FEBRUARY 2004

WEEK ENDING FEBRUARY 14

PRODUCT Cerner HNA Classic Patient Management (U60)/Patient Linking (PHC) software, HNA Classic 306.
CODE HNA Classic 306, Revision 34 and Higher.
RECALLING FIRM/MANUFACTURER Cerner Corporation, Kansas City, MO.
REASON Blood bank software, which included a defect that could result in the failure to accurately display all alloantibodies when linking or combining medical records for the same patient, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Nationwide and Canada.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit numbers: 15012-7080, 15386-3774, 15390-5187 Parts 1 and 2.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock Center, Lubbock, TX.
REASON Blood products, collected from a donor who was taking the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
REASON TX.

PRODUCT Source Plasma.
CODE Unit Number: 02LKYB1506.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Louisville, KY.
REASON Source Plasma was not properly quarantined and was distributed after the receipt of information that disqualified the donor of the product.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON CA.

PRODUCT COBASÓ AMPLICORÓ Analyer, BK Number 020018.
CODE Serial Number 733 & 1464.
RECALLING FIRM/MANUFACTURER Recalling Firm: Roche Diagnostics Corporation, Indianapolis, IN.,
Manufacturer: Roche Instrument Center, Switzerland.
REASON Roche Diagnostics received reports of incorrect labeling on two Thermal Cycler Units for the COBASÒ AmplicorÒ Analyzer. The identification stickers on the Thermal Cycler (TC) and Detection Position (DP) in some units may be reversed.
VOLUME OF PRODUCT IN COMMERCE 750.
DISTRIBUTION Nationwide.

PRODUCT
Human Tissues.
a) CryoGraft Femoral Popliteal Artery, Model No. R020;
b) CryoVein Femoral Vein, Model No. V060;
c) CryoVein Saphenous Vein, Model No. V010;
d) CryoGraft Tibialis Tendon, Model No. T080.
CODE
a) Serial No. 8281067;
b) Serial No. 8281053;
c) Serial No. 8032541;
d) Serial Nos. 8036675, 8036680, 8036668.
RECALLING FIRM/MANUFACTURER CryLife, Inc., Kennesaw, GA.
REASON Human tissues, collected from donors with positive cultures in associated tissues, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 tissues.
REASON ID, KS, KY, NE, and PA.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.

c) Red Blood Cells, Leukocytes Reduced, Irradiated.
d) Platelets.
e) Fresh Frozen Plasma.
f) Plasma, Cryoprecipitate Reduced.
g) Recovered Plasma.
CODE
a) Units 0985261, 1033490;
b) Units 1003857, 1034887, 1051072, 1051086, 1051044;
c) Units 1009129, 1020451, 1035245;
d) Units 0985261, 1003490, 1038304;
e) Units 0985261, 1020451, 1033490, 1034887;
f) Unit 1009129;
g) Units 1003857, 1051072, 1051086.
RECALLING FIRM/MANUFACTURER Memorial Blood Centers, Minneapolis, MN.
REASON Blood products, collected from donors whose responses to multiple donor history questions were not recorded, were distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units.
DISTRIBUTION MN and NY.

PRODUCT Immune Globulin Intravenous (Human); Gammar-P I.V., 10 gm.
CODE Lot A631805.
RECALLING FIRM/MANUFACTURER Aventis Behring L.L.C, Bradley, IL.
REASON Immune Globulin, with an increased rate of adverse event reports associated with allergic reactions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2,671 vials.
REASON TN, NJ, NY, NH, AL, IL, and MO.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 041FQ97343.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL.
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON AL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 41GM57851.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL.
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON AL and Switzerland.

PRODUCT Immune Globulin Intravenous (Human) 10%, Solvent/Detergent Treated; Gamimune N 10%.
CODE Lots 26N33W1, 26N34C1, 26N35V1, 26N36V1.
RECALLING FIRM/MANUFACTURER Bayer Healthcare, LLC, Clayton, NC.
REASON Immune Globulin, with an increased rate of adverse event reports associated with allergic reactions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 4 lots, 10,372 units.
REASON Nationwide.

PRODUCT Red Blood Cells.
CODE Unit 06GV14741.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Los Angeles, 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.
REASON CA.

PRODUCT Source Plasma.
CODE Units 54124936, 54120990, 54117105, 54112889, 54109452, 54104051, 54100794, 54097681, 54092013, 54088306.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Dallas, TX.
REASON Source Plasma, collected from a donor who either tested positive or previously tested positive for hepatitis B by the polymerase chain reaction assay, was distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
REASON IL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 18233-0407 - Parts 1& 2.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 18233-1587.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 06GQ02729, 06LH61766, and 06FY38608.
RECALLING FIRM/MANUFACTURER The American Red Cross Blood Services, Los Angeles, CA.
REASON Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
REASON CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 03LL45980.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southern Region, Atlanta, GA.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON GA.

