JANUARY 2004

WEEK ENDING JANUARY 3

PRODUCT
a) Product: Platelets.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 608263.
RECALLING FIRM/MANUFACTURER Avera McKennan Hospital and University Health Center Sioux Falls, SD.
REASON Blood products, collected from a donor who resided in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION SD.

PRODUCT Source Plasma.
CODE Unit number: 7Y1944, 7Y3038, 7Y3616.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Little Rock, AR,
REASON Blood products, collected from an unsuitable donor based on a previous deferral for illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 Units.
DISTRIBUTION IL.

PRODUCT Platelet Pheresis, Leukoreduced.

CODE Units 21607-3188, 21608-5710.
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Fargo, ND.
REASON Blood products, with platelet counts below the firm's specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION ND.

PRODUCT Red Blood Cells.
CODE Unit number S44288.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Saginaw Valley Blood Program, Saginaw, MI.
REASON Blood product collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers 30183-4639 and 30183-4642.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Bismarck, ND.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION ND.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 01KT79797.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY.
Manufacturer: American Red Cross Blood Services, Binghamton, NY.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 53FM63094.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION D.C.

PRODUCT Red Blood Cells.
CODE Unit number FE87230.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT

a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) unit number KS22273.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA.
REASON Blood products, collected from a donor who disclosed recent blood product administration during the screening process, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number 18FS73085.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT
a) Cryoprecipitated AHF.
b) Plasma, Cryoprecipitate
CODE a) and b) 30181-1841.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Bismarck, ND.
REASON Blood products, which tested positive for anti-Cartwright, were labeled as negative for unexpected antibodies, and distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION ND and NM.

PRODUCT Red Blood Cells, Washed, Irradiated.
CODE Unit number 182L21951.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

WEEK ENDING JANUARY 10

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 8526251.
RECALLING FIRM/MANUFACTURER LifeShare Blood Center, Beaumont, TX.
REASON Blood product, collected from an unsuitable donor who reported traveling to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.

PRODUCT Source Plasma.
CODE Unit number: FBCMKK, FBCMFD, FBCLVC, FBCLQG, FBCLGK, FBCLBT, FBCKSZ, FBCKPG, FBCKGL, FBCKCR, FBCJXD, FBCJSF, FBCJLG, FBCJGX.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Flint, MI.
REASON Blood products, collected from an unsuitable donor who was previously deferred for high risk IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 Units.
DISTRIBUTION IL, and Germany.

PRODUCT Red Blood Cells Deglycerolized.
CODE Unit numbers: 1726544, 1727147, 1726668, 1708423.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Jackson, MS.
REASON Blood products, which were not tested for residual glycerol, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 Units.
DISTRIBUTION MS.

PRODUCT Red Blood Cells Deglycerolized.
CODE Unit numbers: 1727026, 1744890.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Jackson, MS.
REASON Blood products, which were not tested for residual glycerol, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Units.
DISTRIBUTION MS.

PRODUCT Source Plasma.
CODE Unit numbers: 26-BLKBFR-B, 26-BLKBKH-B, 26-BLKBNG-B, 26-BLKBSG-B, 26-BLKBWV-B, 26-BLKCSN-B, 26-BLKCWX-B,
26-BLKDTQ-B, 26-BLKDWR-B, 26-BLKFDC-B, 26-BLKFHB-B, 26-BLKFNS-B, 26-BLKFSD-B, 26-BLSGGP-B.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Rock Island, IL.
REASON Blood products, collected from a donor who had been incarcerated within the past twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 Units.
DISTRIBUTION IL.

PRODUCT Platelets Pheresis.
CODE Unit number L23159.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, collected from an ineligible donor due to recent ingestion of an aspirin-like medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION SC.

PRODUCT Source Plasma.

CODE Unit number NF186435.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., Nutterfort, WV.
REASON Blood product, that tested negative for viral markers, but was not properly quarantined after the receipt of post donation information from the donor related to recent body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Platelets, Pheresis.
CODE Unit 55P38913.
RECALLING FIRM/MANUFACTURER American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AR.
REASON Platelets, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AR.

PRODUCT Platelets Pheresis, Leukocytes Removed.
CODE Unit number: 20GR14912 Part 1.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, ID.
Manufacturer: American Red Cross Blood Services, Great Falls, MT.
REASON Blood product, collected from a donor who was diagnosed with a post donation kidney infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION MT.

PRODUCT
a) Red Blood Cells, Leukocytes Removed.
b) Fresh Frozen Plasma.
c) Liquid Plasma.
CODE
a) Unit numbers: 1811748, 1797093;
b) Unit number: 1797093;
c) Unit number: 1811748.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson, MS.
REASON Blood products, that tested negative for all viral markers, but were collected from an ineligible donor due to a reported history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 Units.
DISTRIBUTION MS, and Switzerland.

