FEBRUARY 2012

FEBRUARY 2012

WEEK ENDING FEBRUARY 25

PRODUCT

1) Platelets Pheresis Leukocytes Reduced Irradiated.

2) Platelets Pheresis Leukocytes Reduced.

CODE

1) Units: 84KS34668, 84KS34717, 84KS34741;

2) Units: 84KS34668, 84KS34668, 84KS34678, 84KS34678, 84KS34688, 84KS34698, 84KS34698, 84KS34703, 84KS34703, 84KS34717, 84KS34759, 84KS34759, 84KS34759, 84KS34765, 84KS34765

RECALLING FIRM/MANUFACTURER The American National Red Cross, Oakland, CA,

REASON Blood products, which were labeled as leukoreduced, but did not meet the requirements for leukoreduced products, were distributed.

VOLUME OF PRODUCT IN COMMERCE 18 units

DISTRIBUTION CA

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced.

CODE Unit: 221044653

RECALLING FIRM/MANUFACTURER

Recalling Firm: Blood Systems, Inc., Las Vegas, NV,

Manufacturer: Green Valley Center, Henderson, NV.

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

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT Cornea.

CODE Units: 070147OD, 070147OS

RECALLING FIRM/MANUFACTURER Donor Network of Arizona, Phoenix, AZ,

REASON Human Corneas, recovered from a donor with risk factors for relevant communicable disease agents and diseases, were distributed

VOLUME OF PRODUCT IN COMMERCE 2 Corneas

DISTRIBUTION AZ

PRODUCT Cornea.

CODE Units: 070095OD, 070095OS

RECALLING FIRM/MANUFACTURER Donor Network of Arizona, Phoenix, AZ,

REASON Human Cornea, with incomplete testing for relevant communicable diseases, was distributed.

VOLUME OF PRODUCT IN COMMERCE 2 Cornea

DISTRIBUTION AZ

PRODUCT Cornea.

CODE Units: 091354ODCEK; 091354OSCEK

RECALLING FIRM/MANUFACTURER Minnesota Lions Eye Bank, Inc., Saint Paul, MN,

REASON Human corneas, recovered from a donor whose eligibility to donate was based on a hemodiluted sample, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION MN, OH

PRODUCT Ortho Clinical Diagnostics, Inc. Rho(D) Immune Globulin (Human) MICRhoGAM Ultra-Filtered PLUS - 50 ug Dose (250 IU*) NDC 0562-7806-01; UPC NDC0562780525, Product Code 780601.

CODE MVP105A1 Expiration Date 11FEB2012, MVP106A1 Expiration Date 14FEB2013

RECALLING FIRM/MANUFACTURER Ortho Clinical Diagnostics Inc., Raritan, NJ,

REASON Two lots of MICRhoGAM, partially mislabeled as RhoGAM, were distributed.

VOLUME OF PRODUCT IN COMMERCE MVP105A1- 727 units; MVP106A1- 214 units

DISTRIBUTION Nationwide

PRODUCT Cornea.

CODE Units: 20110257 1:2; 20110257 2:2; 20110258 1:2; 20110258 2:2

RECALLING FIRM/MANUFACTURER Transplant Services Center UT Southwestern Medical Center, Dallas, TX,

REASON Human Corneas, recovered from a donor with incomplete testing for relevant communicable disease and disease agents, were distributed.

VOLUME OF PRODUCT IN COMMERCE 4 units

DISTRIBUTION TX

PRODUCT Human Cornea.

CODE 108141-OS Expiration Date: May I, 2008

RECALLING FIRM/MANUFACTURER San Diego Eye Bank, San Diego, CA,

REASON Human Corneas, recovered from a donor with risk factors for relevant communicable disease agents or diseases, were distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT Cornea.

CODE Units: 1103084, 1103085

RECALLING FIRM/MANUFACTURER Arkansas Lions Eye Bank & Laboratory, Little Rock, AR

REASON Human corneas, recovered from a donor whose donor testing for relevant communicable disease agents was associated with a sample mix-up, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION AR

PRODUCT Cornea in Optisol GS.

CODE Units: 068911; 069011

RECALLING FIRM/MANUFACTURER Eye Bank For Sight Restoration, New York, Inc., New York, NY,

REASON Human corneas, recovered from a donor who was not adequately tested for relevant communicable disease agents or diseases, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 corneas

DISTRIBUTION NY

PRODUCT Cornea in Optisol GS.

CODE Units: 028609, 028709, 029109, 029209, 029809, 029909, 030309, 030409, 030709, 030809, 031309, 031409, 031709, 031809, 031909, 032109, 032209, 032609, 032809, 032909, 033409, 033509, 033609, 033709, 034009, 034109, 034209, 034309, 034609, 034709, 035309, 035609, 035709, 035809, 035909, 037109, 037209, 037309, 037409, 038509, 040909, 041009

RECALLING FIRM/MANUFACTURER Eye Bank For Sight Restoration, Inc., New York, NY,

REASON Corneas, recovered using excision instruments that had incomplete sterilization cycles, were distributed.

VOLUME OF PRODUCT IN COMMERCE 42 units

DISTRIBUTION NY, CA, Dominican Republic, Venezuela, Mexico, Bolivia, Chile

PRODUCT Alpha-1-Proteinase Inhibitor (Human).

