JULY 2003

WEEK ENDING JULY 5

PRODUCT a) Whole Blood.
b) Red Blood Cells.
c) Red Blood Cells, Leukocytes Reduced.
d) Fresh Frozen Plasma.
CODE a) 12J034329, 12J03430;
b) 12J03431, 12J03429;
c) 12R29793, 12FF22814, 12FF22807, 12Z45886, 12V36196, 12V36187, 12K79908, 12K79899, 12K79851, 12H59516,
12H59507;
d) 12FF22811, 12FF22808, 12Z45888, 12FF22821, 12FF22845, 12FF22842, 12FF22830, 12FF22825, 12FF22824, 12FF22822, 12FF22819, 12FF22815, 12FF22809, 12FF22806, 12Z45905, 12Z45904, 12Z45903, 12Z45900, 12Z45899, 12Z45898, 12Z45897, 12Z45891, 12Z45890, 12Z45887, 12V36195, 12H59550, 12G5948, 12H59547, 12H59542, 12H54541, 12H59539, 12H59530, 12H59224, 12H59522, 12H59520, 12H59510, 12H59508, 12H59504.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC.
REASON Blood products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 2 units;
c) 11 units;
d) 38 units.
DISTRIBUTION NC, and SC.

PRODUCT a) Red Blood Cells. b) Red Blood Cells, Leukocytes Reduced.
CODE
a) Unit number 1329-8160;
b) Unit numbers 11328-8639, 11329-1497, 11329-9750, 11329-3011, 11332-2407, 11331-8358, 11330-4162.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX.
REASON Blood products, with incomplete compatibility testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Platelets.
CODE a) and b) Unit number 4301146.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
REASON Blood products, collected from an ineligible donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit number LL76561.
RECALLING FIRM/MANUFACTURER Blood Bank of the Redwoods, Santa Rosa, CA.
REASON Blood products, which were labeled as leukoreduced, but did not meet the requirements for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.

CODE Unit number 4419947.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
REASON Blood product, which tested negative for the antibody to the human T-lymphotropic virus type I/II, but was collected from a donor who on two occasions previously tested repeatedly reactive for anti-HTLV-I/II, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells. b) Recovered Plasma.
CODE a) and b) Unit number KC38318.
RECALLING FIRM/MANUFACTURER Blood Bank of the Redwoods, Santa Rosa, CA.
REASON Blood products, collected from a donor with a history of IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers 59383727, 59218739, 59216537, 59211846, 59211006, 57864334, 57862231, 57747002, 57745404, 57630281, 57628400, 57623221, 56818826, 56816020, 56266993, 56263411, 56148855, 56143928, 56023237, 56021318.
RECALLING FIRM/MANUFACTURER BioLife Plasma Service, Richmond, VA.
REASON Blood products, which test reactive for syphilis, or were collected from a donor who previously tested reactive for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 20 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE 59-FVCJRD-O, 59-FVCJVG-O, 59-FVCKCX-O, 59-FVCKJG-O, 59-FVCKMN-O, 59-FVCKTB-O, 59-FVCKYT-O, 59-FVCLBY-O, 59-FVCLHY-O, 59-FVCLKW-O, 59-FVCMYB-O, 59-FVCNCF-O, 59-FVCNGP-O, 59-FVCLPX-O, 59-FVCLSC-O, 59-FVCLWD-O.
RECALLING FIRM/MANUFACTURER Aventis BioServices, Inc., dba Seramed BioServices, Champaign, IL.
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 16 units.
DISTRIBUTION IL.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit number 4321553.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
REASON Blood product, collected from a donor whose body temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.

PRODUCT Source Plasma.
CODE HW043730, HW042443, HW042042, HW041484, HW041093, HW040557, HW040197, HW038667, HW037026, HW036468, HW036095, HW035413, HW035022.
RECALLING FIRM/MANUFACTURER Bio Life Plasma Services, Huntington, WV.
REASON Blood products, collected from a donor whose eligibility to donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION NC.

PRODUCT Platelets.
CODE Unit number 4188244.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
REASON Blood product, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Fresh Frozen Plasma.
CODE
a) 27LG53894, 27LG53896, 27LG53892, 27LG53950, 27LG53922, 27LG53890;
b) 27LG53894.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Johnstown, PA.
REASON Blood products, corresponding to Platelets that tested positive for Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION MD, and PA.

