JUNE 2006
WEEK ENDING JUNE 3
PRODUCT
a) Red Blood Cells
Leukocytes Reduced Irradiated,
b) Red Blood Cells,
CODE
a) Units: 6523167, 6524643, 6522293, 6358967,
6524762, 6526262,
6526278, 6522345, 6524779, 6527476, 6358984, 6515098,
6525534, 6525918,
6358985, 6525757, 6527393, 6527396, 6527503, 6527504,
6527520, 6525974,
6527528, 6527553, 6527672, 6527576, 6524015, 6526589,
6526875, 6527746,
6528201, 6528494, 6528835, 6526786, 6528531, 6528926,
6528947, 6520583,
6528755, 6528763, 6520021, 6525339, 6528366, 6529406,
6530059, 6531570,
6515124, 6524076, 6524087, 6528387, 6529652, 9524094,
6524095, 6525373,
6530142, 6532777, 6529703, 6521690, 6522350, 6525687,
6358977, 6527734,
6527737, 6528251, 6527864, 6524056, 6528067, 6528089,
6527509;
b) Units: 6526491, 6471993, 6527586, 6515109, 6527884, 6528290,
6526559
RECALLING FIRM/MANUFACTURER BloodNetUSA, Lakeland, FL
REASON
Blood product, which did not have the monthly
quality control testing for hematocrit, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 76 units
DISTRIBUTION FL
PRODUCT Red Blood Cells (Pheresis) Leukocytes Reduced,
CODE
Units:
10048-8788 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER Blood
Systems Inc., Scottsdale, AZ
REASON Blood products, collected from a donor
whose medical history screening was incomplete, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AZ
PRODUCT
a) Red Blood Cells,
b) Fresh Frozen Plasma,
c) Recovered
Plasma,
CODE
a) Unit numbers: 12GY31921,
12E07907;
b) Unit number: 12E07907;
c) Unit number:
12GY31921
RECALLING FIRM/MANUFACTURER American National Red Cross,
Carolinas Region, Charlotte, NC
REASON Blood products, which tested negative
for hepatitis, but were collected from a donor with a history of Hepatitis A,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION NC and Switzerland
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells, Leukocytes
Reduced, Irradiated,
CODE
a) Unit numbers:
7106574 (parts 1 & 2), 7106575, 7106577, 7106578 (parts 1 & 2),
7106580, 7106582, 7109957, 7109958, 9109959, 7109960, 7109961, 7109962,
7109963, 7110111, 7110112, 7110113, 7110114, 7110115, 7110116, 7110117,
7110118, 5579250, 5579253;
b) Unit number: 7106576, 7110119,
5579252
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Monroe, LA
REASON Blood
products, collected from donors whose arm cleansing procedures were performed
using expired cleansers, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 28 units
DISTRIBUTION LA, MI, NJ, and OH
PRODUCT Platelets,
CODE
Unit number: 8211263
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, Colorado
REASON
Blood product, which was collected from a donor
who had tested initially reactive for HIV-1 p24 antigen, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT Red Blood Cells
CODE
Unit number: 404637
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO, REASON
Blood product, with an unacceptably low hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION CO
PRODUCT Source Plasma,
CODE
Unit number: 0050254171
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma Inc., Beloit, WI
REASON Blood product,
collected from a donor who had previously been incarcerated, was
distributed
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION UK
PRODUCT Source Plasma,
CODE
Unit numbers: 05CILB6476, 05CILB5804
RECALLING
FIRM/MANUFACTURER Interstate Blood Bank, Inc. of Chicago, Chicago, IL,
REASON
Blood products, collected from an ineligible donor
due to a history of an accidental needle stick, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
c) Platelets,
d) Fresh Frozen Plasma,
CODE
a) Unit number: 7872911;
b) Unit numbers:
3179034, 3180261;
c) Unit number: 3180261;
d) Unit numbers: 3179034,
3180261
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON
Blood products, collected from a donor who was
previously deferred, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 6 units
DISTRIBUTION IL
PRODUCT Red Blood Cells,
CODE
Unit number: 2485963
RECALLING
FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood product, in
which the corresponding Platelets were contaminated with Staphylococcus aureus,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Red Blood Cells,
CODE
Unit number: FH44627
RECALLING
FIRM/MANUFACTURER Aurora Area Blood Bank, Aurora, IL
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 IL
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit number:
40LX07434
RECALLING FIRM/MANUFACTURER American National Red Cross,
Heart of America Region, Peoria, IL
REASON Blood product, collected from
a donor whose arm scrub was incorrectly performed, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL
PRODUCT Human Corneas,
CODE
Tissues: CI0472470S, CI047247OD
RECALLING
FIRM/MANUFACTURER Illinois Eye Bank, Chicago, IL
REASON Human tissue for transplantation, which was
incorrectly tested for viral markers in that the blood sample used for testing
was hemodiluted, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2
tissues
DISTRIBUTION MI
PRODUCT
a) Red Blood Cells,
b) Recovered Plasma,
CODE
a) and b) Unit numbers 039J46789 and
039J49308
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Alleghenies Region, Johnstown, PA
REASON Blood products, collected from an ineligible donor
due to a reported history of hepatitis, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 4 units
DISTRIBUTION CA, KY, WV and
Switzerland
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit number: KC19172
RECALLING
FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI, REASON
Blood products, collected from a donor who was at
increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION WI and Switzerland
PRODUCT Source Plasma,
CODE
Unit numbers: OF190501, OF190300, OF189668, OF188962,
OF188778, OF188363, OF187970, OF187667, OF186348, OF186146, OF185792, OF185566,
OF185136, OF184920, OF183886, OF183563, OF183355, OF182851, OF182439, OF182239,
OF181820, OF181613, OF181220, OF181013, OF180191, OF179887, OF179623, OF179159,
OF178778, OF178618, and OF177012
RECALLING
FIRM/MANUFACTURER Biolife Plasma Services L.P., Orlando, FL
REASON
Blood
products, collected from a donor who was permanently deferred, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 31
units
DISTRIBUTION NC
PRODUCT Red Blood Cells,
CODE
Unit number: 6964126
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO, REASON
Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit number:
581351
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Shreveport, LA
REASON Blood product, which did not meet acceptable
product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION LA
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit number:
3782799
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Monroe, LA
REASON Blood product, which did not meet acceptable
product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION LA
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit numbers: 3780994
and 3780907
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Monroe, LA
REASON Blood products, which did not meet acceptable
product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION LA
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit number:
3782972
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Monroe, LA
REASON Blood product, which did not meet acceptable
product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION LA
PRODUCT
a) Red Blood Cells
Leukocytes Reduced
b) Platelets
CODE a) and b) Unit number: 7113736
RECALLING
FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA
REASON Blood product, which was collected from a donor
