APRIL 2002
WEEK ENDING APRIL 6
PRODUCT a) Platelets Unit; b) Recovered Plasma.
CODE a) and b) Unit GR08104.
RECALLING FIRM/MANUFACTURER Reading Hospital and Medical
Center, West Reading, PA
REASON Blood products, collected from a donor taking the drug
Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA and MD.
PRODUCT Red Blood Cells.
CODE Unit 5819727.
RECALLING FIRM/MANUFACTURER LifeSource Blood Services,
Glenview, IL
REASON Blood product, collected from a donor who had
traveled to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Platelets, Pheresis, Leukoreduced.
CODE Unit 40P75174.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services,
Heart of America Region, Peoria, IL
REASON Blood product, which may have been stored at
unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 02FG71597, 02FG71571, 02FG71632, 02FG71573,
02FC58602, 02FC58603, 02LE03383, 02LE03387, 02LE03384, 02LE03386, 02FC58604
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Central Plains Region, Wichita, KS
REASON Leukoreduced blood products, that were filtered two
times, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units.
DISTRIBUTION KS.
PRODUCT a) Red Blood Cells; b) Fresh Frozen Plasma.
CODE a) and b) Unit C93817.
RECALLING FIRM/MANUFACTURER Heartland Blood Centers,
Aurora, IL
REASON Blood products, collected from a donor who was at
increased risk for CJD, due to a history of taking insulin injections, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.
PRODUCT Red Blood Cells
CODE Units 19233-3876, 19237-0198, 19238-9590,
19240-9961.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Reno, NV.
REASON Blood products, collected from a donor who was
diagnosed with Nephrotic Syndrome, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NY, TX, IL and NV.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Platelets, Recall # B-0951-2; d) Recovered Plasma.
CODE a) Unit 2130812; b) and c) Unit 2037458; d) Unit
2130812, 2037458.
RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Institute,
Dba Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood products, which tested negative for anti-HCV,
but were collected from a donor who previously tested repeatedly reactive for
anti-HCV, RIBA indeterminate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MO and OK.
PRODUCT Red Blood Cells, Leukoreduced
CODE Units 29FL59852, 29KJ07081, 29FX57038.
RECALLING FIRM/MANUFACTURER American Red Cross, Mid-Atlantic
Region, Norfolk, 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 3 units.
DISTRIBUTION MD.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Frozen Plasma
for Further Manufacture.
CODE a) and b) Unit 53FP35970.
RECALLING FIRM/MANUFACTURER American Red Cross, Greater
Chesapeake and Potomac Region, Baltimore, MD
REASON Blood products, collected from a donor with a
history of having tested positive for Hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD.
PRODUCT Source Plasma
CODE Units 0010641493, 0010620193, 0010613919,
0010612407, 0010609269, 0010614885, 0010604885, 0010605027, 0010605564, 0010605735, 0010606511,
0010607124, 0010607790, 0010608338, 0010610173, 0010610603, 0010615325,
0010615610, 0010616234, 0010616987, 0010617288, 0010618050, 0010618871,
0010619201, 0010619516, 0010620574, 0010621009, 0010626489, 0010638440,
0010641251, 0010641862, 0010642409,
0010642891.
RECALLING FIRM/MANUFACTURER Nabi Biomedical Center, Ft.
Meyers, FL
REASON Blood products, collected from a donor with a
history of having tested positive for Hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE 33 units.
DISTRIBUTION FL and NC.
PRODUCT a) Red Blood Cells; b) Red Blood Cells,
Leukoreduced; c) Fresh Frozen Plasma; d) Recovered Plasma.
CODE a) and c) Unit 15 009-3060; b) and d) Unit 15
010-5622.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Lubbock, TX.
REASON Blood products, collected from a previously deferred
donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX and NY.
PRODUCT Fresh Frozen Plasma.
