MAY 2005

MAY 2005

WEEK ENDING MAY 7

PRODUCT HNA Classic 306 Patient Manager Blood Bank Software. .
CODE Revision 159 and higher.
RECALLING FIRM/MANUFACTURER Cerner Corporation, Kansas City, MO
REASON Defects in the design of blood bank software could result in loss of patient antibody information.
VOLUME OF PRODUCT IN COMMERCE 246 software packages.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Platelet Pheresis, Leukoreduced.
CODE Unit: 26FQ22950.
RECALLING FIRM The American National Red Cross, Gulf Coast Region, Mobile, AL
REASON Blood product, with an unacceptably high platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit number: 32KQ73643.
RECALLING FIRM/MANUFACTURER American Red Cross, Badger-Hawkeye Region, Madison, WI
REASON Blood products, collected from a donor who had lived in an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WI, and IL.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit: 19GW46817.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood product, collected from a donor who lived in an area considered to be endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit: 101858379.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ
REASON Blood product, collected from a donor who traveled to an area considered to be endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit: 102953958.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ
REASON Blood product, collected from a donor who traveled to an area considered to be endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit: 102920115.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ
REASON Blood product, collected from a donor who traveled to an area considered to be endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.

PRODUCT
Blood Bank Devices.
a) Neonatal Pediatric Aliquot System;
b) Neonatal/Pediatric Syringe System;
c) Blood Administration Set;
d) Plasma/Fluid Transfer Set;
e) Pooling Harness Set;
f) Blood Transfer Bag;
g) Blood Freezing Bag;
h) Stem Cell Freezing Bag;
i) Platelet Sampling Device.
CODE
a) Product Numbers: T2008, T2182, T2183, T2186, T2188, T3000, T3001, T3002, T3003, T3007, T3605, T3607;
b) Product Numbers: 03-960-32, 03-960-33, 03-960-34, 03-960-57;
c) Product Numbers: 03-110-01, 03-110-65, 01-110-85, 03-111-02, 03-111-03, 03-118-01, 03-122-00, 03-122-10, 03-202-13;
d) Product Numbers: 03-220-00, 03220-01, 03-220-10, 03-220-30, 03-220-31, 03-220-50, 03-220-90, 03-220-91, 03-220-92, 03-220-94, 03-220-95, 03-220-99, 03-220-ACP;
e) Product Numbers: T3006, T3194, T3198, T3199, T4004, T4006, T6010, T8004, T6006, T8005, T8006, T8010, T9006;
f) Product Numbers: T3101, T3104, T3106, T3107, T3108, T3109, T3135, T3137, T3160, T3196, T3972, T3992, T3103,
T3106X2, T3108SL, T9700, BT1000, BT300, BT600, C600, C605, C1000-QD, C605SWL, CBC-400;
g) Product Numbers: T3400, T3401, T8703, T8703H;
h) Product Numbers: LN025S01, LN060SO1, LN060T02, LN075S01;
i) Product Numbers: 03-220-AC, 03-220-BC, 03-220-LKY, 03-220-TMR.
RECALLING FIRM/MANUFACTURER Charter Medical Ltd., Winston-Salem, NC
REASON Blood Bank devices, with an inadequate validation of the sterilization cycle, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4,667,444 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Recovered Plasma.
CODE Unit 26FZ09483.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Gulf Coast Region, Mobile, AL
REASON Blood product, collected from a donor considered to be at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Platelets Pheresis, Leukocytes Reduced.
e) Fresh Frozen Plasma.
f) Recovered Plasma.
CODE
a) Units 5169910, 5176203, 5180685;
b) Units 5184908, 5190560, 6101295;
c) Unit 5176203;
d) Unit 2522363;
e) Units 5169910, 5176203, 5180685,
5184908, 6101295;
f) Unit 5190560.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, TX
REASON Blood products, which tested negative for viral markers, but were collected from a donor who 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 14 units.
DISTRIBUTION NY, TX, and Switzerland.

PRODUCT Red Blood Cells (Apheresis).
CODE Unit number: 9037033.
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc., Greenville, SC
REASON Blood product, lacking monthly quality control testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION SC.

PRODUCT
a) Red Blood Cells, Leukocytes Removed, Irradiated.
b) Platelets Leukocytes Removed.
CODE a) and b) Unit number: 19GS59253.
RECALLING FIRM/MANUFACTURER American Red Cross, Tennessee Valley Region, Nashville, TN
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 AR, and TN.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number: 04GC13968 (Part 1).
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA
REASON Platelet Pheresis, possibly contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Red Blood Cells.
CODE Unit 12KR38226.
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected from a donor with a history of Hypereosinophilic Syndrome, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit: EVG005194.
RECALLING FIRM/MANUFACTURER Biomat USA Inc., Houston, TX
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 Spain.

WEEK ENDING MAY 14

PRODUCT Red Blood Cells, Leukoreduced.
CODE Units: 12KZ16113, 12KZ16893.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood products, collected from a donor who had traveled to an area considered to be endemic for malaria, were contributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 4631971.
RECALLING FIRM Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood product, collected from a donor who did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OK.

PRODUCT Platelet Pheresis, Leukocyte Reduced.
CODE Unit: 26FQ22720.
RECALLING FIRM/MANUFACTURER The American Red Cross Blood Services, Gulf Coast Region, Mobile, AL
REASON Blood product, collected from a donor whose health 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 AL.

PRODUCT Platelet, Leukocyte Reduced.
CODE Unit: 19LG19164.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Platelets, Leukocyte Reduced.
CODE Unit: 19GW59852.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Source Plasma.
CODE Units: 0420956032, 0420956329, 0420956963, 0420957236, 0420957860, 0420958156, 0420958541, 0420958925, 0420960188, 0420960469, 0420960984, 0420961353, 0420961833, 0420962277, 0420962725, 0420963631, 0420963955, 0420967478, 0420967943, 0420988995, 0420995104, 04220995734, 0420995941, 0420996972.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Lansing, MI
REASON Blood products, collected from a donor who had previously been deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE 24 units.
DISTRIBUTION FL, and NC.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit: 26FJ34363.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Gulf Coast Region, Mobile, AL
REASON Blood products, collected from a donor who had engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AL, and Switzerland.

PRODUCT Platelets, Leukocytes Removed.
CODE Unit number: 19GW51439.
RECALLING FIRM/MANUFACTURER American Red Cross, Nashville, TN
REASON Blood product, in which the corresponding red blood cell was possibly contaminated with Enterococcus faecalis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Platelet Pheresis, Leukoreduced.
CODE Unit 12W96709.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected in an apheresis collection kit where the set up time may have exceeded the manufacturerís acceptable time period for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 12LW96259.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Region, Charlotte, NC
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 NC.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number: LN12736.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Platelet Pheresis, possibly contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number: 26FQ22938 (Part 1).
RECALLING FIRM/MANUFACTURER American Red Cross, Gulf Coast Region, Mobile, AL
REASON Platelet Pheresis, in which the corresponding blood component was contaminated with coagulase-negative, Staphylococcus and implicated in a transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 04C92255.
RECALLING FIRM/MANUFACTURER American National Red Cross, New England Region, Dedham, MA
REASON Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 04R19468.
RECALLING FIRM/MANUFACTURER American National Red Cross, New England Region, Dedham, MA
REASON Blood product, collected from donors who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit 04P55891.
RECALLING FIRM/MANUFACTURER American National Red Cross, New England Region, Dedham, MA
REASON Blood product, collected from an ineligible donor due to use of the medication Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Units: 26FJ14534, 26FJ21236.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Gulf Coast Region, Mobile, AL
REASON Blood Products, collected from a donor who had previously tested reactive for hepatitis C (HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION AL, and CA.

PRODUCT
a) Red Blood Cells, Leukocyte Reduced.
b) Recovered Plasma.
CODE a) and b) Units: 04KJ03969, 04KM53407.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New England Region, Dedham, MA
REASON Blood Products, collected from a donor with a history of hepatitis C and mononucleosis were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MA, and CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Plasma Frozen.
c) Recovered Plasma. .
CODE
a) Unit numbers: 12FZ13002, 12LE98950, 12LW91617;
b) Unit number: 12LW91617;
c) Unit numbers: 12FZ13002, 12LE98950.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Region, Charlotte, NC
REASON Blood products, which were collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION NC, GA, and CA.

PRODUCT Fresh Frozen Plasma.
CODE Unit 04FC23433.
RECALLING FIRM/MANUFACTURER American National Red Cross, New England Region, Dedham, MA
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION ME.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit 0112239.
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Inc., Lauderhill, FL
REASON Blood product, mislabeled as a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number: 12FC80938.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Region, Charlotte, NC,
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 2 units.
DISTRIBUTION CA, and NC.

PRODUCT Platelets Pheresis, Leukocytes Reduced. .
CODE Units 19LH02074 (Part 1 & Part 2).
RECALLING FIRM/MANUFACTURER American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number: LS05599
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Platelets Pheresis, with a decreased platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Red Blood Cells. .
CODE Unit 4206982.
RECALLING FIRM/MANUFACTURER Florida Blood Services, Inc., St. Petersburg, FL
REASON Blood product, which was collected from a donor who was incorrectly tested for the antibody to the hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells, Irradiated.
CODE Unit numbers: 0198903, 0150196, 0197656.
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL
REASON Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION FL.

PRODUCT Platelet Pheresis, Leukoreduced, Irradiated.
CODE Unit: S14633.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA
REASON Blood product, that was out of controlled storage for an undocumented length of time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 33GR76222, 33GR76195.
RECALLING FIRM/MANUFACTURER American National Red Cross, Connecticut Region, Farmington, CT
REASON Blood products, manufactured from units of whole blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CT.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit number: 4223645.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood products, collected from an unsuitable donor due to the use of Cipro, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 307736899.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Fargo, ND.
REASON Blood product, which was collected from a donor who had surgery within 12 months of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MN.

PRODUCT Source Plasma.
CODE Unit number: BRG012913.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Baton Rouge, LA
REASON Blood product, that tested negative for viral markers, but was collected from a donor whose medical history was not adequately determined at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Spain.

PRODUCT Source Plasma.
CODE Unit 02FNDB1927.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Fargo, ND
REASON Blood product, which was collected from a donor who had a sinus infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Fresh Frozen Plasma (Apheresis).
CODE Unit numbers: 0009621 (FF2, FF3, FF4).
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL
REASON Unlicensed blood products were distributed in interstate commerce.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NY.

