MARCH 2006
WEEK ENDING MARCH 4
PRODUCT
Human Tissue for
Transplantation
a) Tricortical Wedge (R) 1.5 x 2.5 cm, Freeze Dried Irradiated;
b) Tricortical Wedge ( L ) 1.7 x 3.0 cm,
Fresh Frozen Irradiated;
c) Cancellous Crushed 60.0 cc, Freeze Dried, Irradiated;
d) Cancellous Crushed 30.0 cc Freeze Dried,
Irradiated;
e) Achilles Tendon OA ( R ) Fresh Frozen Irradiated;
f) Achilles
Tendon OA ( L ) Fresh Frozen Irradiated;
g) Lumbar;
h) Cancellous
Crushed 30.0 cc Fresh Frozen, Irradiated
CODE
a) Tissue
04091-002;
b) Tissue 04113-003;
c) Tissues 04091-008, 04101-008,
04103-002, 04103-003, 04105-003;
d) Tissues 04091-005, 04091-006,
04091-007, 04101-006, 04101-007, 04102-004, 04102-005,
04104-003,
04104-004, 04104-005, 04105-002, 04109-003, 04109-004, 04120-004, 04124-003,
04124-004, 04138-002, 04138-003, 04140-002, 04143-002, 04143-003,
04146-001, 04152-001;
e) Tissues 04101-003, 04123-004;
f) Tissues
04101-004, 04123-003;
g) Tissues 03049-001, 03051-001, 04091-001, 04102-001, 04103-001, 04104-001, 04105-001,
04106-001, 04107-001,
04108-001, 04109-001, 04113-001, 04120-001, 04122-001, 04123-001,
04124-001;
h) Tissue 04108-002
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Central Texas Regional Blood
& Tissue Center, Austin, TX
Manufacturer: Biomedical Tissue Services,
Fort Lee, NJ
REASON Human
tissues, procured from donors without adequate donor eligibility determinations,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 51
allografts
DISTRIBUTION TX and CO
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells Leukocytes
Reduced
CODE
a) Unit number: 6593705;
b) Unit numbers: 9020193,
6596488
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood products, collected from a donor who visited
a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION CO and NC
PRODUCT Human Corneal Tissues
for Transplantation
CODE Tissues: CI044108 OD
and CI044108 OS
RECALLING FIRM/MANUFACTURER Michigan Eye Bank, Ann
Arbor, MI
REASON Human Corneas,
collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 tissues
DISTRIBUTION MI, CA and Germany
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number:
9042712
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood product, collected from a donor who visited
a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MS
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Unit number:
04FP77650
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
REASON Platelets, possibly
contaminated with Micrococcus species, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION MD
PRODUCT
a) Red Blood Cells
b) Whole
Blood
CODE
a) Unit
number: 1067760;
b) Unit number 1086845
RECALLING
FIRM/MANUFACTURER Northwest Florida Blood Center, Inc., Pensacola, FL
REASON
Blood products, which tested negative for the
antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II), but
were collected from an ineligible donor due to previous positive testing for
anti-HTLV-I/II, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION FL
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Red Blood Cells (Apheresis)
Leukocytes Reduced (distributed as split product)
c)
Platelets Leukocytes Reduced
d) Fresh Frozen Plasma
e) Cryoprecipitated
AHF
f) Plasma
Cryoprecipitate Reduced
g) Recovered Plasma
CODE
a) Unit numbers: 1136792, 1040212, 1011245;
b)
Unit numbers: 1048247-1, 1048247-2;
c) Unit numbers: 1040212, 1011245;
d)
Unit number: 1136792;
e) Unit numbers: 1040212, 1011245;
f) Unit number:
1040212;
g) Unit number: 1011245
RECALLING
FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH
REASON Blood
products, collected from a donor considered to be at increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 12 units
DISTRIBUTION OH and FL
PRODUCT Red Blood Cells
CODE
Unit number: 7836225
RECALLING
FIRM/MANUFACTURER Southeastern Community Blood Center, Tallahassee, FL
REASON
Blood product, collected from a donor who visited
a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number:
04KS96130
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
REASON Blood product,
collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION VT
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number:
04T40641
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
REASON Blood product,
collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MA
PRODUCT Source Plasma
CODE
Unit number: ST0870043
RECALLING
FIRM/MANUFACTURER Stillwater Plasma Center, LLC, Stillwater, OK
REASON
Blood product, which was untested for human
immunodeficiency virus (HIV) by the nucleic acid test (NAT0 method, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Germany
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number:
04LJ24645
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
REASON Blood product,
collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MA
PRODUCT Platelets Pheresis
Leukoreduced
CODE Unit numbers:
04GP60728
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
REASON Blood products,
collected from a donor who visited a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2 unit
