NOVEMBER 2005

WEEK ENDING NOVEMBER 5

PRODUCT Red Blood Cells
CODE Unit numbers: 6834707 and 6831870
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, which were 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 CO and VA

PRODUCT Red Blood Cells
CODE Unit number: 6887152
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was 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 VA

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit number: 6627127
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was 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 CO

PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes Reduced
CODE
a) Unit number: 6886816;
b) Unit number: 6883699
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, which were 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 CO and PA

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit number: 6615745
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was 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 CO

PRODUCT Platelets Pheresis Leukocytes Reduced Irradiated
CODE Unit number: 13X04137
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit, MI
REASON Blood product, which was 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 MI

WEEK ENDING NOVEMBER 12

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes Reduced,
CODE
a) Unit number: 6941703;
b) Unit number: 6943924
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
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 CO

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Cryoprecipitated AHF
c) Recovered Plasma
CODE a), b), and c) Unit number: 2042083
RECALLING FIRM/MANUFACTURER Florida Blood Centers, Inc., Orlando, FL
REASON Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION FL and Austria

PRODUCT
a) Cryoprecipitated AHF
b) Recovered Plasma
CODE a) and b) Unit number: 2845379
RECALLING FIRM/MANUFACTURER Florida Blood Centers, Inc., Orlando, FL
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 2 units
DISTRIBUTION FL and Austria

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 71X07583-8 (Part 2)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Gainesville, FL
REASON Platelets Pheresis, with an unacceptably low volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Source Plasma
CODE Unit Numbers: DF0043780, DF0043940, DF0044021, DF0044229, DF0044300, DF0044515, DF0044615, DF0044822
RECALLING FIRM/MANUFACTURER DCI Biologicals Dunedin, LLC, Dunedin, FL
REASON Blood products, which tested negative for viral markers, but were not properly quarantined after the receipt of post donation information related to recent ear piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION England

PRODUCT Whole Blood for further manufacturer of in-vitro diagnostics
CODE Unit number: TS22173
RECALLING FIRM/MANUFACTURER Advanced BioServices, LLC, dba Trimar Hollywood, Inc., Reseda, CA
REASON Blood product, which tested repeatedly reactive for the antibody to hepatitis C virus (anti-HCV), but was labeled as testing negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Red Blood Cells
CODE Unit number: GC14328
RECALLING FIRM/MANUFACTURER Southern California Permanente Medical Group Blood Donor Center, Downey, CA
REASON Blood product, manufactured from a unit of Whole Blood that was designated as a low volume collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Platelets
CODE Unit number: FL20041
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Platelets, corresponding to a unit of red cells that was possibly contaminated with Streptococcus Beta Hemolytic Group G, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 01W13872
RECALLING FIRM/MANUFACTURER American National Red Cross, New York-Penn Region, West Henrietta, NY
REASON Blood product, corresponding to a unit of Platelets that was possibly contaminated with multiple bacterial species, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NY

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6387988
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
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 CO

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers: 6863756, 6863129 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION CO

PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit number: 6859823;
b) Unit number: 6862067
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
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 CO

PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit numbers: 6509411, 6504021;
b) Unit numbers: 6507181, 6501951
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
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 CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 0744275
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
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 CO

PRODUCT
a) Red Blood Cells
b) Platelets Pheresis, Leukocytes Reduced,
CODE
a) Unit number: 6859717;
b) Unit numbers: 6859717, 6858357 (Parts 1 and 2), 6856025 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
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 6 units
DISTRIBUTION CO

PRODUCT Source Plasma
CODE Unit numbers: 6270363957, 6270363544, 6270362964, 6270361298, 6270360725, 6270360133, 6270359182, 6270358443, 6270358007, 6270357262, 6270356673, 6270355991
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Salt Lake City, UT
REASON Source Plasma, collected from a donor who had received a piercing within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units
DISTRIBUTION NC

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 10190-9399
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., dba United Blood Services, Scottsdale, AZ
REASON Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AZ

PRODUCT Red Blood Cells Pheresis, Leukocytes Reduced
CODE Unit number: 24749-4029 (Part 2)
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., dba United Blood Services, Scottsdale, AZ
REASON Blood product, corresponding to a unit of red cells that was hemolyzed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AZ

PRODUCT
a) Red Blood Cells, Recall # B-0138-6;
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit numbers: 6375156, 6375160, 6375162;
b) Unit numbers: 6375163, 6375143, 6375151, 6375152, 6375155, 6375158
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 21384-1310
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fargo, ND
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 ND

