FEBRUARY 2005
WEEK ENDING FEBRUARY 5
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 1674048.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ.
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
PRODUCT
a) Cryoprecipitated AHF.
b) Plasma.
CODE
a) and b) Unit K43643.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA.
REASON
Blood Products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 5423364.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ.
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number 1620469.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA.
REASON
Blood products, collected from donors whose medical history screening did not
include questioning regarding risk factors for Creutzfeldt-Jacob disease (vCJD),
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ID, and Austria.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit E88636.
RECALLING FIRM/MANUFACTURER
HSCS Blood Center, Bethlehem, PA.
REASON
Platelets, with a low platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 0758932, 0833349 ‚ split unit, 0832859 ‚ split unit.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, San Francisco, CA.
REASON
Platelets, which had an unacceptable platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 0599531.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA.
REASON
Blood product, collected from a donor that had an unsuitable hemoglobin test
during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number 1201788 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit numbers 1621946 and 1621946A.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA.
REASON
Blood products, that were labeled leukoreduced but were not tested to determine
the white blood cell count as required in the firm's standard operating procedures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number 20037-2971.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON
Blood products, collected from a donor whose health history screening was inadequately
performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced.
CODE
Unit numbers 20036-9971 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON
Blood products, collected from a donor whose health history screening was inadequately
performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced
Irradiated.
CODE
a) Unit numbers 01P63784, 01P63738, 01P63646,
01P63584, 01P63503, 01P63484, and 01P63054;
b) Unit numbers 01P63784, 01P63738, 01P63646,
01P63012, 01P63011, 01P63049, and 01P63054;
and the following unit was distributed as
two split products: unit number 01P63681.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New York-Penn Region, West Henrietta, NY.
REASON
Blood products, collected in an apheresis collection kit that possibly had exceeded
the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
NY.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 53L66445.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD.
REASON
Red Cells, after receiving post donation information concerning an arm infection,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
PRODUCT
Capture Solid Phase Test Systems, Capture-R Ready Screen Test Kits.
CODE
Lots 37591, 37592, 39599, 39635.
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA.
REASON
Capture-R test kits, with an increased rate of positive reactions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 lots.
DISTRIBUTION
Nationwide and Canada.
PRODUCT
Capture Solid Phase Test Systems.
a) Capture R Ready-Screen (Pooled Cells);
b) Capture-R Ready Screen (I and II).
CODE
a) Lots 31395, 31396, 33425, 33426, 35481,
35482, 33427, 33428, 35483, 35484, 37542,
37543;
b) Lots 33420, 33421, 35475, 35476, 35477,
37537, 35479, 35480, 37538, 37539, 35478,
37544.
RECALLING FIRM/MANUFACTURER Immucor, Inc. Norcross, GA.
REASON
Capture-R test kits, with an increased rate of positive reactions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 lots.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Capture Solid Phase Test Systems.
a) Capture R Ready Id;
b) Capture-R Ready Screen (I and II).
CODE
a) Lot 37545;
b) Lots 37588, 37589, 37590, 39624, 39634.
RECALLING FIRM/MANUFACTURER Immucor, Inc. Norcross, GA.
REASON
Capture-R test kits, with an increased rate of positive reactions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 lots.
DISTRIBUTION
Nationwide and Internationally.
PRODUCT
Source Plasma.
CODE
Unit number F-17246-011.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Portland, OR.
REASON
Blood product, collected from a donor that did not answer 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
Spain.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit numbers 0375452A, 0375452B, 0375444A, 0375444B, 0375404A, 0375404B, 0375325A,
0375325B, 5301718A, and 5301718B.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA.
REASON
Blood products, manufactured in expired processing bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
WA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number 20037-1877.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON
Blood products, that were not properly quarantined after the donor of the products
reported a post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA and Switzerland.
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced.
CODE
Unit number 20035-9196 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON
Blood products, collected on an apheresis machine where there was no documentation
of evaluation of the filter assemblies as required, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
LA.
PRODUCT
Source Plasma.
CODE
Unit number DNQGBG.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lawton, OK.
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Source Plasma.
CODE
Unit number DNGJSY.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lawton, OK.
REASON
Blood product, collected from a donor that did not answer the medical history
questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
WEEK ENDING FEBRUARY 12
PRODUCT
Source Plasma.
CODE
Units: F-22778-011, F-27249-011, F-27788-011, F-28189-011, F-29064-011, F-29389-011,
F-30075-011, F-30763-011, F-31180-011, F-31764-011, F-32149-011, F-34888-011,
F-35337-011.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corporation, Los Angeles, CA.
