AUGUST 2002
WEEK ENDING AUGUST 3
PRODUCT Source Plasma
CODE Unit 0100410961
RECALLING FIRM/MANUFACTURER Nabi, Chattanooga, TN
REASON Blood product, collected in a manner that
compromises the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT Source Plasma
CODE Unit 35256991.
RECALLING FIRM/MANUFACTURER Nabi, Johnson City, TN
REASON Blood product, collected in a manner that
compromises the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit 35354109.
RECALLING FIRM/MANUFACTURER Nabi, Johnson City, TN
REASON Blood product, collected from a donor who had not
completed the CJD/nvCJD increased risk questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT a) Platelets Pheresis, Leukocytes Reduced; b)
Platelets Pheresis, Leukocytes Reduced Irradiated
CODE a) Unit numbers GS08939, GS08942, GS08947, GS08949,
GS08955, GS08965, GS08966, GS08974, GS08976, GS08982, GS08984, GS09003,
GS09013, GS09020, GS09029, GS09039, GS09073, GS09088, GS09101, GS09124,
GS09885, GS09887, GS09889, GS09897, GS09904, GS09920, GS09925, GS09929,
GS09939, GS09956, GS09967, GS09974, GS09979, GS09981, GS09987, GS09992,
GS10005, GS10023, GS10028, GS10231, GS11132, GS11134, GS11139, GS11142,
GS11144, GS11152, GS11155, GS11156, GS11158, GS11175, GS11186, GS11194,
GS11198, GS11207, GS11208, GS11216, GS11218, GS11227, GS11230, GS11236,
GS11242, GS11254, GS11261, GS12296, GS12300, GS12308, GS12324, GS12334,
GS12340, GS12346, GS12348, GS12352, GS12357, GS12358, GS12361, GS12362,
GS12363, GS12364, GS12374, GS12377, GS12379, GS12381, GS12384, GS12385,
GS12386, GS12389, GS12391, GS12394, GS12395, GS12396, GS12397, GS12404,
GS12405, GS12406, GS12407, GS12411, GS12417, GS12424, GS12427, GS12429,
GS12433, GS12434, GS12436, GS12441, GS12460, GS12470, GS12473, GS12474,
GS12476, GS12478, GS12491, GS12495, GS12498, GS12500, GS12501, GS12502,
GS12503, GS12507, GS12508, GS12514, GS12523, GS12526, GS12530, GS12537,
GS12541, GS12542, GS12544, GS12546, GS12549, GS12550, GS12551, GS12554,
GS12558, GS12560, GS12562, GS12563, GS12565, GS12568, GS12569, GS12570,
GS12572, GS12574, GS12575, GS12576, GS12581, GS12583, GS12584, GS12588, GS12589,
GS12597, GS12598, GS12611,
GS12627,
GS12629, GS12645, GS12653, GS12655, GS12660, GS12666, GS12667, GS12669,
GS12672, GS12677, GS12684, GS12687, GS12691, GS12694, GS12695, GS12696,
GS12708, GS12711, GS12719, GS12722, GS12723, GS12732, GS12734, GS12735,
GS12737, GS12744, GS12745, GS12747, GS12752, GS12755, GS12759, GS12762,GS12769,
GS12772, GS12773, GS12778, GS12787, GS12788, GS12789, GS12792, GS12795,
GS12800, GS12817, GS12839, GS12840, GS12841, GS12844, GS12855, GS12858,
GS12864, GS12872, GS12873, GS12883, GS12884, GS12890, GS12892, GS12895,
GS12896, GS12899, GS12904, GS12916, GS12917, GS12918, GS12919, GS12921,
GS12926, GS12927, GS12929, GS12947, GS12948, GS12955, GS12957, GS12970,
GS12971, GS12972, GS12974, GS12977, GS12988, GS12989, GS09909, GS12332,
GS12370, GS09014, GS09030, GS09045, GS09054, GS09092, GS09105, GS09948,
GS09959, GS09961, GS09977, GS09988, GS10010, GS10229, GS11135, GS11143,
GS11148, GS11159, GS11161, GS11164, GS11169, GS11171, GS11172, GS11195,
GS11196, GS11209, GS11212, GS11213, GS11219, GS11229, GS11247, GS11248,
GS11251, GS11256, GS12298, GS12303, GS12306, GS12307, GS12322, GS12329,
GS12367, GS12399, GS12410, GS12431, GS12450, GS12452, GS12457, GS12459,
GS12462, GS12464, GS12469, GS12471, GS12472, GS12475, GS12477, GS12482, GS12499,
