WEEK ENDING APRIL 21

PRODUCT Red Blood Cells.
CODE Unit #M02854.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia.
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, Pheresis
CODE Unit #53GP12903.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Platelets, Pheresis unit did not have a white blood cell count determination and was labeled as Leukocyte Reduced.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #53GM21201.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION District of Columbia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had lived in the Congo.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit Numbers: 29GV32452 and 29GY08806.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION North Carolina and California.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis B.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit Numbers: a) 8078997; b) 8069032, 8078997, 8076546, 8083812, 8083806, 8076540.
MANUFACTURER LifeShare, Inc., Elyria, Ohio.
DISTRIBUTION Ohio.
QUANTITY a) 1 unit; b) 6 units.
REASON Six units of Platelets were implicated in a transfusion reaction, were found to be contaminated with staphylococcus, Coagulase negative. Corresponding blood products were distributed.

PRODUCT Red Blood Cells.
CODE Unit #K72197.
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 Red Blood Cells.
CODE Unit #GQ19256.
MANUFACTURER Blood Centers of the Pacific, San Francisco, California.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after receiving information concerning a post donation illness.

PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c) Recovered Plasma.
CODE Unit #S66889.
MANUFACTURER Blood Centers of the Pacific, San Francisco, California.
DISTRIBUTION California and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood Products were collected from a donor with a history of hepatitis A.

PRODUCT Platelets, Pheresis.
CODE Unit #LH16695.
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 traveled to an area considered endemic for malaria.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #1564020.
MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky.
DISTRIBUTION Kentucky.
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 Red Blood Cells.
CODE Unit #1577225.
MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit # 0390212.
MANUFACTURER Hoxworth Blood Center, Cincinnati, Ohio.
DISTRIBUTION Ohio and Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit #W06303.
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 Capture-R Ready-Screen (Pooled Cells) - 96 Wells containing Polled Screening Cells; Capture-R Ready-Screen (I and II) 48 Wells containing Screening Cell I and 48 Wells containing screening Cell II; and Capture-R Ready-ID for the identification of unexpected IgG Antibodies to Red Cells
CODE Kit Lot Numbers 43895, 43896, 43897, 43898, 43902, 43893, 43899.
MANUFACTURER Immucor, Inc., Norcross, Georgia.
DISTRIBUTION Nationwide and international.
QUANTITY 1,624 kits were distributed.
REASON When certain lots of the Capture-R Ready plates are read using an automated reading device, a high rate of equivocal or positive test reactions were obtained.

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE Unit #21375-2819.
MANUFACTURER Blood Systems, Inc., Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION North Dakota.
QUANTITY 1 unit was distributed.
REASON Blood product was stored at unacceptable temperatures.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 0333054, 0333050, 0333043, 2270086.
MANUFACTURER Inland Northwest Blood Center, Spokane, Washington.
DISTRIBUTION Washington state.
QUANTITY 4 units were distributed.
REASON Blood products remained at room temperature for an unacceptable length of time during irradiation.

PRODUCT Red Blood Cells
CODE Unit #12439-5644.
MANUFACTURER United Blood Services, Albuquerque, New Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Colorado.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Platelets (expired), for further manufacture.
CODE Unit #0390212.
MANUFACTURER Hoxworth Blood Center, Cincinnati, Ohio.
DISTRIBUTION Ohio and Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria.

WEEK ENDING APRIL 28

PRODUCT Platelets
CODE Unit Numbers: 3455102, 3455105, 3456479, 3456480, 3456495 3480733, 3480737, 3480740, 3485781, 3456519, 3456477, 3456486, 3456494, 3485778, 3485779, 3456497, 3456498, 3456499, 3456502, 3456505, 3456506, 3456511, 3456515, 3456525, 3485800.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
DISTRIBUTION Texas.
QUANTITY 25 units were distributed.
REASON Blood products were labeled with extended expiration dates, were distributed.

PRODUCT Source Plasma.
CODE  99,405 units collected between 7/21/97 and 12/28/99.
MANUFACTURER Centeon Bio Services, Inc., Des Moines, Iowa.
RECALLED BY Aventis Bio-Services, Inc., King of Prussia, Pennsylvania
DISTRIBUTION North Carolina, Illinois, Switzerland, Germany.
QUANTITY 99,405 units were distributed.
REASON Blood products were collected from donors who were not properly screened.