Manufacturer: Alpha Therapeutic Corporation, Portland, OR. .
REASON
Blood products, collected from a donor who had body piercing within twelve months
of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units.
DISTRIBUTION
Spain.
PRODUCT
a) Red Blood Cells.
b) Granulocytes, Platelets Pheresis.
c) Platelets.
d) Platelets Pheresis.
e) Fresh Frozen Plasma.
f) Cryoprecipitated AHF.
g) Cryoprecipitated AHF, Pooled.
h) Recovered Plasma.
CODE
a) Unit numbers: 17G67521, 17KK11407, 17F97853,
17GK05376, 17GK90108, 17GK77844, 17GK57176,
17GK50110, 17GK36465, 17GK27539, 17G99751,
17H05783, and 17G57489;
b) Unit number: 17GS46051;
c) Unit numbers: 17GK05376, 17G67521, 17F97853,
and 17G57489;
d) Unit numbers: 17GS52818, 17GS54875, 17GS57714,
17S36475, 17S43147, 17S44939, and 17GS48667;
e) Unit number: 17F97853;
f) Unit number: 17G99751;
g) Unit number: 17GK36465;
h) Unit numbers: 17G67521, 17KK11407, 17G57489,
17GK27539, 17H057783, 17GK05376, 17GK90108,
17GK77844, 17GK57176, 17GH27257, 17GK36465,
and 17G99751.
RECALLING FIRM/MANUFACTURER
American Red Cross, North Central Region, St. Paul, MN.
REASON
Blood products, that tested negative for antibody to human immunodeficiency
virus type 1 (anti-HIV-1), but were collected from donors that previously tested
repeatedly reactive for anti-HIV-1, were distributed.
VOLUME OF PRODUCT IN COMMERCE
40 units.
DISTRIBUTION
CA, MN, WI, VA, NJ, GA, AR, SC, and MA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
c) Red Blood Cells, Pheresis, Leukocytes Reduced.
d) Recovered Plasma.
CODE
a) Units 26117-2070, 26117-2071, 26117-2072,
26117-2073, 26117-2074, 26117-2075, 26117-2081,
26117-2082, 26117-2083, 26117-2088, 26117-2089,
26117-2090, 26117-2232, 26117-2234, 26117-2237,
26117-2238, 26117-2240, 26117-2242, 26117-6191,
26117-6192, 26117-6193, 26117-6194, 26117-6195,
26117-6196, 26117-6198, 26117-6600, 26117-6601,
26117-6602, 26117-6603, 26117-6605, 26117-6607,
26117-6608, 26117-6609, 26117-6802, 26117-6669,
26117-6670, 26117-6671, 26117-6672, 26117-6675,
26117-6676, 26117-6677, 26117-6678, 26117-6679,
26117-6680, 26117-6682;
b) Unit 26117-2244;
c) Units 26117-6615 (split 1 and split 2),
26117-6187;
d) Units 26117-2081, 26117-2082, 26117-2083,
26117-2088, 26117-2090, 26117-2234, 26117-2235,
26117-2236, 26117-2237, 26117-2238, 26117-2239,
26117-2240, 26117-2241, 26117-2242, 26117-2244,
26117-2279, 26117-2280, 26117-2281, 26117-6194,
26117-6195, 26117-6196, 26117-6602, 26117-6603,
26117-6605, 26117-6607, 26117-6608, 26117-6609,
26117-6679, 26117-6680, 26117-6682, 26117-6802,
26117-2071, 26117-2072, 26117-2073, 26117-2074,
26117-2075, 26117-2077, 26117-6191, 26117-6192,
26117-6193, 26117-6198, 26117-6600, 26117-6601,
26117-6669, 26117-6670, 26117-6671, 26117-6672,
26117-6675, 26117-6676, 26117-6677, 26117-6678.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Fort Smith, AR..
Manufacturing Firm: Blood Systems, Inc., Hot Springs, AR.
REASON
Blood products, collected from donors whose arm scrubs were incorrectly performed,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
100 units.
DISTRIBUTION
AR, CA, FL, MS, TX, and Switzerland.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 207253800.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Lafayette, LA.
REASON
Blood product, collected from a donor in which donor suitability was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells, Leukocytes Reduced. .
CODE
Units 0786733, 0689361.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA..
REASON
Blood products, incorrectly tested for Cytomegalovirus (CMV), but labeled as
CMV negative, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Pheresis.
CODE
Unit 33GC00532.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Connecticut Region, Framington, CT..