split
DISTRIBUTION MA
PRODUCT Red Blood Cells
CODE
Unit number: 9206958
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Life Source, Glenview, IL
Manufacturer:
Life Source Westmont,
Westmont, IL
REASON Blood
product, collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION IL
PRODUCT Recovered Plasma
CODE
Unit number: 11FH01193
RECALLING
FIRM/MANUFACTURER American National Red Cross, Missouri-Illinois Region,
St. Louis, MO
REASON Blood product, collected from a donor who provided
post donation information regarding multiple high-risk behaviors, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Red Blood Cells Pheresis,
Leukocytes Reduced
c) Red Blood Cells, Leukocytes
Reduced, Irradiated
d) Fresh Frozen Plasma
CODE
a) Unit numbers: 11337-1547, 11339-2345, 11339-2346,
11339-1681, 11338-8736, 11339-2833, 11339-2834, 11339-6274, 11339-6275,
11339-6277, 11339-6280, 11338-8799;
b) Unit numbers: 11339-2494 (parts 1
& 2);
c) Unit numbers: 11337-1540, 11339-1780;
d) Unit numbers:
11337-1540, 11337-1547, 11339-2345
RECALLING
FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX
REASON Blood products, collected from donors for whom
donor suitability was not adequately determined, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 19 units
DISTRIBUTION NM, TX, and
Switzerland
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number:
2170881
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center,
Inc., Lexington, KY
REASON Blood product, corresponding to a unit of
platelets contaminated with Propionibacterium acnes, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION KY
PRODUCT Source Plasma
CODE
Unit numbers: BFVFDK, BFTMSM, BFTLZK, BFTHBT, BFTGTW, BFTFXW, BFSFLB
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Inc.,
Fort Worth, TX
REASON Blood products, collected from a donor whose donor
suitability was not adequately determined, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 7 units
DISTRIBUTION IL and Germany
PRODUCT Fresh Frozen Plasma
CODE
Unit number: 55J48091
RECALLING
FIRM/MANUFACTURER American National Red Cross, Greater Ozarks-Arkansas
Region, Little Rock, AR
REASON Blood product, prepared from a whole blood unit
with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION AR
PRODUCT Recovered Plasma
CODE
Unit numbers: 11338-8736, 11339-1681, 11339-1780,
11339-2833, 11339-2834
RECALLING FIRM/MANUFACTURER Blood Systems,
Inc., El Paso, TX.
REASON Blood
products, collected from donors for whom donor suitability was not adequately
determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION NM, TX, and Switzerland
WEEK ENDING MARCH 11
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
11339-4665
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El
Paso, TX
REASON Blood product, manufactured from a unit of Whole
Blood that was designated as a low volume collection, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NM
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
113469013
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX
REASON
Blood product, manufactured from an unsuitable
donor based on travel to an area considered endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Red Blood Cells,
Apheresis, Leukocyte Reduced
CODE Unit: 11347347
(Bags 1 & 2)
RECALLING FIRM/MANUFACTURER Blood Systems, Inc.,
El Paso, TX
REASON Blood products, collected from a donor whose
medical history screening was incomplete, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION NM
PRODUCT Platelets, Leukocytes
Reduced
CODE Unit: 49GV26362
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southwest Region, Tulsa, OK
REASON
Blood product associated with
a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
4204008
RECALLING FIRM/MANUFACTURER Southeastern Community Blood
Center, Tallahassee, FL
REASON Blood product, collected from a donor
who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
11342-1675
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El
Paso, TX
REASON Blood product, collected from a donor who visited
a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NM
PRODUCT Red Blood Cells,
Apheresis
CODE Unit: GV76365
RECALLING
FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Blood product, with a hemoglobin below the
acceptable range, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
06FS82042
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Southern California Region, Pomona, CA
REASON Blood
product, collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
04LQ35545
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
REASON Blood product,
collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT
a) Red Blood Cells
b) Cryoprecipitated
AHF
c) Fresh
Frozen Plasma
CODE a), b), and c) Unit:
53C03234
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Chesapeake and Potomac Region, Baltimore, MD
REASON Blood
products, collected from a donor who had been deferred after receiving a blood
transfusion, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION MD and D.C.
