MARCH 2004
WEEK ENDING MARCH 6
PRODUCT Source Plasma.
CODE Units 0420978389, 0420975233, 0420974910, 0420974449, 0420972858,
0420972479, 0420972015, 0420970602, 0420970194, 0420969654, 0420969345,
0420968622, 0420968291, 0420963158, 0420962747, 0420962424, 0420961904,
0420961558, 0420959025, 0420958740, 0420958245, 0420958041, 0420957258,
0420956959, 0420954582, 0420954331, 0420953708, 0420953459, 0420952854,
0420952541, 0420951308, 0420950310, 0420949933, 0420949017, 0420948453,
0420948149, 0420945993, 0420945789, 0420943150, 0420942609, 0420942042,
0420941776, 0420941049, 0420923017, 0420922485, 0420921263, and 0420920733.
RECALLING FIRM/MANUFACTURER ZLB Biolplasma, Inc., Lansing, MI.
REASON Blood products, which were collected from a donor who had
received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 47 units.
DISTRIBUTION NC.
PRODUCT
a) Red Blood Cells .
b) Recovered Plasma.
CODE a) and b) Unit number KT06328.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor
Services, Annandale, VA.
REASON Blood products collected from an unsuitable donor due to a
history of residing in an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA, and NJ.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 29FJ50329.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Mid-Atlantic Region, Norfolk, VA.
REASON
Blood
products, that tested negative for hepatitis, but were collected from an
ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC, and CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE
a) Units 246305808, 246305337, 246306040;
b) Units 246305337, 246306040.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Dba United Blood
Services, Scottsdale, AZ.
REASON Blood products, which tested reactive for West Nile Virus, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION SD, AZ, and NE.
PRODUCT
a) Red Blood Cells.
b) Cryoprecipitated AHF.
c) Plasma.
d) Recovered Plasma.
CODE
a) Units LC23977, LC22485, LC19751, LC17960, LC12864, FY70865;
b) and c) Unit LC23977;
d) Units LC22485, LC19751, LC17960, LC12864.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Annandale, VA.
REASON Blood products, which tested negative for hepatitis but were
collected from a donor who disclosed a previous positive test for hepatitis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION VA, MD, and NJ.
PRODUCT Source Plasma.
CODE Unit 02PVAA3172.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Portsmouth,
VA.
REASON Source Plasma, incorrectly tested for antibodies to human
immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT
a) Red Blood Cells (Apheresis), Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced.
CODE a) and b) Unit number 0948696.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of
Cincinnati Medical Center, Cincinnati, OH.
REASON Blood products, collected from an unsuitable donor based on
travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 04KW25257.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England
Region, Dedham, MA.
REASON Blood product, collected from an unsuitable donor based on living
in 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 04KE39199.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England
Region, Dedham, MA.
REASON Platelets Pheresis with elevated platelet counts were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.
PRODUCT Fresh Frozen Plasma.
CODE Unit numbers 06FC06975, 06FS79355, 06GM22761, and 06GM22767.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southern
California Region, Los Angeles, CA.
REASON Blood products, associated with units of Red Blood Cells that
contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 15695.
RECALLING FIRM/MANUFACTURER St. Thomas More Hospital Blood Bank, Canon
City, CO.
REASON Blood products, collected from a donor whose health history was
inadequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CO.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 6050919.
RECALLING FIRM/MANUFACTURER West Tennessee Regional Blood Center, Inc.,
Jackson, TN.
REASON Blood products, collected from a donor who engaged in high risk
behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN, and Switzerland.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 53GZ21743 and 53GC41788.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Baltimore, MD.
REASON Blood products, which were collected from a donor who had lived
in a malarial endemic area, wee distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD, and DC.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 3402038.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA.
REASON Blood products, collected from a donor who had body piercing
within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Source Plasma.
CODE Units FBLSST, FBLSJF, FBKYRK.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Flint, MI.
REASON Source Plasma, collected from an ineligible donor, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Germany.
PRODUCT Red Blood Cells (Apheresis).
CODE Unit 04GR13046.
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region,
Dedham, MA.
REASON Red Cells, which tested negative for the antibody to the human
immunodeficiency virus, but were collected from a donor who provided post
donation information regarding having previously tested reactive for the
antibody, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit 13FV25284.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit
MI.
REASON Blood products, which were collected from a donor who had lived
in a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 13GV46511.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit
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, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 06LT35938.
RECALLING FIRM/MANUFACTURER American National Red Cross, Los Angeles,
CA.
REASON Blood products, collected from a donor who engaged in high risk
behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number 8939907.
RECALLING FIRM/MANUFACTURER HemaCare Corporation, Sherman Oaks, CA.
REASON Blood products 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).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Source Plasma.
CODE Unit numbers N-13270-093, G-54002-093, G-54496-093, G-55011-093,
and G-55527-093.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Brownsville,
TX.
REASON Blood products, that tested negative for viral markers, but were
collected from a donor that was subsequently determined to have multiple risk
factors for increased incidence of infection with human immunodeficiency virus
(HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION Spain.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 84LP22212.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern
California Region, Oakland, CA.
REASON Blood products, collected from an ineligible donor due to use of
the medication Lupron, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 084FT45957.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern
California Region, Oakland, 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 Red Blood Cells, Leukocytes Reduced.
CODE Unit number 84FT45660.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern
California Region, Oakland, 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 Red Blood Cells, Leukocytes Reduced.
CODE Unit number 2639592.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, 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 Red Blood Cells, Leukocytes Removed.
CODE Unit number 18FX52571.
RECALLING FIRM/MANUFACTURER American National Red Cross, Great Lakes
Region, Lansing, MI.
REASON Blood product, collected from a donor whose health history
regarding exposure to SARS was not adequately documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT
a) CryoVein, Femoral Vein;
b) CryoVein, Saphenous Vein;
c) CryoGraft, Pulmonary Monocusp Hemi-Artery.
CODE
a) Serial no. 8070656, Model V060;
b) Serial no. 8070255, Model V010;
c) Serial no. 8024373, Model PH10.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
REASON Human tissues intended for transplantation, which were collected from
a donor whose pre-processing cultures tested positive for microorganisms, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH, CT, and MO.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 1041-7834.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Dba United Blood
Services, Scottsdale, AZ.
REASON Blood product, collected from a donor who did not have a complete
medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Plasma.
CODE a) and b) Unit 10042-5484.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Dba United Blood
Services, Scottsdale, AZ.
REASON Blood products, collected from a donor who did not have a
complete medical history interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT
a) Red Blood Cells, Leukocytes Removed.
b) Fresh Frozen Plasma.
CODE
a) Unit numbers: 12FS13948, 12FS03954;
b) Unit number: 12FS03954.
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas
Region, Charlotte, NC.
REASON Blood products, collected from a donor who has a history of
morphea, a form of scleroderma, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC.
PRODUCT Source Plasma.
CODE Unit number 04958451.
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Columbus, OH.
REASON Blood product, collected from an ineligible donor, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 2882508.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, 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
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
c) Recovered Plasma.
CODE
a) and c) Unit number 2888101;
b) Unit number 2013059.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA.
REASON Blood products, collected from an ineligible donor due to use of
the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 042KP09616.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northern
Ohio Region, Cleveland, OH.
REASON Blood product, manufactured in a manner that may have compromised
the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
c) Fresh Frozen Plasma.
CODE
a) Units 004KF65892, 004KV07716, 004KF65868, 004FK43292, 004FR73008, 004GF30699,
004C71218, 004F05735,
004KK79280, 004F05772, 004FJ65467, 004FR73078, 004R02059, 004R01595,
004GF30901;
b) Unit 004FV30630;
c) Unit 004GF30699.
RECALLING FIRM/MANUFACTURER The American Red Cross, New England Region,
Dedham, MA.
REASON Blood products, collected from ineligible donors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 15 units;
b) 1 unit;
c) 1 unit.
DISTRIBUTION MA, ME, NY, and NH.
PRODUCT Platelets.
CODE Unit number 1974538.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc,
Lexington, KY.
REASON Blood product, collected from a donor who was taking an
aspirin-like medication at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Red Blood Cells.
CODE Unit 9220088.
RECALLING FIRM/MANUFACTURER Ogden Medical Center, Inc, Ogden, UT.
REASON Blood product, which was collected from a donor who had received
a body piercing 12 months prior to donation, was collected.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION GA.
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Platelets Leukocytes Reduced.
CODE a) and b) Unit 13GR47550.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit,
MI.
REASON Blood products, which were prepared from an overweight whole
blood unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.
PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit 13LH02168.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit,
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) Platelets Leukocytes Reduced.
c)
Fresh Frozen Plasma.
CODE a), b), and c) Unit 33GL22229.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Farmington, CT.
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 PA, and CT.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 33GY59666.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Farmington, CT.
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 CT.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets Leukocytes Reduced.
c) Fresh Frozen Plasma.
CODE a), b) and c) Unit 33GY58765.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Farmington, CT.
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 VA and CT.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets Leukocytes Reduced.
c) Fresh Frozen Plasma.
CODE a), b) and c) Unit 33GS35546.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Farmington, CT.
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 CT.
PRODUCT "Softbank II" Laboratory Information System.
CODE V.19, V.21, and V.22; Release 3.1.3.
RECALLING FIRM/MANUFACTURER Soft Computer Consultants, Inc., Palm
Harbor, FL.
REASON Defects in the design of blood bank software program could result
in incorrect patient laboratory records.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL, and AL.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 18233-2040.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
REASON Blood product, not properly quarantined after the receipt of post
donation information related to recent body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 38W30830, 38W30810, and 38W30815.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Indiana-Ohio Region, Fort Wayne, IN.
REASON Blood products, manufactured from overweight units of Whole
Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION IN.
PRODUCT
a) Red Blood Cells.
b) Cryoprecipitated AHF.
c) Recovered Plasma.
CODE
a) and b) Unit number 9006306;
c) Unit number 9005724.
RECALLING FIRM/MANUFACTURER Wellmont Health System, Community Blood Bank
of Norton, Norton, VA.
REASON Blood products, that tested negative for antibodies to human
immunodeficiency virus (anti-HIV), but were collected from a donor that
previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA, and MD.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Platelets, Irradiated.
e) Fresh Frozen Plasma.
CODE
a) and c) Unit numbers T25121, R51206, and T46866;
b) Unit number T42906;
d) Unit number K62019;
e) Unit numbers K62019, R51220, and R51206.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood products, incorrectly tested for human immunodeficiency
virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION VA.
PRODUCT Platelets Pheresis.
CODE Unit 1031237.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center UC Medical Center,
Cincinnati, OH.
REASON
Blood
product, which was untested for West Nile Virus (WNV) but subsequently tested
negative for WNV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT Recovered Plasma.
CODE Unit 15695.
RECALLING FIRM/MANUFACTURER St. Thomas More Hospital Blood Bank, Canon
City, CO.
REASON Blood products, collected from a donor whose health history was
inadequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CO.
PRODUCT Fresh Frozen Plasma.
CODE 13FC37030, 13FC37035, 13FE24768, 13FE24771, 13FE24772, 13FE24773,
13FE24777, 13FE24782, 13FE24794, 13FE24795, 13FE24798, 13FE24802, 13FE24803,
13FF39717, 13FF39721, 13FF39725, 13FF39726, 13FF39730, 13FF39733, 13FF39736,
13FF39739, 13FF39741, 13FK12870, 13FK12874, 13FM91263, 13FM91267, 13FM91268,
13FP07677, 13FP07686, 13FQ18161, 13FQ18165, 13FQ18167, 13FQ18170, 13FQ18174,
13FQ18175, 13FQ18176, 13FQ18179, 13FR52896, 13FR52897, 13FR52898, 13FR52903,
13FR52905, 13FR52906, 13FR52918, 13FV19442, 13FW05407, 13FW05408, 13FX00470,
13FX00472, 13FX00480, 13FX00482, 13FX00484, 13FX00486, 13FX00487, 13FX00488,
13FX00492, 13FX00501, 13FX00502, 13FX00505, 13FX00506, 13FX00507, 13GE12212,
13GE12213, 13GE12215, 13GE12218, 13GE12219, 13GE12224, 13GF02642, 13GF02643, 13GF02652,
13GF02653, 13GF02658, 13GL14617, 13GL14619, 13GM78641, 13GM78647, 13GM78648,
13GM78649, 13GM78651, 13GM78653, 13GM78658, 13GM78664, 13GM78665, 13GM78666,
13GM78667, 13GM78670, 13GM78672, 13GM78675, 13GM78678, 13GM78679, 13GM78682,
13GM78684, 13GM78686, 13GM78687, 13GM78689, 13GM78694, 13GM78695, 13GM78698,
13GM78701, 13GM78702, 13GM78703, 13GM78706, 13GM78709, 13GM78711, 13GM78712,
13GQ62931, 13GQ62935, 13GQ62936, 13GR42397, 13GR42399, 13GV40701, 13GV40704,
13GV40710, 13GV40712, 13GV40714, 13GV40719, 13GV40721, 13GW26620, 13GW26623,
13GW26624, 13GX63620, 13GX63621, 13GX63622, 13GX63626, 13GX63629, 13GX63631,
13GX63632, 13GX63633, 13GX63634, 13GX63636, 13GX63637, 13GX63638, 13GX63640,
13GX63645, and 13GX63646.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit,
MI.
REASON Blood products, which were incorrectly labeled with an extended
expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 135 units.
DISTRIBUTION MI and PA.
PRODUCT Platelets Leukocytes Reduced.
CODE Unit 13GL18353.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit,
MI.
REASON Blood product, in which the corresponding Red Blood Cells were
contaminated with gram positive bacilli, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Red Blood Cells.
CODE Unit numbers: 4230033, 4229052.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center,
Indianapolis, IN.
REASON Blood products were distributed although syphilis quality control
was not correctly documented or performed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN.
PRODUCT Red Blood Cells.
CODE Unit 0821949.
RECALLING FIRM/MANUFACTURER Florida Blood Services, Inc., St.
Petersburg, FL.
REASON Blood product, incorrectly tested for the presence of unexpected
antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit numbers 2885115, 2903443, and 2886168.
RECALLING FIRM/MANUFACTURER Central California Blood Center, Fresno, CA.
REASON Blood products that were out of controlled storage for more than
30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number 1993880.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc.,
Lexington, KY.
REASON Blood product, collected from a donor whose body temperature
exceeded the acceptable range, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Platelets Leukocytes Reduced.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit 33GE64292.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Farmington, CT.
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 VA, and CT.
PRODUCT Platelets Leukocytes Reduced.
CODE Unit 33GY52343.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Farmington, CT.