CODE Units: VNB5K015AAA, VNB5K015AAB, VNB5K015AAC, VNB5K015AAD, VNB5K015AAE, VNB5K014AA, VNB5K021AA, VNB5K022AA, VNB5K023AA, VNB5K028AB, VNB5K029AA, VNB5K031AA, VNB5K032AA, VNB5K033AAB, VNB5K033BAB, VNB5K035AA, VNB5K037AB, VNB5K039AA, VNB5K040AA, VNB5K040AB, VNB5K041AC, VNB5K042AA, VNB5K043AA, VNB5K044AA, VNB5K047AAA, VNB5K047BAA, VNB5K048AA, VNB5K049AA, VNB5K050AA, VNB5K051AA, VNB5K051AB, VNB5K052AA, VNB5K053AA, VNB5K056AA, VNB5K057AA, VNB5K058AA, VNB5K059AA, VNB5L001AA, VNB5L001AB, VNB5L002AA, VNB5L003AA, VNB5L004AA, VNB5L005AA, VNB5L006AA, VNB5L007AA, VNB5L008AA, VNB5L009AA, VNB5L009AAA, VNB5L010AA

RECALLING FIRM/MANUFACTURER

Recalling Firm: Baxter Healthcare Corp, Westlake Village, CA,

Manufacturer: Baxter Healthcare Corporation - Baxter AG, Vienna, Austria.

REASON ARALAST NP (Alpha1- Proteinase Inhibitor (Human)), packaged with BAXJECT II Hi-Flow, and associated with particle formation in the reconstituted solution, were distributed.

VOLUME OF PRODUCT IN COMMERCE approximately 122, 088

DISTRIBUTION Nationwide

PRODUCT Corneas,

CODE Units: 2008086085, 2008086086, procured 8/22/2008

RECALLING FIRM/MANUFACTURER Heartland Lions Eye Bank, Kansas City, MO,

REASON Human Corneas, recovered from a donor with risk factors for relevant communicable disease agents and diseases, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION PA, KS

PRODUCT Hepatitis C Virus Encoded Antigen (Recombinant c200) CHIRON HCV c200 Antigen; Stock Number: 4392-801, 4392-802, 4392-805 (4392-805 only item distributed for this lot); (The product is for Further Manufacturing Use/Recombinant).

CODE Lot # 127129

RECALLING FIRM/MANUFACTURER Novartis Vaccine and Diagnostics, Inc., Emeryville, CA

REASON Hepatitis C Virus Encoded Antigen (For Further Manufacturing Use, formulated with a reduced concentration of Dithiothreitol (DTT) in the formulation buffer, was distributed.

VOLUME OF PRODUCT IN COMMERCE 560 mg

DISTRIBUTION Great Britain

PRODUCT Red Blood Cells.

CODE Unit: W088411539285

RECALLING FIRM/MANUFACTURER Blood Bank Of Hawaii, Honolulu, HI,

REASON Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION HI

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W069111149738

RECALLING FIRM/MANUFACTURER Mississippi Blood Services Inc., Flowood, MS,

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION MS

PRODUCT

1) Platelets Pheresis Leukocytes Reduced.

2) Red Blood Cells (Apheresis) Leukocytes Reduced.

CODE

1) W117011504902 (2 units), W117011504169;

2) Unit: W117011500004

RECALLING FIRM/MANUFACTURER

Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA,

Manufacturer: Blood Centers of the Pacific - Santa Rosa Center, Santa Rosa, CA.

REASON Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE 4 units

DISTRIBUTION CA

PRODUCT Corneas procured 7/5/2007 for human transplant.

CODE Units: 20070717, 20070718

RECALLING FIRM/MANUFACTURER Kansas Eye Bank & Cornea Research Center, Inc., Wichita KS,

REASON Human Corneas, recovered from a donor with risk factors for relevant communicable disease agents and diseases, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 corneas

DISTRIBUTION Egypt, IN

PRODUCT Source Plasma.

CODE

Units: 40500409002, 40500401300, 40500382495, 40500377776, 40500354574, 40500339534, 40500334848, 40500413271, 40500397080, 40500297670, 40500329774, 40500290523, 40500068236, 40500078629, 40500071515, 40500034482, 40500025172, 40500021163, 40500046563, 40500098507, 40500019805, 40500012531, 40500087453, 40500091997, 40500058310, 40500114175, 40500109421, 40500101876, 40500147778, 40500141077, 40500155903

RECALLING FIRM/MANUFACTURER Csl Plasma Inc, Knoxville, TN,

REASON Blood products, collected using an abbreviated screening process, for which the donors were not eligible, were distributed.

VOLUME OF PRODUCT IN COMMERCE 31 units

DISTRIBUTION NC, IL, Germany and Switzerland

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W149508100402

RECALLING FIRM/MANUFACTURER Northern California Community Blood Bank, Eureka, CA,

REASON Blood product, manufactured without the entire amount of Optisol added during component preparation, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT Source Plasma.

CODE

Units: 0550670416; 0550669265; 0550667866; 0550666533; 0550665751; 0550663993; 0550663439; 0550662137; 0550660840; 0550659994; 0550658696; 0550657917; 0550656629; 0550655800; 0550654483; 0550653188; 0550651895; 0550651251; 0550659871; 0550649269; 0550647761; 0550647226; 0550643241; 0550642748; 0550619944; 0550619290; 0550618043; 0550617398

RECALLING FIRM/MANUFACTURER

Recalling Firm: ZLB Bioplasma, Inc., Portland, OR,

REASON Blood products, collected from a donor who was previously permanently deferred for unsuitable test results, were distributed.

