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FDAEnforcement ReportThe FDA Enforcement Report is published weekly by the Food and Drug Administration, U.S. Public Health Service, Department of Health and Human Services. It contains information on actions taken in connection with agency regulatory activities. December 3, 1997 97-49 RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II ======== _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-077/078-8. CODE Unit numbers: 04FJ54628, 04FJ46403, 04FJ29961. MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts. RECALLED BY Manufacturer, by letter dated July 12, 1996. Firm-initiated recall complete. DISTRIBUTION Massachusetts. QUANTITY 3 units of each component were distributed. REASON Blood products were collected from a donor taking the drug Methotrexate. _______________ PRODUCT Source Plasma. Recall #B-093-8. CODE Unit #22697H. -2- MANUFACTURER Bloomington Plasma, Inc., Bloomington, Illinois. RECALLED BY Manufacturer, by letter on June 16, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who was not tested for syphilis. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-136/138-8. CODE Unit numbers: a) 10235-3189, 10228-8806, 10232-1932; b) 10232-1932, 10228-8806 c) 10235-3189. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated July 14, 1994. Firm-initiated recall complete. DISTRIBUTION Arizona and Texas. QUANTITY a) 3 units; b) 2 units; c) 1 unit was distributed. REASON Blood products were collected from a therapeutic donor diagnosed with Secondary Erythrocytosis. _______________ PRODUCT Platelets, Irradiated. Recall #B-153-8. CODE Unit #29446-2267. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by letter dated October 15, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood identified as a difficult draw. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-171/173-8. CODE Unit #29104-4474. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated January 26, 1996. Firm-initiated recall complete. DISTRIBUTION Illinois and Mississippi. QUANTITY 1 unit of each component was distributed. REASON Blood products tested negative for the antibody to the human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), but were collected from a donor who was deferred for reporting HIV infection. -3- _______________ PRODUCT Platelet, Pheresis. Recall #B-199-8. CODE Unit numbers: KZ45366, KZ45177, KZ44762, KZ43745, KZ43422, KZ41868. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter dated September 10, 1997. Firm-initiated recall ongoing. DISTRIBUTION Virginia, Maryland, Mississippi. QUANTITY 6 units were distributed. REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria. _______________ PRODUCT Red Blood Cells. Recall #B-210-8. CODE Unit #04KL74647. MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts. RECALLED BY Manufacturer, by letter dated May 31, 1996. Firm-initiated recall complete. DISTRIBUTION New Hampshire. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who had no hemoglobin check performed during screening. _______________ PRODUCT Red Blood Cells. Recall #B-211-8. CODE Unit #KF19875. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by telephone on April 17, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who self-excluded. _______________ PRODUCT Platelets. Recall #B-212-8. CODE Unit #9020845. MANUFACTURER Florida Blood Services, Inc., Tampa, Florida. RECALLED BY Manufacturer, by telephone on August 13, 1996. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor whose health history screening was inadequately performed. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-215/216-8. CODE Unit #9599039. -4- MANUFACTURER Florida Blood Services, Inc., Tampa, Florida. RECALLED BY Manufacturer, by telephone on April 22, 1996. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood products were collected from a donor who had malaria within three years of donation. _______________ PRODUCT Recovered Plasma. Recall #B-222-8. CODE Unit numbers: 36019-8370, 36018-7225. MANUFACTURER United Blood Services, Ventura, California. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated March 18, 1997. Firm- initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 2 units were distributed. REASON Blood product was collected from a donor with an elevated ALT. _______________ PRODUCT a) Red Blood Cells; b) Recovered Plasma. Recall #B-226/227-8. CODE Unit #12GH66247. MANUFACTURER American Red Cross, Wilmington, North Carolina. RECALLED BY American Red Cross, Charlotte, North Carolina, by telephone and letter on August 16, 1996. Firm-initiated recall complete. DISTRIBUTION North Carolina and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who received a tattoo within twelve months of donation. _______________ PRODUCT Red Blood Cells. Recall #B-228-8. CODE Unit #Y39727. MANUFACTURER American Red Cross, Portland, Oregon. RECALLED BY Manufacturer, by letter dated September 2, 1997. Firm-initiated recall complete. 