PRODUCT Recovered Plasma.
CODE Unit number: 5009411.
RECALLING FIRM/MANUFACTURER Altru Health System, Grand Forks, ND
REASON Blood product, which was collected from a donor who tested negative for the antibody for the human immunodeficiency virus (anti-HIV), but previously tested positive for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Red Blood Cells Leukocytes Reduced Irradiated.
CODE
a) Units 04E72996, 04E72997, 04E72998, 04E72999, 04E73000, 04E73001, 04E73002, 04E73003, 04E73004, 04E73005, 04E73008, 04E73009, 04E73010, 04E73011, 04E73012, 04E73013, 04E73014, 04E73016, 04E73017, 04E73018, 04E73020, 04E73021, 04E73022, 04E73023, 04E73024, 04E73025, 04E73026, 04E73027, 04E73028, 04E73029, 04E73030, 04E73031, 04E73032, 04E73033, 04E73034, 04E73035, 04E73036, 04E73037, 04E73038, 04E73039, 04E73040;
b) Unit 04E73006.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Dedham, MA
REASON Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 42 units.
DISTRIBUTION MA, and NY.

WEEK ENDING MAY 21

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit: 26KE44577.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Gulf Coast Region, Mobile, AL
REASON Blood product, collected from a donor who had lived in an area considered to be endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit: 4525832.
RECALLING FIRM: Northern California Community Blood Bank, Eureka, CA
REASON Blood product, collected from a donor who reported travel to an area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA..

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE Units: 6792683, 7002628.
RECALLING FIRM: Carter Blood Care, Bedford, TX
REASON Blood products, which did not meet minimum weight requirements, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Source Plasma.
CODE Unit numbers: 116065, 117073, 117155, 117455, 117698, 117937, 118136, 118511, 118690, 118936, 119160, 119378, 337561, 337823, 338093, 338238, 388108, 388291, 388655, 388718, 389216, and 389383.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, San Angelo, TX
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 22 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers: 118443, 118619, 119019, 119156, 119473, 337554, 337904, 337997, 388204, 388278, 388602, 388700, 388995, 389130, and 389505.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, San Angelo, TX
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Units: 6270288440, 6270287649, 6270286890.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Salt Lake City, UT
REASON Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number: 06GJ78639.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern California Region, Pomona, CA
REASON Blood products, collected from a donor who received a body piercing within twelve months of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells.;
b) Recovered Plasma.
CODE a) and b) Unit number: 06GK44104.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern California Region, Pomona, CA
REASON Blood products tested negative for viral markers but were collected from an ineligible donor due to risk factor for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers: 388131, 388192, 388604, 388876, 389011, 389292, and 389482.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, San Angelo, TX
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION NC.

PRODUCT Whole Blood for Manufacturer of Non-Injectables.
CODE Unit EC005058.
RECALLING FIRM/MANUFACTURER Knoxville Plasma Corporation, Knoxville, TN
REASON Blood product, which tested repeatedly reactive for the antibody to hepatitis C virus (anti-HCV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.

PRODUCT Source Plasma.
CODE Unit number: 398834.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, San Angelo, TX,
REASON Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Red Blood Cells.
CODE Unit 26FF43919.
RECALLING FIRM/MANUFACTURER American National Red Cross, Gulf Coast Region, Mobile, AL
REASON Blood product, which tested positive for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.

PRODUCT Fresh Frozen Plasma.
CODE Unit number: 3186322.
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL
REASON Blood product, collected from an unsuitable donor due to a recent blood product transfusion, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Platelets Pheresis, Irradiated.
CODE Unit number 19LP03488.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Recovered Plasma.
CODE Unit number: 2823825.
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL
REASON Blood product, that tested negative for viral markers, but was collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Source Plasma. .
CODE Unit number: 03RMIC7845.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services, L.P., Grand Rapids, MI
REASON Blood product was collected in a manner that may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers: 360022030 and 360023905.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., South Bend, IN
REASON Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Spain.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Recovered Plasma.
CODE a), b), and c) Unit number: 4556254.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK\
REASON Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OK, TX, and Switzerland.

PRODUCT Source Plasma.
CODE Unit numbers 66171942 and 66169307.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL
Manufacturer: ZLB Bioplasma, Inc., Gresham, OR.
REASON Blood products, collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers: 81359073, 81344802, 81323296, 81319046, 81295418, 81289110, 81282685, 81260539, 81255771, 81252503, and 81243372.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL
Manufacturer: ZLB Bioplasma, Inc., Gresham, OR. .
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION CA.

PRODUCT Source Plasma. .
CODE Unit numbers: 81313570 and 66206521.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL
Manufacturer: ZLB Bioplasma, Inc., Gresham, OR.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Human Tissue for Transplantation, Corneas.
CODE Corneas numbers CT200502-6-2-R-01 and CT200502-6-2-L-01.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tissue Banks International, Baltimore, MD\
Manufacturer: Connecticut Eye Bank and Visual Research Foundation, Inc., New Britain, CT.
REASON Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION Italy.

PRODUCT Source Plasma.
CODE Unit numbers 01BMTA4766, 01BMTA2437, 01BMTA1228, 01BMTA0943, and 01BMTA0728.
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P. Deerfield, IL
Manufacturer: BioLife Plasma Services L.P., Billings, Me.
REASON Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MI.

