WEEK ENDING OCTOBER 6

PRODUCT Fenwal Autopheresis-C Plasmapheresis System, Models A-200, A-201, and A-401.
CODE Product Code Numbers: 4R4550, 4R4560, 4R4561, R4R4585
MANUFACTURER Baxter Healthcare Corporation, Largo, Florida.
SOFTWARE DEVELOPER Baxter Healthcare Corporation, Round Lake, Illinois.
RECALLED BY Baxter Healthcare Corporation, Deerfield, Illinois
DISTRIBUTION Nationwide and Canada.
QUANTITY 5,250 units were distributed
REASON The Autopheresis-C Plasmapheresis instruments with version 6.0 software may proceed to "Saline Rinse" without displaying the "Remove Plasma" prompt.

PRODUCT Source Plasma.
CODE Unit Numbers: 17265546 and 1726358.
MANUFACTURER Plasma Biologicals Services, Inc., Ashville, North Carolina.
DISTRIBUTION California.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor who had been incarcerated.

PRODUCT Source Leukocytes
CODE Unit #3600010.
MANUFACTURER Gulf Coast Regional Blood Center, Houston, Texas.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who had previously been deferred for high risk behavior.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #0972298.
MANUFACTURER Community Blood Bank of Erie County, Erie, Pennsylvania.
DISTRIBUTION Pennsylvania and New Jersey.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who was previously deferred for receiving a tattoo within the past 12 months.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit Numbers: 13GQ24219 and 13GM31649.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 2 units of each component were 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 #13GC68251.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
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: 13FN43186 and 13FN40838.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 2 units of each component were 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 #13L93682.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor traveled to an area considered endemic for malaria.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #13GX17710.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit #3213206.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from an unsuitable donor.

PRODUCT Red Blood Cells.
CODE Unit #30-09381.
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 reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit #03GN23244.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
DISTRIBUTION Georgia.
QUANTITY 1 unit ws 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.
CODE Unit #12X81916.
MANUFACTURER 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 having been diagnosed with Sarcoidosis.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 21GE15613 and 21GE13842 .
MANUFACTURER American Red Cross, Portland, Oregon.
DISTRIBUTION Pennsylvania and Washington state.
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 Source Plasma.
CODE G-11177-036, G-18743-036, G-19332-036, G-51405-036, G-52260-036, G-52708-036, G-53074-036, G-54494-036, G-39009-036, G-39151-036, G-90258-036, G-83456-036, G-87193-036, G-91993-036, G-71947-036, G-72220-036, G-34542-036, G-56940-036, G-73406-036, G-73835-036, G-36957-036, G-37433-036, G-92024-036, G-92720-036, G-93073-036, G-18833-036, G-93518-036.
MANUFACTURER Alpha Therapeutic Corporation, Los Angeles, California.
DISTRIBUTION Florida, New Jersey, Germany, Spain, Austria, Italy.
QUANTITY 27 units were distributed.
REASON Blood products tested negative for HBsAg, but were collected from a donor who previously tested repeatedly reactive for HBsAg.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #29KN20553.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION North Carolina and Puerto Rico.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor with Porphyria Cutanea Tarda.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit #3364313.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were incorrectly tested for anti-HCV.

PRODUCT Platelets, Pheresis.
CODE Unit #2505602.
MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for Cytomegalovirus (CMV), but was collected from a donor who previously tested CMV positive.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 36GW00642, 36GW00648, 36GW00650, 36GW00652, and 36GW00656
MANUFACTURER The American National Red Cross, Columbia, South Carolina.
DISTRIBUTION South Carolina.
QUANTITY 5 units were distributed.
REASON Blood products, tested positive for Cytomegalovirus (CMV), but were labeled as negative for CMV.

PRODUCT Red Blood Cells.
CODE Unit #21KK18380.
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 Fresh Frozen Plasma.
CODE Unit #2257373.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was positive for anti-Rho(D) antibodies, was labeled negative for unexpected antibodies and distributed for transfusion.

PRODUCT Platelets.
CODE Unit Numbers: 3185171, 3185170, 3185417, 3183986, 3348267, 3348269, 3348271, 3183998, 3801648, 3185250, 3185439, 3185440, 3185257, 3185435, 3801649, 3185444, 3800870, 3800865, 3348287, 3800875, 3185437, 3800869, 3185436.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 23 units were distributed.
REASON Blood products were manufactured using a centrifuge that failed quality control testing.

PRODUCT a) Red Blood Cells; b) Platelets; c) Source Leukocytes; d) Fresh Frozen Plasma; e) Recovered Plasma.
CODE Unit Numbers: a) 7812957, 7940442, 7913582, 7875499;b) 7913582, 7875499; c) 7812957; d) 7940442, 7913582;e) 7812957, 7913582.
MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, Florida.
DISTRIBUTION Florida and California.
QUANTITY a) 4 units; b) 2 units; c) 1 unit; d) 2 units ;e) 2 units were distributed.
REASON Blood products were collected from a donor with a history of jaundice.

PRODUCT a) Red Blood Cells, Leukoreduced, Irradiated;b) Cryoprecipitated AHF.
CODE Unit #12GS17921.
MANUFACTURER American Red Cross Blood Services, Durham, North Carolina.
RECALLED BY American Red Cross Blood Services, Charlotte, North Carolina
DISTRIBUTION North Carolina and Georgia.
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 A.

PRODUCT Red Blood Cells.
CODE Unit #3838725.
MANUFACTURER Central Florida Blood Bank, Inc., Orlando, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was identified by the donor for confidential unit exclusion was distributed.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes Reduced; c) Platelets; d) Fresh Frozen Plasma; e) Recovered Plasma.
CODE Unit Numbers: a) 03FC40408, 03FC48774; b) 03LM60825; c) 03LM60825; d) 03FC40408; e) 03FC48774, 03LM60825.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
DISTRIBUTION Georgia and California.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit; d) 1 unit; e) 2 units were distributed.
REASON Blood products were collected from a donor with a history of jaundice.

PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Cryoprecipitated AHF; c) Recovered Plasma.
CODE Unit #21Y60267.
MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon.
DISTRIBUTION Washington State and Oregon.
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) Cryoprecipitated AHF; c) Recovered Plasma.
CODE Unit Numbers: 21KG29045, 21KE06409.
MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services, Portland, Oregon.
DISTRIBUTION Oregon, California, Switzerland.
QUANTITY 2 units of each component were distributed.
REASON Blood products were collected from a donor with a history of having tested positive for Hepatitis C.

PRODUCT a) Red Blood Cells; b) Platelets, Pooled; c) Fresh Frozen Plasma.
CODE Unit Numbers: a) W111758; b) W11758 (Pool #AP13972); c) W111758 (Pool #HP04190).
MANUFACTURER Puget Sound Blood Center and 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 Hepatitis A within one year of donation.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma;d) Recovered Plasma.
CODE Unit Numbers: a) 12GN55638, 12Z24968, 12F00460, 12V11106; b) 12V11106; c) 12GN55638; d) 12Z24968, 12F00460, 12V11106.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
DISTRIBUTION North Carolina, South Carolina, Puerto Rico, California.
QUANTITY a) 4 units; b) 1 unit; c) 1 unit; d) 3 units were distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis B.

PRODUCT Source Plasma
CODE Unit Numbers: T-48341-036, T-48251-036, T-48185-036, T-47969 036, T-47866-036, T-47816-036, T-47738-036, T-47710-036, T-47314-036, T-47191-036, T-47104-036, T-47051-036, T-46988-036, T-46926-036, T-46871-036, T-46811-036, T-46752-036, T-46725-036, T-46682-036, T-46643-036, T-46578-036, T-46554-036, T-46499-036, T-46491-036, T-46462-036, T-46454-036, T-46427-036, T-46410-036, T-46372-036, T-46354-036, T-46325-036, T-46306-036, T-46235-036, T-46215-036, T-46160-036, T-46142-036, T-46085-036, T-46070-036, T-46018-036, T-46000-036, T-45933-036, T-45862-036 .
MANUFACTURER Alpha Therapeutic Corporation, Los Angeles, California.
DISTRIBUTION Spain.
QUANTITY 42 units were distributed.
REASON Blood products were collected form a donor who was incarcerated and received a tattoo within 12 months of donation.

PRODUCT Platelets.
CODE Unit Numbers: 8051249 and 8051250.
MANUFACTURER South Florida Blood Banks, West Palm Beach, Florida.
DISTRIBUTION Florida.
QUANTITY 2 units were distributed.
REASON Blood products were collected from donors who were previously deferred for a history of incarceration.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #03GN25397.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
DISTRIBUTION Georgia and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported multiple high risk behaviors.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 3493449 and 3486282.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 2 units were distributed.
REASON Blood products corresponded to a unit of pooled platelets that was implicated in a transfusion reaction.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma for Non-Injectable Use; e) Recovered Plasma.
CODE Unit Numbers: a) 12FP33160, 12FT71151, 12FP10403, 12FP04489, 12FH57737; b) 12FH57737; c) 12FH57737; d) 12FT71151, 12FP10403; e) 12FP33160, 12FH57737.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
DISTRIBUTION Massachusetts, North Carolina, Switzerland.
QUANTITY a) 5 units; b) 1 unit; c) 1 unit; d) 2 units; e) 2 units were distributed.
REASON Blood products were collected from a donor with a history of having tested positive for hepatitis.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 17FZ26372 and 17FZ26376.
MANUFCTURER American Red Cross Blood Services, St. Paul, Minnesota.
DISTRIBUTION Minnesota.
QUANTITY 2 units were distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Fresh Frozen Plasma.
CODE Unit #7618991.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was distributed in interstate commerce.

PRODUCT a) Black Willow Allergenic, Patient Treatment Vials; b) Black Willow Allergenic, Scratch Test Vials.
CODE Lot Numbers: a) A0010704; b) B0010703 and B0011041.
MANUFACTURER Allergy Laboratories of Ohio, Inc., Columbus, Ohio.
DISTRIBUTION New York and Missouri.
QUANTITY a) 1 vial; b) 3 vials were distributed.
REASON Allergenic extracts were labeled with the incorrect concentrations.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 3491048. 3491053, 3491054, 3491056.
MANUFACTURER Florida Blood Services, Tampa, Florida.
RECALLED BY Florida Blood Services, St. Petersburg, Florida
DISTRIBUTION New Jersey.
QUANTITY 4 units were distributed.
REASON Blood products were labeled with an extended expiration date.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocyte Reduced; c) Platelets; d) Fresh Frozen Plasma.
CODE Unit Numbers: a) 12FS77058, 12FT67413, 12FP05971 b) 12FS81558, 12FS80498, 12FS77970; c) 12FS80498; d) 12FS79487.
COLLECTION SITE American Red Cross Blood Services, Durham, North Carolina.
RECALLED BY American Red Cross Blood Services, Charlotte, North Carolina
DISTRIBUTION North Carolina and Connecticut.
QUANTITY a) 3 units; b) 3 units; c) 1 unit; d) 1 unit distributed.
REASON Blood products were collected from a donor with a history of Idiopathic Thrombocytopenic Purpura.