PRODUCT Red Blood Cells Rejuvenated Deglycerolized.
CODE Unit number: 9408760.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson, MS.
REASON Blood product, manufactured using an expired 1.6% saline solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION MS.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) Units 55KR00469, 55F23591;
b) Unit 55KR00469;
c) Unit 55F23591;
d) Unit 55KR00469.
RECALLING FIRM/MANUFACTURER American National Red Cross, Arkansas Region, Little Rock, AR.
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to previous self-exclusion, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION AR.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets Leukocytes Removed.
c) Platelets Pheresis Leukocytes Removed.
d) Fresh Frozen Plasma
CODE
a) Units 38FE93687, 38FE93682, 38FC92913 (2 units), 38FC92900, 38FE93676, 38FE93702, 38LC52505 (2 units), 38LC52555 (2 units),

38LC52510 (2 units), 38FE93685, 38FE93681, 38FE93688, 38FE93695 (2 units), 38FE93693 (2 units), 38LC52550 (2 units), 38LC52540 (2 units),
38LC52560 (2 units), 38FC92903, 38FE93699 (2 units), 38FE93698, 38FE93689, 38FC92908 (2 units), 38FE93713, 38FE93711, 38FE93707, 38LC52599 (2 units), 38LC52515, 38LC52535 (2 units), 38FC92918 (2 units), 38LC52572, 38LC52545 (2 units), 38LC52571, 38FC92916 (2 units),
38FE93708, and 38FE93696 (2 units);
b) Units 38FC92902, 38FC92900, 38FC92909, 38FC92903, 38FC92901, 38P78680 and 38FC92907;
c) Units 38P78679 (2 units) and 38P78678 (2 units);
d) Units 38P78678, 38FC92900, 38FC92909 and 38FC92911.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Indiana-Ohio Region, Fort Wayne.
REASON Blood products, which were tested incorrectly by NAT upon initial testing but were negative upon subsequent re-testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 53 Units;
b) 7 Units;
c) 4 Units;
d) 4 Units.
DISTRIBUTION IN, and OH.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Platelets, Irradiated.
e) Fresh Frozen Plasma.
CODE
a) Unit numbers T25121, R51206, and T46866;
b) Unit number T42906;
c) Unit numbers T25121, R51206, and T46866;
d) Unit number K62019;
e) Unit numbers K62019, R51220, and R51206.
RECALLING FIRM/MANUFACTURER Recalling Firm: Virginia Blood Services, Richmond, VA.
REASON Blood products, incorrectly tested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 Units.
DISTRIBUTION VA.

PRODUCT Platelets Pheresis.
CODE Unit number: 4005003.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson, MS.
REASON Platelets, without a platelet count being performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION MS.

PRODUCT Red Blood Cells Washed.
CODE Unit number: 1840879.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Jackson, MS.
REASON Blood product, manufactured using an expired processing set, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION MS.