who had visited a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION LA and MI
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE
a) Unit numbers: 12LS86037, 12LS86038, 12LS86039,
12LS86040, 12LS86041,
12LS86043, 12LS86044, 12LS86045, and 12LS86046;
b)
Unit numbers: 12LS86037, 12LS86038, 12LS86039, 12LS86040, 12LS86041,
12LS86043, 12LS86044, 12LS86045, and 12LS86046
RECALLING
FIRM/MANUFACTURER American National Red Cross, Carolinas Region,
Charlotte, NC
REASON Blood
products, for which shipping conditions were undocumented, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 18
units
DISTRIBUTION NC, TN, and Switzerland
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit numbers: 9043583
and 9043587
RECALLING FIRM/MANUFACTURER Blood Connection, Inc.,
Greenville, SC,
REASON Blood products, which were shipped at an
unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION AL and MD
PRODUCT Platelets,
CODE
Unit numbers: 415388, 415374
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, Colorado,
REASON
Blood products, improperly stored after
production, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CO
PRODUCT Red Blood Cells,
CODE
Unit number: 0495082
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO, REASON
Blood product, labeled with an incorrect
expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT Recovered Plasma (for
manufacture of non-injectables),
CODE Unit
number: 7872911
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON
Blood product, collected from a donor who was
previously deferred, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit numbers: 4615668
(split unit)
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON
Platelets, which were not stored under continuous
agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IL
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit number:
40GR79624
RECALLING FIRM/MANUFACTURER American National Red Cross,
Peoria, IL
REASON Blood products, manufactured without the entire
quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION IL
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit number:
3773128
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Shreveport, LA
REASON Blood product, which was manufactured using an
expired leukocyte-reduction filter, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION LA
WEEK ENDING JUNE 10
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit number:
7111357
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Shreveport, LA
REASON Blood product, which was collected from a donor
who had taken the medication Tegison, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION LA
PRODUCT Source Plasma,
CODE
Unit numbers: DBCMCQ, DBCMFK, DBCVNL, DBCVRM, DBCVVW, DBCVZX, DBCWDX, DBCWKQ,
DBCWPB, DBDCHB, DBDCLL, DBDCQH, DBDDNS, DBDDXG, DBDHWN, DBDKKG, and DBDYDL.
RECALLING FIRM/MANUFACTURER
Biomat
USA, Inc., Savannah, GA,
REASON Blood products, which were collected from an
unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF PRODUCT IN COMMERCE
17
units
DISTRIBUTION Germany and TN
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit number:
36LE05370
RECALLING FIRM/MANUFACTURER American National Red Cross,
Columbia, SC
REASON Blood product, which was overweight, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced,
CODE
Unit number:
12FM06591 (double unit)
RECALLING FIRM/MANUFACTURER American Red
Cross Blood Services, Charlotte, NC
REASON Blood products, which were collected from a donor
in which donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NC and TN
PRODUCT Source Plasma,
CODE
Unit numbers: 20008610, 20016932, 20022230, and
20023202.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Amarillo, TX
REASON Blood product, which were collected from an unsuitable
donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION CA
PRODUCT Fresh Frozen Plasma,
CODE
Unit number: 1914498
RECALLING
FIRM/MANUFACTURER Florida’s Blood Centers Inc., Orlando, FL
REASON
Blood product, collected from a donor who was
taking the drug Plaquenil, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NC
PRODUCT Red Blood Cells,
Leukocyte Reduced,
CODE Unit number:
6964511
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO, 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 CO
PRODUCT Red Blood Cells,
Leukocyte Reduced,
CODE Unit number:
06GJ77559
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern California Region, Pomona, CA
REASON Blood product, collected from
a donor who traveled to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocyte Reduced,
CODE Unit numbers: 9027539 and
6703241
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO.,
REASON Blood products, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CO
PRODUCT Red Blood Cells,
CODE
Unit number: 4900044
RECALLING
FIRM/MANUFACTURER Florida Georgia Blood Alliance, Inc., Jacksonville, FL,
REASON
Blood product, collected from a donor who traveled
to an area considered endemic for malaria, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes
Reduced,
CODE
a) Unit number: 10744-5109;
b)
Unit numbers: unit numbers 10744-5109, 10744-5030, 10744-4966, 10743-4029 and
10741-5870
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood products, collected from a donor who
traveled to an area considered endemic for malaria, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION AZ
PRODUCT Source Plasma,
CODE
Unit numbers: AMN010290, AMN010098, AMN009781,
AMN009624, AMN009349, AMG004360, AMG004282, AMN002889, AMN002857, 0G0015747,
0G0015573, 0G0015245, 0G0015077, 0G0015006, 0G0014838, 0G0014754, 0G0014581,
0N0006418, 0N0006376
RECALLING FIRM/MANUFACTURER Biomat USA, Inc.,
Amarillo, TX
REASON Blood products, which tested negative for
hepatitis, but were collected from a donor who was previously deferred for
positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 19 units
DISTRIBUTION Spain
PRODUCT Source Plasma,
CODE
Unit numbers: 20012317, 20012583, 20017867, 20020098,
20025638, 20026210
RECALLING FIRM/MANUFACTURER Biomat USA, Inc.,
Amarillo, TX
REASON Blood products, collected from a donor who was previously
deferred by another donor center, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 6 units
DISTRIBUTION Spain
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit numbers:
10717-7042, 10714-0414
RECALLING FIRM/MANUFACTURER Blood Systems,
Inc., Scottsdale, AZ
REASON Blood products, which tested negative for the
antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected
from a donor who previously tested reactive for the antibody, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AZ
PRODUCT Source Plasma,
CODE
Unit numbers: 0020001522, 0020001937, 0020011292,
0020011783, 0020012217, 0020012695, 0020013549, 0020014191, 0020014595,
0020015077, 0020015486, 0020016053, 0020016491, 0020017047, 0020017849,
0020018322, 0020018714, 0020019136, 0020019626
RECALLING
FIRM/MANUFACTURER Biomat USA, Inc., Amarillo, TX
REASON Blood products,
collected from an ineligible donor due to a history of intravenous drug use,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 19
units
DISTRIBUTION Spain
PRODUCT Source Plasma,
CODE
Unit numbers: 0020006972, 0020008114, 0020033417,
0020033534
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Amarillo,
TX,
REASON Blood products, collected from an ineligible donor
due to a history of intravenous drug use, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 4 units
DISTRIBUTION Spain
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit number:
W045005915223
RECALLING FIRM/MANUFACTURER Community Blood Center of
Greater Kansas City, Kansas City, MO.