PRODUCT Source Plasma
CODE
Unit: WSG009430
RECALLING
FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX
REASON Blood product,
collected from a donor in which donor suitability was not adequately determined,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Spain
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Units: 21FP24437,
21FP24438, 21KT00990, 21KT00993
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southwest Region, Tulsa, OK
REASON
Platelets, which were not stored under continuous
agitation and controlled temperature, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 4 units
DISTRIBUTION TX
PRODUCT Platelets Pheresis,
Leukocytes Reduced Irradiated
CODE Unit:
S56514
RECALLING FIRM/MANUFACTURER HCSC-Blood Center, Bethlehem, PA
REASON
Blood product, quality control tested with expired
reagent, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red Blood Cells
Leukocytes Reduced Irradiated
CODE Unit: D145521
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
REASON Blood product, out of controlled storage for 90 minutes,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WA
PRODUCT Platelets Pheresis Leukocytes
Reduced
CODE
Units: 38GP23754 (2 units),
38GP23774, 38GP23775
(2 units),
38GP23786 (2 units),
38P98742 (2 units),
38P98744 (2
units),
38P98750 (2 units),
38P98753 (2 units),
38P98770 (2
units),
38P98784 (2 units),
38P98792 (2 units),
38P98801 (2 units),
38P98811 (2 units),
38P98812 (2 units),
38P98820 (2 units),
38P98846 (2 units),
38P98870 (2 units),
38P98872, 38P98878 (2
units),
38P98880 (2 units),
38P98896 (2 units)
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region,
Fort Wayne, IN
REASON Blood products, with un-verified platelet counts,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 40
units
DISTRIBUTION IN and OH
WEEK ENDING MARCH 18
PRODUCT
Source Plasma
CODE Units: 390026474, 390026862, 390027539, 390027961,
390028191, 390028598, 390028885, 390033114, 390034877
RECALLING
FIRM/MANUFACTURER Biomat USA, Inc., Houston , TX
REASON
Blood products, collected from an ineligible donor, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION Spain
PRODUCT Source Plasma
CODE Units: 390023514, 390023791, 390032331, 390032554,
390033079, 390033363, 390033574
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston , TX
REASON Blood
products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION Spain
PRODUCT Red Blood Cells, Leukocytes
Reduced
CODE Unit: 011GR53659
RECALLING
FIRM/MANUFACTURER American National Red Cross, Missouri-Illinois
Region, St, Louis, MO
REASON Blood product, collected from a donor in which donor suitability
was not adequately determined, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MO
PRODUCT
a) Red Blood
Cells
b) Platelets, Leukocytes Reduced
c) Fresh Frozen Plasma
CODE
a) Unit numbers:
7963144, 7963155, 7963151, 7963148, 7963449, 2242167, 7963430, 7963437,
7963147;
b) Unit numbers 7963144, 7963148, 7963151, 7963155, 2242167;
c) Unit numbers: 7963144, 7963155, 2242167
RECALLING
FIRM/MANUFACTURER Life Source, Glenview , IL
REASON
Blood products, collected from donors whose health history
screening was inadequately performed, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 17 units
DISTRIBUTION IL and PA
PRODUCT Red Blood
Cells
CODE Unit number: S27452
RECALLING
FIRM/MANUFACTURER Central Illinois Community Blood Center ,
Springfield , IL
REASON Blood product,
collected from an unsuitable donor based on travel to an area considered endemic
for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION IL
PRODUCT
a) Red Blood
Cells
b) Red Blood Cells Leukocytes Reduced
c)
Platelets Leukocytes Reduced,
CODE
a) Unit number: 0869833;
b) Unit numbers: 0958904, 0951844,
0927972, 0899403;
c) Unit numbers: 0951844, 0927972, 0899403
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center ,
Cincinnati , OH
REASON Blood products, collected from a donor
who had emigrated from a country with malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION OH, IN, and KY
PRODUCT Red Blood Cells
(Apheresis) Leukocytes Reduced
