SEPTEMBER 2002
WEEK ENDING SEPTEMBER 7
PRODUCT
Human Tissue for Transplantation of the following types.
a) Skin, Meshed
b) Skin (sq.ft.)
c) Tibia
d) Achilles Tendon with Bone
e) Patellar Ligament; with Quadriceps
f) Patellar Ligament
g) Ilium, Hemi
h) Fibula, Segment
i) Tri-Cortical Block
J) Cortical Wedge Select
k) Fibula, Ring
l) Cancellous, Crushed
m) Cancellous Block
n) Cancellous, Crushed
CODE a) Tissue ID # CTSP000348-009, CTSP000348-010, CTSP000348-011,
CTSP000348-012, CTSP000348-013, CTSP000348-014.
b) Tissue ID # CTSP000348-015, CTSP000348-016.
c) Tissue ID # CTSP000348-017.
d) Tissue ID # CTSP000348-018, SP000348-019.
e) Tissue ID # CTSP000348-020.
f) Tissue ID # CTSP000348-021.
g) Tissue ID # CTSP000348-022.
h) Tissue ID # CTSP000348-023, CTSP000348-024.
i)
Tissue ID # CTSP000348-032.
j) Tissue ID # CTSP000348-033, CTSP000348-034, CTSP000348-035, CTSP000348-036,
CTSP000348-037, CTSP000348-038, CTSP000348-039, CTSP000348-040, CTSP000348-041.
k) Tissue ID # CTSP000348-044, CTSP000348-046, CTSP000348-050.
l) Tissue ID # CTSP000348-053, CTSP000348-054, CTSP000348-055, CTSP000348-056,
CTSP000348-057, CTSP000348-058, CTSP000348-059, CTSP000348-060, CTSP000348-061,
CTSP000348-062.
m) Tissue ID # CTSP000348-063, CTSP000348-064, CTSP000348-065, CTSP000348-066,
CTSP000348-067, CTSP000348-068, CTSP000348-069, CTSP000348-070, CTSP000348-071,
CTSP000348-072, CTSP000348-073, CTSP000348-074, CTSP000348-075, CTSP000348-076,
CTSP000348-077, CTSP000348-078, CTSP000348-079.
n) Tissue ID # CTSP000348-080, CTSP000348-081, CTSP000348-082.
RECALLING FIRM/MANUFACTURER Community Blood Center, dba: Community Tissue
Services (CTS), Dayton, Ohio
REASON
Tissue for transplantation, processed from a donor who tested positive for
hepatitis C virus (HCV) subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE 59 units.
DISTRIBUTION Nationwide.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Units 04KS64220, 04G25447.
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA.
REASON Blood products, collected from a donor who had lived in an area
designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MA.
PRODUCT
Platelets, Pheresis, Leukocytes Reduced
CODE Unit 04GS06136.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New England
Region, Dedham, MA
REASON
Blood product, inappropriately prepared in that the product was distributed in
one platelet bag instead of two, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE Unit S12185.
RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA
REASON
Blood product, which tested non-reactive for antibody to the hepatitis B core
antigen (anti-HBcore), but was collected from a donor who previously tested
reactive on two prior occasions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
Source Plasma.
CODE Units 0015331, 0015469, 0015654.
RECALLING FIRM/MANUFACTURER DCI Biologicals Hot Springs, Inc., Plasmapheresis
Facility, Hot Springs AK
REASON
Blood products, collected from a donor who tested reactive for hepatitis B
surface antigen (HbsAg), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Austria.
PRODUCT
Red Blood Cells, Leukoreduced.
CODE Units 50C19470, 50C19479, 50C19554, 50LG55918, 50C19378, 50C19350,
50LG55838, 50C19960, 50C19973, 50C19976, 50C20073, 50C23477, 50LG58467,
50LG58471, 50LG58483, 50LG57697, 50C23668, 50C23712, 50C23713, 50LH24269, 50LJ36051,
50LJ36210, 50LJ36248, 50C24394.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Western Lake
Erie Region, Toledo, OH
REASON
Blood products, which were incorrectly tested for Cytomegalovirus (CMV), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 24 units.
DISTRIBUTION OH.
PRODUCT
Platelets Pheresis
CODE Unit number R52990.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Miller Memorial Blood Center,
Bethlehem, PA
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT
Platelets Pheresis
CODE Unit number R52937.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Miller Memorial Blood Center,
Bethlehem, PA
REASON
Blood product, 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), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT
Source Plasma
CODE Units 46 DCDYDG 0, 46 DCCWXG 0.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Decatur, IL
REASON
Blood products, collected from a donor with an elevated temperature and whose
health history was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.
PRODUCT
Platelets, Pheresis
CODE Unit R79836.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood
Center, Bethlehem, PA
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit 12GY49326.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Carolinas
Region, Charlotte, NC
REASON
Blood product, which had a positive antibody screening test, but labeled as
negative for unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit G46085.
RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank, Rockford, IL.
REASON Blood product, which was incorrectly tested for anti-HTLV I/II, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT
Fresh Frozen Plasma
CODE Unit number 6745504.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Children's Memorial
Hospital, Chicago, IL
REASON
Blood product, that was not frozen within 8 hours of collection, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit numbers 6745708, 6746142, 6746143, 6746145, 6746146, and 6746147.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Children's Memorial Hospital,
Chicago, IL
REASON
Blood products, that did not have the additive solution included within the
time frames specified by the manufacturer's instructions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION IL.
PRODUCT
Red Blood Cells
CODE Unit numbers T30834, T30836, and T30841.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Miller Memorial Blood Center,
Bethlehem, PA
REASON
Unlicensed blood products were distributed interstate.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NJ.
WEEK ENDING SEPTEMBER 14
PRODUCT
Red Blood Cells.
CODE Unit number 31126-1520.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
Manufacturer: Blood Systems, Inc., Tupelo, MS.
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 AL.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Platelets, Leukocytes Reduced; c)
Fresh Frozen Plasma
CODE a) and b) Units 42T04022, 42Y21481; c) Units 42FT13699, 42FT13702,
42FT13669;
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio
Region, Cleveland, OH
REASON
Blood products, corresponding to units that were implicated in an adverse
transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION OH.
PRODUCT
Red Blood Cells.
CODE Unit R82311.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood
Center, Bethlehem, PA
REASON
Blood product, collected from a donor whose hemoglobin was not documented, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
CODE a) and b) Unit J20383.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood
Center, Bethlehem, PA
REASON
Blood products, collected from a donor who did not answer the question related
to HIV group O risk, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ and PA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Recovered Plasma.
CODE a) and b) Unit 4789809.
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, TX
REASON
Blood products, collected from an unsuitable donor due to behavior associated
with an increased risk of infection with the human immunodeficiency virus
(HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and Switzerland.
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
CODE a) and b) Unit Y101756.
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center and Program, Seattle, WA.
REASON Blood products, which were collected from a donor who had a history of
multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WA and Switzerland.
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma.
CODE a); b) and c) Unit 22GV73236.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Penn Jersey
Region, Philadelphia, PA.
REASON Blood products, which were collected
from a donor who had tested positive for hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION PA and NJ.
PRODUCT
a) Red Blood Cells; b) Red Blood Cells Leukocytes Removed; c) Platelets; d)
Fresh Frozen Plasma.
CODE a) and c) Unit 22GP88556; b) Unit 22LV74399; d) Unit 22LV74399 and
22GP88556.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Penn Jersey
Region, Philadelphia, PA01.
REASON Blood products, which were
collected from a donor who had tested positive for hepatitis (type unknown),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION PA.