PRODUCT a) Red Blood Cells. b) Recovered Plasma.
CODE a) and b) Unit numbers 1922377, 2977052.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN.
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 IN, and Switzerland.

PRODUCT a) Red Blood Cells, Leukocytes; b) Platelets; c) Fresh Frozen Plasma.
CODE a), b) and c) Unit number 4024858.
RECALLING FIRM/MANUFACTURER Gulf Cost Regional Blood Center, Houston, TX.
REASON Blood products, collected from a donor with a history of having tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX, and NJ.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 27GS57799, 27GS57796, 27GS57795, 27GS51187, 27LM15741.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Johnstown, PA.
REASON Blood products, in which the corresponding platelets were contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MD, and PA.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit number 163563648.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Meridian, MS.
REASON Blood product, which was stored at unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT Platelet, Pheresis, Leukoreduced (Split).
CODE Unit number 163562619.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Meridian, MS.
REASON Blood product, which had a high platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MS.

PRODUCT Platelet, Pheresis, Leukoreduced, Irradiated.
CODE Unit number 163650773.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Meridian, MS.
REASON Blood product, which were labeled as leukoreduced, but that failed the quality control specification for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT Platelets.
CODE Unit number 163631724.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Meridian, MS.
REASON Blood product, corresponding to a unit that was observed to have clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT Platelet, Pheresis, Leukoreduced.
CODE Unit number 163643817.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Meridian, MS.
REASON Blood product, which had a high platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT Recovered Plasma.
CODE Unit number 163643156.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Meridian, MS.
REASON Blood product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit number 182306224.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY.
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 TX.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit number 127939517.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Albuquerque, NM.
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 New Mexico.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Pheresis.
c) Fresh Frozen Plasma.
d) Plasma.
CODE
a) Unit numbers 035J70375, 035J70378, 035J70383, 035L37117, 035L37118, 035S10888, 035S10892, 035S10893, 035S10932, 035S10939, 035S10953, 035S10961;
b) Unit numbers 035P39423, 035P39425, and the following split units: 035P39419, 035P39424, 035P39431;
c) Unit number 035P39424;
d) Unit number 035J70377.
RECALLING FIRM/MANUFACTURER American National Red Cross, Roanoke, VA.
REASON Blood products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 22 units.
DISTRIBUTION NJ, PA, MD, VA, and WV.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Fresh Frozen Plasma.
e) Plasma.
f) Recovered Plasma.
CODE
a) Unit numbers 04KS06250, 04KS03106, 04KS50502, 04KS33175;
b) Unit numbers 04KS66640, 04KS63318, 04KK28274;
c) Unit number 04KS33175;
d) Unit number 04KS33175;
e) Unit number 34KS03106;
f) Unit numbers 04KS06250, 04KS50502, 04KS63318, 04KK28274.
RECALLING FIRM/MANUFACTURER American National Red Cross, Dedham, MA.
REASON Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor that was subsequently determined to have a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION CA, NH, MA, ME, NY, and VT.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers 16362-9702 (distributed as two split products), 16362-9712, and 16362-9721.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON Blood products, that were collected during a period of apheresis machine validation but were not properly quality control tested, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MS.

PRODUCT Source Plasma.
CODE Unit numbers G-94520-070, G-94235-070, G-93908-070, G-93531-070, G-93254-070, G-92882-070, G-92625-070, G-92252-070, G-86580-070,

G-86157-070, G-86011-070, G-85597-070, G-85416-070, G-84772-070, G-84343-070, G-84175-070, G-83751-070, G-83598-070, G-83228-070,
G-83058-070, G-82398-070, G-81953-070, G-81776-070, G-80592-070, G-80151-070, G-79833-070, G-79475-070, G-79114-070, G-78812-070,

G-78112-070, G-72032-070, G-71719-070, G-71374-070, G-70999-070, N-92780-070, and N-92738-070.
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to previous reactive viral marker testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 36 units.
DISTRIBUTION CA, Spain, and Switzerland.

PRODUCT Source Plasma.
CODE Unit numbers 70488791, 70485578, and 70484274.
RECALLING FIRM/MANUFACTURER Nabi, Scranton, PA.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers 0090631358 and 0090631136.
RECALLING FIRM/MANUFACTURER Nabi, Scranton, PA.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Korea.

PRODUCT Source Plasma.

CODE Unit numbers 0090629821, 0090630179, 0090630321, 0090630570, and 0090631118.
RECALLING FIRM/MANUFACTURER Nabi, Scranton, PA.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION Korea.