CODE Unit number:
1158274 (half of double unit)
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center , Cincinnati , OH
REASON
Blood product, corresponding to a red cell apheresis unit which was
contaminated with alpha hemolytic streptococcus and involved in a transfusion
reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION
OH
PRODUCT Platelets
Pheresis
CODE Unit number: 71X17854X
RECALLING
FIRM/MANUFACTURER Life South Community Blood Center , Gainesville ,
FL REASON Blood product, with platelet count below the
specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Red Blood Cells Leukocytes
Reduced
CODE Unit number: 11GR63308
RECALLING
FIRM/MANUFACTURER The American National Red Cross, St. Louis , MO , REASON
Blood product, collected from a donor who visited a malarial
endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Red Blood Cells Leukocytes Reduced Irradiated
CODE
a) Unit number: 9528228;
b)
Unit number: 9527635
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center , Indianapolis , IN
REASON Blood products, collected from a donor who
visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 2 units
DISTRIBUTION IN
PRODUCT Red Blood
Cells
CODE Unit number: 4204010
RECALLING
FIRM/MANUFACTURER Southeastern Community Blood Center , Tallahassee
, FL
REASON Blood product, collected
from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Red Blood Cells
c) Fresh
Frozen Plasma
d) Recovered Plasma
CODE
a) Unit numbers: 55F01528, 55F03960,
55FK23434, 55FS07462, 55H00925, 55H03154, 55H74102, 55H80233, 55H81837,
55H95935, 55S17518, 55Y24058;
b) Unit numbers: 55F61764, 55F69702,
55FK03764, 55H43559, 55H45157, 55H53538, 55H55345, 55H61731, 55R05615,
55R92515, 55R96469, 55S81623, 55S98344;
c) Unit numbers: 55F01528,
55FK23434;
d) Unit numbers: 55F03960, 55H00925, 55H03154, 55H95935
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Ozarks-Arkansas Region, Little Rock , AK
REASON
Blood products, collected from a donor
with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 31 units
DISTRIBUTION KY, AR,
TN and MO
PRODUCT
Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers: 55FM09792
(parts 1 & 2)
RECALLING FIRM/MANUFACTURER The
American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AK
REASON Platelets, which were possibly contaminated with
Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION AR
PRODUCT
Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 55P45338
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Ozarks-Arkansas Region, Little Rock, AK
REASON
Platelets, which were possibly contaminated with gram-negative
bacilli, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION
AR
PRODUCT
Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 55FP26004
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Ozarks-Arkansas Region, Little Rock, AK
REASON
Platelets, which were possibly contaminated with coagulase negative
Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION AR
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit number: 1410880
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood
Center, Inc., Amarillo , TX
REASON Blood product, labeled with
an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT
a) Red Blood Cells
b) Platelets
CODE
a) Unit numbers: 19GF27969, 19GF30466;
b) Unit number: 19GF30466
RECALLING FIRM/MANUFACTURER American National Red Cross, Tennessee Valley Region, Nashville ,
TN
REASON Blood products, collected from a donor who
emigrated from an area with increased risk for human immunodeficiency virus
(HIV) Group O, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION TN
PRODUCT
Red Blood Cells Pheresis
CODE Unit numbers: S49169, S49160
RECALLING FIRM/MANUFACTURER HCSC Blood Center ,
Bethlehem , PA ,
REASON Blood products, which failed quality
control specifications, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION PA
PRODUCT
Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 49FP18213 (part 2)
RECALLING FIRM/MANUFACTURER American National Red
Cross, Southwest Region, Tulsa , OK
REASON Blood product,
