DECEMBER 2002
WEEK ENDING DECEMBER 7
PRODUCT Tibialis Tendon Allografts.
CODE Units 7797174, 7797158.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON Human tissues, collected from a donor who was suspected
to have viral encephalitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE a) and b) Unit 42FE60831.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Northern Ohio Region, Cleveland, OH
REASON Blood products, collected from an ineligible donor
due to medication with the drug Proscar, were distributed
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered
Plasma.
CODE a) and b) Unit 16LM59278.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services,Central Ohio Region, Columbus, OH
REASON Blood products, collected from a donor taking the
drug Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ and CA.
PRODUCT Platelets, Leukoreduced, Irradiated.
CODE Units 16GM19154, 16KC21628, 16KC21626.
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Central Ohio Region, Columbus, OH
REASON Blood products, for which documentation of
irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH.
PRODUCT Platelets, Leukoreduced.
CODE Unit 42K52117.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Northern Ohio Region, Cleveland, OH
REASON Blood product, manufactured from a unit of Whole
Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT Source Plasma.
CODE Unit 76179440.
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc.,
Columbus, OH
REASON Blood product, which was collected from a donor with
an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
WEEK ENDING DECEMBER 14
PRODUCT Pooled Plasma, Solvent/Detergent Treated, Type A,
PLAS+SD.
CODE Lot number
FW00315.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Corporate Headquarters, V.I. Technologies, Watertown, MA.
Manufacturer: V.I. Technologies, Melville, NY.
REASON Blood products,
containing fibrin like material, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1,340
units.
DISTRIBUTION Nationwide.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number
04M09382.
RECALLING FIRM/MANUFACTURER The
American National Red Cross, New England Region, Dedham, MA.
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 MA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number
04FR61607.
RECALLING FIRM/MANUFACTURER The
American National Red Cross, New England Region, Dedham, MA
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 MA.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Recovered
Plasma.
CODE a) and b) Unit
numbers 04F89674 and 04V85144.
RECALLING FIRM/MANUFACTURER The
American National Red Cross, New England Region, Dedham, MA
REASON Blood products, that tested negative for the
antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible
donor based on the subsequent disclosure of a previous positive test for anti-HCV,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units.
DISTRIBUTION MA and
CA.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma; c)
Recovered Plasma.
CODE a) Units
01LS22368, 01LS21230, 01LS20144, 01LS18839, 01LS17613, 01LS16265, 01LS14999; b)
Unit 01LS14999; c) Units 01LS22368, 01LS21230, 01LS20144, 01LS18839, 01LS17613,
01LS16265.
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, New York-Penn Region, West Henrietta, NY
REASON Blood products, which tested negative for Hepatitis
B Surface Antigen (HBsAg), but were collected from a donor who previously
tested reactive for HbsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14
units.
DISTRIBUTION NY.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Recovered
Plasma.
CODE a) and b) Unit
01LP40710.
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, New York-Penn Region, West Henrietta, NY
REASON Blood products, which were collected from a donor
who provided information regarding previously testing positive for hepatitis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units.
DISTRIBUTION NY.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Plateletsm; c)
Recovered Plasma.
CODE a); b) and c)
Unit 01Y33966.
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, New York-Penn Region, West Henrietta, NY
REASON Blood products, collected from a donor who provided
information regarding a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units.
DISTRIBUTION NY.
PRODUCT Red Blood Cells
CODE Unit 106043578.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Scottsdale, AZ.
REASON Blood product,
collected from a donor with a history having tested positive for hepatitis A,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION AZ.
PRODUCT Human bone and tissue for transplantation (various
types).
