NOVEMBER 2000

WEEK ENDING NOVEMBER 3

PRODUCT Red Blood Cells.
CODE Unit #18FK35365.
MANUFACTURER American Red Cross Blood Services, Lansing, Michigan.
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 Platelets
CODE Unit Numbers: 8946012 and 3140247.
MANUFACTURER Florida-Georgia Blood Alliance, Jacksonville, Florida.
DISTRIBUTION Florida.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with extended expiration dates.

PRODUCT Platelets, Pheresis
CODE 5305832, 5305944, 5305945, 5305947 (split products)
MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY 4 split units were distributed.
REASON Blood products had unacceptable platelet concentrations.

PRODUCT Platelets.
CODE Unit #13FR14499.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of red blood cells which tested positive for Staphylococcus aureus and was implicated in a febrile transfusion reaction.

PRODUCT Red Blood Cells.
CODE Unit #13GC62153.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was distributed after receiving post donation information that the donor was diagnosed with mononucleosis.

PRODUCT Sepacell(r) Pre-storage Leukocyte Reduction Set.
CODE All lot numbers beginning with A00E, A00F, A00G, A00H.
MANUFACTURER Baxter S.A., Fenwal Division, Parque Industrial Itabo, Zona Franca Industrial de Haina, San Cristobal, Republica Dominica.
RECALLED BY Baxter Healthcare Corporation, Fenwal Division, Deerfield, Illinois
DISTRIBUTION Nationwide, Brazil, Venezuela, Chile, Belgium.
QUANTITY 678,309 units were distributed, with the firm estimating that 20% of the product remains on the market.
REASON Leukocyte reduction filter sets were occasionally leaking during the leukoreduction of units of Red Blood Cells intended for transfusion.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Plasma; e) Cryoprecipitated AHF.
CODE Unit Numbers: a) 03FJ51705, 03FX11152, 03FX11153, 03GF54383, 03GG56390, 03GG56511, 03GL40935, 03GN27088, 03GR45911, 03GZ11572, 03LG10617; b) 03GF54383, 03GR45911; c) 03GG56390, 03GL40935, 03GR45911; d) 03FF57025, 03GZ12145, 03GZ11572; e) 03GZ11572.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
DISTRIBUTION Georgia.
QUANTITY a) 11 units; b) 2 units; c) 3 units; d) 3 units; e) 1 unit.
REASON Blood products were prepared from overweight whole blood units.

PRODUCT Platelets.
CODE Unit #7039272.
MANUFACTURER New York Blood Services (Center West), A Division of New York Blood Center, Inc., New York, New York.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product tested CMV positive was distributed labeled as CMV negative.

PRODUCT Whole Blood, Autologous
CODE Unit 18222-9234.
MANUFACTURER United Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Colorado.
QUANTITY 1 unit was distributed.
REASON Autologous blood product was collected from a donor who reported taking antibiotics for an infection.

PRODUCT Red Blood Cells.
CODE Unit #4763335.
MANUFACTURER National Naval Medical Center, Bethesda, Maryland.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product tested initially reactive for anti-HCV and was not retested in duplicate.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #15006-7928.
MANUFACTURER Blood Systems, Inc., Texas Blood Institute - Lubbock Center, Lubbock, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who was taking the drug Methotrexate.

PRODUCT Platelets, Pheresis, Leukoreduced.
CODE Unit #15009-3782.
MANUFACTURER Blood Systems, Inc., Texas Blood Institute - Lubbock Center, Lubbock, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count was labeled as a standard product.

PRODUCT Fresh Frozen Plasma.
CODE Unit #E24289.
MANUFACTURER Carolina-Georgia Blood Center, Greenville, South Carolina.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was not frozen within 8 hours of whole blood collection.