CODE Units 0678760, 0802089, 0820116, 0678757, 0804122,
0820128, 0802087
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
Cincinnati, OH
REASON Seven units of Platelets, that had been pooled, were
implicated in a transfusion reaction in which the pooled unit was found to be
contaminated
with Staphylococcus, coagulase negative bacteria. Corresponding blood products
were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION OH.
PRODUCT Red Blood Cells.
CODE Unit FX13459.
RECALLING FIRM/MANUFACTURER Gateway Community Blood Program, St. Louis, MO
REASON Blood product, which had an elevated ALT test
result, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MO.
PRODUCT a) Red Blood Cells; b) Plasma, Cryoreduced; c)
Cryoprecipitate AHF, Pooled
CODE a) and b) Unit, 0629832; c) Unit 0524432.
RECALLING FIRM/MANUFACTURER Blood Centers of the
Pacific, San Francisco, CA
REASON Blood products, collected from a donor who was at
increased risk for new variant Creutzfeld-Jakob Disease (nvCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukoreduced.
CODE Unit G00260.
RECALLING FIRM/MANUFACTURER Tacoma-Pierce County Blood
Bank, dba Cascade Regional Blood Services, Tacoma, WA
REASON Blood product, collected from a donor whose
hematocrit/hemoglobin had not been documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.
PRODUCT a) Red Blood Cells; b) Platelets; c) Cryoprecipitate;
d) Fresh Frozen Plasma; e) Recovered Plasma.
CODE a), c) and e) Unit 06GT08456; b) and d) Unit
06GP58249.
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern California Region, Los Angeles, CA
REASON Blood products, which tested negative for anti-HCV,
but were collected from a donor who previously tested positive for anti-HCV,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION CA.
PRODUCT Source Plasma
CODE Unit 31671668.
RECALLING FIRM/MANUFACTURER Nabi BioMedical Center,
Corpus Christi, TX
REASON Blood product, collected from a donor who had not
completed the CJD/nvCJD increased risk questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.
PRODUCT Platelets, Leukoreduced
CODE Unit FK48769.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services
Inc., dba Rhode Island Blood Center,Providence, RI
REASON Blood product, collected from a donor whose
hematocrit/hemoglobin had not been documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.
PRODUCT a) Red Blood Cells for Further Manufacturing; b)
Human Serum
CODE a) Units VF-05986, VF-06225, VF-06612, and VF-06778.
b) Unit VF-05986.
RECALLING FIRM/MANUFACTURER Pyramid Biological
Corporation, Van Nuys, CA
REASON Blood products, which were collected from a donor
who was listed on the California Donor Deferral Registry for testing positive
for an infectious disease, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION NJ and NE.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma.
CODE a), b) and c) Unit 21K25386.
RECALLING FIRM/MANUFACTURER American Red Cross, Pacific
Northwest Regional Blood Services, Portland, OR
REASON Blood products, which were collected from a donor
who admitted to engaging in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OR.
PRODUCT a) Red Blood Cells; b) Cryoprecipitated AHF; c)
Recovered Plasma
CODE a), b) and c) Unit 21KH41204.
RECALLING FIRM/MANUFACTURER American Red Cross, Pacific
Northwest Regional Blood Services, Portland, OR
REASON Blood products, which were collected from a donor
who previously tested positive for the antibody to the hepatitis C virus
encoded antigen (anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OR, CA and Switzerland.
PRODUCT a) Red Blood Cells; b) Plasma.
CODE a) Units 21FL51726, 21FL49281, and 21FL46723; b)
Unit 21FL46723.
RECALLING FIRM/MANUFACTURER American Red Cross, Pacific
Northwest Regional Blood Services, Portland, OR
REASON Blood products, which were collected from a donor
who admitted to engaging in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION OR, WA and Switzerland.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 15-388-3780.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer:
United Blood Services, Lubbock, TX.
REASON Blood product, that failed the red cell recovery
ratio, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukoreduced
CODE Unit 15-387-9343.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ
Manufacturer: United Blood Services, Lubbock, TX.
REASON Blood product, that failed the red cell recovery
ratio, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells
CODE Unit 7310908.