CODE DONOR # 00329204
Item # 550486 Serial # 003292040047 - 003292040049;
Item # 550100 Serial # 003292040001 - 003292040002;
Item # 500060 Serial # 003292040042 - 003292040044 & 003292040050;
Item # 500402 Serial # 003292040038 - 003292040040;
Item # 500730 Serial # 003292040026 - 003292040027;
Item # 500080 Serial # 003292040003 - 003292040007;
Item # 500292 Serial # 03292040045;
DONOR
# 00329983
Item # 500530 Serial # 003299830030;
Item # 500046 Serial # 003299830042;
Item # 500209 Serial # 003299830047 - 003299830049;
Item # 500570 Serial # 003299830052 - 003299830054;
Item # 500210 Serial # 003299830060 - 003299830062;
Item # 500402 Serial # 003299830063 - 003299830065;
Item # 500057 Serial # 003299830067 - 003299830071;
Item # 500080 Serial # 003299830003 - 003299830004;
Item # 500410 Serial # 003299830032 - 003299830033;
Item # 500401 Serial # 003299830066;
Item # 550100 Serial # 003299830001 - 003299830002;
DONOR
# 00828449
Item # 550495 Serial # 008284490047 - 008284490048;
Item # 550100 Serial # 008284490001 - 008284490002;
Item # 500060 Serial # 008284490040 - 008284490042;
Item # 500220 Serial # 008284490043 - 008284490046;
Item # 500585 Serial # 008284490049 - 008294490050;
Item # 500080 Serial # 008284490003 - 008284490006;
DONOR
# 01729322
Item # 150781 Serial # 017293220016 - 017293220020 & 017293220040 -
017293220040;
Item # 100399 Serial # 017293220027 - 017293220030;
Item # 100405 Serial # 017293220023 - 017293220026;
Item # 100585 Serial # 017293220043;
DONOR
# 02329525
Item # 550782 Serial # 023295250003 - 023295250005;
Item # 550494 Serial # 023295250046;
Item # 550776 Serial # 023295250037 – 023295250041; 023295250002;
Item # 500750 Serial # 023295250023 - 023295250024;
Item # 500051 Serial # 023295250054 - 023295250063;
Item # 500585 Serial # 023295250052 - 023295250053;
Item # 500201 Serial # 023295250042 - 023295250045 & 023295250050 -
023295250051
Item # 500530 Serial # 02329520057;
Item # 500402 Serial # 023295250033 - 023295250034;
DONOR
# 02329646
Item # 550100 Serial # 023296460001 - 023296460002;
Item # 550782 Serial # 023296460003 - 023296460005;
Item # 500060 Serial # 023296460037 - 023296460039;
Item # 500410 Serial # 023296460029 - 023296460030;
Item # 500293 Serial # 023296460040 - 023296460041;
Item # 500585 Serial # 023296460047 - 023296460048;
DONOR
# 02329773
Item # 550782 Serial # 023297730001 - 023297730002;
Item # 550495 Serial # 023297730034 - 023297730035;
DONOR
# 03528533
Item # 100080 Serial # 035285330016 - 035285330021 &
035285330057 - 035285330058;
Item # 150486 Serial # 035285330038 - 035285330040;
DONOR
# 03530117
Item # 550495 Serial # 035301170042 - 035301170043;
Item # 550782 Serial # 035301170003 - 035301170004;
Item # 550100 Serial # 035301170001 - 035301170002;
Item # 500750 Serial # 035301170044 - 035301170047;
Item # 500060 Serial # 035301170037 - 035301170039;
Item # 500220 Serial # 035301170023 - 035301170025;
Item # 500410 Serial # 035301170029 - 035301170031;
Item # 500330 Serial # 035301170035;
Item # 500520 Serial # 035301170027;
Item # 500585 Serial # 035301170048;
DONOR
# 0382982
Item # 550100 Serial # 038298200001 - 0382982000;
Item # 500060 Serial # 038298200042 - 038298200044;
Item # 500399 Serial # 038298200036 - 038298200037;
Item # 500410 Serial # 038298200032 - 038298200034;
Item # 500580 Serial # 038298200003 - 038298200007 & 038298200059 -
038298200060;
Item # 500209 Serial # 038298200045 - 038298200048;
Item # 500530 Serial # 038298200030 - 038298200031;
Item # 500330 Serial # 038298200040;
DONOR
# 02329773 Item # 550782 not available
Item # 550495 not available
DONOR # 00328426 Item # 550486 Serial #: 003284260092
DONOR # 00529695 Item # 550776 not available.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Musculoskeletal Transplant Foundation, Edison Corporate Center, Edison,
NJ
Contract
Manufacturer: Osteotech, Inc., Eatontown, NJ.
REASON Human bone and
tissues for transplantation that tested negative for microorganisms, but may
have been exposed to microbial contamination due to failing 0.24 micron
filters, were distributed.
VOLUME OF PRODUCT IN COMMERCE 107
units.
DISTRIBUTION Nationwide.
PRODUCT Human bone and tissue for transplantation-various
types.
CODE Units (52 units)
Donor # Item # Product Description Quantity
F0103410 910120 Cancellous Chips (7 units)
910300 Ilium Tricort. Blk s (1 unit)
910320 Ilium Tricort. Blk L (8 units)
910010 Cortical/Canc Chips (4 units)
910620 Canc/Cortical Dowel (2 units)
911311 Patellar Blk (2 units)
C0194653 319120 Cancellous Chips (8 units)
E0403318 310120 Cancellous Chips (7 units)
F0103729 310120 Cancellous Chips (10 units)
A0101706 920012 Crushed Cortical/Canc. (1 unit)
D0102654 920000 Cancellous Chips (1 unit)
E0403300 910825 Fibula Shaft (1 unit)
RECALLING FIRM/MANUFACTURER Osteotech,
Inc., Eatontown, NJ, by fax dated September 11, 2002.
REASON Human bone and
tissue for transplantation, that was processed using equipment that contained
bacteria in the compressed air line, was distributed.
VOLUME OF PRODUCT IN COMMERCE 52
units.
DISTRIBUTION Washington
DC.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Platelets,
Leukoreduced; c) Fresh Frozen Plasma.
CODE a); b)and c) Unit
42FS71141.
