, Columbus, OH, by fax on May 29, 2009 and June

1, 2009. Firm initiated recall is complete.

Blood products, collected from a donor whose suitability to donate was not

adequately determined, were distributed.

16 units

NC

Source Plasma. Recall # B-1226-10

Units: ST1011282; ST1011801

Stillwater Plasma Center, LLC, Stillwater, OK, by fax on November 24, 2009 and email

on February 4, 2010. Firm initiated recall is complete.

Blood products, collected from a donor possibly at increased risk for variant

Creutzfeldt-Jakob Disease (vCJD), were distributed.

2 units

CA

Source Plasma. Recall # B-1235-10

Units: 3920008149, 3920009137, 3920009990, 3920010735, 3920011176,

3920011523, 3920010140, 3920010705, 3920010220, 3920010899, 3920008314,

3920008587, 3920008978, 3920009154, 3920011115, 3920008818, 3920010372,

3920011170, 3920007632, 3920007925, 3920008127, 3920009107, 3920007203,

3920008363, 3920007721, 3920007853, 3920008318, 3920008996, 3920011129,

3920009101, 3920010150, 3920010673, 3920011570, 3920011110, 3920007923,

3920008224, 3920009556, 3920009796, 3920010802, 3920007292, 3920007178,

3920007655, 3920007929, 3920007584, 3920010078, 3920010422, 3920011531,

3920007208, 3920008178, 3920010176, 3920011284, 3920008670, 3920008815,

3920009146, 3920008004, 3920007518, 3920007125, 3920007586, 3920007750,

3920009979, 3920010328, 3920010960, 3920011496, 3920007955, 3920008444,

3920009149, 3920009953, 3920007625, 3920007902, 3920009447, 3920010712,

3920008182, 3920008159, 3920009170, 3920009425, 3920009640, 3920009151,

3920009481, 3920008295, 3920008769, 3920010332, 3920011577, 3920008999,

3920010189, 3920010927, 3920007106, 3920007278, 3920009891, 3920009233,

3920010107, 3920011185, 3920007022, 3920008312, 3920007607, 3920008247,

3920008758, 3920010415, 3920010720, 3920011149, 3920010191, 3920010473,

3920007663, 3920007086, 3920008827, 3920009800, 3920008568, 3920008949,

3920009812, 3920010129, 3920010378, 3920010901, 3920011155, 3920008442,

3920010425, 3920011272, 3920010097, 3920007855, 3920008523, 3920010267,

3920008345, 3920008536, 3920010747, 3920007273, 3920007770, 3920008503,

3920008851, 3920009029, 3920010426, 3920007163, 3920007524, 3920008814,

3920009726, 3920009856, 3920010933, 3920011485, 3920009191, 3920010418,

3920010764, 3920009999, 3920010201, 3920007716, 3920008231, 3920008386,

3920008805, 3920009835, 3920010364, 3920011169, 3920007542, 3920008269,

3920009519, 3920010036, 3920010261, 3920008782, 3920009580, 3920010446,

3920010968, 3920008398, 3920007778, 3920008725, 3920008834, 3920008963,

3920010375, 3920010895, 3920008430, 3920010386, 3920007952, 3920009034,

3920008802, 3920008158, 3920007089, 3920008678, 3920009074, 3920010387,

3920011270, 3920010293, 3920007680, 3920009291, 3920006972, 3920008797,

3920008984, 3920009500, 3920010026, 3920010402, 3920011112, 3920009526,

3920010346, 3920007836, 3920010224, 3920008505, 3920008730, 3920008982,

3920009166, 3920010352, 3920008453, 3920008844, 3920010132, 3920011188,

3920010965, 3920007120, 3920008772, 3920009562, 3920009799, 3920010797,

3920009616, 3920009929, 3920010055, 3920010995, 3920010102, 3920008125,

3920008392, 3920009104, 3920010684, 3920011240, 3920007098, 3920008500,

3920007912, 3920008123, 3920009505, 3920010067, 3920010384, 3920010748,

3920007032, 3920007303, 3920008238, 3920008989, 3920007059, 3920007943,

3920007961, 3920010853, 3920006939, 3920007522, 3920007775, 3920008010,

3920008753, 3920009095, 3920010196, 3920007673, 3920008190, 3920008639,

3920009142, 3920009439, 3920007920, 3920008625, 3920009122, 3920009944,

3920007000, 3920008355, 3920008602, 3920010158, 3920010946, 3920011494,

3920011163, 3920010270, 3920011131, 3920009512, 3920008565, 3920009065,

3920010350, 3920011187, 3920007063, 3920008494, 3920008986, 3920009941,

3920010766, 3920007555, 3920010399, 3920010778, 3920008510, 3920009207 and

3920010769

Recalling Firm: Talecris Plasma Resources Inc, Research Triangle Park, NC, by facsimile and letter

between February 17, 2009 and February 27, 2009.

Manufacturer: Talecris Plasma Resources Inc., Rockford, IL. Firm initiated recall is complete.

Blood products, collected from a donor in which donor suitability was not adequately determined,

were distributed.

270 units

NC

Recovered Plasma. Recall # B-1237-10

Unit: 17KW89860

Recalling Firm: The American National Red Cross, Saint Paul, MN, by letter dated December 9,

2005 or by electronic notification on December 9, 2005.

Manufacturer: The American National Red Cross - North Central Region, Saint Paul, MN. Firm

22

initiated recall is complete.

Blood product, collected from a donor who received an accidental needle stick, was distributed.

