JANUARY 2007
WEEK ENDING JANUARY 6
PRODUCT
a) Platelets Pheresis
Leukocytes Reduced,
b) Platelets Pheresis Leukocytes
Reduced Irradiated,
CODE
a) Units: R64065
(distributed as split product);
b) Unit: R64065
RECALLING
FIRM/MANUFACTURER Coastal Bend Blood Center, Corpus Christi, TX,
REASON
Blood
products, collected from a donor who had previously donated a syphilis reactive
unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION TX
PRODUCT
a) Red Blood Cells,
b) Cryoprecipitated
AHF,
CODE a) and b) Unit: 0207692
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA., REASON Blood products, collected from a donor whose medical
history screening regarding high risk behavior was incomplete, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA and LA
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit 2020616
RECALLING
FIRM/MANUFACTURER Medic Inc., Knoxville, TN
REASON Blood
products, collected from a donor taking the drug Avodart, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit:
71x18918-4
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers Inc., Huntsville, AL,
REASON Blood Product, prepared in insufficient plasma to
support the platelet yield, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION AL
PRODUCT Platelet Pheresis
Leukocytes Reduced,
CODE Units: 71X134867
(distributed as split product)
RECALLING
FIRM/MANUFACTURER LifeSouth Community Blood Centers Inc., Birmingham, AL
REASON Blood products, possibly contaminated with air, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Fresh Frozen Plasma,
CODE
Unit: 2520384
RECALLING
FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON Blood product, processed
from an overweight unit of whole blood, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION TN
PRODUCT Fresh Frozen Plasma,
CODE
Unit: 2133698
RECALLING
FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON Blood product, without
documentation of freezing time, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TN
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma
CODE a) and b) Unit: 2228266
RECALLING
FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON Blood products, collected from a donor who was
previously deferred due to positive HIV test results, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN
PRODUCT Fresh Frozen Plasma,
CODE
Unit: 2707153
RECALLING
FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON Blood product,
associated with a red cell component which contained clots, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT
a) Fresh Frozen Plasma,
b) Cryoprecipitated
AHF,
c)
Platelet,s Leukocytes Reduced,
CODE
a) Units:
032FC57794, 032KE79017, 032KM36343, 032KR19775;
b) Units: 032KE80431,
032KL13744, 032KR15474, 032KT27278, 032KV12927;
c) Units: 032KM36343,
032KR19775
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Badger-Hawkeye Region , Madison, WI
REASON Blood products,
associated with red cell components which contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11
units
DISTRIBUTION IL, OH, and WI
PRODUCT Fresh Frozen Plasma,
CODE
Unit: 2140706
RECALLING
FIRM/MANUFACTURER Medic, Inc., Knoxville, TNplete.
REASON Blood product, associated with red cell components which contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit: 4971898
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK
REASON Blood products, collected from an ineligible donor
due to use of the medication Methotrexate, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION OK and
Switzerland
PRODUCT Source Plasma,
CODE
Units: CD0178766, CD0178912, CD0179278, CD0179974,
CD0180171, CD0180461, CD0180886, CD0181071, CD0182670, CD0182905, CD0183077,
CD0183376, CD0184085, CD0184324, CD0185217, CD0185644, CD0185877,
CD0186599
RECALLING FIRM/MANUFACTURER DCI Biologicals Carbondale, LLC, Carbondale, IL,
REASON
Blood products, collected from a previously deferred
donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18
units
DISTRIBUTION NC
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets,
c)
Fresh Frozen Plasma,
CODE a), b), and c) Unit:
0264526
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans,
LA, REASON Blood products, collected from
a donor whose donor suitability was not adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION LA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: 5640195 (parts 1
and 2)
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan
N. Goldman Center, Oklahoma City, OK
REASON Blood products, which
were possibly contaminated with Corynebacterium species, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NJ
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
5244696
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
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 OK
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
5345213
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
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 OK
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit:
5251437
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
REASON Platelets,
which was possibly contaminated with Staphylococcus epidermidis, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
5266394
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
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 OK
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 5406703 and
5318318
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
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 OK
PRODUCT
a) Red Blood Cells, Leukocytes
Reduced, Irradiated,
b) Red Blood Cells, (Apheresis),
Leukocytes Reduced,
c) Cryoprecipitate, AHF,
d) Fresh Frozen Plasma,
(Apheresis),
e)