PRODUCT Platelets.
CODE 3613166, 3618961, 3618960, 3618962, 3618965, 3618966, 3689249, 3689253, 3689254, 3689258, 3689263, 3689266, 3890260, and Platelets, Pheresis, units 3613164 and 3618964.
MANUFACTURE Gulf Coast Regional Blood Center, Houston, Texas.
DISTRIBUTION Texas and New York.
QUANTITY 13 units of platelets and 2 units of Platelets, Pheresis were distributed.
REASON Blood products were stored at unacceptable temperatures or manufactured from units of whole blood that were collected at unacceptable temperatures.

PRODUCT Recovered Plasma.
CODE Unit #29KN20553.
MANUFACTURER American Red Cross Blood Services, Norfolk, Virginia.
DISTRIBUTION California.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor with Porphyria Cutanea Tarda.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 12GM57364 and 12LK28263.
COLLECTION SITE American Red Cross Blood Services, Asheville, North Carolina.
RECALLED BY American Red Cross Blood Services, Charlotte, North Carolina
DISTRIBUTION North Carolina.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor with a history of Idiopathic Thrombocytopenic Purpura.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit Numbers 12710 and 12750.
MANUFACTURER Carolina-Georgia Blood Center, Inc., Greenville, South Carolina.
DISTRIBUTION South Carolina.
QUANTITY 2 units were distributed.
REASON Blood products were collected from an unsuitable donor due to use of the medication Propecia.

PRODUCT Red Blood Cells.
CODE 3342073, 3473041, 3218048, 3465987, 3472594.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida, New Jersey, New York.
QUANTITY 5 units were distributed.
REASON Blood products corresponded to a unit of pooled Platelets that was positive for Propionibacterium acnes.

PRODUCT Recovered Plasma.
CODE Unit #3813090.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product corresponded to a unit of platelets that was positive for Staphylococcus waraneri and Propionibacterium acnes, and was implicated in a transfusion reaction.

PRODUCT Cryoprecipitated AHF.
CODE Unit #K14648.
MANUFACTURER Carolina-Georgia Blood Center, Greenville, South Carolina.
DISTRIBUTION Pennsylvania.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from plasma that was not separated from the red blood cells within eight hours of collection.

WEEK ENDING OCTOBER 13

PRODUCT a) Red Blood Cells, Irradiated; b) Platelets, Irradiated.
CODE Contact FDA, Center for Biologics Evaluation and Research, Office of Compliance (301) 827-6220 for individual unit numbers recalled.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia and Maryland.
QUANTITY a) 1,411 units; b) 463 units were distributed.
REASON Blood products, for which there is no documentation of the time of the products were returned to controlled storage temperatures, were distributed.

PRODUCT Cornea.
CODE 2000-201C.
MANUFACTURER Lions Eye Bank for Long Island, Manhasset, New York.
DISTRIBUTION New York.
QUANTITY 1 unit was distributed.
REASON Cornea was collected from a donor who tested repeatedly reactive for the antibody to the Hepatitis B core antigen (anti-HBc), non-confirmable by PCR.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #38FC44906.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
DISTRIBUTION Indiana and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported a history of hepatitis.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #38E72100.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
DISTRIBUTION Michigan and 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 Red Blood Cells.
CODE Unit #13W92939.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a door who traveled to an area considered endemic for malaria.

PRODUCT Platelets Pheresis, Leukocytes Reduced, Double Unit.
CODE Unit #3350538.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with incorrect platelet yields.

PRODUCT Red Blood Cells.
CODE Unit #3138262.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose body temperature had not been documented.

PRODUCT Source Plasma.
CODE Unit Numbers: 07504945, 07503429, 07502620.
MANUFACTURER Plasma Biological Services, Inc., Asheville, North Carolina.
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 twelve months of donation.