1 unit

PA, IL

Source Plasma. Recall # B-1242-10

Units: 355034328, 355038068, 355037506, 355034047, 355035400,

355036992, 355034748, 355037509, 355036344, 355034660, 355034049,

355035378, 355035987, 355036600, 355036869, 355038264, 355033763,

355034152, 355035424, 355034420, 355034011, 355034290, 355035689,

355036221, 355037951, 355034066, 355033877, 355036700, 355034213,

355034078, 355034104, 355034436, 355037817, 355038021, 355035933,

355034056, 355034261, 355036710, 355037648, 355034482, 355038011,

355033838, 355033888, 355034315, 355034429, 355035362, 355036110,

355034931, 355034338, 355035465, 355035786, 355036335, 355037644,

355034597, 355035712, 355034729, 355033863, 355036362, 355036072,

355038632, 355034050, 355033835, 355035945, 355034806, 355038194,

355036840, 355035357, 355036402, 355034440, 355034340, 355034662,

355038186, 355034741, 355035947, 355038074, 355037975, 355036071,

355035562, 355035708, 355036321, 355036487, 355035755, 355034718,

355037996, 355038210, 355036532, 355036557, 355034477, 355035590,

355036049, 355036632, 355037735, 355034027, 355034273, 355036235,

355036834, 355035989, 355035549, 355034025, 355034588, 355036964,

355038160, 355034802, 355035365, 355034836, 355036005, 355036431,

355036931, 355036387, 355037596, 355035484, 355034989, 355035545,

355035859, 355035489, 355035734, 355035917, 355035149, 355038071,

355034180, 355033419, 355035701, 355035888, 355034592, 355035004,

355035564, 355035960, 355034371, 355037656, 355034785, 355035963,

355038183, 355036680, 355036281, 355036922, 355038229, 355034678,

355036928, 355035892, 355037550, 355035577, 355037763, 355034271,

355036694, 355034307, 355037586, 355033800, 355035407, 355033884,

355036461, 355037815, 355035984, 355035823, 355035482, 355036035,

355036613, 355036541, 355037675, 355038052, 355038624, 355037652,

355034022, 355038215, 355035986, 355035569, 355033844, 355029700,

355027624, 355023355, 355023897, 355024461, 355024932, 355025431,

355025642, 355026640, 355027187, 355027308, 355028462, 355027767,

355029605, 355024720, 355025378, 355025077, 355025333, 355029640,

355029616, 355021312, 355021396, 355025415, 355025617, 355025909,

355026906, 355027411, 355028682, 355029001, 355026422, 355028987,

355029224, 355023771, 355025029, 355026720, 355027217, 355028783,

355029595, 355025323, 355027132, 355028444, 355023770, 355025169,

355027851, 355025446, 355026897, 355028670, 355028842, 355029293,

355027947, 355027574, 355026480, 355026985, 355026657, 355023375,

355027888, 355027824, 355026913, 355028219, 355028944, 355029317,

355030033, 355023265, 355023840, 355025350, 355026153, 355026646,

355029250, 355024359, 355026326, 355026509, 355027029, 355023340,

355026678, 355027228, 355028227, 355027599, 355025917, 355027892,

355029735, 355023212, 355023669, 355024412, 355025276, 355027446,

355028661, 355025014, 355028033, 355027536, 355023419, 355023835,

355025000, 355023698, 355025355, 355025659, 355026361, 355026629,

355028812, 355023956, 355024676, 355024986, 355026240, 355028875,

355024236, 355023851, 355024838, 355025334, 355023131, 355023742,

355024700, 355025505, 355028006, 355028291, 355029074, 355029411,

355027815, 355027849, 355027674, 355027453, 355026462, 355028903,

355025318, 355029002, 355021438, 355027956, 355027435, 355028461,

355028821, 355029079, 355027680, 355026632, 355029378, 355027808,

355027826, 355026948, 355027311, 355028549, 355029706, 355023394,

355024767, 355025416, 355025929, 355028018, 355028466, 355029472,

355027843, 355023301, 355028179, 355024453, 355027854, 355023256,

355023426, 355024372, 355024911, 355023600, 355024018, 355024524,

355027317, 355029593, 355027544, 355021462, 355024806, 355025104,

355026506, 355028248, 355027946, 355023094, 355023096, 355023114,

355023342, 355027405, 355023527, 355024296, 355024460, 355024943,

355026344, 355027358, 355027419, 355029478, 355030124, 355023693,

355024382, 355024769, 355021349, 355024325, 355024418, 355029326,

355030065, 355023480, 355024483, 355024647, 355029569, 355026231,

355026731, 355028257, 355027575, 355024238, 355024709, 355024304,

355028020, 355028395, 355025398, 355030099, 355021435, 355025140,

355027006, 355028354, 355025002, 355029708, 355029731, 355024284,

355025087, 355026915, 355028210, 355026269, 355027834, 355026991,

355027461, 355028281, 355028808, 355027972, 355023105, 355023874,

355024935, 355025887, 355030097, 355023740, 355024528, 355026983,

355027270, 355028883, 355023556, 355023690, 355024746, 355025042,

355026260, 355028140, 355026625, 355028131, 355021310, 355021481,

355024518, 355025358, 355025405, 355025908, 355026155, 355026283,

355024021, 355024793, 355025079, 355025465, 355026137, 355029707,

355027847, 355023893, 355025427, 355027363, 355027466, 355028907,

355029613, 355030044, 355021493, 355025968, 355028455, 355027918,

355027352, 355023553, 355025675, 355025993, 355021460, 355027920,

355027991, 355025484, 355026117, 355021282, 355024803, 355023328,

355028379, 355029314, 355029730, 355023550, 355024476, 355026907,

