MAY 2004

WEEK ENDING MAY 1

PRODUCT Human Cornea Tissue.
CODE Number 03-0668-100 and 03-0668-200.
RECALLING FIRM/MANUFACTURER Rocky Mountain Lions Eye Bank, Aurora, CO.
REASON Human tissues for transplantation, procured from a donor who tested negative for antibody to hepatitis C virus (anti-HCV), but was subsequently found to have tested positive for the hepatitis C virus by PCR testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION CO and Mexico.

PRODUCT Human Cornea Tissues for Transplantation.
CODE Unit numbers: 2003-12-6013 and 2003-12-6014.
RECALLING FIRM/MANUFACTURER Heartland Lions Eye Banks, Columbia, Missouri.
REASON Human corneas were distributed from a donor who tested reactive for HCV (antibody and PCR), and the likely cause was a mix-up of samples at the recalling firm.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION Kansas and Greece.

PRODUCT Recovered Plasma.
CODE Unit 20LN16611.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Lewis and Clark Region, Boise, ID.
REASON Blood product, collected from a donor who is considered at increased risk of exposure to Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leucocytes Removed.
CODE Unit 042GE06541.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Blood product, collected from a donor who disclosed travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 0427300.
RECALLING FIRM/MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City, MO.
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 2 units.
DISTRIBUTION KS and Switzerland.

PRODUCT Source Plasma.
CODE Unit number 01GMID0777.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Walker, MI.
REASON Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.

PRODUCT Source Plasma.

CODE Unit numbers 01GMIE8556, 01GMIE5683, 01GMID1586, 01GMIC5645, 01GMIE3993, 01GMIF9041, and 01GMIA3370.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Walker, MI.
REASON Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION Austria.

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced.
CODE Unit numbers 22FS16537, 22KJ92301, 22KR96133, 22KW51632, and 22LV93955.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON Blood products that failed to meet the minimum specification for product volume were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION PA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 2516311.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, TX.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells.
b) Platelets Pheresis, Leukocytes Reduced.
c) Platelets Pheresis, Leukocytes Reduced Irradiated.
d) Recovered Plasma.
CODE
a) Unit number 1700904;
b) Unit numbers 2514413, 2514571, 2514758, 2515054, 2515350, 2515616, 2516353, 2518161, 2518481, 2519479,
2519933, 2520165, 2520555, 2520793, 2521271, 2521724,2525425, and 2525628;
c) Unit numbers 2515908 and 2518918;
d) Unit number 1700904.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, TX,

REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 22 units.
DISTRIBUTION TX, FL, and DC.

PRODUCT Source Plasma.
CODE Unit number GPFWSF.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Flint, MI.
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Red Blood Cells.
CODE Unit number 18FT84951.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood product, that did not have the additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

WEEK ENDING MAY 8

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 20GY11595.
RECALLING FIRM/MANUFACTURER American National Red Cross, Lewis and Clark Region, Boise, ID.
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA, and MT.

PRODUCT
a) Cryoprecipitated AHF.
b) Recovered Plasma.
CODE
a) Unit number 21KC56042;
b) Unit numbers 21KC56042 and 21KG65175.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, 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 new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA, and Switzerland.

PRODUCT Red Blood Cells, Deglycerolized.
CODE Unit number: 9233644.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA.
REASON Red Blood Cells, frozen using expired glycerol, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 21KS14782.
RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Region, Portland, OR.
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 CA.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 21KL58423.
RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Region, Portland, OR.
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 OR.

PRODUCT Source Plasma.
CODE Unit number: 00MMIA2571.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Marquette, MI.
REASON Blood product, collected in a manner that may compromise the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Platelets Pheresis, Leukocytes Removed.
CODE Unit number: 2515050.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, TX.
REASON Blood product, with a decreased platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Source Plasma.
CODE Unit numbers: 00GMIF4892, 00GMIF5391, 01GMIA0969, 01GMIA1738, 01GMIA3448, 01GMIA5160, 01GMIA5980, 01GMIA7787.
RECALLING FIRM/MANUFACTURER Recalling Firm: Community Bio-Resources, Inc., Grand Rapids, MI.

Manufacturing Firm: BioLife Plasma Services L.P., Walker, MI. Firm initiated recall is complete.
REASON Source Plasma, collected from an unreliable donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION Austria.

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit number: 02P66850.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Plains Region, Wichita, KS.
REASON Blood product, which was in transit greater than 48 hours and was possibly exposed to unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KS.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
CODE
a) Unit number: 3074593;
b) and c) Unit number: 3072130.
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH.
REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 2040353.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY.
REASON Blood product, that tested negative for Cytomegalovirus (CMV), but was collected from a donor who previously tested CMV positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Recovered Plasma.
CODE Unit number 41LH49821.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL.
REASON Blood product 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 1 unit.
DISTRIBUTION Switzerland.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Units: 9418546, 9419898, 9425289, 9425314.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA.
REASON Blood products, out of refrigeration for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION LA.

PRODUCT
a) Red Blood Cells, Leukocytes Removed.
b) Plasma, Frozen.
CODE
a) Unit numbers: 03GT56277, 03GT56278;
b) Unit number: 03GZ33045.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern Region, Atlanta, GA.
REASON Blood products, manufactured from a unit of Whole Blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION GA and SC.

PRODUCT Recovered Plasma.
CODE Unit 20GY11595.
RECALLING FIRM/MANUFACTURER American National Red Cross, Lewis and Clark Region, Boise, ID.
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA, and MT.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 20GR15840.
RECALLING FIRM/MANUFACTURER American National Red Cross, Lewis and Clark Region, Boise, ID.
REASON Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION ID.