PRODUCT Red Blood Cells.
CODE Unit #38FK03420.
MANUFACTURER American Red Cross Great Lakes Region, Fort Wayne, Indiana.
DISTRIBUTION Indiana.
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 Cryoprecipitated AHF.
CODE Unit Numbers: 3155759, 3155727, 3155761, 3156704, 3155764, 3330058, 3356874, 3156718, 3157724, 3156714, 3326875, 3156705, 3157706, 3339870, 3186493, 3352521, 3352513, 3352524, 3803089, 3330055, 3187917, 3347502, 3188270, 3803080, 3352424, 3157726, 3187920.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 27 units were distributed.
REASON Blood products were not frozen within the acceptable time limit.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 12LE73325 and 12L47287.
MANUFACTURER American Red Cross Blood Services, Winston Salem, North Carolina.
RECALLED BY American Red Cross Blood Services, Charlotte, North Carolina
DISTRIBUTION North Carolina.
QUANTITY 2 units were distributed.
REASON Blood products were collected from a donor taking the drug Arava.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated AHF; e) Recovered Plasma.
CODE Unit Numbers: a) 3163429, 3176259, 3136116, 3308309, 3316150, 3329126, 3342262, 9109256, 3417590, 3444243, 3456197, 3472818, 3324773, 3421480, 3450727, 3129559, 3151156, 3323891, 3144615, 3173389, 3449581, 3311998, 3457202, 3490183, 3480664, 3150862, 3168696, 3176358, 3472952, 3156453, 3187799;
b) 3842844, 3136116, 3308309, 3316150, 9109256, 3472818, 3324773, 9726114a, 9726114b, 9726331, 3406718, 3417274, 3424156, 3439368, 3129559, 3314409, 3173389, 3151355a, 3151355b, 3153776, 3449581, 3311998;
c) 3421480, 3150862, 3150560, 3329126, 3450727, 3311998, 9109256, 3323891;
d) 3490183, 3150560, 3427162;
e) 3142341, 3163429, 3842844, 3136116, 3308309, 3316150, 3342262, 3417590, 3444243, 3456175, 3472818, 3324773, 3129559, 3151156, 3314409, 3321738, 3144615, 3173389, 3419729, 3457202, 3490183, 3427162, 3444690, 3480664, 3168696, 3176358, 3472952, 3156453, 3187799.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida, Virginia, New York.
QUANTITY a) 31 units; b) 22 units; c) 8 units; d) 3 units; e) 29 units were distributed.
REASON Blood products tested negative for syphilis, but were collected from donors who previously tested reactive for syphilis by confirmatory testing.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #2272081.
MANUFACTURER Central Texas Regional Blood & Tissue Center, Austin, Texas.
DISTRIBUTION Tennessee and Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor whose sex partner lived in an HIV group O risk area.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 62-41602 and 62-38663.
MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan.
RECALLED BY Michigan Community Blood Centers, Grand Rapids, Michigan
DISTRIBUTION Michigan.
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 #17KW04966.
MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, Minnesota.
DISTRIBUTION Pennsylvania.
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 #38-31785.
MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan.
RECALLED BY Michigan Community Blood Centers, Grand Rapids, 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 #62-44493.
MANUFACTURER Saginaw Valley Blood Program, Saginaw, Michigan.
RECALLED BY Michigan Community Blood Centers, Grand Rapids, 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 #18FK21636.
MANUFACTURER 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 a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit #3026574.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit of each component was distributed.
REASON Blood products had invalid test results for HBsAg or HIV-1 p24 Antigen.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #18FE43211.
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 Numbers: a) 0344068, 0344070, 0344072, 0344079, 0344087, 0344097, 0344098, 0974626, 0974627, 0974628, 0974629, 0974630, 0974631, 0974632, 0974633, 0974634, 0974635, 0974636; b) 0344070 and 0344087.
MANUFACTURER Community Blood Bank of Erie County, Erie, Pennsylvania.
DISTRIBUTION Pennsylvania.
QUANTITY a) 18 units; b) 2 units were distributed.
REASON Blood products were incorrectly tested for anti-HBc.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Recovered Plasma.
CODE Unit Numbers: a) 7223446, 7225814, 7226924; b) 7223446, 7225814, 7226924; c) 7225814; d) 7223446, 7226924.
MANUFACTURER Manatee Community Blood Center, Inc., Bradenton, Florida.
DISTRIBUTION Florida.
QUANTITY a) 3 units; b) 3 units; c) 1 unit; d) 2 units were distributed.
REASON Blood products were collected from a donor who was not deferred after reporting a needlestick.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #13L94167.
MANUFACTURER American Red Cross Blood Services, Detroit, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit 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 #36GQ18476.
MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina.
DISTRIBUTION South Carolina.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who reported taking antibiotics for a sore throat.

PRODUCT Red Blood Cells.
CODE Unit #18FQ55394.
MANUFACTURER 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 Platelets.
CODE Unit #65-47098.
MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was distributed after receiving information concerning a post donation illness.

PRODUCT Red Blood Cells
CODE Unit #1667091.
MANUFACTURER Central Kentucky Blood Center (CKBC), Lexington, Kentucky.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Platelets Pheresis, Double Units.
CODE Unit Numbers: 3552481, 3552473, 3391789.
MANUFACTURER Florida Blood Services, Tampa, Florida.
RECALLED BY Florida Blood Services, St. Petersburg, Florida
DISTRIBUTION New York.
QUANTITY 3 double units were distributed.
REASON Unlicensed blood products were distributed in interstate commerce.

PRODUCT Fresh Frozen Plasma.
CODE Unit #7617111.
MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, Indiana.
DISTRIBUTION Kentucky.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was distributed in interstate commerce.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 3029708, 3050047, 3027134, 3027137, 3052590.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 5 units were distributed.
REASON Blood products had invalid test results for HBsAg or HIV-1 p24 Antigen.

PRODUCT PK7100 and PK7200 CMV-PA Automated Blood Grouping Analyzer CMV Test System and Controls:
Olympus PK7100 Automated Blood Grouping System, Product Code 81KSZ;
Olympus PK7200 Automated Microplate System, Product Code 81KSZ;
Olympus PK CMV-PA Cytomegalovirus serological reagents, Product Code MZE.
CODE All lot and serial numbers are affected.
MANUFACTURER PK7100 & PK7200 Automated Analyzer: Olympus Optical Co., Ltd., Tokyo, Japan; PK CMV-PA Systems and Controls: Fujirebio America, Inc., Fairfield, New Jersey; Fujirebio, Inc., Tokyo, Japan; SCIMEDIX Corp., Denville, New Jersey.
RECALLED BY Olympus America, Inc., Irving, Texas (distributor)
DISTRIBUTION North Carolina, California, Louisiana, Florida, Kentucky, Virginia, Illinois, Tennessee, Oklahoma, Canada.
QUANTITY PK7100: 2 analyzers; PK7200 38 analyzers were distributed. 412,000 tests per month were distributed.
REASON Automated test systems, which may have produced incorrect CMV antibody test results.

PRODUCT Red Blood Cells.
CODE Unit #21KC05728.
MANUFACTURER American Red Cross Blood Services, Pacific Northwest Blood Services, Portland, Oregon.
DISTRIBUTION Washington state.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Red Blood Cells, Autologous.
CODE Unit Numbers: 00-81738, 00-81739, 23-40650, 29-01391, 29-01392, 52-00660, 52-00661, 52-00663.
MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan.
DISTRIBUTION Michigan.
QUANTITY 8 units were distributed.
REASON Blood products were labeled with extended expiration dates.

PRODUCT Red Blood Cells.
CODE Unit #38-32919.
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 unacceptable temperature.
 