355023088, 355024496, 355024975, 355025943, 355026245, 355028266,

355028489, 355028796, 355029046, 355023345, 355023784, 355024473,

355023320, 355027412, 355029010, 355029008, 355027541, 355025013,

355025338, 355025991, 355026345, 355029499, 355027535, 355027871,

355024744, 355025291, 355023838, 355024799, 355025407, 355027840,

355027464, 355023545, 355023875, 355023818, 355023531, 355021385,

355026616, 355023767, 355023349, 355027115, 355029743, 355030122,

355025947, 355026753, 355026988, 355028497, 355029064, 355029383,

355023990, 355024290, 355024762, 355026740, 355027643, 355027688,

355023318, 355023810, 355023919, 355024433, 355026215, 355027211,

355028234, 355027831, 355027244, 355028008, 355028274, 355029257,

355027576, 355027609, 355026439, 355027168, 355028373, 355021371,

355023772, 355024022, 355024293, 355024779, 355029559, 355030084,

355021498, 355026677, 355027654, 355027709, 355027593, 355027612,

355027154, 355023262, 355024407, 355025332, 355028003, 355028518,

355028825, 355029068, 355027868, 355023800, 355023982, 355028523,

355028814, 355029060, 355029379, 355027229, 355029698, 355027836,

355027258, 355028742, 355028918, 355027027, 355029421, 355027711,

355027484, 355024745, 355025041, 355028236, 355029015, 355030078,

355027965, 355027988, 355028994, 355028970, 355027925, 355024914,

355026729, 355027224, 355026770, 355027994, 355027844, 355028127,

355023107, 355029713, 355025187, 355026308, 355026715, 355028196,

355028377, 355028747, 355029354, 355023115, 355023734, 355024832,

355025679, 355026171, 355028371, 355030029, 355030127, 355029555,

355025182, 355024834, 355026612, 355029298, 355030100, 355023424,

355023476, 355023958, 355024517, 355025513, 355025686, 355023409,

355027855, 355021360, 355029738, 355028334, 355028858, 355025460,

355025976, 355026273, 355027480, 355028214, 355030121, 355024265,

355024442, 355024650, 355029403, 355025940, 355026467, 355023995,

355024851, 355023117, 355023599, 355026213, 355028778, 355024738,

355021362, 355029543, 355029037, 355023980, 355027530, 355025108,

355025290, 355023541, 355026445, 355028343, 355030086, 355023587,

355023884, 355025980, 355026109, 355027232, 355023352, 355029302,

355026778, 355023985, 355028822, 355027648, 355027583, 355025690,

355027204, 355023108, 355023347, 355027265, 355028479, 355029005,

355023686, 355024363, 355026256, 355028160, 355023244, 355027415,

355029056, 355023386, 355026672, 355027297, 355025693, 355029460,

355028719, 355028878, 355029267, 355024853, 355026411, 355026622,

355029364, 355027802, 355024394, 355024498, 355025977, 355026468,

355026947, 355028468, 355028313, 355026290, 355027023, 355028270,

355028847, 355023327, 355023764, 355026233, 355024952, 355024489,

355024640, 355025923, 355027350, 355023815, 355024395, 355025084,

355026275, 355027371, 355028393, 355023216, 355023412, 355024811,

355025115, 355025651, 355026097, 355024500, 355025625, 355026758,

355028284, 355027685, 355026263, 355026767, 355027159, 355027483,

355027454, 355027633, 355024670, 355023338, 355024318, 355024942,

355021466, 355024440, 355024921, 355025129, 355023307, 355022592,

355023890, 355024025, 355024404, 355023312, 355023464, 355023855,

355024365, 355024680, 355025317, 355026685, 355024447, 355026324,

355026696, 355023123, 355023728, 355023865, 355024996, 355025315,

355025489, 355026166, 355026315, 355026680, 355027143, 355028200,

355028715, 355023099, 355025293, 355023360, 355027032, 355027129,

355028517, 355023944, 355023752, 355027476, 355028442, 355028743,

355028993, 355030119, 355029241, 355027772, 355027683, 355027180,

355028387, 355030118, 355029629, 355029601, 355027919, 355029349,

355025184, 355024288, 355021404, 355028431, 355029218, 355030088,

355023474, 355025981, 355028030, 355025075, 355028132, 355028973,

355029365, 355024652, 355024883, 355025145, 355030019, 355027316,

355028158, 355024491, 355026168, 355025311, 355021444, 355027838,

355028978, 355027246, 355027845, 355027996, 355029030, 355030135,

355028687, 355028198, 355026320, 355024980, 355023533, 355023401,

355023087, 355023368, 355023579, 355023802, 355023983, 355024509,

355024843, 355024977, 355025480, 355025983, 355026331, 355027041,

355028526, 355029115, 355030040, 355025353, 355026761, 355023581,

355024397, 355024885, 355025105, 355026182, 355026369, 355027197,

355028416, 355028949, 355021314, 355021350, 355024003, 355025438,

355027376, 355028324, 355026338, 355028829, 355029408, 355027644,

355026252, 355028293, 355029373, 355024299, 355025492, 355026247,

355028561, 355023290, 355023125, 355023814, 355024292, 355029385,

355023364, 355029621, 355029652, 355030104, 355023809, 355025386,

355025875, 355021477, 355021476, 355025424, 355029078, 355029259

Talecris Plasma Resources, Inc., Bloomington, IL, facsimile and letter between

February 25, 2008 and March 18, 2008. Firm initiated recall is complete.

Blood products collected donors whose suitability determination were inadequately

performed, were distributed.

