WEEK ENDING AUGUST 4

PRODUCT Red Blood Cells.
CODE Unit #16349-5395.
MANUFACTURER Blood Systems, Inc., Jackson, Mississippi.
DISTRIBUTION Mississippi.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from an overweight unit of whole blood.

PRODUCT Red Blood Cells, Pheresis.
CODE Unit #91S00255 (split unit).
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
DISTRIBUTION Massachusetts.
QUANTITY 1 split unit was distributed.
REASON Blood products were collected from a donor who failed to complete the confidential unit exclusion (CUE) form at the time of donation.

PRODUCT Platelets, Pheresis.
CODE Unit #53LT65640.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Maryland.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet count.

PRODUCT Platelets, Pheresis.
CODE Unit #16245-2701.
MANUFACTURER United Blood Services, Hattiesburg, Mississippi.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Mississippi.
QUANTITY 1 unit was distributed.
REASON Leukroreduced blood product had an unacceptable white blood cell count.

PRODUCT Platelets, Pheresis.
CODE Unit #04LP41266.
MANUFACTURER American Red Cross Blood Services, Dedham, Massachusetts.
DISTRIBUTION New York.
QUANTITY 1 unit.
REASON Blood product, which should have been stored in two bags, was combined into one bag and distributed.

PRODUCT Human T-Lymphotropic Virus Types I and II Abbott HTLV-I/HTLV-II EIA Diagnostic Kit.
CODE Lot 63376M302.
MANUFACTURER Abbott Laboratories, Inc., Abbott Diagnostics Division, Abbott Park, Illinois.
DISTRIBUTION California, Louisiana, Tennessee, Washington state, Ohio, Illinois, Missouri.
QUANTITY 31 kits were distributed.
REASON Viral marker test kits exhibited an increased rate of initial reactive test results.

PRODUCT
a) Gamma-ReACT Pool (Pooled Screening cells)
b) Gamma ReACT Duet (Screening cells I & II)
c) Gamma-ReACT Trio (Screening cells 1,2,& 3)
d) Gamma-ReACT Duet-Plus (Screening cells I & II + Dia antigen)
e) Gamma-ReACT Duet-Plus (Screening cells I & II + Cw antigen)
f) Gamma-ReACT Trio-Plus (Screening cells 1,2,& 3 + Dia antigen)
g) Gamma-ReACT Panel 15.
CODE a) Lot R0314/1; b) Lot R0314/5; c) c) Lot R0314/5 d) Lot R0314/5; e) Lot R0314/5; f) Lot R0314/5 g) Lot R0314/15.
MANUFACTURER Gamma Biologicals, Inc., Houston, Texas.
DISTRIBUTION Nationwide and international.
QUANTITY 755 units were distributed.
REASON Reagent red blood cells, which exhibited false positive reactions during antibody screening and identification.

WEEK ENDING AUGUST 11

PRODUCT AntiCoagulant Citrate Phosphate Double Dextrose Solution (CP2D) 200 mL for Collection of blood components with Haemonetics automated apheresis devices only.
CODE Lot Number: CA9M40 (Sub lot D only).
MANUFACTURER Pall Medical, Covina, California.
RECALLED BY Haemonetics Corporation, Braintree, Massachusetts
DISTRIBUTION California, Florida, Indiana, Kentucky, Kansas, Louisiana, Massachusetts, New Mexico, Nevada, New York, Oklahoma, Pennsylvania, Tennessee, Vermont, Wisconsin, Nevada, Texas.
QUANTITY 436 foil pouches were distributed.
REASON Foil pouch may have been imprinted with an extended expiration date that varies from the date on the individual solution bags.