GS12505, GS12519, GS12532, GS12547, GS12556, GS12557, GS12567, GS12571,
GS12580, GS12582, GS12595, GS12621, GS12626, GS12636, GS12641,
GS12681,
GS12693, GS12704, GS12706, GS12707, GS12709, GS12715, GS12721, GS12724,
GS12736, GS12749, GS12750, GS12756, GS12763, GS12777, GS12780, GS12785,
GS12793, GS12798, GS12807, GS12810, GS12816, GS12818, GS12822, GS12823,
GS12830, GS12834, GS12845, GS12848, GS12849, GS12852, GS12859, GS12863,
GS12874, GS12882, GS12888, GS12897, GS12909, GS12915, GS12932, GS12934, GS12936,
GS12939, GS12940, GS12942, GS12945, GS12946, and GS12984;
and
the following unit numbers were distributed as two split units: GS08954,
GS08975, GS08986, GS08989, GS09012, GS09035, GS09037, GS09040, GS09046,
GS09050, GS09055, GS09059, GS09061, GS09067, GS09068, GS09087, GS09095,
GS09096, GS09110, GS09115, GS09118, GS09888, GS09891, GS09900, GS09910,
GS09912, GS09919, GS09931, GS09943, GS09946, GS09950, GS09957, GS09973,
GS09976, GS09984, GS10007, GS10009, GS10029, GS11131, GS11133, GS11136,
GS11137, GS11140, GS11141, GS11145, GS11147, GS11149, GS11153, GS11163,
GS11165, GS11166, GS11167, GS11168, GS11173, GS11174, GS11176, GS11178,
GS11180, GS11182, GS11183, GS11184, GS11187, GS11189, GS11190, GS11191,
GS11192, GS11198, GS11199, GS11200, GS11201, GS11202, GS11206, GS11211,
GS11214, GS11215, GS11217, GS11221, GS11222, GS11224, GS11225, GS11226,
GS11228, GS11231, GS11232, GS11233, GS11234, GS11237, GS11238, GS11239,
GS11241, GS11243, GS11244, GS11245, GS11246, GS11249, GS11253, GS11255,
GS11257, GS11258, GS11259, GS11260, GS11262, GS12295, GS12297, GS12299,
GS12302, GS12304, GS12305, GS12310, GS12312, GS12313, GS12315, GS12316,
GS12317, GS12319, GS12320, GS12321, GS12323, GS12325, GS12326, GS12327,
GS12330, GS12331, GS12333, GS12335, GS12336, GS12337, GS12338, GS12339,
GS12341, GS12342, GS12343, GS12344, GS12347, GS12351, GS12353, GS12360,
GS12365, GS12366, GS12368, GS12369, GS12371, GS12372, GS12375, GS12376,
GS12380, GS12382, GS12387, GS12388, GS12390, GS12392, GS12393, GS12398,
GS12401, GS12402, GS12403, GS12408, GS12409, GS12412, GS12413, GS12414,
GS12415, GS12416, GS12418, GS12419, GS12420, GS12421, GS12422, GS12423,
GS12425, GS12426, GS12430, GS12435, GS12437, GS12438, GS12440, GS12442,
GS12443, GS12445, GS12447, GS12449, GS12451, GS12453, GS12454, GS12455,
GS12456, GS12458, GS12461, GS12463, GS12465, GS12468, GS12480, GS12481,
GS12483, GS12484, GS12485, GS12487, GS12488, GS12490, GS12492, GS12493,
GS12494, GS12496, GS12497, GS12504, GS12506, GS12509, GS12510, GS12511,
GS12512, GS12513, GS12516, GS12517, GS12521, GS12522, GS12524, GS12527,
GS12528, GS12529, GS12531, GS12533, GS12535, GS12536, GS12538, GS12539,
GS12540, GS12543, GS12545, GS12553, GS12555, GS12559, GS12561, GS12564,
GS12566, GS12573, GS12577, GS12578, GS12585, GS12590, GS12594, GS12596, GS12600,
GS12601, GS12602, GS12603, GS12605, GS12606, GS12608, GS12609, GS12613,
GS12616, GS12617, GS12619, GS12620, GS12623, GS12624, GS12630, GS12634,
GS12638, GS12639, GS12640, GS12642, GS12643, GS12644, GS12646, GS12647,
GS12648, GS12649, GS12650, GS12652, GS12654, GS12657, GS12658, GS12659,
GS12661, GS12663, GS12664, GS12665, GS12668, GS12676, GS12678, GS12685,
GS12686, GS12688, GS12690, GS12697, GS12702, GS12705, GS12710, GS12712,
GS12713, GS12714, GS12716, GS12725, GS12728, GS12729, GS12731, GS12733, GS12738,
GS12739, GS12743, GS12751, GS12753, GS12757, GS12758, GS12761, GS12764,
GS12765, GS12766, GS12768, GS12770, GS12775, GS12779, GS12781, GS12782,
GS12783, GS12786, GS12790, GS12791, GS12794, GS12796, GS12797, GS12799,
GS12801, GS12802, GS12804, GS12805, GS12806, GS12809, GS12812, GS12813,
GS12820, GS12825, GS12831, GS12835, GS12836, GS12837, GS12838, GS12842,
GS12843, GS12846, GS12853, GS12856, GS12866, GS12870, GS12876, GS12879,
GS12880, GS12881, GS12885, GS12886, GS12893, GS12900, GS12901, GS12902, GS12903,
GS12905, GS12907, GS12908, GS12910, GS12924, GS12928, GS12930, GS12931,
GS12941, GS12943, GS12944, GS12949, GS12951, GS12952, GS12953, GS12954,
GS12956, GS12959, GS12961, GS12963, GS12964, GS12966, GS12967, GS12968,
GS12973, GS12975, GS12976, GS12979, GS12980, GS12985, GS12991, and GS12992
b)
Unit numbers GS09000, GS09074, GS09125, GS09926, GS11150, GS11252, GS12356,
GS12534, GS12625, GS12633, GS12635, GS12673, GS12700, GS12717, GS12808,
GS12829, GS12847, GS12851, GS12865, GS12913, GS12983, GS09014, GS09054,
GS09078, GS09948, GS09961, GS09977, GS11143, GS11159, GS11161, GS11171,
GS11172, GS11209, GS11212, GS11247, GS11248, GS11251, GS12298, GS12307,
GS12322, GS12329, GS12399, GS12410, GS12431, GS12464, GS12466, GS12471,
GS12472, GS12475, GS12489, GS12505, GS12519, GS12532, GS12547, GS12556,
GS12557, GS12567, GS12571, GS12621, GS12626, GS12636, GS12641, GS12681,
GS12693, GS12707, GS12721, GS12724, GS12736,
GS12749, GS12750, GS12756, GS12763, GS12777,
GS12780, GS12785, GS12793, GS12798, GS12818, GS12819, GS12834, GS12848,
GS12849, GS12852, GS12857, GS12863, GS12869, GS12874, GS12882, GS12888,
GS12897, GS12911, GS12915, GS12932, GS12934, GS12939, GS12942, GS12945, and
GS12984; and the following unit numbers were distributed as two split units:
GS09947, GS12978, GS12981, GS12923, GS12854, GS12754, GS12689, GS12692,
GS12651, GS12675, GS12679, GS12610, GS12618, GS11204, GS11205, GS11162, GS11160, GS11151, and GS09964
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino
and Riverside Counties, San Bernadino, CA
REASON Platelets with a decreased platelet count were
distributed.
VOLUME OF PRODUCT IN COMMERCE a) 1,130 units; b) 136
units.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit number XB65504.
RECALLING FIRM/MANUFACTURER Recalling Firm: Community
Bio-Resources, Inc., Hoover, AL.
Manufacturer:
Community Bio-Resources, Inc., St. Cloud, MN.
REASON Blood product, that was not quarantined after
testing elevated for the alanine aminotransferase (ALT) assay, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.
PRODUCT Source Plasma
CODE Unit numbers 57185583 and 61191778.
RECALLING FIRM/MANUFACTURER SeraCare, Inc., Topeka, KS
REASON Blood products, that tested negative for the antibody
to hepatitis C virus (anti-HCV), were collected from a donor that subsequently
tested repeatedly reactive to anti-HCV, were not properly quarantined, and were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
WEEK ENDING AUGUST 10
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 1848869.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue
Center, San Antonio, TX
REASON Blood product, which was manufactured in a manner
that compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Platelets, Pheresis, Leukocytes Reduced
CODE Unit 7048066 - split unit;
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue
Center, San Antonio, TX.
REASON Platelets, collected from a donor taking the
medication Dipyridamole, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Platelets; d) Fresh Frozen Plasma; e) Recovered Plasma.