PRODUCT Red Blood Cells.
CODE Unit number 41LS09682.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL.

REASON Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 41LW80352.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL.
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 AL, and CA.

PRODUCT
a) Platelets.
b) Platelets Pheresis, Leukocytes Removed.
c) Fresh Frozen Plasma.
d) Red Blood Cells, For Further Manufacturing into Non-injectables.
CODE
a), c) and d) Unit number 5164237;
b) Unit number 2514483.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, TX.
REASON Blood products, that tested negative for Hepatitis B surface antigen (HBsAg) and for the antibody to Hepatitis B core antigen (anti-HBc), but was collected from a donor that previously tested positive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX.

WEEK ENDING MAY 15

PRODUCT
a) Red Blood Cells (apheresis), Leukoreduced.
b) Red Blood Cells (apheresis), Leukoreduced, Irradiated.
CODE
a) and
b) Unit 12801-3649.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Albuquerque , NM.

REASON Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NM.

PRODUCT Source Plasma.
CODE Unit numbers: 02GMIC9069, 02GMIC8689.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Walker , MI.

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 Austria

PRODUCT Platelets.
CODE Unit number: 18GM08262.
RECALLING FIRM/MANUFACTURER American Red Cross, Great Lakes Region, Lansing , MI.

REASON Blood product, associated with an air contaminated red cell unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OK.

PRODUCT Platelets Pheresis, Leukocytes Removed.
CODE Unit numbers: 41FP34043, 41FP34385, 41GP51940, 41GP52041, and 41FP36606.
RECALLING FIRM/MANUFACTURER American Red Cross, Alabama Region, Birmingham , AL.

REASON Blood products, were inappropriately distributed in two bags.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION AL .

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 02FE10432.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Central Plains Region, Wichita, KS..
REASON Blood product, collected from a donor who disclosed travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) Unit number: 41FP36537;
b) Unit number: 41FP36335.
RECALLING FIRM/MANUFACTURER American Red Cross, Alabama Region, Birmingham , AL

REASON Blood products were inappropriately distributed in a single storage bag.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AL.

PRODUCT Source Plasma.

CODE Unit 02GMIE3952.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Walker, MI.

REASON Source Plasma, lacking assurance of sterility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 200341746.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
REASON Platelets, with a platelet count above the firm’s specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Platelets, Leukocytes Reduced.
CODE Units GP55010, GP55019, GP55016, GP55005, GP55007.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.,

REASON Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm’s standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION PA.

PRODUCT Red Blood Cells, leukoreduced, irradiated.
CODE Units: 231486809, 231486815.
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Billings, MT

REASON Blood products, whose irradiated status were not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MT.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells Leukocytes Reduced.
c) Platelets Leukocytes Reduced.
d) Platelets Pooled.
e) Platelets Pooled Leukocytes Reduced.
CODE
a) Units 0876891, 0834735, 0682350, and 0673899;
b) Units 0942312, 0901353, 0866718, and 0871777;
c) Units 0942312, 0901353, and 0866718;
d) U nit 0079834;
e) Unit 0082376.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center UC Medical Center, Cincinnati, OH.

REASON Blood products, which were collected from a donor who had resided in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION OH.

PRODUCT
a) Red Blood Cells.
b) Cryoprecipitated AHF.
c) Plasma Cryoprecipitate Reduced.
CODE a), b), and c) Unit 2040039.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY.

REASON Blood products, which tested negative for infectious diseases by viral marker screening tests but were identified by the donor for confidential unit exclusion, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION KY and Switzerland.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Cryoprecipitated AHF.
d) Recovered Plasma.
CODE a), b), c), and d) Unit 3166918.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood & Tissue Center, Austin, TX.

REASON Blood products, which were collected from a donor who had a history of intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX and FL.

PRODUCT Red Blood Cells.
CODE Unit KL00722.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA

REASON Blood product, which tested negative for the cytomegalovirus (CMV) but was collected from a donor who previously tested positive for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE a) and b) Unit FW06276.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.

REASON Blood products, in which the corresponding Red Blood Cells were positive for coagulase negative staphylococcus and implicated in a transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA.

PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit GP49936.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA,

REASON Blood products, in which the corresponding and implicated in a transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA.

PRODUCT Platelets.
CODE Unit L81323.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI.

REASON Blood product, in which the corresponding Red Blood Cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells.
CODE Units 200326205, 200346790.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ

Manufacturer: Blood Systems, Inc., Lafayette, LA.
REASON Blood products, that failed to meet the minimum specification for product volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA and TN.

PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) Units: 200302771, 200306294, 200306318, 200308415, 200309314, 200314336-split 1 & 2, 200316541, 200317055- split 1 & 2, 200324375, 200324398, 200324452, 200326620, 200326791, 200332875, 200333063, 200343963, 204040341, 204046911, 204054851, 204055171, 204060543, 204065908- split 1 & 2, 204070316-split 1 & 2, 204070921, 200306315-split 2, 200313332-split 2, 204070810-split 2, 204072335-split 2, 204073383-split 2, 204076190-split 2, 204077095-split 2;
b) Units: 200302771, 200308944, 200316541, 200306321 .
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ

Manufacturer: Blood Systems, Inc., Lafayette, LA. Firm initiated recall is complete.
REASON Blood products, which yielded a platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 39 units.
DISTRIBUTION LA, MS, and TX.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 18P58006.
RECALLING FIRM/MANUFACTURER American National Red Cross, Great Lakes Region, Lansing, MI. REASON Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Fresh Frozen Plasma.
CODE Unit 200323059.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale , AZ.