PRODUCT Source Plasma.
CODE Unit numbers 0090631490, 0090631155, 0090631049, 0090630721, 0090630276, 0090630156, and 0090629787.
RECALLING FIRM/MANUFACTURER Nabi, Scranton, PA.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION Korea.

PRODUCT Source Plasma.
CODE Unit numbers 0090631384 and 0090631224.
RECALLING FIRM/MANUFACTURER Nabi, Scranton, PA.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Korea.

PRODUCT Source Plasma. .
CODE Unit number 26-BLQNMR-A.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Rock Island, IL.
REASON Blood product, collected from a donor with an elevated temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit number 163591629.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Meridian, MS.
REASON Blood product, which was determined to have a high hematocrit value, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT Red Blood Cells, Leukoreduced (Split).
CODE Unit number 182307460.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who was taking the drug Cephalexin, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WY.

WEEK ENDING JULY 12

PRODUCT
a) Red Blood Cells.

b) Cryoprecipitated AHF.
CODE a) and b) Unit number 3739820.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
REASON Blood products, collected from a donor whose eligibility to donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, NJ, and NY.

PRODUCT
a) Platelets for Further Manufacture.
b) Recovered Plasma.
CODE a) and b) Unit number 3739820.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
REASON Blood products, collected from a donor whose eligibility to donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, NJ, and NY.

PRODUCT Platelets.
CODE Unit number 4321624.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
REASON Blood product, collected from a donor who had received an MMR vaccination within three weeks of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Source Plasma.

CODE Unit number AEO484.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Lynchburg, VA.
REASON Blood product, that tested initially reactive for hepatitis B surface antigen (HbsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit number 20T28401.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise, ID.
Manufacturer: The American National Red Cross, Salt Lake City, UT. Firm initiated recall is complete.
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 UT.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 16365-7522.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON Blood products, possibly exposed to unacceptable shipping temperatures were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

WEEK ENDING JULY 19

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit number 01GP36549.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New York-Penn Region, West Henrietta, NY.
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 NY.

PRODUCT
a) Red Blood Cells.
b) Plasma. .
CODE a), and b) Units LL29757, LL28289.
RECALLING FIRM/MANUFACTURER Blood Bank of the Redwoods, Santa Rosa, CA.
REASON Blood products, collected from a donor taking the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MO, and CA.

PRODUCT Source Plasma. (2 units),
CODE Unit numbers 0090630898 and 0090631157.
RECALLING FIRM/MANUFACTURER Nabi, Scranton, PA
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Korea.

PRODUCT Source Plasma.
CODE Unit number 0090630899.
RECALLING FIRM/MANUFACTURER Nabi, Scranton, PA.
REASON Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Korea.

PRODUCT Source Plasma.
CODE Unit numbers 74537709 and 74539390.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Everett, WA.
REASON Blood products, collected from an ineligible donor due to previous incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Human Tissue for Transplantation, Corneas.
CODE Tissue numbers 007-02-019 and 007-02-020.
RECALLING FIRM/MANUFACTURER East Tennessee Lions Eye Bank, Knoxville, TN.
REASON Human tissue that was not tested for antibodies to human immunodeficiency virus, type 2 (anti-HIV-2) was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION TN.

PRODUCT Human Tissues for transplantation, Achilles Tendon.
CODE Serial # 7345076.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
REASON Human tissues for transplantation, which were associated with a complaint of alleged microorganism infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION SD.

PRODUCT Human Tissues for transplantation, Saphenous Vein.
CODE Serial # 7235647
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.

REASON Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Human Tissues for transplantation.
a) Femoral Vein with valve;
b) Saphenous Vein.
CODE
a) Serial # 7158918;
b) Serial # 7360291, 7332864, 7360271.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
REASON Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA, FL, NY, and TX.

PRODUCT Human Tissues for transplantation, Saphenous Vein.
CODE Serial # 7291004
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
REASON Human tissue for transplantation, which was associated with a donor whose pre-processing culture detected microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Red Blood Cells.
CODE Unit numbers 7582235 (distributed as two split products), 7581111, and 5231694.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE4 units.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma (1 unit)
CODE
a) Unit numbers 7848956 and 7797922;
b) Unit number 7797922;
c) Unit number 7848956.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from an ineligible donor due to use of the medication Prednisone, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX, NY, and Switzerland.