REASON Platelets, contaminated with
Escherichia coli, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION KS
PRODUCT Red Blood Cells
Leukocytes Reduced Irradiated,
CODE Unit number:
5579252
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Monroe, LA
REASON Blood product, which was collected from a donor in
a manner in which the sterility of the collection system was compromised, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit number:
7046568
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Shreveport, LA
REASON Blood product,
which did not meet acceptable product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Skin Tissue, AlloDerm/Repliform Regnerative Tissue Matrix,
CODE
Lot B9411: 028, 004, 018, 021, 022, 009, 023, 024,
031, 029, 010, 012, 019, 020, 025, 034, 032
RECALLING
FIRM/MANUFACTURER
Recalling Firm: LifeCell Corporation,
Branchburg, NJ,.
Manufacturer: Life
Alaska, Inc., Anchorage, Alaska.
REASON Skin Tissue, that was subsequently found to test
repeatedly reactive for antibodies to Hepatitis B Core Total (IgM/IgG) by a
different facility, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 17 allografts
DISTRIBUTION Nationwide
PRODUCT Bair Hugger Ranger High
Flow Blood/Fluid Warming Disposable Sets,
CODE Lots H2057 through H2182
Part Numbers 24350,
24355, 24365, 24370
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Arizant, Inc., Eden Prarie, MN,
Manufacturer: Biotest Laboratories, Inc., Minneapolis, MN.
REASON
Blood warmers,
manufactured with an inverted bubble trap, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 90,346 sets
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Platelets Pheresis
Leukocytes Reduced,
b) Platelets Pheresis Leukocytes
Reduced Irradiated,
CODE
a) Unit numbers: 7219025
and 4963825;
b) Unit number: 7219025
RECALLING
FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA
REASON Blood
products, which did not meet acceptable product specifications, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION LA and AR
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE
a) and b) Unit number 06LC79662
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern California
Region, Pomona, CA.
REASON Blood
products, which were collected from an unsuitable donor based on risk factors
for variant Creutzfeldt-Jakob Disease (vCJD), were distributed
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA
PRODUCT Recovered Plasma,
CODE
Unit number: 1404421
RECALLING
FIRM/MANUFACTURER Florida’s Blood Centers, Inc., Orlando, FL
REASON Blood product, which were collected from an unsuitable
donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was
distributed
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Austria
PRODUCT
a) Cryoprecipitated,
AHF,
b) Recovered Plasma,
CODE a) and b) Unit number: 9905472
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Florida’s Blood Centers,
Orlando, FL
REASON Blood products, which
were collected from an unsuitable donor based on risk factors for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION FL and Austria
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit number:
71W637488
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Huntsville, AL,
REASON Blood product, which did not meet acceptable
product specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit number: 71W729608
(split product)
RECALLING FIRM/MANUFACTURER LifeSouth Community
Blood Centers, Huntsville, AL,
REASON Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION AL
PRODUCT Fresh Frozen Plasma,
CODE
Unit number: 71N332466
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Montgomery, AL,
REASON
Blood product, which was manufactured from a whole
blood unit in which the associated blood product contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Fresh Frozen Plasma,
CODE
Unit number: 71N86421
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Montgomery, AL,
REASON
Blood product, which was manufactured from a whole
blood unit in which the associated blood product contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Fresh Frozen Plasma,
CODE
Unit number: 71M739834
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Montgomery, AL,
REASON
Blood product, which was manufactured from a whole
blood unit in which the associated blood product contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Fresh Frozen Plasma,
CODE
Unit number: 71N286421
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Birmingham, AL,
REASON
Blood product, which was manufactured from a whole
blood unit in which the associated blood product contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells, Leukocytes
Reduced, Irradiated
c) Red Blood Cells Pheresis,
Leukocytes Reduced,
CODE
a) Unit numbers:
22FC25213, 22FN70870, 22FS29504, 22FS31685, 22FS33988,
22FX12560, 22GH11170,
22GL20516, 22GS11235, 22KE12632, 22KF55143,
22KL18824, 22KV74427, 22KY88734,
22LC18668, 22LC19221, 22LW79321,
22LZ05143, 22FN73316, 22FT97846, 22FS35725,
22KL22816, 22GL18850,
22FL08315, 22LC21758, 22FC29375, 22FQ28297, 22KE12362,
22KW60774,
22KW61254, 22KV70059, 22FC27715, 22KZ70891, 22LW77711, 22KN62203,
22FQ22011, 22GQ09311, 22GS14385, 22FS35873, 22KL13343, 22KL13226,
22GQ05660, 22KX68953, 22LP05620, 22KY86884, 22LC17440, 22KE20785,
22FQ27690, 22LZ03402, 22GQ03917, 22KX70162, 22FS31118, 22LC17396,
22GQ05336, 22FN68150, 22GL25492;
b) Unit numbers: 22KC73557, 22FN67843,
22FZ08262;
c) Unit numbers: (2 units) 22KK67428
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn-Jersey Region,
Philadelphia, PA,
REASON Blood products, for which antigen testing was
performed incorrectly, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 61 units
DISTRIBUTION DE, NJ, OK, and PA
PRODUCT Source Plasma,
CODE
Unit numbers: 00269711, 00282185, 00308281,
00312295, 00318723, 00385343, 00401968, 00413107, 00415873, 00421027, 00423137,
00429788, 00433464, 00442473 00445375
RECALLING
FIRM/MANUFACTURER ZLB Bioplasma, Inc., Lansing, MI,
REASON Blood
products, which tested negative for Hepatitis B surface antigen (HBsAg) and for
the antibody to Hepatitis B core antigen (anti-HBc), but were collected from a
donor who previously tested positive for HBsAg, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 15 units
DISTRIBUTION CA
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit number:
12LE06052
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Carolinas Region, Charlotte, NC
REASON Blood product,
collected from a donor with hemochromatosis, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit number:
71R12673-7
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Center, Dunwoody, GA,.
