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This report is for December 3, 1997. We have not added one single word below the red line. This is an actual report, available to the public, but not advertised. We have chosen this report at random; all read much the same.

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FDA

Enforcement Report

The 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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