PRODUCT
a) Platelets.
b) Plasma.
CODE
a) Unit numbers 28GG43041, 28GG50278, and 28GL22796;
b) Unit numbers 28LQ19214, 28LS21910, and 28KR25184.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southern Region, Atlanta, GA.
REASON Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
REASON GA, and SC.

PRODUCT Source Plasma.
CODE Unit numbers 0460209607, 0460209165, 0460209073, 0460208956, 0460208886, 0460208740, 53909107, 39259646, 39253071, 39246707, 39243928, 39238542, 39235893, 39231246, 39222671, 39216540, 39213358, 39205629, 39201690, 39185310, 39170026, 39155337, 39146601, 39139726, 39128621, 39122902, 39094087, 39092755, 39090102, 39087515, 39085337, 39083272, 39081223, 39073808, 39069412, 39065490, 39051417, 39049599, 39046239, 39044426, 39041081, 39039538, 39036414, 39034823, and 39031990.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Dallas, TX.
REASON Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 45 units.
REASON CA, Germany, and Israel.

PRODUCT Source Plasma.
CODE Unit numbers F-09816-018 and F-00410-018.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Fresno, CA.
REASON Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
REASON NC and Spain.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 6749724.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Children's Memorial Hospital, Chicago, IL.
REASON Blood product, that was not properly quarantined after the donor requested not to use his blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON IL.

PRODUCT Source Plasma.
CODE Unit numbers 46-DCLJDB-A, 46-DCLCHB-A, 46-DCKTQP-A, 46-DCKMBQ-A, 46-DCKLVD-A, 46-DCKLLK-A, and 46-DCKLGS-A.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Decatur, IL.
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION IL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 6748914.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Children's Memorial Hospital, Chicago, IL.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON IL.

PRODUCT Fresh Frozen Plasma.

CODE Unit number 6748386.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Children's Memorial Hospital, Chicago, IL.
REASON Blood product, untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON IL.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) and b) unit numbers 4430407 and 5830925;
c) Unit number 5830925;
d) Unit number 4430407.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood product, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
REASON IL and Scotland.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) Unit numbers 8586724 and 6318658;
b) and c) Unit number 6318658;
d) Unit number 8586724.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL.
REASON Blood products, collected from an ineligible donor due to medication with the drug Imuran, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
REASON IL and Switzerland.

PRODUCT Capture-R_ Ready Screen (Pooled Cells); 960 tests Solid Phase System for the Detection of Unexpected IgG Antibodies to Red Cells.
CODE Lot 03514; Expiration date - February 16, 2001.
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA.
REASON Test kits, possibly packaged with incorrect test wells (microplates), were distributed.
VOLUME OF PRODUCT IN COMMERCE 198 kits.
REASON CA, DE, IA, MN, NJ, TN, Belgium, Germany, and Spain.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Recovered Plasma.
CODE
a) and c) Units 27GY57892, 27GY53190;
b) Unit 27GY57892.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Johnstown, PA.
REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
REASON PA, WV, and MD.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE
a) and b) Unit number 33GF51493.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
REASON CT.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.

c) Red Blood Cells, Leukocytes Reduced, Irradiated.
d) Red Blood Cells, Leukocytes Reduced, Washed, Irradiated.
e) Platelets.
f) Fresh Frozen Plasma.
g) Recovered Plasma.
CODE
a) Units 1048388, 1048454;
b) Units 1020237, 1051044;
c) Units 1018424, 1051106;
d) Unit 1035415;
e) Unit 1048454;
f) Unit 1020237;
g) Unit 1051044.
RECALLING FIRM/MANUFACTURER Memorial Blood Centers, Minneapolis, MN.
REASON Blood products, collected from donors whose responses to multiple donor history questions were not recorded, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION MN and NY.

PRODUCT Recovered Plasma.
CODE Unit number: 41GM57851.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL.
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON AL and Switzerland.

PRODUCT Recovered Plasma.
CODE Unit 33GE71683.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Connecticut Region, Farmington, CT.
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON CA.

PRODUCT Red Blood Cells Leukocytes Reduced Irradiated.
CODE Units 100401058 and 100403495.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ.
REASON Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
REASON AZ.