VOLUME OF PRODUCT IN COMMERCE 28 units

DISTRIBUTION NC, Germany and Switzerland

PRODUCT

1) Red Blood Cells Deglycerolized Leukocytes Reduced.

2) Red Blood Cells Deglycerolized.

3) Red Blood Cells Rejuvenated Deglycerolized. ;

4) Red Blood Cells Rejuvenated Deglycerolized Leukocytes Reduced Irradiated.

CODE

1) Units: 084J90911, 033GR52274, 084FT77211, 084K58706, 084Z88455, 006GL46986;

2) Units: 1668210298, 1271570009, 116KC24821, 1271391458, 116LP53919;

3) Units: U084GF01987, 084GF02053, 084Q91049, 084GF01192;

4) Unit: 084Z66470

RECALLING FIRM/MANUFACTURER The American National Red Cross, Oakland, CA,

REASON Blood products, held at an unacceptable temperature during component preparation, were distributed.

VOLUME OF PRODUCT IN COMMERCE 16 units

DISTRIBUTION CA

PRODUCT Allergenics - Other "STAR Tree". Number of units involved for each product: 1 set (3 vials). Labeling reads in part: "Allergenic Extract Prescription Formula U.S. FDA Lic 467***Name Gutierrez, Patrick Contents 5 mL vial(s) Concentration Conc. (1:20) - 1:2,000 (5mL) ***".

CODE Lot No. AO51545A Expiration Dae: 03/22/06

RECALLING FIRM/MANUFACTURER Allermed Laboratories, Inc., San Diego, CA,

REASON Prescription set of 3 allergenic vials of "STAR Tree", labeled as "PA Tree," was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 set = 3 vials

DISTRIBUTION CA

PRODUCT Immune Globulin Intravenous (Human)

CODE LE09K005AB Exp. Date: March 9, 2012; LE08K015AS Exp. Date: September 15, 2012, LE08K021AB Exp. Date: December 1, 2012 LE08L012AB-Exp. Date: March 29, 2013

RECALLING FIRM/MANUFACTURER

Recalling Firm: Baxter Healthcare Corp, Westlake Village, CA,

Manufacturer: Baxter Biosciences, Lessines, Belgium.

REASON GAMMAGARD S/D [Immune Globulin Intravenous (Human)] 5g, misbranded with an incorrect dilution volume, was distributed.

VOLUME OF PRODUCT IN COMMERCE 9,531 (US) 3000 (Russia)

DISTRIBUTION Nationwide, Russia

PRODUCT

1) Immune Globulin Intravenous (Human), 10% Liquid.

2) Immune Globulin Intravenous (Human).

3) Albumin (Human).

CODE

1) Units: GMGN004791, GMGN004791, GMGM005041, GMGM005041, GMGN004791, GMGP005071, GMGN004791;

2) Units: GMGK105491, GMGL105351;

3) Units: B1NA0TX002, B1NA0TX003, B1NA0TX002, B1NB1VT002

RECALLING FIRM/MANUFACTURER Grifols Biologicals Inc., Los Angeles, CA,

REASON Blood Derivatives, lacking assurance of proper temperature storage during shipment, were distributed.

VOLUME OF PRODUCT IN COMMERCE 13 units

DISTRIBUTION FL, TN

PRODUCT Cryoprecipitated AHF.

CODE Units: W045111317840, W045111317843

RECALLING FIRM/MANUFACTURER Community Blood Center of the Ozarks, Springfield, MO,

REASON Blood products, prepared from plasma which was not frozen within 8 hours of phlebotomy, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION MO

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W069111145098

RECALLING FIRM/MANUFACTURER Mississippi Blood Services Inc., Flowood, MS

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION MS

PRODUCT Red Blood Cells Leukocytes Reduced Irradiated.

CODE Units: 019FZ61073, 019GR73051, 019GR73073, 019GR73074, 019GH02023, 019GK97623

RECALLING FIRM/MANUFACTURER American Red Cross Blood Services Tennessee Valley Region, Nashville, TN,

REASON Blood products, labeled with an extended expiration date, were distributed.

VOLUME OF PRODUCT IN COMMERCE 6 units

DISTRIBUTION TN, KY

WEEK ENDING FEBRUARY 18

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced.

CODE Units: W038111291039; W038111318192

RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL,

REASON Blood products, for which the quality control testing was incomplete, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION FL

PRODUCT

1) Cryoprecipitated AHF.

2) Red Blood Cells.

CODE

1) Unit: 1049261;

2) Units: 1049261, 2022132

RECALLING FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc., Augusta, GA,

REASON Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION GA, SC

PRODUCT

1) Cryoprecipitated AHF.

2) Red Blood Cells Leukocytes Reduced.

3) Plasma Cryoprecipitated Reduced.

CODE 1), 2) and 3) Unit: 003LF63081

RECALLING FIRM/MANUFACTURER The American National Red Cross - Southern Region, Douglasville, GA

REASON Blood products, collected from a donor who was diagnosed with toxic fungus Nigerlysin, were distributed.

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION NC, GA

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W036511154835

RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA,

REASON Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION TX

PRODUCT

1) Red Blood Cells Leukocytes Reduced.

2) Platelets.

