WEEK ENDING MAY 5

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Recovered Plasma.
CODE Unit Numbers: a) X68636, X41073; b) X68636; c) X41073.
MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, Illinois.
DISTRIBUTION Illinois and Switzerland.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #X61997.
MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, Illinois.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Platelets
CODE Unit #H74748.
MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with an elevated ALT.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit #H73322.
MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product had a high white cell count.

PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Cryoprecipitated AHF.
CODE Unit #40LQ02616.
MANUFACTURER American Red Cross Blood Services, Peoria, Illinois.
DISTRIBUTION Illinois.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Famciclovir.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #29KL15823.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION North Carolina.
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) Recovered Plasma.
CODE Unit #FL05785.
MANUFACTURER Central Illinois Community Blood Bank, Springfield, Illinois.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the antibody to the human T- lymphotropic virus type I and II (anti-HTLV-I/II, but was collected from a donor who previously tested reactive for anti-HTLV I/II.

PRODUCT a) Red Blood Cells; b) Platelets for Manufacturing; c) Recovered Plasma.
CODE Unit #16LE49887.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
DISTRIBUTION Ohio, Tennessee, New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 01E38090, 01GW27073, 01KH28896, 01Q32069, 01Y24848.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
DISTRIBUTION New York.
QUANTITY 5 units were distributed.
REASON Blood products were exposed to unacceptable shipping and storage temperatures.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit #0411797.
MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio.
DISTRIBUTION Ohio and Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Proscar.

PRODUCT Source Plasma.
CODE Unit Numbers: 4QT932A, 4QU097A, 4QU308A.
MANUFACTURER Centeon Bio Services, Inc., (now known as Aventis Bio-Services, Inc., Wichita, Kansas.
DISTRIBUTION Illinois.
QUANTITY 3 units were distributed.
REASON Blood products were collected from a donor who had been incarcerated.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocyte Reduced; c) Fresh Frozen Plasma.
CODE Unit Numbers: a) 0387900, 0408296, 0409867, 0413468, 0421815, 0421826, 0421827, 0421831 b) 0408986; c) 0408296, 0408986,0409867.
MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio.
DISTRIBUTION Ohio.
QUANTITY a) 8 units; b) 1 unit; c) 3 units were distributed.
REASON Blood products corresponded to a unit of pooled Platelets which was positive for Propionbacterium species.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #16351-3220.
MANUFACTURER Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Alabama and Mississippi.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the antibiotic Cipro.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #0665258.
MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
DISTRIBUTION Minnesota and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested reactive for syphilis.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit Numbers: H72891 and H72783.
MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois.
DISTRIBUTION Illinois.
QUANTITY 2 units were distributed.
REASON Red Blood Cells were leukoreduced by filtration greater than five days past the time of collection.

WEEK ENDING MAY 19

PRODUCT Red Blood Cells.
CODE Unit #50LJ09396.
MANUFACTURER American Red Cross Blood Services, Toledo Ohio.
DISTRIBUTION Ohio and California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the drug Arava.

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Fresh Frozen Plasma.
CODE Unit Numbers: a) 50F65387, 50F73585, 50F19157, 50FG06830, 50J47190, 50G20515, 50J38230, 50F77310, 50F09658, 50F94240, 50F79185 b) 50G20515; c) 50F65387, 50F73585, 50F19157, 50FG06830, 50J47190, 50J38230, 50F05462, 50F77310, 50F09658, 50F94240, 50F79185.
MANUFACTURER American Red Cross Blood Services, Toledo, Ohio.
DISTRIBUTION Ohio, Illinois, Alabama, Massachusetts, Arkansas, Tennessee, California.
QUANTITY a) 11 units; b) 1 unit; c) 11 units were distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF.
CODE Unit Numbers: a) 21KH22705, 21KK03558, 21Y50418, 21KG02152, 21GJ64276; b) 21KH22705, 21Y50418, 21KG02152, and 21GJ64276.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION Pennsylvania, California, Oregon, Washington state, Oklahoma.
QUANTITY a) 5 units; b) 4 units were distributed.
REASON The blood products were collected from a donor taking the drug Zovirax.

PRODUCT Red Blood Cells, Frozen Plasma.
CODE Unit #29FM22863.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION North Carolina and Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for the antibody to the human immunodeficiency virus, but were collected from a donor who previously tested repeatedly reactive for anti-HIV.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #C02374.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose suitability was not adequately determined.

PRODUCTS Platelets
CODE Unit #L01829.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose suitability was not adequately determined.

PRODUCT a) Red Blood Cells; b) Platelets
CODE Unit #T52088.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose suitability was not adequately determined.

PRODUCT Platelets, Pheresis, Irradiated.
CODE Unit #29FP61279.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was mislabeled as CMV antibody negative.