associated with a unit of Platelets that was possibly contaminated with
Staphylococcus epidermidis, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit number: S34191
RECALLING FIRM/MANUFACTURER Central Illinois Community
Blood Center , Springfield , IL
REASON Blood
product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION IL
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit number: 12K97726
RECALLING
FIRM/MANUFACTURER American National Red Cross, Carolinas Region,
Charlotte , NC
REASON Blood
product, collected from an unsuitable donor who had lived in an area considered
endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION NC
PRODUCT
a) Red Blood
Cells
b) Platelets
CODE a) and b) Unit
number: 36GQ13948
RECALLING FIRM/MANUFACTURER American
National Red Cross, South Carolina Region, Columbia , SC
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 GA and SC
PRODUCT Source Plasma
CODE Unit number: F-04346-072
RECALLING
FIRM/MANUFACTURER Alpha Therapeutic Corporation, Long Beach , CA
REASON
Blood product,
collected from a donor whose suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT
Cryoprecipitated AHF
CODE Unit number: 18FK93076
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing , MI
REASON
Blood product, prepared from
a whole blood unit with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI
PRODUCT
Recovered Plasma
CODE Unit numbers: 7963151, 7963148, 7963449, 7963430,
7963437, 7963147
RECALLING FIRM/MANUFACTURER Life
Source, Glenview , IL
REASON Blood products, collected
from donors whose health history screening was inadequately performed, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION Switzerland
PRODUCT
Source Plasma
CODE Unit numbers: 390026314, 390026908, 390029376,
390033936, 390034379, 390034585
RECALLING FIRM/MANUFACTURER
Biomat USA Inc., Houston , TX
REASON Blood products,
collected from a donor with an incomplete medical history, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION Spain
PRODUCT
Fresh Frozen Plasma (Apheresis)
CODE Unit numbers: 16GJ32136, 16KF46738,
16KF46747, 16KF46753, 16KF46770, 16KF46772, 16KF46806, 16KF46807
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Western Lake Erie Region, Toledo OH
REASON
Blood products, for which shipping conditions
were undocumented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION OH
PRODUCT
Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 49GP23872
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Southwest Region, Tulsa , OK
REASON Blood product,
which 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 1 unit
DISTRIBUTION TX
PRODUCT
Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6884226
RECALLING
FIRM/MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo , TX
REASON Blood product, possibly out of controlled
storage for more than 30 minutes during leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT
a)
Platelets
b)
Platelets, Irradiated
c) Cryoprecipitated AHF
d) Plasma
e) Plasma, Cryoprecipitate
Reduced,
f) Fresh Frozen Plasma
CODE
a) Unit numbers: 20LC35558, 20LY24982, 20J20759, 20M12427, 20V10216, 20E18737,
20L08344, 20L03871, 20LY25179,
20E24984, 20S16574, 20J23542, 20J31644, 20LC40479,
20LC42494, 20LC31887,
20S16175, 20W07749, 20Q06637, 20S18274, 20S19396, 20S20015,
20H22832,
20L05558, 20L10916, 20S20043;
b) Unit numbers: 20S16784, 20X06239;
c)
Unit numbers: 20GM66644, 20GM52701, 20GC09770, 20GM47396, 20GM54517, 20GC11924, 20V66336, 20GZ06587, 20GM60477, 20GZ06044,
20GM47217,
20GM47402, 20GZ14241
d) Unit numbers: 20GM47217, 20GM47396, 20GZ06044, 20GZ06587, 20GC09770, 20GM47402
e) Unit numbers: 20GM54517, 20GM66644,
20GC17095, 20GM52701, 20GZ14241, 20V66336
f) Unit numbers: 20S08009,
20E24984, 20S07006, 20J36485, 20K18675, 20S07859, 20S11028,
20T14251,
20X06239, 20K42128, 20S21398, 20W07862, 20GM56473, 20GM58995, 20GM66973, 20H45488, 20K35169, 20LC30798, 20T09180,
20LZ13098, 20K42415, 20Q16012,
20S16175, 20S16784, 20T13848, 20V29639, 20LC40479, 20LC42013, 20LC33359,
20GC10404, 20E17407, 20E20592, 20J22920, 20J24981, 20J35933, 20J47822,