REASON
Blood product, which failed to meet specification for Red Blood Cell volume,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers 20039-7973, 20039-4557, 20039-4515, 20039-4513, 20039-4542, 20039-4556,
20039-4516, and 20039-4362.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc, Lafayette LA.
REASON
Blood products, incorrectly tested for antibodies to Cytomegalovirus (CMV),
were labeled CMV negative and distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
LA.
PRODUCT
Source Plasma.
CODE
Unit numbers ST-100104, ST-100196, and SP152055.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, San Diego, CA.
REASON
Blood products, collected from a donor whose donor suitability determination
was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Austria.
PRODUCT
Source Plasma.
CODE
Unit numbers VP-190037, VP-191972, VA-147213, VP-191742, VP-191256, VP-191077,
VP-190743, VP-192827, VP-190267, VP-184342, VP-189631, VP-189183, VP-189056,
VP-188894, VP-188796, VP-184997, VP-184480, and VP-190571.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA.
REASON
Blood products, collected from an unsuitable donor based on an unexplained weight
loss, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units.
DISTRIBUTION
Austria.
PRODUCT Recovered Plasma.
CODE
Unit number 2296967.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA.
REASON
Blood product, collected from an ineligible donor due to a recent blood exposure,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 21KK80487.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OR.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 2299037.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA.
REASON
Blood product, which was inappropriately released from quarantine, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ID.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units 029KX23811, 029FK56543.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid-Atlantic Region, Norfolk, VA.
REASON
Blood products, that did not have the complete amount of additive solution included,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD, and NC.
PRODUCT
Source Plasma.
CODE
Unit VP188589.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA.
REASON
Blood product, collected from a donor for which there was no documentation on
the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
PRODUCT
Red Blood Cells.
CODE
Unit number 1199650.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irvin Center, San Francisco, CA.
REASON
Blood product, collected from an ineligible donor due to a reported history
of recent illness or surgery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 20037-3997.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Lafayette, LA.
REASON
Blood product, incorrectly tested for red blood cell antigen C, was labeled
C antigen negative and distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
LA.
PRODUCT
Red Blood Cells.
CODE
Unit number L58731.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI.
REASON
Blood product, collected from a donor whose body temperature was not properly
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Source Plasma.
CODE
Unit number VP-188273.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA.
REASON
Blood product, collected from a donor that did not answer the medical history
questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
PRODUCT
Source Plasma.
CODE
Unit number VP-181710.
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation, Van Nuys, CA.
REASON
Blood product, collected from a donor that did not answer the medical history
questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.
PRODUCT
Source Plasma.
CODE
Unit number F-28129-011.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Portland, OR.
REASON
Blood product, collected from a donor that did not answer 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
Spain.
PRODUCT
Source Plasma.
CODE
Unit number F-27044-011.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Portland, OR.
REASON
Blood product, collected from a donor that did not answer 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
Spain.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced.
c) Platelets Pheresis, Leukocytes Reduced
Irradiated.
d) Plasma.
e) Recovered Plasma.
CODE
a) Unit numbers 21V86982, 21V86983, 21V86984,
21V86985, 21V86986, 21V86987, 21V86988,
21V86989, 21V86990, 21V86991, 21V86992,
21V86993, 21V86994, 21V86995, 21V86996,
21V86997, 21V86998, 21V86999, 21V87000,
21V87001, 21V87002, 21V87003, 21V87004,
21V87005, 21V87006, 21V87007, 21V87008,
21V87010, 21V87011, 21V87012, 21V87013,
21V87014, 21V87015, 21V87016, 21V87018,
and 21LQ05968;
b) Unit numbers 21LQ05970, 21KP44067, 21LQ05962,
21LQ05963, 21LQ05967, 21LQ05968, 21KP44051,
21KP44053, 21KP44056, 21KP44057, 21KP44058,
21KP44059, 21KP44060, 21KP44064, and 21KP44066;
and the following units were distributed as
two split products: unit numbers 21KP44070,
21LQ05964, 21LQ05965, 21LQ05966, 21KP44049,
21KP44050, 21KP44054, 21KP44061, 21KP44063,
and 21KP44065;
c) Unit numbers 21LQ05968, 21LQ05969, 21KP44048,
21KP44052, and 21KP44055;
d) Unit numbers 21V86982, 21V86985, 21V86987,
21V86988, 21V86991, 21V86992, 21V86993,
21V86999, 21V87000, 21V87001, 21V87005,
21V87006, 21V87007, and 21V87008;
e) Unit numbers 21V86983, 21V86984, 21V86986,
21V86989, 21V86990, 21V86994, 21V86995,
21V86996, 21V86997, 21V86998, 21V87002,
21V87003, 21V87004, 21V87009, 21V87010,
21V87011, 21V87012, 21V87014, 21V87015,
21V87016, 21V87017, and 21V87018.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pacific Northwest Region, Portland, OR.