REASON Blood product, which was prepared from a whole blood unit with a
discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CT.
PRODUCT Red Blood Cells, Deglycerolized.
CODE Unit 12K67133.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern
Michigan Region, Detroit, MI.
REASON Blood product, possibly exposed to mercury contamination, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.
PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit numbers: 13FN87530, 13LG95446, 13FR52029, 13FV17503,
13FW04225, 13FY85275, 13GL13560, 13GE11203, 13GL13774, 13FJ99508, 13FM90076, 13GM77935,
13LG96518, 13T97823, 13T97838, 13FM90415, 13GF02331, 13GX63325, 13FE24181,
13FR52205, 13GL13690, 13GQ61447, 13GX63333, 13T97752, 13FW04760, 13FW04586,
13GE11201, 13GE11309, 13FC39622, 13GL13702, 13FJ98466, 13FP06544, 13FR52018,
13FR52032, 13FV17517, 13GL13689, 13FN87174, 13GL13646, 13FW04601, 13FY85658,
13FY85682, 13GE11135, 13FM90399, 13GQ62497, 13FJ99400, 13FM90009, 13FC39608,
13FE24218, 13FE24229, 13FE24325, 13FJ99687, 13FJ99987, 13FM89279, 13FM89667,
13FM90402, 13FM94760, 13FN87525, 13FN87526, 13FP06413, 13FP06550, 13FP06815,
13FQ16689, 13FQ17666, 13FQ17667, 13FQ17668, 13FR52030, 13FR52069, 13FR52122,
13FR52430, 13FV17512, 13FW04188, 13FW04194, 13FW04211, 13FW04292, 13FW04293,
13FW04297, 13FW04298, 13FW04554, 13FW04583, 13FW04757, 13FW04761, 13FX04498,
13FY85244, 13FY85387, 13FY85389, 13FY85420, 13FY85664, 13FY85673, 13FY86746,
13GE11147, 13GE11625, 13GE11664, 13GF02332, 13GL13682, 13GL13712, 13GL13813,
13GM77407, 13GM77414, 13GM78416, 13GQ62365, 13GQ62375, 13GQ62376, 13GQ62378,
13GV39984, 13GX62117, 13GX63326, 13GX63340, 13LG96103, 13LG97037, 13T97615,
13T97624, 13T97951, 13FJ97919, 13GL13659, 13GQ61374, 13FJ99501, 13FM89586 and
13LG96221.
RECALLING FIRM/MANUFACTURER American Red Cross, Southeastern Michigan
Region, Detroit, MI.
REASON Blood products, incorrectly antigen typed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 118 units.
DISTRIBUTION GA, IN, MI, OH, and TN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE
a) Units (01KM16559; 01KM16561; 01KM16563; 01KM16564; 01KM16565; 01KM16566;
01KM16568; 01KM17452; 01W99382; 01W99385; 01W99386; 01W99387; 01W99388;
01W99390; 01W99391; 01W99392; 01W99393; 01W99394; 01W99395; 01W99396;
b) Unit 01KM16567.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, West
Henrietta, NY.
REASON Blood products, possibly prepared more than eight hours after
collection of the corresponding whole blood units, were distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units.
DISTRIBUTION NY.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
CODE
a) Unit number 18FR58493;
b) Uunit numbers 18FW17194, 18FW17195, 18FW17196, 18FW17197, 18FW17198,
18FW17199, 18FW17200, 18FW17201, 18FW17202, 18FW17203, 18FW17204, 18FW17205,
18FW17206, 18FW17207, 18FW17208, 18FW17209, 18FW17210, 18FW17211, 18FW17212,
18FW17213, 18FW17214, 18FW17215, 18FW17216, 18FW17217, 18FW17218, 18FW17219,
18FW17220, 18FW17221, 18FW17225, 18FW17226, 18FW17228, 18FW17229, 18FW17230,
18FW17231, 18FW17232, 18FW17233, 18FW17234, 18FW17235, 18FW17236, 18FW17238,
18FW17239, 18FW17241, 18FW17242, 18FW17243, 18FW17244, 18FW17245, 18FW17246,
18FW17247, 18FW17248, 18FR58475, 18FR58476, 18FR58477, 18FR58478, 18FR58479,
18FR58481, 18FR58483, 18FW58484, 18FR58485, 18FR58486, 18FR58487, 18FR58488,
18FR58489, 18FR58490, 18FR58491, 18FR58492, 18FR58494, 18FR58496, 18FR58497,
18FR58498, 18FR58499, 18FR58500, 18FR58501, 18FR58502, 18FR58503, 18FR58505,
18FR58506, 18FR58508, 18FR58509, 18FR58510, 18FR58511, 18FR58512, 18FR58514,
18FR58515, 18FR58516, 18FR58517, 18FR58519, 18FR58520, 18FR58522, 18FR58523,
18FR58524, 18FR58525, 18FR58526, 18FR58527, 18FR58529, 18FR58532, 18FR58533,
18FR58534, 18FR58535, 18FR58536, 18FR58537, 18FR58538, 18FR58539, 18FR58540,
18FR58541, 18FR58542, 18FR58543, 18FR58545, 18FR58546, 18FR58547, 18FR58548,
18FR58549, 18FR58550, and 18FR58551.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes
Region, Lansing, MI.
REASON Problem: Blood products, manufactured using blood weight scales
that had no quality control testing performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 114 units.
DISTRIBUTION MI, and CA.
PRODUCT Source Plasma.
CODE
Units:
G15357-081, G-15724-081, G-16320-081, G-16716-081, G-17164-081, G-18113-081,
G-18279-081,
G-20765-081,
G-22736-081, G-22828-081, G-23186-081, G-23251-081, G-23408-081, G-23504-081,
G-23666-081,
G-28725-081,
G-28972-081, N-85990-081, N-86018-081, G-62542-081, G-62649-081, G-76098-081,
G-76453-081,
G-76844-081,
G-76978-081, G-88286-081, G-91970-081, G-92438-081, G-92686-081, G-93218-081,
G-05106-081,
G-05753-081,
G-05910-081, G-06322-081, G-06484-081, G-06851-081, G-07074-081, G-08859-081,
G-09163-081,
G-10134-081,
F-00139-081, F-00385-081, F-00958-081, F-01201-081, F-02561-081, F-02838-081,
F-06778-081,
F-07032-081,
N-72120-081, G-44664-081, G-54313-081, G-54476-081, G-54975-081, G-55133-081,
G-55611-081,
G-55758-081,
G-56227-081, G-56381-081, G-56868-081, G-57013-081, G-07937-081, G-08380-081,
G-08605-081,
G-09013-081,
G-09319-081, G-09681-081, G-10676-081, G-11245-081, G-13006-081, G-13933-081.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Charlotte,
NC.
REASON Blood products, collected from a donor whose eligibility to
donate was not adequately verified, were distributed.
VOLUME OF PRODUCT IN COMMERCE 70 units.
DISTRIBUTION NC, Germany, Spain, Switzerland, and the United Kingdom.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units W045003037801, W045003037803, W045003037807, W045003037809,
W045003037810, W045003037811, W045003037815, W045003037817, W045003037818,
W045003037820, W045003037823, W045003037830, W045003037831, W045003037833,
W045003037834, W045003037837.
RECALLING FIRM/MANUFACTURER Community Blood Center of Gtr KC, Kansas
City, MO.