PRODUCT Red Blood Cells.
CODE Unit number 7547785.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
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 TX, and Switzerland.

PRODUCT Red Blood Cells.
CODE Unit number 7547419.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
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 TX, and Switzerland.

PRODUCT Red Blood Cells.
CODE Unit number 7547772.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
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 TX, and Switzerland.

PRODUCT
a) Red Blood Cells.
b) Cryoprecipitated AHF.
CODE a) and b) unit number 7445208.
RECALLING FIRM/MANUFACTURER Recalling Firm: Carter BloodCare, Bedford, TX.
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 TX, and Switzerland.

PRODUCT Red Blood Cells.
CODE Unit number 7450164.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Red Blood Cells.
CODE Unit number 5293106.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Chiron ProcleixÔ System Computer Software.
CODE Version numbers 1.0.1.0, 3.0.3.4, and 2.1.2.0.
RECALLING FIRM/MANUFACTURER Gen-Probe, Inc., San Diego, CA.
REASON A computer software defect could result in invalid calibrator results being used in the determination of assay validity and cut-off for HIV and HCV nucleic acid testing (NAT) test results.
VOLUME OF PRODUCT IN COMMERCE 3 versions.
DISTRIBUTION Nationwide, France, New Zealand, Japan, and Singapore.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit numbers 23147-0769, 23147-0777, 23147-0781, 23147-1510.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Billings, MT.
REASON Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION AL, and MT.

PRODUCT Human Tissues for transplantation.

a) Achilles Tendon;
b) Saphenous Vein.
CODE
a) Serial # 4265408;
b) Serial # 7239995.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
REASON Human tissues for transplantation, which were associated with a complaints of alleged microorganism infection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ, CA, LA, and NB.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 11332-4739.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX.
REASON Unlicensed blood product was distributed interstate.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NM.

PRODUCT a) Platelets. b)Fresh Frozen Plasma.
CODE a) and b) unit number 7419315.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, manufactured from a unit of Whole Blood that had a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Recovered Plasma.
CODE
a), b), and c) Unit number 5304199;
b) (unit was included in Platelet Pool #5186236).
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX, and Switzerland.

PRODUCT Recovered Plasma.
CODE Unit number 7797922.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from an ineligible donor due to use of the medication Prednisone, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX, NY, and Switzerland.

PRODUCT Recovered Plasma.
CODE Unit number 7547785.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
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 TX, and Switzerland.

PRODUCT Recovered Plasma.
CODE Unit number 7547419.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
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 TX, and Switzerland.

PRODUCT Recovered Plasma.
CODE Unit number 7547772.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
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 TX, and Switzerland.

PRODUCT Recovered Plasma.
CODE Unit number 7445208.
RECALLING FIRM/MANUFACTURER Recalling Firm: Carter BloodCare, Bedford, TX.
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 TX, and Switzerland.

PRODUCT Recovered Plasma.
CODE Unit number 7547777.
RECALLING FIRM/MANUFACTURER Recalling Firm: Carter BloodCare, Bedford, TX.
REASON Blood product, 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), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland

WEEK ENDING JULY 26

PRODUCT Human Tissues for transplantation.
CODE
a) Non-Valve Cardiac Tissue;
b) Ortho Tissue;
c) Vein Tissue.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA.
REASON Human tissues for transplantation, for which the firm failed to take adequate corrective measures to address possible infectious disease contamination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 739 units;
b) 4,201 units;
c) 2,973 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Human Tissue for transplantation.
CODE Saphenous Vein Donor #55698, Serial number 6160794.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA.
REASON Human tissues for transplantation, collected from a donor whose companion sample, from a different site, was positive for microorganisms, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Source Plasma.
CODE 0090596020, 0090595738, 0090595384, 0090594996, 0090593998, 0090593747, 0090587411, 0090587175, 0090586834, 0090586584, 0090586206, 0090585760, 0090585310, 0090585079, 0090582887, 0090581850, 0090581641, 0090581219, 0090580795, 0090580287, 0090580065, 0090579480, 0090578141, 0090577937, 0090577512, 0090576982, 0090576679, 0090576383, 0090576109, 0090575745, 0090575478, 0090575103, 0090574796, 37163808, 37162825, 37161811, 37160852, 37157357, 30481220, 41057346, 41054963, 41053188, 41052129, 41044476, 41042311, 41041086, 28539292, 28537311, 28535645, 28534365, 29560035, 29557981, 24785839, 24782807, 24781428, 24647755, 24646260.
RECALLING FIRM/MANUFACTURER NABI Biomedical Center, Scranton, PA.
REASON Blood products, collected from a donor who had body piercing within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 57 units.
DISTRIBUTION CA, and Austria.