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma; d) Cryoprecipitated
AHF; e) Recovered Plasma.
CODE a) Units 22LF52950, 22LF21208, 22LF17037, 22FS33584, 22LE55339, and
22LH65159; b) Units 22LF52950, 22LF21208, 22FS33584, and 22LE55339; c) Units
22LF21208 and 22FS33584; d) Unit 22LF17037; e) Units 22LF52950, 22LE55339, and
22LH65159.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Penn Jersey
Region, Philadelphia, PA.
REASON Blood products, which were
collected from a donor who had tested positive for hepatitis (type unknown),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION PA, NJ, CA, NY and Switzerland.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced;
b) Recovered Plasma.
CODE a) and b) Unit 12GE53454.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region,
Charlotte, NC
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 2 units.
DISTRIBUTION AL and CA.
PRODUCT
Source Plasma.
CODE Unit numbers G67217-076, G66882-076, G66182-076, and G65703-076.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corp., Los
Angeles, CA.
Manufacturer: Alpha Therapeutic Corp., Fayetteville, NC.
REASON Source Plasma was not properly
quarantined after the receipt of information that disqualified the donor of the
product.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION Switzerland.
PRODUCT
Source Plasma.
CODE Unit numbers FN043604, FN043213, FN039989, FN039464, FN039031, FN038494,
FN038198, and FN037586.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Sera-Tec Biologicals
L.P., Fayetteville, NC.
REASON Blood products, collected from
an ineligible donor due to previous blood product administration, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION NC.
PRODUCT
Red Blood Cells.
CODE Units GT01666, GT01668, GT01671, GT01678, GT01681, GT01687, GT01690,
GT01693, GT01696, GT01697, GT01699, GT01711, GT01714, GT01715, GT01718,
GT01720, GT01722, GT01723, GT01726, GT01728, GT01730, GT01732, GT01734,
GT01736, GT01738, GT01740, GT01742, GT01744, GT01747, GT01750, GT01754,
GT01757, GT01759, GT01761, GT01763, GT01838, GT01840, GT01841, GT01843,
GT01844, GT01846, GT01848, GT01849, GT01850, GT01852, GT01853, GT01854,
GT01856, GT01857, GT01859, GT01860, GT01861, GT01863, GT01866, GT01868,
GT01869, GT01929, GT01933, GT01937, GT01939, GT01943, GT01945, GT01946,
GT01957, GT01959, GT01962, GT01969, GT01970, GT01972, GT01974, GT01977,
GT01979, GT01982, GT01984, GT01987, GT02061, GT02065, GT02071, GT02076,
GT02081, GT02083, GT02086, GT02090, GT02093, GT02101, GT02103, GT02108,
GT02134, GT02136, GT02138, GT02140, GT02142, GT02143, GT02145, GT02147,
GT02151, GT02154, GT02157, GT02159, GT02163, GT02166, GT02167, GT02169,
GT02170, GT02171, GT02173, GT02175, GT02176, GT02177, GT02178, GT02179,
GT02180, GT02182, GT02183, GT02184, GT02185, GT02187, GT02188, GT02191,
GT02193, GT02195, GT02197, GT02200, GT02203, GT02205, GT02207, GT02208,
GT02210, GT02211, GT02212, GT02215, GT02217, GT02242, GT02245, GT02246,
GT02249, GT02251, GT02252, GT02253, GT02255, GT02257, GT02260, GT02261,
GT02263, GT02265, GT02270, GT02275, GT02276, GT02279, GT02280, GT02285,
GT02290, GT02292, GT02295, GT02296, GT02299, GT02301, GT02303, GT02306,
GT02308, GT02310, GT02312, GT02314, GT02317, GT02319, GT02321, GT02323,
GT02325, GT02327, GT02358, GT02364, GT02371, GT02373, GT02377, GT02380,
GT02383, GT02385, GT02391, GT02396, GT02402, GT02404, GT02406, GT02409,
GT02412, GT02414, GT02416, GT02417, GT02419, GT02423, GT02426, GT02428,
GT02432, GT02434, GT02436, GT02438, GT02440, GT02659, GT02660, GT02661,
GT02662, GT02663, GT02664, GT02665, GT02666, GT02667, GT02668, GT02669,
GT02670, GT02671, GT02672, GT02673, GT02674, GT02676, GT02678, GT02679, GT02680,
GT02681, GT02682, GT02683, GT02684, GT02685, GT02710, GT02711, GT02712,
GT02713, GT02714, GT02715, GT02716, GT02717, GT02718, GT02719, GT02720,
GT02774, GT02968, GT02970, GT02971, GT02977, GT02980, GT02983, GT02985,
GT03053, GT03056, GT03058, GT03063, GT03064, GT03066, GT03071, GT03073,
GT03075, GT03077, GT03079, GT03085, GT03089, GT03090, GT03092, GT03094,
GT03096, GT03099, GT03101, GT03103, GT03105, GT03107, GT03112, GT03113,
GT03117, GT03119, GT03121, GT03123, GT03126, GT03128, GT03130, GT03132, GT03135,
GT03136, GT03139, GT03142, GT03144, GT03147, GT03150, GT03152, GT03154,
GT03160, GT03161, GT03166, GT03167, GT03170, GT03172, GT03175, GT03177,
GT03180, GT03181, GT03183, GT03185, GT03189, GT03191, GT03193, GT03194,
GT03196, GT03197, GT03211, GT03212, GT03217, GT03220, GT03221, GT03226,
GT03229, GT03231, GT03233, GT03236, GT03238, GT03245, GT03248, GT03250,
GT03252, GT03255, GT03257, GT03259, GT03261, GT03264, GT03265, GT03266,
GT03267, GT03269, GT03270, GT03273, GT03274, GT03276, GT03277, GT03279, GT03281,
GT03283, GT03285, GT03286, GT03287, GT03288, GT03290, GT03292, GT03295,
GT03296, GT03298, GT03299, GT03301, GT03303, GT03308, GT03309, GT03312,
GT03313, GT03315, GT03317, GT03319, GT03321, GT03323, GT03325, GT03326,
GT03354, GT03356, GT03359, GT03363, GT03366, GT03368, GT03371, GT03372,
GT03373, GT03375, GT03376, GT03377, GT03379, GT03380, GT03382, GT03384,
GT03386, GT03388, GT03389, GT03391, GT03393, GT03395, GT03397, GT03399,
GT03400, GT03402, GT03404, GT03406, GT03409, GT03411, GT03413, GT03415, GT03422,
GT03425, GT03427, GT03429, GT03431, GT03433, GT03436, GT03439, GT03442,
GT03445, GT03447, GT03450, GT03452, GT03454, GT03455, GT03459, GT03460,
GT03462, GT03463, GT03465, GT03467, GT03469, GT03471, GT03475, GT03477,
GT03481, GT03484, GT03486, GT03487, GT03488, GT03491, GT03492, GT03494,
GT03497, GT03499, GT03500, GT03501, GT03502, GT03503, GT03505, GT03507,
GT03510, GT03511, GT03513, GT03517, GT03545, GT03547, GT03548, GT03549,
GT03550, GT03551, GT03552, GT03553, GT03554, GT03556, GT03557, GT03586,
GT03589, GT03591, GT03594, GT03596, GT03598, GT03600, GT03640, GT03641,
GT03642, GT03643, GT03644, GT03645, GT03646, GT03647, GT03648, GT03649,
GT03650, GT03651, GT03652, GT03653, GT03654, GT03655, GT03656, GT03658,
GT03659, GT03661, GT03662, GT03663, GT03664, GT03665, GT03666, GT03669,
GT03670, GT03671, GT03673, GT03674, GT03675, GT03676, GT03677, GT03679,
GT03680, GT03683, GT03684, GT03749, GT03752, GT03753, GT03754, GT03756,
GT03757, GT03758, GT03759, GT03760, GT03761, GT03762, GT03763, GT03764, GT03765,
GT03766, GT03767, GT03768, GT03804, GT03806, GT03808, GT03810, GT03813,
GT03815, GT03819, GT03821, GT03823, GT03825, GT03827, GT03828, GT03831,
GT03833, GT03837, GT03841, GT03843, GT03846, GT03847, GT03848, GT03967,
GT03970, GT03973, GT03974, GT03976, GT03977, GT03978, GT03980, GT03982,
GT03983, GT03986, GT03991, GT03992, GT03994, GT03995, GT03996, GT03997,
GT03999, GT04000, GT04002, GT04003, GT04005, GT04009, GT04012, GT04016,
GT04017, GT04019, GT04022, GT04023, GT04026, GT04030, GT04031, GT04032, GT04034,
GT04036, GT04037, GT04039, GT04040, GT04125, GT04131, GT04133, GT04135,
GT04139, GT04142, GT04145, GT04149, GT04155, GT04158, GT04163, GT04174,
GT04178, GT04195, GT04199, GT04201, GT04206, GT04218, GT04232, GT04234,
GT04235, GT04238, GT04241, GT04243, GT04244, GT04246, GT04247, GT04251,
GT04253, GT04256, GT04260, GT04262, GT04265, GT04266, GT04268, GT04270,
GT04273, GT04276, GT04278, GT04339, GT04340, GT04342, GT04345, GT04347,
GT04350, GT04352, GT04354, GT04356, GT04357, GT04360, GT04363, GT04365, GT04366,
GT04368, GT04371, GT04375, GT04377, GT04379, GT04382, GT04387, GT04394,
GT04399, GT04400, GT04402, GT04404, GT04407, GT04412, GT04414, GT04416,
GT04418, GT04420, GT04423, GT04454, GT04456, GT04458, GT04460, GT04462,
GT04464, GT04466, GT04468, GT04470, GT04471, GT04473, GT04476, GT04477,
GT04532, GT04536, GT04540, GT04547, GT04552, GT04553, GT04561, GT04562,
GT04572, GT04574, GT04580, GT04582, GT04585, GT04587, GT04591, GT04595,
GT04597, GT04607, GT04610, GT04611, GT04615, GT04618, GT04621, GT04623, GT04628,
GT04636, GT04645, GT04650, GT04656, GT04659, GT04669, GT04671, GT04674,
GT04678, GT04685, GT04687, GT04690, GT04693, GT04695, GT04699, GT04700,
GT04706, GT04709, GT04710, GT04713, GT04717, GT04744, GT04746, GT04751,
GT04756, GT04761, GT04772, GT04774, GT04776, GT04787, GT04790, GT04792,
GT04794, GT04796, GT04797, GT05026, GT05035, GT05060, and GT05100.
RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center,
Davenport, IA
REASON
Blood products, which were collected from donors whose suitability was not
adequately determined (high risk questions), were distributed.
VOLUME OF PRODUCT IN COMMERCE 710 units.
DISTRIBUTION Nationwide and Switzerland.
PRODUCT a) Blood Cells, Leukocytes Reduced; b) Blood Cells, Autologous; c)
Platelets, Pheresis, Leukocytes Reduced, Irradiated;
d) Platelets, Pheresis, Leukocytes Reduced.
CODE a) Units 04G32454, 04R83499, 04G32448, 04G32459, 04N05464, 04S39268,
04N05474, 04N05473, 04N05468, 04N05452, 04N05475, 04R83508, 04R83504, 04S39274,
04R83516, 04R83502, 04G32443, 04R83491, 04S39284, 04S39301, 04S39309, 04S39323,
04S39299, 04R83524, 04G32438, 04N05448, 04R83510, 04R83503, 04R83514, 04G32453,
04N05467, 04N05463;
b) Units 04R83507, 04N05460, 04N05462, 04N05469;
c) Unit 04LP49174
d) Units 04LP49173, 04LP49167-parts 1 & 2, 04LP49170-parts 1 & 2,
04LP49168.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New England
Region, Dedham, MA
REASON
Blood products, which may have been incorrectly tested for unexpected
antibodies, were distributed.
VOLUME OF PRODUCT IN COMMERCE a) 32 units; b) 4 units; c) 1 unit; d) 6 units.
DISTRIBUTION MA, NY, ME and NH.
PRODUCT
Recovered Plasma.
CODE Units 42E35413, 42E35415, 42FF70742, 42FW89706, 42Y21938.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northern Ohio
Region, Cleveland, OH
REASON
Blood products, corresponding to units that were implicated in an adverse
transfusion reaction, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION OH.
PRODUCT
Platelets.
CODE Unit T44262.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood
Center, Bethlehem, PA
REASON
Blood product, collected from a donor who failed to answer the question
regarding having received a rabies shot in the past 12 months, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT
a) Red Blood Cells Leukocytes Removed; b) Fresh Frozen Plasma.
CODE a) Units 224214908, 224214909, 224214910, 224214911, 224214913, 224214914,
224214915, 224214916, 224214919, 224214921, 224214923, 224214925, 224214926,
224214927, 224214928, 224214929; b) Units 224214909.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Las Vegas, NV.
REASON Blood products, which were possibly collected using a method which could
not guarantee maximum sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE 17 units.
DISTRIBUTION NV.
PRODUCT
Red Blood Cells.
CODE Unit LH13316.
RECALLING FIRM/MANUFACTURER Southern California Permanente Medical Group,
Laboratory Blood Bank, Woodland Hills, CA.
REASON Blood product, which was incorrectly tested for the antibody for
hepatitis C virus encoded antigen (anti-HCV) but was subsequently negative for
anti-HCV upon repeat testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
Recovered Plasma
CODE Units GT01666, GT01668, GT01671, GT01678, GT01681, GT01687, GT01690,
GT01693, GT01696, GT01697, GT01699, GT01711, GT01714, GT01715, GT01718,
GT01720, GT01722, GT01723, GT01726, GT01728, GT01730, GT01732, GT01734,
GT01736, GT01738, GT01740, GT01742, GT01744, GT01747, GT01750, GT01754,
GT01757, GT01759, GT01761, GT01763, GT01838, GT01840, GT01841, GT01843,
GT01844, GT01846, GT01848, GT01849, GT01850, GT01852, GT01853, GT01854,
GT01856, GT01857, GT01859, GT01860, GT01861, GT01863, GT01866, GT01868,
GT01869, GT01929, GT01933, GT01937, GT01939, GT01943, GT01945, GT01946,
GT01957, GT01959, GT01962, GT01969, GT01970, GT01972, GT01974, GT01977,
GT01979, GT01982, GT01984, GT01987, GT02061, GT02065, GT02071, GT02076,
GT02081, GT02083, GT02086, GT02090, GT02093, GT02101, GT02103, GT02108,
GT02134, GT02136, GT02138, GT02140, GT02142, GT02143, GT02145, GT02147,
GT02151, GT02154, GT02157, GT02159, GT02163, GT02166, GT02167, GT02169,
GT02170, GT02171, GT02173, GT02175, GT02176, GT02177, GT02178, GT02179,
GT02180, GT02182, GT02183, GT02184, GT02185, GT02187, GT02188, GT02191,
GT02195, GT02197, GT02200, GT02203, GT02205, GT02207, GT02208, GT02210,
GT02211, GT02212, GT02215, GT02217, GT02242, GT02245, GT02246, GT02249,
GT02251, GT02252, GT02253, GT02255, GT02257, GT02260, GT02261, GT02263,
GT02265, GT02270, GT02275, GT02276, GT02279, GT02280, GT02285, GT02290,
GT02292, GT02295, GT02296, GT02299, GT02301, GT02303, GT02306, GT02308,
GT02310, GT02312, GT02314, GT02317, GT02319, GT02321, GT02323, GT02325,
GT02327, GT02358, GT02364, GT02371, GT02373, GT02377, GT02380, GT02383,
GT02385, GT02391, GT02396, GT02402, GT02404, GT02406, GT02409, GT02412,
GT02414, GT02416, GT02417, GT02419, GT02423, GT02426, GT02428, GT02432, GT02434,
GT02436, GT02438, GT02440, GT02659, GT02660, GT02661, GT02662, GT02663,
GT02664, GT02665, GT02666, GT02667, GT02668, GT02669, GT02670, GT02671,
GT02672, GT02673, GT02674, GT02676, GT02677, GT02678, GT02679, GT02680,
GT02681, GT02682, GT02683, GT02684, GT02685, GT02686, GT02710, GT02711,
GT02712, GT02713, GT02714, GT02715, GT02716, GT02717, GT02718, GT02719,
GT02720, GT02774, GT02968, GT02970, GT02971, GT02977, GT02980, GT02983,
GT02985, GT03053, GT03056, GT03058, GT03063, GT03064, GT03066, GT03069, GT03071,
GT03073, GT03075, GT03077, GT03079, GT03081, GT03085, GT03087, GT03089,
GT03090, GT03092, GT03094, GT03096, GT03099, GT03101, GT03103, GT03105,
GT03107, GT03112, GT03113, GT03117, GT03119, GT03121, GT03123, GT03126,
GT03128, GT03130, GT03132, GT03135, GT03136, GT03139, GT03142, GT03144,
GT03147, GT03150, GT03152, GT03154, GT03160, GT03161, GT03166, GT03167,
GT03170, GT03172, GT03175, GT03177, GT03180, GT03181, GT03183, GT03185,
GT03189, GT03191, GT03193, GT03194, GT03196, GT03197, GT03236, GT03238, GT03245,
GT03248, GT03250, GT03252, GT03255, GT03257, GT03259, GT03261, GT03264,
GT03265, GT03266, GT03267, GT03269, GT03270, GT03273, GT03274, GT03276,
GT03277, GT03279, GT03281, GT03283, GT03290, GT03295, GT03298, GT03299,
GT03301, GT03303, GT03308, GT03309, GT03312, GT03313, GT03315, GT03317,
GT03319, GT03321, GT03325, GT03326, GT03354, GT03356, GT03359, GT03363,
GT03366, GT03368, GT03371, GT03372, GT03373, GT03375, GT03376, GT03379,
GT03380, GT03382, GT03384, GT03386, GT03388, GT03389, GT03391, GT03393, GT03395,
GT03397, GT03399, GT03400, GT03402, GT03404, GT03406, GT03409, GT03411,
GT03413, GT03415, GT03422, GT03425, GT03427, GT03429, GT03431, GT03433,
GT03436, GT03439, GT03442, GT03445, GT03447, GT03450, GT03452, GT03454,
GT03455, GT03459, GT03460, GT03462, GT03463, GT03465, GT03467, GT03469,
GT03471, GT03475, GT03477, GT03481, GT03484, GT03486, GT03487, GT03488,
GT03491, GT03492, GT03494, GT03497, GT03499, GT03500, GT03501, GT03502,
GT03503, GT03505, GT03507, GT03510, GT03511, GT03513, GT03517, GT03545, GT03547,
GT03548, GT03549, GT03550, GT03551, GT03552, GT03553, GT03554, GT03556,
GT03557, GT03586, GT03589, GT03591, GT03594, GT03596, GT03598, GT03600,
GT03640, GT03641, GT03642, GT03643, GT03644, GT03645, GT03646, GT03647,
GT03648, GT03649, GT03650, GT03651, GT03652, GT03653, GT03654, GT03655,
GT03656, GT03658, GT03659, GT03661, GT03662, GT03663, GT03664, GT03665,
GT03666, GT03669, GT03670, GT03671, GT03673, GT03674, GT03675, GT03676,
GT03677, GT03679, GT03680, GT03683, GT03684, GT03749, GT03752, GT03753, GT03754,
GT03756, GT03757, GT03758, GT03759, GT03760, GT03762, GT03763, GT03764,
GT03765, GT03766, GT03767, GT03768, GT03804, GT03806, GT03808, GT03810,
GT03813, GT03815, GT03819, GT03821, GT03823, GT03825, GT03827, GT03828,
GT03831, GT03833, GT03837, GT03841, GT03843, GT03846, GT03847, GT03848,
GT03967, GT03970, GT03973, GT03974, GT03976, GT03977, GT03978, GT03980,
GT03982, GT03983, GT03986, GT03991, GT03992, GT03994, GT03995, GT03996,
GT03997, GT03999, GT04000, GT04002, GT04003, GT04005, GT04009, GT04012,
GT04016, GT04017, GT04019, GT04022, GT04023, GT04026, GT04030, GT04031,
GT04032, GT04034, GT04036, GT04037, GT04039, GT04040, GT04125, GT04131,
GT04133, GT04135, GT04139, GT04142, GT04145, GT04149, GT04155, GT04158,
GT04163, GT04174, GT04178, GT04195, GT04199, GT04201, GT04206, GT04218,
GT04232, GT04234, GT04235, GT04238, GT04241, GT04243, GT04244, GT04246,
GT04247, GT04251, GT04253, GT04256, GT04260, GT04262, GT04265, GT04266,
GT04268, GT04270, GT04273, GT04274, GT04276, GT04278, GT04339, GT04340, GT04342,
GT04345, GT04350, GT04352, GT04354, GT04356, GT04357, GT04359, GT04360,
GT04363, GT04365, GT04366, GT04368, GT04371, GT04375, GT04377, GT04382,
GT04387, GT04390, GT04394, GT04399, GT04400, GT04402, GT04404, GT04407,
GT04412, GT04414, GT04416, GT04418, GT04420, GT04423, GT04454, GT04456,
GT04458, GT04460, GT04462, GT04464, GT04466, GT04470, GT04471, GT04473,
GT04476, and GT04477.
RECALLING FIRM/MANUFACTURER Mississippi Valley Regional Blood Center,
Davenport, IA
REASON Blood products, which were collected from donors
whose suitability was not adequately determined (high-risk questions), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 632 units.
DISTRIBUTION Nationwide and Switzerland.
The
Food and Drug Administration (FDA) announced that Baxter Healthcare Corporation
has notified dialysis centers that certain blood tubing used with Baxter's
Meridian dialysis machines may possibly be linked to five patient deaths and
two injuries. These occurred at two kidney dialysis centers in late August.
Although
the cause of the deaths has not yet been determined, Baxter on September 6
notified hemodialysis centers that it is exploring the possibility that the
patients' hemodialysis treatments may have used the same model dialysis machine
and bloodline set. Baxter told customers to immediately discontinue use of
certain models of Medisystems blood tubing in conjunction with Meridian
dialysis machines and use other Medisystems blood tubing instead.
FDA
is working closely with both Baxter Healthcare of Roundtop, Ill., and
Medisystems Corporation of Seattle, to identify the exact cause of the problem.
Baxter's preliminary investigation found that the two hemodialysis centers
where the incidents occurred may have been using the following:
Blood
tubing--Medisystems Corp., Product Code D3-9694/9793 or K3-9694/9793, Baxter
Product Code 5M9694
Hemodialysis
Machine--Meridian
Alternate Medisystems blood tubing is available. The incidents occurred at Nephrology, Inc., in Mishawaka, Ind., and Physicians Dialysis, Inc., in Grand Rapids, Mich. Further details can be obtained from Baxter's Postmarket Surveillance Group at 1-888-736-2543, option 3.
WEEK ENDING SEPTEMBER 21
PRODUCT
Corneas, Human Tissue for Transplantation.
CODE ID numbers 10-017-00-1172-OS and 10-017-00-1172-OD.
RECALLING FIRM/MANUFACTURER Lions Eye Bank of Oregon, Portland, OR
REASON
Tissue for transplantation was processed from a donor who was found to test
positive for hepatitis C virus (HCV) subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION Italy.
PRODUCT
Red Blood Cells.
CODE Units LT13783 (parts 1 and 2).
RECALLING FIRM/MANUFACTURER Recalling Firm: San Diego Blood Bank, San Diego,
CA.
Manufacturer: North Coastal Donor Center, Vista, CA.
REASON Blood products, which failed quality control testing for red blood cell
volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT
Source Plasma.
CODE Units CCBWKR, CCBVNF, CCBVDL, CCBTJH, CCBSRB, CCBRVZ, CCBRBW, CCBQNJ,
CCBPTX, CCBNPR, CCBMNC, CCBLYR, CCBKPG, CCBKCK, CCBHSZ, CCBHDK, CCBCGT, 978046,
93I578, 93H912, 93G575, 9XM742, 9XM436, 9XM112, 9XL815, 9XL527, 9XL218, 9XK858,
9XK505, 9TZ711, 9TZ044, 9TY785, 9Q1449, 9Q0773, 9Q0621, 9Q0096, 9QZ566, 9M1195,
9LZ516, 9LY913, 9LY276, 9LX503, 9HH252, 9HG569, 9GT182, 9GS989, 9GS160, 9GR845,
9EH635, 9EH416, 9EG759, 9EG535, 9EE019, 9ED844
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 54 units.
DISTRIBUTION IL.
PRODUCT
a) Platelets, Pheresis; b) Platelets, Pheresis, Irradiated.
CODE a) Units 9154841, 9155441, 9165141, 9164851, 9164401, 9163641, 9163111, 9162771,
9162351- part 1, 9162031, 9160271-part 1, 9159971, 9159351, 9159151-part 1,
9158751, 9158401, 9157781, (parts 1 and 2 except as noted); b) Units 9162351,
9160271, 9159151.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis,
IN.
REASON Platelets, collected from a donor who ingested an aspirin containing
product within the past 36 hours, were distributed.
VOLUME OF PRODUCT IN COMMERCE 34 units.
DISTRIBUTION IN.
PRODUCT
Platelets.
CODE Unit R85586.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood
Center, Bethlehem, PA
REASON
Platelets, collected from a donor who ingested an aspirin containing product,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT
Red Blood Cells.
CODE Units LN96013 (A and B).
RECALLING FIRM/MANUFACTURER NBAH Blood Center, New Brunswick, NJ.
REASON Blood products, that failed quality control testing for red cell volume,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ.
PRODUCT
a) Red Blood Cells; b) Platelets; c) Fresh Frozen Plasma
CODE a) Units R44248, R29068, H57223, H16369; b) Units R44248, H57223; c) Units
R44248, R29068.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood
Center, Bethlehem, PA
REASON
Blood products, collected from a donor who was taking Prednisone and Ceftin,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION PA and GA.
PRODUCT
a) Red Blood Cells; b) Platelets.
CODE a) Units R94360, R89749, R89750, C25449, T58163, R94331, R94389, C25446,
T58130, R94304, R94425 , C25459, C25458, R94298, R94271, C25453, C25445,
R94314, R94310, T57528, C25447, C25456, T57824, T57822, T57835, T57533, T57527,
R94272, R94279, C25455, R94333, T58160, R94330, T56491, R94324, R94348, C25450,
T58119; b) Units R94360, R94304, R94298, R94271, R94272, R94279, R94330,
T56496.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood
Center, Bethlehem, PA
REASON
Blood products, manufactured in a manner that compromised their sterility, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 46 units.
DISTRIBUTION PA and NJ.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced; b) Recovered Plasma
CODE a) and b) Unit number 18226-1628.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, that tested negative for hepatitis, but were collected
from an ineligible donor due to a reported history of hepatitis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WY and Switzerland.
PRODUCT
a) Red Blood Cells; b) Platelets Pooled, Leukocytes Reduced; c) Fresh Frozen
Plasma.
CODE a) and c) Unit number 0666843; b) Pool number 0079562.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati
Medical Center, Cincinnati, OH
REASON
Blood products, collected from an unsuitable donor due to a history of
jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units, 1 pool.
DISTRIBUTION OH and KY.
PRODUCT
Red Blood Cells
CODE Unit number 31127-3647.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
Manufacturer: Blood Systems, Inc., Tupelo, MS.
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 MS.
PRODUCT
a) Red Blood Cells; b) Recovered Plasma.
CODE a) and b) Unit LL06031.
RECALLING FIRM/MANUFACTURER San Diego Blood Bank, San Diego, CA
REASON
Blood products, collected from a donor with a history of hepatitis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT
Saphenous Vein Allografts Tissues
CODE Tissues 6088627, 6103286, 6103294.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON
Tissues for transplant were collected from a donor who had not been properly
evaluated.
VOLUME OF PRODUCT IN COMMERCE 3 tissues.
DISTRIBUTION MI, MN and NJ.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Units 040GR61357 and 040LW18210.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Heart of America
Region, Peoria, IL
REASON
Blood products, incorrectly labeled as being crossmatch compatible, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.
PRODUCT
Red Blood Cells
CODE Unit number 20280-4361.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON Blood product, manufactured from a unit of Whole Blood that was stored
at an improper temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced
CODE Unit number 20399-0176.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale,
AZ.
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON Blood product, collected from an ineligible donor due to use of an
unknown medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced
CODE Unit number 20399-0172.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON Blood product, collected from an ineligible donor due to medication with
an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT
Source Plasma
CODE Unit numbers BYGYBM, BYGXPH, BYGWZP, BYGWPJ, BYGWCV, BYGVRK, BYGVGS, BYGTWM,
BYGTLH, BYGSZG, BYCHZK, BYCHNY, BYCFZR, BYCFGL, BYGXTR, BYGXJR, BYGWWD, BYGWLJ,
BYGVYC, BYGVPB, BYGVCT, BYGTPF, BYGTDR, BYGSRS, BYCHSP, BYCHGV, and BYCFLF.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis Bio-Services, Inc., King of
Prussia, PA
Manufacturer: Aventis Bio-Services, Inc., Charlotte, NC.
REASON Blood products, that tested negative for viral markers, but were
collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 27 units.
DISTRIBUTION IL.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated
CODE Unit numbers E60831 and E71691.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers,
Aurora, IL
REASON Blood products that were out of controlled storage for more than 30
minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.
PRODUCT
a) Red Blood Cells; b) Platelets
CODE a) and b) Unit T40541.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a Miller Memorial Blood
Center, Bethlehem, PA
REASON
Blood products, collected from a donor who failed to answer the question
regarding having had any shots or vaccinations in the past 6 weeks, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ and PA.
PRODUCT
Source Plasma
CODE Unit numbers CN042103 and CN042482.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Sera-Tec Biologicals
L.P., Charlotte, NC
REASON
Blood products, collected from an ineligible donor based on previous elevated
testing for alanine aminotransferase (ALT), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.
PRODUCT
Source Plasma
CODE Unit number CN043594.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Sera-Tec Biologicals
L.P., Charlotte, NC
REASON
Blood product, that tested negative for the antibody to hepatitis C virus
(anti-HCV), was collected from a donor that subsequently tested repeatedly
reactive to anti-HCV, was not properly quarantined, and was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated
CODE Unit numbers E71730 and E71717.
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers,
Aurora, IL
REASON Blood products that were out of controlled storage for more than 30
minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.
PRODUCT
a) Red Blood Cells; b) Platelets for Further Manufacture; c) Recovered Plasma
CODE a); b) and c) Unit 4104844.
RECALLING FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center,Augusta,
GA
REASON Blood products, which were collected from a donor who had received a
bone transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION GA and Switzerland.
PRODUCT
Red Blood Cells
CODE Unit number 20401-0802.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON Blood product, collected from an ineligible donor due to medication with
an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit number 20400-6355 (distributed as 2 split units).
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON Blood product, collected on an apheresis machine where there was no
documentation of evaluation of the filter assemblies as required, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA.
PRODUCT
Red Blood Cells
CODE Unit number 20401-0726.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON Blood product, that tested out of specification for hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT
Reagent Red Blood Cells of the following types a) Panocell-10; b) Panocell-10,
Ficin treated; c) Panoscreen;
d)
Panoscreen, Ficin treated.
CODE a) Lot numbers 38975 and 38978; b) Lot number 38975-E; c) Lot numbers
38976 and 38977; d) Lot number 38976-E.
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA
REASON
Reagent red blood cells were distributed that may have been contaminated with microorganisms.
VOLUME OF PRODUCT IN COMMERCE 6 lots.
DISTRIBUTION Nationwide and Internationally.
PRODUCT a) Saphenous Vein; b) Tibialis Tendon.
CODE a) Units 7026668 and 7026694; b) Units 7032451,
7032431, 7032467, and 7032402.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON Human tissues for transplantation was processed from
a donor who was found to test positive for hepatitis C virus (HCV) subsequent
to distribution.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION MA, TN and WA.
PRODUCT a) Red Blood Cells; b) Platelets.
CODE a) and b) Unit number 3036575.
RECALLING FIRM/MANUFACTURER Community Blood Center,
Dayton, OH
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 OH.
PRODUCT Platelets Pheresis.
CODE Unit number 24FH29397.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, River Valley Region, Louisville, KY
REASON Platelets Pheresis with an elevated platelet count
based on volume of product collected were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Platelets.
CODE Unit number 1897423.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood
Center, Inc., Lexington, KY
REASON Blood product, collected from an ineligible donor
due to recent ingestion of aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Plasma; e) Cryoprecipitated AHF.
CODE a) units 0323252, 0324242, 0326009, 0326011,
0327049, 0327059, 0327159, 0327877, 0327895, 0328204, 0328207, 0328212,
0329744,
0329763,
0329764, 0329769, 0331226, 0331231, 0331238, 0331239, 0331243, 0331246,
0331249, 0331330, 0332967, 0337109, 0337116, 0338936, 0338944, 0340142,
0340149, 0340219, 0340221, 0340233, 0340240, 0340242, 0340270, 0340273,
0340282, 0340975, 0340977, 0340987, 1289010, 1289067, 1289369, 1289374,
1289416, 1289759, 1289950, 1289996, 1290002, 1290161, 1290196, 1291546, 1291549,
1293201, 1293222, 1293227, 1293228, 1293244, 1293251, 1293258, 1293264,
1293282, 1293309, 1293426, 1293432, 1293439, 1293449, 1293467, 1293469,
1293484, 1293489, 1293493, 1293517, 1293537, 1293542, 1293550, 1293557,
1293572, 1293574, 1293579, 1293583, 1293586, 1293600, 1293604, 1293806,
1293808, 1293820, 1293836, 1293843, 1293858, 1293865, 1293869, 1293871,
1293888, 1293895, 1294049, 1294071, 1294078, 1294081, 1294102, 1294104,
1294114, 1294130, 1294134, 1294146, 1294152, 1294156, 1294165, 1294167, 1294172,
1294180, 1294181, 1294187, 1294198, 1294214, 1294512,
1294568,
1294598, 1294792, 1294803, 1294809, 1294815, 1295045, 1295442, 1295443,
1295540, 1295555, 1295558, 1295562, 1295568, 1295775, 1295778, 1295780,
1295784, 1295785, 1295786, 1295789, 1295790, 1295933, 1295940, 1295947,
1295949, 1295960, 1295963, 1295964, 1295965, 1296001, 1296064, 1296144,
1296149, 1296165, 1296173, 1296176, 1296177, 1296205, 1297926, 1297929,
1297930, 1297934, 1297950, 1297956, 1298170, 1298185, 1298197, 1298205,
1298207, 1298432, 1298437, 1298440, 1298441, 1298448, 1298451, 1298505,
1298511, 1298528, 1298543, 1298548, 1298553, 1298576, 1298580, 1298583,
1298638, 1298643, 1298646, 1298648, 1298658, 1298662, 1298676, 1298681,
1298683, 1298783, 1298786, 1298789, 1298795, 1298818, 1298915, 1298919,
1298920, 1298932, 1298937, 1298938, 1298945, 1298967, 1298971, 1298974,
1298982, 1298997, 1299102, 1299108, 1299110, 1299126, 1299334, 1299351,
1299354, 1299356, 1299362, 1299370, 1299394, 1299397, 1299407, 1299408,
1300007,
1300021, 1300038, 2184770, 2184797, 2185306, 2185308, 2185378, 2185397,
2185402, 2185426, 2185707, 2185709, 2185716, 2185748, 2185756, 2185765,
2185941, 2185948, 2185958, 2185961, 2186307, 2186318, 2186467, 2186817,
2186827, 2186839, 2186867, 2186881, 2186972, 2186980, 2187026, 2187035,
2187045, 2187222, 2187228, 2187236, 2187237, 2187245, 2187330, 2187333,
2187339, 2187350, 2187852, 2187877, 2188557, 2188561, 2188575, 2190417,
2190422, 2190433, 2190442, 2190451, 2190452, 2190457, 2190461, 2190465,
2190489, 2190499, 2190502, 2190509, 2190513, 2190519, 2190520, 2190731,
2190737, 2190740, 2190768, 2190775, 2190913, 2190929, 2190949, 2190961,