PRODUCT Human Tissue for Transplant: Various Musculoskeletal Tissues, Skin, and Blood Vessels
CODE Each graft is uniquely identified with a nine or ten digit graft number.
MANUFACTURER LifeNet, Virginia Beach, Virginia.
DISTRIBUTION Nationwide, Canada, Puerto Rico, Israel.
QUANTITY 1,434 allografts.
REASON Various tissues for transplant were collected from twenty donors who had not been properly evaluated.

PRODUCT Red Blood Cells.
CODE Unit #21373-0196.
MANUFACTURER Blood Systems, Inc., Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Michigan.
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 Source Plasma.
CODE Unit Numbers: 99-EWIA-4754 and 99-EWIA-5416.
MANUFACTURER Community Bio-Resources, Inc., Eau Claire, Wisconsin.
DISTRIBUTION Austria.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT Source Plasma.
CODE Unit Numbers: Units 99-SMNC-1358, 99-SMNC-1690, 99-SMNC-2371, 99-SMNC-3875, 99-SMNC-4143.
MANUFACTURER Community Bio-Resources, Inc., St. Cloud, Minnesota.
RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama
DISTRIBUTION Austria.
QUANTITY 5 units were distributed.
REASON Blood products were collected from a donor who had received an MMR vaccination within four weeks of donation.

PRODUCT Source Plasma.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER Interstate Blood & Plasma, Inc., Madison, Wisconsin.
RECALLED BY Interstate Blood Bank, Inc., Memphis, Tennessee
DISTRIBUTION California.
QUANTITY 44 units were distributed.
REASON Blood products were collected from a donor who had body piercing within twelve months of donation.

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit Numbers: 24KS29226, 24GK15680, 24KN07785.
MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky.
DISTRIBUTION Indiana and Kentucky.
QUANTITY 2 units were distributed.
REASON Blood products were collected from donors whose hemoglobin had not been documented.

PRODUCT Platelets, Pheresis.
CODE Unit #18219-9392.
MANUFACTURER United Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTED Wyoming.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.

PRODUCT Platelets, Pheresis, Leukocytes Reduced
CODE Unit Numbers: 24204-3038-01 and 24204-3038-02.
MANUFACTURER Blood Systems, Inc., Rapid City, South Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY 2 units were distributed.
REASON Blood products had unacceptable platelet counts.

PRODUCT Pulmozyme R, (dornase alfa), Inhalation Solution, each carton contains 5 foil pouches each containing 6 single use 2.5 mL ampules, a recombinant inhalation solution.
CODE Lot Numbers: H9706A, H9708A, H9709A, H9710A, H9711A, H9715A, H9716A, H97120A, H9721A, H9727A, H9730A, H9731A, H9732A, K9702A, K9703A, K9704A, K9707A, K9708A, K9712A, K9714A, K9715A, K9718A, K9719A.
MANUFACTURER Genentech, Inc., South San Francisco, California.
DISTRIBUTION Nationwide.
QUANTITY 4,729,950 ampules were distributed.
REASON Single-use ampule may have a minuscule puncture at the tip of the ampule thus compromising the integrity of the container closure and allowing product leakage.

PRODUCT Platelets, Pheresis, Leukocytes Reduced
CODE Unit #26159-6817-02.
MANUFACTURER United Blood Services, Fort Smith, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was shipped at an unacceptable temperature.

PRODUCT Red Blood Cells, Irradiated.
CODE Unit Numbers: T36089 and T36092.
MANUFACTURER Blood Centers of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 2 units were distributed.
REASON Unlicensed blood products were distributed without obliteration of the firm's license number.

PRODUCT Fresh Frozen Plasma.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled
MANUFACTURER Marathon County Blood Bank, Inc., Wausau, Washington state.
DISTRIBUTION Michigan, Indiana, North Carolina, New York, California, Texas.
QUANTITY 241 units were distributed.
REASON Unlicensed blood products were distributed in interstate commerce.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit #30171-6914.
MANUFACTURER Blood Systems, Inc., Bismark, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION North Dakota.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the drug Navane.

PRODUCT Red Blood Cells.
CODE Unit number 18219-1198.
MANUFACTURER United Blood Services, Inc., Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Wyoming.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Platelets.
CODE Unit #50LG11374.
MANUFACTURER American Red Cross Blood Services, Toledo, Ohio.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented.