DECEMBER 2000

WEEK ENDING DECEMBER 1

PRODUCT Plasma, Cryo Poor.
CODE Unit Numbers: 12430-3715, 12430-4007, 12430-4010, 12430-4011, 12430-4012, 12430-4013, 12430-4014, 12430-4016, 12430-4017, 12430-4019, 12430-4272, 12430-4277, 12430-4279, 12430-4284, 12430-4285, 12430-4286, 12430-4287, 12430-4289, 12430-4291, 12430-4292, 12430-4293, 12430-4294, 12430-4536, 12430-4540, 12430-4543, 12430-4549, 12430-4552, 12430-4554, 12430-4556, 12430-4565, 12430-5568, 12430-5589, 12430-5612, 12430-5616, 12430-7501, 12430-7503, 12430-7504, 12430-7507.
MANUFACTURER United Blood Services, Albuquerque, New Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION New Mexico.
QUANTITY 38 units were distributed.
REASON Blood products were incorrectly tested for unexpected antibodies.

PRODUCT Red Blood Cells, Pheresis.
CODE Unit #LJ60105.
MANUFACTURER Mid-South Regional Blood Center, Memphis, Tennessee.
DISTRIBUTION Tennessee.
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 #8507209.
MANUFACTURER Poudre Valley Health Systems Blood Bank, Fort Collins, Colorado.
DISTRIBUTION Colorado.
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 Platelets, Pooled.
CODE Unit #P01467.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had experienced a life-threatening allergic reaction to a medication.

PRODUCT Red Blood Cells.
CODE Unit #31125-6025.
MANUFACTURER Blood Systems, Inc., Tupelo, Mississippi.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Mississippi.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

WEEK ENDING DECEMBER 8

PRODUCT Source Plasma.
CODE Unit Numbers: 28123613 and 28121978.
MANUFACTURER Interstate Blood Bank, Inc. of Chicago, Chicago, Illinois.
DISTRIBUTION California.
QUANTITY 2 units were distributed.
REASON Unsuitable blood products were not properly quarantined.

PRODUCT Source Plasma.
CODE Unit Numbers: 0178444 and 0178628.
MANUFACTURER Bowling Green Biologicals, Inc., Bowling Green, Kentucky.
DISTRIBUTION Kentucky.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who had been taking an antibiotic.

PRODUCT Recovered Plasma.
CODE Unit #7740253.
MANUFACTURER Department of Air Force, Lackland AFB, Texas.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a history of having tested positive for hepatitis.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets; d) Platelets Pheresis, Leukocytes Reduced.
CODE Unit Numbers: 2001084, 2001090, 2001091, 2001099, 2001100, 2001102, 2001107, 2001110, 2001135, 2001141, 2001146, 2001147, 2001152, 2001156, 2001157, 2001159, 2001163, 2001165, 2001168, 2001173, 2001176, 2001177, 2001178, 2001179, 2001182, 2001184, 2001185, 2001186, 2001187, 2001188, 2001190, 2001194, 2001195;
b) 2001086, 2001112, 2001115, 2001121, 2001133, 2001136, 2001137, 2001138, 2001140, 2001143, 2001151, 2001154, 2001181;
c) 2001086, 2001090, 2001099, 2001102, 2001107, 2001110, 2001112, 2001133, 2001135, 2001137, 2001138, 2001140, 2001141, 2001143, 2001146, 2001147, 2001151, 2001154, 2001156, 2001159, 2001163, 2001165, 2001170, 2001172, 2001178, 2001179, 2001181, 2001184, 2001188;
d) 2001083, 2001114, 2001160, 2001166, 2001183.
MANUFACTURER Blood Bank of Delaware, Newark, Delaware.
DISTRIBUTION Delaware and Maryland.
QUANTITY a) 33 units; b) 13 units; c) 29 units; d) 5 units were distributed.
REASON Blood products were mislabeled as CMV antibody negative.

PRODUCT Platelets, Pooled.
CODE Unit #P00665.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had experienced a life-threatening allergic reaction to a medication.

PRODUCT a) Sandoglobulin(r), Immune Globulin Intravenous (Human) 3 Grams lyophilized (single use vial);
b) Sandoglobulin(r), Immune Globulin Intravenous (Human) 6 Grams lyophilized (single use vial), Expires AUG 2001.
CODE a) Expires 4/2001 Lot number on vial: 00790-00009 Lot number on outer carton: 009B1935; b) Lot number on vial: 00791-00146 Lot number on outer carton: 146B3971.
MANUFACTURER ZLB Central Laboratory, Blood Transfusion Service, Swiss Red Cross, Wankdorfstrasse, Switzerland.
RECALLED BY Novartis Pharmaceutical Corporation, East Hanover, New Jersey
DISTRIBUTION Nationwide.
QUANTITY a) 7,092 vials; b) 2,969 vials were distributed.
REASON Drug products were manufactured in part from the same bulk material used to produce another lot which was rejected because it failed the end product pyrogenicity test.

PRODUCT Recovered Plasma.
CODE Unit #8600650.
MANUFACTURER Poudre Valley Health Care, Inc., Fort Collins, Colorado.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood products tested negative for antibodies to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), but was collected from a donor who previously tested repeatedly reactive for anti-HIV-1.