Manufacturing Firm: Blood Systems, Inc., Lafayette , LA.
REASON Blood products, collected from donors who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA and Switzerland .

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells Pheresis, Leukocytes Reduced Units.
c) Platelets Pheresis, Leukocytes Reduced.
d) Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) Units 200333109, 200333115, 200333120, 200333121;
b) Units 200333104-split 1 & 2, 200333106;
c) Units 200333116-split 1 & 2, 200333097, 200333107, 200333111, 200333119;
d) Unit 200333117.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale , AZ.

Manufacturing Firm: Blood Systems, Inc., Lafayette , LA. Firm initiated recall is complete.
REASON Blood products, collected from donors whose health history regarding exposure to SARS was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION LA, MS, and TX.

PRODUCT Platelets.
CODE Unit numbers: T12510, T12511, T12512, T12513, T49125, T49126, T49139, T49140, T49142, T49317, T49318, T49327, T49331, T12447, T12457, T12869, T49259, T49264, T49268, T49269, T49276, T49281, T49374, T49378, T49380, T49383, T49384, T49385, T49392, T49522, T64893, T64896, T64897, T64962, T64971, T12458, T12870, T12871, T49517, T49528, T49532, T49538, T49539, T49386, T49271, T49513, T49527, T49531, T64970, T12421, T12423, T12427, T12444, T12448, T12449, T12451, T12452, T12521, T12523, T12562, T12563, T12569, T12570, T12573, T12574, T12575, T12577, T12578, T12708, T12712, T12720, T12771, T12773, T12775, T12789, T12790, T12794, T12810, T12812, T12814, T12815, T12816, T12817, T12819, T12823, T12824, T12825, T12835, T12838, T12840, T12862, T12864, T12866, T12868, T12876, T49127, T49130, T49134, T49135, T49136, T49141, T49261, T49262, T49263, T49266, T49277, T49278, T49280, T49311, T49329, T49332, T49347, T49393, T49441, T49442, T49443, T49444, T49446, T49447, T49448, T49502, T49504, T49505, T49512, T49516, T49530, T49534, T49537, T49545, T49547, T49548, T49549, T49551, T49554, T49555, T64892, T64894, T64895, T64898, T64899, T64902, T64903, T64904, T64905, T64906, T64909, T64919, T64923, T64924, T64926, T64928, T64974, T64976, T64977, T64978, T81910, T81913, T81914, T81916, W90060, W90065, W90066, W90067, W90074, W90079, W90082, W90083, W90093, W90100, W90102, W90117, W90118, W90119, W90120, W90122, W90151, W90159, W90162, W90163, W90166, W90167, W90177, W90238, W90322, W90323, W90324, W90326, W90327, W90329, W90331, W90332, W90333, W90334, W90336, W90337, W90338, W90339, W90340, W90343, W90344, W90346, W90347, W90348, W90350, W90351, W90380, W90381, W90382, W90383, W90385, W90386, W90391, W90404, W90168, W90081, W90087, W90088, W90084, W90098, W90094, W90164, W90165, W90171, W90173, W90176, W90406, W90408, W90061, W90064, W90069, W90070, W90071, W90072, W90073, W90076, W90146, W90148, W90149, and W90150.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers , Traverse City , MI.
REASON Platelets were distributed with a possibly decreased platelet count.
VOLUME OF PRODUCT IN COMMERCE 239 units.
DISTRIBUTION MI.

PRODUCT Whole Blood.
CODE Unit number R12801.
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield , IL.
REASON Blood product, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but was collected from a donor that previously tested repeatedly reactive for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number G90770.
RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank, Inc., Rockford , IL.
REASON Blood product, possibly contaminated with coagulase negative Staphylococcus sp. Bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced Irradiated.
c) Platelets, Leukocytes Reduced.

CODE
a) U nit numbers 0939800 and 0920610;
b) U nit number 0939800;
c) Unit number 0920610.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center , University of Cincinnati Medical Center, Cincinnati , OH.
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION OH, and KY.

PRODUCT Platelets.
CODE Unit number 2038122.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington , KY.
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Platelets.
CODE Unit number 0807811.
RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria , OH.
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Red Blood Cells.
CODE Unit number 5185107.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center , Austin , TX.
REASON Blood product was not properly quarantined after receipt of information that made the donor of the product ineligible due to a risk factor for infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Platelet Pheresis, Leukoreduced (split product).
CODE Units: 20407-7627-01, 20407-7627-02.
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Lafayette , LA.
REASON Blood products, which were labeled “leukoreduced”, although a White Blood Count (WBC) had not been performed on them, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA.

PRODUCT Red Blood Cells. Recall # B-1219-4; Recovered Plasma.
CODE a) and b) Unit number 2301050.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center , Austin , 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 a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, and Switzerland .

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit number 9314978.
RECALLING FIRM/MANUFACTURER The Blood Center , New Orleans , LA.
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 LA, and Switzerland .

PRODUCT Red Blood Cells
CODE Unit number 9919171.
RECALLING FIRM/MANUFACTURER The Blood Center , New Orleans , LA.
REASON Blood product, corresponding to a unit of Platelets that was pooled and was possibly contaminated with Staphylococcus sp. Bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Red Blood Cells.
CODE Unit numbers: 3197069, 3197071, 3197076, 3197077, 3197078, 3197079, 3197080, 3197081, 3197082, 3197083, 3197084, 3197085, 3197086, 3197087, 3197088, and 3197090.
RECALLING FIRM/MANUFACTURER Community Blood Center of Greater Kansas City , Kansas City , MO.
REASPM Blood product, manufactured from a unit of Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION KS, and MO.