PRODUCT Red Blood Cells.
CODE Unit number 38J52107.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN
REASON Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Units 6270288602, 6270287728.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Salt Lake City, UT
REASON Source Plasma, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob Disease (CJD) and variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 301858029.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturing Firm: Blood Systems, Inc., Fargo, ND.
REASON Blood product, incorrectly tested for Cytomegalovirus (CMV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION ND.

PRODUCT Source Plasma.
CODE Unit numbers: SW078409, SW078919, SW079683, SW079964.
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services, Deerfield, IL
Manufacturer: BioLife Plasma Services, Seattle, WA.
REASON Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to the receipt of tattoos and body piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers 360006619, 360006901, 360007404, 360007682, 360008247, 360008549, 360009562, 360009793, 360011443, 360012052, 360012397, 360012693, 360013182, 360013621, 360014261, 360014605, 360015194, 360018471, 360018976, 360019646, 360020309, 360020449, 360020930, and 360021752.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., South Bend, IN
REASON Blood products, that tested negative for viral markers, but were collected from a donor that did not have the routine physical examination performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 24 units.
DISTRIBUTION Spain.

PRODUCT Source Plasma.
CODE Unit number: F-10011-009.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., Tacoma, WA
REASON Blood product, collected from an unsuitable donor based on an unexplained weight loss, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Spain.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number: 4503041.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products collected from a donor whose suitability determination was inadequately performed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OK, and Switzerland.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) Unit numbers: 18FT95844 and 18FT95847;
b) Unit number: 18FT95847.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI
REASON Blood products collected from a donor whose suitability determination was inadequately performed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Platelets, Irradiated.
e) Platelets, Leukocytes Reduced.
f) Fresh Frozen Plasma.
g) Recovered Plasma. .
CODE
a) Unit numbers 38KT00312 and 38KT10720 (4 split units);
b) Unit numbers 38FE89461, 38FE89487, 38FE89831, 38FE89876, 38H86598, 38H86889, 38H86910, 38H86927, 38H87310, 38H87542, 38H87626, 38H87684, 38H87749, 38H87771, 38H88128, 38H88260, 38H88264, 38H88289, 38H88305, 38H88351, 38H88510, 38H88741, 38H88873, 38H88974, 38H89019, 38H89048, 38H89063, 38H89066, 38H89070, 38H89079, 38H89084, 38H89090, 38H89112, 38H89309, 38H89348, 38H89399, 38H89402, 38H89492, 38H89515, 38H89556, 38H90129, 38H90171, 38H90313, 38H90496, 38H90692, 38H90756, 38H90811, 38H90816, 38H90904, 38H90970, 38H91058, 38H91236, 38H91258,
38H91283, 38H91444, 38H91620, 38H91798, 38H91869, 38H91948, 38H91970, 38H91986, 38H92022, 38H92063, 38H92080, 38H92356, 38H92432, 38H92454, 38H92462, 38H92464, 38H92613, 38H92623, 38H92624, 38H92625, 38H92651, 38H92659, 38H92686, 38H92739, 38H92880, 38H92908, 38H92918, 38H93088, 38H93111, 38H93122, 38H93129, 38H93135, 38H93262, 38H93404, 38H93467, 38H93539, 38H93547, 38H93661, 38H93749, 38H93772, 38H93775, 38H93792, 38H93845, 38H93980, 38H94097, 38H94108, 38H94119, 38H94454, 38H94484, 38H94503, 38H94524, 38H94530, 38H94531, 38H94554, 38H94597,
38H94647, 38H94722, 38H94734, 38H94735, 38H94742, 38H94748, 38H94749, 38H94753, 38H94755, 38H94763, 38H94770, 38H94891, 38H95078, 38H95109, 38H95166, 38H95204, 38H95506, 38H95743, 38H95920, 38H95928, 38H95956, 38H95983, 38H95994, 38H95996, 38H96006, 38H96012, 38H96022, 38H96024, 38H96111, 38H96173, 38H96205, 38H96400, 38H96405, 38H96497, 38H96661, 38H96843, 38H96959, 38H97005, 38H97249, 38H97327, 38H97353, 38H97450, 38H97685, 38H97869, 38H97882, 38H97900, 38H98140, 38H98196, 38H98213, 38H98274, 38H98368, 38H98695, 38H98803, 38H99506, 38H99509,
