WEEK ENDING OCTOBER 1

PRODUCT a) Platelets; b) Fresh Frozen Plasma.
CODE Unit #16LE49081.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component.
REASON Blood products were prepared from a unit of whole blood with an extended collection time.
 

WEEK ENDING OCTOBER 15

PRODUCT Source Leukocytes
CODE Unit #11R38444.
MANUFCTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that could compromise the sterility of the product.

PRODUCT Platelets, Pheresis
CODE Unit #24203-4626.
MANUFACTURER United Blood Services, Rapid City, South Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY 1 unit was distributed.
REASON Blood product was not stored in a sufficient amount of plasma to support the platelet count.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #17KX33294.
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
DISTRIBUTION Ohio and California.
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 Red Blood Cells
CODE Unit #17KJ72020.
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who was taking the drug Methotrexate at the time of donation.

PRODUCT Red Blood Cells
CODE Unit Numbers: 17KL56716 and 17KH61058.
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
DISTRIBUTION Minnesota.
QUANTITY 2 units were distributed.
REASON Blood products were not tested for CMV, were labeled CMV negative and distributed.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #17GJ70231.
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
DISTRIBUTION Michigan and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products which tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1, Western blot negative.

PRODUCT Platelets
CODE 17KJ61161, 17KJ61164, and 17KJ61165.
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
DISTRIBUTION Ohio and Wisconsin.
QUANTITY 3 units were distributed.
REASON Blood products were collected in a manner that could compromise the sterility of the products.

PRODUCT Red Blood Cells
CODE Unit #21GM96984.
MANUFCTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION Washington state.
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 #21KL06219.
MANUFACTURER American Red Cross Blood Services, Portland, Oregon.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT Platelets, Pheresis
CODE Unit numbers: 21370-6845 and 21370-6843.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION North Dakota.
QUANTITY 2 units were distributed.
REASON Blood products had unacceptable platelet counts.

PRODUCT Red Blood Cells
CODE Unit #21369-6719.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
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 Platelets, Pheresis
CODE Units Numbers: 21370-9975-01, 21370-9975-02, 21371-4437-01, 21370-9941-01, 21370-9941-02, 21371-4366-02, 21371-4437-02.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUITON North Dakota.
QUANTITY 7 units were distributed.
REASON Blood products had unacceptable platelet counts.

PRODUCT Platelets, Pheresis
CODE Unit #21370-1211.
MANUFACTURER United Blood Services, Fargo, North Dakota.
DISTRIBUTION North Dakota.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.

PRODUCT a) Red Blood Cells; b) Platelets
CODE Unit #6552383.
MANUFACTURER New York Blood Services (Center West), a Division of New York Blood Center, Inc., (NYBC), New York, New York.
DISTRIBUTION New York.
QUANTITY 1 unit 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 #LS29253.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
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) Red Blood Cells, Leukocytes Reduced; c) Platelets, Pooled
CODE Unit Numbers: a) LS20953; b) LS23641; c) FP92127.
MANUFCTURER The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
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 #LS23908.
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 whose hematocrit had not been determined.

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers: FJ47423, KM17514, LH48638.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 3 units were distributed.
REASON Blood products had unacceptable platelet counts.

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit #LW66431.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit #LS21551.
MANUFACTURER The Blood Center of Southeastern Wisconsin.
DISTRIBUTION Wisconsin.
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, Leukocytes Reduced; b) Cryoprecipitated AHF, Pooled
CODE Unit Numbers: a) GP86336; b) FP78864.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Cytotec (misoprostol).

PRODUCT Platelets, Pheresis, Leukocytes Reduced
CODE Unit Numbers: LH46042, LH46244, LH46397
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 3 units were distributed.
REASON Blood products were collected from a donor taking the drug Piroxicam.

PRODUCT a) Red Blood Cells; b) Platelets
CODE Unit #42FY03478.
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
DISTRIBUTION Ohio.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Acyclovir.

PRODUCT Corneas
CODE Lot Numbers 006-99-351, 006-99-352.
MANUFACTURER East Tennessee Lions Eye Bank, Knoxville, Tennessee.
DISTRIBUTION Tennessee and Florida.
QUANTITY 2 units were distributed.
REASON Corneas were from a donor who tested repeatedly reactive for HBsAg

PRODUCT Red Blood Cells
CODE Unit #11FF48063.
MANUFACTURER American Red Cross, St. Louis, Missouri.
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 Platelets, Pheresis.
CODE Unit #11LS12517B.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION Missouri.
QUANTITY 1 unit was distributed.
REASON Blood product was not leukoreduced, was labeled as leukoreduced and distributed.