REASON Blood product, associated with a unit Fresh Frozen
Plasma that contained fibrin strands, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
c) Fresh Frozen Plasma,
CODE
a)
Unit numbers: 0811198, 0599335, 0817525, 0193594, 0817817, 0813394,
0200709,
0819895, 0201646, 0201591, 0201649, 0201752, 0201256, 0599936,
0825694,
0826943, 0827348;
b) Unit numbers: 0820430, 0820883
c) Unit numbers:
0817879, 0686104, 0822648, 0825158, 0825159, 0824875
RECALLING
FIRM/MANUFACTURER The Blood Connection, Inc., Greenville, SC
REASON
Blood products, associated with units of Fresh
Frozen Plasma or Cryoprecipitated AHF that contained clots, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 25
units
DISTRIBUTION FL, GA, MO, NY, NC, and SC
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit numbers: 0858632, 0215096, 0862185, 0862337,
0862184;
b) Unit numbers: 0862148
RECALLING
FIRM/MANUFACTURER The Blood Connection, Inc., Greenville, SC
REASON
Blood products, associated with units of
Cryoprecipitated AHF that contained clots, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 25 units
DISTRIBUTION AL, MA, NJ, and
SC
PRODUCT Source Plasma,
CODE
Unit numbers: 03DILA0446, 03DILA0457, 03DILA0490,
03DILA0689, 03DILA1358, 03DILA1471, 03DILA1511, 03DILA1533, 03DILA1824,
03DILA3288, 03DILA3889, 03DILA4338, 03DILA4545, 03DILA4868, 03DILA4920,
03DILA5046, 03DILA5047, 03DILA5471, 03DILA5590, 03DILA5593, 03DILA5685,
03DILA5832, 03DILA5841, 03DILA5864, 03DILA6360, 03DILA7309, 03DILA8492,
03DILA9159, 03DILA9533, 03DILA9552, 03DILA9937, 03DILA9983, 03DILB0187,
03DILB0683, 03DILB1016, 03DILB1342, 03DILB1698, 03DILB1794, 03DILB1798,
03DILB1854, 03DILB2083, 03DILB2638, 03DILB2743, 03DILB2745, 03DILB2849,
03DILB3185, 03DILB3692, 03DILB3940, 03DILB4003, 03DILB4478, 03DILB4517,
03DILB5110, 03DILB5206, 03DILB5224, 03DILB5260, 03DILB5265, 04DILA0358,
04DILA0361, 04DILA1281, 04DILA1714, 04DILA3137, 04DILA3281, 04DILA3358,
04DILA3514, 04DILA3518, 04DILA3741, 04DILA3951, 04DILA4728, 04DILA4859,
04DILA4920, 04DILA5817, 04DILA6420, 04DILA6640, 04DILA6995, 04DILA8196,
04DILA8789, 04DILA9143, 04DILA9449, 04DILB0687, 04DILB1222, 04DILB1736,
04DILB1901, 04DILB1908, 04DILB2366, 04DILB2409, 04DILB2413, 04DILB3506,
04DILB4035, 04DILB4089, 04DILB4368, 04DILB4685, 04DILB5090, 04DILB5307,
04DILB5507, 04DILB6113, 04DILB6430, 04DILB7895, 04DILB7916, 04DILB8180,
04DILB8185, 04DILB8469, 04DILB9505, 04DILB9514, 04DILB9615, 04DILC0511,
04DILC0941, 04DILC1344, 04DILC1739, 04DILC2248, 04DILC2407, 04DILC2653,
04DILC3151, 04DILC4624, 04DILC4905, 04DILC5006, 04DILC5319, 04DILC5440,
04DILC6447, 04DILC7178, 04DILC7637, 04DILC7668, 04DILC7942, 04DILC8165,
04DILC8329, 04DILC8420, 04DILC8716, 04DILC9120, 04DILC9200, 04DILC9510,
04DILD0420, 04DILD0794, 04DILD1639, 04DILD2633, 04DILD2961, 04DILD2966,
04DILD2994, 04DILD3166, 04DILD3892, 04DILD4098, 04DILD4456, 04DILD4754,
04DILD4821, 04DILD4896, 04DILD5919, 04DILD6567, 05DILA0024, 05DILA1080,
05DILA1923, 05DILA2124, 05DILA2276, 05DILA2658, 05DILA2781, 05DILA3162,
05DILA3725, 05DILA4380, 05DILA4981, 05DILA5175, 05DILA5714, 05DILA6222,
05DILA6375, 05DILA6977, 05DILA8385, 05DILA8894, 05DILA9584, 05DILA9724,
05DILA9913, 05DILB0054, 05DILB0403, 05DILB1343, 05DILB1352, 05DILB1814,
05DILB4102, 05DILB4123, 05DILB4259, 05DILB4284, 05DILB4301, 05DILB4586,
05DILB4591, 05DILB4622, 05DILB5054, 05DILB5385, 05DILB5566, 05DILB5615,
05DILB5769, 05DILB5869, 05DILB6348, 05DILB6391, 05DILB7756, 05DILB8310,
05DILB8620, 05DILB9443, 05DILC1221, 05DILC1729, 05DILC2958,
05DILC3584
RECALLING FIRM/MANUFACTURER BioLife Plasma Services,
L.P., DeKalb, IL
REASON Blood products, collected from donors for whom
donor suitability was not adequately determined, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 195 units
DISTRIBUTION CA and MD
PRODUCT Recovered Plasma,
CODE
Unit numbers: 10714-0414,
10717-7042
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood products, which tested negative for the antibody to
the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor
who previously tested reactive for the antibody, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION VA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit numbers: 0886849,
0887099, 0887098, 0886465
RECALLING FIRM/MANUFACTURER The Blood
Connection, Inc., Greenville, SC
REASON Blood products, which were out
of controlled storage for more than 30 minutes during leukoreduction, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION SC
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit number:
8367889
RECALLING FIRM/MANUFACTURER Atlanta Blood Services,
Atlanta, GA
REASON Blood product, which was incorrectly labeled as
being negative for unexpected antibodies, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Source Plasma,
CODE
Unit numbers: WN0056261, WN0056262, WN0056264,
WN0056265, WN0056275, WN0056278, WN0056281, WN0056292, WN0056312, WN0056318,