REASON Blood products, collected from donors with inaccurate hemoglobin
determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION MO, and KS.
PRODUCT Source Plasma.
CODE Unit # SH935056.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Harrisburg,
PA.
REASON Blood product, collected from an ineligible donor, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION France.
PRODUCT Source Plasma.
CODE Unit # SH914499.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Harrisburg,
PA.
REASON Blood product, collected from an ineligible donor, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.
PRODUCT Source Plasma.
CODE Unit # SH910399.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Harrisburg,
PA.
REASON Blood product, collected from an ineligible donor, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 18233-3650.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who did not have a
complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WY, and Switzerland.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 18232-4789.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected from a donor who did not have a
complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WY, and Switzerland.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
c) Cryoprecipitated AHF.
CODE
a) Units 12799-0947, 12799-0948, 12800-5406, 12800-5526, 12800-6624,
12800-7072, 12800-4324;
b) Units 12800-4324, 12800-5526;
c) Unit 12800-7072.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Albuquerque, NM.
REASON Blood products, collected from ineligible donors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION NM, TX, RI, and Switzerland.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Platelets Irradiated.
e) Cryoprecipitated AHF.
f) Plasma.
g) Fresh Frozen Plasma.
h)
Recovered Plasma. Recall # B-0864-4.
CODE
a) Unit numbers 18FT23562, 18FT10811, 18FT08290, 18Q99612, 18Q90725, 18Q81863,
18Q79442, 18Q58960, and 18Q52216;
b) Unit numbers 18FT31584, 18FV16891, 18FT26060, 18FV10579, 18FT06307,
18FT02732, 18Q88417, 18Q86307, 18Q84436, and 18Q73195;
c) Unit numbers 18FV16891, 18FT26060, 18FT10811, 18FT08290, 18FT06307,
18Q99612, 18Q90725, 18Q88417, 18Q84436, 18Q81863, 18Q73195, and 18Q52216;
d) Unit number 18FT02732;
e) Unit numbers 18FT10811, 18Q90725, and 18FT23562;
f) Unit number 18FT23562;
g) Unit numbers 18Q81863 and 18Q79442;
h) Unit numbers 18FT31584, 18FV16891, 18FT26060, 18FV10579, 18FT10811,
18FT08290, 18FT06307, 18FT02732, 18Q99612, 18Q90725, 18Q88417, 18Q86307,
18Q84436, 18Q73195, 18Q58960, and 18Q52216;
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes
Region, Lansing, MI.
REASON Blood products, collected from an unsuitable donor due to
behavior associated with an increased risk of infection with hepatitis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 54 units.
DISTRIBUTION MI, CA, MA, NJ, NY, PR, TN, and Switzerland.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit V63255.
RECALLING FIRM/MANUFACTURER Stanford Medical School Blood Center, Palo
Alto, CA.
REASON Blood products, which were collected from a donor who emigrated
from an area of high risk for human immunodeficiency virus (HIV) Group O, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells.
CODE Unit T86580.
RECALLING FIRM/MANUFACTURER Stanford Medical School Blood Center, Palo
Alto, CA.
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 CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 224250339 (split).
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Las Vegas, NV.
REASON Blood products, which were collected in a manner that compromised
the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NV.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 224245527.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Las Vegas, NV.
REASON Blood product, which did not have a red blood cell volume
documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NV.
PRODUCT Recovered Plasma.
CODE Units 12799-0947, 12799-0948, 12800-5406, 12800-6624, 12800-7072.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc.,
Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Albuquerque, NM.
REASON Blood products, collected from ineligible donors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NM, TX, RI, and Switzerland.
PRODUCT Cryoprecipitated AHF.
CODE Unit 192493870.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Reno, NV.
REASON Blood product, which was prepared from plasma that was not frozen
within 8 hours of phlebotomy, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NV.
PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Units 192476855, 192476857 (split), 192476850, and 192476854
(split).
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Las Vegas, NV.
REASON Blood products, which were not stored under continuous agitation,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION NV.
PRODUCT Platelets.
CODE Units: J43948, J43970, J43983, J43987, J70486, M11785, M11790,
M11865, M41050, M41053, M41059, M41060, M73651, M73652, M73653, R90405, R90424,
R90457, R90460, S28993, S29003, S29009, S29012, S29015, S29017, S29023, S29024,
S29025, S29026, S29032, S29034, S29035, S29039, S29057, S29063, S29087, S29101,
S73352, S73366, S73367, S73369, S73371, S73385.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Saginaw
Valley Blood Program, Saginaw, MI.
REASON Platelets, with an unacceptably low count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 43 units.
DISTRIBUTION MI.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 0844856.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center,
San Francisco, 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 Red Blood Cells, Leukocytes Reduced.
CODE Unit number 1199038.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center,
San Francisco, 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 Red Blood Cells, Leukocytes Reduced.
CODE Unit number 1214220.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center,
San Francisco, CA.
REASON Blood product, collected from a donor that did not have a
hematocrit or hemoglobin test during the donor screening process, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number 0785530.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center,
San Francisco, CA.
REASON Blood products, collected from an ineligible donor due to use of
the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
CODE a) and b) Unit number 1203061.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center,
San Francisco, CA.
REASON Blood products, that tested negative for viral markers, but were
collected from an ineligible donor due to behavior known to increase risk of infection
with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Irradiated.
CODE
a) Unit numbers 1213219 and 1214060;
b) Unit numbers 1214117, 1213309, and 1212692.
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 5 units.
DISTRIBUTION CA.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 71W25003-3.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers,
Gainesville, FL.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.
PRODUCT
Source
Plasma.
CODE Units HP101972, 06884864, 06883003, HP100241, 05106806, 05069811,
05068012, 05062959, 04760511, 04752707, 04750888, 04743965, 04740940, 04726067,
04723806, 04720034, 04717584, 04558880, HP96856, HP96286, 04554196, 04529064,
04526414, 04257233, 04253716, 04099215, 04096856, 04093145, 04092308, 04029779,
04027577, 04022503, 04020165, 04011606, 93382991, 93277303, 93274579, 93089166,
93086882, 93082693, 93710404, 93705615, 93702874, 93599504, 93596749, 92800007,
92798069, 92794504, 92679887, 92677043, 92672819, 92554078, 92418714, 92415706,
92309944, 92307537, 92298200, 92292253, 92249523, 92243231, 91327055, 91321114,
91299475, 91293787, 91197689, 91194626, 91137401, 91133175, 91065186, 91063472,
91053695, 91052254, 91027818, 91021540, 90989667, 90750465, 90098079, 90093944,
90089923, 90085611, 90189272, 90185823, 79190305, 79187497, 79181457.
RECALLING FIRM/MANUFACTURER Interstate Blood Bank, Inc., of Chicago,
Chicago, IL.
REASON Source Plasma, collected from an unreliable donor, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 85 units.
DISTRIBUTION CA, and Ireland.
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Recovered Plasma.
CODE a) and b) Unit number 1896710.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services Inc., Jackson,
MS.
REASON Blood products, collected from a donor who disclosed a history of
hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MS, and Switzerland.
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 5077822.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Eastern Maine Medical
Center, Bangor, ME.
REASON Blood Products, collected from a donor who had received MMR
vaccine prior to donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION ME.
_______________________________
PRODUCT
a) Cryoprecipitated AHF.
b) Cryoprecipitated AHF, Pooled.
c) Fresh Frozen Plasma
d) Fresh Frozen Plasma, Irradiated.
e) Plasma, Cryo-Reduced.
f) Platelets.
g) Platelets, Irradiated.