RECALLING FIRM/MANUFACTURER Department of the Airforce,
Lackland AFB, TX
REASON Blood product, which tested initially reactive for
syphilis, was distributed. Confirmatory
testing determined that the unit was non-
reactive
for syphilis.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells
CODE Unit 2124613.
RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH
REASON Blood product, labeled with an extended expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Platelets, Pheresis, Leukocytes Reduced; d) Cryoprecipitated AHF,
Pooled; e) Recovered Plasma.
CODE a) Units R11670, R11672, R11673, R11675, R11676,
R11679, R11681, R11682; b) Units R11680, KZ59382, KZ59383, KZ59384; c) Units
R11671-1, R11671-2, R11674-1, R11677-1, R11677-2, R11678-1; d) Units KZ59382;
pool number P14117; e) Units KZ59382, KZ59383, KZ59384, FJ70472.
RECALLING FIRM/MANUFACTURER The Blood Center of
Southeastern Wisconsin, Inc., Milwaukee, WI
REASON Blood products, not tested according to the
manufacturer’s directions for HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE 23 units.
DISTRIBUTION WI.
PRODUCT Source Plasma
CODE Unit CP-15665.
RECALLING FIRM/MANUFACTURER Pyramid Biological Corp.,
Van Nuys, CA
REASON Blood product, which was collected from a donor
whose health history screening was not adequately performed in that there was
no documentation on the donor history form that a satisfactory arm inspection
was conducted, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.
PRODUCT Recovered Plasma
CODE Units 21FL51726 and 21FL49281.
RECALLING FIRM/MANUFACTURER American Red Cross, Pacific
Northwest Regional Blood Services, Portland, OR
REASON Blood products, which were collected from a donor
who admitted to engaging in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION OR, WA and Switzerland.
WEEK ENDING APRIL 13
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 04KL49450 and 04KL43072.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
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 and NH.
PRODUCT Platelets.
CODE Unit number V42197.
RECALLING FIRM/MANUFACTURER Tacoma-Pierce County Blood
Bank, Cascade Regional Blood Services, Tacoma, WA
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 WA.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Recovered
Plasma.
CODE a) and b) Unit number 04FK21925.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
REASON Blood products that were collected in a manner that
may have compromised the sterility of the products were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MA and CA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 04J27447.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 04FJ35112.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.
PRODUCT a) Platelets Pheresis, Leukocytes Reduced,
Irradiated; b) Platelets Pheresis, Leukocytes Reduced.
CODE a) Unit number 10624-0282; b) Unit number
10705-9517.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
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 AZ.
PRODUCT a) Platelets Pheresis, Leukocytes Reduced,
Irradiated; b) Platelets Pheresis, Leukocytes Reduced.
CODE a) Unit number 10719-9177; b) Unit numbers
10718-3881 and 10721-3150.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
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 AZ.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 10713-4357.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT Capture-P? Test System for the detection of IgG
antibodies to platelets.
CODE Lot number 24015.
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA
REASON Test kit, labeled with the incorrect expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 lot.
DISTRIBUTION Italy, England, Portugal and Germany.
PRODUCT a) Red Blood Cells; b) Platelets; c) Fresh Frozen
Plasma.
CODE a), b) and c) Unit number 33LJ95792.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Connecticut Region, Farmington, CT
REASON Blood products, that tested negative for viral
markers, but were collected from a donor that subsequently admitted to multiple
risk
factors
for increased incidence of infection with human immunodeficiency virus (HIV),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CT.
PRODUCT Fresh Frozen Plasma.
CODE Unit number 10721-4912.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood product, associated with a unit of Red Blood
Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced.
CODE a) Unit number 15008-6865; b) Unit unit numbers
15005-6388, 15012-0938, and 15006-5474.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Lubbock, TX
REASON Blood products, collected from an ineligible donor
due to a history of ulcerative colitis and medication with the drug Asacol,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX and CA.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced.
CODE a) Unit number 15010-1762 (distributed as two split
units); b) Unit number 15386-3499 (distributed as two split units).
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Lubbock, TX
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 TX.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Recovered
Plasma.
CODE a) and b) Unit number 15010-5538.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Lubbock, TX
REASON Blood products, that tested negative for the
antibodies to human immunodeficiency virus (anti-HIV), but were collected from
an ineligible donor due to a history of symptoms associated with HIV infection,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and NY.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 15388-7066 and 15386-8153 (distributed
as 2 split units).
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Lubbock, TX
REASON Blood products, that tested negative for
Cytomegalovirus (CMV), but were collected from a donor who previously tested
CMV positive, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.
PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated
CODE Unit number 4211180C.
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc.,
Anchorage, AK
REASON Platelets with a decreased platelet count were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AK.
PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE Unit number 4211823A.
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc.,
Anchorage, AK
REASON Platelets with a decreased platelet count were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AK.
PRODUCT Human Skin
CODE Unit 02004-001 and 02004-002.
RECALLING FIRM/MANUFACTURER Central Texas Regional Blood
and Tissue Center, Austin, TX
REASON Human Skin, collected from a donor who subsequently
tested positive for antibody to the Hepatitis B core antigen (anti-HBc) by
another tissue procurement organization, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Platelets, Pheresis
CODE Units 7305426 - triple collection.
RECALLING FIRM/MANUFACTURER Manatee Community Blood
Center, Bradenton, FL
REASON Blood products, with an extended expiration date,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION FL.
PRODUCT a) Red Blood Cells, Leukoreduced; b) Red Blood
Cells, Irradiated; c) Red Blood Cells; d) Platelets
CODE a) Units 3766496, 3783247,3690143; b) Unit 3558717;
c) Units 3634313, 3296209, 3153661, 2990884, 2896390, 2855360, 2671789;
d)
Units 3690143, 3634313, 3558717, 3153661, 2896390, 2855360; e) Units 3871294, 3634313,
3558717.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
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 17 units.
DISTRIBUTION TX, NY, FL and NJ.
PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers 9222711A, 9222711B, and 9222711C.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc.,
Scarborough, ME
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 ME.
PRODUCT a) Red Blood Cells; b) Platelets
CODE a) and b) Unit number 0694114.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
University of Cincinnati Medical Center, Cincinnati, OH
REASON Blood products, collected from an ineligible donor
due to medication with the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH and KY.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 12M13817.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected from an ineligible donor
due to a low hemoglobin value, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) and b)Unit numbers 01GJ38388 and 01GJ41651.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, New York-Penn Region, West Henrietta, NY
Manufacturer:
American Red Cross Blood Services, Syracuse, NY.
REASON Blood products, collected from an ineligible donor
due to medication with the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NY and Switzerland.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b) Platelets
CODE a) Unit numbers 01LS30019, 01LS28803, and 01LS27855;
b) Unit numbers 01LS28803 and 01LS27855
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, New
York-Penn Region, West Henrietta, NY
Manufacturer:
American Red Cross Blood Services, Hamburg, NY.
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 5 units.
DISTRIBUTION NY.
PRODUCT a) Red Blood Cells; b) Recovered Plasma
CODE a) and b) Unit numbers 8202458, 8203138, 8204813,
8206392, 8207525, 8047007, and 8051739.
RECALLING FIRM/MANUFACTURER LifeSource Blood Services,
Glenview, IL
REASON Blood products, collected from ineligible donors due
to medication with the drug Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION IL, Switzerland and Scotland.
PRODUCT Red Blood Cells
CODE Unit numbers GX30901, GX35351, and GX37768.
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernadino
and Riverside Counties, San Bernadino, CA
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 CA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 10712-0149.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood product, collected from an unsuitable donor
based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AZ.
PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number GK24900 (distributed as two split
units).
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer:
Tri-Counties Blood Bank, Santa Barbara, CA.
REASON Blood product, that was labeled leukoreduced but was
not tested to determine the white blood cell count as required in the firm's
standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers 10720-0914 and 10720-5518.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood products that were out of controlled storage
for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AZ.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 04FN14410.
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
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 VT.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Cryoprecipitated AHF; c) Recovered Plasma
CODE a), b) and c) Unit number 10626-5833.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Scottsdale, AZ
REASON Blood products, collected from an ineligible donor
due to a history of a human tissue transplant in the previous 12 months, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION AZ and Switzerland.
PRODUCT Recovered Plasma
CODE Unit numbers 15008-6865 and 15006-5474.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Lubbock, TX
REASON Blood products, collected from an ineligible donor
due to a history of ulcerative colitis and medication with the drug Asacol,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX and CA.
PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 15386-8043 (distributed as 2 split
units).
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Lubbock, TX
REASON Blood product, collected on an apheresis machine
where there was no documentation of evaluation of the filter assemblies as
required, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.
PRODUCT Fresh Frozen Plasma
CODE Unit number 20FC14453.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American
National Red Cross, Lewis and Clark Region, Boise, ID
Manufacturer:
American Red Cross Blood Services, Missoula, MT.
REASON Blood product, corresponding to a unit of Red Blood
Cells that may have been bacterially contaminated with Propionibacterium acnes,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MT.
PRODUCT Red Blood Cell
CODE Unit 7138553.
RECALLING FIRM/MANUFACTURER Manatee Community Blood
Centers, Inc., Bradenton, FL
REASON Blood product, labeled with an extended expiration
date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.
PRODUCT Source Leukocytes
CODE Units 3871294, 3634313, 3558717.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood
Center, Houston, TX
REASON Blood products, collected from a donor who reported
travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX, NY, FL and NJ.
WEEK ENDING APRIL 20
PRODUCT a) Red Blood Cells; b) Recovered Plasma.
CODE a) Unit numbers 15005-5707, 15007-7758, 15010-6106,
and 15012-0471; b) Unit numbers 15007-7758 and 15010-6106.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
Lubbock, TX
REASON Blood products, that tested negative for the
antibody to hepatitis C virus (anti-HCV), but were collected from an unsuitable
donor based previous repeatedly reactive testing for anti-HCV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION TX, CA and NY.
PRODUCT a) Red Blood Cells; b) Red Blood Cells, Leukocytes
Reduced; c) Fresh Frozen Plasma.
CODE a) Unit Numbers: 53FE38703, 53FE38710, 53FE38712,
53GF14940, 53GF14941, 53GF14943, 53GF15017, 53GF15018, 53GF15019, 53GF15020,