WN0056327
RECALLING FIRM/MANUFACTURER DCI Biologicals Wilmington, LLC, Wilmington, NC,
REASON
Blood products, which were untested for viral
markers by the nucleic acid test (NAT) method, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 11 units
DISTRIBUTION NC
PRODUCT Recovered Plasma, (non-injectable use),
CODE
Unit number
E29448
RECALLING FIRM/MANUFACTURER Blood Center of the St. Johns,
Inc., St. Augustine, FL,
REASON Blood product, which was collected from an
unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1
unit
DISTRIBUTION FL
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit number: 7121540 (2
parts)
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers,
Alexandria, LA
REASON Blood products, which did not meet acceptable
product specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION LA
WEEK ENDING JUNE 17
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Platelets Leukocytes Reduced,
CODE
a) and b) Unit number: LL24568
RECALLING
FIRM/MANUFACTURER Healthcare Provider Services, DBA Rhode Island blood
Center, Providence, RI
REASON Blood products, collected from a donor who
traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 2 units
DISTRIBUTION MA and
RI
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Red Blood Cells
(Apheresis) Leukocytes Reduced,
c) Platelets Pheresis Leukocytes Reduced,
d)
Platelets Pheresis Leukocytes Reduced Irradiated,
e)
Plasma Frozen Cryoprecipitate Reduced,
f) Cryoprecipitated AHF,
g) Recovered Plasma,
CODE
a) Units: 12 FV22498, 12FY92543, 12GF13319,
12GY67376, 12KP82111, 12LW87682, 12V 38895;
b) Unit numbers: 12KL58931(2
units), 12KR46287 (2 units);
c) Unit numbers: 12KJ05484, 12KJ06104 (2 units),
12W 84617 (2 units), 12W 86287;
d) Unit number: 12 W86287;
e) and f) Unit
numbers: 12FV22498, 12FY92543;
g) Unit numbers: 12GF13319, 12GY67376,
12KP82111, 12LW87682
RECALLING FIRM/MANUFACTURER American National
Red Cross, Carolinas Blood Service Region, Charlotte, NC,
REASON Blood products, collected
from ineligible donors, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 28 units
DISTRIBUTION OK, NC, GA, CA, TN, PR, and
Switzerland
PRODUCT Platelets Pheresis Leukocytes
Reduced
CODE Unit number: 8504053
RECALLING
FIRM/MANUFACTURER Atlanta Blood Services, Atlanta, GA,
REASON
Blood
product, which was collected from a donor in which donor suitability was not
adequately determined, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE
Unit numbers: 17GX43325, 17GX43326
RECALLING
FIRM/MANUFACTURER The American National Red Cross, North Carolina Region,
St. Paul, MN,
REASON Blood products, which may have been leukocyte
reduced twice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION MN and MA
PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced,
CODE
Unit numbers: 10742-8299 Parts 1 and
2
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Scottsdale, AZ.
REASON
Blood products, collected from a donor who
traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 2
units
DISTRIBUTION AZ
PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE
Unit numbers: 10744-6042, 10740-7992
RECALLING
FIRM/MANUFACTURER Blood Systems Inc., Scottsdale, AZ, .
REASON Blood products,
collected from a donor who traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AZ
PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE
Unit number: 004LJ29600
RECALLING
FIRM/MANUFACTURER The American National Red Cross, New England Region,
Dedham, MA,
REASON Blood product, collected from a donor who traveled
to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION VT
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit number: 9104035
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,.
REASON
Blood
product, collected from a donor who traveled to an area endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit number: 9010749
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,
REASON
Blood
product, collected from a donor who traveled to an area endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit number: 33GY99000
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Connecticut Region,
Farmington, CT
REASON Blood product, collected from a donor
who traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CT
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit number: 9007549
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,
REASON
Blood
product, collected from a donor who traveled to an area endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT Red Blood Cells,
CODE
Unit
number: 9009615
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial
Blood Center, Denver, CO,
REASON Blood product, collected from a donor who traveled
to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit number: 9073600
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,.