CODE 1) and 2) Unit: W0352113064466

RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,

REASON Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION NJ, TX

PRODUCT

1) Red Blood Cells Leukocytes Reduced.

2) Cryoprecipitated AHF.

CODE 1) and 2) Unit: W0352112197543

RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,

REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE2 units

DISTRIBUTION Austria, NJ, TX

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Units: W115911046158; W115911043989

RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA,

REASON Blood products, collected from a donor who traveled to a malaria endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION CA

PRODUCT Source Plasma.

CODE Units: 11BWAF4730; 11BWAF3784; 11BWAF7776

RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Bellingham, WA,

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

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION Austria

PRODUCT

1) Red Blood Cells. ;

2) Red Blood Cells Leukocytes Reduced.

CODE 1) Unit: 021KR16676; 2) Units: 021KR24813, 021KR31207

RECALLING FIRM/MANUFACTURER American National Red Cross, Portland, OR,

REASON Blood products, which tested negative for the antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II), but were collected from an ineligible donor due to previous positive testing for anti-HTLV-I/II, were distributed.

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION OR, MD

PRODUCT Red Blood Cells.

CODE Units: 5124375, 5123098

RECALLING FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc., Augusta, GA

REASON Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION GA

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: 21FV18243

RECALLING FIRM/MANUFACTURER American National Red Cross, Portland, OR,

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT

1) Red Blood Cells.

2) Fresh Frozen Plasma.

CODE 1) and 2) Unit: W036811197484

RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Inc., Hialeah, FL,

REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION FL

PRODUCT

1) Red Blood Cells Leukocytes Reduced.

2) Platelets Pooled Leukocytes Reduced.

3) Fresh Frozen Plasma.

CODE

1) and 3) Unit: 2302674;

2) Unit: 2907904

RECALLING FIRM/MANUFACTURER Community Blood Centers/S Florida Inc., Lauderhill, FL,

REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION FL

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W158011101034

RECALLING FIRM/MANUFACTURER Arup Laboratories, Inc., Sandy, UT,

REASON Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION UT

PRODUCT Cornea.

CODE Units: 111139OSCN, 111139ODCN:

RECALLING FIRM/MANUFACTURER Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN,

REASON Human tissue allografts, recovered from a donor whose eligibility was not properly evaluated, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION MA, IN

PRODUCT Platelets Pheresis Leukocytes Reduced.

CODE Unit: 8815100 (Parts 1 & 2)

RECALLING FIRM/MANUFACTURER

Recalling Firm: Blood Centers of the Pacific, San Francisco, CA,

Manufacturer: Blood Centers of the Pacific, Redding, CA.

REASON Blood products, for which the sterility may have been compromised during manufacturing, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION CA

PRODUCT

1) Cryoprecipitated AHF.

2) Red Blood Cells.

CODE 1) and 2) Unit: 4132630

RECALLING FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc., Augusta, GA,

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

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION GA, Israel

PRODUCT Cornea.

CODE Unit: 20110479R1

RECALLING FIRM/MANUFACTURER Lifepoint, Inc., Charleston, SC,

REASON Human tissue allografts, recovered from a donor whose eligibility was not properly evaluated, were distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION OK

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: 6055672

RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Fairfield, CA,

REASON Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Units: 2910743, 2910744, 2910745

RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, San Francisco, CA,

REASON Blood products, collected from donors whose hematocrit determinations were performed incorrectly, were distributed.

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION CA

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: 8749509

RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, San Francisco, CA

REASON Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W038111267557

RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL,

REASON Blood products, collected from a donor who received a piercing within 12 months of the donation, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION FL

PRODUCT Red Blood Cells Leukocytes reduced,

CODE Unit: 003LL78916

RECALLING FIRM/MANUFACTURER The American National Red Cross – Southern Region, Douglasville, GA

REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Al, GA

PRODUCT Platelets Pheresis Leukocytes reduced,

CODE Units: W069111139652; W069111139501; W069111129373; W069111129619

RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Flowood, MS,

REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE 4 units

DISTRIBUTION MS

PRODUCT Red Blood Cells.

CODE Unit: W036810016261

RECALLING FIRM/MANUFACTURER Community Blood Centers of South FL, Inc., Orlando, FL,

REASON Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Switzerland, NY

PRODUCT Red Blood Cells.

CODE Unit: W120611302296

RECALLING FIRM/MANUFACTURER Michigan Blood, Saginaw, MI,

REASON Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION MI

PRODUCT FLUVIRIN (Influenza Virus Vaccine) 2010-2011 Formula Multidose Vials.

CODE Lot: 111812P1

RECALLING FIRM/MANUFACTURER Novartis Vaccines and Diagnostics Limited, Liverpool, UK

REASON Fluvirin (Influenza Virus Vaccine) 2010-2011 Formula Multidose Vial, with the possibility of a cracked vial neck, was distributed.

VOLUME OF PRODUCT IN COMMERCE 78,832 vials

DISTRIBUTION Nationwide

PRODUCT Human cornea.

CODE Units: 105013OD, 105013OS, Expiration date 01/14/2006.

RECALLING FIRM/MANUFACTURER San Diego Eye Bank, San Diego, CA,

REASON Human corneas, recovered from an ineligible donor, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION CA, TX

PRODUCT

1) Source Leukocytes.

2) Recovered Plasma.