PRODUCT Cryoprecipitated AHF.
CODE Unit 50LG80935.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH.
REASON Blood products, corresponding to a unit of red cells that was implicated in a transfusion reaction and found to be contaminated with Streptococcus oralis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit 7827826.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX.
REASON Blood products, collected from a donor that did not answer a medical history question concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.
CODE Units 5329576, 7587566, and 5300890 (split unit).
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX.
REASON Blood products, which did not have quality control testing for hematocrit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.
CODE Unit 7892624.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX.
REASON Blood products, collected from a donor who affirmatively answered a medical history question related to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL, and Switzerland.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.

b) Fresh Frozen Plasma.
CODE a), and b) Unit number 5077836.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Eastern Maine Medical Center, Bangor, ME.
REASON Blood products, that tested repeatedly reactive for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION ME.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a), an b) Unit number 4349455.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
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 2 units
DISTRIBUTION TX, and NJ.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated.
CODE a), and b) Unit number 4179284.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
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 TX, and NJ.

PRODUCT a) Platelets. Recall # B-1349-3; b) Fresh Frozen Plasma.
CODE a) Unit numbers 38LC18763, 38H54665, 38H54672, 38FC66777, 38LC13501, 38H52839, 38H52015, 38K99105 and 38FC57207;
b) Unit numbers 38L64002, 38H54665, 38H54672, 38H52839, 38FK14212, 38LC12671, 38H52015, 38FH08706, 38FC61062 and 38K82831.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN.
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 9 units; b) 10 units.
DISTRIBUTION IN, MT, and MS.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 38P80509.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN.
REASON Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Recovered Plasma.
CODE a) and b) Unit number 38FC90836.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN.
REASON Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN, and CA.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Platelets. c) Fresh Frozen Plasma.
CODE a), b), and c) Unit number 1892984.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX.
REASON Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Fresh Frozen Plasma.
CODE a) and b) Unit number 2356275.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX.
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 TX, and WI.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Cryoprecipitated AHF, Pooled. c) Plasma, Cryoprecipitate Reduced.
CODE a) and c) Unit number 2348972; b) Unit number 4018697.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX.
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; 1 pool.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Recovered Plasma.
CODE a) and b) Unit number 2336335.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX.
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.
DISTRIBUTION TX and FL.

PRODUCT Human Tissue for Transplantation, Pulmonic Valve.
CODE Unit number 202683.
RECALLING FIRM/MANUFACTURER Alabama Tissue Center, Inc., Birmingham, AL.
REASON Human tissue was inadequately tested for infectious disease in that the blood sample used for testing may have been hemodiluted.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION FL.

PRODUCT a) Red Blood Cells. b) Red Blood Cells, Leukocytes Reduced. c) Platelets.d) Cryoprecipitated AHF. e) Source Leukocytes.
f) Recovered Plasma.
CODE a) Unit numbers 3358116, 3336687, 3296389, 3262624, 3228118, 3124127, 3099634, 3055028, 3022898, 2987487, 2855967, 2819888, and 2765485;
b) Unit number 3188732;
c) Unit numbers 3336687, 3296389, 3228118, 3124127, 2987487, 2855967, 2819888, and 2765485;
d) Unit number 3022898;
e) Unit numbers 3406252, 3358116, 3336687, 3262624, 3228118, 3124127, 3099634, 3055028, 3022898, 2987487, 2855967, 2819888, and 2765485;
f) Unit numbers 3358116, 3336687, 3296389, 3228118, 3099634, 2819888, 3262624, 3188732, 3124127, 3055028, 2855967, and 2765485.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
REASON Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 13 units;
b) 1 unit;
c) 8 units;
d) 1 unit;
e) 13 units;
f) 12 units.
DISTRIBUTION CA, TX, MI, NY, NJ, FL, NE, WA, and PR.