WEEK ENDING OCTOBER 20

PRODUCT Platelets.
CODE Unit Numbers: 3185171, 3185170, 3185417, 3183986, 3348267, 3348269, 3348271, 3183998, 3801648, 3185250, 3185439, 3185440, 3185257, 3185435, 3801649, 3185444, 3800870, 3800865, 3348287, 3800875, 3185437, 3800869, 3185436.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 23 units were distributed.
REASON Blood products were manufactured using a centrifuge that failed quality control testing.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit Numbers: a) 81-33372, 81-31830, 81-30379, 81-28766; b) 81-33372, 81-31830.
MANUFACTURER Northwest Michigan Blood Program, Traverse City, Michigan.
RECALLED BY Michigan Community Blood Centers, Grand Rapids, Michigan
DISTRIBUTION Florida and Michigan.
QUANTITY a) 4 units; b) 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.
CODE Unit Numbers: a) 81-28968, 81-33545; b) 81-28968.
MANUFACTURER Northwest Michigan Blood Program, Traverse City, Michigan.
RECALLED BY Michigan Community Blood Centers, Grand Rapids, Michigan
DISTRIBUTION Michigan.
QUANTITY a) 2 units; b) 1 unit 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 #65-17673.
MANUFACTURER Michigan Community Blood Centers, Grand Rapids, 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 s) Red Blood Cells; b) Platelets.
CODE Unit Numbers: a) 18347-9597; b) 16347-9565, 16347-9566, 16347-9572, 16347-9598, 16347-9600, 16349-0789, 16349-1185, 16349-1188, 18347-9597.
MANUFACTURER Blood Systems, Inc., Hattiesburg, Mississippi.
DISTRIBUTION Mississippi.
QUANTITY a) 1 unit; b) 9 units were distributed.
REASON Blood products were prepared from overweight whole blood units.

PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets.
CODE Unit #18FE65459.
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) Recovered Plasma.
CODE Unit #38FK02777.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
DISTRIBUTION Indiana and New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had taken the medication Methotrexate.

PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
CODE Unit Numbers: a) 32KF46845 and 32KF32535; b) 32KF32535; c) 32KF46845.
MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin.
DISTRIBUTION Iowa and Wisconsin.
QUANTITY a) 2 units; b) 1 unit; c) 1 unit distributed.
REASON Blood products were collected from a donor who reported previously testing positive for hepatitis.

PRODUCT a) Platelets; b) Cryoprecipitated AHF; c) Recovered Plasma.
CODE \Unit Numbers: a) 32KG96828; b) 32KM11803; c) 32KM11803 and 32KG96828.
MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin.
DISTRIBUTION Illinois, Wisconsin, New York, Switzerland.
QUANTITY a) 1 unit; b) 1 unit; c) 2 units were distributed.
REASON Blood products were collected from a donor who reported previously testing positive for anti-HCV.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit #32KC00739.
MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin.
DISTRIBUTION Iowa and Wisconsin.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who reported previously testing positive for hepatitis.

PRODUCT Red Blood Cells.
CODE Unit #32LG00698.
MANUFACTURER American Red Cross Blood Services, Chicago, Illinois.
RECALLED BY American Red Cross Blood Services, Madison, Wisconsin
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected in a manner that could compromise the sterility of the product.

PRODUCT Platelets.
CODE Unit #32KG90713.
MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for anti-HBc.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced.
CODE Unit Numbers: a) 17KC08284; b) 17KF91138 and 17KL77510.
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
DISTRIBUTION Minnesota and Wisconsin.
QUANTITY a) 1 unit; b) 2 units were distributed.
REASON Blood product corresponded to a unit of pooled platelets that was positive for Serratia marcescens and implicated in a transfusion reaction.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #9437822.
MANUFACTURER Medic Regional Blood Center, Knoxville, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for anti-HBc, but were collected from a donor who previously tested repeatedly reactive for anti-HBc on two separate occasions, and also tested repeatedly reactive for anti-HBc on a subsequent donation.

PRODUCT Platelets, Pheresis, Leukoreduced.
CODE Unit #32LP00737.
MANUFACTURER American Red Cross Blood Services, Chicago, Illinois.
RECALLED BY American Red Cross Blood Services, Madison, Wisconsin
DISTRIBUTION Illinois.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who traveled to an area considered endemic form malaria.

PRODUCT Red Blood Cells.
CODE Unit #32KF62196.
MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin.
DISTRIBUTION Illinois.
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 #32KQ31773.
MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin.
DISTRIBUTION Illinois and New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who had close contact with a hemophiliac who tested positive for HBsAg and HIV were distributed prior to receipt of this information.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #32KL01022.
MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin.
DISTRIBUTION Iowa and California.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor who reported previously testing positive for hepatitis.

PRODUCT a) Red Blood Cells; b) Platelets; c) Recovered Plasma.
CODE Unit #17KF65369.
MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, Minnesota.
DISTRIBUTION Pennsylvania, Minnesota, California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from an unsuitable donor.

PRODUCT Red Blood Cells.
CODE Unit #12436-1245.
MANUFACTURER United Blood Services, Albuquerque, New Mexico.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION New Mexico.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose hemoglobin had not been documented.

PRODUCT Source Plasma.
CODE Unit Numbers: 91454874, 91456656, 89940495, 89942307, 89945858, 94318180, 94242089, 94243864
MANUFACTURER Sera-Tec Biologicals, Ltd., Norfolk, Virginia.
DISTRIBUTION California.
QUANTITY 8 units were distributed.
REASON Blood products were collected from a donor who had been deferred due to a history of incarceration.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 17KW09327 and 17KW09332.
MANUFACTURER American Red Cross, St. Paul, Minnesota.
DISTRIBUTION Pennsylvania and Iowa.
QUANTITY 2 units were distributed.
REASON Blood products were collected from two donors who reported travel to an area designated as endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit #2277494.
MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit Numbers: a) 53FR54570, 54FQ51284, 53L87653; b) 53FR54570, 53L87653.
MANUFACTURER American Red Cross Blood Services, Baltimore, Maryland.
DISTRIBUTION Virginia, Maryland, District of Columbia.
QUANTITY a) 3 units; b) 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) Recovered Plasma.
CODE Unit #4783555.
MANUFACTURER Department of the Navy, National Naval Medical Center, Blood Bank, Bethesda, Maryland.
DISTRIBUTION Maryland and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for anti-HCV, but were collected from a donor who previously tested reactive for anti-HCV.