38H99518, 38H99592, 38KT00068, 38KT00098, 38KT00106, 38KT00108, 38KT00113, 38KT00133, 38KT00141, 38KT00142,
38KT00152, 38KT00155, 38KT00164, 38KT00176, 38KT00216, 38KT00220, 38KT00226, 38KT00232, 38KT00247, 38KT00254, 38KT00590, 38KT00607, 38KT00767, 38KT00814, 38KT00824, 38KT00970, 38KT00979, 38KT00996, 38KT01018, 38KT01159, 38KT01168, 38KT01207, 38KT01531, 38KT01747, 38KT01794, 38KT01860, 38KT02218, 38KT02420, 38KT02537, 38KT02630, 38KT02750, 38KT02782, 38KT02796, 38KT02857, 38KT02859, 38KT02860, 38KT02871, 38KT02883, 38KT02930, 38KT02948, 38KT02951, 38KT02955, 38KT03156, 38KT03208, 38KT03213,
38KT03363, 38KT03367, 38KT03371, 38KT03379, 38KT03380, 38KT03385, 38KT03389, 38KT03390, 38KT03392, 38KT03421, 38KT03475, 38KT03512, 38KT03520, 38KT03584, 38KT03598, 38KT03635, 38KT03925, 38KT03942, 38KT04229, 38KT04278, 38KT04603, 38KT04763, 38KT04790, 38KT04794, 38KT05046, 38KT05077, 38KT05090, 38KT05094, 38KT05242, 38KT05255, 38KT05461, 38KT05480, 38KT05489, 38KT05564, 38KT05777, 38KT06004, 38KT06054, 38KT06127, 38KT06191, 38KT06265, 38KT06267, 38KT06272, 38KT06300, 38KT06368, 38KT06398,
38KT06421, 38KT06424, 38KT06437, 38KT06469, 38KT06493, 38KT06607, 38KT06612, 38KT06630, 38KT06822, 38KT06905, 38KT07155, 38KT07725, 38KT07751, 38KT07881, 38KT07998, 38KT08007, 38KT08046, 38KT08204, 38KT08222, 38KT08240, 38KT08242, 38KT08272, 38KT08283, 38KT08522, 38KT08558, 38KT08682, 38KT08692, 38KT08739, 38KT08800, 38KT09049, 38KT09098, 38KT09109, 38KT09227, 38KT09307, 38KT09388, 38KT09561, 38KT09722, 38KT09732, 38KT09753, 38KT09755, 38KT09757, 38KT09758, 38KT09766, 38KT09768, 38KT09773,
38KT09778, 38KT09787, 38KT09791, 38KT09798, 38KT09805, 38KT09806, 38KT09809, 38KT09816, 38KT09817, 38KT09822, 38KT09850, 38KT10027, 38KT10148, 38KT10387, 38KT10426, 38KT10447, 38KT10454, 38KT10490, 38KT10544, 38KT10552, 38KT10561, 38KT10565, 38KT10581, 38KT10591, 38KT10633, 38KT10634, 38KT10690, 38KT10748, 38KT10880, 38KT10924, 38KT10936, 38KT10964, 38KT10965, 38KT10972, 38KT10989, 38KT11005, 38KT11010, 38KT11037, 38KT11136, 38KT11437, 38KT11444, 38KT11553, 38KT11601, 38KT11787, 38KT11931,
38KT11943, 38KT11945, 38KT11966, 38KT11968, 38KT11984, 38KT12105, 38KT12115, 38KT12116, 38KT12127, 38KT12130, 38KT12132, 38KT12138, 38KT12142, 38KT12149, 38KT12339, 38KT12355, 38KT12391, 38KT12621, 38KT12810, 38KT13008, 38KT13025, 38KT13026, 38KT13104, 38KT13110, 38KT13138, 38KT13173, 38KT13306, 38KT13483, 38KT13580, 38KT13698, 38KT13710, 38KT13843, 38KT13859, 38KT13860, 38KT13862, 38KT13868, 38KT13898, 38KT13905, 38KT13923, and 38KT13980; and the following units were distributed as two split products: Unit numbers 38LC48030, 38H87730, 38KT13824, 38KT13364, 38KT12214, 38KT12215, 38KT12323, 38KT09801, 38KT08436, 38KT06358, 38KT06251, 38KT06172, 38KT06180, 38KT06000, 38KT03989, 38KT03617, 38KT03348, 38KT03350,
38KT03351, 38KT03352, 38KT01959, 38KT01257, 38KT00833, 38KT00737, 38H99159, 38H98325, 38H98149, 38H97253,
38H97095, 38H95990, 38H94800, 38H94767, 38H92548, and 38H91981;
c) Unit numbers 38H88128, 38H88741, 38H89399, 38H90496, 38H90904, 38H90388, 38H93129, 38H93135, 38H93980,
38H96400, 38H97882, 38H98695, 38KT00814, 38KT00824, 38KT01018, 38KT06607, 38KT06612, 38KT06630, 38KT07155,
38KT09388, 38KT09399, 38KT09561, 38KT10027, 38KT10148, 38KT10924, 38KT10936, 38KT10964, 38KT11931, and 38KT11966;
d) Unit number 38KT11968;
e) Unit numbers 38H89402, 38H94891, 38H98196, and 38H98213;
f) Unit numbers 38H86598, 38H87310, 38H88128, 38H88741, 38H89399, 38H89402, 38H89461, 38H90496, 38H90904,
38H93980, 38H94891, 38H96843, 38H97685, 38H97882, 38H98695, 38KT00814, 38KT00824, 38KT01747, 38KT03942,
38KT04603, 38KT04790, 38KT05480, 38KT05487, 38KT06612, 38KT06630, 38KT07155, 38KT09388, 38KT09561, 38KT09822, 38KT09850, 38KT10027, 38KT10148, 38KT10720, 38KT10924, 38KT10936, 38KT10964, 38KT11931, 38KT11943, 38KT11966, 38KT11968, 38KT12355, 38KT12621, and 38KT13173;
g) Unit numbers 38FE89461, 38FE89487, 38FE89831, 38FE89876, 38H86889, 38H86910, 38H86927, 38H87542, 38H87626,