CODE
a) Unit Numbers: 016LQ19689, 016LE71866, 016LT21861, 016LG37166, 016GW04038,
016KC22003, 016LV77250,
016LV77256, 016LZ17921, 016LH47406, 016LS88841, 016GW04936, 016LR45882,
016GP02503, 016LY00412,
016LV70508, 016LX41165, 016LG35099, 016KG03182, 016GQ02090, 016KC19290,
016LS86138, 016LZ17481,
016LE83551, 016LL58227, 016GW06185, 016GW08516, 016GW08514, 016LX34241,
016GJ08983, 016KC19100,
016LM59904;
b) Unit Numbers: 016LR37048 (pool #5707), 016LY94390 (pool #6643), 016LX38258
pool #7380), 016KC22027 (pool #9737), 016LE69637 (pool #6459), 016LG27655 (pool
#6821), 016LV68157 (pool #7294), 016LX38256 (pool #7393),
016LC16386 (pool #7539), 016LV70370 (pool #7746), 016LG36896 (pool #8243),
016GW04056 (pool #8248),
016LX48197 (pool #8911), 016LS73532 (pool #6228), 016LV69465 (pool #7569),
016LY95032 (pool #6781),
016LZ13718 (pool #5451), 016LE63110 (pool #5409), 016LY84891 (pool #5483),
016LV58222 (pool #5666),
016LS69489 (pool #5704), 016LY87037 (pool #5754), 016LL49474 (pool #5814),
016LS73630 (pool #6257),
016LE68922 (pool #6334), 016LX34099 (pool #6599), 016LY94226 (pool #6656),
016LY94589 (pool #6724),
016LG29701 (pool #7055), 016LT20324 (pool #7094), 016GM07807 (pool #7119),
016LZ15873 (pool #7376),
016LH49826 (pool #7709), 016LG37653 (pool #8391), 016LV77495 (pool #8897),
016LS68671 (pool #5549),
016LS69328 (pool #5690), 016LE64154 (pool #5653), 016LG24802 (pool #5987),
016LL51004 (pool #6846),
016LR45895 (pool #8191), 016LV59025 (pool #5764), 016GW04313 (pool #8263),
016LY83722 (pool #5315),
016LV56821 (pool #5292), 016LS67083 (pool #5387), 016LS68014 (pool #5504),
016LV58223 (pool #5618),
016LS70036 (pool #5757), 016LX30637 (pool #5797), 016LH43977 (pool #6235),
016LX33150 (pool #6316),
016LY92501 (pool #6484), 016LS74467 (pool #6323), 016LS74424 (pool #6322),
016LE69623 (pool #6472),
016LS75581 (pool #6548), 016LS75840 (pool #6537), 016LS75908 (pool #6533),
016LX34187 (pool #6635),
016LY94229 (pool #6603), 016LG27712 (pool #6671), 016LG27922 (pool #6774),
016LG28623 (pool #6980),
016LV67156 (pool #7089), 016LM53265 (pool #7593), 016LL54765 (pool #7999),
016LV73519 (pool #8236),
016LE81927 (pool #8319), 016KC14141 (pool #5791), 016LT18715 (pool #5792);
c) Unit Numbers: 016LL53863, 016LG22957, 016GW03073, 016LV68495, 016LM50302,
016LW33727, 016LW42490,
016LC13673, 016LS85828, 016LQ20358, 016LZ16993, 016LS84433, 016LE70074,
016LN26138, 016LW41672,
016LW42924, 016LQ19851, 016KC16962, 016LE75970, 016LR53489, 016LE66020,
016LH59705, 016LM47701,
016LW42869, 016GM05069, 016LT19359, 016LY93717, 016LE70693, 016LS76739,
016LV72470, 016LR45510,
016LV73390, 016LY83709, 016LR37008, 016LM49792, 016LR40523, 016LH26022,
016LV62763, 016LT20555,
016LH53821, 016LW51829, 016LN38046, 016LW31534, 016LS67515, 016LW41535,
016LW41610, 016LE63367,
016GM02066, 016LM47550, 016LW42594, 016LV58731, 016LE64792, 016LG24657,
016LY89773, 016LY89746,
016LY93452, 016LW46059, 016LG29384, 016LR42686, 016GS00537, 016LW50374,
016LM56036, 016LE80566,
016LV73408, 016LR46484, 016LR46599, 016LX45395, 016GJ09706, 016LS87315,
016KC13363, 016LW42362,
016LW42757, 016LS71844, 016LN27697, 016LY92942, 016LH46442, 016LH46725,
016LH47735, 016LY00196,
016LE82545, 016LG44149, 016LV62039, 016LL49161, 016LV64905, 016LM54254,
016LV57035, 016GW12424;
d) Unit number 016lN33525;
e) Unit Numbers: 016LV77495, 016LC16386, 016LS69489, 016LY86374, 016LR37048,
016GP02503, 016KG03182,
016LG29701, 016LG27922, 016LG27655, 016GW08516, 016GW08514, 016LS70036,
016LV59025, 016LG37166,
016KC19100, 016LQ19689, 016GP01995, 016GW04038, 016GM07807, 016LS74467,
016LS74424, 016LH47406,
016LV70370, 016LH49826, 016LL54765, 016KC22003, 016LE69623, 016LG36896,
016GW04056, 016LS75581,
016LE69637, 016LE74523, 016LM59904, 016LE63110, 016LS69328, 016LZ17921,
016LS88841, 016GW04313,
016LV56821, 016LS67083, 016LY87037, 016LX30637, 016LY92501, 016LL51004,
016LV67156, 016LT20324,
016LV68157, 016LX38256, 016LV70508, 016LG35099, 016LV73519, 016LT21861,
016LE81927;
f) Unit Numbers: 016LQ20365, 016LH49271, 016LE66148, 016LC05940, 016LH39581,
016LE94152, 016LG22957,
016LV57035, 016LY87732, 016LG24657, 016LV62763, 016LV68495, 016LE64327,
016LV58731, 016LQ19876,
016LV73607, 016LW42869, 016LV59775, 016LW46742, 016LW50374, 016GQ01658,
016LS85353, 016LW51829,
016LS26454, 016LN23131, 016LM47196, 016LS68152, 016LR36415, 016LT18484,
016LM47701, 016LW42490,
016LW42594, 016LV58790, 016LH41857, 016LW42757, 016LS71844, 016LY91258,
016LY92942, 016LS76220,
016LR40191, 016LR40761, 016KC16962, 016LT20555, 016LR42686, 016LX40460,
016LE78850, 016LR46484,
016LE95156, 016LH26022, 016LW41535, 016LW41610, 016LE63400, 016LX29786,
016LS68636, 016LM47339,
016LE64446, 016LE65820, 016LM50302, 016LS76029, 016LS76739, 016GP01622,
016GS00537, 016LW49177,
016LL55188, 016LS84445, 016LZ16993, 016LE80566, 016LV73390, 016KC22003,
016LY84448, 016LX29927,
016LS72076, 016LR45510, 016LH59705, 016LH53821, 016LY88664, 016LS73083,
016LS81750, 016LE82545,
016LG37607, 016LG37627, 016LG44149, 016LS26461, 016LY84594, 016LW41672,
016LV57019, 016GW01134,
016LT20775, 016LE70693, 016GW12424;
g) Unit Numbers: 016LH47735, 016LE77008, 016LH52010, 016GW02345, 016LL63897,
016GW01162.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central
Ohio Region, Columbus, OH.