PRODUCT Recovered Plasma.
CODE Unit #29FC60013.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a history of jaundice.

PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered Plasma.
CODE Unit #29KZ02684.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION Georgia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered Plasma.
CODE Unit #29FS79924.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION Maryland and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis A.

PRODUCT Recovered Plasma.
CODE Unit #1167692.
MANUFACTURER Long Island Blood Services, A Division of New York Blood Center, Inc., Millville, New York.
RECALLED BY New York Blood Services [Center West], A Division of New York Blood Center, Inc., New York, New York
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the drug Proscar.

PRODUCT Red Blood Cells
CODE Unit #29GV35782.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the drug Zovirax.

PRODUCT Carticel (Autologous Cultured Chondrocytes).
CODE Lot #C81713.
MANUFACTURER Genzyme ñ Tissue Repair, Cambridge, Massachusetts.
DISTRIBUTION Massachusetts.
QUANTITY 2 vials were distributed.
REASON Tissue repair product was contaminated with Staphylococcus epidermis.

PRODUCT Platelets.
CODE Unit #24KY35576.
MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky.
DISTRIBUTION Indiana.
REASON Blood product was collected from a donor taking the drug Piroxicam.

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF. Recall #B-642/643-0.
CODE Unit Numbers: a) 21KH15621, 21GJ98979, 21GY24752; b) 21GJ98979.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION California, Oregon, Washington state.
QUANTITY a) 3 units; b) 1 unit.
REASON Blood products were collected from a donor who reported previously testing repeatedly reactive for anti-HCV.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 21GC74661, 21GC74691, 21GC74983.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION Oregon.
QUANTITY 3 units were distributed.
REASON Blood products were not leukoreduced were distributed labeled as leukoreduced.

PRODUCT a) Red Blood Cells; b) Cryoprecipated AHF; c) Recovered Plasma.
CODE Unit #21KH21928.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION California and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported previously testing positive for hepatitis C.

PRODUCT Source Plasma
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER Serex International, Inc., Van Nuys, California.
DISTRIBUTION California, Florida, Georgia, Illinois, Massachusetts, Maryland, Michigan, Minnesota, Missouri, North Carolina, New Jersey, Ohio, Pennsylvania, Utah, Virginia, Canada, Germany and Sweden.
QUANTITY Approximately 20,703 units were distributed.
REASON Blood products were collected from donors with a history of sex with another male or intravenous (IV) drug use.

PRODUCT Recovered Plasma.
CODE Unit #01KX36736.
MANUFACTURER American Red Cross Blood Services, West Henrietta, New York.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with Multiple Sclerosis.

PRODUCT Red Blood Cells, Recovered Plasma.
CODE Unit #21FM34769.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION Oregon, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who previously tested positive for hepatitis C.

PRODUCT Recovered Plasma.
CODE Unit #50LJ09396.
MANUFACTURER American Red Cross Blood Services, Toledo, Ohio.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the drug, Arava.

PRODUCT Platelets, Irradiated.
CODE Unit #S02285.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose arm inspection had not been documented.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit #1491890.
MANUFACTURER New York Blood Services [Center West], A division of New York Blood Center, Inc., New York, New York.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Red Blood Cell, Irradiated.
CODE Unit Numbers: 1523905 and 1523926.
MANUFACTURER Long Island Blood Services, A Division of New York Blood Center, Inc., Millville, New York.
RECALLED BY New York Blood Services [Center West], A Division of New York Blood Center, Inc., New York, New York
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood products were labeled with extended expiration dates.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit Numbers: 12440-6573 and 12440-6575.
MANUFACTURER United Blood Services, Albuquerque, New Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION New Mexico.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with extended expiration dates.

PRODUCT Platelets.
CODE Unit #21GC80823.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole blood with an extended collection time.

WEEK ENDING MAY 26

PRODUCT Red Blood Cells.
CODE Unit #LS08403.
MANUFACTURER Blood Centers of the Pacific, San Francisco, California.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had traveled to an area designated as endemic for malaria.

PRODUCT Platelets.
CODE Unit 24KL36651.
MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Drug product was collected from a donor taking the drug Plavix (clopidogrel bisulfate).