38H87684, 38H87749, 38H87771, 38H88260, 38H88264, 38H88289, 38H88305, 38H88351, 38H88510, 38H88650,
38H88873, 38H88974, 38H89048, 38H89063, 38H89066, 38H89070, 38H89079, 38H89084, 38H89090, 38H89112,
38H89309, 38H89348, 38H89492, 38H89515, 38H89556, 38H90129, 38H90171, 38H90313, 38H90692, 38H90756,
38H90811, 38H90816, 38H90970, 38H91058, 38H91236, 38H91258, 38H91283, 38H91444, 38H91620, 38H91798,
38H91869, 38H91948, 38H91970, 38H91986, 38H92022, 38H92063, 38H92080, 38H92356, 38H92432, 38H92454,
38H92462, 38H92464, 38H92613, 38H92623, 38H92624, 38H92625, 38H92651, 38H92659, 38H92686, 38H92739,
38H92880, 38H92908, 38H92918, 38H93088, 38H93111, 38H93122, 38H93129, 38H93135, 38H93262, 38H93404,
38H93467, 38H93539, 38H93547, 38H93661, 38H93749, 38H93772, 38H93775, 38H93792, 38H93845, 38H94097,
38H94108, 38H94119, 38H94454, 38H94484, 38H94503, 38H94524, 38H94530, 38H94531, 38H94554, 38H94597,
38H94647, 38H94722, 38H94732, 38H94735, 38H94742, 38H94743, 38H94748, 38H94749, 38H94753, 38H94755,
38H94763, 38H94770, 38H95078, 38H95109, 38H95166, 38H95204, 38H95506, 38H95743, 38H95920, 38H95928,
38H95956, 38H95983, 38H95994, 38H95996, 38H96006, 38H96012, 38H96022, 38H96024, 38H96111, 38H96173,
38H96205, 38H96497, 38H96661, 38H96959, 38H97005, 38H97249, 38H97327, 38H97353, 38H97450, 38H97869,
38H97900, 38H98140, 38H98196, 38H98213, 38H98274, 38H98368, 38H98803, 38H99506, 38H99509, 38H99518,
38KT00068, 38KT00098, 38KT00106, 38KT00108, 38KT00113, 38KT00133, 38KT00141, 38KT00142, 38KT00152, 38KT00155, 38KT00164, 38KT00176, 38KT00216, 38KT00220, 38KT00226, 38KT00232, 38KT00247, 38KT00254, 38KT00590, 38KT00607, 38KT00970, 38KT00979, 38KT00996, 38KT01018, 38KT01159, 38KT01168, 38KT01207, 38KT01531, 38KT01794, 38KT01860, 38KT02218, 38KT02420, 38KT02537, 38KT02630, 38KT02750, 38KT02782, 38KT02796, 38KT02857, 38KT02859, 38KT02860, 38KT02871, 38KT02883, 38KT02930, 38KT02948, 38KT02951,
38KT02955, 38KT03156, 38KT03208, 38KT03213, 38KT03363, 38KT03367, 38KT03371, 38KT03379, 38KT03380, 38KT03385, 38KT03389, 38KT03390, 38KT03392, 38KT03421, 38KT03475, 38KT03512, 38KT03520, 38KT03584, 38KT03598, 38KT03635, 38KT03925, 38KT04229, 38KT04278, 38KT04763, 38KT04794, 38KT05046, 38KT05077, 38KT05086, 38KT05090, 38KT05094, 38KT05242, 38KT05255, 38KT05461, 38KT05489, 38KT05564, 38KT05777, 38KT06004, 38KT06054, 38KT06127, 38KT06191, 38KT06265, 38KT06267, 38KT06272, 38KT06300, 38KT06368,
38KT06398, 38KT06421, 38KT06424, 38KT06437, 38KT06469, 38KT06493, 38KT06607, 38KT06822, 38KT06905, 38KT07725, 38KT07751, 38KT07881, 38KT07998, 38KT08007, 38KT08046, 38KT08204, 38KT08222, 38KT08240, 38KT08242, 38KT08272, 38KT08283, 38KT08522, 38KT08558, 38KT08682, 38KT08692, 38KT08739, 38KT08760, 38KT08800, 38KT09049, 38KT09098, 38KT09109, 38KT09227, 38KT09307, 38KT09399, 38KT09722, 38KT09732, 38KT09753, 38KT09755, 38KT09757, 38KT09758, 38KT09766, 38KT09768, 38KT09773, 38KT09778, 38KT09787,
38KT09791, 38KT09798, 38KT09805, 38KT09806, 38KT09809, 38KT09816, 38KT09817, 38KT09933, 38KT10387, 38KT10426, 38KT10447, 38KT10454, 38KT10490, 38KT10544, 38KT10552, 38KT10561, 38KT10565, 38KT10581, 38KT10591, 38KT10633, 38KT10634, 38KT10690, 38KT10748, 38KT10880, 38KT10965, 38KT10972, 38KT10989, 38KT11005, 38KT11010, 38KT11037, 38KT11136, 38KT11437, 38KT11444, 38KT11553, 38KT11555, 38KT11601, 38KT11787, 38KT11945, 38KT11984, 38KT12105, 38KT12115, 38KT12116, 38KT12127, 38KT12130, 38KT12132,
38KT12138, 38KT12142, 38KT12149, 38KT12339, 38KT12391, 38KT12810, 38KT13008, 38KT13025, 38KT13026, 38KT13104, 38KT13110, 38KT13138, 38KT13275, 38KT13301, 38KT13306, 38KT13483, 38KT13580, 38KT13698, 38KT13710, 38KT13843, 38KT13859, 38KT13860, 38KT13862, 38KT13868, 38KT13898, 38KT13905, 38KT13923, 38KT13929, 38KT13941, 38KT13980, and 38KT14160.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN
REASON Blood products, collected from donors whose medical history screening did not include adequate questioning regarding risk factors for Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 904 units.
DISTRIBUTION AL, CA, GA, IN, KY, MA, MD, MI, OH, SC, TX, and Switzerland