PRODUCT Recovered Plasma
CODE Unit number: 6104967
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
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 Switzerland

PRODUCT Red Blood Cells
CODE Unit number; 5200924
RECALLING FIRM/MANUFACTURER Ogden Medical Center, Inc., Ogden, UT
REASON Blood product, which tested positive for the hepatitis C virus (HCV), but was not labeled with a biohazard label, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION UT

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 6851683
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Platelets Pheresis
CODE Unit numbers: 304740, 306352, 306356 (Parts A & B)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which tested negative for the cytomegalovirus (CVM) but were collected from a donor who previously tested positive for CMV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION CO

PRODUCT Source Plasma,
CODE Unit number: F-02138-046
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 6527304, 6411412
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, which may have reached an unacceptable temperature during shipment and may have been hemolyzed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 101876268
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., dba United Blood Services, Scottsdale, AZ
REASON Blood product, collected from a donor who was at risk for Leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AZ

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 322969
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was not leukoreduced within the appropriate time period after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 320429, 323441, 324132
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, which were not leukoreduced within the appropriate time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated
CODE Unit number: 320447
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was not leukoreduced within the appropriate time period after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

WEEK ENDING NOVEMBER 19

PRODUCT Cryoprecipitated AHF
CODE Unit number: 6871879
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Platelet Pheresis Leukocytes Reduced
CODE Unit numbers: 12W82020 (2-unit split), 12LT52752
RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION NC

PRODUCT Source Plasma
CODE Unit numbers: 0161196, 0161568
RECALLING FIRM/MANUFACTURER DCI Biologicals LLC, Farmington, NM
REASON Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NC

PRODUCT
Recall # B-0082-6;
b) Cryoprecipitated, AHF
c) Recovered Plasma, 
CODE a), b), and c) Unit number 50LJ6517
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH
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), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION OH and Switzerland

PRODUCT Red Blood Cells
CODE Unit number: 6600558
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from a donor who visited an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT Red Blood Cells
CODE Unit number: 7015334
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
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 FL

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6446070
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
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 CO

PRODUCT Red Blood Cells
CODE Unit number: 6827154
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from a donor who visited an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells
CODE Unit number: 6529429
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from a donor who visited an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocyte Reduced
CODE Unit number: 6529389
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from a donor who visited an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocyte Reduced
CODE Unit numbers: 13FV21747, 13GV40788
RECALLING FIRM/MANUFACTURER American Red Cross, Southern Michigan Region, Detroit, MI
REASON Blood products, which tested negative for the antibody to human T-lymphotropic virus type I/II (anti-HTLV-I/II), but were collected from a donor who previously tested repeatedly reactive for anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MI

PRODUCT Source Plasma
CODE Unit numbers: AB0849380, AB0850550, AB0851162, AB0851385, AB0852130, AB0852363, AB0853199, AB0853459, AB0854269, AB0854541, AB0855627, AB0856342, AB0856536, AB0857489, AB0857755, AB0858421, AB0858705, AB0859613, AB0859882, AB0860718, AB0861010, AB0861651, AB0862004, AB0862672, AB0862894, AB0863535, AB0863817, AB0864419, AB0864877, AB0865870, AB0866479, AB0867255, AB0867676, AB0868316, AB0868623, AB0869393, AB0869722, AB0870384, AB0870845, AB0871432, AB0871747, AB0872840, AB0873062, AB0874025, AB0874230, AB0875006, AB0875338, AB0876056, AB0876323, AB0876915, AB0877210, AB0877913, AB0878265, AB0878972, AB0879203, AB0880030, AB0880299, AB0881079, AB0881539, AB0882026, AB0882543, AB0882992, AB0883487, AB0883963, AB0884547, AB0884985, AB0885329, AB0886016, AB0886487, AB0886937, AB0887401, AB0888021, AB0888514, AB0888901, AB0889328, AB0889801, AB0890390, AB0890847, AB0891449, AB0891887, AB0893016, AB0893354, AB0893937, AB0894376, AB0894950, AB0896187, AB0896451
RECALLING FIRM/MANUFACTURER Bio-Save Resources of Albuquerque LLC, Albuquerque, NM
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 87 units
DISTRIBUTION England

PRODUCT ETI-LAB Applications Disk (for programming Bio-Rad HIV-1/HIV-2 Plus O EIA Assay), CODE Version 1.0
RECALLING FIRM/MANUFACTURER Diasorin, Inc., Stillwater, MN
REASON Defect in the design of HIV-1/2 testing software resulting in an incorrect incubation temperature.
VOLUME OF PRODUCT IN COMMERCE 11
DISTRIBUTION MA, NY, MT, AL, MS, SD, LA, and CT

PRODUCT Source Plasma
CODE Unit numbers: 24103589, 24103144, 24102561, 24102143, 24101621, 24101241, 24093439, 24093023, 24092430
RECALLING FIRM/MANUFACTURER Ohio Blood Plasma, Inc, Cincinnati, OH
REASON Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION NC

PRODUCT Human Cornea for Transplantation
CODE Tissue 05-0048-100
RECALLING FIRM/MANUFACTURER Oklahoma Lions Eye Bank, Oklahoma City, OK
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-HBcore) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue
DISTRIBUTION OK

PRODUCT Red Blood Cells
CODE Unit number: 5852368
RECALLING FIRM/MANUFACTURER Life Source, Glenview, IL
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT Red Blood Cells
CODE Unit number: X22036
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA
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 VA

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets
CODE a) and b) Unit number: 2076958
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY
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 KY

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 042KW24944
RECALLING FIRM/MANUFACTURER American National Red Cross, Northern Ohio Region, Cleveland, OH
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 OH

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 3147176, 3147312, 3145668
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, San Francisco, CA
REASON Red Cells, lacking proper documentation of antigen phenotyping, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION CA

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit numbers: 06LW78976, 06LW78978, 06LW78981, 06GX38981, 06GX38983, 06GX38984, 06GX38985, 06FS79436, 06GG61847, 06GG61846
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southern California Region, Pomona, CA
REASON Blood Products, which may have been exposed to unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION CA

PRODUCT Source Plasma
CODE Unit numbers: 0814904, 0815839, 0818938, 0819436, 0820974, 0821296, 0822917, 0823214, AB0826584, AB0826866, AB0827715, AB0827965, AB0828694, AB0828950, AB0829718, AB0829925
RECALLING FIRM/MANUFACTURER Bio-Save Resources of Albuquerque LLC, Albuquerque, NM
REASON Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units
DISTRIBUTION United Kingdom

PRODUCT Platelets Pheresis Leukoreduced
CODE Unit number: 101968830 (distributed as 2 split products)
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Scottsdale, AZ
REASON Blood products, possibly contaminated with coagulase-negative staphyloccus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AZ

PRODUCT Panoscreen I, II, III
CODE Lot 37010A, Expiration 25 Sep 03
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA
REASON Panoscreens, packaged with the incorrect Master List, were distributed.
VOLUME OF PRODUCT IN COMMERCE 684
DISTRIBUTION Nationwide

PRODUCT Fresh Frozen Plasma (Apheresis)
CODE Unit number: 210430
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Fresh Frozen Plasma, not frozen within 6 hours of collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Fresh Frozen Plasma (Apheresis)
CODE Unit numbers: 197501, 197767, 202815, 202817, 203439, 203448, 215347
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Fresh Frozen Plasma, not frozen within 6 hours of collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION CO

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 4718426
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Platelets, possibly contaminated with microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

WEEK ENDING NOVEMBER 26

PRODUCT Source Plasma
CODE Unit number: 40583167
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Muskegon, MI
REASON Source Plasma, collected from an ineligible donor who had been permanently deferred due to drug use, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit number: 6577083
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was not manufactured in accordance with the manufacturer’s instructions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
c) Platelets
d) Recovered Plasma
CODE
a) Unit numbers: 13FN51729 and 13FN56751;
b) Unit number: 13GV09117;
c) and d) Unit numbers: 13FN51729, 13FN56751 and 13GV09117
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit, MI
REASON Blood products, which were collected from a donor who reported close contact with someone with a history of hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION CA, MI, and PR

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced
CODE Unit number: 10194-9490
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Scottsdale, AZ
REASON Blood product, for which the dual pheresis unit was found to be hemolyzed, was distributed
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AZ

PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced
b) Red Blood Cells Leukocytes Reduced,
CODE
a) Unit numbers: 101894646, 101891164, 101882852, 101900353, 101899040;
b) Unit numbers: 307426363, 247492303, 101911143
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Scottsdale, AZ
REASON Blood products, which were not evaluated when associated split units were returned due to possible hemolysis, were distributed
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION AZ