REASON
Blood
product, collected from a donor who traveled to an area endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT Source Plasma,
CODE
Unit
numbers: NG0049022, NG0049602, NG0050070, NG0050305, NG0050701, NG0051112,
NG0051372, NG0051749, NG0052003, NG0052405, NG0052773, NG0053160, NG0053465,
NG0053757, NG0054197, NG0054559, NG0054772, NG0055021
RECALLING
FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX,
REASON Blood products, collected from a donor considered to be at
increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 18
units
DISTRIBUTION KY
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit number: 9014761
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,
REASON
Blood
product, collected from a donor who traveled to an area endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE
Unit number: 6919328
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO, .
REASON
Blood
product, collected from a donor who traveled to an area endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CO
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Platelets Pheresis Leukocytes Reduced,
CODE
a) Unit numbers: 06FH15632, 06FH17842;
b) Unit
number: 06KL33064
RECALLING FIRM/MANUFACTURER The American National
Red Cross, Southern California Region, Pomona, CA,
REASON Blood
product, collected from a donor who traveled to an area endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION CA
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit number: 8611585
RECALLING
FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL, .
REASON
Blood
product, with platelet yield below the specified minimum requirement, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION FL
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit numbers: 4932104 (distributed as split
product)
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc.,
Orlando, FL,
REASON Blood products, with platelet yields below the
specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2
units
DISTRIBUTION FL
PRODUCT Recovered Plasma,
CODE
Unit
number: 1008433
RECALLING FIRM/MANUFACTURER Aultman Hospital Blood
Bank, Canton, OH, .
REASON Blood product, which was
untested for viral markers, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION MD
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit number: 17FX76089
RECALLING
FIRM/MANUFACTURER American National Red Cross, North Central Region, St.
Paul, MN,
REASON Blood product, corresponding to a unit of
Platelets that was possibly contaminated with Pseudomonas fluorescens and
implicated in an adverse transfusion reaction, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE
Unit number: 003FK46986
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta,
GA,
REASON Blood product, which was
inappropriately distributed in a single storage bag, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells,
b) Red Blood
Cells, Leukocytes Reduced,
c) Red Blood Cells, Pheresis,
Leukocytes Reduced,
d) Red Blood Cells, Leukocytes
Reduced, Irradiated,
e) Platelets,
f) Cryoprecipitated AHF,
g) Fresh Frozen
Plasma,
h) Fresh Frozen Plasma Pheresis,
i) Plasma, Cryoprecipitate Reduced,
CODE
a) Unit number: 20033-0049;
b) Unit numbers:
20033-0573, 20033-0717, 20033-6816, 20033-6822, 20030-7116, 20032-7095,
20032-7096, 20032-7097, 20032-7098, 20032-7099, 20032-7100, 20032-7101,
20032-7102, 20032-7103, 20032-7107, 20032-7108, 20032-7109, 20032-7112,
20032-7113, 20032-7114, 20032-7115, 20032-7117, 20032-7118, 20032-7119,
20032-7120, 20032-7121, 20032-7538, 20032-7539, 20032-7540, 20032-7554,
20032-7555, 20032-7556, 20032-7557, 20032-7564, 20032-7565, 20032-7567,
20032-7569, 20032-7573, 20032-9334, 20032-9338, 20032-9342, 20033-0043,
20033-0044, 20033-0048, 20033-0581, 20033-0661, 20033-0947, 20033-0948,
20033-0949, 20033-0950, 20033-0951, 20033-0952, 20033-5763, 20033-5764,
20033-5765, 20033-5767, 20033-5771, 20033-5774, 20033-5775, 20033-5778,
20033-5908, 20033-5915, 20033-5920, 20033-6051, 20033-6053, 20033-6054,
20033-6055, 20033-6061, 20033-6062, 20033-6063, 20033-6064, 20033-6089,
20033-6094, 20033-6095, 20033-6100, 20033-6107, 20033-6108, 20033-6112,
20033-6130, 20033-6135, 20033-6136, 20033-6289, 20033-6290, 20033-6291,
20033-6293, 20033-6294, 20033-6310, 20033-8048, 20033-8052, 20033-8058,
20033-8059, 20033-8079, 20033-8081, 20033-8082, 20033-8083, 20033-8094;
c) Unit numbers: 20032-7546 (part 1 & 2), 20032-7559
(part 1 & 2), 20032-7566 (part 1 & 2), 20032-9329 (part 1 & 2),
20033-5766 (part 1 & 2), 20033-6060 (part 1 & 2), 20033-6084 (part 1
& 2), 20033-6303 (part 1 & 2), 20033-8084 (part 2);
d) Unit numbers:
20032-9328, 20033-6045;
e) Unit numbers: 20033-6289, 20033-6290, 20033-6291,
20033-6293, 20033-6294, 20033-6295, 20033-8079, 20033-8081, 20033-8082,
20033-8083, 20033-8086, 20033-8094, 20033-8096, 20033-8097,
20033-8098;
f) Unit numbers: 20030-3558, 20030-3559, 20030-3560, 20030-4175,
20031-8064, 20031-8066, 20031-8067, 20031-8726, 20031-8734, 20031-8735,
20031-9123, 20032-7088, 20032-8427;
g) Unit numbers: 20030-3470,
20030-5457, 20030-5458, 20030-5459, 20030-5460, 20030-5473, 20030-5850,
20030-5856, 20030-6277, 20031-6505, 20031-6508, 20031-6742, 20031-6743,
20031-6746, 20031-6750, 20031-6812, 20031-6816, 20031-6822, 20031-6849,
20031-6912, 20031-6913, 20031-6932, 20031-7152, 20031-7405, 20031-7454,
20031-7455, 20031-7597, 20031-8051, 20031-8052, 20031-8065, 20031-8159,
20031-8162, 20031-8470, 20031-8474, 20031-8476, 20031-8478, 20031-8480,
20031-8482, 20031-8483, 20031-8484, 20031-8633, 20031-8662, 20031-8675,
20031-8859, 20032-0242, 20032-0244, 20032-0252, 20032-0255, 20032-0257,
20032-0261, 20032-0264, 20032-0265, 20032-2714, 20032-2985, 20032-2996,
20032-3057, 20032-3060, 20032-3061, 20032-3063, 20032-3343, 20032-3368,
20032-3383, 20032-3386, 20032-3388, 20032-3635, 20032-3637, 20032-3639,
20032-3641, 20032-3656, 20032-3658, 20032-3659, 20032-3660, 20032-7005,
20032-7012, 20032-7013, 20032-7101, 20032-7538, 20032-7539;
h) Unit
numbers: 20030-6256 (split 1 & 2), 20033-5968;
i) Unit number:
20030-3653
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ, .