PRODUCT Source Plasma.
CODE Unit numbers 01GMIA1503, 01GMIA1820, 01GMIA3412, 01GMIA3774, 01GMIA5464, 01GMIA5858, 01GMIA7603, 01GMIB0212, 01GMIB4059, 01GMIB4413, 01GMIB5373, 01GMIB6053, and 01GMIB6646.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Walker , MI.
REASON Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to recent ear piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION Austria .

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced Irradiated.
c) Fresh Frozen Plasma.
CODE
a) Unit numbers 02FK10622, 02FK10623, 02FK10624, 02FK10625, 02FK10626, 02FK10627, 02FK10630, 02FK10631, 02FK10632, 02FK10633, 02FK10634, 02FK10635, 02FK10636, 02FK10637, 02FK10638, 02FK10641, 02FK10642, 02FK10643, 02FK10644, 02FK10645, 02FK10647, 02FK10649, 02FK10650, 02FK10651, 02FK10652, 02FK10653, 02FK10654, 02FK10655, 02FK10656, 02FK10657, 02FK10658, 02FK10661, 02FK10662, 02FK10663, 02FK10664, 02FK10665, 02FK10666, 02FK10667, 02FK10668, and 02FK10669;
b) Unit numbers 02FK10639, 02FK10640, and 02FK10648;
c) Un it numbers 02FK10649, 02FK10652, and 02FK10657.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Central Plains Region, Wichita, KS.
REASON Blood products, manufactured from units of Whole Blood that were collected in the incorrect size collection bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE 46 units.
DISTRIBUTION KS, OK, CA, and AL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 21KM50929.
RECALLING FIRM/MANUFACTURER American National Red Cross, Portland , OR.
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 CA.

PRODUCT Source Plasma.
CODE Units: WF0080642, WF0080806, WF0081157, WF0081329, WF0081855, WF0082151, WF0082398, WF0082626, WF0082792, WF0083060, WF0083289, WF0083555.
RECALLING FIRM/MANUFACTURER DCI Biologicals Wichita Falls Inc., Wichita Falls , TX.
REASON Blood Products, collected from donor whose health history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Units: WF0080229, WF0080411, WF0080882, WF0080902, WF0082227, WF0082358, WF0082904, WF0083142, WF0083483, WF0083649, WF0084306, WF0085220, WF0085439, WF0085948, WF0086376, WF0086656.
RECALLING FIRM/MANUFACTURER DCI Biologicals Wichita Falls Inc., Wichita Falls , TX.
REASON Blood Products, collected from donor considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION KY.

PRODUCT Red Blood Cells, leukoreduced.
CODE Unit 20030-2727.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lafayette , LA.
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 LA, and Switzerland .

PRODUCT Source Plasma.
CODE Units WF0080734, WF0083353, WF0083737, WF0083820, WF0084323.
RECALLING FIRM/MANUFACTURER DCI Biologicals Wichita Falls, LLC, Wichita Falls , TX.
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION KY.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 5191958.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood & Tissue Center , Austin , TX .
REASON Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.

CODE Unit: 20030-8755.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lafayette , LA.
REASON Blood product, collected from a donor visited an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit: 084J 35090.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern California Region,

Oakland , CA.
REASON Blood product, collected from a donor who visited an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukoreduced Reduced.
CODE Unit number: 163724172.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale , AZ.

Manufacturing Firm: Blood Systems, Inc., Meridian , MS .
REASON Blood product, that was labeled leukoreduced prior to receipt of the leukoreduction assay results, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated.
b) Recovered Plasma.
CODE a) and b) Unit number: 163699068.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale , AZ.

Manufacturing Firm: Blood Systems, Inc., Hattiesburg , MS .
REASON Blood products, which were collected from a donor whose sexual partner lived in an area with increased risk for human immunodeficiency virus (HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MS, and Switzerland .

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 41LP28571.
RECALLING FIRM/MANUFACTURER American Red Cross, Alabama Region, Birmingham , AL.
REASON Blood product, which failed red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL .

PRODUCT Platelets Pheresis, Irradiated.
CODE Unit numbers: 22KG75128, 22LE01688.
RECALLING FIRM/MANUFACTURER American Red Cross, Penn-Jersey Region, Philadelphia , PA.
REASON Blood products, not stored under continuous agitation and controlled temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ.

PRODUCT Red Blood Cells.
CODE Units: 5107945, 5107946, 5107947, 5107948, 5107949, 5107950, 5107951, 5107952, 5107953, 5107955, 5107957, 5107958, 5107959, 5107960, 5107961, 5107962.
RECALLING FIRM/MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City, MO.
REASON Blood products, exposed to shipping temperature above acceptable limits, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION KS and MO.

PRODUCT Source Plasma.
CODE Units 03RMIB2437, 03RMIB2753.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Kentwood , MI.
REASON Source Plasma, collected from a donor who was not properly asked the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.

CODE Unit 02GMIA8485.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Walker , MI.
REASON Source Plasma, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria .

PRODUCT Red Blood Cells, Apheresis, Leukocytes Reduced.
CODE Unit 200348734.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale , AZ.

Manufacturing Firm: Blood Systems, Inc., Lafayette , LA.
REASON Red Cells, that were below the acceptable range for absolute RBC volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE Units 21KF35238, 21FL73965, 21KJ83908.
RECALLING FIRM/MANUFACTURER American National Red Cross, Portland , OR.
REASON Red Cells, that lacked assurance of proper storage temperatures due to improper documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION WA.