PRODUCT a) Panocell-10 Ficin Treated, Reagent Red Blood Cells b) Panocell-10 Reagent Red Blood Cells.
CODE a) Lot 48737E; b) Lot 48737.
MANUFACTURER Immucor, Inc., Norcross, Georgia.
DISTRIBUTION Nationwide, Canada, Italy, Germany, England, Belgium.
QUANTITY a) 232 sets; b) 603 sets were distributed.
REASON Reagent red blood cells were positive for the Jsa antigen, were identified on the antigen profile sheet as Jsa negative.

PRODUCT Source Plasma.
CODE Unit #0054771.
MANUFACTURER DCI Biologicals Carbondale, Inc., Carbondale, Illinois.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who previously had an elevated ALT on two separate occasions.

PRODUCT Recovered Plasma for manufacture of non-injectable products.
CODE Unit #13W98469.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for the HIV-1 p24 antigen, but was collected from a donor who subsequently tested repeatedly reactive for the HIV-1 p24 antigen.

PRODUCT Red Blood Cells.
CODE Unit #81-31327.
MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan.
RECALLED BY Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was received at an undocumented temperature was redistributed.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #FG20271.
MANUFACTURER Healthcare Provider Services, 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 whose hemoglobin/hematocrit results were not documented during screening.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #26162-1369.
MANUFACTURER Blood Systems, Inc., Fort Smith, Arkansas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Arkansas.
QUANTITY 1 unit was distributed.
REASON Blood product remained at room temperature for an unacceptable length of time during leukoreduction.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Irradiated; c) Platelets; d) Platelets, Irradiated; e) Fresh Frozen Plasma; f) Recovered Plasma; g) Recovered Plasma for Further Manufacture of Non-Injectable Products Only.
CODE Unit Numbers: a) 13FY32442, 13FY32443, 13FY32444, 13FY32445, 13FY32446, 13FY32448, 13GC56172, 13GC56173, 13GC56174, 13GC56175, 13GC56176, 13GC56177, 13GC56178, 13GC56179 and 13GC56182
b) 13FY32447 and 13GC56180
c) 13FY32442, 13FY32443, 13FY32444, 13FY32445, 13FY32446, 13FY32447, 13FY32448, 13GC56172, 13GC56173, 13GC56175, 13GC56176, 13GC56177, 13GC56178, 13GC56179 and 13GC56180
d) 13GC56174
e) 13GC56179
f) 13FY32442, 13FY32443, 13FY32444, 13FY32445, 13FY32446, 13FY32447, 13FY32448, 13GC56172, 13GC56173, 13GC56175, 13GC56176, 13GC56177, 13GC56178, 13GC56180 and 13GC56182
g) 13GC56174.
MANUFACTURER American Red Cross, Detroit, Michigan.
DISTRIBUTION Michigan, California, New York.
QUANTITY a) 15 units; b) 2 units; c) 15 units; d) 1 unit; e) 1 unit; f) 15 units; g) 1 unit distributed.
REASON Blood products were incorrectly tested for human immunodeficiency virus (HIV) p24 antigen.

WEEK ENDING NOVEMBER 10

PRODUCT a) Platelets, Pheresis; b) Platelets, Pheresis, Irradiated.
CODE Unit Numbers: a) 18216-7680-01, 18216-7751-01; b) 18216-7680-02.
MANUFACTURER UNITED Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Wyoming.
QUANTITY a) 2 units; b) 1 unit.
REASON Blood products had unacceptable platelet counts.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit #3499909.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Platelets, Pheresis was leukoreduced by filtration greater than 72 hours past the time of collection.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit #3568224.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Platelets, Pheresis were leukoreduced by filtration greater than 72 hours past the time of collection.

PRODUCT Platelets Pheresis, Irradiated.
CODE Unit #18P41974 (split unit).
MANUFACTURER American Red Cross Blood Services, Lansing, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 split 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 numbers: 38-19676, 62-20275, 62-29892.
MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan.
RECALLED BY Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan
DISTRIBUTION Michigan, Mississippi.
QUANTITY 3 units were distributed.
REASON Blood products were collected from a donor with Graves Disease.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #21N08794.
MANUFACTURER American Red Cross Blood Service, Pacific Northwest Regional Blood Services, Portland, Oregon.
DISTRIBUTION California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose blood donation record had two confidential unit exclusion stickers attached.