PRODUCT Source Plasma.
CODE ZA916, 464327, 469928, CDCNSH, CDCSCR, 7ZD768, CDBLLC, CDFBSP, CDDDYQ, CDCCXZ, CDDFFD, CDDFCM, CDJWDF, CDJKKZ, CDJJSV, CDJHXP, CDJHDX, CDLRTF, CDJMRW, CDHCJK, CDKHJC, CDGHHW, CDCKVL, 8PU901, 9TE166, 9TG183, 9TG126, 9TE797, 9TF193, 9TF175, 9TF505, 921256, CDGBXC, 921801, 9ZA540, CDCQHF, CDBKPP, CDFLRC, CDDMKW, 922608, CDCDDC, CDDJBB, CDFYVG, CDGCVJ, CDGDQF, CDJKCV, CDKCQL, CDHXNQ, CDHXVP, CDHXZG, CDHYNP, CDLMDV, CDJRGJ, CDLHBK, 9TJ512, CDHSYJ, CDHXSJ, CDFXGL, CDBYDF, CDHVGW, CDBQQD, 9N2319, 8DV636, CDHFTF, CDBWNX, CDBGSY, 8PV083, CDCMMZ, CDBHNG, CDKBSL, CDHYMG, CDLPCK, 7ZD727, 7ZD901, 8PU944, 8PV630, 8PV839, 8PV947, 921127, 921432, 921496, 921597, 921600, 921683, 921790, 921856, 922010, 922171, 922258, 922400, 922409, 922548, 922948, 923228, 923280, 923468, 976650, 977075, 977198, 9N1275, 9N2250, 9N2343, 9N2438, 9R0741, 9RP819, 9TE051, 9TE220, 9TE221, 9TE457, 9TE780, 9TF016, 9TF019, 9TF043, 9TF167, 9TF332, 9TF334, 9TF819, 9TF984, 9TG168, 9TG314, 9TG484, 9TI022, 9TI382, 9TI471, 9TI866, 9TJ426, 9TJ438, 9TJ679, 9TJ972, 9TK296, 9TK404, 9TK632, 9TI703, 9ZA059, 9ZA062, 9ZA430, 9ZA533, 9ZA566, 9ZA988, 9ZA997, CDBBJB, CDBBRJ, CDBCQF, CDBDHX, CDBDNL, CDBDWZ, CDBDXM, CDBFGS, CDBFXY, CDBFZK, CDBFZN, CDBHBS, CDBHJP, CDBHXP, CDBHYC, CDBJRF, CDBJRH, CDBJVL, CDBJXB, CDBJXM, CDBJXT, CDBKCY, CDBKDD, CDBKPH, CDBLCH, CDBLGF, CDBLQN, CDBLZP, CDBNRV, CDBQHM, CDBQZN, CDBRRP, CDBSDN, CDBSXX, CDBVBT, CDBWRD, CDBYKP, CDCCKD, CDCCLG, CDCFYD, CDCHGT, CDCLQB, CDCMWD, CDCNKS, CDCNRP, CDCPYH, CDCRYS, CDCRYT, CDCSFL, CDCTHH, CDCWXD, CDCXJX, CDCXQB, CDCXQD, CDCXQH, CDCXQM, CDCXQY, CDCYVK, CDCZDN, CDDBPC, CDDCRY, CDDFMG, CDDGMJ, CDDHGG, CDDJDB, CDDKCC, CDDKFP, CDDKTR, CDDLCX, CDDMKY, CDDRCS, CDDTDC, CDDTDK, CDDVCH, CDDVMS, CDDVSD, CDDWNV, CDDWXF, CDDYHJ, CDDYSP, CDDZHH, CDFCRG, CDFDGX, CDFDNQ, CDFGQN, CDFGRB, CDFGWJ, CDFJLY, CDFKTN, CDFKYJ, CDFLJD, CDFQZL, CDFTNL, CDFTZN, CDFXJJ, CDFYDH, CDFZHS, CDFZYM, CDGBFC, CDGCKB, CDGDYR, CDGFDZ, CDGFNH, CDGFNL, CDGFRJ, CDGFRX, CDGGSX, CDGHJJ, CDGMBF, CDCZDG, CDHCBV, CDHDHB, CDHDMN, CDHDRS, CDHFTG, CDHFYT, CDHGKZ, CDHGLG, CDHGMQ, CDHGQK, CDHJHR, CDHKBZ, CDHSMK, CDHXDQ, CDHYBB, CDHZMN, CDHZNQ, CDJBSQ, CDJCCH, CDJCZK, CDJDHM, CDJDYC, CDJDYJ, CDJFRY CDJGDL, CDJHBC, CDJHDW, CDJJCX, CDJKBL, CDJLZT, CDJMZZ, CDJNWM, CDJQMH, CDJQSG, CDJRBL, CDJRTN, CDKDBV, CDKDCG, CDKDJW, CDKDLC, CDKFDG, CDKHLQ, CDKHZL, CDKJDZ, CDKKRK, CDLBYN, CDLHDM, CDLHQD, CDLHSW, CDLJWS, CDLKSG, CDLLLB, CDLLLX, CDLLTB, CDLNFZ, CDLNTD, CDLPWF, CDLPYJ, CDLQLR, CDLRMV, CDLSHD, CDFMLX, CDFQYY, CDLSDL.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Little Rock, AR.
REASON Source Plasma, collected from ineligible donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE 314 units.
DISTRIBUTION MA, CA, IL, Germany, and Switzerland.

WEEK ENDING JANUARY 17

PRODUCT Platelets.
CODE Units V06573, C27625, V06578, V06581, V06576, V06572.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA.
REASON Platelets, manufactured with an incorrect centrifuge setting, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 unit.
DISTRIBUTION PA.

PRODUCT Platelets Pheresis Leukocytes Removed.
CODE Unit number: 21KP42835.
RECALLING FIRM/MANUFACTURER American National Red Cross, Pacific Northwest Region, Portland, OR.
REASON Blood product, labeled as leukocyte reduced but the white blood cell count was incorrectly performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OR.