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, Northern Ohio Region, Cleveland, OH
REASON Blood products, collected from a donor with a
history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units.
DISTRIBUTION OH.
PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 01GL57919.
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, New York-Penn Region, West Henrietta, NY
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 NY.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Red Blood
Cells; c) Fresh Frozen Plasma; d) Platelets; e) Recovered Plasma.
CODE a) Unit 50E21595;
b) Unit 50F89525, 50F67302, 50H68164; c) Unit 50E21595; d) Unit 50H68164; e)
Unit 50F89525, 50F67302, 50H68164.
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, Western Lake Erie Region, Toledo, OH
REASON Blood products, collected from a donor who provided
post donation information regarding a history of hepatitis and participating in
high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9
units.
DISTRIBUTION OH, IN
and WI.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 26172-2009,
26172-2140, 26172-2170.
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Ft. Smith, AR
REASON Blood products, quarantined due to possible
hemolysis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units.
DISTRIBUTION AR.
PRODUCT Blood Grouping Reagents of the following types: a) ID-Micro Typing System_ MTS ABD
Monoclonal and Reverse Grouping;
b) ID-Micro Typing System_ MTS ABD Monoclonal Grouping;
c) ID-Micro Typing System_ MTS Anti-A (Murine Monoclonal) Grouping Card.
CODE a) Lot numbers
110901037-01, 110901037-02, 110901037-03, 110901037-04, 110901037-05,
110901037-06, 110901037-07, 110901037-08, 110901037-09, 110901037-10,
110901037-11, 110901037-12, 110901037-13, 110901037-14, 110901037-15,
110901037-16, 110901037-17, 110901037-18, 110901037-19, 110901037-20,
110901037-21, 050401037-04, 050401037-05, 050401037-06, 050401037-07
071701037-05, 071701037-06, 071701037-07, 071701037-08, 071701037-09,
071701037-10, 071701037-11, 071701037-12, 071701037-13, 071701037-14,
071701037-15, 071701037-16, 071701037-17;
b) Lot numbers 012102053-01, 012102053-02, 012102053-03; c) Lot numbers
101901039-01 and 101901039-02.
RECALLING FIRM/MANUFACTURER Micro
Typing Systems, Inc., Pompano Beach, FL.
REASON ABO Blood
Grouping Reagents, that exhibited a decreased reactivity with type A2B red
blood cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE 43
lots.
DISTRIBUTION Nationwide,
Mexico, Spain, Canada and Germany.
PRODUCT Red Blood Cells.
CODE Unit number
3955774.
RECALLING FIRM/MANUFACTURER Houchin
Community Blood Bank, Bakersfield, CA.
REASON Blood product,
collected from an unsuitable donor based on travel to an area considered
endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION CA.
PRODUCT Products from low volume collections: a) Whole
Blood; b) Whole Blood, Irradiated; c) Red Blood Cells; d) Red Blood Cells,
Leukocytes; e) Red Blood Cells, Irradiated; f) Platelets; g) Platelets,
Irradiated; h) Cryoprecipitated.
CODE a) Unit numbers
2335406, 3425628, 3582615, 4546214, 8060743, 8561359, 9555505, and 9555824;
b) Unit number 4548684;
c) Unit numbers 1492171, 1493680, 1494691, 1495833, 1496366, 1498136, 1498714,
1499385, 1499888, 1767419, 1770418, 1771067, 1771295, 1772367, 1774113,
1774473, 1777786, 1779669, 2158019, 2161408, 2162258, 2162266, 2162272,
2162312, 2165356, 2165802, 2167610, 2170435, 2172447, 2173477, 2174172, 2174262,
2176717, 2178868, 2179075, 2181976, 2182328, 2183366, 2183890, 2185893,
2186055, 2186378, 2186552, 2186825, 2187385, 2187745, 2188872, 2191323,
2193490, 2195234, 2196636, 2196726, 2197897, 2198121, 2198374, 2198406,
2198411, 2198770, 2198853, 2213941, 2216265, 2217806, 2218184, 2220939,
2222027, 2222815, 2222929, 2334548, 2338637, 2339051, 2339258, 2343919,
2345876, 2347650, 2347907, 2348310, 2354461, 2355358, 2355747, 2356036,
2365998, 2427862, 2428144, 2428171, 2428622, 2429013, 2430781, 2434400,
2434415, 2434609, 2436072, 2436083, 2437871, 2443322, 2446268, 2447460,
2447468, 2448739, 2448744, 2449354, 2450503, 2450913, 2450932, 2450943,
2450958, 2452009, 2455522, 2455807, 2456284, 2702617, 2705259, 2706411,
2706674, 2711501, 2713381, 2714499, 3029818, 3030528, 3420284, 3420351,
3420773, 3420788, 3421999, 3422172, 3422592, 3423235, 3423437, 3425310,
3425457, 3426063, 3426189, 3426310, 3426901, 3427956, 3428441, 3428733,