875 units

NC

__________________________________

May 26

__________________________________

Source Plasma. Recall # B-0678-10

Units: 0530606664, 0530605663, 0530604648, 0530607381

CSL Plasma, Lexington, KY, by letters dated September 3, 2009. Firm initiated recall

is complete.

Source Plasma, collected from a donor with an expired physical, was distributed.

4 units

Switzerland, IL

Red Blood Cells Leukocytes Reduced. Recall # B-1154-10

Units: 157038222, 157039083, 157046855, 157047230

Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by telephone on March 23,

2007 or by letter dated July 25, 2007.

Manufacturer: Blood Systems, Inc - Lubbock Center, Lubbock, TX. Firm initiated

recall is complete.

Blood products, collected from donors whose hemoglobin determinations were

performed incorrectly, were distributed.

4 units

23

NM, TX

1) Red Blood Cells Leukocytes Reduced. Recall # B-1245-10;

2) Plasma Frozen. Recall # B-1246-10

1) and 2) Unit: W053309800279

Community Blood Center, Inc., Appleton, WI, by letter dated December 9, 2009 and

by e-mail on December 9, 2009. Firm initiated recall is complete.

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob

Disease (vCJD), were distributed.

2 units

Switzerland, WI

1) Recovered Plasma. Recall # B-1248-10;

2) Red Blood Cells. Recall # B-1249-10;

3) Platelets Pooled Leukocytes Reduced. Recall # 1250-10

1) and 2) Unit: W120609243337;

3) Unit: W-120609383496

Recalling Firm: Michigan Community Blood Centers, Saginaw, MI, by facsimile on

December 23, 2009.

Manufacturer: Michigan Community Blood Centers, Midland, MI. Firm initiated recall

is complete.

Blood products, collected from a donor who resided in an area considered at risk for

human immunodeficiency virus (HIV) Group O, were distributed.

3 units

Switzerland, MI

Source Plasma. Recall # B-1260-10

Unit: 0360131077

Biomat USA, Inc., South Bend, IN, by letter dated December 7, 2007. Firm initiated

recall is complete.

Blood product, which was not tested for viral markers, was distributed.

1 unit

Spain

1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1268-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1269-10

1) Units: W091009175131 (2 units), 7879207 (2 units);

2) Unit: 7454100

Oklahoma Blood Institute, Sylvan N Goldman Center, Oklahoma City, OK, by

facsimile on January 8, 2010 and January 11, 2010. Firm initiated recall is complete.

Blood products, collected from a donor who was previously deferred for testing

positive for the human immunodeficiency virus (HIV), were distributed.

5 units

IN, OK

1) Red Blood Cells Leukocytes Reduced. Recall # B-1271-10;

2) Recovered Plasma. Recall # B-1272-10

1) and 2) Unit: W142808306794

Tri-Counties Blood Bank, San Luis Obispo, CA, by telephone on January 12, 2010

and by letter dated February 8, 2010. Firm initiated recall is complete.

Blood products, collected from a donor who previously tested positive for Hepatitis C,

were distributed.

2 units

Switzerland, CA

1) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1279-10;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1280-10;

3) Plasma Frozen. Recall # B-1281-10

1) Units: 151704474 (part 1); 151704474 (part 2);151704482 (part 1); 151704482

(part 2); 151704483 (part 1); 151704483 (part 2); 151704487 (part 1); and

151704487 (part 2);

2)Units:151704472;151704473;151704481;151704469;151704476;151704478;1517

04479;151704480;151704484;151704485;151704490;

3) Unit: 151704480

Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by facsimile on October 4,

2007.

Manufacturer: Blood Systems, Inc - Lubbock Center, Lubbock, TX. Firm initiated

recall is complete.

Blood product, lacking assurance of having been maintained at an acceptable

temperature during shipping, was distributed.

20 units

TX

1) Red Blood Cells Leukocytes Reduced. Recall # B-1288-10;

2) Recovered Plasma. Recall # B-1289-10;

3) Cryoprecipitated AHF. Recall # B-1290-10

1), 2), and 3) Unit: W149509908890

Northern California Community Blood Bank, Eureka, CA, by fax and e-mail on

October 23, 2009. Firm initiated recall is complete.

Blood products, collected from a donor considered to be at increased risk for variant

Creutzfeldt-Jakob Disease (vCJD), were distributed.

3 units

Austria, CA

Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1309-10

Units: W036809306420A; W036809306420C

Community Blood Centers/S Florida, Inc., Lauderhill, FL, by telephone on September

4, 2009. Firm initiated recall is complete.

Blood products, which did not meet QC specifications for pH, were distributed.

2 units

FL

1) Liquid Plasma. Recall # B-1373-10;

2) Red Blood Cells. Recall # B-1374-10;

3) Fresh Frozen Plasma. Recall # B-1375-10

1) Units: W001708005659, W001708005630;

2) Units: W001708005630, W001708005631, W001708005632, W001708005636,

W001708005639, W001708005640, W001708005641, W001708005642,

W001708005643, W001708005644, W001708005645, W001708005649,

W001708005650, W001708005652, W001708005653, W001708005654,

W001708005655, W001708005656, W001708005658, W001708005660;

3) Units: W001708005631, W001708005632, W001708005633, W001708005639,

W001708005640, W001708005641, W001708005642, W001708005644,

W001708005646, W001708005648, W001708005652, W001708005653,

W001708005654, W001708005655, W001708005660

Department AF 81st Med. Group/SGSC Keesler AFB MC Blood Bank, Keesler AFB,

MS, by telephone and facsimile on November 25, 2008 and by letter dated

November 25, 2008. Firm initiated recall is complete.