PRODUCT Red Blood Cells.
CODE Unit #22KQ41400.
MANUFACTURER American Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the drug Imuran.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #22FK00641.
MANUFACTURER American Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had previously been deferred due to a history of hepatitis.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit Numbers: a) 22KJ46523, 22KJ47123, 22KY38267, 22KJ48819, 22GZ88101; b) 22KJ46523, 22KJ47123, 22KY30142; MANUFACTURER American Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania and New Jersey.
QUANTITY a) 5 units; b) 3 units were distributed.
REASON Blood products were collected from donors who reported having traveled to or having lived in areas designated as endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 04KT10555 and 04KM77473.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION Massachusetts.
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) Fresh Frozen Plasma; c) Recovered Plasma.
CODE Unit Numbers: a) 16340-0912, 16341-7881; b) 16340-0912; c) 16341-7881.
COLLECTED BY United Blood Services, Hattiesburg, Mississippi.
PROCESSED BY United Blood Services, Meridian, Mississippi.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Mississippi and Switzerland.
QUANTITY a) 2 unit; b) 1 unit; c) 1 unit was distributed.
REASON Blood products were collected from a donor with a history of hepatitis.

PRODUCT Platelets, Pheresis, Leukoreduced.
CODE Unit #W63259.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the drug Colchicine.

PRODUCT Fenwal Blood-Pack Units with platelet storage containers used in the collection of blood and blood components: a) Product code C4R1464: Baxter Fenwal Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit; Transfer Pack Container with Adsol Red Cells Preservation Solution; Quadruple for Collection and Processing of 450 ml Blood; with Integral Donor Tube; contains natural rubber latex; for export only. Lots M99I22163, M99I23161
b) Product code 4R1411P: Baxter Fenwal Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit; Transfer Pack Container with Adsol Red Cells Preservation Solution; Quadruple for Collection and Processing of 450 ml Blood; with Integral Donor Tube. Lots M99I27188, M99122189
c) Product code 4R3433: Baxter Fenwal Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit; Transfer Pack Container with Adsol Red Cells Preservation Solution; Triple for Collection and Processing of 450 ml Blood; with Lab-Site Sampling Site. Lot M99J14045
d) Product code 4R3448: Baxter Fenwal Anticoagulant Citrate Phosphate Dextrose Solution, USP (CPD) Blood-Pack Unit; Transfer Pack Container with Adsol Red Cells Preservation Solution; Quadruple for Collection and Processing of 500 ml Blood; with Lab-Site Sampling Site. Lots M99J01059, 99J01059A.
CODE See Above.
MANUFACTURER Baxter Healthcare of Puerto Rico, Maricao, Puerto Rico.
RECALLED BY Baxter Healthcare Corporation, Deerfield, Illinois
DISTRIBUTION Massachusetts, Wisconsin, South Carolina, Florida, Ohio, Texas, South Dakota, Oklahoma.
QUANTITY 74,916 units distributed.
REASON Platelet containers, labeled with a platelet storage time of five days, was produced in part with a plastic that can not support this expiration period.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
CODE Unit #04J00484.
MANUFACTURER American Red Cross, Dedham, Massachusetts.
DISTRIBUTION Massachusetts and New Hampshire.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had engaged in high risk activities.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #28LQ19260.
MANUFACTURER American Red Cross Blood Services, Charleston, South Carolina (collection site).
RECALLED BY American Red Cross Blood Services, Columbia, South Carolina
DISTRIBUTION South Carolina.
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 #28LG04611.
MANUFACTURER American Red Cross Blood Services, Myrtle Beach, South Carolina (collection site).
RECALLED BY American Red Cross Blood Services, Columbia, South Carolina
DISTRIBUTION South Carolina.
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 #42W10679.
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) Fresh Frozen Plasma; d) Plasma, Cryoreduced; e) Cryoprecipitated AHF; f) Recovered Plasma.
CODE Unit Numbers: a) 12R75813, 12GY131242, 12R71435, 12R69329, 12R68076, 12R65466, 12GY01208; b) 12R75813, 12R71435, 12R68076, 12R65466; c) 12R75813, 12GY13242; d) 12R69329; e) 12R69329; f) 12R71435, 12R68076, 12R65466, 12GY01208.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
DISTRIBUTION North Carolina, Puerto Rico, South Carolina, Tennessee, California.
QUANTITY a) 7 units; b) 4 units; c) 2 units; d) 1 unit; e) 1 unit; f) 4 units were distributed.
REASON Blood products, which tested negative for antibody to the Human Immunodeficiency Virus Type 1 (anti-HIV-1), but were collected from a donor who reported previously testing positive for HIV, were distributed prior to receipt of this information.