Recovered Plasma,
CODE
a), c) and e) Unit:
5409082;
b) and d) Unit: 5277238
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK
REASON Blood products, collected from a donor who had
received a body piercing within twelve months of donating, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION OK and Switzerland
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
22KV88204
RECALLING FIRM/MANUFACTURER American National Red Cross,
Penn-Jersey Region, Philadelphia, PA
REASON Blood product, corresponding to a unit of
Platelets that was possibly contaminated with Staphylococcus species, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
4315420
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, collected from a
donor with a history of lymphoma, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION OK
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: 0401852 and
0401872A
RECALLING FIRM/MANUFACTURER Metrowest Medical Center,
Framingham, MA
REASON Blood products,
labeled with an extended expiration date, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION MA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
5620500
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, which was
possibly contaminated with Moraxella species, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AR
PRODUCT
a) Platelets Pheresis,
Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes
Reduced, Irradiated,
CODE
a) Unit: 9609264 (Part
1);
b) Units: 9609264 (Parts 2 and 3);
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,
REASON
Platelets, which were possibly contaminated with
Propionibacterium species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION CO and TN
PRODUCT Recovered Plasma,
CODE
Unit: 0207692
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA., REASON Blood products,
collected from a donor whose medical history screening regarding high risk
behavior was incomplete, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION Switzerland
PRODUCT Platelets Pheresis,
Leukocytes Reduced, Irradiated,
CODE Unit:
2056181
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN,
REASON
Blood product, exposed to unacceptable
temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT Red Blood Cells,
Deglycerolized Leukocytes Reduced, Irradiated
CODE Unit: 2061311
RECALLING
FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON Blood product, that
was irradiated twice, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TN
PRODUCT Platelets,
CODE
Unit: 5319057
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK
REASON Blood product, manufactured from a unit of Whole Blood
with an extended collection time, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NY
PRODUCT Recovered Plasma,
CODE
Unit: 4315420
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center,
Oklahoma City, OK
REASON Blood product, collected from a donor with a history of
lymphoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION Switzerland
WEEK ENDING JANUARY 20
PRODUCT
a) Red Blood
Cells,
b) Platelets,
CODE a) and b) Unit KT10444
RECALLING
FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON
Blood products, which were possibly
contaminated with Enterococcus faecalis, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION PA
PRODUCT Red Blood
Cells, Leukocytes Reduced
CODE Unit
5466120
RECALLING FIRM/MANUFACTURER Oklahoma Blood
Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, collected from a donor with a
history of leukemia, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION OK
PRODUCT Red Blood
Cells, Leukocytes Reduced,
CODE Unit
033GW32048
RECALLING FIRM/MANUFACTURER American National
Red Cross, Connecticut Region, Farmington, CT,
REASON Blood product, manufactured from an
overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CT
PRODUCT Red Blood
Cells, Leukocytes Reduced,
CODE Unit
5776608
RECALLING FIRM/MANUFACTURER Oklahoma Blood
Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON
Problem: Blood product, manufactured
from an overweight unit of Whole Blood, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit 5449602
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman
Center, Oklahoma City, OK
REASON Blood product, collected in a manner that may
compromise the sterility of the product, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit:
2049665
RECALLING FIRM/MANUFACTURER Medic Inc.,
Knoxville, TN,
REASON Blood product, collected from a donor who visited
a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TN
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit:
2232609
RECALLING FIRM/MANUFACTURER Medic Inc.,
Knoxville, TN
REASON Blood product, collected from a donor
who visited a malarial endemic area, was distributed
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
2225579
RECALLING FIRM/MANUFACTURER Medic Inc.,
Knoxville, TN,
REASON Blood product, collected from a donor who visited
a malarial endemic area, was distributed
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TN
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Units:
2057429, 2705728, 2046688
RECALLING
FIRM/MANUFACTURER Medic Inc., Knoxville, TN,
REASON
Blood
products, collected from a donor who visited a malarial endemic area, were
distributed
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION TN
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
5243510
RECALLING FIRM/MANUFACTURER Sylvan N. Goldman
Center, Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood products,
collected from a donor who visited a malarial endemic area, were
distributed
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Units:
5241017, 4999508
RECALLING FIRM/MANUFACTURER Sylvan N.
Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK
REASON
Blood
products, collected from a donor who visited a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OK and FL
PRODUCT
a) Red Blood
Cells Leukocytes Reduced,
b) Platelets,
c) Fresh Frozen Plasma,
CODE
a), b), and c) Unit:
4994918
RECALLING FIRM/MANUFACTURER Sylvan N. Goldman
Center, Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood
products, collected from a donor with a history of lymphoma, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION OK and TX
PRODUCT
a) Red Blood
Cells Leukocytes Reduced,
b) Red Blood Cells,
c) Fresh Frozen Plasma,
d) Recovered Plasma,
CODE
a) Units: 4588939,
4685381,4800041, 4892978, 4882799, 4883439, 4956157;
b) Unit:
4662465;
c) Units: 4800041, 4883439;
d) Units: 4588939, 4662465, 4685381,
4800041, 4892978, 4882799, 4956157
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Sylvan N. Goldman Center, Oklahoma
Blood Institute, Oklahoma City, OK,
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 17 units
DISTRIBUTION OK, MS, MI,
CA, and Switzerland
PRODUCT
a) Red Blood
Cells Leukocytes Reduced,
b) Recovered Plasma,
CODE
a) and b) Unit:
5346932
RECALLING FIRM/MANUFACTURER Sylvan N. Goldman
Center, Oklahoma Blood Institute, Oklahoma City, OK
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 2 units
DISTRIBUTION OK and
Switzerland
PRODUCT
a) Red Blood
Cells Leukocytes,
b) Recovered Plasma,
CODE a) and b) Unit:
5208304
RECALLING FIRM/MANUFACTURER Sylvan N. Goldman
Center, Oklahoma Blood Institute, Oklahoma City, OK,
REASON
Blood
products, collected from a donor considered to be at increased riskfor variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT
IN COMMERCE 2 units
DISTRIBUTION OK and
Switzerland
PRODUCT Source Plasma,
CODE
Units: 02JWIB9722, 02JWIC0263,
02JWIC0607, 02JWIC4253, 02JWIC4904, 02JWIC5216, 02JWID2018, 02JWID2958,
02JWID3310, 02JWID8505, 02JWID8842, 02JWID9390, 02JWID9844, 02JWIE0468,
02JWIE0836, 02JWIE1435, 02JWIE1812, 02JWIE2609, 02JWIE3289, 02JWIE3887,
02JWIE4309, 02JWIE4818, 02JWIE5277, 02JWIE5825, 03JWIA0857, 03JWIA1249,
03JWIA1850, 03JWIA2192, 03JWIA2825, 03JWIA3180, 03JWIA3724, 03JWIA4092,
03JWIA4691, 03JWIA5042, 03JWIA5586, 02JWIC1157, 02JWIC1458, 02JWIC2095,
02JWIC2551, 02JWIC3031, 02JWIC3491, 02JWIC3975, 02JWIC6689, 02JWIC7051,
02JWIC7609, 02JWIC7898, 02JWIC8547, 02JWIC8906, 02JWIC9494, 02JWIC9793,
02JWID0630, 02JWID1144, 02JWID1592, 02JWID3884, 02JWID4247, 02JWID4827,
02JWID5189, 02JWID5713, 02JWID6578, 02JWID6926, 02JWID7624,
02JWID7970
RECALLING FIRM/MANUFACTURER BioLife Plasma
Services L.P., Janesville, WI
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 62
units
DISTRIBUTION MI and Austria
PRODUCT
a) Red Blood
Cells Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit:
4499508
RECALLING FIRM/MANUFACTURER Sylvan N. Goldman
Center, Oklahoma Blood Institute, Oklahoma City, OK,
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 COMMERCE2 units
DISTRIBUTION OK and
Switzerland
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 2073589 (Part A)
RECALLING
FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON
Platelets, possibly contaminated with
Bacillus species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TN
PRODUCT Platelets
Pheresis, Leukocytes Reduced, Irradiated,
CODE Units: 2070144 (Parts A &
B)
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON
Platelets,
possibly contaminated with coagulase negative Staphylococcus species, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN
PRODUCT Platelets
Pheresis, Leukocytes Reduced
CODE Unit: 2069807
RECALLING
FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON
Platelets, possibly contaminated with
coagulase negative Staphylococcus species, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Units: 2072153 (Parts A &
B)
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON
Platelets, possibly
contaminated with Bacillus species, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2
units
DISTRIBUTION TN
PRODUCT Platelets
Pheresis, Leukocytes Reduced Irradiated
CODE Unit: 2076285
RECALLING
FIRM/MANUFACTURER Medic, Inc., Knoxville, TN,
REASON
Platelets, possibly contaminated with
Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION TN
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Units: 71X322842 (Parts 1 and
2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth
Community Blood Centers, Inc, Gainesville, FL
Manufacturer: LifeSouth Community Blood Centers, Inc., Montgomery, AL.