PRODUCT Source Plasma.
CODE Units 02RMIA1015 and 02RMIA1376.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Kentwood, MI.
REASON Blood products, which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Platelets Pheresis, Leukocytes Removed.
CODE Unit numbers: 4002986A, 4002843B, 002842A,4004765,4004949, 400517A, 4004987B, 4005129A, 6008748B, 1765445A, 6009234, 6008803B, 4004266A, 4004266B, 4004279B, 4002087A, 6009485B, 4003349A, 4003349B, 4004287A, 4003375A, 6009043A, 6010382A, 4004246B, 4005030A,
6009557B, 4002658A, 4002538B, 4003375B, 4003700B, 4004042A, 4004408, 4004419A, 4005026A, 4005026B, 4005098B, 6009674A, 6011097A, 6009485A, 4004891A, 4004891B, 6010424B, 4003436A, 4004372B, 4005010A, 1767930A, 1767930B, 6009184, 4002687, 4002538A, 4002842A, 4003566A, 4003700A, 4003943B, 4004449, 4004553B, 4005030B, 4004987A, 4005129B, 6008379, 6008743A, 6009642, 4002371B, 4003523A, 4003878,
4002161, 4003988A, 4004288A, 4005092A, 4005092B, 4002470A, 4002470B, 4002428A, 4002428B, 4002792A, 4002646A, 4002646B, 4002657B, 4002574A, 4002574B, 6009683A, 4002540B, 4002539A, 4002539B, 4002497A, 4002498, 4002674, 4002986B, 4002950, 4002952B, 4003601A, 4004045, 4004038A, 4004038B, 4004042B, 4003940A, 4003940B, 4003917, 4004372A, 4004394, 4004388A, 4004388B, 4004341A, 4004341B, 4004075A,
4004075B, 4004309A, 4004306, 4004317, 4004657B, 4004469A, 4004469B, 4004502, 4004499A, 4004446A, 4004446B, 4004448A, 4004448B, 4004431, 4004806B, 4004807B, 4004786A, 4004786B, 4004788, 4004611, 4004598A, 4004598B, 4004564, 4004553A, 4004669, 4004996A, 4004996B, 4004995A, 4004995B, 4005010B, 4005017B, 4005027A, 4005027B, 4005041A, 4005046A, 4005046B, 4005022A, 4005022B, 4005008A, 4005008B, 4004988A, 4004988B, 4004982A, 4004982B, 4005004A, 4005004B, 4005082, 4005087A, 4005087B, 4005115A, 4005115B, 4005116A, 4005116B, 4005117A, 4005117B, 4005118, 4005120A, 4005120B, 4005122A, 4005122B, 4005103A, 4005103B, 4005108A, 4005098A, 4005049A, 4005049B, 4005060B, 4005065B, 4005067A, 4005067B, 4005079A, 4005079B, 4005076A, 4005076B, 4002166A, 4002166B, 4002198A, 4002198B, 4002202A, 4002202B,
6009674B, 6009337A, 6009337B, 6008532A, 6008532B, 4002087B, 6010893A, 6010893B, 6009982A, 6009982B, 6010937A, 6010937B, 6008739A, 6008739B, 6008302A, 6008302B, 6009867, 6009240, 6009631, 4003297A, 4003297B, 4003843, 4003844B, 4003875, 4003817, 4004886A, 4004886B, 4004890A, 4004890B, 6010377A, 6010377B, 6101424A, 1762577A, 1762577B, 1762582A, 1762582B, 1764318A, 1764318B, 1766673, 4002755A,
4002755B, 4003034, 4003437B, 4004126A, 4004126B, 4004146A, 4004146B, 4004156A, 4004156B, 4004163A, 4004182A, 4004182B, 4004246A, 4004259A, 4004259B, 4004262A, 4004262B, 4004264A, 4004264B, 4004278A, 4004278B, 4004298A, 4004298B, 4005176A, 4005200A, 4006050.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Jackson, MS.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 274 units.
DISTRIBUTION MS and TN.

PRODUCT Human Tissues for Transplantation.
CODE
LA03-027 Cornea OD, Cornea OS
LA03-027 Saphenous Vein R, Saphenous Vein L
LA03-027 Fascia Lata R, Fascia Lata L
LA03-027 Anterior/Posterior Tibialis Tendons R, Anterior/Posterior Tibialis Tendons L
LA03-027 Leg En Bloc R, Leg En Bloc L
LA03-027 Achilles Tendon with Calcaneus and Talus R, Achilles Tendon with Calcaneus and Talus L
LA03-027 Hemipelvis R, Hemipelvis L.
FIRM/MANUFACTURER Life Alaska, Inc., Anchorage, AK.
REASON Human tissues for transplantation, that tested negative for viral markers, but was procured from an ineligible donor due to a subsequent disclosure of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 Tissues.
DISTRIBUTION GA, WA, and FL.

PRODUCT Source Plasma
CODE Unit numbers 03NVAA1115 and 03NVAA1333.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., Norfolk, VA.
REASON Blood products, that tested negative for viral markers, but were collected from a donor that did not have the routine physical examination performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 18FT74469.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI and CA.

PRODUCT Platelets.
CODE Unit number: 6496274
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA.
REASON Platelets, manufactured from a unit of whole blood that was collected from a donor who had taken aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells Leukocytes Reduced.
c) Platelets.
d) Platelets Pheresis Leukocytes Reduced.
CODE
a) Units 8423901, 8272616, and 8422540;
b) Unit 4232060;
c) Unit 4232060;
d) Unit 4801387.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN.
REASON Blood products, which were collected from donors whose donor history screening was incomplete resulting in not adequately determining donor suitability, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION IN and Austria.

PRODUCT Red Blood Cells.
CODE Unit number: 6591597.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Monroe, LA.
REASON Blood product, collected from a donor who lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION LA.

PRODUCT Source Plasma.
CODE Units 46DCDDLNA and 46DCDDJJA.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Decatur, IL.
REASON Blood product, which was collected from a donor who had received a body piercing within twelve months of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 07FQ12155.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Arizona Region, Tucson, AZ.

REASON Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
a) Unit number 21KC55663;
b) Unit number 21KC62206.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR.
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OR.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 21GL76580.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Platelets.
CODE Unit number 1913835.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson, MS.
REASON Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to the application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT Platelets Pheresis, Leukocytes Reduced.

CODE Unit numbers 6018055A and 6018055B.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson, MS.
REASON Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MS.

PRODUCT
a) Red Blood Cells, Leukocytes Removed.
b) Recovered Plasma.
CODE a) and b) Unit number: 12L64147.
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC.
REASON Blood products, collected from an ineligible donor due to a reported history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC and CA.

PRODUCT Red Blood Cells.

CODE Units 55S20665, 55S20666, 55S20667, 55S20668, 55S20670, 55S20671, 55S20672, 55S20673, 55S20674, 55S20675, 55S20676, 55S20677, 55S20678, 55S20679, 55S20680, 55S20681, 55S20682, 55S20684, 55S20686, 55S20689, 55S20690, 55S20692, 55S20693, 55S20694, 55S20695, 55S20697, 55S20699, 55S20700, 55S20702, 55S20704.
RECALLING FIRM/MANUFACTURER American National Red Cross, Arkansas Region, Little Rock, AR.
REASON Blood products, collected using trip scales that had not been properly quality controlled, were distributed.
VOLUME OF PRODUCT IN COMMERCE 30 units.
DISTRIBUTION AR, PA, AL, and MO.

PRODUCT Source Plasma.

CODE Unit MI041110.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Muncie, IN.
REASON Blood product, which was not initially tested for syphilis, but was negative upon subsequent testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 18FK75848 and 18FK75849.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood products that were possibly out of controlled storage for more time than allowable were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT Platelets, Leukocytes Reduced.
CODE Unit 33GR55016.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Connecticut Region, Farmington, Connecticut.
REASON Blood product, prepared from a donation that had discrepant start and stop collection times documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CT.

PRODUCT

a) Platelets, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) 33GK46050.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Connecticut Region, Farmington, Connecticut.
REASON Blood product, prepared from a donation that had discrepant start and stop collection times documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Units.
DISTRIBUTION CT.

PRODUCT Red Blood Cells, Leukocytes Removed, Irradiated.
CODE Unit number: 8144627.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA.
REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION LA.

PRODUCT Recovered Plasma.
CODE Units 8272616 and 4232060.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN.
REASON Blood products, which were collected from donors whose donor history screening was incomplete resulting in not adequately determining donor suitability, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN and Austria.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit numbers: 12FV10267, 12FY77662.
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC.
REASON Red Blood Cells, manufactured from a unit of Whole Blood more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Units.
DISTRIBUTION NC, and PA.

PRODUCT Platelets.
CODE Unit numbers 013FC38664, 013FX03114, 013FX03130, 013GE13991, 013GE14003, and 013GE14013.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI.
REASON Blood products, exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 Units.
DISTRIBUTION MI.

PRODUCT Human Tissue for Transplantation, Corneas.
CODE Tissue numbers 03-1409-100 and 03-1409-200.
RECALLING FIRM/MANUFACTURER Rocky Mountain Lions Eye Bank, Aurora, CO.
REASON Human tissue for transplantation, that tested repeatedly reactive for hepatitis B surface antigen (HBsAg) at a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Tissues.
DISTRIBUTION CO.

PRODUCT Whole Blood.
CODE Unit numbers: 8209071, 8209106.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA.
REASON Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Units.
DISTRIBUTION TX.

PRODUCT Platelets Pheresis, Leukocytes Removed.
CODE Unit numbers: 17201-2445, Parts 1 and 2.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen, TX.
REASON Plateletpheresis units, with incorrectly tested platelet counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Units.
DISTRIBUTION TX.