Blood products, which were incorrectly tested for viral markers, were distributed.

37 units

NJ, LA, FL, D.C.

1) Red Blood Cells Leukocytes Reduced. Recall # B-1266-10;

2) Platelets Pheresis Leukocytes Reduced. Recall # B-1267-10

1) Units: W040709178309, W040709334574;

2) Units: W040709681421 (2 units)

Indiana Blood Center, Indianapolis, IN, by telephone on November 10, 2009. Firm

initiated recall is complete.

24

Blood products, which were incorrectly test for human T-lymphotropic virus types I &

II (anti-HTLV-I/II), were distributed.

4 units

IN

Recovered Plasma. Recall # B-1270-10

Unit: 7454100

Oklahoma Blood Institute, Sylvan N Goldman Center, Oklahoma City, OK, by

facsimile on January 8, 2010 and January 11, 2010. Firm initiated recall is complete.

Blood product, collected from a donor who was previously deferred for testing

positive for the human immunodeficiency virus (HIV), was distributed.

1 unit

IN, OK

_______________________

June 2

_______________________

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0349-10

Unit: 024FF07722 (2 units)

American Red Cross Blood Services, Saint Louis, MO, by telephone on December

15, 2008 and by letters dated January 15, 2009 and April 20, 2009. Firm initiated

recall is complete.

Blood products, for which quality control testing was not performed, were distributed.

2 units

KY

Source Plasma. Recall # B-0530-10

Units: 6120217900, 6120217310, 6120219544

CSL Plasma, Inc., Columbia, SC, by, letter on March 17, 2009. Firm initiated recall is

complete.

Blood products, for which physical examination was undocumented, were distributed.

3 units

Switzerland; IL

Source Plasma. Recall # B-1324-10

Units: TA2002497; TA2002724; TA2003225; TA2004361; TA2143790; TA2144131;

TA2145043; TA2145477; TA2146044; TA2146285; TA2146888; TA2147459;

TA2148579

DCI Biologicals Texarkana LLC, Texarkana, AR, by fax, letter and e-mail on July 17,

2008. Firm initiated recall is complete.

Blood products, collected from a donor with high risk behavior, were distributed.

13 units

NC, England

1) Red Blood Cells Leukocytes Reduced. Recall # B-1328-10;

2) Plasma Frozen. Recall # B-1329-10

1) and 2) Unit: W117009320905

Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by

telephone on January 22, 2010 and by letter dated January 22, 2010.

Manufacturer: Blood Centers of The Pacific - North Bay Center, Fairfield, CA. Firm

initiated recall is complete.

Blood products, collected from a donor with a history of hepatitis A, were distributed.

2 units

CA

1) Red Blood Cells. Recall # B-1335-10;

2) Plasma Frozen within 24 hours (FP24). Recall # B-1336-10

1) Units: KL26509, W088609300606, W088609303912;

2) Units: KL26509, W088609303912

Providence Health System Southern California, Burbank, CA, by letter dated January

13, 2010. Firm initiated recall is complete.

Blood products, collected from a donor who was previously deferred for high risk

behavior, were distributed.

5 units

CA

PRODUCT

Source Plasma. Recall # B-1344-10

Units: 0360038200, 0360034032, 0360032192, 0360031470, 0360030857,

0360030527, 030028617, 0360028249, 0360027393 and 0360027156

Biomat USA, Inc., South Bend, IN, by letter dated July 3, 2007. Firm initiated recall

is complete.

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob

Disease (vCJD), were distributed.

10 units

Spain

Source Plasma. Recall # B-1349-10

Unit: 09MMTH7388

BioLife Plasma Services, L.P., Missoula, MT, by facsimile on January 8, 2010. Firm

initiated recall is complete.

Blood product, collected from a donor who had not had an annual physical

performed, was distributed.

1 unit

CA

1) Red Blood Cells Leukocytes Reduced. Recall # B-1356-10;

2) Recovered Plasma. Recall # B-1357-10

1) and 2) Unit: 016KG36090

American Red Cross Blood Services, Central Ohio Region, Columbus, OH, by

telephone on August 18, 2009 and by electronic notification on August 19, 2009.

Firm initiated recall is complete.

Blood products, which were not quarantined after receiving post donation information

concerning an illness following donation, were distributed.

2 units

OH, CA

Red Blood Cells Leukocytes Reduced. Recall # B-1364-10

Unit: W090709018777

Blood Bank Of The Redwoods, Santa Rosa, CA, by facsimile and electronic

notification on August 13, 2009. Firm initiated recall is complete.

Blood product, collected from a donor who was previously deferred for testing

positive for the human immunodeficiency virus (HIV), was distributed.

1 unit

Switzerland and CA

__________________

Red Blood Cells Leukocytes Reduced. Recall # B-1333-10

Unit: W142809405927, W142809405931, W142809405924, W142809405925,

W142809405922, W142809405939

Recalling Firm: Tri-Counties Blood Bank dba UBS- Central Coast, Santa

Barbara, CA, by telephone on December 1, 2009.

Manufacturer: Tri-Counties Blood Bank dba Community Blood Bank, Inc., Rancho

Mirage, CA. Firm initiated recall is complete.

Blood products, which were incorrectly labeled as being collected from volunteer

25

donors, were distributed.

6 units

CA

Recovered Plasma. Recall # Recall # B-1365-10

Unit: W090709018777

Blood Bank Of The Redwoods, Santa Rosa, CA, by facsimile and electronic

notification on August 13, 2009. Firm initiated recall is complete.

Blood product, collected from a donor who was previously deferred for testing

positive for the human immunodeficiency virus (HIV), was distributed.

1 unit

Switzerland and CA

Recovered Plasma. Recall # B-1367-10

Unit: 6312464

South Texas Blood & Tissue Center, San Antonio, TX, by facsimile on October 1,

2009. Firm initiated recall is complete.

Blood product, collected from a donor who was taking the medication finasteride,

was distributed.

1 unit

Austria, TX

_________________________________________

June 9

1) Cryoprecipitated AHF, Pooled. Recall # B-0952-10;

2) Recovered Plasma. Recall # B-0953-10

Unit: W036309244038X

Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on June 28,

2009.

Manufacturer: BloodCenter of Wisconsin, Inc., Brown Deer, WI. Firm initiated recall

is complete.

Blood products, collected from a donor considered to be at increased risk for variant

Creutzfeldt-Jakob Disease (vCJD), were distributed.

2 units

WI, Switzerland

___________________________________

June 16

Red Blood Cells Leukocytes Reduced. Recall # B-1393-10

Units: 238852, 2439038, 2455159, 2499047

Central Kentucky Blood Center Inc., Lexington, KY, by letter on February 23, 2010.

Firm initiated recall is complete.

Blood products, which were collected from a donor who had traveled to a malarial

endemic area, were distributed.

4 units

KY

1) Red Blood Cells. Recall # B-1408-10;

2) Fresh Frozen Plasma. Recall # B-1409-10

1) and 2) Unit: 6136713

Hemacare Corp., Van Nuys, CA, by letter dated January 22, 2010. Firm initiated

recall is complete.

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob

Disease (vCJD), were distributed.

2 units

CA

Source Plasma. Recall # B-1429-10

Units:

I56009010, I56008001, I56013568, I56013220, I56013070, I56014727,

I56014536, I56012710, I56012406,

I56012202, I56011624, I56011538, I56010643, I56010603, I56010081,

I56009601, I56009421, I56009163, 392024806, 392024519, 392024360,

392023993, 392023885, 392023528, 392023302, 392023025, 392022863,

392022497, 392022309, 392022055, 392021901, 392021628, 392021438,

392020289, 392020152, 392019787, 392019536, 392019354, 392019045,

392018894, 392018605, 392018502, 392018181, 392017941, 392017713,

392017543, 392017310, 392016846, 392016698, 392016353, 392016190,

392015892, 392015684, 392015443, 392015300, 392014971, 392014887,

392014474, 392014367, 392013471, 392013288, 392012960, 392012794,

392012569, 392012368, 392012034, 392011306, 392010624, 392011896,

392010184, 392010022, 392009293, 392008544, 392008340, 392007488,

392007312, 392007029, 392006423, 392006114, 392002497, 392002254,

392002087, 392001836, 392001729, 392001459, 392001325, 392001123,

392000963, 392000739, 392000576, I56024163, I56024048, I56023511,

I56023407, I56023247, I56023130, I56022945, I56022832, I56022613, I56021894,

I56021805, I56021598, I56021541, I56021369, I56021266, I56021106,

I56020827, I56020729, I56020361, I56020168, I56019995, I56019837, I56019618,

I56019423, I56019365, I56019172, I56019129, I56018840, I56018751,

I56018595, I56018515, I56018300, I56018049, I56017918, I56017753,

I56015596, I56015529 and I56014261

Recalling Firm: Talecris Plasma Resources Inc., Research Triangle Park, NC, by fax

on April 24, 2008.

Manufacturer: Talecris Plasma Resources Inc., Rockford, IL. Firm initiated recall is

complete

Blood products, collected from a donor who was previously permanently deferred,

were distributed.

128 units

NC and Austria

__________________________

Source Plasma. Recall # B-1486-10

Units: 4920198227, 4920196062, 4920195831, 4920194386, 4920193638,

4920192943, 4920191433, 4920191141, 4920189989, 4920189137, 4920188652,

4920187523, 4920187285, 4920185930, 4920185134, 4920183956, 4920180532,

4920180153, 4920178805, 4920178007, 4920177050, 4920176808, 4920175479,

4920174944, 4920169659, 4920168711, 4920168121, 4920167283, 4920165983,

4920165243, 4920163932, 4920163439, 4920162391, 4920162154, 4920161170,

4920160166, 4920159830, 4920158652, 4920158163, 4920157419, 4920157098

Recalling Firm: CSL Plasma. Boca Raton, FL, by email on June 25, 2009.

Manufacturer: CSL Plasma, Springfield, OH. Firm initiated recall is complete.

Blood products, collected using an abbreviated screening process for which the

donor was not eligible, were distributed.

41 units

IL, Germany, Switzerland

Source Plasma. Recall # B-1496-10

Unit: 4030250588

Recalling Firm: ZLB Bioplasma Inc., Boca Raton, FL, by email on July 11, 2008.

Manufacturer: ZLB Bioplasma Inc., Louisville, KY. Firm initiated recall is complete.

Blood product, untested for Hepatitis B surface antigen (HBsAg), and the antibodies

to the human immunodeficiency virus type 1/2 (anti-HIV-1/2), Hepatitis C virus

encoded antigen (anti-HCV), Hepatitis B core antigen (anti-HBc), and Syphilis, was

distributed.

1 unit

IL

____________________________

June 23

Source Plasma. Recall # B-1443-10

Units: 05ANCB2927, 05ANCB2106, 05ANCB1986

Plasma Biological Services, Asheville, NC, by facsimile on December 15, 2009. Firm

initiated recall is complete.