PRODUCT Source Plasma.
CODE Unit HKCKKT.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Louisville , KY.
REASON Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma.
CODE Units: 43722846, 43051649, 42599364, 42595243, 27195222, 27191675, 25835328, 25834468, 25832341, 23778771, 23777590, 23776036, 23775022, 23773226, 23770683, 23769113, 23767713, 23764767, 23763067, 19693361, 19692135, 20058067, 20057121, 20054779, 20053819, 20052041, 20050986, 21768781, 21767937, 21765186, 21762888, 20770365, 20769321, 20765873, 20764135, 20762773, 17124584, 17123839, 79352697, 79351515, 79029629, 79028684, 79026529, 79022132, 79021159, 79018395, 79016636, 79014809, 79013093, 79010795, 78729964, 78728172, 78726987, 78724761, 78723986, 74224869, 74222803, 74027880, 74025350, 74023615, 74021123, 70018905, 70017731, 70014686, 70012637, 70011210, 69958182, 69956003, 69955174, QP25028, QP24243, and 20767174.
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Muskego , MI.
REASON Blood products, which tested negative for infectious diseases by viral marker screening tests, but were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 72 units.
DISTRIBUTION CA.

PRODUCT Recovered Plasma.
CODE Unit 200322897.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale , AZ.

Manufacturing Firm: Blood Systems, Inc., Lafayette , LA.
REASON Blood products, incorrectly antigen typed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA.

PRODUCT Platelets.
CODE Unit numbers: 200330273, 200330274, 200330276, 200330280, 200330282, 200330941, 200330946, 200332047, 200332054, 200332055, 200332058, 200332380, and 200334296.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale , AZ.

Manufacturing Firm: Blood Systems, Inc., Lafayette , LA.
REASON Blood products, that lacked assurance of proper storage temperatures due to lack of adequate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION LA.

PRODUCT Recovered Plasma.
CODE Unit 20030-2727.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lafayette , LA.
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 LA, and Switzerland .

PRODUCT Red Blood Cells.
CODE Unit: E42654.
RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton , CA.
REASON Blood product, collected from a donor whose body temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

WEEK ENDING MAY 22

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Plasma.
d) Recovered Plasma.
CODE
a) and c) Unit 29GH23522;
b) and d) Units 29GH31592, 29GV46982, 29GL60563, 29GL58582.
RECALLING FIRM/MANUFACTURER American National Red Cross, Mid-Atlantic Region, Norfolk, VA.
REASON Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION CA, VA, MD, NC, and DC.

PRODUCT Recovered Plasma.
CODE Unit 20LN17501.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Lewis and Clark Region, Boise, ID.

REASON Blood product, collected from an unsuitable donor due to behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV) or the hepatitis B virus (HBV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers: 02GMIA9345, 02GMIB0175, 02GMIB0616, 02GMIB1333, 02GMIB1746, 02GMIB2451, 02GMIB2990, 02GMIB3751, 02GMIB4272, 02GMIB5088, 02GMIB5584, 02GMIB6320,
02GMIB6781, 02GMIB7619, 02GMIB8089, 02GMIB8891, 02GMIB9415,
02GMIC0282, 02GMIC0782, 02GMIC1632, 02GMIC2080, 02GMIC2878,
02GMIC3358, 02GMIC4072, 02GMIC5314, 02GMIC5789, 02GMIC6548,
02GMIC7022, 02GMIC8485, 02GMIC9565, and 02GMID0815.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Walker, MI.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 31 units.
DISTRIBUTION Austria.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 02FX14033, 02FX13685.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Wichita, KS.
REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, and KS.

PRODUCT Source Plasma.
CODE Unit 00YARD7489.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services LP, Fayetteville, AR.
REASON Source Plasma, which tested negative for the hepatitis B surface antigen (HbsAg), but was collected from a donor who subsequently tested repeatedly reactive for HbsAg, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Source Plasma.
CODE Units 01YARC4191, 01YARC4578, 01YARC5137, 01YARC5437, 01YARC6030, 01YARC6286.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services LP, Fayetteville, AR.
REASON Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION MI.

PRODUCT Source Plasma.
CODE Unit numbers: WF0080876, WF0081121, WF0081457, and WF0081634.
RECALLING FIRM/MANUFACTURER DCI Biologicals Wichita Falls, LLC, Wichita Falls, TX.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION KY.

PRODUCT
a) Fresh Frozen Plasma.
b) Plasma Frozen.
CODE
a) Units: 004L48803, 004GF29211, 004G45538, 004E57175, 004L54038, 004J50649;
b) Units: 004FS53489, 004V02079, 004S50290, 004S50296.
RECALLING FIRM/MANUFACTURER American National Red Cross, New England Region, Dedham, MA.

REASON Blood products, associated with units of Red Blood Cells assigned the "CLOT" designation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION MA, NH, and NY.

PRODUCT Source Plasma.
CODE Units: N-55655-162, N-55668-162, F-01099-162, F-01502-162, F-01693-162.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, El Paso, TX.
REASON Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells.
CODE Unit number: GG00387.
RECALLING FIRM/MANUFACTURER BloodSource-Merced County, Merced, CA.
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 CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Plasma, Frozen.
CODE
a) and b) Unit 084KM04079. RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern California Region, Oakland, CA.
REASON Blood products, collected from a donor with a history of cancer, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers: WF0080620, WF0081075, and WF0081254.
RECALLING FIRM/MANUFACTURER DCI Biologicals Wichita Falls, LLC, Wichita Falls, TX.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for variant Creutzfeldt-Jakob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION KY.