CODE 1) and 2) Unit: W0352112197543

RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX

REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION Austria, NJ, TX

PRODUCT Plasma.

CODE Unit: 4132630

RECALLING FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc., Augusta, GA

REASON Blood product, collected from a donor with a history of high-risk behavior, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION GA, Israel

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced.

CODE Units: 36FR30507, 36FR30614, 36GT24029

RECALLING FIRM/MANUFACTURER The American National Red Cross, Columbia, SC

REASON Blood products, which were labeled with an incorrect volume, were distributed.

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION SC

PRODUCT Recovered Plasma.

CODE Units: W0415110415312, W0415110063843

RECALLING FIRM/MANUFACTURER Blood Systems, Inc. dba United Blood Services, Lubbock, TX,

REASON Blood products, collected from a donor who previously contracted hepatitis A, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION Switzerland,

PRODUCT Platelets Pheresis Leukocytes Reduced.

CODE Unit: W043811321284

RECALLING FIRM/MANUFACTURER LifeShare Community Blood Services, Elyria, OH,

REASON Blood products, which did not meet acceptable product specifications, were distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION OH

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W051511076178

RECALLING FIRM/MANUFACTURER

Recalling Firm: Memorial Blood Centers, Saint Paul, MN,

Manufacturer: Memorial Blood Centers – Duluth, Duluth, MN.

REASON Blood products, collected from a donor with Hemachromatosis, were distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION NC

PRODUCT Recovered Plasma.

CODE Unit: 003LL78916

RECALLING FIRM/MANUFACTURER The American National Red Cross – Southern Region, Douglasville, GA,

REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Al, GA

PRODUCT Recovered Plasma.

CODE Unit: W036810016261

RECALLING FIRM/MANUFACTURER Community Blood Centers of South FL, Inc., Orlando, FL,

REASON Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Switzerland, NY

PRODUCT Platelets Pheresis Leukocytes Reduced.

CODE Units: W037711178794, W037711184734

RECALLING FIRM/MANUFACTURER Hoxworth Blood Center UC Medical Center, Cincinnati, OH,

REASON Blood products, which were labeled with an incorrect volume, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION OH

PRODUCT

1) Red Blood Cells Leukocytes Reduced.

2) Platelets Pooled Leukocytes Reduced Irradiated.

CODE

1) Unit: W120611282699;

2) Unit: W120611382175

RECALLING FIRM/MANUFACTURER Michigan Blood, Saginaw, MI,

REASON Blood products, collected from a donor with an elevated body temperature, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION MI

PRODUCT Recovered Plasma.

CODE Unit: 021LV60639

RECALLING FIRM/MANUFACTURER American National Red Cross, Portland, OR,

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

WEEK ENDING FEBRUARY 11

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W036311106953

RECALLING FIRM/MANUFACTURER BloodCenter of Wisconsin, Inc., Milwaukee, WI,

REASON Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Switzerland, WI

PRODUCT Platelets Pheresis Leukocytes Reduced.

CODE Units: W117011316737 Part A; W117011316737 Part B

RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific - Irwin Center, San Francisco, CA,

REASON Blood products, which did not meet acceptable product specifications, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION CA

PRODUCT Recovered Plasma.

CODE Unit: W038111221977

RECALLING FIRM/MANUFACTURER

Recalling Firm: Florida's Blood Centers, Inc., Melbourne, FL,

Manufacturer: Florida's Blood Centers, Inc., Rockledge, FL.

REASON Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION FL

PRODUCT Platelets Pheresis Leukocytes Reduced.

CODE Unit: W117011320583W

RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific - Irwin Center, San Francisco, CA,

REASON Blood product, which did not meet acceptable product specifications, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W0907110088081

RECALLING FIRM/MANUFACTURER

Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA,

Manufacturer: Blood Centers of the Pacific - Santa Rosa Center, Santa Rosa, CA.

REASON Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT Red Blood Cells.

CODE Unit: W036810164860

RECALLING FIRM/MANUFACTURER Community Blood Centers of Florida, Inc., Miami, FL,

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Switzerland, FL

PRODUCT

1) Red Blood Cells.

2) Fresh Frozen Plasma.

CODE 1) and 2) Unit: W036811091200

RECALLING FIRM/MANUFACTURER Community Blood Centers/S Florida, Inc., Lauderhill, FL,

REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION FL

PRODUCT

1) Fresh Frozen Plasma. ;

2) Red Blood Cells.

CODE 1) and 2) Unit: W036811142436

RECALLING FIRM/MANUFACTURER Community Blood Centers of Florida, Inc., Miami, FL,

REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION FL

PRODUCT Red Blood Cells.

CODE Unit: W036809319362

RECALLING FIRM/MANUFACTURER Community Blood Centers/S FL, Inc., Lauderhill, FL

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Switzerland, NY

PRODUCT

1) Red Blood Cells. ;

2) Cryoprecipitated AHF, Pooled.

CODE

1) Unit: W036810151637;

2) Unit: W036810801560

RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Inc., Lake Worth, FL,

REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION Switzerland, FL

PRODUCT Source Plasma.

CODE Unit: LC0702393

RECALLING FIRM/MANUFACTURER Las Cruces Biologicals LLC, Las Cruces, NM,

REASON Blood product, collected from a donor who received a tattoo within one year of donation, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION UK

PRODUCT

1) Recovered Plasma. ;

2) Platelets Pooled Leukocytes Reduced.