Manufacturer: Blood Systems, Inc., Baton Rouge, LA.
REASON
Blood products, collected from
donors for whom donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 226
units
DISTRIBUTION AZ, LA, MS, NM, TN, and
TX
PRODUCT Source Plasma,
CODE
Unit
numbers: LYT110, LYR760, LYR375, LYR290, LYP705, LYP372, LYP245, 1RU518, 1MT162,
JPY444, JPY958, JPY874, JNV900, JNY977, JNY337, JNY212, JNY973, JCR864, JCR418,
JCR328, JCP889, JCP815, JCP624, JCP507, JCP267, JCP175, JCN995, JCN681, JCN433,
JCN291, JCN165, JCN015, JOA116, JOA040, 8057GH, 2933BC, 0430BC, 0195BC, 08152X,
07294X, 07022X, 06656X, 37209U, 37015U, 36121U, 35716U, 35624U, 34454U, Y81112,
Y80598, Y79888, Y79159, V78465, V91945, V91420, V90651, V90521, V90089, V90019,
V89617, V89445, V88266, H30887, R84533, R83427, R82644, C47918, C47534, C47201,
C46956, C46519, C46302, C45499, C45086, D15635, D15564, D15236, YHA861, YHA753,
YHB409, YHD402, YHD274, WRD822, WRD683
RECALLING
FIRM/MANUFACTURER Aventis Bio-Services, Inc., Montgomery, AL, .
REASON
Blood products, which tested negative for the
antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected
from a donor who was previously deferred for testing positive for HIV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 84
units
DISTRIBUTION NC
PRODUCT Source Plasma,
CODE
Unit
numbers: NG0046355, NG0046660, NG0046936, NG0047193, NG0047669, NG0048726,
NG0049215, NG0049590, NG0049865, NG0050332, and NG0053478
RECALLING
FIRM/MANUFACTURER DCI Biologicals Nacogdoches LLC, Nacogdoches, TX
REASON
Blood products, collected from a donor whose
medical history screening did not include questioning regarding risk factors for
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 11
units
DISTRIBUTION KY
PRODUCT Source Plasma,
CODE
Unit
numbers: 20049036, 20049126, 20049837, 20049901, 20050593, 20050727, 20051369,
and 20051553
RECALLING FIRM/MANUFACTURER Biomat USA, Inc.,
Amarillo, TX,
REASON Blood products, which were collected from a donor
who was incarcerated, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 8
units
DISTRIBUTION CA
PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE
Unit number: 8835585
RECALLING
FIRM/MANUFACTURER NBAH Blood Center, New Brunswick, NJ,
REASON
Blood
product, which was collected from an unsuitable donor based on risk factors for
variant Creutzfeldt - Jakob Disease (vCJD), was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE
a) and
b) Unit numbers: 8835584
RECALLING FIRM/MANUFACTURER NBAH Blood
Center, New Brunswick, NJ,
REASON Blood products, which were collected
from an unsuitable donor based on risk factors for variant Creutzfeldt - Jakob
Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NJ
PRODUCT Source Plasma,
CODE
Unit
numbers: 0440594567, 0440594387, 0440593801, 0440592886, 0440592638, 0440586312,
0440585421, 0440583630, 0440582802, 0440582163, 0440581945, 0440581575,
0440554700, 0440554344, 0440579372, 0440578241, 0440577894, 0440575435,
0440576972, 0440572145, 0440567000, 0440566804, 0440565152, 0440564673,
0440564494, 0440561276, 0440560995, 0440560708, 0440560327, 0440559996,
0440559796, 0440559190, 0440559106, 0440558254, 0440558029, 0440557194,
0440556676, 0440553205, 0440552877, 0440552551, 0440545112, 0440544891,
0440544009, 0440543448, 0440543209, 0440542819, 0440539697, 0440539286,
0440539079, 0440538604, 0440538357, 0440529867, 0440529391, 0440528669,
0440528061, 0440527085, 0440526514, 0440526360, 0440587800, 0440587436,
0440584839, 0440584644, 0440584279, 0440583391, 0440583204, 0440581639,
0440581165, 0440580423, 0440580276, 0440574982, 0440574489, 0440574296,
0440573957, 0040573061, 0440572447, 0440572280, 0440571868, 0440571666,
0440571326, 0440571129, 0440570552, 0440569239, 0440569000, 0440568746,
0440568557, 0440568334, 0440568161, 0440567885, 0440567681, 0440567388,
0440567157, 0440566912, 0440566654, 0440566367, 0440566107, 0440565830,
0440565852, 0440565497, 0440565276, 0440564998, 0440564729, 0440564443,
0440564156, 0440563905, 0440563587, 0440563360, 0440562999, 0440562784,
0440562397, 0440562199, 0440561799, 0440561629, 0440557896, 0440557720,
0440557385, 0440557174, 0440556825, 0440556691, 0440555645, 0440555235,
0440554726, 0440554569, 0440553944, 0440552840, 0440551041, 0440550713,
0440550331, 0440550145, 0440549776, 0440549575, 0440549219, 0440549021,
0440548361, 0440547519
RECALLING FIRM/MANUFACTURER ZLB Bioplasma,
Inc., Charleston, SC,
REASON Blood products, collected from ineligible donors,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 134
units
DISTRIBUTION NC
PRODUCT Fresh Frozen Plasma,
CODE
Unit number: 71N293749
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Birmingham, AL,
REASON
Blood product, which was manufactured from a whole
blood unit in which the associated blood product contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Fresh Frozen Plasma,
CODE
Unit number: 71N060653
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Montgomery, AL,
REASON
Blood product, which was manufactured from a whole
blood unit in which the associated blood product contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT Fresh Frozen Plasma,
CODE
Unit number: 71N060585