PRODUCT Platelets, Leukocytes Reduced.
CODE Unit number 33GT49143.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood product, collected from a donor that did not answer one of the medical history questions related to risk factors for Creutzfeldt-Jakob disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CT.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit number 4012460.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK.
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 NC, and TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers: 163713147, 163713130.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AR.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS.
REASON Blood products, which exceeded specifications for product volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MS.

PRODUCT Source Plasma.
CODE Unit WLN005829.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Wilmington, DE.
REASON Source Plasma, that tested negative for hepatitis C, but was collected from a donor that subsequently tested positive for hepatitis C by PCR testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Spain.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 16363680.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc, Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Dba United Blood Services, Meridian, MS.

REASON Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT Source Plasma.
CODE Units F06859162, F07035162.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., El Paso, TX.
REASON Blood products, collected from an unreliable donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Units F00230162, F00659162, F01046162, F01301162.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., El Paso, TX.
REASON Blood products, collected from a donor who had received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Units F00071162, F00589162, F01167162, F01303162, F06545162, F06729162.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., El Paso, TX.
REASON Blood products, collected from an unreliable donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers 923113, 923145, 923249, 923295, 923391, 923445, 9N1211, 9N1264, 9N1361, 9N1401, 9TK005, 9TK064, 9TK163, 9TK220, 9TK336, 9TK445, 9TK479, CDBZNZ, CDBZRR, CDBZZT, CDCBFK, CDCBGZ, CDCBML, CDCBPF, CDCCKC, CDCCPH, CDCCRJ, CDCFGL, CDCFJT, CDCCWV, CDCCZD, CDCDFT, CDCDJB, CDCDWV, and CDCDYT.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc. Little Rock, AK.
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 35 units.
DISTRIBUTION IL and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers: 16375-5330 and 16375-7125.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AR.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS.
REASON Blood products, collected from donors whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MS and AL.

PRODUCT Red Blood Cells.
CODE Unit number: 224153528.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AR.
Manufacturing Firm: Blood Systems, Inc., Las Vegas, NV.
REASON Blood Product, that was not properly quarantined after the donor reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION NV.

PRODUCT Red Blood Cells.
CODE Unit GG63262.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.
REASON Blood product, that tested negative for Cytomegalovirus (CMV), but was collected from a donor who previously tested CMV positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Platelets.
CODE Unit LV35930.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.
REASON Platelets, corresponding to red cells that were contaminated with Staphylococcus and implicated in an adverse transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Source Plasma.
CODE Units G05027040, G05216040, G05917040, G06697040, G09194040, G10141040, G10335040, G13018040, G13177040, G14342040, G14912040, G15267040, G15518040, G16080040, G32904040, G33117040, G33567040, G33791040, G35221040, G92990040, G93602040, G93858040, G94370040, G94735040, N06617040, and N06651040.
RECALLING FIRM/MANUFACTURER Alpha Therapeutics Corporation, Killeen, TX.
REASON Blood products, which were collected from a donor with a history of unexplained needle marks, were distributed.
VOLUME OF PRODUCT IN COMMERCE 26 units.
DISTRIBUTION NC, CA, and Germany.

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit 71W547050.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Gainesville, FL.
REASON Blood product, which had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells.
CODE Unit LV11053.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.
REASON Blood product, that tested negative for Cytomegalovirus (CMV), but was collected from a donor who previously tested CMV positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Red Blood Cells.
CODE Unit KC76624.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.
REASON Red Cells, manufactured with a volume that was below the firm's minimum specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 53H01480.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Baltimore, MD.
REASON Blood products, which were collected from a donor who was taking the medication Enbrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MD.

PRODUCT Source Plasma.
CODE Units LO092196, LO092605, LO091025.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Lorain, OH.
REASON Source Plasma, not tested for syphilis and unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC.

PRODUCT Recovered Plasma.
CODE Unit GE56269.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.
REASON Blood product, collected from a donor who subsequently reported taking the medication, Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b) and c) Unit FT05643.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.
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 3 units.
DISTRIBUTION PA.

PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE a) and b) Units 02FC27818, 02LG11762.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Wichita, KS.
REASON Blood products, corresponding to units of clotted red cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX, and KS.

PRODUCT
a) Platelets, Pheresis, Leukocytes Reduced.
b) Platelets, Pheresis, Leukocytes Reduced, Irradiated.
CODE a) and b) Unit 01LZ37595.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, West Henrietta, NY.
REASON Platelets, with a low plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY.

PRODUCT Source Plasma.
CODE Unit numbers: OT165990, OT166196, OT167383, OT167745, OT168150, OT168456, OT169039, OT169204, OT169922, OT170383, OT170699, OT171020, OT171373, OT171773, OT172394, OT172467, OT173043, OT173143, OT173646, OT173827, OT174337, OT174478, OT174933, OT175124, OT175553, OT176522, OT176702, OT177139, OT177344, OT177844, OT178096, OT178444, OT178666, OT179349, OT179548, OT181048, OT181253, OT187034, OT187620, OT188836, OT189182, OT190126, OT190560, OT192267, OT192480, OT193587, OT194176, OT194337, OT194927, OT195013, OT195668, OT195836, OT196558, OT197320, OT197944, OT199244, OT199433, OT200186, OT200742, OT200918, OT202447, OT202792, OT202968, OT203327, OT203663, OT204364, OT204455, OT205123, OT205172, OT205898, OT205927, OT188000, and OT188342.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Odessa, TX.
REASON Blood products, collected from an unsuitable donor based on previous deferral for IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 73 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 02LJ00581.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Wichita, KS.
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 KS.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 01GJ58532.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, West Henrietta, NY.
REASON Blood products, collected from a donor taking Lupron, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY and CA.