PRODUCT Red Blood Cells, Leukoreduced, Irradiated.
CODE Unit #41FQ66760.
MANUFACTURER The American National Red Cross, North Birmingham, Alabama.
DISTRIBUTION Alabama.
QUANTITY 1 unit was distributed.
REASON Blood product tested positive for Cytomegalovirus (CMV) but was labeled negative for CMV.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #38H54178.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
DISTRIBUTION Indiana and New York.
QUANTITY 1 unit of each component was distributed.
REASON Blood product was collected from a donor who lived in an HIV Group O risk area.

PRODUCT Red Blood Cells, Autologous.
CODE Lot #32KF63177.
MANUFACTURER American Red Cross Blood Services, Madison, Wisconsin.
DISTRIBUTION Wisconsin.
QUANTITY 1 unit was distributed.
REASON Blood product which tested repeatedly for anti-HBc, was distributed without a biohazard label.

PRODUCT Red Blood Cells.
CODE Unit #87-12399.
MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was not separated from the unit of whole blood and refrigerated within eight hours of collection.

PRODUCT Rabies Vaccine, Imovax Rabies I.D.
CODE Lot Numbers: N1204-2, P0030-2, and P0313-3.
MANUFACTURER Aventis Pastuer SA, Marcy L' Etoile, Lyon, France.
RECALLED BY Aventis Pasteur, Inc., Swiftwater, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY 5,656 syringes of lot P0313, 5,375 syringes of lot P0030, and 5,932 syringes of lot N1204.
REASON Rabies vaccine failed to demonstrate adequate potency throughout the dating period.

PRODUCT Red Blood Cells.
CODE Unit #17KJ94652.
MANUFACTURER American Red Cross Blood Services, St. Paul Minnesota.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Fresh Frozen Plasma, implicated in a transfusion reaction, was found to be contaminated with Propionbacterium acnes. The corresponding Red Blood Cells had been distributed.

PRODUCT Red Blood Cells Leukoreduced.
CODE Unit #C42758.
MANUFACTURER Virginia Blood Services, Richmond, Virginia.
DISTRIBUTION Virginia.
QUANTITY 1 unit was distributed.
REASON Blood product tested reactive for syphilis.

PRODUCT Red Blood Cells, Irradiated.
CODE Unit numbers: 7715854 and 7715861.
MANUFACTURER Department of the Navy, National Navy Medical Center, Blood Bank, Bethesda, Maryland.
DISTRIBUTION District of Columbia
QUANTITY 2 units were distributed.
REASON Unlicensed blood products were distributed in interstate commerce.

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE Unit numbers: 17FZ19683, 17FZ19684, and 17FZ19695.
MANUFACTURER American Red Cross, North Central Blood Services, St. Paul, Minnesota.
DISTRIBUTION Minnesota.
QUANTITY 3 units were distributed.
REASON Blood products were stored at unacceptable temperatures.

PRODUCT Platelets Pheresis.
CODE Unit #12W41015.
MANUFACTURER American Red Cross Blood Services, Charlotte, North Carolina.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was stored at an unacceptable temperature.

PRODUCT Platelet Pheresis.
CODE Unit numbers: 03P19916 and 03P19919.
MANUFACTURER American Red Cross Blood Services, Atlanta, Georgia.
DISTRIBUTION Georgia.
QUANTITY 2 units were distributed.
REASON Blood products were stored under inappropriate conditions.

PRODUCT Whole Blood.
CODE Unit #3601045.
MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Fresh Frozen Plasma.
CODE 36LQ21799, 36LQ21813, 36LQ21818, 36LQ21839, 36LQ21826, and 36LQ21842.
MANUFACTURER American Red Cross Blood Services, Columbia, South Carolina.
DISTRIBUTION South Carolina.
QUANTITY 6 units were distributed.
REASON Blood products were labeled with an extended expiration date.

PRODUCT Red Blood Cells Irradiated.
CODE Unit #2287731.
MANUFACTURER Central Texas Regional Blood and Tissue Center, Austin, Texas.
DISTRIBUTION Texas.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Platelets Pheresis, Leukoreduced.
CODE Unit #41GP29618.
MANUFACTURER The American National Red Cross, Birmingham, Alabama.
DISTRIBUTION Alabama.
QUANTITY 1 unit was distributed.
REASON Unlicensed blood product was labeled with the firmís license number.

PRODUCT Fresh Frozen Plasma, Pheresis, Donor Retested.
CODE Unit numbers: 4800553, 4800570, 4800559, 4800704, 4800561, 4800705, and 4800698.
MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY 7 units were distributed.
REASON Unlicensed blood products were labeled with the firmís license number.

PRODUCT Source Plasma.
CODE Unit #VL056119.
MANUFACTURER Sera-Tec Biologicals Limited Partnership, Shreveport, Louisiana.
DISTRIBUTION North Carolina.
QUANTITY 1 unit was distributed.
REASON Blood product was untested for viral markers.

WEEK ENDING OCTOBER 27

PRODUCT Red Blood Cells.
CODE Unit #110-9262.
MANUFACTURER General Hospital Corporation, doing business as Massachusetts General Hospital, Boston, Massachusetts.
DISTRIBUTION Massachusetts.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to an area designated as endemic for malaria.