PRODUCT Source Plasma.
CODE Unit #C-10868-079.
MANUFACTURER Alpha Therapeutic Corporation, Seattle, Washington.
RECALLED BY Alpha Therapeutic Corporation, Los Angeles, California
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who was previously deferred for unexplained needle marks.

PRODUCT a) Platelets, Pheresis, Leukoreduced; b) Fresh Frozen Plasma.
CODE Unit #9030157.
MANUFACTURER Blood Bank of Delaware, Inc., Newark, Delaware.
DISTRIBUTION Delaware.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Proscar.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #16LW38680.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
DISTRIBUTION Ohio.
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 a) Red Blood Cells; b) Platelets.
CODE Unit numbers: a) 1637600, 1653535, 1668881; b) 1637600.
MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky.
DISTRIBUTION Kentucky.
QUANTITY a) 3 units; b) 1 unit distributed.
REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit #41FY97807.
MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama.
DISTRIBUTED Alabama.
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) Recovered Plasma.
CODE Unit #0334343.
MANUFACTURER Inland Northwest Blood Center, Spokane, Washington.
DISTRIBUTION Washington state and Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of jaundice.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 15006-1226 and 15387-3393.
MANUFACTURER Blood Systems, Inc., South Plains Blood Services, Lubbock, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas and California.
QUANTITY 2 units were distributed.
REASON Blood product was collected from a donor taking the Asacol.

PRODUCT Platelets, Pheresis, Leukocytes Reduced,
CODE Split Units 26158-4652-01, 26158-4652-02, 26158-4653-01, 26158-4653-02, 26158-4643-02.
MANUFACTURER United Blood Services, Hot Springs, Arkansas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Arkansas.
QUANTITY 5 split units were distributed.
REASON Blood products, which had unacceptable platelet counts.

PRODUCT Source Plasma.
CODE Unit #99OW14310.
MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin.
RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama
DISTRIBUTION Missouri.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that compromises the sterility of the unit.

PRODUCT Red Blood Cells.
CODE Unit #21KK27439.
MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon.
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.
CODE Unit #KL64588.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit of each component 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) Recovered Plasma.
CODE Unit #21FT28071.
MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who had a tattoo within 12 months of donation.

PRODUCT Source Plasma.
CODE Unit numbers: G-77949-009, G-78929-009, G-76921-009, G-79859-009, G-80377-009, G-80718-009, G-81234-009, G-81567-009, G-82209-009, G-82579-009, G-83023-009, G-83247-009, G-83858-009, G-84164-009, G-84735-009, G-85109-009, G-85541-009, G-85952-009, G-86316-009, G-87011-009, G-87355-009, G-88293-009, G-88812-009, G-89246-009.
MANUFACTURER Alpha Therapeutic Corporation, Tacoma, Washington.
DISTRIBUTION Spain.
QUANTITY 24 units were distributed.
REASON Blood products were collected from a donor who had body piercing within twelve months of donation.

PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered Plasma, Frozen.
CODE Unit #41FY98784.
MANUFACTURER The American National Red Cross, Birmingham, Alabama.
DISTRIBUTION Alabama and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of jaundice.

PRODUCT a) Red Blood Cells; b) Platelets Pooled.
CODE Unit Numbers: a) W111757; b) HP04176.
MANUFACTURER Puget Sound Blood Center & Program, Seattle, Washington.
DISTRIBUTION Washington state.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had been exposed to an individual with hepatitis A.

