WEEK ENDING JANUARY 7

PRODUCT Recovered Plasma.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER UCLA Medical Center Blood Bank, Los Angeles, California.
DISTRIBUTION California.
QUANTITY 1,181 units were distributed.
REASON Blood products were not tested for viral markers in accordance with the test kit manufacturer's instructions.

PRODUCT Plasma, Liquid.
CODE Unit #04R45293.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION Masschusetts.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a history of hepatitis.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #29FG69942.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION North Carolina.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Red Blood Cells.
CODE Unit #1590828.
MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the drug Minocin.

PRODUCT Various Human Tissue for Transplant including: Cancellous Chips, Serrated Fibula Wedges, Iliac Crest Wedge, Fibula Shaft, Fascia Lata, Semitendinosis Tendon, Femur Proximal Right, Acetabulum Right, Cortical Cancellous Granules, Cortical Cancellous Chips, Achilles Tendon, Bone Tendon, Humerus Whole Left with Cuff, Humerus Whole Right with Cuff, Putty, Femoral Cross Section with Dowel, Patella Wedge, Femoral Head, Allogenic Bone Matrix, Illium Bicort Strip.
CODE Donor Numbers: 03610788 (54 tissues), 03606576 (47 tissues), 03612141 (12 tissues).
MANUFACTURER Musculoskelatal Transplant Foundaton, Edison, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY Donor Numbers: 03610788 (54 tissues), 03606576 (47 tissues), 03612141 (12 tissues).
REASON Tissues for transplant, which were incorrectly tested for HBsAg, or anti-HIV-1/2, were distributed.

PRODUCT Platelets.
CODE Unit #1597234.
MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON A unit of platelets was prepared from a whole blood unit collected from a donor who had taken aspirin within 72 hours of donation.

PRODUCT Platelets, Pheresis, Leukocyte Reduced.
CODE Unit #4056616.
MANUFACTURER Community Blood Center, Dayton, Ohio.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product had an inadequate rest time.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #042Y98571.
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for anti-HCV but were collected from a donor who previously tested reactive for anti-HCV, RIBA indeterminate.

PRODUCT Red Blood Cells.
CODE Unit #049Y57565.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was tagged as crossmatched that had not been crossmatched.

PRODUCT Red Blood Cells, Leukodepleted, Washed.
CODE 4360420, 1095560, 2278498.
MANUFACTURER New York Blood Services (Center West), A Division of New York Blood Center, Inc., New York, New York.
DISTRIBUTION New York.
QUANTITY 3 units were distributed.
REASON Red Blood Cells, leukoreduced by filtration greater than five days past the time of collection were distributed for transfusion.

PRODUCT Fresh Frozen Plasma, Pheresis
CODE Unit #3444193.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON A pheresis blood product with discrepant collection times was distributed.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #22404-2629.
MANUFACTURER Blood Services, Inc., Henderson, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who received a tissue transplant within a year of donation.

 
WEEK ENDING JANUARY 14

PRODUCT Human Eye Tissue, Left Cornea.
CODE 21108LC.
MANUFACTURER Lions Eye Bank of Delaware Valley at Wills Eye Hospital, Philadelphia, Pennsylvania.
RECALLED BY Lions Eye Bank of Delaware Valley, Philadelphia, Pennsylvania
DISTRIBUTION Delaware.
QUANTITY 1 cornea.
REASON Cornea was collected from a donor whose serum tested repeatedly reactive for Anti-HCV, RIBA positive, and had HCV RNA detected by PCR.

PRODUCT Corneas.
CODE Identification Numbers 98-0439, 98-0440, 98-1429,98-1430.
MANUFACTURER Central Florida Lions Eye and Tissue Bank, Tampa, Florida.
DISTRIBUTION Florida, California, Iowa, North Carolina.
QUANTITY 4 units were distributed.
REASON Corneas were obtained from two donors who tested repeatedly reactive for anti-HBc.

PRODUCT Source Plasma
CODE Unit Numbers: N-65354-165, G-92950-165, G-93343-165 , G-93704-165, G-94143-165, G-94637-165, G-94889-165.
MANUFACTURER Pyramid Biologicals Corporation, Plasma Center, Las Vegas, Nevada.
DISTRIBUTION California.
QUANTITY 7 units were distributed.
REASON Blood products tested negative for anti-HCV, but were collected from a donor who previously tested reactive for Hepatitis C.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit Numbers: a) 49GR11001, 49GR11002, 49GR11003, 49GR11004, 49GR11005, 49GR11006, 49GR11010, 49GR11011, 49GR11013,49GR11014, 49GR11015, 49GR11016, 49GR11018, 49GR11019;
b) 49GR11001, 49GR11002, 49GR11003, 49GR11004, 49GR11005, 49GR11006, 49GR11007, 49GR11008, 49GR11009, 49GR11010, 49GR11011, 49GR11013, 49GR11014, 49GR11015, 49GR11016, 49GR11017, 49GR11018, 49GR11019.
MANUFACTURER American Red Cross Blood Services, Farmers Branch, Texas.
RECALLED BY American Red Cross Blood Services, Tulsa, Oklahoma
DISTRIBUTION Texas.
QUANTITY a) 14 units; b) 18 units were distributed.
REASON Blood products were collected in a manner that compromises the sterility of the units.

PRODUCT a) Red Blood Cells; b) Plasma, Frozen; c) Platelets; d) Cryoprecipitated AHF.
CODE Unit Numbers: a) 53GC16693, 53R30080, 53GL72510, 53H14442; b) 53GC16693; c) 53R30080, 53H14442; d) 53GL72510.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland.
QUANTITY a) 4 units; b) 1 unit; c) 2 units; d) 1 unit.
REASON Blood products were collected from a donor with a history of Dermatomyositis.

PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets, Pheresis.
CODE Unit Numbers: a) 53FC86035, 53C01075; b) 53L10841; c) 53P75727 part A, 53P75727 part B.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland, District of Columbia, Virginia.
QUANTITY a) 2 units; b) 1 unit; c) 1 split unit.
REASON Blood products, which tested positive for CMV antibodies, or were not tested for CMV antibodies, were labeled as CMVnegative and distributed.

PRODUCT Source Plasma.
CODE Unit Numbers: N-68443-165, G-42216-165, G-42418-165, G-43567-165, G-43711-165, G-44365-165, G-46018-165, G-46463-165, G-46916-165, G-47087-165, G-47498-165, G-47694-165, G-48126-165, G-48542-165, G-48731-165, G-52296-165, G-52454-165, G-53000-165, G-53197-165, G-53714-165
MANUFACTURER Pyramid Biologicals Corporation, Plasma Center, Las Vegas, Nevada.
DISTRIBUTION California.
QUANTITY 20 units were distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT a) Red Blood Cells; b) Cryoprecipitates; c) Recovered Plasma.
CODE Unit Numbers: (a) 4533168; (b&c) 1507272 and 4533168.
MANUFACTURER Carter Blood Care, Bedford, Texas.
DISTRIBUTION Texas, California, Switzerland.
QUANTITY a) 1 unit; (b&c) 2 units of each component.
REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (HIV-1), but were collected from a donor who previously tested repeatedly reactive for the antibody, Western Blot negative.

PRODUCT Human Tissue for Transplant: Various Musculoskeletal Tissues and Skin Allografts
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual deposit numbers recalled.
MANUFACTURER LifeLink Tissue Bank, Tampa, Florida.
DISTRIBUTION Nationwide.
QUANTITY 1,248 allografts.
REASON Various tissues for transplant which were collected from 33 donors who had not been properly evaluated.

PRODUCT Red Blood Cells, Irradiated.
CODE Unit Number X48634.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was mislabeled as CMV antibody negative.

PRODUCT Red Blood Cells.
CODE Unit #N53342.
MANUFACTURER Penn State Geisinger Health System, Hershey, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who tested initially reactive for HIV-1-p24, and was not re-tested in duplicate as required by the manufacturerís instruction.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit Number 5086435.
MANUFACTURER BloodCare, Dallas, Texas.
DISTRIBUTION Texas.
QUANTITY 1 Unit of each component was distributed.
REASON Blood products were distributed from a donor who may have traveled to an area that is endemic for malaria. Firm-initiated recall complete.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #50X09401.
MANUFACTURER American Red Cross Blood Services, Toledo, Ohio.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of hepatitis.

PRODUCT Red Blood Cells, Washed
CODE Unit #1074778.
MANUFACTURER New Jersey Blood Services, a Division of New York Blood Center, Inc., New Brunswick, New Jersey.
RECALLED BY New York Blood Services (Center West), New York, New York
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit #22403-7686.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada. (Collection Site)
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit Numbers a) 22405-7444, 22404-4586; b) 22404-4586.
MANUFACTURER Blood Services, Inc., Las Vegas, Nevada (Collection Site).
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY a) 2 units; b) 1 unit.
REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCTS a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Plasma; e) Recovered Plasma.
CODE Unit Numbers: a) 42R48217, 42Q49094, 42G43250; b) 42R48217, 42Q49094, 42G43250; c) 42R48217; d) 42G43250; e) 42Q49094.
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
DISTRIBUTION Ohio.
QUANTITY a) 3 units; b) 3 units; c) 1 unit; d) 1 unit; e) 1 unit.
REASON Blood products were collected from an unsuitable donor.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #55R06708.
MANUFACTURER American Red Cross Blood Services, Little Rock, Arkansas.
DISTRIBUTION Arkansas and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of hepatitis.

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit #10602-4554.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit Numbers: a) 10593-9114 and 10597-3928; b) 10593-9114.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Scottsdale, Arizona
DISTRIBUTION Arizona and California.
QUANTITY a) 2 units; b) 1 unit.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit #10608-0088.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma.
CODE Unit #10598-7222.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY 3Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Arizona, Texas, Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of hepatitis.

PRODUCT Platelets.
CODE Unit #10594-5601.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Arizona.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced, Irradiated
CODE Unit Numbers: a) 10601-9960; b) 10598-8832.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Arizona.
QUANTITY 1 unit of each component was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells, Irradiated.
CODE Unit Numbers: 1355409 and 12FH82785.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with extended expiration dates.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #16J92337.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component.
REASON Blood products had an acceptable ALT but were collected from a donor who previously had an elevated ALT on two separate occasions.

PRODUCT Corneas
CODE MSN-1999-1039, MSN-1999-1040.
MANUFACTURER The Eye Bank of Wisconsin, Inc., Madison, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 2 units were distributed.
REASON Corneas were collected from a donor who tested repeatedly reactive for HCV by EIA, and RIBA negative.

PRODUCT Allergenic Extract Alternaria Tenuis, Strength 1:10 w/v.
CODE Lot #K9913248.
MANUFACTURER Bayer Corporation, Hollister-Steir Laboratories, LLC, Spokane, Washington.
DISTRIBUTION Florida, Illinois, Louisiana, Montana, Texas.
QUANTITY Six vials with the incorrect expiration date were distributed.
REASON Allergenic extracts were labeled with an extended expiration date.