MAY 2008

WEEK ENDING MAY 3

PRODUCT Human Corneal tissue for Transplant, 
CODE 14330701 and 14330702
RECALLING FIRM/MANUFACTURER The North Carolina Eye Bank, Inc., Winston Salem, NC,
REASON Eye tissue(s) that were mislabeled (in that an appropriate specimen for RPR testing was not used), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 corneas
DISTRIBUTION TX

WEEK ENDING MAY 10

PRODUCT Baxter Fenwal Amicus Separator Apheresis Device, CODE Product code 4R4580, PASSPORT program binders
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fenwal, Inc, Lake Zurich, IL, 
Manufacturer: Baxter Healthcare Corporation, Largo, FL. 
REASON Fenwal failed to provide users participating in the Post Approval Surveillance Study of Platelet Outcomes, Release Tested (PASSPORT) program with the chart listing the minimum plasma volumes for product containers utilized for 7-day platelet storage.
VOLUME OF PRODUCT IN COMMERCE 8 binders
DISTRIBUTION AZ, FL, GA, IA, NJ and NY

PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Platelets Leukocytes Reduced, 
CODE a) and b) Unit: 033FN02430
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Farmington, CT, 
REASON Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CT

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced, CODE Units: 125935807 Part 1; 125935807 Part 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, 
Manufacturer: Blood Systems, Inc., Albuquerque, NM. 
REASON Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NM

PRODUCT Fresh Frozen Plasma, 
CODE Unit: 6735774
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, East Orange, NJ, 
REASON Blood product, which was manufactured from a whole blood unit in which an associated blood product contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT Platelets Pheresis Leukocytes Reduced, 
CODE Unit: 1676106
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, East Orange, NJ, 
REASON Blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT Red Blood Cells Leukocytes Reduced, 
CODE Unit: 9217244
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Source Plasma, 
CODE Units: 05MILA4654 and 05MILA4473
RECALLING FIRM/MANUFACTURER
Recalling Firm: Interstate Blood Bank, Inc., Memphis, TN,
Manufacturer: Interstate Blood Bank, Inc., of Wisconsin, Milwaukee, WI. 
REASON Blood products, collected from a donor who was previously deferred by another donor center, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA

PRODUCT
a) Cryoprecipitated AHF, 
b) Red Blood Cells Leukocytes Reduced, 
CODE a) and b) Units: 307748309
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ, 
Manufacturer: Blood Systems, Inc., Fargo, ND. 
REASON Blood products, that tested negative for viral markers, but was collected from a donor that subsequently reported a previous reactive test for Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION ND, SD

PRODUCT
a) Platelets, 
b) Red Blood Cells Leukocytes Reduced, 
CODE a) and b) Units: X8726477
RECALLING FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL,
REASON Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH, FL

PRODUCT
a) Red Blood Cells, 
b) Plasma Frozen, 
CODE a) and b) Units: 1427097
RECALLING FIRM/MANUFACTURER The Blood Center of New Jersey, East Orange, NJ
REASON Blood products, which were manufactured from a whole blood unit in which an associated blood component contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NJ

PRODUCT
a) Red Blood Cells Leukocytes Reduced, 
b) Platelets,
CODE a) and b) Unit: 4248419
RECALLING FIRM/MANUFACTURER Florida’s Blood Center, Inc., Orlando, FL, 
REASON Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL

PRODUCT Red Blood Cells Leukocytes Reduced, 
CODE Unit: 8543670
RECALLING FIRM/MANUFACTURER Poudre Valley Health Care, Inc., Blood Bank, Fort Collins, CO,
REASON Donor reported travel to a malarial endemic area, but was allowed to donate.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated, 
b) Platelets Pheresis Leukocytes Reduced, 
CODE
a) Unit: 9182374;
b) Units: 9182383 (Parts 1 & 2), 9182399 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO, 
REASON Blood products, which were labeled as leukoreduced, but were incorrectly tested for white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION CO

PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 003L69997
RECALLING FIRM/MANUFACTURER The American National Red Cross – Southern Region, Douglasville, GA
REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA, Switzerland

PRODUCT Red Blood Cells Leukocytes Reduced, 
CODE Unit: 18GT19723
RECALLING FIRM/MANUFACTURER The American National Red Cross Great Lakes Region, Lansing, MI,
REASON Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA, MI

PRODUCT Red Blood Cells, 
CODE Unit: 3947035
RECALLING FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL
REASON Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 4770325
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 Platelets Pheresis Leukocytes Reduced Irradiated, CODE Unit: 307448453
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, 
Manufacturer: Blood System, Inc., Fargo, ND. 
REASON Blood product, in which the quality control testing was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION ND

PRODUCT Source Plasma, 
CODE Units: I72055952; I72059174; I72059814; I72059934; I72060332; 364004552; 364005502; 364010412
RECALLING FIRM/MANUFACTURER International BioResources, Llc, Fort Worth, TX
REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION NC

PRODUCT Source Plasma, 
CODE Units: 364011291; 364011590; 364012979
RECALLING FIRM/MANUFACTURER International BioResources, Llc, Fort Worth, TX,
REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION NC

PRODUCT Source Plasma, 
CODE Units: I72060086; 364004121; 364005123; 364007816; 364009292; 364009978
RECALLING FIRM/MANUFACTURER International BioResources, Llc, Fort Worth, TX,
REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION NC

PRODUCT Source Plasma, 
CODE Unit: 364013060
RECALLING FIRM/MANUFACTURER International BioResources, Llc, Fort Worth, TX
REASON Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Source Plasma, 
CODE Unit: 04BNDH3938
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services LP, Deerfield IL, 
Manufacturer: BioLife Plasma Services, L.P., Bismarck, ND. REASON Blood product, not quarantined after information was received concerning post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Whole Blood  CPD,
CODE Units: J41071, J41074, J41076, J41081, J41088
RECALLING FIRM/MANUFACTURER Central Pennsylvania Blood Bank, Hummelstown, Pa, 
REASON Blood products, collected from donors whose hemoglobin determinations were incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION PA

PRODUCT Fresh Frozen Plasma, 
CODE
Units: 04R73046, 04R73049, 04R73050, 04R73051, 04R73054, 04R73055, 04R73056, 04R73057, 04R73060, 04R73065, 04R73067, 04R73070, 04R73073, 04R73074, 04R73076, 04R73078, 04R73079, 04R73081
RECALLING FIRM/MANUFACTURER ARC Blood Services, New England Region, Dedham, MA
REASON Blood products, which may have been stored at an incorrect temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units
DISTRIBUTION MA, NY, PA

PRODUCT Recovered Plasma, 
CODE Unit: 003L69997
RECALLING FIRM/MANUFACTURER The American National Red Cross – Southern Region, Douglasville, GA
REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA, Switzerland

PRODUCT Source Plasma, 
CODE Units GZ047095, GZ046673, GZ046543, GZ046276, GZ046134, GZ045820, GZ043452, GZ043118, GZ018276, GZ018116, 06GINA2726 and 06GINA2687
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Gary, IN
REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units
DISTRIBUTION CA and Austria

PRODUCT Source Plasma, 
CODE Unit: GZ042249
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Gary, IN,
REASON Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Blood and Blood Products for Reprocessing, 
CODE Unit: 18GT19723
RECALLING FIRM/MANUFACTURER The American National Red Cross Great Lakes Region, Lansing, MI
REASON Blood product, collected from donors whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA, MI

PRODUCT Recovered Plasma, 
CODE Unit: 4243496
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc. Orlando, FL
REASON Blood product, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but was collected from a donor who was subsequently determined to have previously tested positive for HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria