MAY 2002
WEEK ENDING MAY 4
PRODUCT Red Blood Cells,
Leukoreduced.
CODE Unit 10710-8430.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturing: United Blood Services, Scottsdale, AZ.
REASON Blood product, which had a questionable weight, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT Red Blood Cells (Split
unit).
CODE Unit 7475468.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford,
TX
REASON Blood product, collected on equipment that had not
been validated for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells.
CODE Unit 7569915.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford,
TX
REASON Blood product, collected on equipment that had not
been validated for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Platelets
CODE a) Unit numbers 13GQ38081 and 13FM67664; b) Unit
numbers 13FJ70697 and 13GQ49909; c) Unit numbers 13FJ70697, 13GQ49909, and
13FM67664.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Southeastern Michigan Region, Detroit, MI
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 7 units.
DISTRIBUTION MI.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets; c) Recovered Plasma
CODE a) ; b) and c) Unit number 13FF26684.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Southeastern Michigan Region, Detroit, MI
REASON Blood products, that tested negative for viral
markers, but were collected from a donor that subsequently admitted to multiple
risk
factors for increased incidence of infection with human immunodeficiency virus
(HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI and Switzerland.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number GS12348.
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino
and Riverside Counties, San Bernadino, CA
REASON Blood product, that was labeled leukoreduced but had
an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 13FR21364.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Southeastern Michigan Region, Detroit, MI
REASON Blood product, collected from an ineligible donor,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Source Plasma
CODE Unit numbers TO359049, TO359002, TO358943, TO358916,
TO358858, TO358824, TO358766, TO358738, TO358674, TO358650, TO358586, TO358558,
TO358418, TO358339, TO358306, TO358208, TO358165, TO358075, TO358036, TO357956,
TO357920, TO357826, TO357798, TO357693, TO357649, TO357544, TO357503, TO357415,
TO357378, TO357172, TO357125, TO357008, TO356965, TO356790, TO356725, TO356593,
TO356545, TO356429, TO356364, TO356258, TO356208, TO356107, TO356054, TO355954,
TO355903, TO355715, and TO355685.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec
Biologicals Limited Partnership, BioLife Plasma Services, L.P., North
Brunswick, NJ Manufacturer: Sera-Tec Biologicals Limited Partnership,
Toledo, OH.
REASON Blood products, that tested negative for the
antibody to hepatitis C virus (anti-HCV), but were collected from a donor
that
previously tested repeatedly reactive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 47 units.
DISTRIBUTION MA.
PRODUCT Source Plasma
CODE Unit numbers 05008704, 05010097, 03932537, 03933886,
03936306, 03937860, 03940273, 05271764, 26815831, 26819372, 26921389,
26922638,
26924526, 26925806, 26927213, 26928425, 26930114, 24771405, 24772884, 24774475,
24776462, 24777841, 24779708, 24731201, 24733069, 24734301, 24735773, 24737012,
24739764, 24740364, 30133105, 30133693, 30135741, 30136373, SD690332, SD690349,
SD690422, SD690434, SD690492, SD690524, SD690559, SD690590, SD690639, and
SD690681.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec
Biologicals Limited Partnership, BioLife Plasma Services, L.P., North
Brunswick, NJ Manufacturer: Sera-Tec Biologicals Limited Partnership,
BioLife Plasma Services, L.P., Dayton, OH.
REASON Blood products, that tested negative for the
antibody to hepatitis C virus (anti-HCV), but were collected from a donor
that
previously tested repeatedly reactive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 44 units.
DISTRIBUTION CA and MA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number FG47702.
RECALLING FIRM/MANUFACTURER Healthcare Provider
Services, Inc., dba Rhode Island Blood Center,Providence, RI
REASON Blood product, collected from a donor that did not
have a hematocrit or hemoglobin test during the donor screening
process,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets,
Leukocytes Reduced; c) Fresh Frozen Plasma.
CODE a) ; b) and c) Unit number FM47817.
RECALLING FIRM/MANUFACTURER Healthcare Provider
Services, Inc., dba Rhode Island Blood Center, Providence, RI
REASON Blood products, collected from an unsuitable donor
based on body piercing within the previous twelve months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MA and RI.
PRODUCT a) Platelets, Leukocytes Reduced; b) Fresh Frozen
Plasma
CODE a) and b) Unit number FK39798.
RECALLING FIRM/MANUFACTURER Healthcare Provider
Services, Inc., dba Rhode Island Blood Center, Providence, RI
REASON Blood products, collected from an ineligible donor
due to use of the medication Coumadin at the time of donation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION RI.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) and b) Unit number 22LN86137.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Penn-Jersey Region, Philadelphia, PA.
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 PA.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma
CODE a) ; b) and c) Unit number 22LQ87649.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Penn-Jersey Region, Philadelphia, PA
REASON Blood products, that were not appropriately
quarantined after the donor, subsequent to the donation of the recalled
products,
reported
behavior known to increase risk of infection with human immunodeficiency virus
(HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NJ and PA.
PRODUCT Source Plasma
CODE Unit number 00CIAA4989.
RECALLING FIRM/MANUFACTURER Community Bio-Resources,
Inc., Cedar Rapids, IA
Firm
on label: Community Bio-Resources, Inc., Grand Rapids, MI.
REASON Blood product, collected from an ineligible donor
due to recent application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.
PRODUCT Source Plasma
CODE Unit numbers 00CIAC1994, 00CIAC1474, and 00CIAB5628.
RECALLING FIRM/MANUFACTURER Community Bio-Resources,
Inc., Cedar Rapids, IA
Firm
on label: Community Bio-Resources, Inc., Grand Rapids, MI.
REASON Blood products, collected from donors whose medical
history screening did not include questioning regarding risk factors for
variant
Creutzfeldt-Jacob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Austria.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 50C13227.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Western Lake Erie Region, Toledo, OH
REASON Blood product, collected from a donor who had a
history of drug use, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit
21KL40355.
RECALLING FIRM/MANUFACTURER American Red Cross, Pacific
Northwest Regional Blood Services,Portland, OR
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 CA.
PRODUCT Platelets
CODE Unit number 4103784.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
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 1 unit.
DISTRIBUTION TX and NJ.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets
CODE a) Unit numbers 3982598 and 4068621; b) Unit number
4068621.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
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 3 units.
DISTRIBUTION TX.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets
CODE a) and b) Unit number 4048712.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
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 TX and NJ.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets
CODE a) and b) Unit number 4017059.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
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 TX and NJ.
PRODUCT a) Red Blood Cells; b) Platelets Irradiated
CODE a) Unit numbers 3619763 and 3643393; b) Unit number
3619763.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
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 3 units.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 4125752.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
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 TX.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 11330-2731.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El
Paso, TX
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 TX.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Recovered
Plasma
CODE a) and b) Unit number 11329-1769.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El
Paso, TX
REASON Blood products, collected from an ineligible donor
due to medication with the drug Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and VA.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets; c) Recovered Plasma
CODE a) and c) Unit numbers 4124849, 4025209, and
4006335; b) Unit number 4124849.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
REASON Blood products, collected from a donor who should
have been deferred due to use of the medication Arthrotec, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION TX and PA.
PRODUCT a) Platelets Pheresis, Leukocytes Reduced; b)
Platelets Pheresis, Leukocytes Reduced Irradiated; c) Plasma
CODE a) Unit numbers 4104172, 4083014, and 4082903; b)
Unit number 4082903; c) Unit number 4104130.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
REASON Blood products, collected from a donor who should
have been deferred due to use of the medication Arthrotec, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION TX.
PRODUCT Source Plasma
CODE Unit numbers TO361990, 57122083, 58843956, 59159810,
59155492, 59153320, 59098201, 59030706, 59092094, 59031321, 59160076,
59034964,
59040316, 59156444, 59034650, 59032465, 59159483, 59038511, 59036692, 59159360,
59156581, 59100430, 59037453, 59160410, 59039280, 59036739, 59097877, 59152880,
59153269, 59156987, 61142534, 61157996, 61263703, 61268210, 61265851, 61261778,
61159327, 61155411, 61262348, 61151383, 61153325, 61262904, 61260849, 61263017,
61144729, 61140639, 61261297, 61144439, 61149915, 61147454, 61144323, 61262249,
61149854, 61143807, 61267596, 61262812, 61157347, 61263291, 61157859, 61152809,
61153493, 61143524, 61267855, 61267848, 61151727, 61159747, 61267800, 61265943,
61262744, 61267886, 61264342, 61266858, 61159914, 61154827, 61151895, 61147249,
61154209, 61266773, 61158269, 61159815, and 61263666.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sera-Tec Biologicals Limited Partnership,
BioLife Plasma Services, L.P., North Brunswick, NJ Manufacturer: Sera-Tec
Biologicals Limited Partnership, BioLife Plasma Services, L.P., Toledo,
OH.