PRODUCT Source Plasma.
CODE Unit Numbers: 07065316, 07063206, 07028885.
MANUFACTURER Sera-Tec Biologicals, Pittsburgh, Pennsylvania.
DISTRIBUTION California.
QUANTITY 3 units were distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Source Plasma.
CODE Unit #11355748.
MANUFACTURER Sera-Tec Biologicals, Pittsburgh, Pennsylvania.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who tested reactive for syphilis within two days of donation.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #21KE07861.
MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon.
DISTRIBUTION Georgia.
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 #21Y57701.
MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon.
DISTRIBUTION California.
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, Leukocytes Reduced
CODE Unit #18222-3483.
MANUFACTURER United Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Wyoming.
QUANTITY 1 unit was distributed.
REASON Blood product was mislabeled as CMV antibody negative.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit Numbers: a) 056J51046, 056K26775, 056K16228, 056G21567 b) 056K26775, 056G21567; c) 056J51046, 056K16228, 056G21567
MANUFACTURER American Red Cross Blood Services, Albany, New York.
DISTRIBUTION New York, North Carolina, California.
QUANTITY a) 4 units; b) 2 units; c) 3 units were distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma.
CODE Unit Numbers: a) 23028-7086, 23139-1030; b) 23028-7086; c) 23028-7086, 23139-1030.
MANUFACTURER United Blood Services, Billings, Montana.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Arizona, Montana, Switzerland.
QUANTITY a) 2 units; b) 1 unit; c) 2 units were distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis B.

PRODUCT Licensed, sterile, stable, lyophilized blood factors derived from pooled human plasma; Centeon L.L.C., Kankakee, Illinois 60901; these products were packaged with vials of Sterile Water for Injection for reconstitution, as well as administration sets:
a) Mononine Coagulation Factor IX (Human), Monoclonal Antibody Purified; for the prevention and control of bleeding in Factor IX deficiency, also known as Hemophilia B or Christmas disease; 1000 Units, NDC #0053-7668-04
b) Monoclate-P Antihemophilic Factor (Human), Factor VII:C Pasteurized Monoclonal Antibody Purified; for treatment of classical hemophilia, also known as Hemophilia A
i) 250 Units, NDC #0053-7656-01
ii) 500 Units, NDC #0053-7656-02
iii) 1000 Units, NDC #0053-7656-04
The Mononine and Monoclate-P products were packaged with administration set packets labeled in part: Sterile Administration Components for I.V. Infusion, Manufacturer: B. Braun Medical Inc., Bethlehem, PA 18018. The alcohol swabs packaged within this packet were labeled as Sterile Steri Wipe 1 Alcohol Swab, Anajay, Inc., Charlotte, NC 28213.
CODE All in-date lots of both products which expire prior to April 2002.
MANUFACTURER Aventis Behring L.L.C., Bradley, Illinois.
RECALLED BY Aventis Behring L.L.C., King of Prussia, Pennsylvania
SWAB COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill, Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY a) 65,700 vials; b) 13,000 250-unit vials, 19,000 500-unit vials, 28,500 1000-unit vials were distributed.
REASON The Steri Wipe Alcohol Swabs, packaged with Mononide and Monoclate-P were recalled by Clinipad Corporation due to lack of assurance of sterility.

PRODUCT Platelets.
CODE Unit #8083106.
MANUFACTURER LifeShare, Inc., Elyria, Ohio.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from donors who had taken aspirin within 72 hours of donation.

PRODUCT Platelets, Pheresis.
CODE Unit Numbers: 24FH14908, 24FY00091, 24FY00514, 24FY01229, 24FH17914, 24FY01605, 24FY02042, 24FY02233, 24FY02307, 24FH20518, 24FY02540, 24FY02605, 24FY02664, 24FY02793.
MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky.
DISTRIBUTION Kentucky and Indiana.
QUANTITY 14 units were distributed.
REASON Blood products were collected from a donor taking the drug Piroxicam.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #13GR08042.
MANUFACTURER American Red Cross, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 0309271 and 0309450.
MANUFACTURER Inland Northwest Blood Center, Spokane, Washington.
DISTRIBUTION Idaho.
QUANTITY 2 units were distributed.
REASON Blood products which were positive for the Jkb antigen were transfused to a patient with a Jkb antibody.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 4941682, 4955933, 4955940, 4955942.
MANUFACTURER Blood Care, Dallas, Texas.
DISTRIBUITON Texas.
QUANTITY 4 units were distributed.
REASON Blood products which were crossmatch incompatible, were distributed for transfusion.

PRODUCT Platelet, Pheresis.
CODE Unit #38P45033-1.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product corresponding to a split product that was found to be contaminated with Klebsiella pneumonia and implicated in a post-transfusion reaction.

PRODUCT Plasma, Cryoreduced.
CODE Unit Numbers: 29FF32893, 29FF33421, 29FF33428, 29FF33440, 29FF33496, 29FF33498, 29FF33499, 29FF33503, 29FF33505, 29FF33506, 29FF33512, 29KL14281.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION North Carolina.
QUANTITY 12 units were distributed.
REASON Blood products had expiration dates that were extended by four years.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 53J60690, 53J60692, 53Y81897, 53Y81898.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland and the District of Columbia.
QUANTITY 4 units were distributed.
REASON Red Blood Cells either did not meet the hematocrit, or were suspected of not meeting the hematocrit.