3432198, 3432217, 3432712, 3440369, 3441084, 3583331, 3583856, 3584482, 3585455,
3585935, 3586086, 3587474, 3587934, 3590561, 3592612, 3593775, 3595049,
3597366, 3598798, 3599663, 3901327, 4059774, 4060395, 4061776, 4062961,
4063374, 4064938, 4070372, 4072552, 4075132, 4075679, 4115784, 4116119,
4117569, 4124505, 4124515, 4125391, 4317454, 4317511, 4324467, 4327281,
4327418, 4330077, 4332571, 4417024, 4417212, 4417238, 4417742, 4417994,
4423663, 4424406, 4427351, 4429501, 4430196, 4549596, 4551221, 4552922,
4554502, 4554504, 4555970, 4559558, 4566822, 4567198, 4811225, 4814277, 4816167,
4816591, 4817894, 4820463, 4820820, 5081320, 5082488, 5083471, 5084347,
5085140, 5086125, 5089467, 5089706, 5089955, 5091475, 5091999, 5093042,
5096307, 5098366, 5507085, 5507504, 5507706, 5510564, 5522549, 5528967,
5530278, 5605012, 5705528, 5807121, 5807486, 5808903, 5811048, 5811280,
5815868, 5817540, 5817959, 5822534, 5824058, 5825400, 5825599, 5826840,
5827141, 5828613, 5908634, 5912519, 5913698, 5913962, 5914024, 5914624,
5917173, 6082401, 6082644, 6083327, 6087318, 6087906, 6088101, 6088111, 6089480,
6090076, 6090462, 6093170, 6096270, 6097616, 6099160, 6099867, 6116357,
6119502, 6123599, 6123807, 6124647, 6127236, 6127776, 6129441, 6131813,
6133697, 6133945, 6138031, 6138332, 6138351, 6141504, 6229705, 6230870,
6230923, 6231415, 6231636, 6231667, 6233964, 6234343, 6236412, 6307785,
6310537, 6311614, 6313108, 6314199, 6314379, 6315996, 6317834, 6318018,
6319693, 6321001, 6321011, 6321117, 6401278, 6401495, 6402228, 6404682,
6405147, 6406037, 6407328, 6407492, 6408312, 6607275, 6610250, 6610444, 6610447,
6612218, 6612987, 6617714, 6620088, 6621215, 6909228, 6909737, 6910539,
6911074, 6911962, 6912034, 6915206, 6915279, 6915750, 6915870, 6918514,
6920279, 7047162, 7047335, 7047940, 7049758, 7051551, 7052072, 7052188,
7052191, 7052593, 7056087, 7056772, 7057379, 7057928, 7499231, 7499555,
7537123, 7538033, 7539507, 7540845, 7541000, 7542727, 7544078, 7544905,
7544977, 7545050, 7546264, 7781883, 7782394, 7859612, 7860608, 7860776,
7863528, 7863613, 7863792, 7864641, 7917158, 7917649, 7918534, 7919052, 7920454,
7923259, 7923739, 7925504, 7932280, 7932356, 7932549, 7936184, 7936630,
7937767, 7937989, 7938914, 7939495, 8056087, 8062248, 8063913, 8067084,
8068609, 8069224, 8081694, 8172728, 8177475, 8180159, 8181987, 8182528,
8182538, 8207790, 8208082, 8554924, 8555883, 8571260, 8600581, 8600680,
9036611, 9037716, 9037828, 9038559, 9038608, 9041142, 9041853, 9044116,
9045067, 9046007, 9046344, 9048000, 9048745, 9049100, 9409874, 9549969,
9556291, 9558064, 9565357, 9568361, 9811883, 9812604, 9813033, 9813547, 9814142,
9815070, 9815711, 9815818, 9818823, 9819494, 9820566, 9821226, 9821535,
9821672, 9822030, 2341330, 4116890, 2183057, 3427996, 3583158, and 8208175
d) Unit numbers 4556145, 2442364, 5527866, 6098009, 7863535, 8554912, 8555059,
8556292, 8559734, 8560598, 9549729, 9552960, 9556822, 9557106, 9557113,
9557135, 9557349, 9559368, 9560974, 9562457, 9564731, and 9569555;
e) Unit numbers 2197921, 4816364, 5087931, 6135351, and 8561922;
f) Unit numbers 1492171, 1493680, 1494691, 1495833, 1498136, 1498714, 1767419,
1770418, 2158019, 2161408, 2162258, 2162266, 2162272, 2165802, 2172447,
2173477, 2174262, 2178868, 2182328, 2191323, 2193490, 2213935, 2216265,
2427862, 2428171, 2429013, 2430781, 2434400, 2434415, 2443322, 2446268,
2448739, 2448744, 2449354, 2450913, 2450932, 2450943, 2455807, 2702617,
3422172, 3441084, 3583331, 3585935, 3590561, 3593775, 3595049, 4317454,
4317511, 4327418, 4417212, 4417238, 4417742, 4417994, 4423663, 4424406,
4427351, 4429501, 4549596, 4566822, 4816167, 5082488, 5091475, 5096307, 5807121,
5807486, 5809491, 5811280, 5825400, 5825599, 5826840, 5908634, 5909548,
5914624, 6081605, 6088101, 6088111, 6089480, 6090462, 6116357, 6123807,
6131813, 6229705, 6230870, 6230923, 6231415, 6307785, 6310537, 6311614,
6314199, 6407492, 6408312, 6610250, 6610444, 6610447, 6612218, 6909737,
6911074, 6911962, 6912034, 6915206, 6915279, 6915750, 6920279, 7499555,
7537123, 7538033, 7544078, 7781883, 7782394, 7859612, 7860608, 7860776,
7864641, 7917649, 7918534, 7932280, 8172728, 8182528, 8182538, 8207790, 9037828,
9041142, 9050029, 9549969, 9812604, 9821226, 9821535, and 9822030;
g) Unit numbers 2170435, 6138332, 6612987, 7925504, and 4551221;
h) Unit numbers 1774113, 2179075, 2185893, 2186825, 2196726, 3432217, 6231636,
6404682, 8180159, 9048745, and 9049100.