CODE

1) Unit: W088411547723;

2) Unit: W088411403959 (includes platelet unit W088411547723)

RECALLING FIRM/MANUFACTURER Blood Bank Of Hawaii, Honolulu, Hawaii,

REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION Hawaii, Austria

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W037911173836

RECALLING FIRM/MANUFACTURER LifeServe Blood Center, Des Moines, IA

REASON Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION IA

PRODUCT

1) Fresh Frozen Plasma.

2) Red Blood Cells.

3) Platelets.

CODE

1) and 2) Units: 1160756; 1103330;

3) Unit: 1103330

RECALLING FIRM/MANUFACTURER Memorial Blood Centers, Saint Paul, MN,

REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed

VOLUME OF PRODUCT IN COMMERCE 5 units

DISTRIBUTION VT, VA, MN

PRODUCT Platelets Pooled Leukocytes Reduced.

CODE Unit: W3769110004168

RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody, GA,

REASON Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION GA

PRODUCT Source Plasma.

CODE Unit: 3400123817

RECALLING FIRM/MANUFACTURER Talecris Plasma Resources, Inc., Raleigh, NC,

REASON Blood product, collected from a donor whose scheduled physical examination was incomplete, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION NC

PRODUCT Recovered Plasma.

CODE Unit: W036311106953

RECALLING FIRM/MANUFACTURER BloodCenter of Wisconsin, Inc., Milwaukee, WI,

REASON Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Switzerland, WI

PRODUCT Recovered Plasma.

CODE Unit: 27FL54666

RECALLING FIRM/MANUFACTURER American Red Cross Greater Alleghenies Region, Johnstown, PA,

REASON Blood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W227011045013

RECALLING FIRM/MANUFACTURER Community Blood Center of Carolinas, Charlotte, NC,

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION NC

PRODUCT Recovered Plasma.

CODE Unit: 18KS00427

RECALLING FIRM/MANUFACTURER American National Red Cross Great Lakes Region, Lansing, MI,

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT Platelets Pheresis Leukocytes Reduced.

CODE W036311308198 (2 units)

RECALLING FIRM/MANUFACTURER BloodCenter of Wisconsin, Inc., Milwaukee, WI,

REASON Blood products, for which the quality control testing for White Blood Cell count was performed incorrectly, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION WI

PRODUCT Recovered Plasma.

CODE Unit: W036810164860

RECALLING FIRM/MANUFACTURER Community Blood Centers of Florida, Inc., Miami, FL,

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Switzerland, FL

PRODUCT Recovered Plasma.

CODE Unit: W036809385276

RECALLING FIRM/MANUFACTURER Community Blood Centers of South FL, Inc., Orlando, FL

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT Recovered Plasma.

CODE Unit: W036809319362

RECALLING FIRM/MANUFACTURER Community Blood Centers/S FL, Inc., Lauderhill, FL,

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Switzerland, NY

PRODUCT Recovered Plasma.

CODE Unit: W036810151637

RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Inc., Lake Worth, FL,

REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Switzerland, FL

PRODUCT Red Blood Cells.

CODE Unit: W3038110110236

RECALLING FIRM/MANUFACTURER Ochsner Health System Blood Bank, New Orleans, LA

REASON Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION LA

PRODUCT Recovered Plasma.

CODE Unit: 1160756

RECALLING FIRM/MANUFACTURER Memorial Blood Centers, Saint Paul, MN,

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

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION VT, VA, MN

WEEK ENDING FEBRUARY 4

PRODUCT Red Blood Cells.

CODE Unit: W303811009911V

RECALLING FIRM/MANUFACTURER Ochsner Health System Blood Bank, New Orleans, LA,

REASON Blood product, collected from a donor who had travelled to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION LA

PRODUCT

1) Red Blood Cells Leukocytes Reduced.

2) Cryoprecipitated AHF.

CODE 1) and 2) Unit: 011FW34628

RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Saint Louis, MO,

REASON Blood products, collected from a donor who had previously tested positive for hepatitis C (HCV), were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION TN, AR

PRODUCT Platelets Pheresis Leukocytes Reduced.

CODE Units: 7093153 (BAG1); 7093153 (BAG2)

RECALLING FIRM/MANUFACTURE

Recalling Firm: New York Blood Center,

Manufacturer: New York Blood Center, Inc., Westbury, NY.

REASON Blood products, possibly contaminated with Propionibacterium acnes, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION NY

PRODUCT Platelets Pheresis Leukocytes Reduced Irradiated.

CODE Units: 7078881(BAG1); 7078881(BAG2)

RECALLING FIRM/MANUFACTURER

Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY,

Manufacturer: New York Blood Center, Inc., Westbury, NY.

REASON Blood products, possibly contaminated with Propionibacterium species, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units (split)

DISTRIBUTION NJ

PRODUCT Platelets Pheresis Leukocytes Reduced.

CODE Unit: 7194007

RECALLING FIRM/MANUFACTURER

Recalling Firm: New York Blood Center,

Manufacturer: New York Blood Center, Inc., Westbury, NY. e.

REASON Blood product, possibly contaminated with Bacillus species, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION NY

PRODUCT

1) Red Blood Cells Leukocytes Reduced.

2) Fresh Frozen Plasma.

3) Red Blood Cells.