REASON
Blood products, incorrectly tested for the antibodies to human immunodeficiency
virus, types 1 and 2 (anti-HIV-1/2), were distributed.
VOLUME OF PRODUCT IN COMMERCE
112 units.
DISTRIBUTION
OR, WA, CA, TX, KS, and GA.
WEEK ENDING FEBRUARY 19
PRODUCT
Platelets.
CODE
Unit J08361.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.,
REASON
Blood product, which was manufactured from a whole blood unit in which the associated
red blood cells contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Source Plasma.
CODE
Unit numbers: 02OWIF8936, 02OWIF9969, 02OWIG0416.
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, Oshkosh, WI.,
REASON
Blood products, collected from a donor who had received MMR vaccine prior to
donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Austria.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit number 6207723.
RECALLING FIRM/MANUFACTURER
Blood Center of New Jersey, Inc., East Orange, NJ.,
REASON
Blood product, associated with a unit of Red Blood Cells that contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE
a) and b) Unit numbers FG97141, LE89604.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence,
RI.
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
MI, RI, and NY.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 0662304.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA.
REASON
Blood product, collected from a donor who did not have a hematocrit or hemoglobin
test performed during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 261185685.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR.
REASON
Blood product, collected using a hematocrit centrifuge that did not have quality
control performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AR.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 18V62680.
RECALLING FIRM/MANUFACTURER
American Nation Red Cross, Great Lakes Region, Lansing, MI.
REASON
Blood product, collected from a donor who did not have a hemoglobin test during
the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 18GM14239.
RECALLING FIRM/MANUFACTURER
American Nation Red Cross, Great Lakes Region, Lansing, MI.
REASON
Blood product, collected from a donor who did not have a hemoglobin test during
the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
a) Platelets, Leukocytes Reduced.
b) Cryoprecipitated AHF.
c) Fresh Frozen Plasma.
d) Plasma, Cryoprecipitate Reduced.
Recall # B-0554-5.
a) Unit 11GR41559;
b) Units 11FF84655, 11GL56432, 11GT44260,
11FW01586, 11FY19538, 11GW37928, 11GY28128,
11GV49410, 11FZ51078, 11GF35711, 11GW40541,
11FM82085;
c) Units 11GQ48977, 11GG22094, 11GT44209;
d) Units 11FF84655, 11LJ80341, 11FW01586,
11FY19538, 11GY28128, 11GV49410, 11FZ51078,
11KE39913, 11GV50515, 11GF35711, 11GW40541,
11FM82085.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Missouri-Illinois Region, St. Louis, MO.
REASON
Blood products, associated with units of Red Blood Cells that contained clots,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
28 units.
DISTRIBUTION
AL, AK. IL, GA, MO, OK, TN, and PR.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 33GR63495.
RECALLING FIRM/MANUFACTURER
American Nation Red Cross, Connecticut Region, Farmington, CT.
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
CT.
PRODUCT
Source Plasma.
CODE
Unit numbers: 51188702, 51180645, 39865724, 39845245, 39841193, 39822437, 39818829,
39810144, 39805799, 39797636, 39790842, 39782007, 39774132, 39771247, 39762955,
and 39758354.
RECALLING FIRM/MANUFACTURER
ZLB Bioplastic, Inc, Medford, OR.,
REASON
Blood products, collected from a donor with a history of body piercing, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units.
DISTRIBUTION
CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number LK98270.
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA.
REASON
Blood products, collected from an ineligible donor due to a reported history
of Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and Switzerland.
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced
Irradiated.
CODE
a) Unit numbers 2013896, 2011743, 2010157,
and 2007667;
b) Unit numbers 2005997 and 2001553.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
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
6 units.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
b) Platelets.
CODE
a) and b) Unit number 2043842.
RECALLING FIRM/MANUFACTURER
Medic, Inc. Knoxville, TN.
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
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers 2015686 and 2023382.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
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
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2515035.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
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
TN.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2029927.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
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
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 18GC25187.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lansing, MI
REASON
Blood product, which was collected from a donor in which the hematocrit result
was not documented on the blood donation record, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Red Blood Cells.