RECALLING FIRM/MANUFACTURER LifeSource
Blood Services, Glenview, IL.
REASON Blood products,
manufactured from units of Whole Blood designated as either: 1) low volume
collections; or 2) difficult collections, were distributed.
VOLUME OF PRODUCT IN COMMERCE a)
8 units; b) 1 unit; c) 446 units; d) 22 units; e) 5 units; f) 128 units; g) 5;
h) 11.
DISTRIBUTION IL, WI,
GA, RI and NY.
PRODUCT Source Plasma.
CODE Units 60510389,
62553803, 62556828, 62559027,62561525.
RECALLING FIRM/MANUFACTURER BioLife
Plasma Services L.P., Dayton, OH.
REASON Blood products,
which were not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units GK42654,
GK42550, GK42599, GK42680, GK42601, GK42597, GK42653.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Tri-Counties Blood Bank, Santa Barbara, CA.
REASON Blood products,
collected from donors with inaccurate hematocrit determinations, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units.
DISTRIBUTION CA.
PRODUCT Source Plasma.
CODE Unit 183174.
RECALLING FIRM/MANUFACTURER Aventis
Bio-Services, Inc., Springfield, OH.
REASON Blood product,
which tested negative for viral markers, but was collected from a donor whose
medical history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Unit YA133071.
RECALLING FIRM/MANUFACTURER Pyramid
Biological Corporation, San Diego, CA.
REASON Blood product,
which were collected from donor whose health history was not adequately
performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION Austria.
PRODUCT Fresh Frozen Plasma.
CODE Unit
50FP08281(Part 1 and 2), 50FP08282(Part 2), 50FP08283 (Part 1 and 2), 50FP08284
(Part 1 and 2), 50FP08285, 50FP08287(Part 2).
RECALLING FIRM/MANUFACTURER American
Red Cross Blood Services, Western Lake Erie Region, Toledo, OH
REASON Blood products, which may have been shipped at
unacceptable temperatures,were distributed.
VOLUME OF PRODUCT IN COMMERCE 9
units.
DISTRIBUTION CA and
NY.
PRODUCT Source Plasma.
CODE Unit numbers
N-65481-139, N-65476-139, N-65386-139, N-65031-139, N-64716-139, and N-64710-139.
RECALLING FIRM/MANUFACTURER Alpha
Therapeutic Corporation, Mobile, AL.
REASON Source Plasma,
that was exposed to unacceptable storage temperatures and was not properly
relabeled as Source Plasma, Salvaged, was distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units.
DISTRIBUTION CA and
Spain.
PRODUCT Source Plasma.
CODE Unit number
317353.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Aventis Bio-Services, Inc., Knoxville, TN02.
Manufacturer: Aventis Bio-Services, Inc., Springfield, OH.
REASON Blood product,
collected from a donor whose arm inspection was not documented, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit.
DISTRIBUTION NC.
PRODUCT a) Platelets; b) Platelets, Irradiated; c)
Cryoprecipitated AHF; d) Fresh Frozen Plasma; e) Plasma.