PRODUCT a) Whole Blood; b) Red Blood Cells; c) Platelets; d) Platelets, Pheresis; e) Cryoprecipitated AHF; f) Fresh Frozen Plasma; g) Plasma, Frozen; h) Recovered Plasma.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER The American National Red Cross, Madison, Wisconsin.
DISTRIBUTION Wisconsin, Iowa, Michigan, Illinois, Florida, Alabama, California, Georgia, Idaho, Massachusetts, Missouri, Nebraska, Puerto Rico, Ohio, Tennessee, West Virginia, , Switzerland.
QUANTITY a) 1 unit; b) 149 units; c) 68 units; d) 20 units; e) 14 units; f) 30 units; g) 2 units; h) 128 units were distributed.
REASON Blood products tested negative for antibody to human immunodeficiency virus type 1 (anti-HIV-1), but were collected from donors that previously tested repeatedly reactive for anti-HIV-1.

PRODUCT Platelets, Pheresis.
CODE Unit #LP07164.
MANUFACTURER Mid-South Regional Blood Center, Memphis, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after receiving information concerning a post donation illness.

WEEK ENDING DECEMBER 15

PRODUCT Platelets, Pheresis.
CODE Unit numbers: 16KF24889 (two units), 16KF24890 (two units), 16KF24891 (two units), 16KF24892 (two units), 16KF24893.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
DISTRIBUTION Ohio and Arizona.
QUANTITY 9 units were distributed.
REASON Blood products were processed in a manner that may have compromised the sterility of the units.

PRODUCT a) Red Blood Cells; b) Platelets; c) Plasma.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland, Virginia, Pennsylvania, District of Columbia.
QUANTITY a) 221 units; b) 22 units; c) 72 units were distributed.
REASON Blood products were collected from donors whose arms had not been adequately prepared prior to venipuncture.

PRODUCT Corneas.
CODE Unit numbers: 2000-11-3001 and 2000-11-3002.
PROCURING FIRM Heartland Lions Eye Banks, Springfield, Missouri.
RECALLED BY Heartland Lions Eye Banks, Columbia, Missouri
DISTRIBUTION Kansas and Ohio.
QUANTITY 2 units were distributed. The corneas were returned and destroyed.
REASON Corneas were collected from a donor who tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc).

PRODUCT Corneas.
CODE 2000-10-4007.
PROCURING FIRM Heartland Lions Eye Banks, Columbia, Missouri.
RECALLED BY Heartland Lions Eye Banks, Columbia Missouri
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Cornea was collected from a donor who tested repeatedly reactive for the antibody to the Hepatitis C virus and the Hepatitis B core antigen.

WEEK ENDING DECEMBER 29

PRODUCT Red Blood Cells.

CODE Unit #8508574.

MANUFACTURER Poudre Valley Health Systems Blood Bank, Fort Collins, Colorado.

DISTRIBUTION Colorado.

QUANTITY 1 unit was distributed.

REASON Blood product was collected from an unsuitable donor.

PRODUCT Red Blood Cells.

CODE Unit #19239-1332.

MANUFACTURER Blood Systems, Inc., Reno, Nevada.

RECALLED BY Blood Systems, Inc., Scottsdale, Arizona

DISTRIBUTION Florida.

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 Plasma, Frozen.

CODE Unit #0718930.

MANUFACTURER Blood Centers of the Pacific, San Francisco, California.

DISTRIBUTION California.

QUANTITY 1 unit was distributed.

REASON Blood product was collected from a donor with a history of hepatitis A.

PRODUCT Platelets, Pheresis.

CODE Unit K12435 (distributed as two split units).

MANUFACTURER Mississippi Valley Regional Blood Center, Davenport, Iowa.

DISTRIBUTION Iowa and Illinois.

QUANTITY 2 split units were distributed.

REASON Blood product was collected from a donor who should have been deferred due to use of the medication Arthrotec.

PRODUCT a) Red Blood Cells; b) Platelets; c) Platelets, Pheresis; d) Cryoprecipitated AHF; e) Fresh Frozen Plasma; f) Plasma, Frozen; g) Recovered Plasma.

CODE Unit Numbers: a) 20FC04463, 20FC10488, 20LY05794, 20LZ04696, 20LY07856, 20LY09224, 20LY13842, 20FC04471, 20FC04980, 20FC07112, 20FC08089, 20FC04468, and 20GY02708;

b) 20LY09224 and 20LY13842; c) 20GE01399, 20GE01453A, 20GE01453B, and 20GE01752;

d) 20FC08089; e) 20LY13842; f) 20FC10488; g) 20FC04463, 20LY05794, 20LZ04696, 20LY07856, 20LY09224, 20FC04471, 20FC04980, 20FC07112, 20FC08089, 20FC04468, and 20GY02708.

MANUFACTURER The American National Red Cross, Boise, Idaho.

DISTRIBUTION Idaho, California, Montana, Switzerland.

QUANTITY a) 13 units; b) 2units; c) 4 units; d) 1 unit; e) 1 unit; f) 1 unit; g) 11 units were distributed.

REASON Blood products were either: 1) incorrectly tested for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2); or that tested negative for anti-HIV-1/2, but were collected from donors that should have been deferred due to previous incorrect testing for anti-HIV-1/2.