REASON Blood products, that tested negative for viral
markers, but were collected from donors whose medical history screening was
inadequately
performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 81 units.
DISTRIBUTION CA and Germany.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Red Blood Cells, Irradiated; d) Red Blood Cells, Leukocytes Reduced
Irradiated,
CODE a) Unit numbers 22LW49435, 22FK85781, 22KT24204,
22GE53036, 22GE53039, 22GE53040, 22GE53041, 22GE53061, 22LW49490, 22KW22284, 22LV67872, 22LV67866, 22FM95319,
22GK75839, 22GK75846, 22GW67635, 22GW67636, 22GY96255, 22KC20140, 22KC20142,
22KX32016, 22GK68981, 22GK68982, 22GY96254, 22KM50552, 22KZ34950, 22LN84521, 22LN84524,
22LN84530, 22GY96251, 22KC18530, 22KP41999, 22KZ34936, 22FM95323, 22GE53044,
22GK68983, 22KC18526, 22KC18528, 22KK33210, 22KK33211, 22KT24206, 22KZ34937,
22KZ34938, 22KZ34940, 22LQ77081, 22LV67867, 22LV67873, 22LV67874, 22FK85793,
22GY96262, 22GY96263, 22GT99139, 22KZ34922, 22FK85790, 22FM95322, 22GE53038,
22GK75841, 22GY96248, 22GY96256, 22GY96264, 22GY96265, 22KC18529, 22KX23999,
22KX32005, 22LN84522, 22LN84526,
22LN84528, 22LN84529, 22LV67871, 22LW49566, 22GY96258, 22GY96260, 22KK33208,
22KK33209, 22KZ34939, 22FK85734, 22LQ77061, 22FM95321, 22KM50555, 22FK85797,
22KX32006, 22KZ34945, 22LQ77053, 22GK68976, 22KN16964, 22KX32001, 22KX32002,
22LV67858, 22FK85736, 22LQ77000, 22FK85779, 22KJ51781, 22KM50542, 22KM50544,
22KM50546, 22GE53047, 22KZ34947, 22FM95320, 22KP52002, 22LV67870, 22GE53037,
22KJ51779, 22KZ34921, 22GK68973, 22GW67631, 22KC18527, 22KZ34941, 22KZ34944,
22GT99092, 22FK85757, 22FK85758, 22FW74414, 22FW74415, 22GE53060, 22GE53082,
22GK75840, 22GW67638, 22KK33213, 22KZ34943,
22LQ77050,
22LQ77067, 22GY96257, 22GY96259, 22GY96261, 22GY96266, 22KN16960, 22KN16961,
22KN16962, 22KT24205, 22KX23998;
b)
Unit numbers 22GE53081, 22FW74407, 22GW67633, 22KK33214, 22LQ77082, 22KC18522,
22LN84525, 22FM95310, 22GY96202,
22GE53042, 22GE53046, 22KC18535, 22KN16963, 22LN84527, 22LW49491, and
22GK68980;
c)
Unit numbers 22FK85735, 22FK85773, 22KC18533, 22KM50554, 22KX24000, 22LV67869,
22GE53045, 22GW67637, 22KC18523, 22KM50553, 22GY96249, 22KJ51780, 22KJ51782,
22FW74410, 22GK68974, 22GK68979, 22GW67634, 22GY96246, 22GY96247, 22KM50556,
22KN19887, 22KZ34946, and 22LY72573;
d)
Unit numbers 22LQ77005, 22LV67859, 22KK33212, 22LV67861, 22KC18524, 22KC18534,
22KN16959, 22KZ34949, 22GE52979, 22GK68975, and 22LY72595.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Penn-Jersey Region, Philadelphia, PA
REASON Blood products, that may have been out of
specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE 180 units.
DISTRIBUTION NJ and PA.
PRODUCT Source Plasma
CODE Unit number 99CIAF1089.
RECALLING FIRM/MANUFACTURER Community Bio-Resources,
Inc., Cedar Rapids, IA
Firm
on label: Community Bio-Resources, Inc., Grand Rapids, MI.
REASON Blood product, that tested negative for viral
markers, but was collected from a donor whose medical history screening was
inadequately
performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.