PRODUCT Red Blood Cells
CODE Unit #11GS24405.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION Missouri.
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 #01Q28075.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
DISTRIBUTION New York.
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 Platelets, Pheresis
CODE Unit #01P40175.
MANUFACTUER American Red Cross Blood Services, Rochester, New York.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #FQ00476.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin and Switzerland.
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 Platelets, Pheresis
CODE Unit numbers: LH47856 and LH47866.
MANUFACTURER The Blood Center of Southeastern Wisconsin.
DISTRIBUTION Illinois and Kentucky.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with extended expiration dates.

PRODUCT Platelets, Pheresis
CODE Unit #LH47383-2.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE Unit #LW73582.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported a blood exposure within 12 months of donation.

PRODUCT a) Red Blood Cells; b) Platelets
CODE Unit #0639181.
MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
DISTRIBUTION Minnesota and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose donor history screening was incomplete.

PRODUCT a) Red Blood Cells; b) Platelets; c) Cryoprecipitated AHF; d) Plasma
CODE Unit #0628498
MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
DISTRIBUTION Minnesota.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose donor history screening was incomplete.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #0541726.
MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
DISTRIBUTION Minnesota and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood Products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from a donor who previously tested repeatedly reactive for anti-HIV-1.

PRODUCT a) Red Blood Cells; b) Platelets
CODE Unit numbers: a) 9899846; b) 9956517.
MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio.
DISTRIBUTION Ohio.
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 a) Red Blood Cells; b) Platelets
CODE Unit #9884566.
MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio.
DISTRIBUTION Ohio.
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 Platelets
CODE Unit #9927324.
MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio.
DISTRIBUTION Ohio.
QUANTITY 1 unit 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 #9901181.
MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio.
DISTRIBUTION Ohio.
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
CODE Unit #01KK46334.
MANUFACTURER American Red Cross Blood Services, Rochester, New York.
DISTRIBUTION New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who was taking the drug Valtrex.

PRODUCT Red Blood Cells
CODE Unit #11LV24886.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION Kansas.
QUANTITY 1 unit was distributed.
REASON Blood products tested negative for the human T lymphotropic virus types I and II (anti-HTLV-I/II), but were collected from a donor who previously tested indeterminate for HTLV-I/II.

PRODUCT a) Red Blood Cells; b) Recovered Plasma; c) Source Leukocytes for Manufacture
CODE Unit #0706297.
MANUFACTURER Bergen Community Regional Blood Center, Paramus, New Jersey.
DISTRIBUTION New Jersey and New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had a tattoo within 12 months of donation.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #11FC48766.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION New York and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Red Blood Cells
CODE Unit #L59278.
MANUFACTURER Healthcare Provider Services, Inc., doing business as Rhode Island Blood Center, Providence, Rhode Island.
DISTRIBUTION Rhode Island.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported a history of Babesiosis and Lyme Disease.

PRODUCT Platelets, Pheresis
CODE Unit Numbers: W88673, X11087, X11137, X11249, X11281, X11339, X11340.
MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, Illinois.
DISTRIBUTION Illinois.
QUANTITY 7 units were distributed.
REASON Blood products were collected from donors whose suitability was not adequately determined.

PRODUCT Platelets
CODE Unit #49LH38956.
MANUFACTURER American Red Cross Blood Services, Waco, Texas.
RECALLED BY American Red Cross Blood Services, Tulsa, Oklahoma
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of clotted red blood cells.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE FDA, Center for Biologics Evaluation and Research, Contact Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER United Blood Services, Bismarck, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION California, Florida, New York, Texas, Alabama, Arkansas, Massachusetts, Mississippi, New Jersey, North Carolina, North Dakota, South Carolina, South Dakota, and Switzerland.
QUANTITY a) 388 units; b) 2 units were distributed.
REASON Blood products were collected from donors whose donor history screening was inadequately performed.

PRODUCT a) Red Blood Cells; b) Platelets, Pooled; c) Fresh Frozen Plasma.
CODE Unit Numbers: a) Q85686; FP82338; c) Q85686.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
DISTRIBUTION Mississippi and Wisconsin.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Cytotec (misoprostol).