PRODUCT Platelets, Pheresis.
CODE Unit #36FP09047 (split unit).
MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina.
DISTRIBUTION South Carolina.
QUANTITY 1 split unit was distributed.
REASON Leukoreduced blood products had unacceptable white blood cell counts.

PRODUCT Platelets, Pheresis.
CODE Unit #22KG28227 (split unit).
MANUFACTURER American Red Cross Blood Services, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 1 split unit was distributed.
REASON Split apheresis products were prepared from a unit with an unacceptable platelet yield.

PRODUCT
a) Saphenous Vein , Model No. V010
b) Medial Menisus with Bone - Right, Model No. M010
c) Lateral Meniscus with Bone - Left, Model No. M040
d) Achilles Tendon, Model No. T010
e) Patellar Tendon - Hemi, Model No. T030
CODE
a) Serial numbers: 6182275, 6182267, 3873358, 3868354
b) Serial number 4123077
c) Serial number 4124251
d) Serial numbers 4134079, 4124197
e) Serial numbers 4124243, 4124235, 4124227, 4124219
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Arkansas, California, Colorado, Florida, Kentucky, Massachusetts, Tennessee.
QUANTITY 12 allografts were distributed.
REASON Various tissues for transplant which were collected from donors who had not been properly evaluated.

PRODUCT
a) Lateral Meniscus with Bone - Right, Model No. M020
b) Medial Meniscus with Bone - Left, Model No. M030
c) Lateral Meniscus with Bone - Left, Model No. M040
d) Achilles Tendon, Model No. T010
e) Patellar Tendon - Hemi, Model No. T030
f) Saphenous Vein , Model No. V010.
CODE
a) Serial number 4145852
b) Serial number 4146018
c) Serial number 4146026
d) Serial numbers 4146107, 4146093
e) Serial numbers 4146085, 4146077, 4146069, 4146034
f) Serial numbers 6295134, 6295126.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Arkansas, California, Georgia, Illinois, New Jersey, North Carolina, Pennsylvania, Utah, Virginia.
QUANTITY 11 allografts.
REASON Various tissues for transplant which were collected from a donor who had not been properly evaluated.

PRODUCT Pulmonary Artery, Model M030.
CODE Serial #3968944.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Tissue for transplant was collected from a donor who had not been properly evaluated.

PRODUCT a) Red Blood Cells, Leukoreduced; b) Fresh Frozen Plasma.
CODE Unit #12FV87215.
MANUFACTURER American Red Cross Blood Services, Durham, North Carolina.
RECALLED BY American Red Cross Blood Services, Charlotte, North Carolina
DISTRIBUTION North Carolina and South Carolina.
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) Fresh Frozen Plasma.
CODE Unit #12X79059.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
DISTRIBUTION Tennessee and North Carolina.
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) Platelets; c) Cryoprecipitated AHF; d) Plasma Cryoreduced.
CODE Unit #12P04293.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
DISTRIBUTION Tennessee and North Carolina.
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 Numbers: a) 3102150, 3108623, 3105929, 1058230; b) 3105929, 1058230.
MANUFACTURER Scott & White Memorial Hospital and Scott, Sherwood and Brindley Foundation, Temple, Texas.
DISTRIBUTION Texas and Florida.
QUANTITY a) 4 units; b) 2 units were distributed.
REASON Blood products tested negative for HBsAg and anti-HBc, but were collected from donors who previously tested repeatedly reactive for HBsAg, and confirmed positive by neutralization, or repeatedly reactive for anti-HBc, followed by a single reactive test result 5 months later.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #16LY71010.
MANUFACTURER American Red Cross Blood Services, Columbus, Ohio.
DISTRIBUTION Ohio and New Jersey.
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 #42FR78860.
MANUFACTURER American Red Cross Blood Services, Cleveland, 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 a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Fresh Frozen Plasma; d) Recovered Plasma.
CODE Unit Numbers: a) 12FC70974, 12GZ04807, 12FC70051, 12GZ04021, 12FC67792, 12FC66978, 12GZ00744, 12FC65463, 12FC64250, 12FC63419, 12FC60897; b) 12FC73549, 12FC72981, 12GZ06569, 12GZ05939, 12GZ03435; c) 12FC70974, 12GZ04807 d) 12FC73549, 12FC72981, 12GZ06569, 12GZ05939, 12FC70051, 12GZ04021, 12GZ03435, 12FC67792, 12FC66978, 12GZ00744, 12FC65463, 12FC64250, 12FC63419, 12FC60897.
MANUFACTURER The American National Red Cross, Charlotte, North Carolina.
DISTRIBUTION North Carolina, New York, California, Puerto Rico, and Switzerland.
QUANTITY a) 11 units; b) 5 units; c) 2 units; d) 14 units were distributed.
REASON Blood products tested negative for the antibody to human immunodeficiency virus (anti-HIV), but were collected from a donor who previously tested repeatedly reactive for anti-HIV.

PRODUCT Red Blood Cells, Leukocytes Reduced, Frozen.
CODE Unit #2238261.
MANUFACTURER South Texas Blood and Tissue Center, Victoria, Texas.
RECALLED BY South Texas Blood and Tissue Center, San Antonio, Texas
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had a tattoo within 12 months of donation.

PRODUCT Red Blood Cells.
CODE Unit #49G89711.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
DISTRIBUTION Oklahoma.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose hemoglobin was below the acceptable level.

PRODUCT a) Red Blood Cells, Leukoreduced; b) Cryoprecipitated AHF.
CODE Unit #49LG48061.
MANUFACTURER American Red Cross Blood Services, Tulsa, Oklahoma.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood products tested negative for anti-HCV, but were collected from a donor who previously tested repeatedly reactive for anti-HCV, and RIBA non-reactive.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit #4806389.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with a history of hepatitis.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit #4806097.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was not quarantined after receiving information concerning an illness.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit Numbers: 19LQ07112 and 19LY22241.
MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee.
DISTRIBUTION Tennessee and Switzerland.
QUANTITY 2 units of each component.
REASON Blood products were collected from a donor who reported previously testing positive for hepatitis were distributed prior to receipt of this information.

PRODUCT Platelets, Pheresis.
CODE Unit #22KG35256.
MANUFACTURER American Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION New Jersey.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was distributed in interstate commerce.

PRODUCT Platelets.
CODE Unit #36LC13165.
MANUFACTURER The American National Red Cross, Columbia, South Carolina.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole blood with an extended collection time.

PRODUCT Red Blood Cells, Irradiated.
CODE Unit Numbers: 22KJ54920, 22GK74280, 22LY71331.
MANUFACTURER American Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION New Jersey and Pennsylvania.
QUANTITY 3 units were distributed.
REASON Blood products were stored at unacceptable temperatures.

PRODUCT Red Blood Cells for Further Manufacture.
CODE Unit #22KY30142.
MANUFACTURER American Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION Michigan.
QUANTITY 1 unit.
REASON Blood product was collected from a donor who reported having traveled to or having lived in areas designated as endemic for malaria.

PRODUCT Fresh Frozen Plasma.
CODE Unit Numbers: 19GK34199, 19GK34200, 19GK34202, 19GK34204, 19GK34205,19GK34207, 19GK34208, 19GK34210, 19GK34211, 19GK34212, 19GK34213, 19GK34214, 19GW35262, 19GW35263, 19GW35265, 1GW35267, 19GW35269, 19GW35270, 19GW35271, 19GW35272, 1GW35273, 19GW35274, 19GW35279, 19GW35281, 19GW35282, 19GW35283, 19GW35284.
MANUFACTURER American Red Cross Blood Services, Nashville, Tennessee.
DISTRIBUTION Tennessee and Kentucky.
QUANTITY 27 units were distributed.
REASON Blood products had extended expirations.

PRODUCT Platelets.
CODE Unit #22KC11156.
MANUFACTURER American Red Cross, Philadelphia, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a whole blood unit that had discrepant start and end times documented.

PRODUCT Fresh Frozen Plasma.
CODE Unit #36Q56305.
MANUFACTURER The American National Red Cross, Columbia, South Carolina.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from a unit of whole blood with an extended collection time.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
CODE Unit #04H88110.
MANUFACTURER The American National Red Cross, Dedham, Massachusetts.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an unsuitable donor due to previous elevated test results for alanine aminotransferase (ALT).

PRODUCT Platelets
CODE Unit #49LG44024.
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 was prepared from a unit of whole blood with an extended collection time.

PRODUCT Red Blood Cells
CODE Unit #33GJ09652.
MANUFACTURER American Red Cross, Farmington, Connecticut.
DISTRIBUTION Connecticut.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Red Blood Cells, Leukoreduced.
CODE 36FK22217, 36FK22200, 36FK22209, 36FK22186, 36FK22189, 36FK22208, 36FK22182, 36FK22183, 36FK22193, 36FK22201, 36FK22202, 36FK22206, 36FK22210, 36FK22187, 36FK22191, 36FK22212.
MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina.
DISTRIBUTION South Carolina.
QUANTITY 16 units were distributed.
REASON Blood products were leukoreduced greater than 24 hours after collection.

WEEK ENDING AUGUST 18

PRODUCT Red Blood Cells.
CODE Unit #03GK49002.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
DISTRIBUTION Georgia.
QUANTITY 1 unit was distributed.
REASON Blood product, which was positive for the Jka antigen, was distributed for a patient with a history of anti-Jka.

PRODUCT Platelets, Pheresis.
CODE Unit #12W38812.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported a history of Sarcoidosis.

PRODUCT Platelets, Pheresis.
CODE Unit #42KF02679.
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
DISTRIBUTION Ohio.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that may have compromised the sterility of the units.

PRODUCT a) Red Blood Cells; b) Red Blood Cells Leukocytes Reduced; c) Platelets
CODE Unit Numbers: a) 1634-4733; b-c) 16344-0998.
MANUFACTURER Blood Systems, Inc., Meridian, Mississippi.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Mississippi.
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 Carticel (Autologous Cultured Chondrocytes).
CODE Lot C92930.
MANUFACTURER Genzyme Tissue Repair, Cambridge, Massachusetts.
DISTRIBUTION Germany.
QUANTITY 1 unit was distributed.
REASON Tissue repair product was contaminated with Staphylococcus hominis subspecies hominis.

PRODUCT Platelets.
CODE Unit #16352-6254.
MANUFACTURER Blood Systems, Inc., Merdian, Mississippi.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Mississippi.
QUANTITY 1 unit was distributed.
REASON Platelets were prepared from a unit collected from a donor who had taken aspirin within three days of donation.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Plasma; e) Recovered Plasma.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER Department of the Navy, National Naval Medical Center, Bethesda, Maryland.
DISTRIBUTION California, District of Columbia, Georgia, Maryland, New Jersey, New Mexico.
QUANTITY a) 424 units; b) 21 units; c) 32 units; d) 4 units; e) 389 units were distributed.
REASON Blood products were collected from donors who had not been questioned about mucus membrane exposure to blood or body fluids.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit Numbers: 12441-1646 and 12441-7104.
MANUFACTURER United Blood Services, Albuquerque, New Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION New Mexico.
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 #49FJ72273.
MANUFACTURER American Red Cross Blood Services, Wichita, Falls, Texas.
RECALLED BY American Red Cross Blood Services, Tulsa, Oklahoma
DISTRIBUTION Texas.
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, Leukocytes Reduced.
CODE Unit #4806281.
MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had body piercing within 12 months of donation.

PRODUCT Platelets, Pheresis
CODE Unit #7035107 (split unit).
MANUFACTURER South Texas Blood and Tissue Center, San Antonio, Texas.
DISTRIBUTION Texas.
QUANTITY 1 split unit was distributed.
REASON Blood products, which were not leukoreduced, were distributed, labeled as leukoreduced.

PRODUCT Platelets, Pheresis.
CODE Unit #02P45742.
MANUFACTURER American Red Cross Blood Services, Wichita, Kansas.
DISTRIBUTION Kansas.
QUANTITY 1 unit was distributed.
REASON Blood product, which was not tested for CMV antibodies, was distributed, labeled CMV negative.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 02FC60049 and 02FC60050.
MANUFACTURER American Red Cross Blood Services, Wichita, Kansas.
DISTRIBUTION Kansas.
QUANTITY 2 units were distributed.
REASON Blood products which tested CMV positive, were distributed labeled CMV negative.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 12441-1647 and 12441-7109.
MANUFACTURER United Blood Services, Albuquerque, New Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION New Mexico.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit #02FH60145.
MANUFACTURER American Red Cross Blood Services, Wichita, Kansas.
DISTRIBUTION Kansas.
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 #02FC64884.
MANUFACTURER American Red Cross Blood Services, Wichita, Kansas.
DISTRIBUTION Kansas.
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 #02FJ51330.
MANUFACTURER American Red Cross Blood Services, Wichita, Kansas.
DISTRIBUTION Kansas.
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 #16345-4733.
MANUFACTURER Blood Systems, Inc., Meridian, 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.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #02FG76856.
MANUFACTURER American Red Cross Blood Services, Wichita, Kansas.
DISTRIBUTION Kansas.
QUANTITY 1 unit was distributed.
REASON Blood product, which did not met the criteria for red blood cell recovery after leukoreduction, was distributed, labeled as leukoreduced.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS --
WEEK ENDING AUGUST 25

PRODUCT
a) Standardized Kentucky (June) Bluegrass Pollen Extract
b) Standardized 3 Grass Pollen Mix
c) Standardized 6 Grass Pollen Mix
d) NWU Standardized Grass Mix
e) Individual Patient Treatment Vials - Drops
f) Individual Patient Treatment Vials - Injectable.
CODE Standardized Kentucky (June) Bluegrass Pollen Extract, 10,000 BAU/ml, Lot D512082B
Standardized 3 Grass Pollen Mix Lot D8010509
Standardized 6 Grass Pollen Mix Lot D8010508
NWU Standardized Grass Mix Lot D8012801
Individual Patient Treatment Vials - First lot number listed -16470106
Individual Patient Treatment Vials - 15 or 30 ml of sterile injectable vials - First lot number listed - 16475007. For a complete list of lot numbers, contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220.
MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, Ohio.
DISTRIBUTION Illinois, Maryland, Minnesota, Indiana, Ohio, New York, West Virginia, Arizona.
QUANTITY a) 5/5ml vials, 8/10 ml vials, 1/30 ml vial, 5/50 ml vials b) 1/50 ml vial; c) 1/20 ml vial; d) 3 vials; e) 46 vials of 15 or 30 ml vials of oral drops; f) 34 vials were distributed.
REASON Allergenic extracts may have been contaminated with Penicillium sp.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit numbers: a) 19GN41477, 19GN41478, 19GN41480, 19GN41490, 19GN41493,19GN41550, 19GN41551, 19GN41552, 19GN41558,19GN41563,19GN41583; b) 19GN41477, 19GN41478 c) 19GN41477, 19GN41493, 19GN41550, 19GN41551, 19GN41552, 19GN41558, 19GN41563, 19GN41583.
MANUFACTURER American Red Cross Blood Services, Paducah, Kentucky.
RECALLED BY American Red Cross Blood Services, Nashville, Tennessee
DISTRIBUTION Kentucky, Tennessee, Californa.
QUANTITY a) 11 units; b) 2 units; c) 8 units were distributed.
REASON Blood products were collected in a manner that may have compromised the sterility of the units.

PRODUCT Platelets.
CODE Unit #1672794.
MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Platelets were prepared from a unit collected from a donor who had taken aspirin within three days of donation.

PRODUCT Platelets.
CODE Unit #24KW26445.
MANUFACTURER American Red Cross Blood Services, Louisville, Kentucky.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Platelets were prepared from a unit collected from a donor who was taking Feldene.

PRODUCT a) Red Blood Cells; b) Platelets
CODE Unit #42FR79545.
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 Arava.

PRODUCT Platelets, Pheresis, Leukocytes Reduced
CODE Unit #H81499.
MANUFACTURER Northern Illinois Blood Bank, Rockford, Illinois.
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Patellar Tendon - Hemi, Model No. T030, Serial Numbers 4092163, 4092155 , 4092228, 4092201, 4100344, 4100336, 4100328, 4161335, 4161343, 4161351, 4161378
Saphenous Vein, Model No. V010, Serial Numbers 3917983, 6297862, 6297897, 6287972, 6287999
Achilles Tendon, Model No. T010, Serial Numbers 4100379, 4161386, 4161394, 4142659
Pulmonary Trunk Patch, Model No. P010, Serial Numbers 3999319, 6008879
ALT Pulmonary Artery, Model No. A035 Serial Number 6276385
Ascending Thoracic Aorta, Model No. A010, Serial Numbers 6100589, 6056547
Quadriceps Tendon, Model No. T050, Serial #4121139
Semiendinosus Tendon, Model No. T060, Serial #4121112
Saphenous Vein, Model No. V010, Serial #6210848
Pericardium, Model No. PM00, Serial Numbers 3887715, 3889114
Lateral Meniscus - Bone -Right, Model No. M020, Serial Numbers 4062205, 4161297, 4142624
Medial Meniscus - Bone -Right, Model No. M010, Serial Numbers 4161289, 4142616
Medial Meniscus - Bone - Left, Model No. M030 Serial Numbers 4161319, 4142675
Lateral Meniscus - Bone - Left, Model No. M040, Serial Numbers 4161327, 4142683
Patellar Tendon, Model No. T020, Serial Numbers 4142691, 4142632
Pulmonary Branch Patch, Model No. P020, Serial #6298168
Pulmonary Hemi-Artery, Model No. PH00, Serial #6297854.
CODE See above.
MANUFACTURER CryoLife, Inc., Kennesaw, Georgia.
DISTRIBUTION Arizona, California, Colorado, Florida, Illinois, Kansas, Kentucky, Massachusetts, Minnesota, Nevada, New Jersey, Virginia, Wisconsin, Canada, Korea.
QUANTITY 43 units were distributed.
REASON Various human bone and musculoskeletal tissues for transplant, which were collected from donors who had not been properly
evaluated.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #8504156.
MANUFACTURR Community Blood center, Dayton, Ohio.
DISTRIBUTION Ohio and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with a history of jaundice.

PRODUCT Whole Blood.
CODE Unit #Y25309.
MANUFACTURER Aurora Area Blood Bank, Aurora, Illinois.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Autologous whole blood unit tested repeatedly reactive for Anti-HBc was not labeled with "biohazard" label.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets; d) Cryoprecipitated AHF; e) Fresh Frozen Plasma;
d) Recovered Plasma.
CODE Unit Numbers: a) 0427406, 9983270; b) 9940305;c) 0427406, 9940305, and pooled unit 66876 d) 66870 (pooled unit); e) 0427406, 9940305;
f) 9983270.
MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, Ohio.
DISTRIBUTION Ohio, Kentucky, Florida.
QUANTITY a) 2 units; b) 1 unit; c) 2 units and 1 pooled unit; c) 1 pooled unit; d) 1 pooled unit; e) 2 units; f) 1 unit distributed.
REASON Blood products were collected from a donor whose spouse tested positive for Hepatitis B.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c) Platelets;d) Recovered Plasma.
CODE Unit numbers: a) 42R45027, 42R42872, 42J14585;b) 42R45027, 42J14585; c) 42R45027; d) 42R42872.
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
DISTRIBUTION Ohio and California.
QUANTITY a) 3 units; b) 2 units; c) 1 unit; d) 1 unit distributed.
REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis A.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit Numbers: a) 33KM60726, 33KG72300, 33KE03595, 33KK88749, 33KJ80302, 33KL79920, 33KY21491 b) 33KG72300, 33KK88749, 33KJ80302, 33KL79920, 33KY21491, 33LM29901; c) 33KM60726, 33KG72300, 33KE03595, 33KK88749, 33KJ80302, 33KL79920, 33KY21491, 33LM29901.
MANUFACTURER American Red Cross Blood Services, Farmington, Connecticut.
DISTRIBUTION Alabama, Connecticut, North Carolina, California.
QUANTITY a) 7 units; b) 6 units; c) 8 units were distributed.
REASON Blood products tested negative for HbsAg and anti-HBc, but were collected from donors whose previous confirmatory test results were reclassified as HbsAg positive.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #15009-7288.
MANUFACTURER United Blood Services, Inc., Texas Blood Institute-Lubbock Center, Lubbock, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was distributed after receiving information from the donor concerning a post donation illness.