PRODUCT Source Plasma
CODE Unit number 99CIAC0832.
RECALLING FIRM/MANUFACTURER Community Bio-Resources,
Inc., Cedar Rapids, IA
Firm
on label: Community Bio-Resources, Inc., Grand Rapids, MI.
REASON Blood product, collected from an ineligible donor
due to recent immunization with hepatitis B vaccine, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.
PRODUCT Source Plasma
CODE Unit number 99CIAF3129.
RECALLING FIRM/MANUFACTURER Community Bio-Resources,
Inc., Cedar Rapids, IA
Firm
on label: Community Bio-Resources, Inc., Grand Rapids, MI.
REASON Blood product, collected from an ineligible donor
due to recent immunization with hepatitis B vaccine, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.
PRODUCT a) Red Blood Cells; b) Red Blood Cells,
Leukoreduced; c) Red Blood Cells, For Further Manufacturing Use Only
CODE a) Units 21FM59725, 21GC85348, 21GC85353, 21GC85369,
21GV05804, 21KL21586, 21KL21591, 21KL21618, 21KM14182, 21KM14206,
21KR08135, 21KR08155, 21KR08307, 21KR08308,
21KR08310, 21KR08311, 21KR08317, 21KR08329;
b)
Units 21FL41218, 21FL41230, 21FM59572, 21FM59590, 21FM59593, 21FM59608, 21FQ10839,
21GY62093, 21KE08539, 21KE08543,
21KG32929, 21KJ35096, 21KJ35099, 21KK24167, 21KK24250, 21KL21512,
21KL21519;
c)
Units 21KL21516, 21KL21550.
RECALLING FIRM/MANUFACTURER American Red Cross, Pacific
Northwest Regional Blood Services, Portland, OR
REASON Blood products, which were stored at incorrect
temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 37 units.
DISTRIBUTION CA and MI.
PRODUCT Source Leukocytes
CODE Unit number 4103784.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center,
Houston, TX
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 1 unit.
DISTRIBUTION TX and NJ.
PRODUCT Source Leukocytes
CODE Unit numbers 3988510 and 4048712.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
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 TX and NJ.
PRODUCT Source Leukocytes
CODE Unit number 4017059.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
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 1 unit.
DISTRIBUTION TX and NJ.
PRODUCT Antihemophilic Factor (recombinant), Kogenate
CODE Lot number 670J039.
RECALLING FIRM/MANUFACTURER Bayer Corporation, Berkeley,
CA
REASON Antihemophilic factor, that may exhibit decreased
potency when stored at room temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 lot.
DISTRIBUTION Nationwide and Taiwan.
WEEK
ENDING MAY 11
PRODUCT a) Red Blood Cells; b) Red Blood
Cells, Leukocytes Reduced; c) Fresh Frozen Plasma.
CODE a) Unit Numbers: 53FE38703,
53FE38710, 53FE38712, 53GF14940, 53GF14941, 53GF14943, 53GF15017, 53GF15018,
53GF15019, 53GF15020, 53GF15021, 53GF15022, 53GF15023, 53GF15024, 53GF15043,
53GF15044, 53GF15045, 53GF15048, 53GF15049, 53GF15063, 53GF15064, 53GF15065,
53GF15066, 53GF15067, 53GF15068, 53GF15087, 53GF15088, 53GF15089, 53GF15090,
53GF15091, 53GF15092, 53GF15132, 53GF15133, 53GF15134, 53L95008, 53L95009,
53L95010, 53L95011, 53L95012, 53FL61648, 53FL61649, 53FL61650, 53FL61651,
53FL61652, 53FL61654, 53FL61655, 53FL61656, 53FL61657, 53FL61658, 53FL61659,
53FL61660, 53FL61662, 53FL61663, 53FL61664, 53FL61665, 53FL61666, 53FL61667,