PRODUCT Red Blood Cells, Leukocyte Reduced.
CODE Unit: 6029773.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson, MS
REASON Blood products, processed in a centrifuge that had not had Quality Control testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells.
CODE Unit: S24936.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA
REASON Blood product, lacking proper manufacturing documentation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced. 5;
c) Fresh Frozen Plasma.
CODE
a) Units 053FE70643, 053GQ93574;
b) Units 053Y95499, 053FL05759, 053FC11286, 053GQ94217, 053GE70455, 053FH98091, 053FH98092;

c) Units 053R04687, 053FL05759, 053FC10882, 053FN86838, 053R04682, 053GE70458, 053FN86835, 053T98395, 053V09102, 053V09103, 053FE71448, 053FC10881, 053FC08856, 053FC10879, 053Q95086, 053GJ31776, 053R01074, 053FN86832, 053V09100, 053R05246.
RECALLING FIRM/MANUFACTURER American National Red Cross, Greater Chesapeake and Potomac Regions, Baltimore, MD.
REASON Blood products, which may have been manufactured from units of whole blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 29 units.
DISTRIBUTION MD, VA, and D.C.

PRODUCT Red Blood Cells.
CODE Unit numbers: 7167094 and 7167480.
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL
REASON Blood products, collected from an unsuitable donor due to use of the medication Propecia, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL.

PRODUCT Platelets, Leukocytes Reduced.
CODE Unit number: 19LE17867.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood product, manufactured from a unit of Whole Blood that Had an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units: 30186-8032, 30186-8033, 30186-8035, 30186-7952, and 30186-7955.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc, Scottsdale, AZ.
Manufacturer: Blood Systems, Inc, Fargo, ND.
REASON Blood products, possibly out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MN, and ND.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number: 7799146.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, IN
REASON Platelets Pheresis were not tested for platelet count.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT Cryoprecipitated AHF, Pooled.
CODE Unit number: 18FW59516.
RECALLING FIRM/MANUFACTURER American National Red Cross, Great Lakes Region, Lansing, MI
REASON Blood product, manufactured from a unit of Whole Blood that had a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 18FT96634.
RECALLING FIRM/MANUFACTURER American National Red Cross, Great Lakes Region, Lansing, MI
REASON Blood product, collected in a expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

WEEK ENDING MAY 28

PRODUCT Red Blood Cells.
CODE Unit number: 0415261.
RECALLING FIRM/MANUFACTURER Community Blood Bank of Erie County, Erie, PA
REASON Blood product, collected from an ineligible donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Red Blood Cells, Leukocyte Reduced.
CODE Units: 26KM26856, 26KM24219, 26KM22400.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Gulf Coast Region, Mobile, AL
REASON Blood Products, collected from a donor who had previously tested reactive for hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION FL, and AL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 4574634.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers: 06FE67715, 06FE69512.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern California Region, Pomona, CA
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 CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers: 9455499, 7769028, 7768962, 7768316, 7769185, 7769172, 7768699, 7768210, 7769203, 7769396, 7769409, 7751988, 7751957, 7768798, 7768976, 7768867, 7768700, 7768920, 7751983, 7751976, 7769133, 7759243, 7751933, 7769267, 7768779.
RECALLING FIRM/MANUFACTURER West Tennessee Regional Blood Center, Jackson, TN\
REASON Blood products, manufactured in a manner that may have compromised the sterility of the unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 25 units.
DISTRIBUTION TN.

PRODUCT Source Plasma.
CODE Unit numbers 0360026786, 0360027056.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., South Bend, IN
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Spain.

PRODUCT Source Plasma.
CODE Unit numbers 360039169, 360039257, and 360040492.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., South Bend, IN
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Spain.

PRODUCT Source Plasma.
CODE Unit numbers 360008967, 360009388, and 360009605.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., South Bend, IN
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Spain.

PRODUCT Source Plasma.
CODE Unit numbers 0360039709, 0360038954, 0360038562, and 0360038300.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., South Bend, IN
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION Spain.

PRODUCT Source Plasma.
CODE Unit numbers 360034617, 360035095, 360035411, 360035863, and 360036164.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., South Bend, IN
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION Spain.

PRODUCT Source Plasma.
CODE Unit numbers: 81398430, 81393015, 81375776, 81370962, 81366095, 81355358, 81348909, 81206964, 66241812, 66235477, 66232551, 66226314, 66223443, 66217602, 66209867, 66204039, 66198284, and 66195009.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL
Manufacturer: ZLB Bioplasma, Inc, Gresham, OR.
REASON Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers: 66168317, 66172185.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Services, Boca Raton, FL
Manufacturer: ZLB Bioplasma, Inc, Gresham, OR.
REASON Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE
a) Unit numbers: 19GW17900, 19GZ19698, 19GJ34204, and 19GN14987;
b) Unit number: 19GW17900.
RECALLING FIRM/MANUFACTURER American Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood products, collected from an unsuitable donor due to the use of the medication, Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION TN.