REASON
Blood
Products, corresponding to units of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 32 units;
b) 71 units;
c) 87 units;
d) 1 units;
e) 54 units;
f) 90 units;
g) 6 units.
DISTRIBUTION Nationwide and PR.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers 6014624 and 6014626.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson,
MS.
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 MS.
PRODUCT Recovered Plasma.
CODE Unit number 1807364.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson,
MS.
REASON
Blood product,
that tested negative for viral markers, but was collected from an unsuitable
donor due to the application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.
PRODUCT Platelets.
CODE Unit number 2030795.
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc.,
Lexington, KY.
REASON Blood product, collected from an ineligible donor due to recent
ingestion of aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.
PRODUCT Red Blood Cells.
CODE Unit number 224731.
RECALLING FIRM/MANUFACTURER Aultman Hospital Association Blood Bank,
Canton, OH.
REASON Blood product, that tested negative for the antibody to hepatitis
C virus (anti-HCV), but was collected from an ineligible donor based on a
previous positive test for anti-HCV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 8422677.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc.,
Indianapolis, IN.
REASON An associated product was found to be contaminated with
Staphylococcus aureus.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.
PRODUCT Source Plasma.
CODE G-24395-093, G-24878-093, G-25128-093, G-25590-093, G-25845-093,
G-26240-093, G-26459-093, G-33208-093,
G-33426-093, G-33895-093, G-34121-093, G-34577-093, G-34820-093, N-16745-093,
G-82456-093, G-82830-093,
G-84254-093, G-84628-093, G-85120-093, G-85614-093, G-36085-093, G-86464-093,
G-86881-093, G-87290-093,
G-87711-093, G-88131-093, G-88538-093, G-89015-093, G-89476-093, G-89846-093,
G-90260-093, G-90763-093,
G-91208-093, G-93375-093, G-93797-093, G-94167-093, G-94616-093, G-95002-093,
G-95439-093, G-95831-093,
G-96252-093, G-96631-093, G-97015-093, G-97364-093, G-97689-093, G-98019-093,
G-98366-093, G-98711-093,
G-99066-093, G-99411-093, G-99754-093, G-05106-093, G-05404-093, G-05731-093,
G-06103-093, G-06444-093,
G-06805-093, G-07145-093, G-07381-093, G-07678-093, T-45875-093, T-46055-093,
T-46204-093, T-46379-093,
T-46524-093, T-46732-093, T-46886-093, T-47089-093, T-47249-093, T-47409-093,
T-47542-093, T-47750-093,
T-47921-093, T-47994-093, T-48167-093, T-48255-093, T-48410-093, T-48482-093,
T-48627-093, T-48698-093,
T-48829-093, T-48890-093, T-49022-093, T-49083-093, T-49201-093, T-49248-093,
T-49363-093, T-49430-093,
T-49558-093, T-49625-093, T-49754-093, G-19776-093, G-19973-093, G-20346-093,
G-20525-093, G-20898-093,
G-21082-093, G-21472-093, G-21679-093, G-22052-093, G-22286-093, G-22663-093,
G-22881-093, G-23226-093,
G-23422-093, G-23817-093, G-24020-093, G-24406-093, G-24608-093, G-24954-093,
G-25178-093, G-25543-093,
G-25779-093, G-26166-093, G-26383-093, G-26785-093, G-27007-093, G-27390-093,
G-27587-093, G-29078-093,
G-29260-093, G-29648-093, G-29842-093, G-32089-093.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp, Brownsville, TX.
REASON Source Plasma, collected from an unreliable donor, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 124 units.
DISTRIBUTION NC, CA, Switzerland, United Kingdom, Italy, and Spain.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) Unit # 16LR26866.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Central
Ohio Region, Columbus, OH.
REASON Blood products, collected from a donor with a history of
jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH.
PRODUCT Red Blood Cells.
CODE Unit KC38138.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA.
REASON Blood product, which was collected from a donor who was taking
the drug Profasi (Human Chorionic Gonadotropin (HCG), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.
PRODUCT Red Blood Cells.
CODE Unit number 0393311.
RECALLING FIRM/MANUFACTURER Community Blood Bank of Erie County, Erie,
PA.
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 PA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 0683271.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, San Francisco,
CA.
REASON Blood product, collected from a donor whose body temperature was
not properly recorded, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Fresh Frozen Plasma.
CODE Units number 1769227, 1771858, 1762330, 1762606, 1763286, 1794103,
1767897, 1762031, 1747922, 1761509, 1776139, 1769554, 1775662, 1774849,
1780595, 1772555, 1776346, 1777664, 1779868, 1784604, 1790776, 1778983, 1778882,
1759617, 1762119, 1778387, 1771699, 1777039, 1777044, 1777628, 1776509,
1761469, 1761497, 1778662, 1758504, 1739624, 1771560, 1759729, 1759240,
1759572, 1759656, 1759672, 1778573, 1779985, 1758449, 1782403, 1772590,
1773510, 1779021, 1773567, 1760988, 1773676, 1769551, 1778398, 1773800,
1773848, 1771748, 1761316, 1766579, 1767999, 1759614, 1730925, 1769549,
1784605, 1779288, 1794106, 1742744, 1776714, 1777582, 1762115, 1772360,
1796934, 1760997, 1776115, 1777302, 1761001, 1776098, 1762345, 1763208,
1778649, 1762768, 1767778, 1767784, 1778724, 1776683, 1778636, 1762112,
1778582, 1762332, 1751091, 1769378, 1786649, 1771545, 1762359, 1762030,
1777274, 1761292, 1761306, 1760860, 1774800, 1778395, 1778394, 1794901,
1763120, 1767888, 1767905, 1749914, 1769556, 1761958, 1771568, 1761366,
1774782, 1776345, 1779299, 1761365, 1761359, 1761345, 1761342, 1776112,
1761325, 1771586, 1771707, 1781607, 1780190, 1781613, 1781611, 1779289,
1778532, 1776069, 1772431, 1776026, 1778703, 1797187, 1778981, 1767791, 1711695,
1775409, 1750120, 1767899, 1759667, 1783138, 1776707, 1772042, 1794900,
1775663, 1761317, 1767886, 1761415, 1797262, 1773973, 1761511, 1760989,
1761501, 1796935, 1761494, 1760870, 1761417, 1771759, 1761308, 1761313,
1784297, 1748030, 1762315, 1769192, 1769377, 1762118, 1769672, 1771192,
1793893, 1776092, 1777289, 1776689, 1775338, 1776717, 1775481, 1780478,
1779345, 1776950, 1762290, 1778638, 1762342, 1775484, 1761310, 1776711,
1776708, 1778648, 1777729, 1760696, 1779303, 1778657, 1778388, 1783351, 1777299,
1778695, 1777303, 1777042, 1776511, 1763392, 1769685, 1775944, 1778552,
1777172, 1775190, 1779310, 1763211, 1744337, 1758605, 1769188, 1776705,
1761282, 1769189, 1776519, 1780121, 1777787, 1759665, 1761491, 1776031,
1760410, 1734425, 1778641, 1760336, 1762334, 1762335, 4002619, 1783139,
1758002, 1777330, 1754947, 1777300, 1778728, 4002681, 1777296, 1772573,
1777295, 1762392, 1773136, 1760693, 1796653, 1777291, 1777301, 1769226,
1758517, 1769458, 1769496, 1778396, 1745987, 1778551, 1769553, 1778571, 1760695,
1760698, 1771442, 1785583, 1760049, 1778389, 1769785, 1770243, 1778580,
1769190, 1770822, 1772808, 1769558, 1775687, 1776760, 1775381, 1761253,
1777288, 1775472, 1772601, 1779083, 1775488, 1775492, 1777270, 1760198,
1775471, 1761311, 1776027, 1776030, 1776510, 1761343, 1794102, 1766667,
1761318, 1750128, 1763100, 1774662, 1774482, 1774484, 1760498, 1774608,
1774629, 1778700, 1774738, 1775084, 1750129, 1760300, 1776165, 1762533,
1760092, 1762299, 1760631, 1762271, 1762270, 1752547, 1758446, 1760303, 1754216,
1750883, 6007488, 1763122, 1762396, 1763099, 1760694, 1760411, 1762318,