PRODUCT Source Plasma.
CODE Unit Numbers: 99MWIA9375, 99MWIA9868, 99MWIB0555, 99MWIB1520, 99MWIB4275, 99MWIB4905, 99MWIB2177, 99MWIB2602, and 99MWIB3456.
MANUFACTURER Community Bio-Resources, Inc., Menasha, Wisconsin.
DISTRIBUTION Michigan and Austria.
QUANTITY 9 units were distributed.
REASON Blood products were collected from a donor who reported an accidental blood exposure.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #GV02665.
MANUFACTURER Central Blood Bank, Pittsburgh, Pennsylvania.
DISTRIBUTION Pennsylvania and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were incorrectly tested for the hepatitis B surface antigen (HBsAg).

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Irradiated; c) Platelets; d) Platelets, Irradiated; e) Cryoprecipitated AHF; f) Source Leukocytes.
CODE Unit Numbers: a) 18GH27895, 18GH09690; b) 18GG14050, 18GG12514; c) 18GH09690; d) 18GG12514; e) 18GH27895; f) 18GG14050.
MANUFACTURER American Red Cross Blood Services, Lansing, Michigan.
DISTRIBUTION Michigan, Ohio, New Jersey, California.
QUANTITY a) 2 units; b) 2 units; c) 1 unit; d) 1 unit; e) 1 unit; f) 1 unit.
REASON Blood products were collected from a donor who was taking the drug, Methotrexate.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Component Code 12750; Unit #17FX27543.
MANUFACTURER American Red Cross Blood Services, North Central Blood Services, St. Paul, Minnesota.
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON The first half of a split Platelet, Pheresis unit was found to be contaminated with coagulase negative Staphylococci. The second half of the unit had been distributed.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #FL06548.
MANUFACTURER Central Illinois Community Blood Bank, Springfield, Illinois.
DISTRIBUTION Illinois and Switzerland.
QUANTITY 1 unit of each component was distributed.
REASON Blood products tested negative for anti-HIV 1/2, Western blot indeterminate.

PRODUCT Platelets, Pheresis.
CODE Unit Numbers: 0057202, 15-0050503, 15-0050711, 15-0054275, 13-0062404, 15-0060786, 15-0060996, 15-0067237.
MANUFACTURER United Blood Services, Midland, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas.
QUANTITY 8 units were distributed.
REASON Blood products were collected from a donor taking the drug, Asacol for colitis.

PRODUCT Platelets, Pheresis, Leukoreduced.
CODE Unit #15-0060020.
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 yield.

PRODUCT a) Red Blood Cells; b) Platelets.
CODE Unit #11322-8681.
MANUFACTURER Blood Systems, Inc., El Paso, Texas.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Texas and New Mexico.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who traveled to an area considered endemic for malaria.

PRODUCT Red Blood Cells.
CODE Unit #17KC09905.
MANUFACTURER American Red Cross Blood Services, North Central Blood Services, St. Paul, Minnesota.
DISTRIBUTION Michigan.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who reported travel to a malarial endemic area and who had an accidental blood exposure.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit #3380145.
MANUFACTURER Florida Blood Services, Tampa, Florida.
RECALLED BY Florida Blood Services, St. Petersburg, Florida
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product had a high white blood cell count.

PRODUCT Red Blood Cells.
CODE Unit Numbers: 3441487, 3444401, 3153462.
MANUFACTURER Florida Blood Services, St. Petersburg, Florida.
DISTRIBUTION Florida.
QUANTITY 3 units were distributed.
REASON Blood products were collected from donors whose body temperature had not been documented or whose hemoglobin check was marked as unsatisfactory.

PRODUCT Red Blood Cells.
CODE Unit #FS38678.
MANUFACTURER Inova Health Care Services, Inova Health Care Services Blood Donor Services, Annandale, Virginia.
DISTRIBUTION District of Columbia.
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 #38FC57767.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
DISTRIBUTION Indiana.
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 #13GV03679.
MANUFACTURER American Red Cross Blood Services, Detroit, 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 #18221-5814.
MANUFACTURER United Blood Services, Cheyenne, Wyoming.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION New Jersey.
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) Fresh Frozen Plasma.
CODE Unit #FE35894.
MANUFACTURER Inova Health Care Services, Inova Health Care Services, Annandale, Virginia.
DISTRIBUTION District of Columbia.
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 Platelets.
CODE Unit #X69877.
MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, Illinois.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor whose body temperature had not been documented.

PRODUCT Platelets.
CODE Unit #16336-7165.
MANUFACTURER Blood Systems, Inc., Meridian, 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) Recovered Plasma.
CODE Unit Numbers: a) 4172756, 5300138, 4172738, 4172793, 8956410, 2905325, 2905403, 5300686, 5300736, 5302521, 2284183, 8956034, 1759079, 4173689, 4480005, 5301835, 5303420, 4174762, 1759804, 1760707, 8955327, 4480703, 2907716; b) 4172756, 5300138, 4172738, 4172793, 8956410, 2905325, 5300686, 5300736, 5302521, 2284183, 8956034, 1759079, 4173689, 4480005, 5301835, 4174762, 1759804, 1760707, 8955327, 4480703, 2907716.
MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida.
DISTRIBUTION Florida and Pennsylvania.
QUANTITY a) 23 units; b) 21 units were distributed.
REASON Blood products were incorrectly tested for syphilis.

PRODUCT Platelets, Pheresis, Leukoreduced.
CODE Unit #41FP28444.
MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama.
DISTRIBUTION Alabama.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet yield.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit Numbers: 41GE27476 and 41GN21979.
MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama.
DISTRIBUTION Alabama and California.
QUANTITY 2 units of each component was distributed.
REASON Blood products were collected from a donor with a history of hepatitis.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #41GM34235.
MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama.
DISTRIBUTION Alabama.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable red blood cell recovery after leukoreduction.