PRODUCT a) Red Blood Cells; b) Platelets; c) Cryoprecipitate AHF; d) Recovered Plasma.
CODE Unit #41FJ48012.
MANUFACTURER The American National Red Cross, Birmingham, Alabama.
DISTRIBUTION Alabama and Switzerland.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT Platelets, Pheresis, Leukoreduced.
CODE Unit #21KP08755 (two units).
MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon.
DISTRIBUTION Oregon.
QUANTITY 1 double unit was distributed.
REASON Blood products were labeled as having tested CMV antibody negative.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit #41LV13581.
MANUFACTURER American Red Cross, Birmingham, Alabama.
DISTRIBUTION Alabama.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor taking the drug Methotrexate.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit Numbers: a) 41GQ77354, 41GG08959, 41GQ74215; b) 41GQ77354, 41GG08959, 41GQ74215.
MANUFACTURER The American National Red Cross, Birmingham, Alabama.
DISTRIBUTION Alabama, California, New York, Switzerland.
QUANTITY 3 units of each component were distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT Platelets.
CODE Unit #87-13404.
MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan.
RECALLED BY Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who took the drug Zocar, within 12 hours of donation.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit Numbers: a) 03GT43980, 03GY14922, 03GY14927, 03LT46140, 03LT46148, 03LT46163; b) 03GY14922.
MANUFACTURER American Red Cross Blood Services, Savannah, Georgia.
RECALLED BY American Red Cross Blood Services, Atlanta, Georgia
DISTRIBUTION Georgia.
QUANTITY a) 6 units; b) 1 unit distributed.
REASON Blood products corresponded to six units of Platelets that were implicated in a transfusion reaction.

PRODUCT Source Plasma.
CODE Unit Numbers: 99OWID2473, 99OWID3049, 99OWID3774.
MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin.
RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama
DISTRIBUTION Austria.
QUANTITY 3 units were distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Source Plasma.
CODE 98OWIA4637, 98OWIA5348, 98OWIA6206, 98OWIA9297, 98OWIA9615, 98OWIB1414, 98OWIB2156.
MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin.
RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama
DISTRIBUTION Minnesota and Austria.
QUANTITY 7 units were distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Source Plasma.
CODE Unit #00OWIA0521.
MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin.
RECALLED BY Community Bio-Resources, Inc, Hoover, Alabama
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that may have compromised the sterility of the units.

PRODUCT Source Plasma.
CODE Unit Numbers: Units 99OWIC9828, 99OWID0480, 99OWID1245, 99OWID2022, 99OWID2733, 99OWID3278
MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin.
RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama
DISTRIBUTION Minnesota and Austria.
QUANTITY 6 units were distributed.
REASON Blood products were collected from a donor who had been immunized with MMR vaccine, within four weeks of the donations.

PRODUCT Source Plasma.
CODE Unit #98OWID3342.
MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin.
RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who was not asked any of the pre-donation donor screening questions.

PRODUCT Source Plasma.
CODE Unit #99OWIB8782.
MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin.
RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who was not asked any of the pre-donation donor screening questions.

PRODUCT Red Blood Cells.
CODE Unit #3446633.
MANUFACTURER Florida Blood Services, Tampa, Florida.
RECALLED BY Florida Blood Services, St. Petersburg, Florida
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who received a Yellow Fever vaccine within two weeks of donation.

PRODUCT a) Antihemophilic Factor (Recombinant), Kogenate, b) Antihemophilic Factor (Recombinant) Helixate.
CODE Lots Numbers: a) 670H076, 1670H071C; b) 670H071E.
MANUFACTURER Bayer Corporation, Berkeley, California.
DISTRIBUTION Nationwide, Canada, Taiwan.
QUANTITY a) 16,009 vials; b) 1,116 vials were distributed.
REASON Product may fall below the labeled potency when stored at 25 degrees C.

PRODUCT Recovered Plasma.
CODE Unit #15006-1226.
MANUFACTURER Blood Systems, Inc., South Plains Blood Services, Lubbock, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas and California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the drug Asacol.

PRODUCT Red Blood Cells.
CODE Unit #7219622.
MANUFACTURER Department of the Air Force, Malcolm Grow USAF Medical Center, Andrews AFB, Maryland.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Blood product tested RPR positive and negative by confirmatory testing.