CODE
a) Unit numbers 1492188, 1492567, 1492902, 1492930,1493254, 1493462, 1493507,
1493605, 1493676, 1493886, 1494528, 1494547, 1495070, 1495123, 1495982,
1497697, 1498445, 1499038, 1765913, 1766069, 1766467, 1766690, 1767579,
1768415, 1769948, 1770301, 1770896, 1772740, 1772955, 1778485, 2160505,
2161860, 2163917, 2164818, 2165453, 2165471, 2165753, 2165806, 2165812,
2168043, 2168156, 2168624, 2168980, 2169967, 2170216, 2170222, 2171067,
2171295, 2174516, 2175553, 2175572, 2175858, 2177066, 2177081, 2177195, 2178101,
2179132, 2179153, 2182392, 2182402, 2185002, 2186073, 2186123, 2187789,
2191948, 2192459, 2192479, 2194509, 2195272, 2198570, 2216225, 2216395,
2217798, 2219439, 2332947, 2336155, 2336157, 2336189, 2336209, 2345149,
2346993, 2352280, 2352426, 2363778, 2425650, 2426126, 2426387, 2426512,
2426591, 2426698, 2427165, 2427208, 2428689, 2430074, 2431658, 2431695,
2432331, 2432496, 2432843, 2433191, 2433248, 2433782, 2433783, 2436390,
2437052, 2437888, 2437942, 2439360, 2439362, 2440436, 2441018, 2441024, 2441047,
2441052, 2441363, 2441812, 2443680, 2444448, 2446272, 2447152, 2449726,
2702712, 2703213, 2704012, 2704215, 2704462, 2709607, 2709919, 2712901,
2713386, 2713389, 2713599, 3423177, 3423178, 3423179, 3426526, 3432021,
3439456, 3579049, 3581469, 3581872, 3582628, 3583345, 3586836, 3587310,
3589982, 3591037, 3591040, 3593075, 3595545, 3596068, 3596257, 3599504,
4058881, 4059559, 4061078, 4061520, 4061726, 4073823, 4077981, 4317398,
4318171, 4320088, 4320226, 4320398, 4320577, 4320974, 4321264, 4321767,
4322222, 4322659, 4323120, 4323121, 4325156, 4326509, 4326510, 4326562,
4326673, 4326758, 4326851, 4326862, 4327004, 4327006, 4413705, 4413706,
4413707, 4413708, 4413709, 4413711, 4413713, 4413715, 4413716, 4413718,
4413719, 4413720, 4413721, 4413722, 4413723, 4413724, 4413726, 4413729,
4413730, 4413731, 4413732, 4413733, 4413736, 4413738, 4413739, 4413741,
4413743, 4413744, 4413913, 4415080, 4415257, 4415686, 4417282, 4417511,
4418331, 4418338, 4419590, 4420532, 4420907, 4421161, 4421833, 4423142, 4423550,
4425134, 4426375, 4427427, 4428733, 4548275, 4549177, 4549320, 4550273,
4556098, 4557344, 5081944, 5083309, 5084235, 5084271, 5085344, 5807275,
5808769, 5809174, 5809746, 5809768, 5810184, 5810887, 5811455, 5811909,
5813749, 5814497, 5814528, 5814552, 5814715, 5815351, 5815961, 5816099,
5819762, 5819813, 5820120, 5820121, 5827459, 5827586, 5907641, 5907799,
5908173, 5908811, 5909555, 5910160, 5910297, 5910914, 5912428, 5912736,
5913743, 5914366, 5914379, 5914705, 5914776, 5914880, 5914921, 5915424, 5915675,
5916932, 5918228, 6085322, 6088357, 6089469, 6090321, 6096742, 6097127,
6116877, 6116898, 6117104, 6117448, 6118044, 6118047, 6119913, 6122161,
6123052, 6123714, 6123790, 6123809, 6124494, 6126325, 6127904, 6127907,
6128109, 6130674, 6131110, 6131849, 6131904, 6136182, 6136183, 6136184,
6137157, 6140859, 6227536, 6227558, 6229444, 6229522, 6229626, 6229692,
6230874, 6231822, 6231852, 6232159, 6232201, 6232304, 6308388, 6309549,
6309600, 6311467, 6313196, 6313580, 6313773, 6313778, 6313780, 6313949, 6314681,
6318267, 6607117, 6607826, 6608178, 6608361, 6608668, 6608756, 6608809,
6608885, 6609339, 6609730, 6610320, 6610553, 6612233, 6613274, 6615524,
6615563, 6615564, 6615568, 6616019, 6616658, 6617159, 6908818, 6909167,
6909296, 6909352, 6909357, 6910249, 6911971, 6912409, 6912474, 6912875,
6912881, 6913000, 6913475, 6913870, 6915276, 6915766, 6915999, 6916002,
6916097, 6916178, 6916190, 6917332, 6918212, 6918652, 6919099, 6919117,
6921034, 7050575, 7497686, 7498565, 7498741, 7538463, 7539015, 7539786, 7540682,
7541639, 7542966, 7542968, 7543676, 7543984, 7544003, 7544123, 7544126,
7544380, 7547498, 7780330, 7780375, 7781132, 7782368, 7782720, 7783346,
7783628, 7783840, 7858044, 7858700, 7858873, 7859394, 7859843, 7860315,
7860475, 7860479, 7860574, 7861243, 7861903, 7864308, 7865292, 7865294,