CODE a) Units 13GX34966, 13FG62170, 13GM08425, 13FH28978,
13GC34272, 13FT73918, 13R68472, 13FH02638, 13M66285, 13FL15865,
13FL02563,
13FL09120, 13Y17218, 13G75554, 13H71289, 13J42253, 13H46724, 13FC78193,
13J99465, 13H38465, 13Y75922, 13J70168, 13H85317;
b)
Units 13GC87026, 13GM42194, 13FC01158, 13X75264;
c)
Units 13GC87026, 13GM42194, 13FC01158, 13FH28978, 13X75264, 13FT73918,
13R68472, 13M66285, 13FL02563, 13Y17218, 13G75554,
13H71289, 13J42253, 13H46724, 13FC78193, 13J99465,
13H38465, 13J88020, 13Y75922, 13J70168, 13H85317;
d)
Units 13GX34966, 13FC01158, 13GM08425, 13R68472, 13FL02563;
e)
Units 13GM42194, 13FG62170, 13FH28978, 13GC34272, 13X75264, 13FT73918,
13FH02638, 13M66285, 13FL15865, 13Y42290, 13FL09120, 13Y17218, 13G75554,
13H71289, 13J42253, 13H46724, 13FC78193, 13J99465, 13H38465, 13J88020,
13Y75922, 13J70168, 13H85317.
RECALLING FIRM/MANUFACTURER American Red Cross,
Southeastern Region, Detroit, MI.
REASON Blood products, which tested non-reactive for
anti-HIV-1/2, but were collected from a donor who previously tested repeatedly
reactive for anti-HIV-1/2, were distributed.
VOLUME OF PRODUCT IN COMMERCE 76 units.
DISTRIBUTION MI, CA and FL.
PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit FJ65609.
RECALLING FIRM/MANUFACTURER Healthcare Provider
Services, Inc., dba Rhode Island Blood Center (RIBC), Providence, RI
REASON Blood product, not quarantined after receiving post
donation information related to a family member diagnosed with
Creutzfeldt-Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets; c) Recovered Plasma.
CODE a) and b) Unit 13GM64690; c) Units 13GM64690,
13FH88809.
RECALLING FIRM/MANUFACTURER American Red Cross,
Southeastern Region, Detroit, MI
REASON Blood products, collected from a donor who had lived
in Western Europe for greater than 6 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MI and CA.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Fresh
Frozen Plasma.
CODE a) and b) Unit 01KX57413.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, New York-Penn Region, West Henrietta, NY
REASON Blood products, collected from a donor who tested
negative for anti-HIV-1/2, but previously tested repeatedly reactive for
anti-HIV-1/2, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY.
PRODUCT a) Red Blood Cells
b)
Red Blood Cells Leukoyctes
c)
Red Blood Cells, Leukocytes Reduced, Irradiated
d)
Cryoprecipitate
e)
Fresh Frozen Plasma
f)
Platelets
g)
Recovered Plasma
CODE
a)
Unit 10726-2811;
b)
Units 10724-3241, 10724-3242, 10724-8418, 10724-8433, 10725-1817, 10725-1819,
10725-1822, 10725-1824, 10725-1826, 10725-3842, 10725-3852, 10725-3857,
10725-3859, 10725-3866, 10725-5583, 10725-5669, 10725-5672, 10725-5673,
10725-5674, 10725-5677, 10725-5773, 10725-5776, 10725-6373, 10725-6384,
10725-7790, 10725-8045, 10725-9103, 10726-1334, 10726-1345, 10726-2813, 10726-2816,
10725-3851;
c)
Unit 1725-5589;
d)
Units 10725-3859, 10725-3866, 10725-5589, 10725-7790, 10726-1334;
e)
Units 10724-8418, 10725-1822, 10725-3851, 10725-3857, 10725-5583, 10725-5673,
10725-5773, 10725-5776, 10725-6373;
f)
Units 10726-2811, 10726-2813, 10726-2815;
g)
Units 10724-3241, 10724-3242, 10724-8433, 10725-1817, 10725-3842, 10725-3852,
10725-5674, 10725-8045, 10725-5589;
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., (AKA
United Blood Services of Arizona), Scottsdale, AZ
REASON Blood products, collected in a manner that
compromises the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE 59 units.
DISTRIBUTION AZ and Germany.
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c)
Platelets; d) Fresh Frozen Plasma.
CODE a) Unit numbers 22FK79402 and 22GV60131; b) Unit
number 22FK79402; c) Unit number 22GV60131; d) Unit number 22GV60131.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Penn-Jersey Region, Philadelphia, PA
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 5 units.
DISTRIBUTION NJ and PA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 09V61425, 09V61426, 09V61430, 09V61432,
09V61433, 09V61437.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services,Midwest Region, Omaha, NE
REASON Blood products, shipped at an unacceptable
temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION NE.
PRODUCT Source Plasma.
CODE Units 10 80V364, 10 80U146, 10 80V933, 10 80Y301, 10
9D3090, 10 9D3833, 10 41H596, 10 9EE875, 10 9E1979, 10 9EJ330, 10 9FV366, 10
9GT957, 10 9HH836, 109HJ069, 10 9L1031, 10 9L1958, 10 9L3155, 10 9L4447, 10
9M4889, 10 9M5933, 10 9T2180, 10 9T3161, 10 9X0630, 10 93J729, 10 93K638, 10
93L423, 10 80U884, 10 80V643, 10 80X757, 10 9D0630, 10 9D3353, 10 9D4127, 10
41H877, 10 9EF179, 10 9E1372,
10
9FU738, 10 9FW173, 10 9GU300, 10 9HI049, 10 9L0784, 10 9L1711, 10 9L2806, 10
9L3877, 10 9M4531, 10 9M5561, 10 9Q2097, 10 9T2391, 10 9T3339, 10 9XP003, 10
93J925, 10 93K977, 10 93M366, 10 93M530, 10 930279, 10 CCDBHZ, 10 CCDDRL, 10
CCFLKB, 10 93N949, 10 CCCJVB, 10 CCDBWL, 10 CCDFHP, 10 80W621, 10 9Q3093, 10
80W937.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Kansas City, MO
REASON Blood products, collected from a donor with a
history of using hard drugs, were distributed.
VOLUME OF PRODUCT IN COMMERCE 64 units.
DISTRIBUTION IL and Germany.
PRODUCT a) Red Blood Cells;
b) Cryo Poor Plasma; c) Cryoprecipitated AHF.
CODE a); b) and c) Unit KS35991.
RECALLING FIRM/MANUFACTURER Central Blood Bank,
Pittsburgh, PA
REASON Blood products, collected from a donor that subsequently
provided disqualifying information, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION PA and OH.
PRODUCT Human Cornea Tissue
CODE Tissue #
2002-06-3005 and # 2002-06-3006.
RECALLING FIRM/MANUFACTURER Recalling Firm: Heartland Lions Eye Banks, Columbia, MO
Procuring
Organization: Heartland Lions Eye Banks, Springfield, MO.
REASON Human corneas, collected from a donor who
subsequently tested positive for antibody to the Hepatitis B core antigen
(anti-HBc) by another tissue procurement organization, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION KS and MD.
PRODUCT
a)
Helixate FS, Antihemophilic Factor (Recombinant), 615 IU/vial,
b)
Helixate FS, Antihemophilic Factor (Recombinant), 624 IU/vial,
c)
Kogenate FS, Antihemophilic Factor (Recombinant), 655 IU/vial,
d)
Kogenate FS, Antihemophilic Factor (Recombinant), 639 IU/vial,
e)
Lypholized powder for injection.
CODE a) Lot 372J001C; b) Lot 372J023A; c) Lot 372J009A;
d) Lot 372J033C.
RECALLING FIRM/MANUFACTURER Recalling Firm: Bayer
Corporation, Biological Products, Berkley, CA
Manufacturer:
Bayer Corporation, Pharmaceutical Division, Elkhart, IN.
REASON Product did not meet the potency specification when
store at room temperature.
VOLUME OF PRODUCT IN COMMERCE a) 9,817 distributed; b)
11,160 distributed; c) 22, 208 distributed; d) 9,593 distributed.
DISTRIBUTION PA and Canada.
PRODUCT Platelets.
CODE Unit 1784604.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue
Center, San Antonio, TX.
REASON Platelets, collected from a donor taking the
medication Dipyridamole, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 16LM59332.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services,Central Ohio Region, Columbus, OH
REASON Red Blood Cells, that failed the red cell recovery
ratio, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 units.
DISTRIBUTION OH.
PRODUCT Platelets.
CODE Units 09V61417, 09V61426, 09V61427, 09V61428,
09V61431, 09V61435, 09V61436, 09V61437, 09V61438, 09V61441
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services,Midwest Region, Omaha, NE
REASON Blood products, shipped at an unacceptable temperature,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION NE.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) Units
02FH98883, 02FH98884, 02FH98885, 02FH98886, 02FH98887, 02FH98888,
02FH98889, 02FH98890, 02FH98891, 02FH98892, 02FH98893, 02FH98894, 02FH98895,
02FH98896, 02FH98897, 02FH98898, 02FH98899, 02FH98900, 02FH98901, 02FH98902,
02FH98903, 02FH98904, 02FH98905, 02FH98906, 02FH98907, 02FH98908, 02FH98909,
02FH98910, 02FH98911, 02FH98912, 02FH98913, 02FH98914, 02FH98915;
b)
Units 02FH98884, 02FH98885, 02FH98886,
02FH98887, 02FH98888, 02FH98889, 02FH98890, 02FH98891, 02FH98892, 02FH98893,
02FH98894, 02FH98895, 02FH98896, 02FH98897, 02FH98898, 02FH98899, 02FH98900,
02FH98901, 02FH98902, 02FH98903, 02FH98904, 02FH98905, 02FH98906, 02FH98907,
02FH98908, 02FH98909, 02FH98910, 02FH98911, 02FH98912, 02FH98913, 02FH98914,
02FH98915.
RECALLING FIRM/MANUFACTURER American Red Cross, Central
Plains Region, Wichita, KS
REASON Blood products, exposed to unacceptable shipping
temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE a) 33 units; b) 32 units.
DISTRIBUTION KS.
PRODUCT Red Blood Cells.
CODE Unit KL05327.
RECALLING FIRM/MANUFACTURER Central Blood Bank,
Pittsburgh, PA
REASON Blood product, labeled with incorrect or missing
antibody information, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WV.
WEEK
ENDING AUGUST 17
PRODUCT Platelets, Pheresis,
Leukocytes Reduced.
CODE Units 12469-8003,
12469-9377.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Blood Systems,
Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Albuquerque, NM.
REASON Blood products, which were
labeled as leukoreduced, but did not meet the requirements for a leukoreduced
product, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units.
DISTRIBUTION
NM.
PRODUCT a) Red Blood Cells; b) Red
Blood Cells, Leukocytes Reduced.
CODE a) Unit 12449-9367; b) Unit
12451-7894.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: United Blood
Services, Albuquerque, NM.
REASON Blood products, collected
from a donor who had traveled to an area designated as endemic for malaria,
were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units.
DISTRIBUTION
MD and
NM.
PRODUCT Red Blood Cells, Leukocytes
Reduced.
CODE Unit 18223-8780.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: United Blood
Services, Cheyenne, WY.
REASON Blood product, collected
from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION
MS.
PRODUCT Red Blood Cells, Leukocytes
Reduced.
CODE Unit 12472-1680.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: United Blood
Services, Albuquerque, NM.
REASON Blood product, collected
from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION
NM.
PRODUCT Red Blood Cells, Leukocytes
Reduced.
CODE Unit number 36264-6036.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems,
Inc., Ventura, CA.
REASON Blood product, manufactured
in a manner that may have compromised the sterility of the unit, was
distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION
CA.
PRODUCT Platelets Pheresis,
Leukocytes Reduced.
CODE Unit number 41FP32037.
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL
REASON Platelets Pheresis with an
elevated platelet count based on volume of product collected were distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION
AL.
PRODUCT Platelets Pheresis,
Leukocytes Reduced.
CODE Unit number 041FP31572.
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL
REASON Platelets Pheresis with an
elevated platelet count based on volume of product collected were distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION
AL.
PRODUCT Platelets Pheresis,
Leukocytes Reduced.
CODE Unit numbers 041GP47502 and
041GP47503 (distributed as two split units).
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL
REASON Platelets Pheresis with an
elevated platelet count were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units.
DISTRIBUTION
AL.
PRODUCT Platelets Pheresis,
Leukocytes Reduced.
CODE Unit numbers 41FP31994,
41GP48203, 41GP48632 (distributed as two split units), 41GP31997, 41FP30974,
41FP32115, 41FP31607 (distributed as two split units), and 41FP31664
(distributed as two split units).
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL
REASON Platelets
Pheresis with unacceptable platelet counts were distributed.
VOLUME OF
PRODUCT IN COMMERCE 11 units.
DISTRIBUTION
AL.
PRODUCT a) Red Blood Cells; b)
Platelets; c) Fresh Frozen Plasma.
CODE a); b) and c) Unit 22LY49320.
RECALLING
FIRM/MANUFACTURER American Red Cross, Penn Jersey Region, Philadelphia, PA
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
PA.
PRODUCT Source Plasma
CODE Units 60225252, 60227225,
60228840, 58492246, 58493748, 58496800, 58497753, 58499993, 61620988, 61623477,
61625846, 61627611, 61670891, 62632263, 62635240, 62637503, 62639521, 62902298,
62904520, 62907200, 62909167.
RECALLING
FIRM/MANUFACTURER SeraCare, Inc., SerCare Acquisitions, Inc., Everett, WA
REASON Blood products, that tested
negative for viral markers, but were collected from a donor who had previously
been deferred due to high risk behaviors associated with increased incidence of
infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF
PRODUCT IN COMMERCE 21 units.