PRODUCT Red Blood Cells.
CODE Unit #21KH41040.
MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon.
DISTRIBUTION Oregon.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Red Blood Cells.
CODE Unit numbers: 18GH61201, 18GH61216, 18GF28863.
MANUFACTURER American Red Cross, Lansing, Michigan.
DISTRIBUTION Michigan.
QUANTITY 3 units were distributed.
REASON Blood products were stored at unacceptable temperatures.

PRODUCT Platelets.
CODE Unit Numbers: 17KP77920, 17KP77925, 17KP77926, 17KP77927, 17KP77928, 17KP77930 through 17KP77939, 17KP77941, 17KP77942.
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
DISTRIBUTION Minnesota and Iowa.
QUANTITY 17 units were distributed.
REASON Blood products were collected in expired blood collection bags.

WEEK ENDING NOVEMBER 17

PRODUCT Platelets, Pheresis.
CODE Unit #0586993.
MANUFACTURER Coral Therapeutics, Inc., Braintree, Massachusetts.
DISTRIBUTION Maine.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for anti-HCV.

PRODUCT Red Blood Cells.
CODE Unit #42FX89592.
MANUFACTURER American Red Cross Blood Services, Cleveland, 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; c) Platelets, Pheresis.
CODE Unit Numbers: a) 18FT25111; b) 18FT25111; c) 18P40771.
MANUFACTURER American Red Cross, Lansing, Michigan.
DISTRIBUTION Michigan.
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 #18FT34246.
MANUFACTURER American Red Cross, Lansing, Michigan.
DISTRIBUTION Michigan.
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, Leukoreduced.
CODE Unit #18FR49796 and 18FW08848.
MANUFACTURER American Red Cross, Muskegon, Michigan.
RECALLED BY American Red Cross, Lansing, Michigan
DISTRIBUTION Michigan and California.
QUANTITY 2 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.
CODE Unit #18FS40538.
MANUFACTURER American Red Cross, Muskegon, Michigan.
RECALLED BY American Red Cross, Lansing, Michigan
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 Red Blood Cells.
CODE Unit Numbers: 26159-0168 and 26160-9973.
MANUFACTURER Blood Systems, Inc., Rogers, Arkansas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Arkansas and Texas.
QUANTITY 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) Platelets; c) Recovered Plasma.
CODE Unit Numbers: a) 13L87732, 13L91123; b) 13L87732; c) 13L87732, 13L91123.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan, California, New York.
QUANTITY a) 2 units; b) 1 unit; c) 2 units were distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #M97-0103.
MANUFACTURER Union Memorial Hospital, Baltimore, Maryland.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for anti-HCV.

PRODUCT Source Plasma.
CODE Unit #80523048.
MANUFACTURER NABI Biomedical Center, Pensacola, Florida.
RECALLED BY NABI Biomedical Center, Boca Raton, Florida
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for anti-HCV.

PRODUCT Platelets, Pheresis.
CODE Unit #97K12609.
MANUFACTURER National Institute of Health, Warren G. Magnuson Clinical Center, Bethesda, Maryland.
DISTRIBUTION Maryland.
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 #15329042.
MANUFACTURER NABI Biomedical Center, Huntington, West Virginia.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who was not asked any of the pre-donation screening questions.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma.
CODE Unit Numbers: a) 6121790, 2166913, 7770084; b) 2166913; c) 2166913; d) 6121790.
MANUFACTURER Life Source, Glenview, Illinois.
DISTRIBUTION Illinois, California, Scotland.
QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 1 unit distributed.
REASON Blood products tested negative for the antibody to the human T-lymphotropic virus, but were collected from a donor who previously tested repeatedly reactive for anti-HTLV.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced and Irradiated; c) Platelets, Pooled; d) Recovered Plasma.
CODE Unit Numbers: a) LW93016; b) LW89401; c) PO1447; d) LW93016.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of jaundice.

PRODUCT Source Plasma.
CODE Unit Numbers: 33-3LS076, 33-3K7728, 33-3K7775, 33-3K7813, 33-3K7870.
MANUFACTURER Aventis Bio-Services, Inc., West Allis, Wisconsin.
RECALLED BY Aventis Bio-Services, Inc., Knoxville, Tennessee
DISTRIBUTION Illinois and Germany.
QUANTITY 5 units were distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Source Plasma.
CODE Unit Numbers: 17114516, 17113014, 17111713.
MANUFACTURER Interstate Blood Bank, Inc. of Wisconsin, Kenosha, Wisconsin.
RECALLED BY Interstate Blood Bank, Inc., Memphis, Tennessee
DISTRIBUTION California.
QUANTITY 3 units were distributed.
REASON Blood products were collected from a donor who had body piercing within 12 months of donation.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit #LH52904.
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 Platelets, Pheresis, Leukocytes Reduced.
CODE Unit #LH53504.
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 Platelets Pheresis, Leukocytes Reduced.
CODE Unit Numbers: 24205-9415-01 and 24205-9415-02.
MANUFACTURER Blood Systems, Inc., United Blood Services, Rapid City, South Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION South Dakota.
QUANTITY 2 units were distributed.
REASON Blood products had high platelet counts.

PRODUCT Red Blood Cells.
CODE Unit #LW69352 and LW80229.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor taking the drug Cytotec (misoprostol).

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit Numbers: a) R07374; b) R07372.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected in a manner that compromises the sterility of the units.

PRODUCT Whole Blood.
CODE Unit #166482.
MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for Group D Streptococcus, was distributed after receiving post donation information concerning a gastrointestinal illness.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #21GY59346.
MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon.
DISTRIBUTION Georgia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #5132756.
MANUFACTURER Central Texas Regional Blood & Tissue Center, Austin, Texas.
DISTRIBUTION Texas and Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Recovered Plasma.
CODE Unit #7864522.
MANUFACTURER Meek Blood Center, Hendrick Medical Center, Abilene, Texas.
DISTRIBUTION Colorado.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose suitability was not adequately determined.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Source Leukocytes, For Research Use Only.
CODE Unit #3608757.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT Platelets for Non-Injectable Use.
CODE Unit #18FW08848.
MANUFACTURER American Red Cross, Muskegon, Michigan.
RECALLED BY American Red Cross, Lansing, Michigan
DISTRIBUTION Michigan and California.
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 Numbers: 41-42407 and 61-70174.
MANUFACTURER Michigan Community Blood Centers, Grand Rapids, Michigan.
DISTRIBUTION Michigan.
QUANTITY 2 units were distributed.
REASON Blood product was collected from a donor who had a history of pernicius anemia.

PRODUCT Platelets, Pheresis.
CODE 97K11436, 97K11502, 97K11505, 97K11583, 97K11593, 97K11804, 97K11886, 97K11991, 97K12081.
MANUFACTURER National Institute of Health, Warren G Magnuson Clinical Center, Bethesda, Maryland.
DISTRIBUTION District of Columbia.
QUANTITY 9 units were distributed.
REASON Unlicensed blood products were distributed in interstate commerce.

PRODUCT Red Blood Cells.
CODE Unit #98K03043 and 98K03228.
MANUFACTURER National Institute of Health, Warren G. Magnuson Clinical Center, Bethesda, Maryland.
DISTRIBUTION District of Columbia.
QUANTITY 2 units were distribute .
REASON Unlicensed blood products were distributed in interstate commerce.

PRODUCT Red Blood Cells.
CODE Unit #LS44555-1 and LS44555-2.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Minnesota.
QUANTITY 2 units were distributed.
REASON Unlicensed blood products were distributed in interstate commerce.