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers, Montgomery, AL,
REASON
Blood product, which was manufactured from a whole
blood unit in which the associated blood product contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION AL
PRODUCT
a) Red Blood Cells,
b) Red Blood
Cells Leukocytes Reduced Irradiated,
c) Platelets,
d) Platelets Pheresis Leukocytes Reduced;
e) Platelets Pheresis Leukocytes Reduced Irradiated,
f) Fresh Frozen Plasma,
CODE
a) Unit
numbers: 1279803, 1279820, 1279821, 1363777, 1363819, 1511840;
b) Unit
number: 1279826;
c) Unit number: 1363777;
d) Unit numbers: 1411036 - part
2, 1411041, 1411047-1&2, 1411048, 8574658 -- part 2, 8574661-1&2,
85474717, 8574739- 1&2, 8574742;
e) Unit numbers: 1411036- part 2,
4968568, 8574651, 8574656;
f) Unit numbers: 1279803, 1279820, 1279821,
1279826, 1363777, 1363819
RECALLING FIRM/MANUFACTURER New York
Blood Center, Inc., New York, NY,
REASON Blood products, collected using expired arm
cleansers, were distributed.
VOLUME OF PRODUCT IN COMMERCE 30
units
DISTRIBUTION NY, NJ, CA, MS, and
D.C.
PRODUCT
a) Fresh Frozen Plasma,
b) Platelets
Pheresis Leukocytes Reduced,
CODE
a) Unit number:
8504628;
b) Unit number: 8504628 (split unit)
RECALLING
FIRM/MANUFACTURER Atlanta Blood Services, Atlanta, GA,.
REASON Blood
products, which were collected from a donor in which donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3
units
DISTRIBUTION GA
PRODUCT Fresh Frozen Plasma,
CODE
Unit numbers: 0307633, 0872087, and
0869837
RECALLING FIRM/MANUFACTURER Blood Connection, Inc,
Greenville, SC, .
REASON Blood products, which were manufactured from whole
blood in which the associated blood components contained clots, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION GA and SC
PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE
Unit number: 12GN59461
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Asheville, NC,
REASON
Blood product, which was collected from a donor
who had lived in a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC
PRODUCT Autologous Whole Blood,
CODE
Unit number: 6350850
RECALLING
FIRM/MANUFACTURER NBAH Blood Center, New Brunswick, NJ,
REASON
Whole Blood, collected from an ineligible
autologous donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE
Unit numbers: 10743-9240, 10743-8714
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ,
REASON
Blood
products, lacking assurance of acceptable temperatures during shipping, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AZ
PRODUCT Platelets Pheresis Leukocytes Reduced,
CODE Unit numbers: 10772-3234, 10772-3235, 10772-3238,
10772-3239
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ, .
REASON Blood products, in transit longer than 24 hours
and without constant agitation, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4
units
DISTRIBUTION AZ
PRODUCT Source Plasma,
CODE
Unit
number: FGDCBG
RECALLING FIRM/MANUFACTURER Aventis Bio-Services,
Inc., Montgomery, AL,
REASON Blood product, collected from a donor for whom
donor suitability was not adequately determined, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit number: 246332262
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., Rapid City, SD, .
REASON Blood
product, which was not manufactured in accordance with acceptable
specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SD
PRODUCT
a) Red Blood Cells,
b) Fresh Frozen
Plasma,
CODE
a) Unit number: V24469 ad
V24472;
b) Unit number: V24472
RECALLING
FIRM/MANUFACTURER Virginia Blood Services, Community Blood Center of
Carolinas, Charlotte, NC,
REASON Blood products, which may have been
shipped at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 3
units
DISTRIBUTION NC
PRODUCT
a) Red Blood Cells,
b) Fresh Frozen
Plasma,
c) Cryoprecipitated AHF,
CODE
a) Unit numbers: 0204148, 0204339, and 0829853;
b)
Unit numbers: 0686901 and 0832697;
c) Unit numbers: 0205138
RECALLING
FIRM/MANUFACTURER Blood Connection, Inc., Greenville, SC, .
REASON
Blood
products, which were manufactured from whole blood in which the associated blood
components contained clots, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 6 units
DISTRIBUTION PA, NC, GA, NY, and
SC
PRODUCT Source Plasma,
CODE
Unit
numbers: G43249097, G43452097, G44250097, G44548097, G45210097, G46095097,
G46336097, and G47061097
RECALLING FIRM/MANUFACTURER Alpha
Therapeutics Corp., San Diego, CA,
REASON Blood products, which were collected
from a donor who had surgery within 12 months prior to donation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 8
units
DISTRIBUTION Spain
PRODUCT
a) Red Blood Cells,
B) Red Blood
Cells Leukocytes Reduced,
CODE
a) Unit numbers:
0789511, 0594815, 07799769, 0802461, 0596840, 0597205, 0596624, 0801896,
0803855, 0598306, 0802500, 0598326, 0805435, 0597091, 0597570, 0598053,
0598110, 0597581, 0805094, and 0806130;
b) Unit number:
0597606
RECALLING FIRM/MANUFACTURER Blood Connection, Inc.,
Greenville, SC,
REASON Blood products, which were manufactured from whole
blood in which the associated blood components contained clots, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 21
units
DISTRIBUTION GA, and SC