PRODUCT Fresh Frozen Plasma.
CODE Unit 100403369.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ.
REASON Blood product, which was incorrectly labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON AZ.

PRODUCT Recovered Plasma.
CODE Unit 18233-1587.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD and Switzerland.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
c) Cryoprecipitated AHF.
d) Plasma, Cryoprecipitate Reduced.
CODE
a) Unit 12FR71395, 12FP69526;
b) Unit 12FR71395;
c) and d) Unit 12FP69526.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, North Carolina.
REASON Blood products, collected from a donor with a history of H.E.L.L.P. Syndrome, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 Units.
REASON NC, and GA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Fresh Frozen Plasma.
CODE
a), b) and c) Unit number 33GY58675.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
REASON CT and VA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number 33GS38497.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
REASON CT and CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Fresh Frozen Plasma.
CODE
a) b)and c) Unit number 33GE62577.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
REASON CT and VA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number 33GR50536.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor that did not answer one of the medical history questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
REASON CT.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number 33GJ51767.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
REASON CT and CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number 33GT37607.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
REASON CT and CA.

WEEK ENDING FEBRUARY 21

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 042J46996.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH.
REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a) and b) Unit 042X73012.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH.
REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a), and b) Unit number 33GL21535.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CT, PA, and CA.

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit GH24820.
RECALLING FIRM/MANUFACTURER Inova Heath System, Blood Donor Services, Annandale, VA.
REASON Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Units (2 units) T36877, C52923.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA.
REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION VA.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit number T47785.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA.
REASON Blood products, collected from a donor whose sexual partner had resided in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA.

PRODUCT Platelets Pheresis.
CODE Unit numbers 5476105A and 5476105B.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Eastern Maine Medical Center, Bangor, ME.
REASON Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION ME.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit numbers 5476258.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Eastern Maine Medical Center, Bangor, ME.
REASON Blood products, collected from an ineligible donor due to a history of Crohn's disease and medication with the drug Asacol, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION ME.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number 9161629.
RECALLING FIRM/MANUFACTURER Vermont Blood Center, Williston, VT.
REASON Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VT.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number R52197 (distributed as two split products).
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit number R59006.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Inc., Richmond, VA.
REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Units.
DISTRIBUTION VA.

PRODUCT Recovered Plasma.
CODE Unit number 33GL21535.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CT, PA, and CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 153960907 (2 units), 153961336, 153960904, 153961335, 153960698, 153960696 (2 units), 153960908, and 153960697.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX.
REASON Blood products, which were stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.

b) Recovered Plasma.
CODE a) and b) Unit 33GS34695.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Farmington, CT.
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA, and CT.

PRODUCT
a) Red Blood Cells Leukocytes Reduced
b) Platelets Leukocytes Removed
c) Recovered Plasma.
CODE a), b) and c) Unit 33GE59239.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Farmington, CT.
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA, CA, and CT.

PRODUCT
a) Red Blood Cells Leukocytes Reduced
b) Platelets Leukocytes Removed
c) Recovered Plasma
CODE a), b) and c) Unit 33GE14908.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Farmington, CT.
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA, CA, and CT.

PRODUCT
a) Red Blood Cells Leukocytes Reduced
b) Platelets Leukocytes Removed
c) Recovered Plasma
CODE a), b) and c) Unit 33GT31503.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Farmington, CT.
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA, and CT.

PRODUCT Fresh Frozen Plasma
CODE Unit 33FF07515.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Farmington, CT.
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Recovered Plasma.
CODE Unit number: FC44228.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL.
REASON Blood product, that was not properly quarantined after the donor reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT Recovered Plasma.
CODE Unit numbers: J15585/1, J15587/1, J15589/1, J15593/1, J15609/1, J15614/1, J15621/1, J15625/1, J15627/1, J15629/1, J15630/1, J15631/1, J15641/1, J15647/1, J15651/1, J15656/1, J15660/1, J15661/1, J15666/1, J15688/1, J15698/1, J15710/1, J15713/1, J15714/1, J15716/1, J15720/1, J15721/1, J15722/1, J15723/1, J15724/1, J15725/1, J15726/1, J15728/1, J15729/1, J15757/1, J15780/1, J15787/1, J15793/1, J15799/1, J15800/1,
J15804/1, J15807/1, J15828/1, J15831/1, J15832/1, J15833/1, J15838/1, J15840/1, J15842/1, J15850/1, J15852/1, J15862/1, J15863/1, J15867/1, J15869/1, J15868/1, J15870/1, J15872/1, J15875/1, J15876/1, J15879/1, J15880/1, J15881/1, J15903/1, J15907/1, J15916/1, J15918/1, J15921/1, J15927/1, J15930/1, J15938/1, J15939/1, J15940/1, J15944/1, J15948/1, J15951/1, J15955/1, J15960/1, J15962/1, J15956/1, J15959/1, J15963/1,
J15965/1, J15968/1, and J15970/1.
RECALLING FIRM/MANUFACTURER Johnston Memorial Hospital, Abingdon, VA.
REASON Blood products, collected from a donor whose health screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 85 Units.
DISTRIBUTION PA.