PRODUCT a) Red Blood Cells; b) Plasma
CODE Unit #53KQ53856.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION District of Columbia.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Immune Globulin Intravenous (Human) Venoglobulin-S 10%.
CODE Lot Numbers
5 Gram Vials (11): GR8041A GR8041AB GR9008A GR8050A GR8050AB GR9014A GR8066A GR8067A GR9019A GR9026A GR9027A
10 Gram Vials (43): GR8042A GR8056A GR9002A GR8042AB GR8057A GR9003A GR8043A GR8057AB GR9009A GR8045A GR8061A GR9010A GR8046A GR8061AB GR9011A GR8047A GR8063A GR9013A GR8048A GR8064A GR9015A GR8049A GR8065A GR9018AGR8052A GR8069A GR9020A GR8052AB GR8070A GR9021A GR8053A GR8073A GR9022A GR8053AB GR8083A GR9024A GR8053AC GR8084A GR9034AGRGR8055A GR9001A GR9035A GR8055AB
20 Gram VIALS (23): GR8044A GR8062AB GR9007A GR8044AB GR8062AC GR9012A GR8051A GR8068A GR9016A GR8051AB GR8071A GR9023A GR8054A GR8072A GR9025A GR8054AB GR9004A GR9029A GR8054AC GR9005A GR9036A GR8062A GR9006A.
MANUFACTURER Alpha Therapeutic Corporation, Los Angeles, California.
DISTRIBUTION Nationwide and Guam.
QUANTITY 128,127 vials were distributed; firm estimated that 32,032 vials remained on market at time of recall initiation.
REASON Blood products were labeled with expiration dates that exceeds product stability.

PRODUCT a) Red Blood Cells; b) Platelets
CODE Unit #22LY51913.
MANUFACTURER American Red Cross Blood Services, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania, New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood product was collected from a donor whose arm inspection prior to phlebotomy was not documented.

PRODUCT Red Blood Cells
CODE Unit Numbers: 21372-1733, 21372-1818, 21372-2047, 21372-2049, 21372-2213, 21372-3440.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION North Dakota.
QUANTITY 6 units were distributed.
REASON Blood products remained at room temperature for an unacceptable length of time during shipment.

PRODUCT Red Blood Cells, Leukoreduced
CODE Unit #21368-0149.
MANUFACTURER United Blood Services, Fargo, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION North Dakota.
QUANTITY 1 unit of each component was distributed.
REASON Blood product failed the requirement for red blood cell recovery.

PRODUCT Red Blood Cells
CODE Unit #Q97861.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood products were distributed in interstate commerce.

PRODUCT Recovered Plasma
CODE Unit #GP86336.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the drug Cytotec (misoprostol).

PRODUCT Platelets, Pheresis
CODE Unit #LH47902-1.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable white blood count was distributed labeled as leukoreduced.

PRODUCT Red Blood Cells, Leukoreduced
CODE Unit #KZ34632.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product.

PRODUCT Recovered Plasma
CODE Unit #11LV24886.
MANUFACTURER American Red Cross Blood Services, St. Louis, Missouri.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood products tested negative for the human T lymphotropic virus types I and II (anti-HTLV-I/II), but were collected from a donor who previously tested indeterminate for HTLV-I/II.

PRODUCT Platelets
CODE Unit #22KJ34493.
MANUFACTURER American Red Cross Blood Services, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product with a positive antibody screen, was distributed, labeled as negative for unexpected antibodies.

PRODUCT Red Blood Cells
CODE Unit #X31125.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with extended expiration date.

PRODUCT Red Blood Cells, Washed
CODE Unit #22395-2131.
MANUFACTURER United Blood Services, Las Vegas, Nevada.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Nevada.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration time.

PRODUCT Recovered Plasma
CODE FDA, Center for Biologics Evaluation and Research, Contact Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER United Blood Services, Bismarck, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION California, Florida, New York, Texas, Alabama, Arkansas, Massachusetts, Mississippi, New Jersey, North Carolina, North Dakota, South Carolina, South Dakota, Texas, and Switzerland.
QUANTITY 392 units were distributed.
REASON Blood products were collected from donors whose donor history screening was inadequately performed.
 

WEEK ENDING OCTOBER 22

PRODUCT Platelets, Pheresis
CODE Unit #KK00833.
MANUFACTURER Gateway Community Blood Program, St. Louis, Missouri.
DISTRIBUTION Missouri.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with an elevated ALT.