53GF15021, 53GF15022, 53GF15023, 53GF15024, 53GF15043, 53GF15044, 53GF15045,
53GF15048, 53GF15049, 53GF15063, 53GF15064, 53GF15065, 53GF15066, 53GF15067,
53GF15068, 53GF15087, 53GF15088, 53GF15089, 53GF15090, 53GF15091, 53GF15092,
53GF15132, 53GF15133, 53GF15134, 53L95008, 53L95009, 53L95010, 53L95011, 53L95012,
53FL61648, 53FL61649, 53FL61650, 53FL61651, 53FL61652, 53FL61654, 53FL61655,
53FL61656, 53FL61657, 53FL61658, 53FL61659, 53FL61660, 53FL61662, 53FL61663,
53FL61664, 53FL61665, 53FL61666, 53FL61667, 53FL61668, 53FL61669, 53FL61670,
53FL61671, 53FK40381, 53FK40384, 53FK40385, 53FP11665, 53FP11666, 53FP11667,
53FP11668, 53FL61814, 53FL61834, 53FL61836, 53FL61837, 53FJ43839, 53FJ43840,
53FJ43841, 53FJ43842, 53FJ43843, 53FJ43844, 53FJ43845,
53FJ43847, 53FJ43848, 53FJ43849, 53FJ43850,
53FJ43852, 53FJ43853, 53FJ43854, 53FJ43855, 53FJ43856, 53FJ43857, 53FJ43858,
53FJ43859, 53FJ43860, 53FJ43861, 53FJ43862, 53FJ43863, 53FJ43864, 53FJ43865,
53FJ43867, 53GV21812, 53FJ43905, 53GR10346, 53GR10347, 53Y67539, 53Y67540, 53Y67576, 53Y67577,
53GV21496, 53GV21497, 53GV21498, 53GV21499, 53GV21500, 53GV21501,
53GV21502, 53GV21503, 53GV21504, 53GV21505, 53GV21506, 53GV21510, 53GV21526,
53GV21527, 53FP11410, 53FM16938, 53FM16939, 53FM16940, 53FM16941,
53M68875, 53M68876, 53M68877,
53M68878, 53M68879,
53M68880, 53FN36829, 53FN36832,
53FJ43517, 53FJ43518, 53FJ43519, 53FJ43520, 53FJ43521, 53FJ43522, 53FJ43531,
53FJ43532, 53FJ43533, 53FJ43534, 53FJ43535, 53FJ43536, 53FJ43537, 53FJ43538,
53FJ43539, 53FJ43541, 53FJ43542, 53FJ43543, 53FJ43544, 53FJ43545, 53FJ43546,
53FJ43553, 53FJ43554, 53FJ43555, 53FJ43602, 53FJ43603, 53FJ43604, 53GQ55535,
53T44878, 53T44879, 53GC08568, 53GL88735, 53GL88740, 53GL88742,
53GL88745, 53GL88746, 53GL88747, 53GC08566, 53GC08569, 53GC08572, 53GC08573,
53GC08574, 53FE37524, 53Z17569,
53Z17570, 53Z17571,
53Z17572, 53Z17573, 53Z17574,
53FL60442, 53FL60443, 53FL60445, 53LL27415, 53LL27416, 53LL27417,
53LL27418, 53LL27419, 53LL27420, 53LL27421, 53LL27425, 53LL27426, 53FJ41836,
53FJ41837, 53FJ41838, 53FJ41839, 53FJ41840, 53FJ41841, 53FJ41842, 53FJ41843,
53FJ41844, 53FJ41857, 53FJ41858, 53FJ41859, 53FJ41860, 53FJ41861, 53FJ41862,
53FJ41863, 53FJ41864, 53FJ41865, 53FJ41866,
53FJ41867, 53FJ41868, 53FJ41869, 53FJ41870, 53FJ41871, 53FJ41872, 53FJ41873,
53FJ41874, 53FJ41875, 53FJ41876; b) Unit numbers 53GF14939, 53GF14942,
53Y67541, 53Y67575; c) Unit numbers 53GF15022, 53GF15043, 53GF15047, 53GF15063,
53FJ43862, 53GV21498, 53GV21500, 53M68875,
53FJ43532, 53GC08568, 53GL88742, 53GC08569, 53LL27422, 53FJ41842, 53FJ41859, 53FJ43847, 53FN36829.
RECALLING FIRM/MANUFACTURER American Red Cross, Greater
Chesapeake and Potomac Region,
Baltimore, MD
REASON Blood products, that were produced from 500 ml units
of Whole Blood that were collected in 450 ml bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 237 units.
DISTRIBUTION MD, VA, DC, PA, GA and Puerto Rico.
PRODUCT a) Platelets, Pheresis; b) Platelets, Pheresis,
Leukocytes Reduced.
CODE a) Unit 7415061, 7415078, 7304965-1, 7304965-2; b)
Unit 7415111, 7415169, 7415285.
RECALLING FIRM/MANUFACTURER Manatee Community Blood
Centers, Inc., Bradenton, FL
REASON Platelets, that exceeded the manufacturer’s
recommendation for platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION FL, NY and PA.
PRODUCT a) Red Blood Cells, Leukocytes Reduced; b)
Platelets, Leukocytes Reduced.
CODE a) and b) Unit 42T01458.
RECALLING F