PRODUCT Source Plasma. Units (17 units)
CODE Units 78819733, 78815803, 78814233, 74335008, 74339020, 77121165, 77124685, 78812963, 74333592, 74535893, 78816961, 78819184, 74332335, 74334407, 77121028, 77124456, 77126887.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services LP, Athens, OH.
REASON Blood products, collected from donors with a recent history of body piercing within the past 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Units FW096035, FW095897, FW095522, FW095319, FW095038, FW094497, FW094303.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Fort Wayne, IN.
REASON Source Plasma, collected from a donor who was previously deferred for incarceration, was distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.

CODE
a) Unit number: 16LM61145;
b) Unit number: 16LM55380.
RECALLING FIRM/MANUFACTURER The American Red Cross, Central Ohio Region, Columbus, OH.
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 OH.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
c) Recovered Plasma.
CODE a), b), and c) Unit 50LG82999.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH.
REASON Blood products, collected from a donor who engaged in high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH, and Switzerland.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
c) Recovered Plasma.
CODE
a) and b) Units 50LG88414, 50LG69283;
c) Unit 50LG88414.

RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH.
REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION CA, IL, OH, and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 31135-7497.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS.
REASON Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced.
CODE Unit number 31135-7821.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS.
REASON Blood product, collected from a donor whose health screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.

CODE
a) and b) Unit number 31133-5450.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS.
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 MS.

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced.

CODE Unit number 31132-0954 (distributed as two split products).
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS.
REASON Blood product, that tested out of specification for hemoglobin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MS.

PRODUCT Source Plasma.
CODE Unit numbers 67775439, 67772834, 67766505, 67764747, 67750528, 67747481, 67742332, 67739660, 67734825, 67732685, 67726332, 67722099, and 67719310.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Johnson City, TN.
REASON Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION CA.

PRODUCT Platelets Pheresis.
CODE Unit 18P58323.
RECALLING FIRM/MANUFACTURER American National Red Cross, Great Lakes Region, Lansing, MI.
REASON
Platelets Pheresis, with an unacceptably low volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE1 unit.

DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells. Recall # B-1164-4;
b) Red Blood Cell, leukoreduced, autologous.
CODE
a) Units: 0428817, 0428818, 0428820, 0428821, 0428822, 0428823, 0428824, 0428825, 0428826, 0428827, 0428828,
0428829, 0428830, 0428831, 0428832, 0428833, 0428834, 0428835, 0428836, 0428837.
b) Units: 8573176, 8573177,8573178
RECALLING FIRM/MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City, MO.
REASON Blood products, stored in coolers for periods in excess of the maximum storage time established during validation of the containers, were distributed.
VOLUME OF PRODUCT IN COMMERCE 23 units.
DISTRIBUTION KS, and MO.

PRODUCT Red Blood Cells.

CODE Units: 7077250, 7077251, 7077252, 7077253, 7077254, 7077256, 7077258, 7077259, 7077260, 7077261, 7077262, 7077263, 7077264, 7077265, 7077266, 7077267, 7077268
RECALLING FIRM/MANUFACTURER Recalling Firm: Community Blood Center of Greater Kansas City, Kansas City, MO.
Manufacturing Firm: Community Blood Center of Greater Kansas City, Topeka, KS.

REASON Blood products, manufactured from Whole Blood units that reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION KS, and MO.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 33GK52252.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood product, collected from a donor that did not answer one of the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CT.

PRODUCT Red Blood Cells, Leukocytes Reduced Washed.
CODE Unit numbers: 22422-1355, 22422-0916, 22422-8187, 22422-3783, 22422-6052, and 22422-6050.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Las Vegas, NV.
REASON Blood products, manufactured in expired processing bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION NV.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 50LJ713443 and 50LJ71131.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Western Lake Erie Region, Toledo, OH.
REASON Blood products, that did not have the complete amount of additive solution included, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 163679466.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AR.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS.
REASON Blood product, possibly out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT Recovered Plasma.
CODE Unit 16363680.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc, Scottsdale, AZ.

Manufacturing Firm: Blood Systems, Inc., Dba United Blood Services, Meridian, MS.

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 MS, and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 16367-7113.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AR.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS.
REASON Blood Product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION MS.