REASON
Blood
products, which were possibly contaminated with Klebsiella Pneumoniae, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Unit: 5496819 (Part 2)
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman
Center, Oklahoma City, OK
REASON Platelets, possibly
contaminated with Bacillus species, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Units: 5472779 (Parts 1 &
2)
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
REASON Platelets, possibly contaminated with
Bacillus species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION NY
PRODUCT Human Corneas
for Transplantation,
CODE Tissues:
06-0207-100, 06-0207-200
RECALLING FIRM/MANUFACTURER East
Tennessee Lions Eye Bank, Knoxville, TN,
REASON Human tissues for
transplantation, which tested negative for hepatitis prior to distribution, but
were subsequently found to test repeatedly reactive for antibodies to hepatitis
B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 tissues
DISTRIBUTION NC
PRODUCT
a) Red Blood
Cells, Leukocytes Reduced,
b) Recovered Plasma,
CODE
a) and b) Units: 5219381,
4759725
RECALLING FIRM/MANUFACTURER Oklahoma Blood
Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON
Blood products, collected from a
donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION OK, VA, and
Switzerland
PRODUCT
a) Red Blood
Cells, Leukocytes Reduced,
b) Red Blood Cells, Leukocytes
Reduced, Irradiated,
CODE
a) Units:
2603603, 2515530, 2707266;
b) Unit: 2423264
RECALLING
FIRM/MANUFACTURER Medic, Inc., Knoxville, TN,
REASON
Blood products, which tested negative
for the antibody to hepatitis B core antigen (anti-HBc), but were collected from
a donor who tested repeat reactive for anti-HBc on two previous occasions, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION TN
PRODUCT
a) Red Blood
Cells,
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Units: 6546930, 6734352, 9112829,
9735551, 6734369, 6927409,
6546910, 6734581, 6745390, 6745392, 6745402,
9112861, 9200537,
9729838, 9733088, 9733113, 9733119, 9735077, 9735099,
9735558,
9735570, 6546920, 6739230, 6741358, 6741369, 6741373, 6741400,
6741413, 6742451, 6742947, 9112865, 9112887, 9112893, 9200529,
6732344,
9112853, 9112858, 9200526, 9200546, 6741352, 6741362;
b) Units: 9733074,
9733077, 9733065, 9733084, 6927393, 9733080,
6927378, 9729823, 9729832,
9733108, 9733116, 6734371, 9200515,
9729847
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,
REASON Blood products, which were 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 55 units
DISTRIBUTION CO and UT
PRODUCT Red Blood
Cells, Leukocytes Reduced,
CODE Unit
22KL29993
RECALLING FIRM/MANUFACTURER American National
Red Cross, Penn-Jersey Region, Philadelphia, PA
REASON Blood product, manufactured without the entire
quantity of additive solution added, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT
a) Red Blood
Cells Pheresis, Leukocytes Reduced,
b) Fresh Frozen Plasma Pheresis,
CODE
a) and b) Unit
5464246
RECALLING FIRM/MANUFACTURER Oklahoma Blood
Institute, Sylvan N. Goldman Center, Oklahoma City, OK,
REASON Blood products, collected from an ineligible
donor due to use of the medication Aygestin, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OK
PRODUCT
a) Red Blood
Cells, Leukocytes Reduced,
b) Platelets,
c) Fresh Frozen Plasma,
CODE a), b), and c) Unit: 5379562
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman
Center, Oklahoma City, OK
REASON Blood products, collected
from an ineligible donor due to use of the medication Aygestin, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION AR, and LA
PRODUCT Platelets
Pheresis Leukocytes Reduced Irradiated,
CODE Units: 040P11342 (split
product)
RECALLING FIRM/MANUFACTURER The American
National Red Cross, Heart of America Region, Peoria, IL
REASON
Blood
products, out of controlled storage for an undocumented length of time, were
distributed
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION IL
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Unit:
5398400
RECALLING FIRM/MANUFACTURER Sylvan N. Goldman
Center, Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood product, collected from a donor whose
hemoglobin was not recorded during screening, was distributed
VOLUME
OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT Red Blood
Cells
CODE Units: 3938036,
3938009
RECALLING FIRM/MANUFACTURER New York Blood Center
Inc., New York, NY,
REASON Blood products, which lacked assurance
of acceptable temperatures during shipping, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION NY
PRODUCT
a) Platelets
Pheresis, Leukocytes Reduced,
b) Platelets Pheresis,
Leukocytes Reduced, Irradiated.