PRODUCT
Medical Devices
a) Medtronic One Source Pack; Medtronic Ideal Maxpac Total System
CODE
a) Model BT711EM;
b) Model TS8285R and TS8285R2
RECALLING FIRM/MANUFACTURER Medtronic Perfusion Systems, Brooklyn Park, MN
REASON Medical devices, assembled with recalled blood transfer bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3,325 devices
DISTRIBUTION AL and OR

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit number: 7065528
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was collected from a donor who had received acupuncture within twelve months of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Source Plasma
CODE Unit numbers: 6270288132, 6270285132, 6270282958, and 6270280365
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc. South Salt Lake City, UT
REASON Blood products, which were collected from a donor who was not adequately assessed for risk factors for variant Creutzfeldt-Jakob Disease (VCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION NC

PRODUCT
a) Red Blood Cells
b) Recovered Plasma
CODE a) and b) Unit number: 6134003
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, which were collected from a donor in which the confidentiality of the donor screening process was compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO and Switzerland

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit number: 320006
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was not manufactured in accordance to the manufacturer’s instructions for leukocyte reduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit numbers: 576166, 327673, 332511, 327670, 320556, and 325996
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was not manufactured in accordance to the manufacturer’s instructions for leukocyte reduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION CO

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit number: 6376729
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was collected in a manner that possibly compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Source Plasma
CODE Unit numbers: 0348295, 0348725, 0349250, 0350117, 0350780, 0351277, 0351789, 0352539, and 0352936
RECALLING FIRM/MANUFACTURER Las Cruces Biologicals LLC, Las Cruces, NM
REASON Blood products, which were collected from a donor who had received a tattoo and body piercing within twelve months of the donations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION United Kingdom

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Red Blood Cells, Leukocytes Reduced, Irradiated
CODE
a) Unit numbers: 2239344, 2478382, 2478435, 2478933, 2478947, 2479566, 2479982, 3922519,
3923974, 3923990, 3924276, 3924914, 5564897, 5564904, 5564911, 5851572, 5851585, 5852269,
5852270, 5852278, 5852286, 5852320, 5853133, 5853140, 5853149, 5853151, 5853181, 5853183,
5853186, 5853209, 5853214, 5853217, 5934531, 5934537, 5934556, 6158148, 6158156, 6158176,
6158293, 6158298, 6158304, 6158705, 6158712, 6253972, 6335940, 6336068, 6336074, 6336332,
7960439, 9207581, 9594803, 9594817, 2239344, 2239720, 2478382, 2478409, 2478933, 2479566,
2479982, 3922519, 3923974, 3923990, 3924276, 3924914, 3924922, 5564897, 5564904, 5564911,
5851572, 5851585, 5852269, 5852270, 5852278, 5852286, 5852320, 5853133, 5853140, 5853149,
5853151, 5853181, 5853183, 5853186, 5853209, 5853214, 5853217, 5934531, 5934556, 6158148,
6158176, 6158293, 6158298, 6158304, 6158705, 6158712, 6253972, 6335620, 6335940, 6336068,
6336074, 6336332, 6336339, 7960439, 9207581, 9594803, 9594817
b) Unit numbers: 2478435, 2478947, 5934537, 9207599, 2239720, 2478409, 3924922, 6335620,
6336339, 9207599
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL\
REASON Blood products, lacking assurance of sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE 115 units
DISTRIBUTION IL

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 12W96270
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers: H73745 (split unit)
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA
REASON Blood products, which were incorrectly labeled as leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units 

DISTRIBUTION VA

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 7058743
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont, TX
REASON Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers: 7672590, 7671775
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont, TX
REASON Blood products, which yielded a platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers: 7243299, 7243374, 3766110
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Beaumont, TX
REASON Blood products, which yielded a platelet count that was below the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION NY and TX

PRODUCT Platelets
CODE Unit number: X27249
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA
REASON Blood product, collected from an ineligible donor due to recent ingestion of aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION VA

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Recovered Plasma
CODE a) and b) Unit number: 6492916
RECALLING FIRM/MANUFACTURER Community Blood Bank, Inc., Rancho Mirage, CA
REASON Blood products, collected from a donor who was previously deferred for a piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA and FL

PRODUCT Red Blood Cells Pheresis
CODE Unit numbers: 4701671 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX\
REASON Blood products, collected from a donor who was previously deferred for a piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX

PRODUCT
a) Red Blood Cells
b) Fresh Frozen Plasma
CODE a) and b) Unit number: 20Q01346
RECALLING FIRM/MANUFACTURER American National Red Cross, Salt Lake City, UT
REASON Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION UT

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Fresh Frozen Plasma
CODE a) and b) Unit number: 0685687
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, San Francisco, CA
REASON  Blood products, which were collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA

PRODUCT Fresh Frozen Plasma
CODE Unit number: Y00593
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA,
REASON Blood Product, which was collected from an unsuitable donor based on risk factors for Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION VA

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 33FP49389 (part 1)
RECALLING FIRM/MANUFACTURER American National Red Cross, Connecticut Region, Farmington, CT
REASON Platelets, which were possibly contaminated with Staphylococcus capitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CT

PRODUCT
a) Fresh Frozen Plasma
b) Plasma, Cryoprecipitate Reduced,
c) Cryoprecipitated AHF
CODE
a) Unit numbers: 20LC59938, 20T40482;
b) and c) Unit number: 20S52399
RECALLING FIRM/MANUFACTURER American National Red Cross, Lewis and Clark Region, Boise, ID
REASON Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION AZ, CA, and ID

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 18237-5645
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Cheyenne, WY. 
REASON Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WY

PRODUCT Recovered Plasma
CODE Unit number: 1882568
RECALLING FIRM/MANUFACTURER Florida’s Blood Centers Inc., Orlando, FL
REASON Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Red Blood Cells Leukoreduced
CODE Unit number: 04FV39993
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA
REASON Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NY

PRODUCT Red Blood Cells Leukoreduced
CODE Unit numbers: 04FK62209, 04FR91414
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA
REASON Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MA

PRODUCT Red Blood Cells
CODE Unit number: 7836225
RECALLING FIRM/MANUFACTURER Southeastern Community Blood Center, Tallahassee, FL
REASON Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 2291251
RECALLING FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL
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 FL

PRODUCT Red Blood Cells Leukocytes Reduced Irradiated
CODE Unit numbers: 216416, 216426, 217686, and 221020
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, which were labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION CO

PRODUCT Red Blood Cells Leukocytes Reduced Irradiated
CODE Unit number: 6970056
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit number: 6520472
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was not properly tested for syphilise, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AR

PRODUCT Platelets Pheresis, Leukocytes Reduced, Irradiated
CODE Unit numbers: 108LJ35032 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER American National Red Cross, Arizona Region, Tucson, AZ
REASON Blood products, which may have reached unacceptable temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AZ

PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Red Blood Cells
CODE
a) Unit numbers: 7004332, 6147133, 7004333, 7004329, 6147126, 6146856, 7004311, 6146848;
b) Unit number: 6147203
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Red Cells, invalidated due to a NAT testing error, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION CO

PRODUCT Red Blood Cells
CODE Unit number: 6174296
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Red Blood Cells, incorrectly tested for HIV/HCV NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit numbers: 8500750, 8500733
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., dba United Blood Services, Ventura, CA
REASON Red Cells, leukoreduced by filtration greater than five days post collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA

PRODUCT Platelets, Leukocytes Reduced
CODE Unit number K80698
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA
REASON Blood product, which was labeled leukoreduced, but had an unacceptable white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION VA

PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes Reduced, Irradiated
CODE a) and b) Unit number: X22856
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA
REASON Blood product, which 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 2 units
DISTRIBUTION VA

PRODUCT Red Blood Cells Pheresis, Leukocytes Reduced
CODE Unit number: 6445597 (Part 1)
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL
Manufacturer: LifeSource, Skokie, IL. 
REASON Blood product, which was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm’s standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT Source Plasma
CODE Unit number: VA-138504
RECALLING FIRM/MANUFACTURER Pyramid Biological Corp., Van Nuys, CA
REASON Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Recovered Plasma
CODE Unit number: 18237-5645
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Cheyenne, WY. 
REASON Blood product, collected from a donor who did not have a complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Switzerland

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 17FX30081
RECALLING FIRM/MANUFACTURER American National Red Cross, Salt Lake City, UT
REASON Blood product, which was exposed to unacceptable storage temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION UT

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated
CODE Unit numbers: 06FE71888, 06FE71890, 06FE71918
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Pomona, CA
REASON Blood products, which were out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION CA