PRODUCT Platelets, Pheresis.
CODE Unit #41FP28285.
MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama.
DISTRIBUTION Alabama.
QUANTITY 1 unit was distributed.
REASON Blood product had an unacceptable platelet yield.

PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukoreduced; c) Recovered Plasma.
CODE a&c) Unit #41FX29256; b&c) Unit #41FW23379;
MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama.
DISTRIBUTION Alabama and California.
QUANTITY a) 1 unit; b) 1 unit; c) 2 units were distributed.
REASON Blood products tested negative for anti-HCV, but were collected from a donor who previously tested initially reactive for anti-HCV with no duplicate repeat testing.

PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE Unit #41LX28008.
MANUFACTURER American Red Cross Blood Services, Birmingham, Alabama.
DISTRIBUTION Alabama and California.
QUANTITY 1 unit of each component was distributed.
REASON Blood products were collected from a donor who received a tattoo within 12 months of donation.

PRODUCT Red Blood Cells, for further manufacture of non-injectable products.
CODE Unit #PA04786.
MANUFACTURER Interstate Blood Bank, Inc., Memphis, Tennessee.
DISTRIBUTION Minnesota.
QUANTITY 1 unit was distributed.
REASON Blood product tested repeatedly reactive for anti-HIV-1/2.

PRODUCT Red Blood Cells.
CODE Unit #0901255.
MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product was distributed after receiving post donation information that made the unit unsuitable for transfusion.

PRODUCT Red Blood Cells.
CODE Unit #38FC47791.
MANUFACTURER American Red Cross Blood Services, Fort Wayne, Indiana.
DISTRIBUTION Indiana.
QUANTITY 1 unit was distributed.
REASON Blood product was prepared from an overweight unit of whole blood.

PRODUCT a) Reagent Red Blood Cells, Panoscreen I and II; b) Reagent Red Blood Cells, Panoscreen I, II, and III.
CODE a) Lot #41764; b) Lot #41758.
MANUFACTURER Immucor, Inc., Norcross, Georgia.
DISTRIBUTION Japan and Hong Kong.
QUANTITY a) 221 kits; b) 248 kits were distributed.
REASON Reagent Red Blood Cells showed intermittent discoloration and microbial contamination.

PRODUCT Reagent Red Blood Cells, Panoscreen I, II, and III.
CODE Lot #39718.
MANUFACTURER Immucor, Inc., Norcross, Georgia.
DISTRIBUTION Japan.
QUANTITY 212 kits were distributed.
REASON Reagent Red Blood Cells showed hemolysis and microbial contamination.

PRODUCT Source Plasma.
CODE Unit # 98MW1B4931.
MANUFACTURER Community Bio-Resources, Inc., Menasha, 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) Red Blood Cells; b) Pooled Cryoprecipitated AHF; c) Recovered Plasma.
CODE Unit Numbers: a&c) Unit #17KR55494; b) Pooled Unit 736 (containing unit 17KR55494).
MANUFACTURER American Red Cross Blood Services, St. Paul, Minnesota.
DISTRIBUTION Iowa, Minnesota, Switzerland.
QUANTITY 1 unit and 1 pooled unit were distributed.
REASON Blood products were collected from a donor with an elevated body temperature.

PRODUCT Fresh Frozen Plasma.
CODE Unit #16339-0417.
MANUFACTURER United Blood Services, Meridian, Mississippi.
RECALLED BY Blood Systems, Inc., Scottsdale, Arizona
DISTRIBUTION Mississippi.
QUANTITY 1 unit was distributed.
REASON Fresh Frozen Plasma was frozen more than eight hours after whole blood collection.

PRODUCT Red Blood Cells, Leukoreduced, Irradiated.
CODE Unit Numbers: 2279729 and 2279706.
MANUFACTURER Florida-Georgia Blood Alliance, Jacksonville, Florida.
DISTRIBUTION Florida.
QUANTITY 2 units were distributed.
REASON Blood products were labeled with extended expiration dates.

PRODUCT Red Blood Cells.
CODE Unit #FY91260.
MANUFACTURER Inova Health Care Services, Inova Health Care Services Blood Donor Services, Annandale, Virginia.
DISTRIBUTION District of Columbia.
QUANTITY 1 unit was distributed.
REASON Blood product tested negative for HBsAg, but was distributed prior to completion of HBsAg.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #65-43882, 65-43684, 65-43068, 65-43680.
MANUFACTURER Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, Michigan.
DISTRIBUTION Michigan.
QUANTITY 4 units were distributed.
REASON Blood product was labeled with an extended expiration date.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit Numbers: 4962250, 2821022, 1085348, 1482203, 1436935, 2822025, 1560040.
MANUFACTURER New York Blood Services (Center West), A Division of New York Blood Center, Inc., New York, New York.
DISTRIBUTION New York.
QUANTITY 7 units were distributed.
REASON Blood products were leukoreduced using expired filters.

PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE Unit #2911304.
MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida.
DISTRIBUTION Florida and Georgia.
QUANTITY 1 unit was distributed.
REASON Blood products were collected from a donor whose arm inspection was not documented as being performed.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #8959784.
MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was leukoreduced greater than five days after the collection date.

PRODUCT Red Blood Cells.
CODE Unit #4183630.
MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, Florida.
DISTRIBUTION Florida.
QUANTITY 1 unit was distributed.
REASON Blood product was collected from a donor who was taking the drug Propecia.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit #0903930.
MANUFACTURER West Tennessee Regional Blood Center, Inc., Jackson, Tennessee.
DISTRIBUTION Tennessee.
QUANTITY 1 unit was distributed.
REASON Blood product was labeled with an extended expiration date.