PRODUCT a) Allergenic Extract 5 Mold Mix, 5 ml, Testing-Scratch-Prick; b) Allergenic Extract 5 Mold Mix, 5 ml, Injectable;c) Allergenic Extract 5 Mold Mix, 5 ml, Oral Drops.
CODE Lot Numbers: a) B9006659, B9007298, B9007499, B9007510, B0008829, B0008976, B0009261, B0009941
b) 16906510, 16907910, 16908425, 16929203, 16935407, 16935606, 16936018, 16931701, 16937418, 16929001, 16933601, 16933701, 16934901, 16939203, 16939602, 16941601, 16942601, 16945004, 16946202, 16946401, 16946901, 16947501, 16947901, 16952112, 16948111, 16948712, 16945202, 16945403, 16953810, 16933201, 16956416, 16956502, 16957209, 16957701, 16958914, 16959503, 16956608, 16957505, 16957605, 16967003, 16962807, 16963204, 16967401, 16964615, 16966803, 16968207, 16969805, 16970902, 16971402, 16971702, 16971802, 16971902, 16971102, 16968309, 16968905, 16969303, 16969605, 16904314, 16972711, 16973108, 16973411, 16973713, 16974107, 16977006, 16977604, 16978002, 16979501, 16977109, 16977404, 16982641, 16982704, 16983003, 16978102, 16978302, 16978402, 16978801, 16978901, 16979601, 16983801, 16976802, 16979301, 16983101, 16985014, 16985231, 16987402, 16988908, 16989111, 16989409, 16988001, 16988101, 16985125, 16985613, 16991704, 16992102, 16992801, 16988201, 16988301, 16994204, 16994305, 16994902, 16995801, 16996101, 16996317, 16996506, 16985708, 16991504, 16986218, 16993106, 16991804, 16986804, 16986904, 16992202, 16988610, 16989013, 16993010, 16989311, 16989604, 16998126, 16986304, 16999205, 16999304, 16998603, 16982502, 16999604, 16987502, 16987702, 16995601, 17001722, 17002136, 17000502, 17000901, 17001101, 17001520, 17001806, 17001903, 17001610, 17007525, 17005108, 17007604, 16999802, 17005803, 17006003, 17000302, 17006720, 16998405, 17005303, 17006202, 17007909, 16998303, 17001201, 17002304, 17005202
c) 17002428, 16974429, 16980028, 17002525, 17002627, 16952227, 16974564, 16980206, 16993207, 17008110, 16974709, 16980310, 16989807, 17002708, 16949209, 16989930, 16915806, 16984206, 17002806, 16967503, 16926525, 16952505, 16975149, 16943104, 16990103, 17003102, 16926901, 16927101, 16927201, 16927701, 17003304, 17003402, 16981021, 17003562, 16984324, 16975420, 16975545, 16990502, 16950201, 17008403, 16966002, 16976903, 17008603, 16966101, 16984401, 16997102, 16984601, 16984801, 16990701, 16984923, 16990801, 16993601, 16997201, 17003701, 17008901, 17009301, 16966325, 16982013, 16991119, 16938617, 16917416, 16917508, 17009849, 16938747, 16993856, 17004217, 16966715, 16976117, 16976706, 16993914, 16976313, 16915102, 16960704, 17010006, 16915210,
MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, Ohio.
DISTRIBUTION Connecticut, Kentucky, Maryland, Ohio, California, Pennsylvania, Illinois.
QUANTITY a) 17 vials; b) 152 individual patient treatment vials c) 75 individual patient treatment vials were distributed.
REASON Allergenic extracts were labeled with extended expiration dates.

PRODUCT Recovered Plasma.
CODE Unit #42FR79545.
MANUFACTURER American Red Cross Blood Services, Cleveland, Ohio.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor taking the drug Arava.