1763068, 1757020, 1762395, 1756348, 1762699, 1762340, 6010159, 1762339,
4002201, 1763101, 1760136, 1760697, 1777073, 6010620, 1761495, 1777104,
1761493, 4003162, 1761492, 1761002, 4002788, 1777103, 1761409, 4002196,
1760197, 1761499, 1767917, 1759712, 1760334, 1761344, 6010392, 1759751,
1759754, 1763196, 1777035, 1761319, 1761021, 1759758, 1762113, 1762111,
1760091, 1762110, 6011090, 1762107, 1762079, 1762032, 4002448, 1759507, 1761000,
1759510, 1760856, 1760142, 1760979, 1759172, 1761510, 1777269, 1761508,
1760992, 1761504, 1760994, 1760995, 1760857, 1778659, 1778581, 1778584,
1778585, 1778634, 1778650, 1778651, 1778729, 1778658, 1777759, 1778660,
1778661, 1791221, 1778691, 1778693, 1778706, 1763201, 1778656, 1777367,
1776698, 1771569, 1776715, 1776719, 1777271, 1777292, 1777293, 1791722,
1777307, 1793813, 1777519, 1777605, 1793988, 1793987, 1777666, 1777696,
1778739, 1777297, 1779654, 1783348, 1783349, 1783989, 1783990, 1785742, 1785919,
1778725, 1779308, 1790091, 1779665, 1787424, 1780597, 1779987, 1779988,
1780191, 1780210, 1786648, 1790775, 1778741, 1791220, 1778921, 1791204,
1791203, 1779124, 1779139, 1783137, 1783995, 1783133, 1780598, 1781429,
1781432, 1781435, 1781585, 1782402, 1776686, 1779293, 1769379, 1768713,
1768878, 1768879, 1768994, 1746544, 1769248, 1769591, 1769254, 1768177,
1769380, 1769382, 1769383, 1769504, 1769552, 1769555, 1776712, 1769249,
1767780, 1763207, 1763209, 1763297, 1766572, 1766574, 1766577, 1766578, 1768711,
1766580, 1768709, 1767789, 1767885, 1767887, 1767901, 1767948, 1767950,
1769593, 1750121, 1775668, 1776682, 1774151, 1769557, 1774607, 1775012,
1775123, 1796394, 1775547, 6010160, 1794690, 1776385, 1776454, 1776523,
1776559, 1776677, 1776679, 1775485, 1772222, 1771588, 1771694, 1774213,
1771567, 1796395, 1771587, 1772088, 1771714, 1770692, 1770274, 1772432,
1772587, 1772711, 1773179, 1771441, 1776032, 1777495, 1769251, 1760637,
1776071, 1756615.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson,
MS.
REASON Blood products, not placed in the freezer within required
timeframes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 528 units.
DISTRIBUTION MS, IL, NJ, AR, CA, VA, TX, and TN.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 0682280.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center,
San Francisco, CA.
REASON Blood product, collected from a donor whose arm inspection was
not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 1835817, 1835811, 1835808, 1835815, 1834528, and
1835858.
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson,
MS.
REASON Blood products, found to be out of specification for red blood
cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION MS.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 6020172 (distributed as two split products).
RECALLING FIRM/MANUFACTURER Mississippi Blood Services, Inc., Jackson,
MS.
REASON Blood products, that were labeled leukoreduced but failed quality
control testing due to an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MS.
PRODUCT Red Blood Cells, Washed.
CODE Unit number 20LC51429.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Lewis and
Clark Region, Boise, ID.
REASON Blood product, that was found to be out of specification for red
blood cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION ID.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
a) Unit number FC32925;
b) Unit number FC32928.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aurora Area Blood Bank,
Heartland Blood Centers, Aurora, IL.
Manufacturer: Heartland Blood Centers, Tinley Park, IL. Firm initiated
recall is complete.
REASON Blood products, that were not leukoreduced within the appropriate
time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WI, and IN.
PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE Unit # FC70332.
RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL.
REASON The irradiated Red Blood Cells were labeled with an extended
expiration date.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units # 18233-0183, 18233-0185, 18233-0189, 18233-0200.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ.
REASON Blood products, collected on trip scales that were incorrectly
calibrated, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION WY.
PRODUCT Source Plasma.
CODE Unit number 53DDSDPD.
RECALLING FIRM/MANUFACTURER International BioResources, LLC, Melrose
Park, IL.
REASON Blood product, which did not have the arm inspection documented
on the donation record, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced.
CODE
a) Unit number LE30532 (distributed as two split products);
b) Unit number LE47395.
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 3 units.
DISTRIBUTION MA and RI.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c)
Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a) and b) Unit numbers 13FQ08979 and 13T92433;
c) Unit number 13T92433;
d) Unit number 13FQ08979.
RECALLING FIRM/MANUFACTURER The American National Red Cross,
Southeastern Michigan Region, Detroit, MI.
REASON Blood products collected from an unsuitable donor due to a
history of residing in an area considered at increased risk of exposure to new
variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION MI and CA.
PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: 15391-7336.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX.
REASON Blood product, collected from a donor who was taking Isosorbide
Mononitrate at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 0680168.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center,
San Francisco, CA.
REASON Blood Products, which were negative for all viral markers, but
were collected from a donor whose donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA and Switzerland.
PRODUCT Human Cornea Tissue.
CODE Tissue 01-1320.
RECALLING FIRM/MANUFACTURER Lions Eye Bank of Central Texas, Manor, TX.
REASON Human tissue for transplantation, that tested negative for
hepatitis prior to distribution, but was subsequently found to test repeatedly
reactive for antibodies to the hepatitis B surface antigen (HBsAg) by a
different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a) and b) Unit 33GS41637.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Connecticut
Region, Farmington, CT.
REASON Blood products, collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA and CT.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a) and b) Unit 33GS41641.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA and CT.
PRODUCT
Red Blood
Cells, Leukocytes Removed.
CODE Unit number 8350055.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Alexandria, LA.
REASON Blood product, that was not properly quarantined after the donor
reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit 18233-5020.
RECALLING FIRM/MANUFACTURER Blood Systems Inc. Cheyenne, WY.
REASON Blood products, collected from a donor whose medical history
screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY and Switzerland.
PRODUCT Red Blood Cells.
CODE Unit number: 8239861.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA.
REASON Blood product, collected from an ineligible donor who was
previously deferred for body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT
a) Red Blood Cells.
b)
Red Blood Cells, Leukocytes Removed, Irradiated.
c) Recovered Plasma.