2190971, 2190986, 2191033, 2191048, 2191049, 2191098, 2191099, 2191102,
2191105, 2191109, 2191110, 2191449, 2191464, 2191509, 2191566, 2191574,
2191585, 2191592, 2191623, 2191637, 2191658, 2191663, 2191674, 2191693,
2191698, 2191712, 2192736, 2192746, 2192749, 2192761, 2192767, 2192774,
2192776,
2193047, 2193052, 2193371, 2193553, 2193554, 2193556, 2193558, 2193572,
2193589, 2193593, 2194119, 2194123, 2194127, 2194141, 2194385, 2194392,
2194393, 2194411, 2194414, 2194430, 2194453, 2195051, 2195057, 2195062,
2195342, 2195347, 2195435, 2195440, 2195442, 2195472, 2195511, 2195532,
2195536, 2195540, 2195782, 2195789, 2195792, 2195808, 2196042, 2196081,
2196084, 2196111, 2196118, 2196126, 2196128, 2196163, 2196165, 2196167,
2196170, 2196175, 2196179, 2196181, 2196184, 2197417, 2197423, 2197435,
4128413, 4128456, 4128465, 4128475, 4129187, 4129206, 4129243, 4129250,
4129255, 4130416, 4130427, 4130435, 4130440, 4130454, 4130463, 4130470,
4130472, 4130474, 4130485, 4130486, 4130496, 4130507, 4130510, 4130616,
4130624, 4130629, 4130632, 4130637, 4130641, 4130643, 4130646, 4130648,
4130659, 4130797, 4130801, 4130803, 4130810, 4130811, 4130822, 4130826,
4131103, 4131126, 4131128, 4131131, 4131133, 4131169, 4131172, 4131175,
4131184, 4131186, 4131297, 4131300, 4131310, 4131312, 4131428, 4131434,
4131448, 4131449, 4131453, 4131454, 4131475, 4131549, 4131553, 4131554,
4131558, 4131561, 4131562, 4131564, 4132403,
4132410, 4133017, 4133027, 4133037, 4133042, 4133044, 4133046, 4133047,
4133049, 4133051, 4133063, 4133323, 4133329, 4133342, 4133395, 4133399,
4133406, 4133442, 4133656, 4133658, 4133660, 4133666, 4133669, 4133670,
4133757, 4133771, 4133815, 4133830, 4134259, 4134269, 4134396, 4134400,
4134402, 4134405, 4134408, 4134410, 4134411, 4134418, 4134725, 4134733,
4134752, 4134761, 4134781, 4134783, 4134788, 4135516, 4135520, 4135535,
4135536, 4135538, 4135541, 4135553, 4135558, 4135569, 4135584, 4135586,
4135678, 4135703, 4135743, 4135752, 4135812, 4135937, 4135942, 4136224,
4136235, 4136238, 4136239, 4136240, 4136325, 4136679, 4136681, 4136698,
4136701, 4136704, 4136718, 4136828, 4136831, 4136832, 4136834, 4136839,
4136851, 4136857, 4136859, 4136864,
4136866,
4136868, 4136885, 4136890, 4137088, 4137205, 4137210, 4137213, 4137216,
4137219, 4137221, 4137224, 4137229, 4137249, 4137251, 4137252, 4137255,
4137256, 4137490, 4137499, 4138592, 4138629, 4138631, 4138636, 4138669,
4138680, 5076772, 5076787, 5076793, 5076804, 5077169, 5077193, 5079543,
5079548, 5079562, 5079894, 5079895, 5079897, 5080218, 5080220, 5080258,
5080263, 5081069, 5081070, 5081087, 5081089, 5081604, 5081614, 5081630,
5081650, 5081681, 5081687, 5081716, 5081722, 5081729, 5081740, 5081792,
5081811, 5081823, 5081886, 5081887, 5081901, 5081913, 5081916, 5082015,
5082021, 5082030, 5082044, 5082053, 5082055, 5082234, 5082240, 5082243,
5082252, 5082253, 5082257, 5082545, 5082553, 5082555, 5082562, 5082706,
5082713, 5082717, 5082726, 5082728, 5082732, 5082734, 5083194, 5083200,
5083283, 5083290;
b)
units 0327877, 0331226, 0338936, 1288996, 1289374, 1289759, 1289800, 1289945,
1290161, 1293217, 1293227, 1293228, 1293244, 1293251, 1293257, 1293426,
1293432, 1293484, 1293493, 1293537, 1293550, 1293579, 1293806, 1293817,
1293836, 1293843, 1293851, 1293869, 1294102, 1294104, 1294114, 1294598,
1294998, 1295011, 1295540, 1295562, 1295786, 1296149, 1296165, 1296173,
1297930, 1298197, 1298511, 1298528, 1298543, 1298548, 1298553, 1298576, 1298583,
1298638, 1298683, 1298818, 1298967, 1298974, 1298997, 1299110, 1299334,
1299337, 1299370, 1299407, 2184770, 2184797, 2185306, 2185397, 2185948,
2185958, 2185961, 2186306, 2186817, 2186907, 2186912, 2187222, 2187237,
2187877, 2188557, 2190433, 2190509, 2190519, 2190520, 2190731, 2190740,
2190929, 2190961, 2190971, 2191075, 2191091, 2191098, 2191099, 2191454,
2191464, 2191574, 2191603, 2191674, 2191712, 2192736, 2193556, 2193558,
2194392, 2195057, 2195062, 2195444, 2195471, 2195472, 2195511,
2195532,
2195782, 2195787, 2195789, 2196040, 2196048, 2196049, 2196184, 2196186,
2197417, 2197423, 4129243, 4129250, 4130427, 4130435, 4130446, 4130472,
4130616, 4130632, 4130659, 4130803, 4130810, 4131184, 4131428, 4131429,
4131438, 4131448, 4131453, 4131454, 4131468, 4134400, 4134790, 4135703,
4135743, 4135752, 4135942, 4136707, 4136856, 4136861, 4136866, 4136868,
4137088, 4137095, 4137213, 4137490, 4138583, 4138592, 4138638, 5079562,
5079893, 5079897, 5081069, 5081630, 5081647, 5081681, 5081729, 5081913,
5082015, 5082030, 5082252, 5082253, 5082290, 5082294, 5083281, 9058590, and
9063189;
c)
units 0324242, 0326011, 0326014, 0327049, 0327059, 0327159, 0327877, 0327895,
0329744, 0329769, 0331249, 0332971, 1289067, 1290161, 1291533, 1293201,
1293244, 1293251, 1293258, 1293264, 1293432, 1293817, 1293888, 1293895,
1294104, 1294114, 1294506, 1295780, 1295936, 1295940, 1298548, 1298553,
2186817, 2187228, 2187245, 2188557, 2190461, 2190465, 2190509, 2190929,
2190949, 2192761, 2192767, 2195062, 2195102, 2195347, 4130632, 4130637,
4130797, 4130810, 4130811, 4130826, 4131125, 4131126, 4131184, 4131186,
4131312, 4131434, 4131453, 4131454, 4131780, 4131783, 4135678, 4135942,
4136704, 4136710, 4136718, 4136834, 4136851, 4136859, 4136864, 4136868,
5076804, 5079895, 5079897, 5081796, 5081823, 5081838, 5081886, 5081887,
5081901, 5082030, 5082055, 5083200, 5083283, and 5083290;
d)
units 0324242, 0327059, 0329744, 0331231, 0331249, 0331335, 2186827, 2187236,
4130516, and 5081716;
e)
units 0324242, 0327059, 0329744, 0331231, 0331236, 0331249, 1290002, 1290196,
2187022, 2190502, 2193554 and 5081716.
RECALLING FIRM/MANUFACTURER Community Blood Center of
Greater Kansas City, Kansas City, MO
REASON Blood products, collected from donors whose health
history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE a) 629 units; b) 170 units;
c) 86 units; d) 10 units; e) 12 units.
DISTRIBUTION MO, KS, NJ, TX, IN, TN, MD, FL and MA.
PRODUCT Platelet, Pheresis.
CODE Unit R66987.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a
Miller Memorial Blood Center, Bethlehem, PA
REASON Blood product, which was labeled as leukoreduced,
but failed to meet the, criteria for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE a) and b) Unit R57511.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a
Miller Memorial Blood Center, Bethlehem, PA
REASON Blood products, collected from a donor who lived in
an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA and NJ.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma.