DISTRIBUTION
CA.
PRODUCT a) Red Blood Cells; b)
Platelets; c) Plasma, Frozen.
CODE a); b) and c) Unit
21GH93947.
RECALLING
FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services,
Portland, OR
REASON Blood products, that tested
negative for viral markers, but were collected from a donor who 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
OK.
PRODUCT a) Red Blood Cells; b)
Platelets.
CODE a) and b) Unit 22KR71901.
RECALLING
FIRM/MANUFACTURER American Red Cross, Penn Jersey Region, Philadelphia, PA
REASON Blood products, collected
from a donor with a history of having tested positive for anti-HCV, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units.
DISTRIBUTION
PA.
PRODUCT Source Plasma.
CODE Units 58518540, 58681473,
58684177, 58685433.
RECALLING
FIRM/MANUFACTURER Recalling Firm: SeraCare, Inc., Colorado Springs, CO
REASON Blood products, collected
from a donor who tested positive for syphilis, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 4 units.
DISTRIBUTION
CA.
PRODUCT Source Plasma.
CODE Units IN0010564, IN0010483.
RECALLING
FIRM/MANUFACTURER Recalling Firm: SeraCare, Inc., Colorado Springs, CO
REASON Blood products, collected
from a donor who was not tested for syphilis, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units.
DISTRIBUTION
Spain.
PRODUCT Red Blood Cells, Leukocytes
Reduced.
CODE Unit 21KL46102.
RECALLING
FIRM/MANUFACTURER American Red Cross, Pacific
Northwest Regional Blood Services, Portland, OR.
REASON Blood product, collected
from a donor whose temperature was not accurately determined, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION
OR.
PRODUCT a) Red Blood Cells; b)
Frozen Plasma; c) Recovered Plasma.
CODE a) Units 21FL53241,
21FS22716;
b) Unit 21FL53241; c) Unit
21FS22716.
RECALLING
FIRM/MANUFACTURER American Red Cross, Pacific Northwest Blood Services, Portland, OR
REASON Blood products, collected
from a donor with a history of having tested positive for hepatitis, were
distributed.
VOLUME OF
PRODUCT IN COMMERCE 4 units.
DISTRIBUTION
OR,
Washington, DC and Switzerland.
PRODUCT Red Blood Cells, Leukocytes
Reduced.
CODE Unit numbers 41FP31181 and
41FP31188.
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Alabama Region, Birmingham, AL
REASON Blood products, that were
not leukoreduced within the appropriate time period from collection, were
distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units.
DISTRIBUTION
AL.
PRODUCT Source Plasma.
CODE Units 9M5023, 9M4309,
9M3666, 9L4278, 9L3371, 9L2830, 9L2451, 9L1933, 9L1193, 9L0881, 9HI935, 9HI484,
9HH808, 9HH547, 9GU857, 9GU611, 9GT956, 9GT720, 9FW104, 9FV502, 9FV053, 9EJ683,
9EJ537.
RECALLING
FIRM/MANUFACTURER Aventis Bio-Services, Inc., Kansas City, MO
REASON Source Plasma, collected
from a donor taking anti-depressant drugs, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 23 units.
DISTRIBUTION
IL and
Germany.
PRODUCT Frozen Plasma
CODE Unit 21KE15405.
RECALLING
FIRM/MANUFACTURER American Red Cross, Pacific Northwest Regional Blood Services,
Portland, OR
REASON Blood product, collected
from a donor who developed a hematoma, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION
OR.
WEEK ENDING AUGUST 24
PRODUCT
Source Plasma.
CODE Units 33-Y52355, 33-ZBY627, 33-ZBY772, 33-Y52621,
33-Y52699, 33-ZB2688, 33-ZB2870, 33-ZB3049, 33-ZB3222, 33-ZB3337,
33-ZB3466, 33-ZGM313, 33-3JX151, 33-3JZ216, 33-3JZ288, 33-3JZ404, 33-3JZ577, 33-3JZ835, 33-3J0084,
33-3J0152, 33-3J0241, 33-2V0018,
33-84I141, 33-84I224, 33-84I437,
33-84I619, 33-84I720, 33-84I954, 33-84J132, 33-84K037, 33-84K152, 33-84K339, 33-84K468, 33-84K666,
33-84K797,
33-84L319, 33-84L433, 33-84L643, 33-84L791, 33-84L980, 33-84M120, 33-84M425, 33-84M610, 33-84M732,
33-84M928, 33-84N089, 33-84N452, 33-84N603, 33-84N773, 33-84O231, 33-84O312,
33-84O571, 33-84O643, 33-84O887, 33-84O963, 33-84P145, 33-84P254, 33-84P411,
33-84P513, 33-84P684, 33-84P793, 33-84P952, 33-84Q087, 33-84Q327, 33-84Q501,
33-84Q576, 33-84Q757.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Aventis Bio-Services, Inc., Knoxville, TN.