7865295, 7914518, 7917546, 7917604, 7917761, 7917925, 7918065, 7918067,
7918081, 7918248, 7920206, 7922833, 7923548, 7923732, 7923895, 7924988,
7925653, 7925663, 7925879, 7925895, 7926555, 7926621, 7926909, 7927327, 7929149,
7929346, 7929351, 8172625, 8172794, 8173152, 8175318, 8175581, 8176151,
8176258, 8176447, 8177280, 8177434, 8177522, 8177551, 8178967, 8179011,
8179283, 8179285, 8180011, 8600575, 8600893, 9809533, 9811197, 9812153,
9812269, 9812319, 9813756, 9817357, 9822700, and 2330827
b)
Unit numbers 2170447, 4413336, 4413727, 4567570, 5813898, 6120361, 6123446,
6609029, 7498312, 4413725, and 4413742
c)
Unit numbers 1774114, 2177571, 2178197, 2179048, 2179546, 2180383, 2182087,
2182257, 2182892, 2182926, 2183017, 2183061, 2184130, 2184262, 2184283,
2184348, 2184636, 2185911, 2187271, 2187596, 2187858, 2188727, 2189324,
2196838, 2196839, 4325989, 6407949, 6615221, 7931612, and 9049824
d) Unit numbers 1492188, 1492567, 1492902, 1493462, 1493507, 1493605, 1495123,
1496580, 1498445, 1766069, 1766467, 1767579, 1770301, 1772740, 1772955,
1778485, 2163917, 2165453, 2165471, 2168156, 2168624, 2168980, 2169967,
2170222, 2170447, 2171067, 2171295, 2171661, 2172527, 2172794, 2172933,
2175553, 2178101, 2178780, 2179153, 2182392, 2182402, 2183057, 2186880,
2188112, 2191948, 2191951, 2192459, 2192479, 2192736, 2198570, 2215163,
2217798, 2218344, 2218598, 2221514, 2221515, 2221517, 2221523, 2330827,
2332626, 2345230, 2352426, 2363778, 2425650, 2426126, 2426387, 2427165,
2428200, 2430074, 2432843, 2433191, 2433248, 2436390, 2437888, 2438399,
2439304, 2441018, 2441024, 2441047, 2441052, 2441607, 2447152, 2449726,
2455864, 2704215, 2709607, 2713032, 2713386, 2713389, 2713599, 3428856,
3431678, 3581469, 3583345, 3587310, 3589982, 3590084, 3591037, 3591040,
3592100, 3594484, 3595233, 4058881, 4061520, 4077462, 4317398, 4318171,
4320226, 4320398, 4321264, 4322659, 4323120, 4323121, 4324433, 4324983,
4325156, 4326509, 4326510, 4326673, 4326758, 4413707, 4413708, 4413709,
4413710, 4413711, 4413713, 4413715, 4413716, 4413718, 4413719, 4413720,
4413721, 4413722, 4413723, 4413724, 4413725, 4413726, 4413727, 4413728,
4413729, 4413730, 4413731, 4413732, 4413736, 4413738, 4413739, 4413741,
4413742, 4413743, 4413744, 4414883, 4415080, 4415162, 4417282, 4417511,
4418338, 4419590, 4420194, 4421833, 4423550, 4425134, 4428733, 4428940,
4556457, 4557344, 5081944, 5808307, 5809746, 5810887, 5811089, 5811455,
5811631, 5811682, 5811909, 5814079, 5814528, 5814552, 5816099, 5817593,
5818802, 5819762, 5820120, 5820121, 5827586, 5907799, 5909555, 5910160,
5910297, 5914880, 5914921, 5915424, 5918228, 6088357, 6089469, 6096042,
6096742, 6097127, 6115711, 6117104, 6117151, 6118044, 6118047, 6119913,
6120361, 6123052, 6123714, 6124494, 6124969, 6127546, 6127574, 6128548,
6130674, 6131101, 6136182, 6136183, 6136185, 6137157, 6140859, 6229522,
6231852, 6232159, 6232201, 6232304, 6308388, 6309549, 6309600, 6313580,
6313949, 6316405, 6318267, 6608178, 6608361, 6608668, 6608885, 6609029,
6615563, 6615564, 6615570, 6616019, 6617159, 6908818, 6909296, 6912409,
6912474, 6913000, 6913706, 6913870, 6915766, 6916178, 6917332, 6918652,
7497686, 7498312, 7498565, 7498741, 7538463, 7539229, 7539786, 7540354,
7541639, 7542966, 7542968, 7543398, 7543676, 7543984, 7544003, 7544380, 7780330,
7780375, 7781132, 7782368, 7782720, 7783346, 7783628, 7783789, 7783840,
7858873, 7859434, 7859843, 7860475, 7862125, 7864308, 7917546, 7917761,
7918065, 7918081, 7918248, 7920206, 7923895, 7925663, 7926895, 7926909,
7926910, 7927833, 7929149, 7929346, 7929351, 7930130, 8067440, 8172625,
8172794, 8175581, 8176151, 8177551, 8179011, 8179283, 8179285, 8179849,
8180011, 9042630, 9810557, 9812153, 9812319, 9817357, 9818364, and 9822700
e) Unit numbers 2177571, 2178197, 2179048, 2179546, 2180383, 2182892, 2183017,
2184262, 2187271, 2187596, 2188727, 2189324, 3435084, 4325989, and 6615221.