CODE a); b) and c) Unit 22FR70315.
RECALLING FIRM/MANUFACTURER American Red Cross,
Penn-Jersey Region, Philadelphia, PA
REASON Blood products, collected from a donor who provided
post donation information regarding
having tested positive for hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION PA and NJ.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Red Blood
Cells, Leukoreduced, Irradiated; c) Platelets; d) Fresh Frozen Plasma; e)
Cryoprecipitate, Pooled; f) Recovered Plasma.
CODE a) Units 1796324, 1751564; b) Unit 1765739; c) Unit
1751564; d) Unit 1751564; e) Unit 4014230; f) Units 1765739, 1796324.
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue
Center, San Antonio, TX
REASON Blood products, collected from a donor who provided
post donation information of having
liver disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION TX and FL.
PRODUCT Platelet, Pheresis
CODE Unit R89121.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a
Miller Memorial Blood Center, Bethlehem, PA
REASON Blood product, which had an unacceptable red cell
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT Platelets, Leukocytes Reduced.
CODE Unit 16LG38876.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Central Ohio Region, Columbus, OH
REASON Blood product, corresponding to a unit of Red Blood
Cells that was implicated in a transfusion reaction and found to be
contaminated with Staphylococcus epidermitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Fresh
Frozen Plasma.
CODE a) and b) Unit 10728-4529.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Scottsdale, AZ.
REASON Blood products, collected from a donor whose
temperature was not accurately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT Source Plasma.
CODE Units G92771-076, G87177-076.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alpha Therapeutic Corporation, Los Angeles,
CA
Manufacturer: Alpha Therapeutic Corporation, Fayetteville,
NC.
REASON Source Plasma, collected from a donor who had a
tattoo applied within the past 12 months, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Switzerland.
PRODUCT Platelets, Pheresis
CODE Unit R83158.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, t/a
Miller Memorial Blood Center, Bethlehem, PA
REASON Blood product, manufactured with an increased red
cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number M13910.
RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank,
Inc., Rockford, IL
REASON Blood product, that tested positive for
Cytomegalovirus (CMV), but was labeled negative for CMV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets;
c) Cryoprecipitated AHF; d) Recovered Plasma
CODE a); b); c) and d) Unit number 30GE20865.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northeastern Pennsylvania Region, Ashley, PA
REASON Blood products, collected from an unsuitable donor
due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION PA, MA, NY and Switzerland.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets; c) Cryoprecipitated AHF; d) Recovered Plasma.
CODE a); b); c) and d) Unit number 30LV04215.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northeastern Pennsylvania Region, Ashley, PA.
REASON Blood products, collected from an unsuitable donor
due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION PA, NY and Switzerland.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets; c) Platelets Pheresis.
CODE a) and b) Unit number 30GJ40729; c) Unit numbers
30GP19527, 30GP18692, 30GP18471, and 30GP17810 (all units distributed as two
split units).
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northeastern Pennsylvania Region, Ashley, PA.
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 10 units.
DISTRIBUTION PA.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Red Blood
Cells, Frozen; c) Platelets
CODE a) Unit number 30GN31405; b) and c) Unit number
30GN28512.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northeastern Pennsylvania Region, Ashley, PA.
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 PA and CT.
PRODUCT Source Plasma
CODE Unit numbers BRKVYK, BRKXNW, BRLCKQ, BRLJNL, BRLKKN,
BRMLPV, BRMMQZ, BRMPCN, BRMQCN, BRMRFM, BRMSQQ, BRMTGJ, BRMXCJ, and BRQHSJ.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aventis
Bio-Services, Inc., Knoxville, TN
Manufacturer:
Aventis Bio-Services, Inc., Akron, OH.
REASON Blood products, that tested negative for viral
markers, but were collected from an ineligible donor due to body piercing in
the previous 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION IL and Germany.
PRODUCT Counterfeit PROCRIT? (Epoetin Alfa) labeled as
40,000 IU/mL, 13,472 distributed.
CODE Lot numbers: P002641 - Exp. Date 9/03 P002384 - Exp. Date 3/03.
RECALLING FIRM/MANUFACTURER Recalling Firm: Bindley
Trading Company, Grapevine, TX
Manufacturer:
Unknown
REASON Counterfeit drug products, with a concentration of
active ingredient less than labeled, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13,472.
DISTRIBUTION Nationwide.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 04FS45055, 04FS45061.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, New England Region, Dedham, MA
REASON Blood products, that lacked assurance of sterility,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 042G30721, 042R59346, 042C09764, 042FE62665,
042FE67461, 042FE67472, 042FE67462, 042FE67474, 042FE67465, 042FE67475,
042E37707, 042FJ04857, 042FJ04853, 042FJ04849, 042FJ04859, 042Y27010, 042FR93720, 042M03902, 042X37454,
042T99665, 042FE67466, 042FE67476, 042FE67467, 042FE67477, 042FE67471,
042FQ98669, 042FJ04852, 042FJ04860, 042FJ04858, 042FJ04856, 042FY33670.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Northern Ohio Region, Cleveland, OH.
REASON Blood products, that were not leukoreduced within a
24-hour time frame, or lacked assurance
of sterility, were distributed.
VOLUME OF PRODUCT IN COMMERCE 31 units.
DISTRIBUTION OH.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 03S08471.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern
Region, Atlanta, GA
REASON Blood product, collected from a donor who had lived
in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Platelets
CODE Unit 03GZ26738.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern
Region, Atlanta, GA
REASON Blood product, collected from a donor who had lived
in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 03LC19596.
RECALLING FIRM/MANUFACTURER American Red Cross, Southern
Region, Atlanta, GA
REASON Blood product, collected from a donor who had not
completed a nvCJD increased risk question, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma; d) Cryoprecipitate AHF; e) Recovered Plasma.
CODE a) Units 30LV02834, 30LV02008, 30GY12011; b) and c)
Unit 30GY12011; d) Unit 30LV02008; e) Units 30LV02834, 30LV02008.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Northwestern Pennsylvania Region, Ashley, PA
REASON Blood products, collected from a donor with a
history of having a confirmed positive test for Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION PA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 18225-2729.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
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 a) Cryoprecipitated AHF; b) Plasma
CODE a) and b) Unit number 30GE27973.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northeastern Pennsylvania Region, Ashley, 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 MA and NY.
PRODUCT a) Red Blood Cells; b) Red Blood Cells Leukocytes
Removed; c) Fresh Frozen Plasma; d) Plasma; e) Cryoprecipitated AHF;
f)
Recovered Plasma.
CODE a) Unit 30LE01772; b) Units 30LV05371, 30LE02174, 30LE01885,
and 30LE01434; c) Unit 30LE01772; d) Unit 30LV0537; e) Units 30LV05371 and
30LE02174; f) Units 30LE02174 and 30LE01434.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Northeastern Pennsylvania Region, Ashley, PA.
REASON Blood products, which were collected from a donor
with a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION PA, NY and Switzerland.
PRODUCT Source Plasma.
CODE Unit 71FPBJCM.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc.,
Greenville, SC
REASON Blood product, which was not tested for syphilis,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Platelets; d) Platelets, Leukocytes Reduced.
CODE a) and c) Unit number 42FS67962; b) and d) Unit
number 42X43881.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Northern Ohio Region, Cleveland, OH
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 4 units.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Fresh
Frozen Plasma.
CODE a) and b) Unit number 04N07571.
RECALLIN