PRODUCT Fresh Frozen Plasma.
CODE Unit numbers: 16371-0696, 16371-0693, 16371-0695, and 16371-0698.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AR.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS.
REASON Blood products, prepared more than eight hours after collection of the corresponding units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 Units.
DISTRIBUTION MS.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers: 16370-2521, 16369-5497, 16371-3951, and 16369-6182 (all units distributed as two split products).
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AR.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS.
REASON Blood Products, collected on an apheresis machine where there was no documentation of evaluation of the filter assemblies as required, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 Units.
DISTRIBUTION MS, and AL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 16371-7342.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AR.
Manufacturing Firm: Blood Systems, Inc., Meridian, MS.
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 MS.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Fresh Frozen Plasma.
e) Recovered Plasma.
CODE
a) Units: 5183297, 5183298, 5183302, 5183309, 5183319, 5183335, 5183355, 5183356, 5183359, 5183360, 5183362,
5183368, 5183379, 5183383, 5183389, 5183391, 5183392, 5183399, 5183401, 5183421, 5183422, 5183428, 5183435,
5183436, 5183450, 5183454, 5183462, 5183467, 5183469, 5183475, 5183483, 5183484, 5183485, 5183486, 5183487,
5183490, 5183491, 5183492, 5183494, 5183500, 5183504, 5183507, 5183521, 5183527, 5183538, 5183542, 5183544,
5183545, 5183551, 5183559, 5183560, 5183565, 5183566, 5183569, 5183571, 5183572, 5183577, 5183578, 5183579,
5183583, 5183591, 5183593, 5183598, 5183600, 5183611, 5183612, 5183614, 5183620, 5183623, 5183625, 5183627,
5183634;
b) Units: 5183227, 5183229, 5183239, 5183240, 5183247, 5183251, 5183260, 5183272, 5183283, 5183290, 5183307,
5183325, 5183409, 5183423, 5183464, 5183472;
c) Units: 5183227, 5183229, 5183239, 5183240, 5183247, 5183252, 5183283, 5183297, 5183298, 5183302, 5183309,
5183319, 5183325, 5183335, 5183355, 5183389, 5183392, 5183399, 5183401, 5183409, 5183421, 5183423, 5183428,
5183435, 5183436, 5183467, 5183484, 5183485, 5183486, 5183490, 5183491, 5183500, 5183504, 5183507, 5183527,
5183538, 5183544, 5183545, 5183551, 5183559, 5183560, 5183565, 5183566, 5183571, 5183572, 5183578, 5183579,
5183583, 5183591, 5183593, 5183598, 5183600, 5183611, 5183612, 5183614, 5183620, 5183623, 5183627, 5183634;
d) Units: 5183229, 5183239, 5183240, 5183247, 5183290, 5183307, 5183319, 5183325, 5183355, 5183379, 5183389,
5183392, 5183401, 5183507, 5183527, 5183538;
e) Units: 5183227, 5183252, 5183260, 5183272.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood & Tissue Center, Austin, TX.
REASON Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 167 units.
DISTRIBUTION TX, and FL.

PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit 3016032.
RECALLING FIRM/MANUFACTURER Wellmont Health System, Kingsport, TN.
REASON Blood products, collected from a donor whose temperature was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.

PRODUCT Red Blood Cells.
CODE Unit 02FC53951.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Wichita, KS.
REASON Red Cells, created greater than eight hours after the collection of the Whole Blood unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Units YM073373, YM073013, YM072637, YM072402, YM071852, YM071608, YM071147, YM070952, YM070496, YM070333, YM069704, YM069251, YM068944, YM068626, YM067397, YM066837, YM066134.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Ypsilanti, MI.
REASON Source Plasma, which tested negative for syphilis, but was collected from a donor who previously tested reactive for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced.
CODE Unit number 31134-8679.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS.
REASON Blood product that was out of controlled storage for more than 30 minutes was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT Source Plasma.
CODE Unit number 35384458.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Johnson City, TN.

REASON Blood product, that tested negative for viral markers, but was collected from a donor that was previously deferred due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.

CODE Unit 0660109.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH.

REASON Blood product, which was incorrectly labeled as Kpa antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

WEEK ENDING MAY 29

PRODUCT Source Plasma.
CODE Units FJQYFY, FJQYLZ.
RECALLING FIRM/MANUFACTURER Aventis Bio Services, Roanoke, VA.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells.
b) Platelets
c) Fresh Frozen Plasma.
d) Cryoprecipitated AHF.
e) Recovered Plasma.
CODE
a) Unit numbers: FL09540, FL09539, GE63466, FT06502, FS53238, GP59472, KG97136, GV55730, GE63793, KJ60095,
KH47496, KC75435;
b) Unit numbers: GV55730, KJ60095, FT06502;
c) Unit numbers: GV55730, KJ60095;
d) Unit numbers: KH47496, KC75435;
e) Unit numbers: GE63466, FT06502, FS53238, GP59472, KH47496, KC75435.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA.
REASON Blood products, collected using a phlebotomy method that may have compromised the sterility of the products were distributed.
VOLUME OF PRODUCT IN COMMERCE 25 units.
DISTRIBUTION PA.

PRODUCT Red Blood Cells.
CODE Unit number: 3202505.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, TX.
REASON Blood product, which was untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells (Apheresis).
CODE Unit numbers: 18FS78428 (2 parts).
RECALLING FIRM/MANUFACTURER American Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood products, collected from a donor who did not have a hematocrit value performed during the donor screening process, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit S74864.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Saginaw Valley, Saginaw, MI.
REASON Blood products, collected from a donor who was taking the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI and Switzerland.

PRODUCT Red Blood Cells.

CODE Unit 11333-6706.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX.
REASON Blood product, which was not quarantined after receiving information concerning a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NM.

PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE a) and b) K64301.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood Products, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT Platelets.
CODE Unit numbers: K82663 and K85159.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT Platelets.
CODE Unit number: T79712.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Platelets.
CODE Unit numbers: K85379.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Fresh Frozen Plasma.
CODE Unit number K96664.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 18GC17339.
RECALLING FIRM/MANUFACTURER American Red Cross, Great Lakes Region, Lansing, MI.

REASON Blood products, collected from a donor who was taking an antibiotic, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 16LV94600.
RECALLING FIRM/MANUFACTURER American National Red Cross, Central Ohio Region, Columbus, OH.
REASON Blood product, with an unacceptable hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers: 40FE79800, 40FT17003.
RECALLING FIRM/MANUFACTURER American National Red Cross, Heart of American Blood Services Region, Peoria, IL.
REASON Blood products, with unacceptable hematocrits, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.