RECALLING FIRM/MANUFACTURER LifeSource
Blood Services, Glenview, IL.
REASON Blood products,
manufactured from units of Whole Blood designated as either: 1) low volume collections;
or 2) difficult collections, were distributed.
VOLUME OF PRODUCT IN COMMERCE a)
484 units; b) 11 units; c) 30 units; d) 312 units; e) 15 units.
DISTRIBUTION IL, WI,
GA, RI and NY.
WEEK ENDING DECEMBER 21
PRODUCT Hemacare Blood Bank Data Management System
CODE Version 5.2b(b).
RECALLING FIRM/MANUFACTURER Mediware
Information Systems, Inc., Melville, NY.
REASON Blood bank
computer software, which had a defect that could cause antigen test results to be
associated with the wrong unit or sample, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
version.
DISTRIBUTION Nationwide,
Singapore and Canada.
WEEK ENDING DECEMBER 28
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Fresh
Frozen Plasma.
CODE a) and b) Unit number 5444947.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from a donor that did not answer one of the
medical history questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Human Tissue
for Transplantation, Corneas.
CODE Numbers 02-0954-100 and 02-0954-200.
RECALLING FIRM/MANUFACTURER Rocky Mountain Lions Eye Bank, Aurora, CO.
REASON Human tissue for transplantation was incorrectly tested for viral
markers in that the blood sample used for testing was likely hemodiluted.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION FL and Saudi Arabia.
PRODUCT Red Blood Cells.
CODE Units 0372386, 8726578.
RECALLING FIRM/MANUFACTURER Florida Blood Services Inc., St. Petersburg, FL.
REASON Blood products, corresponding to a unit of Pool Platelets that were
implicated in a transfusion fatality, and found to be contaminated with
Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL.
PRODUCT Red Blood
Cells, Leukoreduced.
CODE Unit 107252493.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ.
REASON Blood product, collected from an unsuitable donor based on travel to an
area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT Red Blood
Cells, Leukoreduced.
CODE Unit 362637279.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Ventura, CA.
REASON Blood product that were out of controlled storage for more than 30
minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood
Cells, Leukocytes Reduced.
CODE Unit GR16766.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc.,
Milwaukee, WI
REASON
Blood product, collected from a donor who reported living in an area designated
as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Platelets; d) Platelets, Pheresis, Leukocytes Reduced,
CODE a) Unit GR12072; b) Units T82950, FW26155; c) Unit T82950; d) Units
FW27489, FW28839, FW30438, FW33069, FW35112.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin,
Milwaukee, WI
REASON
Blood products, collected from a donor who reported travel to an area
designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION WI.
PRODUCT Platelets,
Pooled, Irradiated.
CODE Unit FS02754 - pooled Platelet ID number - P16417.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc.,
Milwaukee, WI
REASON
Blood product, collected from a donor who reported travel to an area designated
as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WI.
PRODUCT a) Red Blood
Cells, Leukocytes Reduced; b) Platelets, Pooled.
CODE Units GR30167, LE48596; Unit GR30167 - pooled Platelet ID # - P21990.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeastern Wisconsin, Inc.,
Milwaukee, WI
REASON
Blood products, collected from a donor who reported travel to an area
designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION WI.
PRODUCT Platelet,
Pheresis, Leukoreduced; Platelet, Pheresis, Leukoreduced, Irradiated.
CODE (Split unit),Unit 01LZ27665.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New York-Penn
Region, West Henrietta, NY
REASON
Blood products, incorrectly labeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY.
PRODUCT Red Blood Cells, Leukoreduced.
CODE Units 107357155, 107357157, 107357158, 107357160, 107357161.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ.
REASON Blood products that were out of controlled storage for more than 30
minute were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION AZ.
PRODUCT a) Whole
Blood; b) Red Blood Cells; c) Red Blood Cells, Leukocytes Reduced; d) Platelets
Pheresis, Leukocytes Reduced;
e) Recovered Plasma.
CODE a) Unit number 012LR12973; b) Unit number 012LR12971; c) Unit numbers
012LJ45951 and 012LJ45968; d) Unit numbers 012W63899, 012W63898, 012W63897,
012W63907, 012W63896, and 012W63895; the following units were distributed as
two split units: 012W63894, 012W63893, 012W63901, 012W63900, 012W63906,
012W63905, 012W63904, 012W63903, 012W63902, 012W63908, 012KJ90766, and
012W63878; e) Unit numbers 012LJ45958 and 012LJ45951.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region,
Charlotte, NC
REASON
Blood products, incorrectly tested for human immunodeficiency virus (HIV) p24
antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 36 units.
DISTRIBUTION SC, NC, CA and TN.