PRODUCT Human Tissue for Transplantation, Pulmonic Valve.
CODE Unit number 2502656.
RECALLING FIRM/MANUFACTURER Alabama Tissue Center, Inc., Birmingham, AL.
REASON Human tissue was procured from an unsuitable donor due to a possible familial history of Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION MI.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Recovered Plasma.
CODE a) and b) Unit numbers 27GG17859 and 27GG16746.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION PA, and CA.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Recovered Plasma. Recalled # B-1393-3.
CODE a), and b) Unit number 4128753.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
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 2 units.
DISTRIBUTION TX, and NJ.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 4368681.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
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 TX.

PRODUCT a) Red Blood Cells. b) Platelets. Recall # B-1396-3.
CODE a) Unit numbers 34026249 and 32022579; b) Unit number 34026249.
RECALLING FIRM/MANUFACTURER W. E. and Lela I. Stewart Blood Center, Tyler, TX.
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 3 units.
DISTRIBUTION TX.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 6812013.
RECALLING FIRM/MANUFACTURER W. E. and Lela I. Stewart Blood Center, Tyler, TX.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.
CODE Unit numbers 11020334, 31028492, and 31028500.
RECALLING FIRM/MANUFACTURER W. E. and Lela I. Stewart Blood Center, Tyler, TX.
REASON Blood products that were labeled as Red Blood Cells, Leukocytes Reduced, but had not been leukocyte reduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Cryoprecipitated AHF. c) Recovered Plasma.
CODE a), b), and c) Unit number 21GE31093.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR.
REASON Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OR, CA, and Switzerland.

PRODUCT a) Red Blood Cells. b) Red Blood Cells, Leukocytes Reduced. c) Plasma. d) Recovered Plasma.
CODE a) and c) Unit number 21GW24094; b) and d) Unit numbers 21GW33411 and 21GW32322.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR.
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 6 units.
DISTRIBUTION OR, CA, and WA.

PRODUCT Platelets.
CODE Unit number 7841543.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, prepared from a donation that had discrepant start and stop collection times documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Recovered Plasma.
CODE Unit 7892624.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX.
REASON Blood products, collected from a donor who affirmatively answered a medical history question related to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL, and Switzerland.

PRODUCT a) Red Blood Cells. b) Cryoprecipitated AHF. c) Recovered Plasma.
CODE a), b), and c) Unit number 7823699.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX, and Switzerland.

PRODUCT a) Platelets, Pheresis, Leukocytes Reduced. b) Platelets, Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) Units # 21KP31384, 21KP31385; b) Unit # 21KP31387.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services.
REASON Platelets, labeled with an incorrect volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OR, and CA.

PRODUCT Recovered Plasma.
CODE Unit number 4179284.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.

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 TX, and NJ.

PRODUCT Platelets for Further Manufacture.
CODE Unit number 2356275.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX.
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 1 unit.
DISTRIBUTION TX, and WI.

PRODUCT Platelets Pheresis.
CODE Unit numbers 0000010 and 0000012.
RECALLING FIRM/MANUFACTURER The Extracorporeal Alliance, L.L.C., Lansing, MI.
REASON Blood products, incorrectly tested for viral markers due to the use of expired blood sample tubes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit numbers 8237532, 8237542, and 6811952.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, IN.
REASON Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IN.

PRODUCT Red Blood Cells.
CODE Unit numbers 6839759 and 6839765.
RECALLING FIRM/MANUFACTURER W. E. and Lela I. Stewart Blood Center, Tyler, TX.
REASON Blood product, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 6814186.
RECALLING FIRM/MANUFACTURER W. E. and Lela I. Stewart Blood Center, Tyler, TX.
REASON Platelets, not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers 6810493, and 6810498.
RECALLING FIRM/MANUFACTURER W. E. and Lela I. Stewart Blood Center, Tyler, TX.
REASON Blood products, that were labeled leukoreduced but were not tested for white blood cell count within the time frames required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 10026857.
RECALLING FIRM/MANUFACTURER W. E. and Lela I. Stewart Blood Center, Tyler, TX.
REASON Blood product, that was labeled leukoreduced but were not tested for white blood cell count within the time frames required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells. b) Recovered Plasma.
CODE a), and b) Unit number 30017971.
RECALLING FIRM/MANUFACTURER W. E. and Lela I. Stewart Blood Center, Tyler, TX.
REASON Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, and Switzerland.

PRODUCT Red Blood Cells.
CODE Unit number 12011334.
RECALLING FIRM/MANUFACTURER W. E. and Lela I. Stewart Blood Center, Tyler, TX.
REASON Blood product, collected from an ineligible donor due to a history of a chronic ulcerative condition, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.