PRODUCT Source Plasma
CODE Unit number 53-DDPMWH-A.
RECALLING FIRM/MANUFACTURER International BioResources, LLC, Melrose Park, IL.
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

WEEK ENDING FEBRUARY 28

PRODUCT Red Blood Cells.
CODE Unit number 3853788.
RECALLING FIRM/MANUFACTURER Department of the Army, Walter Reed Army Medical Center Blood Bank, Washington, D.C.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 12798-8583.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Albuquerque, NM.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NM.

PRODUCT
a) Platelets, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 16LQ29428.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Ohio Region, Columbus, OH.
REASON Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH and CA.

PRODUCT
a) Platelets, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 42Y36933.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH.
REASON Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.

PRODUCT
a) Cryoprecipitated AHF,
b) Plasma, Cryoprecipitate Reduced.
CODE a) and b) Unit 40FE77901.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Heart of America Region, Peoria, IL.
REASON Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA and CA.

PRODUCT Source Plasma.
CODE Units G55267093, G54808093, G54098093, G53859093, G53196093, G52942093, G50387093, G50047093, G42106093, G41955093, G40956093, G40796093, G40403093, G40217093, G39814093, G31834093, G32460093, G32275093, G30291093, G30036093, and G29763093.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Brownsville, TX.
REASON Blood products, which were collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units.
DISTRIBUTION United Kingdom and Switzerland.

PRODUCT Source Plasma.
CODE Units T46092093, T46242093, T46419093, T46577093, T46775093, T46964093, T47148093, T47318093, T47446093, T47670093, T47742093, T47917093, T47998093, T48174093, T48265093, T48924093, T48956093, T50699093, and T50762093.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Brownsville, TX.
REASON Blood products, which were collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 19 units.
DISTRIBUTION Spain.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 04FS58223.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Red Blood Cells.
CODE Unit numbers G22802 and G24297.
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL.
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.

PRODUCT Red Blood Cells
CODE Unit number F74670.
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 3504479.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit FH30932.
RECALLING FIRM/MANUFACTURER Inova Health System, Blood Donor Services, Annandale, VA.
REASON Blood products, collected from a donor who tested negative for anti-HIV-1/2, but previously tested positive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) Unit FE85050;
b) Units FH28172, FE81745;
c) Unit FE81745;
d) Units FH28172, FE85050.
RECALLING FIRM/MANUFACTURER Inova Health System, Blood Donor Services, Annandale, VA.
REASON Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who provided post donation information regarding having previously tested reactive for the antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION VA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 3506042.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA.
REASON Blood product, collected from an unsuitable donor based on travel 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 number 2109714.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA.
REASON Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to recent body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
c) Recovered Plasma.
CODE a), b), and c) Unit number 3634274.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA.
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA and Germany.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 18GG61710.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood product, that was found to be out of specification for red blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 18FK71587.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI. and CA.

PRODUCT Platelets.
CODE Unit numbers 18FT62086, 18GN18637, and 18FQ18530.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
c) Recovered Plasma.
CODE a), b), and c) Unit number 18GM02228.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI, and Switzerland.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a) and b) Unit number 0946038.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH.
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.

PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit number 6803864.
RECALLING FIRM/MANUFACTURER Lifeshare, Inc., Elyria, OH.
REASON Blood products, which were collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Units 2533815 and 3628762.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA.
REASON Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 3629969.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA.
REASON Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 3408521.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA.
REASON Blood products, which were collected from a donor who was at increased risk for new variant Creuztfeldt Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA. and Austria.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 3301589.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA.
REASON Blood products, which were collected from a donor who was born or emigrated from an area with increased risk of human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 0945492.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, UC Medical Center, Cincinnati, OH.
REASON Blood product, which tested repeatedly reactive for the antibody to the hepatitis C virus encoded antigen (anti-HCV) but was negative by confirmatory testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 1030501.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, UC Medical Center, Cincinnati, OH.
REASON Blood product, which tested positive for the E antigen, but was incorrectly labeled as E antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.