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 a) Red Blood Cells; b) Platelets c) Fresh Frozen Plasma d) Source Leukocytes for Manufacture e) Recovered Plasma. Recall #B-230/234-8. -5- CODE Unit numbers: a) 29GT70107, 29GT62663, 29GT58842, 29GG87374 b) 29GG87374; c) 29GT70107 d) 29GT58842; e) 29GT62663, 29GG87374. MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia. RECALLED BY Manufacturer, by letter between June 3 and 4, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina, Virginia, California, Massachusetts. QUANTITY a) 4 units; b) 1 unit; c) 1 unit; d) 1 unit; e) 2 units were distributed. REASON Blood products were collected from a donor with a history of cancer. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-235/236-8. CODE Unit #03H05636. MANUFACTURER American Red Cross Blood Services, Miami, Florida. RECALLED BY Manufacturer, by telephone on September 5, 1997, and by letter on September 8, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor whose partner tested positive for hepatitis C. _______________ PRODUCT Red Blood Cells. Recall #B-237-8. CODE Unit #25FS21515. MANUFACTURER American Red Cross Blood Services, Syracuse, New York. RECALLED BY Manufacturer, by telephone on November 13, 1995. Firm-initiated recall complete. DISTRIBUTION New York. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of Platelets that was positive for Streptococcus veridans, and implicated in a transfusion reaction. _______________ PRODUCT a) Red Blood Cells; b) Platelets c) Fresh Frozen Plasma d) Fresh Frozen Plasma, for further manufacture e) Cryoprecipitated AHF f) Recovered Plasma. Recall #B-243/248-8. -6- CODE Unit numbers: a) 12FQ29146, 12FE49258, 12FC43655; b) 12FQ29146; c) 12FE49258; d) 12FQ29146 and 12FC52296; e&f) 12FC43655. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated September 15, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina and California. QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 2 units; e) 1 unit; f) 1 unit was distributed. REASON Blood products were collected from a donor who was taking the drug, Amantadine. _______________ PRODUCT Platelets, Pheresis. Recall #B-249-8. CODE Unit #12FM88745. MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina. RECALLED BY Manufacturer, by letter dated August 4, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who received an MMR vaccine within three weeks of donation. _______________ PRODUCT a) Corneal Human Tissues; b) Scleral Human Tissues. Recall #B-252/253-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER Alabama Eye Bank, Inc., Birmingham, Alabama. RECALLED BY Manufacturer, by letter beginning October 1, 1997. Firm-initiated recall complete. DISTRIBUTION Alabama, California, Florida, Georgia, Illinois, Indiana, Michigan, Missouri, New York, North Carolina, Ohio, South Carolina, Tennessee, Lebanon. QUANTITY a) 154 units; b) 21 units were distributed. REASON Human tissues for transplant were not tested for HIV-2. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma c) Cryoprecipitate AHF; d) Recovered Plasma. Recall #B-258/261-8. CODE Unit numbers: 10229-6555, 10224-7119 b) 10229-6555; c) 10224-7119 d) 10224-7119. MANUFACTURER United Blood Services, Scottsdale, Arizona. -7- RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letters dated January 22 and 30, 1996. Firm-initiated recall complete. REASON Blood Products were collected from a donor with a history of Hepatitis. _______________ PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma. Recall #B-267/269-8. CODE Unit #21GK62763. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by letter dated January 8, 1997, by telephone on December 31, 1996, and by letter on July 1, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon, Washington state, Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who had a history of intravenous (IV) drug use. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma. Recall #B-273/275-8. CODE Unit #KL74136. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter dated September 9, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected in a manner that could compromise the sterility of the products. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-276/277-8. CODE Unit #KJ31838. MANUFACTURER Virginia Blood Services, Richmond, Virginia. RECALLED BY Manufacturer, by letter dated August 25, 1997. Firm-initiated recall complete. DISTRIBUTION Virginia. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria. _______________ PRODUCT Platelet Pool. Recall #B-280-8. CODE Unit #03S00652. MANUFACTURER American Red Cross Blood Services, Miami, Florida. -8- RECALLED BY Manufacturer, by telephone on April 4, 1996. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was labeled with an extended expiration date. RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS III ======= _______________ PRODUCT Source Plasma. Recall #B-143-8. CODE Unit numbers: AD0851, AD0864, AD0880. MANUFACTURER Decatur Plasma, Inc., Decatur, Illinois. RECALLED BY Manufacturer, by letter on June 13, 1997. Firm-initiated recall complete. DISTRIBUTION North Carolina. QUANTITY 3 units were distributed. REASON Blood products were collected from donors who were not tested for syphilis. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-146-8. CODE Unit #29445-4963. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on August 22, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood identified as a difficult draw. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-147-8. CODE Unit #29446-0970. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on August 26, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood identified as a difficult draw. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-150-8. CODE Unit #29446-4191. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on September 2, 1997, and by letter on October 14, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. -9- REASON Blood product was prepared from a unit of whole blood identified as a difficult draw. _______________ PRODUCT Cryo-poor Plasma. Recall #B-151-8. CODE Unit #29446-3089. MANUFACTURER United Blood Services, Chicago, Illinois. RECALLED BY Manufacturer, by telephone on September 5, 1997, and by letter dated October 14, 1997. Firm-initiated recall complete. DISTRIBUTION Illinois. QUANTITY 1 unit was distributed. REASON Blood product was prepared from a unit of whole blood identified as a difficult draw. _______________ PRODUCT Recovered Plasma. Recall #B-182-8. CODE Unit #03V03703. MANUFACTURER American Red Cross Blood Services, Miami, Florida. RECALLED BY Manufacturer, by letter on January 7, 1997. Firm-initiated recall complete. DISTRIBUTION Switzerland. QUANTITY 1 unit was distributed. REASON Blood product corresponded to a unit of clotted Red Blood Cells. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma. Recall #B-202/206-8. CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated March 12, 1996. Firm-initiated recall complete. DISTRIBUTION Arizona, Mississippi, Switzerland. QUANTITY a) 21 units; b) 11 units; c) 3 units; d) 3 units; e) 8 units were distributed. REASON Blood products were collected from donors whose body temperatures at the time of donation may have been greater than 99.6 F. _______________ PRODUCT Platelets, Pheresis. Recall #B-209-8. CODE Unit #LH37946. MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts. -10- RECALLED BY Manufacturer, by letter dated February 12, 1997. Firm-initiated recall complete. DISTRIBUTION New Hampshire. QUANTITY 1 unit was distributed. REASON Blood product for which the date and time of receipt was not documented. _______________ PRODUCT a) Red Blood Cells; b) Platelets. Recall #B-213/214-8. CODE Unit #9590804. MANUFACTURER Florida Blood Services, Inc., Tampa, Florida. RECALLED BY Manufacturer, by telephone on April 5, 1996. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor with an elevated body temperature. _______________ PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma. Recall #B-219/221-8. CODE Unit #10502-9811. MANUFACTURER United Blood Services, Scottsdale, Arizona. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by letter dated May 5, 1997. Firm-initiated recall complete. DISTRIBUTION Arizona and Switzerland. QUANTITY 1 unit of each component was distributed. REASON Blood products had an acceptable ALT but were collected from a donor who previously had an elevated ALT on two separate occasions. _______________ PRODUCT Red Blood Cells. Recall #B-229-8. CODE Unit #03FW55736. MANUFACTURER American Red Cross, Atlanta, Georgia. RECALLED BY Manufacturer, by telephone on September 2, 1997, and by letter dated September 10, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit was distributed. REASON Blood product was collected from a donor who reported cold and flu symptoms after donation. _______________ PRODUCT Fresh Frozen Plasma. Recall #B-242-8. CODE Unit numbers: 03H03993 and 03H03995. MANUFACTURER American Red Cross Blood Services, Miami, Florida. RECALLED BY Manufacturer, by telephone on February 3, 1997. Firm-initiated recall complete. -11- DISTRIBUTION Florida. QUANTITY 2 units were distributed. REASON Blood products were not frozen within 8 hours of whole blood collection. _______________ PRODUCT Red Blood Cells. Recall #B-271-8. CODE Unit #17182-2574. MANUFACTURER United Blood Services, McAllen, Texas. RECALLED BY Blood Systems, Inc., Scottsdale, Arizona, by telephone on September 17, 1997. Firm-initiated recall complete. DISTRIBUTION Texas. QUANTITY 1 unit was distributed. REASON Blood product may have remained at room temperature for more than 30 minutes. _______________ PRODUCT Whole Blood. Recall #B-272-8. CODE Unit #21R45004. MANUFACTURER American Red Cross Blood Services, Portland, Oregon. RECALLED BY Manufacturer, by telephone on August 21 and 22, 1997. Firm-initiated recall complete. DISTRIBUTION Oregon. QUANTITY 1 unit was distributed. REASON Blood product may have remained at room temperature more than 30 minutes. _______________ PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma. Recall #B-278/279-8. CODE Unit #03KJ03020. MANUFACTURER American Red Cross Blood Services, Miami, Florida. RECALLED BY Manufacturer, by telephone on June 18, 1997. Firm-initiated recall complete. DISTRIBUTION Florida. QUANTITY 1 unit of each component was distributed. REASON Blood products were collected from a donor who took antibiotics within 48 hours of donation. END OF ENFORCEMENT REPORT FOR DECEMBER 3, 1997. BLANK PAGES MAY FOLLOW. ####
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