CODE
Unit number J74486.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.
REASON
Blood product, which was collected from a donor who had traveled to a malarial
endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
a) Fresh Frozen Plasma.
b) Recovered Plasma.
CODE
a) Unit R11475;
b) Unit S77924.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Saginaw, MI.,
REASON
Blood products, which were collected from a donor who was at increased risk
for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI, and Switzerland.
PRODUCT
Red Blood Cells
CODE
Unit L59363.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI
REASON
Blood product, which was collected from a donor who had traveled to a malarial
endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
c) Cryoprecipitated AHF,
CODE
a) Units FH33677 and KS29554;
b) Unit KS29554;
c) Unit FH33677.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA
REASON
Blood products, which were collected from a donor who was at risk for Creutzfeldt-Jakob
Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MD and VA.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) Units KT32875, KT26949, KT14157, and KT19784;
b) Units KT19784 and KT14157;
c) Units KT32875, KT19784, and KT14157;
d) Unit KT26949.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA
REASON
Blood products, which were collected from a donor who was at risk for Creutzfeldt-Jakob
Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units.
DISTRIBUTION
VA, and Switzerland.
PRODUCT
Red Blood Cells.
CODE
Unit FW23828.
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Annandale, VA
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
VA.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit 231453457.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Billings, MT
REASON
Blood product, which was incorrectly tested and labeled as negative for the
Kell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WY.
PRODUCT
Platelets, Irradiated.
CODE
Unit number 0799631.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, Irwin Center, San Francisco,
CA
Manufacturer: Blood Centers of the Pacific, North Bay Center, Fairfield, CA.
REASON
Blood product that was removed from controlled storage for more than allowed
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 04KT65714.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA
REASON
Blood product, collected from an ineligible donor due to a history of a chronic
ulcerative condition, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VT.
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
Unit 5403969.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ
REASON
Platelets, possibly contaminated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
PRODUCT
Red Blood Cells (Apheresis), Leukocytes Reduced Irradiated.
CODE
Unit number 2048005 (distributed as two split products).
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN
REASON
Blood products, that were found to be out of specification for red blood cell
recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit 18GC25141.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Lansing, MI
REASON
Blood product, which did not have the collection time documented on the blood
donation record, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
WEEK ENDING FEBRUARY 26
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit 04FV33396.
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA
REASON
Blood products, which tested negative for hepatitis, but were collected from
an ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA and MA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit 4710672.
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON
Blood product, possibly contaminated with gram positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2700282.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
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
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 9541010.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN
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
TN.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number LG01239.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center Providence,
RI,
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
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number 1199130.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells.
CODE
Unit number 0777325.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA
REASON
Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
Unit numbers: 2046381, Parts A and B.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN
REASON
Platelets, possibly contaminated with Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number: 2043318.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN
REASON
Platelets, with a positive bacterial culture, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 01GQ88843.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West
Henrietta, NY
Manufacturer: American Red Cross Blood Services, Albany, NY.
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
NY.
PRODUCT
Source Plasma.
CODE
Unit number ST339750.
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services L.P., San Antonio, TX
REASON
Blood product was collected in a manner that may compromise the sterility of
the product.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma. .
CODE
a) and b) Unit C38498.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA
REASON
Blood products, which were collected from a donor who had taken the medication
Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA, and Switzerland.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number: K84749.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood products, in which the corresponding platelet product was possibly contaminated
with Enterobacter cloacae, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
GA.
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) Unit number: 2049523, Part B;
b) Unit number: 2049523, Part A.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) Unit number: 2041358, Part B;
b) Unit number: 2041358, Part A.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN
REASON
Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
Platelets.
CODE
Unit number: L24221.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN
REASON
Blood product, collected from an unsuitable donor due to the use of the medication,
Gabitril, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit FT58209.
RECALLING FIRM/MANUFACTURER
Innova Health Care Services, Blood Donor Services, Annandale, VA
REASON
Blood products, collected from a donor who had a history of melanoma, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and VA.
PRODUCT
Source Plasma.
CODE
Unit numbers WSG009908 and WSG009430.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX
REASON
Blood products, collected from a donor that did not answer the medical history
questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Spain.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number K39627.
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Bank, Springfield, IL
REASON
Blood product possibly exposed to unacceptable shipping temperatures was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Recovered Plasma.
CODE
Unit number 0538408.
RECALLING FIRM/MANUFACTURER
Somerset Medical Center Blood Bank, Somerville, NJ
REASON
Blood product, collected from an unsuitable donor due to a history of residing
in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob
Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.