PRODUCT Various Human Tissue for Transplant: a) Femoral Head w/o Cartilage; b) Fascia Lata;
c) Tricortical Ilium Wedge; d) Cancellous Chips; e) Cortical Strut Units; f) NA Shaft.
CODE Unit Numbers a) 990450001, 990450002; b) 990450003, 990450004; c) 990450006, 990450008, 990450009, 990450010, 990450011; d) 90450014, 990450015, 990450016, 990450017, 990450018, 990450019, 990450020, 990450021, 990450022, 990450023, 990450024, 990450027, 990450028, 990450032, 990450033;e) 990450038, 990450039, 990450040, 990450043; f) 990450044, 990450045.
MANUFACTURER AlloSource, Denver, Colorado.
DISTRIBUTION Alabama, Colorado, Florida, Illinois, Indiana, Oklahoma, Pennsylvania, New York, Texas.
QUANTITY a) 2 units; b) 2 units; c) 5 units; d) 15 units; e) 4 units; f) 2 units were distributed.
REASON The tissues for transplant were collected from a donor who tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBC).

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; Recovered Plasma.
CODE FDA, Center for Biologics Evaluation and Research, Contact Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER United Blood Services, Bismarck, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION California, Florida, New York, Texas, Alabama, Arkansas, Massachusetts, Mississippi, New Jersey, North Carolina, North Dakota, South Carolina, South Dakota and Switzerland.
QUANTITY a) 388 units; b) 2 units; c) 392 units were distributed.
REASON Blood products were collected from donors whose donor history screening was inadequately performed.

PRODUCT Fresh Frozen Plasma
CODE Unit #0102681.
MANUFACTURER Ashford Blood Bank, Inc., Santurce, Puerto Rico.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit was distributed.
REASON Blood product containing positive antibodies, but labeled as negative for unexpected antibodies.

PRODUCT a) Platelets, Pheresis; b) Platelets Pheresis, Irradiated.
CODE a) 10594-2996, 10597-6162; b) 10598-3087, 10602-5101.
MANUFACTURER United Blood Services, Scottsdale, Arizona.
RECALLED BY Blood Systems, Inc., Scottsdale Arizona
DISTRIBUTION Nevada, Arizona.
QUANTITY 2 units of each component were distributed.
REASON Blood products had unacceptable platelet counts.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets, Pooled
CODE Unit Numbers: a) LG99113 b) FR01339 c) FP73927, FP79567.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY a) 1 unit; b) 1 unit; c) 2 units were distributed.
REASON Blood products were collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT a) Red Blood Cells; b) Plasma
CODE Unit #53KQ53856.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Washington, D.C.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Red Blood Cells
CODE Unit Number 0103796.
MANUFACTURER Ashford Blood Bank, Inc., Santurce, Puerto Rico.
DISTRIBUTION Puerto Rico.
QUANTITY 1 unit was distributed.
REASON Blood product was not tested for HIV ½, prior to release, and subsequently tested non-reactive for HIV ½.
 

WEEK ENDING OCTOBER 29

PRODUCTS Platelets
CODE FDA, Center for Biologics Evaluation and Research, Contact Office of Compliance (301) 827-6220 for individual unit numbers recalled
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
DISTRIBUTION Texas.
QUANTITY 66 units were distributed.
REASON Blood products were manufactured from whole blood that had been stored at unacceptable temperatures.

PRODUCTS a) Red Blood Cells; b) Platelets
CODE Unit #5110466.
MANUFACTURER BloodCare, Dallas, Texas.
RECALLED BY BloodCare, Dallas, Texas
DISTRIBUTION Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported travel outside of the United States.

PRODUCTS Red Blood Cells
CODE Unit #49W24415.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported having lived in an area designated as endemic for malaria.

PRODUCTS a) Red Blood Cells; b) Platelets
CODE Unit #30GG38186.
MANUFACTURER American National Red Cross, Ashley, Pennsylvania.
DISTRIBUTION Pennsylvania and Massachusetts.
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.

PRODUCTS a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
CODE Unit #30GG59449.
MANUFACTURER American National Red Cross, Ashley, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Lupron.

PRODUCTS a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced.
CODE Unit Numbers: a) 21FL34345, 21FL34367, 21GC58777, 21KK08098; b) 21GC58868, 21GC58968, 21KG17209, 21KH18300, 21KH18318, 21KH18320.
MANUFACTURER American Red Cross, Portland, Oregon.
DISTRIBUTION Oregon and California.
QUANTITY a) 4 units; b) 6 units were distributed.
REASON Blood products were exposed to unacceptable shipping temperatures.

PRODUCTS a) Red Blood Cells; b) Cryoprecipitated AHF.
CODE a) 30GE08879 and 30GS09969; b) 30GE08879.
MANUFACTURER American National Red Cross, Ashley, Pennsylvania.
DISTRIBUTION Pennsylvania and Massachusetts.
QUANTITY a) 2 units; b) 1 unit was distributed.
REASON Blood products were collected from a donor whose body temperature had not been recorded or which was identified for confidential exclusion.