WEEK ENDING JANUARY 24

PRODUCT Human Tissue, CryoVein Saphenous Vein - Model # V010.
CODE Serial Number 798727.
RECALLING FIRM/MANUFACTURER CryoLife, Inc. Kennesaw, GA.
REASON Human tissue, collected from a donor who subsequently tested positive for HBsAg, by another tissue procurement organization, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells, Leukocytes Removed.
b) Red Blood Cells.
c) Recovered Plasma.
CODE
a) Unit numbers: 9562670, 8526630, 8341903;
b) Unit numbers: 6582194, 6990834;
c) Unit numbers: 9562670, 8526630, 6582194, 8341903.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Monroe, LA.
REASON Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION LA, and MI.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 16KF38213.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central Ohio Region, Columbus, OH.
REASON Blood product, collected under conditions where the sterility of the product may have been compromised, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Cryoprecipitated AHF.
CODE Unit 50X20699.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH.
REASON Blood product, collected from a donor who was taking anti-viral medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 15395-0503,15395-0505, 15395-0509.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc. - Lubbock Center, Lubbock, TX.
REASON Blood products, collected from donors with inaccurate hematocrit determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units (12 units) 15395-6206-04710, 5395-7175-04710, 15395-5947-04741, 15395-6049-04741, 15395-6078-04741, 15395-6203-04741, 15395-6239-04741, 15395-5947-04761, 15395-6049-04761, 15395-6078-04761, 15395-6203-04761, 15395-6239-04761
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Lubbock Center, Lubbock, TX.
Manufacturer: Blood Systems, Inc., San Angelo, TX.
REASON Blood products, collected from donors with inaccurate hematocrit determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit number 9559426.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA.
REASON Blood product was not irradiated but was distributed with labeling that indicated that the unit had been irradiated.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.

b) Recovered Plasma.
CODE
a) and b) Unit number 8378473.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA.
REASON Blood products, that were not properly quarantined after the donor of the products reported a post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA and Switzerland.

PRODUCT Red Blood Cells.
CODE Unit numbers 6597472 and 6598271.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Monroe, LA.
REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA.

PRODUCT Red Blood Cells
CODE Unit number 3813097.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Monroe, LA.
REASON Blood product, that tested negative for the antibody to hepatitis B core antigen (anti-HBc), but was collected from a donor that had been previously deferred for reactive testing for anti-HBc, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) Unit numbers 01LT21495 and 01LT26998;
b) and c) Unit number 01LT21495;
d) Unit number 01LT26998.
RECALLING FIRM/MANUFACTURER

Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY.
Manufacturer: American Red Cross Blood Services, Tonawanda, NY.
REASON Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that subsequently reported a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NY and Switzerland.

PRODUCT Recovered Plasma.
CODE Unit 12FV18103.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC.
REASON Blood product, which was collected from a donor with a history of positive test results for hepatitis B and hepatitis C, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Fresh Frozen Plasma.
CODE a), b) and c) unit number 33GK46079.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CT.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 15394-4205, 15394-4234, 15394-4239, 15394-4333, 15394-4335, 15394-4344, 15394-4347, 15394-4391, 15394-4406, 15394-4416, 15394-4472, 15394-4479, 15394-4481, 15394-7700, 15394-7794, 15394-7874, 15394-7977, 15394-8002, 15395-2340, 15394-4345, 15394-4350 (double collection), 15394-4394 (double collection), 15394-7851 (double collection), 15394-4366 (double collection), 15394-7701 (double collection), 15394-7945 (double collection), 15394-3057, 15394-7007.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc. - Lubbock Center, Lubbock, TX.
REASON Blood products, collected from donors with inaccurate hemoglobin determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 34 units.
DISTRIBUTION TX, CO, and NJ.

PRODUCT Platelets, Pheresis, Leukocytes Reduced, Irradiated.
CODE Unit 41FP40550.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL.
REASON Blood product, collected from a donor who was taking Soriatane, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 042J48589.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH.
REASON Blood product, which was collected from a donor who had lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Recovered Plasma.
CODE Units 041FL97032, 041GQ09211, 041GQ06957, 041GQ02065, and 041GQ00398.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL.
REASON Blood products, which were collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 15391-8373.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc. Lubbock Center, Lubbock, TX.
REASON Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX and CA.

PRODUCT Red Blood Cells (Apheresis).
CODE Unit number: 042KW17418.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH.
REASON Blood product, collected on equipment that had not been validated for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Platelets, Leukocytes Reduced.
CODE a) and b) unit number 33GE71687.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CT and CA.

PRODUCT
a) Red Blood Cells, Leukocytes.
b) Platelets, Leukocytes Reduced.
c) Recovered Plasma.
CODE a), b), and c) Unit number 33GM19708.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CT and CA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 17201-4699.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen, TX.
REASON Platelets Pheresis with an elevated platelet count based on volume of product collected were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 18231-2655.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers 41FP39735, 41FP39767, and 41FP39761.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL.
REASON Blood products, that were labeled leukoreduced but were not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION AL.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma
CODE a) and b) Unit number 41GM40739.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL.
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 41GQ07121.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL.
REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 18232-7748.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY.
REASON Blood product, quarantined due to incomplete records, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY.

PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Recovered Plasma.
CODE a) and b) Unit 18231-3841.
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 18232-8571.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc. Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 18232-7057.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc. Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 027LT20986.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Johnstown, PA.
REASON Red Cells, which tested positive for anti-Kell and labeled as negative for unexpected antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WV.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit numbers: 26116-4623, 26116-4643, and 26116-5675.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR.
REASON Blood products, which were incorrectly tested for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION AR.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets Leukocytes Reduced.
CODE a) and b) Unit 1019361.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, UC Medical Center, Cincinnati, OH.
REASON Blood products, which initially tested negative for the antibody to the hepatitis B core antigen (HBcAb) but subsequently tested repeatedly reactive for HBcAb, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH, and FL.

PRODUCT Source Plasma.
CODE Unit numbers 0181090015, 0181089703, 0181089401, 0181089172, 0181088815, 0181088543, 0181088321, 0181088052, 0181087656, 0181087416, 0181087133, 0181086834, 0181086584, 0181085724, 0181085047, 0181084848, 0181084386, 0181084056, and 0181083713.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Columbus, OH.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 19 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Units 0181083790, 0181083737, 0181084335, 0181084690, 0181085009.
RECALLING FIRM/MANUFACTURER ZLB Plasma Services, Columbus, OH.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jakob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) Units 15390-8839, 15394-2270;
b) Unit 15390-8839.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc, Lubbock Center, Lubbock, TX.
REASON Blood products, collected from a donor who had surgery within the past 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 042T23024.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH.
REASON Red Cells, which tested Jk(a-) and labeled as Jk(b-), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT
a) Cryoprecipitated AHF.
b) Fresh Frozen Plasma.
c) Plasma.
CODE
a) Unit numbers 030GK04914, 030GL34689, 030GE33435, 030GL29636, 030GW56970, and 030GN61911;
b) Unit numbers 030GL31093 and 030GW66868;
c) Unit numbers 030GK04914, 030GL29636, and 030GN61911.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA.
REASON Blood products, manufactured from units of Whole Blood that were not correctly documented as to collection status and could not be ruled out as traumatic collections, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION PA, MA, CT, and NY.

PRODUCT
a) Platelets, Leukocytes Reduced.
b) Fresh Frozen Plasma..
CODE a) and b) Unit number 33GK46042.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, manufactured from a unit of Whole Blood that had an extended collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CT.

PRODUCT
a) Platelets, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 33GM19870.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Connecticut Region, Farmington, CT.
REASON Blood products, manufactured from a traumatic collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CT.

PRODUCT Recovered Plasma.
CODE Unit number: 15391-8373.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc. Lubbock Center, Lubbock, TX.
REASON Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX and CA.

PRODUCT Recovered Plasma.
CODE Unit number 33GE71687.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CT and CA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 41GF74423.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AL.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 41GP56186.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL.
REASON Platelets, that were not stored with continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 12Y33579, 12Y33577, 12FV15779, 12733578, 12733576, 12733575, 12Q64287, 12H57731, 12GY56167, 12GY56166, 12GY56165, 12GY56163, 12GY56162, 12GY56152, 12GY54488, 12GY56157, 12GY56156, 12GY56154, 12GY56153, 12GY52527.
RECALLING FIRM/MANUFACTURER The American Red Cross, Carolinas Blood Services Region, Charlotte, NC.
REASON Red Cells, prepared more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 20 units.
DISTRIBUTION NC.

PRODUCT Recovered Plasma.
CODE Unit number: 18232-8571.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY and Switzerland.

PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 12800-2200.
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Albuquerque, NM.
REASON Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NM.

PRODUCT Recovered Plasma.
CODE Unit number: 18232-7057.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY and Switzerland.

PRODUCT
a) Platelets Pheresis, Leukocytes Removed.
b) Plasma.
CODE
a) Unit numbers: 042KW09378 (Parts 1 and 2), 042KW08360 (Parts 1 and 2), 042KW05277 (Parts 1 and 2), 042KW02313 (Parts 1 and 2), 042KW01788 (Parts 1 and 2), and 042KW00619 (Parts 1 and 2);
b) Unit number: 042KW09378.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern Ohio Region, Cleveland, OH.
REASON Blood products, collected from a donor who was on long-term antibiotic therapy, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units.
DISTRIBUTION OH.

PRODUCT
a) Red Blood Cells.

b) Cryoprecipitated AHF.
CODE
a) Units 50X02048, 50X04836, 50Y04501, and 50X10586;
b) Unit 50X02048.
RECALLING/MANUFACTURER American Red Cross Blood Services, Toledo, OH.
REASON Blood products, which were collected from a donor who was taking an anti-viral medication, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MI and OH.

PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 26114-5572
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR.
REASON Blood product, which was incorrectly tested for antigen typing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AR.

PRODUCT Recovered Plasma.
CODE Unit 1019361.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, UC Medical Center, Cincinnati, OH.
REASON Blood products, which initially tested negative for the antibody to the hepatitis B core antigen (HBcAb) but subsequently tested repeatedly reactive for HBcAb, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH, and FL.

WEEK ENDING JANUARY 31

PRODUCT Human Tissues.
CODE
02932 #201 (TNA60) Left hemi-patellar tendon,
02932 #203 (TNR60) Right patellar tendon,
02932 #204 (TAL60) Left achilles tendon,
02932 #205 (TAR60) Right achilles tendon,
02932 #206 (TI060) Anterior tibialis tendon,
02932 #207 (TI060) Anterior tibialis tendon.
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center, DBA Northwest Tissue Center, Seattle, WA.
REASON Human tissue, procured from a donor whose associated tissue was initially positive for Bacteroides species, was implanted. The recipient developed an infection from the same organism.
VOLUME OF PRODUCT IN COMMERCE 6 tissues.
REASON WA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 13GV46511.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON MI.

PRODUCT Source Plasma.
CODE Unit SBG029367.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., South Bend, IN.
REASON Blood product, collected from a donor who did not complete a vCJD increased risk question, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON Spain.

PRODUCT Red Blood Cells.
CODE Units 12LT52149 (Parts 1 & 2).
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC.
REASON Red Cells, lacking quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
REASON NC.

PRODUCT Red Blood Cells, Frozen.
CODE Unit 12GH12550.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC.
REASON Red Cells, labeled with a weight that was below the firm's minimum specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON NC.

PRODUCT Source Plasma.
CODE Units: G-50415-018, G-50068-018, G-48810-018, G-47721-018, G-46289-018, G-46031-018, G-45061-018, G-44782-018, G-43015-018,

G-42574-018, G-41173-018, G-40573-018, G-39338-018, G-38960-018, G-35073-018, G-34108-018, G-33780-018, G-32854-018, G-31635-018,

G-31287-018, G-30525-018, G-30192-018, G-29439-018, G-29150-018, G-28194-018, G-27844-018, G-26894-018, G-26634-018, G-25659-018,

G-25341-018, G-24224-018, G-23770-018, G-12839-018, G-13125-018, G-14386-018, G-14736-018, G-17239-018, G-32515-018.
RECALLING FIRM/MANUFACTURER
Recall Firm: Alpha Therapeutic Corporation, Bakersfield, CA.
Manufacturer: Alpha Therapeutic Corporation, Fresno, CA.
REASON Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 38 units.
REASON CA, Spain, and New Zealand.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 041LP31068, 041LP31055.
FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
REASON AL, and Switzerland.

PRODUCT Source Plasma.
CODE Unit numbers: WN0002859, WN0002877, WG0017369, WG0017512, WG0017728, WG0017870, WG0018254, WG0018375, WG0018600,
WG0018713, WG0018988, WG0019187, WG0019325, WG0019454, WG0019587, WG0019750, WG0019872, WG0019992, WG0020139, WG0020272, WG0020486, WG0020680, WG0020764, WG0020972, WG0021042, WG0021239, WG0021331, WG0021516, WG0021586, WG0021781, WG0021858, WG0022031, WG0022119, WG0022308, WG0022401, WG0022607, WG0022693, WG0022853, WG0022949, WG0023134, WG0023252, WG0023440, WG0023552, WG0023755, and WG0023858.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Wilmington, DE.
REASON Blood products, that tested negative for syphilis, but were collected from an ineligible donor based on previously reactive testing for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 45 units.
REASON Spain.

PRODUCT Red Blood Cells.
CODE Unit number 1999412.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON KY.

PRODUCT Source Plasma.
CODE Unit number 53948342.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Dallas, TX.
REASON Blood product, that tested negative for viral markers, but was collected from a donor that was previously deferred due to risk factor for increased incidence of infection with human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON CA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 17200-5228.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen, TX.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 15392-4572, 15392-7033, and 15393-0711 (Parts 1 & 2).
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock Center, Lubbock, TX.
REASON Blood products, that lacked assurance of proper storage temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
REASON TX.

PRODUCT Source Plasma.
CODE Unit CP21278.
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Colton, CA.
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON Austria.

PRODUCT Source Plasma.
CODE Unit CT100496.
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Colton, CA.
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON Austria.

PRODUCT Recovered Plasma.
CODE Units 041LP31068, 041LP31055.
FIRM/MANUFACTURER American Red Cross Blood Services, Birmingham, AL.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
REASON AL, and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 26117-1784.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR.
REASON Blood product, that was not properly quarantined after the receipt of post donation information concerning medication with an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
REASON AR.