26

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob

Disease (vCJD), were distributed.

3 units

CA

Source Plasma. Recall # B-1444-10

Units: 4020414265, 4020412231, 4020411195, 4020384136, 4020382910

CSL Plasma Inc., Akron, OH, by electronic notification on December 12, 2008 and

December 15, 2008. Firm initiated recall is complete.

Blood products, collected from a donor who did not receive a complete physical

examination, were distributed.

5 units

Germany, IL

1) Red Blood Cells. Recall # B-1451-10;

2) Fresh Frozen Plasma. Recall # B-1452-10

1) Units: W227709392471, W227709390798, W227708313034;

2) Units: W227709390798, W227708313034

Mid-South Regional Blood Center, Memphis, TN, by facsimile on October 27, 2009.

Firm initiated recall is complete.

Blood products, collected from a donor with a history of high risk behavior, were

distributed.

5 units

TN

Source Plasma. Recall # B-1453-10

Units: 4590054884, 4590054380, 4590053950, 4590053385, 4590053089,

4590052523, 4590051779, 4590051556, 4590050586, 4590048999

Octapharma Plasma, Inc., Jacksonville, FL, by e-mail on December 23, 2009. Firm

initiated recall is complete.

Blood products, collected from a donor who did not receive a complete physical

examination, were distributed.

10 units

Austria

Cryoprecipitated AHF, Pooled. Recall # B-1458-10

Units: W037909161775, W037909161947, W037909161959, W037909161958,

W037909177533

Blood Center of Iowa, Des Moines, IA, by telephone on February 2, 2010. Firm

initiated recall is complete.

Blood products, which were labeled with extended expiration dates, were distributed.

5 units

WI, IA

Red Blood Cells Leukocytes Reduced. Recall # B-1532-10

Unit: W038109025323

Florida's Blood Centers, Inc., Melbourne, FL, by letter dated February 3, 2010. Firm

initiated recall is complete.

Blood product, which was not tested for HIV/HCV NAT, was distributed.

1 unit

FL

Source Plasma. Recall # B-1445-10

Units: 3260000142, 3260000173, 3260004707, 3260005722

Talecris Plasma Resources Inc., Lake Charles, LA, by facsimile on January 8, 2009.

Firm initiated recall is complete.

Blood products, which reached unacceptable temperatures during storage, were

distributed.

4 units

NC

Source Plasma. Recall # B-1490-10

Units: 4010407937, 4010407906, 4010407944, 4010407922

ZLB Plasma, Cleveland, OH, by letter on August 14, 2009. Firm initiated recall is

complete.

Blood products, collected from a donor whose suitability to donate was not

adequately determined, were distributed.

4 units

IL

____________________________

June 30

Source Plasma. Recall # B-1518-10

Units: TA0009385, TA0009509, TA0009802, TA0009915, TA0010386, TA0010622,

TA0009110

Recalling Firm: DCI Biologicals Texarkana, LLC, Gallup, NM, by letters dated July

24, 2008 and July 28, 2008.

Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR. Firm initiated recall

is complete.

Blood products, collected from a donor who received a tattoo within 12 months of

donation, were distributed.

7 units

NC, Austria

1) Red Blood Cells. Recall # B-1519-10;

2) Fresh Frozen Plasma. Recall # B-1520-10

1) and 2) Unit: 2410916

Community Blood Center, Dayton, OH, by letter dated April 17, 2008. Firm initiated

recall is complete.

Blood products, collected from a donor taking the medication Avodart, were

distributed.

2 units

OH

Source Plasma. Recall # B-1551-10

Units: TA2027243; TA2027466; TA2027967; TA2028589; TA2029646; TA2034008;

TA2034254

DCI Biologicals Texarkana, LLC, Texarkana, AR, by fax, letter and e-mail on

October14, 2008. Firm initiated recall is complete.

Blood products, collected from a donor who failed to answer questions regarding risk

for vCJD, were distributed.

7 units

NC

Source Plasma. Recall # B-1552-10

Units: 392024241, 392024888, 392024736, 392024460, 392023913, 392023630,

392022516, 392022315, 392021477, 392019895, 392019018, 392018776,

392017949, 392017800, 392016873, 392015873, 392015695, 392021266,

392014979, 392014796, 392014513, 392014318, 392014004, 392013315,

392011484, 392011296, 392010995, 392010791, 392011918, 392011746,

392010035, 392009822, 392009567, 392009386, 392009013, 392008696,

392007424, 392007190, 392006837, 392006655, 392003751, 392003669,

I56018212, I56018076, I56017991, I56016744, I56016629, I56016549, I56016464,

I56016382, I56016060, I56015712, I56015693, I56015156, I56015051, I56014305,

27

I56014146, I56013685, I56013373, I56013201, I56012705, I56012233, I56008497

and I56008467

Recalling Firm: Talecris Plasma Resources Inc., Research Triangle Park, NC, by fax

on August 21, 2008.

Manufacturer: Talecris Plasma Resources, Inc., Rockford, IL. Firm initiated recall is

complete.

Blood products, collected from a donor who was previously permanently deferred,

were distributed.

64 units

NC, Austria

Fresh Frozen Plasma. Recall # B-1576-10

Unit: W010407004016

Department of the Army, Brooke Army Medical Center, Fort Sam, Houston, TX, by

fax on October 26, 2007. Firm initiated recall is complete.

Blood product, collected from a donor whose risk for variant Creutzfeldt-Jakob

Disease (vCJD) was undetermined, was distributed.