CODE

1) Units: 8024103, 8024709, 8024763, 8024872, 8025899, 8026169, 8026835, 8026912, 8256059, 8257997, 8258762, 8260282, 8262532, 8262757, 8263193, 8263660, 8264954, 8265620, 8265853, 8265884, 8267001, 8267247, 8267334, 8267341, 8528962, 8529727, 8530030, 8530199, 8631321, 8531455, 8532354, 8533857, 8534221, 8535635, 8535918, 8703544;

2) Units: 8024103, 8024763, 8026169, 8256059, 8258327, 8263193, 8263660, 8265853, 8534221;

3) Units: 8258327, 8262922

RECALLING FIRM/MANUFACTURE Houchin Blood Services, Bakersfield, CA,

REASON Blood products, collected from donors for whom the confirmatory syphilis testing was invalid, were distributed.

VOLUME OF PRODUCT IN COMMERCE 47 units

DISTRIBUTION CA

PRODUCT

1) Red Blood Cells Irradiated.

2) Fresh Frozen Plasma.

CODE 1) and 2) Unit: 6398030

RECALLING FIRM/MANUFACTURER

Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY,

Manufacturer: New York Blood Center, Inc., Westbury, NY.

REASON Blood products, collected from a donor who resided in a HIV Group O risk area, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION NY

PRODUCT Platelets.

CODE Unit: W141607134773

RECALLING FIRM/MANUFACTURE Puget Sound Blood Center and Program, Seattle, WA,

REASON Blood product, collected from a donor who received an accidental needlestick, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION WA

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W141608393436

RECALLING FIRM/MANUFACTURE Puget Sound Blood Center and Program, Seattle, WA,

REASON Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION WA

PRODUCT Source Plasma.

CODE

Units: YZ134554; YZ134442; YZ134016; YZ133462; YZ133287; YZ132960; YZ132834; YZ137246; YZ136452; YZ132650; YZ132541; YZ132387; YZ132313; YZ131809; YZ132071; YZ131911; YZ132143; YZ137728; YZ131636; YZ131570; YZ131382; YZ131267; YZ131151; YZ131054; YZ130944; YZ130760; YZ130550; YZ130299; YZ130083; YZ129646; YZ129347; YZ129060; YZ128774; YZ128393; YZ127642; YZ127383; YZ127058; YZ126839; YZ126477; YZ126149; YZ125822; YZ125465; YZ125156; YZ124786; YZ124486; YZ124136; YZ123729; YZ123039

RECALLING FIRM/MANUFACTURER

Recalling Firm: Interstate Blood Bank Inc., Memphis, TN,

Manufacturer: Interstate Blood Bank, Inc. of Wisconsin, Milwaukee, WI.

REASON Blood products, collected from a donor whose physical exam was incomplete, were distributed.

VOLUME OF PRODUCT IN COMMERCE 48 units

DISTRIBUTION CA, Switzerland, Germany

PRODUCT Recovered Plasma.

CODE Unit: W036509040254

RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA,

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

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION Switzerland

PRODUCT Source Plasma.

CODE Unit: 4230120678

RECALLING FIRM/MANUFACTURE Talecris Plasma Resources, Inc., Lakewood, CO,

REASON Blood product, collected from a donor whose physical was overdue, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION NC

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W043211081841

RECALLING FIRM/MANUFACTURER Blood Assurance Inc., Chattanooga, TN,

REASON Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION NC, IN

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W115911253311

RECALLING FIRM/MANUFACTURE Central California Blood Center, Fresno, CA,

REASON Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT

1) Fresh Frozen Plasma.

2) Red Blood Cells Leukocytes Reduced.

3) Platelets.

CODE 1), 2), 3) Unit: W227710393356

RECALLING FIRM/MANUFACTURER Mid-South Regional Blood Center, Memphis, TN,

REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION TN

PRODUCT Platelets Pheresis Leukocytes Reduced.

CODE Unit: W125611612207

RECALLING FIRM/MANUFACTURER Blood Bank Of San Bernardino And Riverside Counties, San Bernardino, CA,

REASON Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT

1) Fresh Frozen Plasma.

2) Red Blood Cells Leukocytes Reduced.

3) Platelets Pheresis Leukocytes Reduced.

4) Red Blood Cells Leukocytes Reduced Irradiated.

5) Platelets Pheresis.

6) Cryoprecipitated AHF.

CODE

1) Units: 8524533, 8523217, 8523212, 8522888, 8522517, 8520956, 8520866, 8520566, 8518459, 8516167, 8515721, 8515306, 8509520, 8507985, 8507051, 8506473, 8506135, 8505966, 8504888, 8504859, 8503492, 8400608, 8400301, 8251520, 8251186, 8250870, 8517742, 8515024, 8512076, 8250864, 8250618, 8248716, 8247987, 8247186, 8246565, 8246492, 8246195, 8245612, 8244684, 8244335, 8244192, 8243368, 8243024, 8242853, 8242677, 8242664, 8241216, 8240992, 8240679, 8240126, 8240119, 8238843, 8238674, 8238007, 8237984, 8236739, 8235606, 8235316, 8233667, 8233387, 8235618, 8233032, 8230292, 8229661, 8229313, 8228745, 8228646, 8226114, 8226019, 8225395, 8224171, 8224006, 8222451, 8222230, 8220620, 8220410, 8219981, 8218933, 8218784, 8218217, 8217108, 8217098, 8239371, 8216349, 8215798, 8215748, 8215588, 8214141, 8212732, 8212708, 8212686, 8211763, 8210987, 8210328, 8209105, 8207340, 8205982, 8204130, 8022603, 8022429, 8021395, 8021155, 8020726, 8020407, 8020062, 8019942, 8019886, 8019584, 8019561, 8018502, 8018475, 8018222, 8018101, 8017502, 8016944, 8016775, 8016710, 8015584, 8014264, 8013072, 8012649, 8010955, 8010331, 8009746, 8009329, 8008837, 8007181, 8006946, 8005841, 8004218, 8005327, 8002571;