53FL61668, 53FL61669, 53FL61670, 53FL61671, 53FK40381, 53FK40384, 53FK40385,
53FP11665, 53FP11666, 53FP11667, 53FP11668, 53FL61814, 53FL61834, 53FL61836,
53FL61837, 53FJ43839, 53FJ43840, 53FJ43841, 53FJ43842, 53FJ43843, 53FJ43844,
53FJ43845, 53FJ43847, 53FJ43848, 53FJ43849, 53FJ43850, 53FJ43852, 53FJ43853,
53FJ43854, 53FJ43855, 53FJ43856, 53FJ43857, 53FJ43858, 53FJ43859, 53FJ43860,
53FJ43861, 53FJ43862, 53FJ43863, 53FJ43864, 53FJ43865, 53FJ43867, 53GV21812,
53FJ43905, 53GR10346, 53GR10347, 53Y67539,
53Y67540, 53Y67576, 53Y67577, 53GV21496, 53GV21497, 53GV21498,
53GV21499, 53GV21500, 53GV21501, 53GV21502, 53GV21503, 53GV21504, 53GV21505,
53GV21506, 53GV21510, 53GV21526, 53GV21527, 53FP11410, 53FM16938, 53FM16939,
53FM16940, 53FM16941, 53M68875,
53M68876, 53M68877, 53M68878,
53M68879, 53M68880, 53FN36829, 53FN36832, 53FJ43517, 53FJ43518,
53FJ43519, 53FJ43520, 53FJ43521, 53FJ43522, 53FJ43531, 53FJ43532, 53FJ43533,
53FJ43534, 53FJ43535, 53FJ43536, 53FJ43537, 53FJ43538, 53FJ43539, 53FJ43541,
53FJ43542, 53FJ43543, 53FJ43544, 53FJ43545, 53FJ43546, 53FJ43553, 53FJ43554,
53FJ43555, 53FJ43602, 53FJ43603, 53FJ43604, 53GQ55535, 53T44878, 53T44879,
53GC08568, 53GL88735, 53GL88740, 53GL88742, 53GL88745, 53GL88746,
53GL88747, 53GC08566, 53GC08569, 53GC08572, 53GC08573, 53GC08574, 53FE37524,
53Z17569, 53Z17570, 53Z17571, 53Z17572,
53Z17573, 53Z17574, 53FL60442,
53FL60443, 53FL60445,
53LL27415, 53LL27416,
53LL27417, 53LL27418, 53LL27419, 53LL27420, 53LL27421, 53LL27425, 53LL27426,
53FJ41836, 53FJ41837, 53FJ41838,
53FJ41839, 53FJ41840,
53FJ41841, 53FJ41842, 53FJ41843, 53FJ41844, 53FJ41857, 53FJ41858, 53FJ41859,
53FJ41860, 53FJ41861, 53FJ41862,
53FJ41863, 53FJ41864,
53FJ41865, 53FJ41866, 53FJ41867, 53FJ41868, 53FJ41869, 53FJ41870, 53FJ41871,
53FJ41872, 53FJ41873, 53FJ41874,
53FJ41875, 53FJ41876;
b) Units 53GF14939,
53GF14942, 53Y67541, 53Y67575;
c) Units 53GF15022,
53GF15043, 53GF15047, 53GF15063, 53FJ43862, 53GV21498, 53GV21500, 53M68875,
53FJ43532, 53GC08568, 53GL88742,
53GC08569, 53LL27422,
53FJ41842, 53FJ41859, 53FJ43847, 53FN36829.
RECALLING
FIRM/MANUFACTURER American Red Cross, Greater Chesapeake and Potomac Region, Baltimore,
MD
REASON Blood products, that were
produced from 500 ml units of Whole Blood that were collected in 450 ml bags,
were distributed.
VOLUME OF
PRODUCT IN COMMERCE 237 units.
DISTRIBUTION
MD,
VA, Washington DC, PA, GA and Puerto Rico.
PRODUCT a) GS National Weed Mix; b)
Candida/Monilia albicans; c) GS Mold Mix; d) Box Elder.
CODE a) Lot P32181A2; b) Lot
M15532A6; c) Lot M0337B3A2; d) Lot 82461A6.
RECALLING
FIRM/MANUFACTURER Greer Laboratories, Inc., Lenoir, NC
REASON Allergenic extracts, which
were labeled with an incorrect concentration of 1:20 w/v instead of the correct
concentration of 1:10 w/v, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 6 vials.
DISTRIBUTION
NJ,
NY, TX, VA and Thailand.
PRODUCT Gamimune? N, 10% (Immune
Globulin Intravenous)
CODE Lots 648X078 and 648X062.
RECALLING
FIRM/MANUFACTURER Bayer Corp., Clayton, NC
REASON Intravenous drug PRODUCTs,
which contained particulate matter, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 8,961 vials.
DISTRIBUTION
Nationwide.