1 unit

NJ

1) Red Blood Cells Leukocytes Reduced. Recall # B-1595-10;

2) Recovered Plasma. Recall # B-1596-10

1) and 2) Unit: W035209185910Z

Carter BloodCare/ WE & Lela I Stewart Blood Center, Inc., Tyler, TX, by letter dated

March 2, 2010 and by e-mail on March 2, 2010 and March 10, 2010. Firm initiated

recall is complete.

Blood products, collected from a donor who received a blood transfusion within a

year of donation, were distributed.

2 units

TX

1) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-1597-10;

2) Fresh Frozen Plasma. Recall # B-1598-10;

3) Red Blood Cells. Recall # B-1599-10

1) Unit: W120609383914;

2) and 3) Unit: W120609207864

Michigan Blood, Saginaw, MI, by facsimile on February 12, 2010 and February 16,

2010. Firm initiated recall is complete.

Blood products, collected from a donor with a history of exposure to and treatment

for rabies, were distributed.

3 units

MI

1) Red Blood Cells. Recall # B-1603-10;

2) Fresh Frozen Plasma. Recall # B-1604-10;

3) Recovered Plasma. Recall # B-1605-10

1) and 2) Unit: W035409010150;

3) Unit: 3167933

Community Blood Center, Dayton, OH, by telephone and facsimile on February l,

2010. Firm initiated recall is complete.

Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob

Disease (vCJD), were distributed.

3 units

Austria, OH

Platelets Pheresis Leukocytes Reduced. Recall # B-1606-10

Unit: W117010154265 (2 units)

Blood Centers of the Pacific – Irwin Center, San Francisco, CA, by telephone on

February 10, 2010 and by letter dated February 12, 2010. Firm initiated recall is

complete.

Blood products, which were not quarantined after receiving post donation information

concerning an illness following donation, were distributed.

2 units

CA

Platelet Pheresis Leukocytes Reduced. Recall # B-1610-10

Unit: W035410004669 (7 units)

Community Blood Center, Dayton, OH, by telephone on February 18, 2010. Firm

initiated recall is complete.

Blood products, labeled with an extended expiration date, were distributed.

7 units

OH

1) Red Blood Cells Leukocytes Reduced. Recall # B-1613-10;

2) Cryoprecipitated AHF, Pooled. Recall # B-1614-10

1) Unit: W038110054274;

2) Unit: W038110982894

Florida’s Blood Centers – Lake Park, Lake Park, FL, by telephone on February 17,

2010 and March 12, 2010 and by letters dated February 24, 2010 and March 15,

2010. Firm initiated recall is complete.

Blood products, manufactured from units of Whole Blood that were overweight, were

distributed.

2 units

FL

Red Blood Cells Leukocytes Reduced. Recall # B-1640-10

Unit: W036209625278

Belle Bonfils Memorial Blood Center, Denver, CO, by telephone on February 17,

2010. Firm initiated recall is complete.

Blood product, which was incorrectly labeled as negative for the K red cell antigen,

was distributed.

1 unit

CO

Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1556-10

Unit: 2880059

Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH, by

letter dated June 11, 2007. Firm initiated recall is complete.

Blood product, which did not have a platelet count performed, was distributed.

1 unit

OH

_______________________________

July 7

Red Blood Cells, Recall # B-1521-10

Unit: 3157921

Community Blood Center, Dayton, OH, by letter dated November 4, 2008. Firm

initiated recall is complete.

Blood product, collected from a donor taking the medication Proscar, was distributed.

1 unit

28

OH

Red Blood Cells. Recall # B-1661-10

Units: 4818826, 4821498

National Naval Medical Center Bb, Bethesda, MD, by fax on September 3, 2008,

January 13, 2009, April 21, 2009 and June 30, 2009. Firm initiated recall is complete.

Blood products, collected from a donor who traveled to an HIV Group O risk area,

were distributed.

2 units

Afghanistan, Bahrain

Red Blood Cells Leukocytes Reduced. Recall # B- 1662-10

Unit: W03509005931

Community Blood Center dba Community Tissue Services, Dayton, OH, by

telephone on January 18, 2010 and letter dated January 19, 2010. Firm initiated

recall is complete.

Blood product, collected from a donor who was previously deferred, was distributed.

1 unit

OH

Whole Blood. Recall # B-1623-10

Unit: 0822633; 0822638; 0822670; 0822708

LifeShare Community Blood Services, Elyria, OH, by letter on November 17, 2008.

Firm initiated recall is complete.

Blood products, collected in 500 mL bags but labeled as 450 mL, were distributed.

4 units

OH

1) Red Blood Cells Leukocytes Reduced. Recall # 1668-10;

2) Recovered Plasma. Recall # 1669-10

1) and 2) Unit: W221609400615

Central Texas Regional Blood and Tissue Center, Austin, TX, by telephone on

December 7, 2009 and e-mail and fax on December 8, 2009. Firm initiated recall is

complete.

Blood products, collected from a donor who received a bone graft within one year of

donating, were distributed.

2 units

Austria, TX

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1813-10

Units: 7164980, 7131248, 7131274, 7164847, 7131800, 7131665, 7131673,

7131538, 7131348, 7131712

South Texas Blood & Tissue Center, San Antonio, TX, by fax on October 18, 2007.

Firm initiated recall is complete.

Blood products, for which Quality Control was not performed, were distributed.

10 units

TX

Platelet Pheresis Leukocyte Reduced-7 day. Recall # B-1861-10

Unit: 4761440

Florida Blood Services, Inc., St Petersburg, FL, by telephone on July 18, 2007 and

fax on July 19, 2007. Firm initiated recall is complete.

Blood product, with positive bacterial detection testing, was distributed.