2) Units: 8524533, 8523217, 8523212, 8522888, 8522517, 8520956, 8520866, 8520566, 8518459, 8516167, 8515721, 8515306, 8509520, 8507985, 8507051, 8506473, 8506135, 8505966, 8504888, 8504859, 8503492, 8400608, 8400301, 8251520, 8251186, 8250870, 8517742, 8515024, 8512076, 8250864, 8250618, 8248716, 8247987, 8247186, 8246565, 8246492, 8246195, 8245612, 8244684, 8244335, 8244192, 8243368, 8243024, 8242853, 8242677, 8242664, 8241216, 8240992, 8240679, 8240126, 8240119, 8238843, 8238674, 8238007, 8237984, 8236739, 8235606, 8235316, 8233667, 8233387, 8235618, 8233032, 8230292, 8229661, 8229313, 8228745, 8228646, 8226114, 8226019, 8225395, 8224171, 8224006, 8222451, 8222230, 8220620, 8220410, 8219981, 8218933, 8218784, 8218217, 8217108, 8217098, 8239371, 8216349, 8215798, 8215748, 8215588, 8214141, 8212732, 8212708, 8212686, 8211763, 8210987, 8210328, 8209105, 8207340, 8205982, 8204130, 8022603, 8022429, 8021395, 8021155, 8020726, 8020407, 8020062, 8019942, 8019886, 8019584, 8019561, 8018502, 8018475, 8018222, 8018101, 8017502, 8016944, 8016775, 8016710, 8015584, 8014264, 8013072, 8012649, 8010955, 8010331, 8009746, 8009329, 8008837, 8007181, 8006946, 8005841, 8004218, 8005327, 8002571;

3) Units: 8002043, 8002043, 8016705;

4) Units: 8017002, 8019053, 8215848, 8242596, 8226135, 8241570, 8242761, 8226135, 8240289, 8241570, 8242596, 8242761, 8524698;

5) Units: 8009438, 8009438;

6) Unit: 8226019

RECALLING FIRM/MANUFACTURER Houchin Blood Services, Bakersfield, CA,

REASON Blood products, collected from donors whose confirmatory syphilis testing was invalid, were distributed.

VOLUME OF PRODUCT IN COMMERCE 179 units

DISTRIBUTION CA

PRODUCT

1) Platelets Pooled Leukocytes Reduced Irradiated.

2) Red Blood Cells.

CODE 1) and 2) Unit: W141608155030

RECALLING FIRM/MANUFACTURER

Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, .

Manufacturer: Puget Sound Blood Center and Program, Everett, WA.

REASON Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION OH, WA

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W141608081223

RECALLING FIRM/MANUFACTURE

Recalling Firm: Puget Sound Blood Center, Seattle WA,

Manufacturer: Puget Sound Blood Center and Program, Seattle, WA.

REASON Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT

1) Red Blood Cells Leukocytes Reduced.

2) Platelets Pooled Irradiated.

CODE Unit: W141608612612

RECALLING FIRM/MANUFACTURER

Recalling Firm: Puget Sound Blood Center, Seattle, WA,

Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA.

REASON Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION WA

PRODUCT Red Blood Cells.

CODE Unit: 4025538

RECALLING FIRM/MANUFACTURE Walter L. Shepeard Community Blood Center, Inc., Augusta, GA,

REASON Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION SC

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: 020FZ43165

RECALLING FIRM/MANUFACTURER

Recalling Firm: American National Red Cross, Lewis and Clark Region, Salt Lake City, UT,

Manufacturer: American National Red Cross, Kalispell, MT.

REASON Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT

1) Red Blood Cells.

2) Recovered Plasma.

CODE 1) and 2) Unit: 4023955

RECALLING FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc., Augusta, GA,

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

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION GA, FL

PRODUCT Red Blood Cells.

CODE Unit: W141607418092

RECALLING FIRM/MANUFACTURER

Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA,

Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. .

REASON Blood product, collected from a donor who did not respond to the question regarding contact with an unhealed smallpox vaccination site.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION WA

PRODUCT Recovered Plasma.

CODE Unit: W043211081841

RECALLING FIRM/MANUFACTURER Blood Assurance Inc., Chattanooga, TN,

REASON Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION NC, IN

PRODUCT Fresh Frozen Plasma.

CODE Unit: W1165103072828

RECALLING FIRM/MANUFACTURE Ogden Medical Center, Inc. Ogden, UT,

REASON Blood product, manufactured from plasma that was not frozen within 8 hours of phlebotomy, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION UT

PRODUCT Plasma.

CODE Unit: W092911501136

RECALLING FIRM/MANUFACTURER Poudre Valley Health Care, Inc. Blood Bank, Fort Collins, CO,

REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION PA