PRODUCT Fresh Frozen Plasma.
CODE Unit Numbers: LW88030 and LW88034.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 2 units were distributed.
REASON Two units of Fresh Frozen Plasma were not separated and frozen within eight hours of phlebotomy.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit #30173-1469.
MANUFACTURER Blood Systems, Inc., Bismark, North Dakota.
COLLECTION SITE Blood Systems, Inc., Minot, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION North Dakota.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of ulcerative colitis.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced; c) Platelets, Pooled; d) Fresh Frozen Plasma; e) Recovered Plasma.
CODE Unit Numbers: a) FR23981, FR26646; b) LE22353 c) P02582; d) LE22353; e) FR23981.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Tennessee, Wisconsin, Switzerland.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit; e) 1 unit distributed.
REASON Blood products were collected from a donor who received a tissue transplant (surgery) within a year of donation.

PRODUCT Recovered Plasma.
CODE Unit Numbers: LW69352 and LW80229.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Switzerland.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor taking the drug Cytotec (misoprostol).

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit #30176-1612.
MANUFACTURER Blood Systems, Inc., United Blood Services, Bismark, North Dakota.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION North Dakota.
QUANTITY 1 unit was distributed.
REASON Red Blood Cells failed red cell recovery ratio.

WEEK ENDING NOVEMBER 24

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma.
CODE Unit Numbers: a) 1623716, 1575633, 1540205, 1532107, 1443918; b) 1532107; c) 1540205, 1532107; d) 1575633, 1443918, 1623716; e) 1623716, 1575633, 1443918.
MANUFACTURER Central Kentucky Blood Center, Lexington, Kentucky.
DISTRIBUTION Kentucky and Maryland.
QUANTITY a) 5 units; b) 1 unit; c) 2 units; d) 3 units; e) 3 units were distributed.
REASON Blood products were collected from a donor who traveled to an HIV Group O risk area.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced; c) Platelets; d) Cryoprecipitated AHF; e) Fresh Frozen Plasma; f) Plasma, Cryoprecipitate Removed; g) Platelets, For Use In Manufacturing Non-injectable Products; h) Recovered Plasma for Manufacturing Non-injectable Use; i) Recovered Plasma j) Red Blood Cells For Manufacturing Use Only.
CODE Unit Numbers:
a) 33254, 61904, 81154, 93768, 114908, 122387, 141076, 142063, 142928, 144116, 146672, 146966, 151538, 153173, 162436, 198471, 199887, 212127, 225424, 236591, 236943, 259493, 260511, 261441, 264431, 269709, 271352, 275619, 275909, 286843, 305116, 309324, 313558, 320674, 322027, 328252, 334154, 336309, 336566, 346491, 350474, 356253, 363109, 385074, 391255, 405154, 422542, 433187, 436137, 446142, 450031, 475653, 480487, 492733, 493991, 505254, 0549846, 0557471, 0572366, 0580525, 0590047, 0591611, 0626189, 0637137, 0638018.
b) 255096, 286289, 381093, 0605622, 0615745, 0523966
c) 33254, 61904, 93768, 122387, 141076, 142063, 144116, 146672, 146966, 151538, 153173, 162436, 198471, 212127, 225424, 236943, 260511, 261441, 264431, 269709, 275909, 286289, 286843, 313558, 320674, 328252, 336309, 336566, 350474, 356253, 381093, 385074, 391255, 422542, 436137, 446142,
480487, 492733, 505254, 0557471, 0572366, 0605622, 0615745, 0638018, 0523966, 0549846, 0637137, 9008508
d) 199887, 322027, 275619, 9002498, 9003200, 9005860, 9007402, 9008322, 9012466, 9401051, 9402023
e) 93768, 142063, 146672, 146966, 153173, 225424, 255096, 260511, 264431, 275909, 286289, 286843, 336309, 336566, 350474, 356253, 381093, 385074, 391255, 405154, 436137, 475653, 492733, 0523966, 0572366, 0637137, 0638018
f) 275619, 9009621, 9012466, 9401053
g) 236591, 255096, 405154, 405201, 433187, 475653, 493991, 0591611
h) 2345, 15748, 117920, 139369, 238588, 242145, 267471, 269131, 274131, 276821, 276872, 392600, 393147, 393966, 431541, 450031, 0524652, 0591611, 9002498, 9003200, 9005860, 9007402, 9008322
i) Units 10385, 81154, 114908, 141076, 142928, 144116, 151538, 199887, 212127, 236591, 236943, 239938, 243991, 259493, 261441, 269709, 271352, 305116, 309324, 313558, 320674, 322027, 328252, 334154, 346491, 363109, 405201, 422542, 446142, 480487, 493991, 505254, 0557471, 0580525,
0590047, 0605622, 0615745, 0626189; j) 405201.
MANUFACTURER Memorial Blood Centers of Minnesota, Minneapolis, Minnesota.
DISRIBUTIUON Minnesota, Mississippi, California, Texas, Florida, Pennsylvania, New York, Switzerland.
QUANTITY 59 units; b) 6 units; c) 48 units; d) 11 units; e) 27 units; f) 4 units; g) 8 units; h) 23 units; i) 38 units; j) 1 unit distributed.
REASON Blood products tested negative for the antibody to the human immunodeficiency virus type 1 (anti-HIV-1), but were collected from donors who previously tested repeatedly reactive for anti-HIV-1 or anti-HIV 1/2.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets, Pooled; d) Platelets, Pheresis, Leukocytes Reduced; e) Fresh Frozen Plasma; f) Recovered Plasma.
CODE a) KM18724, KM20631, KM23192; b) KM21839; c) PO2060; d) KM24177; e) KM21839; f) KM18724, KM20631.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin and Switzerland.
QUANTITY a) 3 units; b) 1 unit; c) 1 unit; d) 1 unit; e) 1 unit; f) 2 units were distributed.
REASON Blood products were collected from a donor having been diagnosed with Sarcoidosis.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit numbers: KM206521-1, KM206521-2, LH53726-1, LH53726-2, LH54278, LW85817-1, LW85817-2, R07225.
MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 8 units were distributed.
REASON Blood products had unacceptable platelet counts.