CODE
a) Unit numbers: 8103966, 8103968, 8124908, 8124909, 8124914, 8124917, 8111126,
8111127, 8111128, 8111129,
8111130, 8111131, 8111133, 8111134, 8111135, 8111136, 8111137, 8111138,
8111141, 8111143, 8111144, 8111145,
8111167, 8111169, 8111170, 8132006, 8132007, 8103983, 8103937, 8103938,
8103942, 6590493, 6590529, 6590530,
8103970, 8103971, 8103976, 8103977, 8103978, 8103979, 8103980, 8103943, 8103945,
8103947, 8103948, 8103949,
8103954, 8103955, 8103958, 8103960, 8103961, 8103963, 6586947, 6586948,
6580882, 6580884, 6580885, and
6580494;
b) Unit number: 8103967;
c) Unit numbers: 8103964, 8103966, 8103967, 8103968, 8124908, 8124909, 8124914,
8124917, 8111126, 8111127,
8111128, 8111129, 8111130, 8111131, 8111133, 8111134, 8111135, 8111136,
8111137, 8111138, 8111141, 8111143,
8111144, 8111145, 8111167, 8111169, 8111170, 8132006, 8132007, 8103983,
8103937, 8103938, 8103942, 6590493,
6590529, 6590530, 8103970, 8103971, 8103976, 8103977, 8103978, 8103979,
8103980, 8103943, 8103945, 8103947,
8103948, 8103949, 8103954, 8103955, 8103958, 8103960, 8103961, 8103963,
6586947, 6586948, 6580882, 6580884,
6580885, and 6580494.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA.
REASON Blood products, which were incorrectly tested for syphilis, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 119 units.
DISTRIBUTION LA, TX, and Switzerland.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 7790422 (distributed as two split products).
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis,
IN.
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 IN.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets
CODE
a) Unit number T11160;
b) Unit number T10314;
c) Unit numbers T11160 and T10314.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Traverse
City, MI.
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.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 0933836.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of
Cincinnati Medical Center, Cincinnati, OH.
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 KY.
PRODUCT
Red Blood
Cells, Leukocytes Reduced.
CODE Unit number 0924469.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of
Cincinnati Medical Center, Cincinnati, OH.
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 OH.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 8446151.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA.
REASON Blood product, that was labeled leukoreduced but had an elevated
white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.
PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 6942917 (distributed as two split products).
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA.
REASON Blood products, that were labeled leukoreduced but had an elevated
white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA.
PRODUCT Red Blood Cells, Pheresis, Leukoreduced,
CODE Units: 18233-5842 (component 04761), 18233-5842 (component 04741).
RECALLING FIRM/MANUFACTURER Blood Systems Inc., Cheyenne, WY.
REASON Blood products, collected from a donor whose medical history
screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WY.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Units 18GN10295, 18GN09949.
RECALLING FIRM/MANUFACTURER American National Red Cross, Great Lakes
Region, Lansing, MI.
REASON Blood products, collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit number 8226541.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA.
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 LA and MI.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
b) Platelets.
CODE a) and b) Unit number 8226542.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Shreveport, LA.
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 LA and MI.
PRODUCT
a) Red Blood Cells (Apheresis), Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced.
CODE a) and b) Unit number FG81581.
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 2 units.
DISTRIBUTION MA.
PRODUCT
Red Blood
Cells, Leukocytes Reduced.
CODE Unit number FG75316.
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 RI.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 5477083.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc. Eastern Maine
Medical Center, Bangor, ME.
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 ME.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit number 8502965.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Alexandria, LA.
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 LA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 8508987 and 8351272.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Alexandria, LA.
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 LA.
PRODUCT Red Blood Cells.
CODE Unit numbers 8351307 and 8149893.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Alexandria, LA.
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 LA and TX.
PRODUCT
a) Fresh Frozen Plasma.
b) Cryoprecipitated AHF.
c) Cryoprecipitated AHF, Pooled.
CODE
a) Unit numbers: 18FJ64991, 18FV53677;
b) Unit numbers: 18FY08852, 18N88603;
c) Unit number: 18GC13058.
RECALLING FIRM/MANUFACTURER American Red Cross, Great Lakes Region,
Lansing, MI.
REASON Blood products, associated with units that contained clots, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION AK and MI.
PRODUCT Platelets.
CODE Unit number: T77028.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood product, associated with a unit of Red Blood Cells that
contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.
PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit L84633.
RECALLING FIRM/MANUFACTURER Virginia Blood Service, Inc., Richmond, VA.
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 2 units.
DISTRIBUTION VA.
PRODUCT
Recovered
Plasma.
CODE Unit number 004GK46858.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England
Region, Dedham, MA.
REASON Blood product, that tested negative for hepatitis, but was
collected from an ineligible donor due to a subsequent disclosure of previous
positive hepatitis testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.
PRODUCT
a) Red Blood Cells.
Platelets.
CODE a) and b) Unit number S49714.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Saginaw, MI.
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 MI.
PRODUCT Recovered Plasma.
CODE Unit number 71H98074-5.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers,
Gainesville, FL.
REASON Blood product collected from an unsuitable donor due to a history
of residing in an area considered at increased risk of exposure to new variant
Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT Recovered Plasma.
CODE Unit 0680168.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center,
San Francisco, CA.
REASON Blood Products, which were negative for all viral markers, but
were collected from a donor whose donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA and Switzerland.
PRODUCT Recovered Plasma.
CODE Unit 33GS41637.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA and CT.
PRODUCT Recovered Plasma.
CODE Unit 33GS41641.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Connecticut Region, Farmington, CT.
REASON Blood products, collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA and CT.
PRODUCT Recovered Plasma.
CODE Unit 18233-5020.
RECALLING FIRM/MANUFACTURER Blood Systems Inc. Cheyenne, WY.
REASON Blood products, collected from a donor whose medical history
screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY and Switzerland.
PRODUCT Red Blood Cells, Leukocytes Removed.
CODE Unit number: LE71662.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba
Rhode Island Blood Center, Providence, RI.
REASON Blood product, that did not have the entire quantity of additive
solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit number T11538.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Traverse
City, MI.
REASON Blood products, collected from a donor with an elevated body
temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI, and TX.
PRODUCT
Red Blood
Cells, Leukocytes Removed, Irradiated.
CODE Unit number: H63292.
RECALLING FIRM/MANUFACTURER Sacramento Medical Foundation, Sacramento,
CA.
REASON Blood product, labeled with the incorrect expiration date, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Washed, Irradiated.
CODE Units V00478, S42242.
RECALLING FIRM/MANUFACTURER Delta Blood Bank, Stockton, CA.
REASON Blood products, washed using expired processing sets, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Platelets, For Further Manufacturing.
CODE Unit 18GN09949.
RECALLING FIRM/MANUFACTURER American National Red Cross, Great Lakes
Region, Lansing, MI.
REASON Blood products, collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets
CODE a) and b) Unit 26115-7302.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc. Fort Smith, AR.
REASON Blood products, collected from an ineligible donor, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AR.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 8118448 and 8118436.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Alexandria, LA.
REASON Blood products, that were labeled leukoreduced but failed quality
control testing due to an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 004FF39194, 004FF39178, 004FF39190, 004FF39201, and
004FF39205.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England
Region, Dedham, MA.
REASON Blood products, that were leukoreduced within the appropriate
time period after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MA.