PRODUCT Source Plasma.
CODE Unit numbers: 194421, 194753, 195244, 117749, 116175, 338319, 116402, 338380, 116889, 388250, 117598, 388431, 117233, 388656, 388971, and 388961.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., San Angelo, TX
REASON Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit number: SX006203.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services, L.P., San Marcos, TX
REASON Blood product, that tested negative for the antibody to hepatitis C virus (anti-HCV), but was collected from an ineligible due to previous reactive testing for anti-HCV, was distriburted.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 4763267.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
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 AR.

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced Irradiated.
CODE Unit number 4731245.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
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 OK.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 30656-1786 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Fargo, ND.
REASON Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION ND, and CA.

PRODUCT Source Plasma.
CODE Unit number 01BNDB7845.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Bismarck, ND
REASON Blood product, collected in a manner that may have resulted in saline contamination of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Source Plasma.
CODE Unit numbers 02MWIB9905 and 02MWIB9992.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Menasha, WI
REASON Blood products, incorrectly tested for antibodies to human immunodeficiency virus (anti-HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Austria.

PRODUCT Source Plasma.
CODE Unit numbers 118616, 118816, 119062, 119214, 119486, 337637, 337882, 338085, 338336, 388562, 388757, 388966, 389177, 389403, 389634, 389853, 390187, 390398, and 390670.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., San Angelo, TX
REASON Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 19 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit number SX038639.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., San Marcos, TX
REASON Blood product, that tested negative for viral markers, but was collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers: OT302212, OT301704, OT301476, OT300996, OT300890, OT300401, OT300332, OT299803, OT299515, OT299142, OT298911, OT298500, OT298265, OT297844, OT297599, OT297177, OT296894, OT296519, OT296294, OT295881, OT295618, OT295221, OT294979, OT294575, OT294305, OT293914, OT293689, OT293374, OT293121, OT292792, OT292574, OT292284, OT292055, OT291626, OT291458, OT287071, OT286814, OT286472, OT286121, OT285919, OT285364, OT285211, OT284621, OT284413, OT284108, and OT283929.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services, L.P., Odessa, TX
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to intravenous (IV) drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 46 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells.
CODE Unit number: 19LF04677.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN
REASON Blood product, that tested positive for the Kell red blood cell antigen, but was labeled as Kell antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT Recovered Plasma.
CODE Unit numbers: 6417705, 6416855, and 6418495.
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL
REASON Blood products, collected from an unsuitable donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION FL.

PRODUCT Source Plasma.
CODE Unit numbers ST154044, ST274228, ST273296, ST272953, ST272460, ST272151, ST260563, and ST259943.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., San Antonio, TX
REASON Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION NC, and CA.

PRODUCT Source Plasma.
CODE Unit numbers SX102319, SX102258, and SX101991.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., San Marcos, TX
REASON Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers: SX065909 and SX067365.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., San Marcos, TX
REASON Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC, and NY.

PRODUCT Source Plasma. .
CODE Unit number: SX009225.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., San Marcos, TX
REASON Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 4406395.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
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 OK.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 4599999.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
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 OK.

PRODUCT Source Plasma.
CODE Unit numbers 50011505, 50012075, 50012994, 50013515, 50013992, 50014506, 50014686, 50015077, 50015256, 50015713, 50028241, and 50028441.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION Spain.

PRODUCT
a) Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 1388809.
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc. Orlando, FL
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 FL.

PRODUCT Source Plasma.
CODE Unit numbers 93866200, 93860567, 93658447, 93652919, 93179775, 93176514, 93172516, 93028660, 93023276, 93021432, 92708952, 92706897, and 93861939.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson, TN
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to possible intravenous (IV) drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced. .
CODE a) and b) Unit number FM98548.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI,
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 RI.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma. .
CODE a), b), and c) Unit number 0673238.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, Irwin Center, San Francisco, CA
Manufacturer: Blood Centers of the Pacific, Peninsula South Bay Center, Burlingame, CA.
REASON Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers 00BNDB3831, 00BNDB3833, 00BNDB3834, 00BNDB3835, 00BNDB3836, 00BNDB3837, 00BNDB3839, 00BNDB3840, 00BNDB3843, 00BNDB3845, 00BNDB3846, 00BNDB3848, 00BNDB3850, 00BNDB3855, 00BNDB3856, 00BNDB3857, 00BNDB3858, 00BNDB3859, 00BNDB3861, 00BNDB3863, 00BNDB3865, 00BNDB3866, 00BNDB3867, 00BNDB3868, 00BNDB3869, 00BNDB3871, 00BNDB3872, 00BNDB3875, 00BNDB3876, 00BNDB3878, 00BNDB3880, 00BNDB3881, 00BNDB3882, 00BNDB3883, 00BNDB3885, and 00BNDB3950.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., Bismarck, ND
REASON Blood products, incorrectly tested for antibodies to hepatitis C virus (anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 36 units.
DISTRIBUTION Austria.