PRODUCT Indicator Red Cells.
CODE Lot number 20549, included with Capture-CMV (Lots 20585, 20586, and 20587) and Capture-S Test Kits (Lots 20588 and 20589.
MANUFACTURER Immucor, Inc., Norcross, Georgia.
DISTRIBUTION Nationwide, Canada, Italy, Spain.
QUANTITY 405 test kits were distributed.
REASON Indicator red cells exhibited loss of anti-IgM activity.

PRODUCT Source Plasma.
CODE Unit #98OWIE4986.
MANUFACTURER Community Bio-Resources, Inc., Oshkosh, Wisconsin.
RECALLED BY Community Bio-Resources, Inc., Hoover, Alabama
DISTRIBUTION Austria.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had a Hepatitis B immunization one day prior to the date of donation.

PRODUCT a) Platelets; b) Fresh Frozen Plasma.
CODE Unit #13GQ11638.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON A unit of red blood cells implicated in a transfusion reaction was found to be contaminated with gram positive cocci. Corresponding blood products were distributed.

PRODUCT Capture-S Reactive Control.
CODE Lot Numbers: QA3633, included with Capture-S Test Kits, lots 12399, 14446, 16493, 18541, 20589, 22636, 24684, 12397, 14445, 16492, 18540, 20588, 22635, 24683.
MANUFACTURER Immucor, Inc., Norcross, Georgia.
DISTRIBUTION Nationwide, Italy, Spain, Republic of Georgia.
QUANTITY 585 test kits were distributed.
REASON Reactive control serum exhibit loss of reactivity.

PRODUCT Reagent Red Blood Cells, Panocell-10, Ficin Treated.
CODE Lot #30285-E.
MANUFACTURER Immucor, Inc., Norcross, Georgia.
DISTRIBUTION Nationwide, Canada, Italy, Germany.
QUANTITY 197 sets were distributed.
REASON Ficin solution have a shorter expiration date than the accompanying reagent red blood cells.