PRODUCT a) Red Blood Cells,
Leukocytes Reduced; b) Platelets; c) Cryoprecipitated AHF; d) Source
Leukocytes; e) Recovered Plasma.
CODE a) and b) Unit numbers
3910061 and 3940851; c) Unit number 3940851; d) and e) Unit number 3910061.
RECALLING
FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood products, that tested
negative for hepatitis, but were collected from an ineligible donor due to a
previous donationís association with a case of post transfusion hepatitis, were
distributed.
VOLUME OF
PRODUCT IN COMMERCE 7 units.
DISTRIBUTION
TX and
NJ.
PRODUCT a) Red Blood Cells,
Leukocytes Reduced; b) Cryoprecipitated AHF; c) Recovered Plasma.
CODE a), b) and c) Unit number
4036819.
RECALLING
FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood products, that tested
negative for viral markers, but were collected from an ineligible donor due to
behavior known to increase risk of infection with human immunodeficiency virus
(HIV), were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units.
DISTRIBUTION
TX and
NJ.
PRODUCT a) Red Blood Cells; b) Red
Blood Cells, Leukocytes Reduced Irradiated; c) Platelets;
d) Cryoprecipitated AHF; e)
Fresh Frozen Plasma; f) Source Leukocytes; g) Recovered Plasma.
CODE a) Unit number 3688363; b)
Unit numbers 3891739 and 4078543; c) Unit numbers 3688363 and 3891739; d) Unit
number 4078543;
e) Unit 3688363 and 3891739;
f) Unit number 3688363; g) Unit number 4078543.
RECALLING
FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood products, that tested
negative for viral markers, but were collected from an ineligible donor due to
behavior known to increase risk of infection with human immunodeficiency virus
(HIV), were distributed.
VOLUME OF
PRODUCT IN COMMERCE 10 units.
DISTRIBUTION
TX, CA
and NJ.
PRODUCT Source Plasma
CODE Unit number T-61446-011.
RECALLING
FIRM/MANUFACTURER Alpha Therapeutic Corp., City of Industry, CA
REASON Source Plasma was not
properly quarantined and was distributed after the receipt of information that
disqualified the donor of the product.
VOLUME OF
PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION
CA.
PRODUCT Source Plasma.
CODE Unit numbers G-72002-072,
G-70794-072, G-69959-072, G-66335-072, G-64132-072, G-63667-072, G-62160-072,
G-60922-072, G-60210-072, G-59372-072, and G58697-072.
RECALLING
FIRM/MANUFACTURER Alpha Therapeutic Corp., City of Industry, CA
REASON Source Plasma, that tested
negative for hepatitis B, but were collected from a donor that the recalling
firm was notified had previously tested positive for hepatitis B by the
polymerase chain reaction assay, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 11 units.
DISTRIBUTION
Spain
and Sweden.
PRODUCT Source Plasma.
CODE Unit numbers: GN0000435,
GN0000441, GG0003350, GG0003476, GG0003526, GG0003674, GG0003745, GG0003866,
GG0003932, GG0004038, GG0004141, GG0004174, and GG0004357.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Sera Care,
Inc., American Plasma, Inc., Colorado Springs, CO
Manufacturer: Sera Care, Inc., American Plasma, Inc.,
Pasadena, TX.
REASON Blood products, collected
from an unsuitable donor due to a history of residing in the United Kingdom for
more than 6 months, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 13 units.
DISTRIBUTION
Spain.
PRODUCT Red Blood Cells, Leukocytes
Reduced.
CODE Unit number 06LK46053.
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Southern California Region, Los
Angeles, CA
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
CA.
PRODUCT Red Blood Cells, Leukocytes
Reduced.
CODE Unit number 07FV01589.
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Arizona Region, Tucson, AZ
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
PA.
PRODUCT Red Blood Cells, Leukocytes
Reduced.
CODE Unit number 36262-4102.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems,
Inc., Ventura, CA.
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
CA.
PRODUCT Platelets Pheresis,
Leukocytes Reduced.
CODE Unit numbers GK26054,
GK23475, GK25054, and GJ84134.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Tri-Counties Blood Bank, Santa Barbara, CA.
REASON Blood products, collected
from donors whose health history screening was inadequately performed in that
the donors were not questioned about the recent use of aspirin, were
distributed.
VOLUME OF
PRODUCT IN COMMERCE 4 units.