20K21758, 20K66139, 20L03871, 20L08344, 20L08628, 20L11138, 20M08108, 20M10263, 20M10324, 20Q16011, 20S08862,
20S13057, 20S14546, 20S16574,
20S16850, 20S18274, 20S20043, 20S30521, 20T09509, 20V06863, 20V10216,
20V13835, 20V17474, 20H46307, 20W07753, 20LC42757, 20H23105, 20J19522,
20K39551, 20S11390, 20T39028, 20LS04670, 20K42979, 20LC31887, 20LC33589, 20LS04008, 20M23936, 20LC38741, 20LC41859,
20LC63078, 20LY24982,
20LY25179, 20L09196, 20K35154, 20LC35558, 20S20015, 20W07750,
20J23542,
20K21295, 20L10916, 20M12427, 20S16776, 20S27273, 20S49460, 20V06033,
20M15052, 20T09548
RECALLING FIRM/MANUFACTURER American National Red Cross, Lewis and Clark Region, Boise , ID
REASON
Blood products, prepared from whole
blood units with a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 146 units
DISTRIBUTION AZ, CA, ID, MT, NY, OR, and UT
PRODUCT
Platelets
CODE Unit number: 9421376
RECALLING
FIRM/MANUFACTURER Community Blood Centers of South Florida, Inc.,
Lauderhill , FL
REASON Blood product, which tested negative
for the antibody to the human immunodeficiency virus (anti-HIV), but was
collected from a donor who previously tested repeatedly reactive for HIV and
negative by Western blot test, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NY
WEEK ENDING MARCH 25
PRODUCT Red Blood Cells
Deglycerolized
CODE Unit number:
71N112433
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Center, Gainesville, FL
REASON Blood product, which was not deglycerolized in
accordance with specifications, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION FL
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit number:
6908785
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center
Inc., Amarillo, TX
REASON Blood product, collected from a donor whose
suitability to donate was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT Red Blood Cells,
Apheresis, Leukocytes Reduced
CODE Unit
numbers: 12KT28263 (Bag 1 and 2)
RECALLING
FIRM/MANUFACTURER American National Red Cross, Carolinas Region,
Charlotte, NC
REASON Blood products,
collected from an unsuitable donor who had traveled to an area considered
endemic for malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION NC
PRODUCT Source Plasma
CODE
Unit number: 04FNCB8494
RECALLING
FIRM/MANUFACTURER BioLife Plasma Services L.P., Fayetteville, NC
REASON
Blood product, not properly quarantined after the
receipt of post donation information related to a recent tattoo and piercing,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT Platelet pheresis,
Leukocytes Reduced (Part 2)
CODE Unit number:
03LY14644
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern Region, Atlanta, GA
REASON Plateletpheresis, with an elevated platelet count, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Source Plasma
CODE
Unit numbers: JK0004400, JK0004648, JK0004935,
JK0005720, JK0006527, JK0007402, JK0007703, JK0009410, JK0009579, JK0010225,
JK0010491, JK0011168, JK0011415, JK0011958, JK0012154
RECALLING
FIRM/MANUFACTURER DCI Biologicals Orlando LLC, Jacksonville, FL
REASON
Blood
products, collected from a donor who had not had an annual physical performed,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 15
units
DISTRIBUTION NC
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
c) Red Blood Cells,
Apheresis, Leukocytes Reduced
CODE
a) Unit number: 042GF00934;
b) Unit number:
042FC17808;
c) Unit numbers: 042C18461 and 042C18462 (split unit)
RECALLING FIRM/MANUFACTURER American National Red Cross, Northern
Ohio Region, Cleveland, OH
REASON Blood products, which were incorrectly tested for syphilis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION OH
PRODUCT Fresh Frozen Plasma
CODE
Unit number: W001605002207
RECALLING
FIRM/MANUFACTURER Department of the Air Force, 88th Medical Group/SGQC,
Wright Patterson AFB, OH
REASON Blood product, mislabeled as to ABO/Rh, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT
a) Red Blood Cells
b) Recovered
Plasma
CODE a) and b) Unit number: 7271261
RECALLING
FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood products, collected from a donor who
provided post donation information regarding multiple high-risk behaviors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA and IL
PRODUCT Fresh Frozen Plasma
CODE
Unit numbers: 55C04664, 55C04757, 55C04758,
55R59723
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Ozarks-Arkansas Region, Little Rock, AK
REASON Blood products, stored at an unacceptable
temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION AR
PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
c) Red Blood Cells, Leukocytes Reduced
Irradiated
d) Red Blood Cells, Apheresis, Leukocytes Reduced
e) Platelets, Leukocytes Reduced,
f) Fresh
Frozen Plasma
CODE
a) Unit numbers: 042GQ03072,
042GW02051, 042GW02055, 042GF00933, 042GQ03068, 042GQ03071,
042GW02056, 042GF00932, 042GQ03070, 042GW02049, 042GQ03067, 042GQ03073,
042GW02053, 042GW02052, 042GW02050, 042GW02054, 042GF00931;
b) Unit
numbers 042FF92662, 042FF92675, 042FF92708, 042FF92709, 042FF92710,
042FF92711, 042GC14448, 042L23763, 042L23818, 042L23820, 042L23824,042L23825, 042L23826, 042L23835, 042M15910,
042FF92666, 042FF92670,
042FF92673, 042FF92705, 042FF92716, 042FF92717, 042FF92720, 042FF92724, 042FG14523, 042FG14537, 042FH37221, 042FH37223,
042FP08123, 042FP08127,
042FQ23477, 042FX41613, 042FX41616, 042GC14449, 042GC14451,
042GC14459, 042GC14475, 042GC14478, 042GC14483, 042GC14484, 042GC14487,
042GS05747, 042GS05748, 042GS05749, 042GS05750, 042GS05751, 042GS05755,
042GS05758, 042GS05759, 042H45085, 042H45088, 042H45097, 042H45102,
042H45104, 042H45105, 042H45106, 042H45107, 042H45116, 042H45118, 042L23749, 042L23792, 042L23794, 042L23798, 042L23805,
042L23806, 042L238070,
42L23808, 042L23810, 042L23811, 042L23819, 042L23821, 042L23822, 042L23827, 042L23828, 042L23829,
042L23830,042L23833, 042L23837,
042M15914, 042R81015, 042R81017, 042R81022, 042R81023, 042R81027,
042R81032, 042R81035, 042R81036, 042R81037, 042R81040, 042S07657,
042S07661, 042S07662, 042S07663, 042S07668, 042S07670, 042S07674, 042S07681, 042S07682, 042L23746, 042X05722,
042X05725, 042X05726,
042X05729, 042G55415, 042FY62172, 042GS05764, 042X05696, 042F61478, 042FF92683, 042FF92712, 042GS05761, 042R81031,
042R81038, 042X05632,
042X05633, 042X05643, 042FP08142, 042FX41611, 042T35758, 042T35765, 042X05634, 042X05636, 042X05639, 042FH37233,
042GC14469, 042GS05760,
042GS05763, 042GS05765, 042H45103, 042L23836, 042R81029, 042S07730, 042X05721, 042H45100, 042L23785, 042FC17800,
042FC17802, 042FC17807,
042FC17818, 042FG14548, 042FG14550, 042FQ23466, 042FQ23479, 042FX41612, 042FX41614, 042H45092, 042H45101, 042L23751,
042L23831, 042S07689,
042FF92676, 042FG14528, 042FG14531, 042FG14536, 042GC14485,
042GC14486, 042GS05742, 042L23755, 042R81039, 042S07673, 042H45117,
042L23780, 042FY62166, 042FY62173, 042F61476, 042F61477, 042F61482,
042FC17793, 042FC17799, 042FC17816, 042GS05739, 042GS05757, 042H45110,
042H45111, 042L23743, 042L23744, 042L23745, 042L23747, 042L23773, 042L23779, 042L23783, 042L23786, 042R81014, 042R81021,
042FY62170, 042FC17796,
042FC17797, 042FC17803, 042FC17805, 042FC17806, 042FC17809, 042FC17815, 042FC17817, 042FF92672, 042FF92674, 042FF92677,
042FP08145, 042FQ23468,
042FQ23473, 042FQ23475, 042GS05753, 042GS05754, 042H45093, 042H45119, 042L23760, 042L23764, 042L23767, 042S07728,
042S07729, 042S07732,
042T35754, 042T35756, 042T35759, 042T35761, 042T35764, 042X05705, 042X05706, 042X05707, 042X05710, 042X05711,
042X05723, 042X05730,
042FJ31992, 042FJ31998,
042FJ32002, 042FJ32003, 042FJ32006, 042FJ32008, 042FH37219, 042FH37222, 042FH37226, 042FH37234,
042GC14488, 042GS05744,
042H45096, 042H45109, 042L23788, 042L23801, 042L23809, 042L23812, 042S07664, 042FJ32001, 042FY62164, 042FF92682,
042FF92685, 042FF92686,
042FG14520, 042FG14530, 042FH37218, 042FP08119, 042FP08122, 042FP08126, 042FP08129, 042FP08137, 042FQ23488, 042FQ23489,
042FX41606, 042GC14465,
042H45091, 042H45108, 042L23816, 042R81024, 042S07666, 042X05647, 042X05649, 042X05650, 042G55406, 042G55408,
042G55409, 042G55413,
042G55416, 042FF92681, 042FQ23487, 042L23757, 042S07669, 042L23759, 042FH37214, 042FH37229, 042G55426, 042FF92667,
042FF92678, 042FF92680,
042L23775, 042F61481, 042FH37236, 042FQ23471, 042L23776, 042L23778, 042L23790, 042S07686, 042S07687, 042S07688,
042X05642, 042FJ32011,
042G55421, 042T35748,
042FY62167, 042FY62168, 042FC17819,
042GS05740, 042FG14551, 042FG14553, 042FG14554, 042FG14555, 042FQ23470,
042FQ23472, 042FQ23474, 042FQ23478, 042FQ23483, 042FQ23485, 042FQ23486,
042H45112, 042H45120, 042H45121, 042L23748, 042L23761, 042M15919,
042S07676, 042G55405, 042G55410, 042G55414, 042G55418, 042G55422, 042G55423, 042G55425, 042FP08138, 042FP08139, 042FQ23465,
042FQ23481, 042S07721,
042S07731, 042X05704, 042X05709, 042X05712, 042X05717,
042X05718, 042X05621, 042FG14521, 042GC14473, 042GS05756, 042L23834,
042S07672, 042X05600, 042X05605, 042X05610, 042X05617, 042X05618, 042X05620, 042X05626, 042T35729, 042T35738, 042T35745,
042T35750, 042H45114,
042G55407, 042G55420, 042FH37220, 042FP08121, 042FP08125,
042FP08128, 042FP08132, 042GC14466, 042H45086, 042H45090, 042H45095,
042H45099, 042L23777, 042L23787, 042L23815, 042R81026, 042X05604, 042X05606, 042X05614, 042X05627, 042X05637, 042X05644,
042G55419, 042T35752,
042FF92719, 042FG14524, 042FG14525, 042FG14529, 042FH37227, 042FH37231, 042FH37235, 042L23756, 042S07667, 042X05631,
042T35731, 042T35747,
042FF92663, 042FF92664, and 042FF92722;
c) Unit number: 42F61481;
d)
Unit numbers: 042C18457 (split unit), 042C18458 (split unit), 042C18459
(split unit), 042C18463
(split unit), 042C18466 (split unit), 042Y47001, 042C18465, (split unit), 042E52663 (split unit),
042E52667 (split unit),
042C18464 (split unit), 042E52655 (split unit), 042Y47000 (split unit),
042Y47002, 042E52657 (split unit), 042E52661 (split unit), 042C18467
(split unit), 042E52666,
and 042E52662;
e) Unit numbers 042FX41606,
042FX41613, 042FX41614, 042FX41616, 042GS05747, 042GS05748,
042GS05754, 042GS05757, 042GS05764, 042X05607, 042X05609, 042X05611,
042X05615, 042X05617, 042X05618, 042X05619, 042X05620, 042X05623, 042X05625, 042X05628, 042X05629, 042X05630, 042X05631,
042X05632, 042X05633,
042X05634, 042X05636, 042X05637, 042X05638, 042X05639, 042X05641, 042X05644, 042X05645, 042X05648, 042T35729,
042T35738, 042T35745,
042T35750, 042F08143, 042F41609, 042G05762, 042X05709, 042X05717, 042X05719, 042F41612, 042G05763, 042F08139,
042F08141, 042F08145,
042F08147, 042G05765, 042S07721, 042S07728, 042S07731, 042S07732, 042T35753, 042T35754, 042T35756, 042T35759,
042T35764, 042X05603,
042X05608, 042X05613, 042X05614, 042X05624, 042X05626, 042X05700, 042X05705, 042X05707, 042X05711, 042X05718,
042X05725, 042X05726,
042F31992, 042F31993, 042F32001, 042F32002, 042F32005,
042F32006, 042F32009, 042T35744, 042T35749, 042T35752, 042X05704,
042X05712, 042X05721, 042X05723, 042X05730, 042F32011, 042S07722, 042X05706, 042T35731, 042X05650, 042FP08142, 042GS05751,
042GS05755, 042X05697,
042X05713, 042X05635, 042T35755, 042T35757, 042T35760, 042T35763, 042F31995, 042F31996, 042T35748, 042F41607,
042F41608, 042G05750,
042G05752, 042G05758, 042G05759, 042G05761, 042T35758, 042X05600, 042X05604, 042X05605, 042X05606, 042X05610,
042X05696, 042X05710,
042X05722, 042X05728, 042X05729, 042X05642, 042X05647, 042X05649, 042X05640, 042X05643, 042X05646, 042T35730,
042T35732, 042T35742, and
042T35734;
f) Unit numbers 042FP08147, 042FX41609, 042FX41615, 042GS05764, 042X05726, 042FJ31997, 042FJ32007,
042FJ32010, 042FJ32012,
042T35732, 042T35734,
042FJ31995, 042T35735, 042T35736, and
042T35737
RECALLING FIRM/MANUFACTURER American National Red Cross,
Northern Ohio Region, Cleveland, OH
REASON Blood products, which were incorrectly tested for syphilis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 591
units
DISTRIBUTION OH
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Unit numbers: 2800037
(distributed as 2 split products), 2800052, 4728036
RECALLING
FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, IN
REASON
Blood products, labeled leukoreduced but with
white blood counts that had not been verified, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 4 units
DISTRIBUTION IN