Manufacturing Firm: Aventis Bio-Services, Inc., West Allis, WI.
REASON Blood products,
collected from a donor who had engaged in high risk behaviors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 67
units.
DISTRIBUTION IL and
Germany.
PRODUCT
CryoGraft Left Medial Femoral Condyle (1 allograft), Model No. FC30.
CODE Serial Number
7707353.
RECALLING FIRM/MANUFACTURER CryoLife,
Inc., Kennesaw, GA.
REASON Tissue repair
product, processed outside of processing timelines, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION NV.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 12P23867.
RECALLING FIRM/MANUFACTURER American
Red Cross, Carolinas Regional Blood Services, Charlotte, NC
REASON Blood product, collected from a donor whose
hemoglobin level was documented as unacceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION NC.
PRODUCT
Source Plasma.
CODE Unit 71528373.
RECALLING FIRM/MANUFACTURER Aventis
Bio-Services, Inc., Champaign, IL, by fax on December 19, 2001.
REASON Blood product,
which had an elevated ALT test result, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION CA.
PRODUCT
a) Platelets, Recall # B-1729-2; b) Fresh Frozen Plasma
CODE a) and b) Unit
GP43332.
RECALLING FIRM/MANUFACTURER Central
Blood Bank, Pittsburgh, PA.
REASON Blood products,
corresponding to a unit of Red Blood Cells that was possibly contaminated with
coagulase negative Staphylococcus sp. bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units.
DISTRIBUTION PA.
PRODUCT
Source Plasma.
CODE Units XIW251,
4FY613, Z9S282, Z7N503, 4FZ391, 7MR753.
RECALLING FIRM/MANUFACTURER Aventis
Bio-Services, Inc., Kansas City, MO.
REASON Blood products,
which tested negative for hepatitis B surface antigen (HbsAg)but collected from
a donor who previously tested reactive for HbsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units.
DISTRIBUTION IL,
Germany and Switzerland.
PRODUCT
a) Red Blood Cells, Leukoreduced;b)Recovered Plasma.
CODE a) and b) Units
09FK21597, 09FK10783
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, Midwest Region, Omaha, NE
REASON Blood products, which tested negative for viral
markers, but were collected from a donor that subsequently admitted to a
previous positive test for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units.
DISTRIBUTION NE,
Puerto Rico and Switzerland.
PRODUCT
Red Blood Cells, Leukoreduced.
CODE Units 41FL88756,
41FL88365.
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, Alabama Region, Birmingham, AL
REASON Blood products, collected from a donor who reported
having lived in an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units.
DISTRIBUTION AL.
PRODUCT
Red Blood Cells, Leukoreduced
CODE Units 41GE54819.
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, Alabama Region, Birmingham, AL
REASON Blood product, collected from a donor who reported
having lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION AL.
PRODUCT
Red Blood Cells, Leukoreduced.
CODE Units 41GE54840.
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, Alabama Region, Birmingham
REASON Blood product, collected from a donor who reported
having lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION AL.
PRODUCT
Source Plasma.
CODE Units 04FK27144,
04FK10531.
RECALLING FIRM/MANUFACTURER American
Red Cross, New England Region, Dedham, MA
REASON Blood products, collected from a donor who was at
increased risk for new variant Creutzfeld Jakob Disease (nvCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units.
DISTRIBUTION CA and
Switzerland.
PRODUCT
a) Red Blood Cells, Leukoreduced; b) Cryoprecipitate; c) Recovered Plasma.
CODE a); b) and c)
Unit FK53666.
RECALLING FIRM/MANUFACTURER Healthcare
Provider Services Inc., dba Rhode Island Blood Center, Providence, RI
REASON Blood products, collected from an ineligible donor
due to medication with the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units.
DISTRIBUTION RI and
Switzerland.
PRODUCT
Platelets, Pheresis
CODE Units (2 units)
04GS05536 - split unit.
RECALLING FIRM/MANUFACTURER American
Red Cross, New England Region, Dedham, MA
REASON Blood products, collected in a manner that
compromised their sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units.
DISTRIBUTION MA.