DISTRIBUTION
CA.
PRODUCT a) Red Blood Cells; b) Fresh
Frozen Plasma.
CODE a) Unit numbers 4027280 and
4036581; b) Unit number 4034722
RECALLING
FIRM/MANUFACTURER Recalling Firm: Department of
the Navy, Bureau of Medicine and Surgery, Navy Blood Program Office,
Washington, DC Manufacturer: Naval
Medical Center, San Diego, CA.
REASON Blood products, that tested
negative for the antibody to hepatitis C virus (anti-HCV), but were collected
from unsuitable donors based previous repeatedly reactive testing for anti-HCV,
were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units.
DISTRIBUTION
NV, MD
and CA.
PRODUCT Platelets
CODE Unit number 4165088.
RECALLING
FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood product, collected
from a donor for which documentation of the inspection of the adequacy of the
venipuncture site was not available, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION
TX.
PRODUCT a) Red Blood Cells; b) Red
Blood Cells, Leukocytes Reduced; c) Red Blood Cells, Leukocytes Reduced
Irradiated; d) Platelets;
e) Platelets Irradiated; f)
Cryoprecipitated AHF; g) Plasma; h) Fresh Frozen Plasma; i) Source Leukocytes;
j) Recovered Plasma.
CODE a) Unit number 4054997l;
b) Unit numbers 4054961, 4054967, 4054972, 4054973, 4054978,
4054983, 4054999, 4055001, 4055004, 4061730, 4061732, 4061733, 4061736,
4061739, 4061745, 4061748, 4061750, 4064453, 4064455, 4064457, 4064466,
4064468, 4064470, 4064474, 4064475, 4064480, 4064493, 4064495, 4064501,
4054502, 4064505, 4064507, 4064509, 4064511, 3993353, 4051254, 4051258,
4051258, 4051260, 4051260, 4051261, 4051265, 4051275, 4051278, 4051283, 4051292,
4051297, 4051304, 4051308, 4084598, 4084601, 4084603, 4084605, 4084607,
4084608, 4084611, 4084613, 4084616, 4084618, 4032420, 4032427, 4049648,
4051311, 4051316, 4051318, 4084226, 4084240, 4084241, 4084243, 4084246,
4084250, 4063092, 4063095, 4063101, 4063111, 4063118, 4063118, 4063125,
4063160, 4066609, 4066596, 4066613, 4066616, 4066620, 4083955, 4083962,
4083976, 4083977, 4083994, 4083998, 4084207, 4084208, 4084008, 4084011,
4084013, 4084017, 4084024, 4084029, 4027681, 4027683, 4051362, 4051364, 4084114,
4084119, 4084123, 4084128, 4084132, 4084135, 4084143, 4084146, 4084148,
4084151, 4084154, 4084156, 4084158, 4084160, 4084163,
4084175, 4084179, 4125062,
4125068, 4125078, 4125081, 4125083, 4125087, 4125089, 4125089, 4125093,
4125099, 4125100, 4125107, 4125114, 4125115, 4125121, 4125125, 4125129,
4125131, 4125134, 4125139, 4125143, 4125150, 4123563, 4123568, 4090942,
4090974, 4091044, 4030990, 4030990, 4030994, 4030998, 4030998, 4031002,
4031005, 4031005, 4031010, 4068890, 4068896, 4068919, 4068685, 4063995,
4068703, 4068708, 4031000, 4125075, and 4031000;
c) Unit numbers 4054986,
4027694, 4068879, and 4068938;
d) Unit numbers 4054961, 4054962, 4054967, 4054972, 4054973, 4054978, 4054983, 4054986, 4054997, 4055001, 4061730, 4061732, 4061733, 4061736, 4061739, 4061745, 4061748, 4061750, 4064453, 4064459, 4064466, 4064468, 4064470, 4064474, 4064493, 4064495, 4064501, 4054502, 4064505, 4064507, 4064509, 4064511, 3993353, 4051254, 4051261, 4051265, 4051275, 4051278, 4051283, 4051297, 4051304, 4051308, 4084598, 4084601, 4084603, 4084605, 4084607, 4084608, 4084611, 4084613, 4084616, 4032420, 4049648, 4051311, 4051316, 4051318, 4084226, 4084237, 4084240, 4084241, 4084246, 4084250, 4063092, 4063095, 4063111, 4066609, 4066596, 4066613, 4066616, 40666