CODE
a) Unit: 2076816 (Part B);
b) Unit: 2076816
(Part A)
RECALLING FIRM/MANUFACTURER Medic, Inc,
Knoxville, TN
REASON Platelets, possibly contaminated with
Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION TN
PRODUCT Platelets
Pheresis, Leukocytes Reduced
CODE Unit: 5458639
RECALLING
FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman
Center. Oklahoma City, OK
REASON Platelets, possibly
contaminated with Bacillus species, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Red Blood
Cells, Leukocytes Reduced,
CODE Unit:
2071441
RECALLING FIRM/MANUFACTURER Medic, Inc.,
Knoxville, TN
REASON Blood product, for which there
was no documentation of weld acceptability for the sterile docking of the
filter, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT Recovered
Plasma
CODE Unit:
2710197
RECALLING FIRM/MANUFACTURER Medic, Inc.,
Knoxville, TN,
REASON Blood product, which was not quarantined
after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TN
PRODUCT Red Blood
Cells, Leukocytes Reduced,
CODE Unit:
2801011
RECALLING FIRM/MANUFACTURER Medic, Inc.,
Knoxville, TN
REASON Blood
product, which contained a clot, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION TN
PRODUCT
a) Red Blood
Cells, Leukocytes Reduced,
b) Red Blood Cells, Leukocytes
Reduced, Irradiated,
c) Fresh Frozen Plasma,
CODE
a) Units: 2140453, 2140455, 2140460,
2140466, 2140469, 2140479, 2140483, 2140488, 2140494, 2140497, 2140502, 2140856,
2140858, 2140860, 2140865, 2140835, 2230832, 2230845, 2230848, 2230849, 2230851,
2230854, 2230857, 2230858, 2230861, 2230863, 2230870, 2230872, 2230874, 2230875,
2230881, 2230884, 2230885, 2230894, 2230896, 2231360, 2231362, 2231368, 2231370,
2231373, 2231376, 2231377, 2231381, 2231383, 2231525, 2334634, 2334636, 2334639,
2334640, 2334642, 2334643, 2334645, 2334647, 2334649, 2334651, 2334654, 2334656,
2334660, 2334662, 2334666, 2334862, 2334864, 2334865, 2334867, 2334869, 2334872,
2334873, 2334876, 2334877, 2334879, 2334884, 2334888, 2334889, 2334890, 2334891,
2334893, 2334894, 2334895, 2334901, 2334931, 2334933, 2334934, 2334936, 2334938,
2334939, 2334940, 2334941, 2334943, 2334944, 2334952, 2335061, 2335063, 2335065,
2335066, 2335070, 2335075, 2335076, 2335077, 2335078, 2335082, 2335085, 2335086,
2335090, 2335091, 2335096, 2335099, 2335101, 2335105, 2335113, 2335115, 2335118,
2335128, 2335130, 2335133, 2335135, 2335185, 2335255, 2429772, 2429774, 2429776,
2429778, 2429780, 2429783, 2429785, 2429787, 2429789, 2429792, 2429794, 2429795,
2429796, 2429798, 2429800, 2429801, 2429804, 2429805, 2429807, 2429813, 2429815,
2429816, 2429819, 2429930, 2429932, 2429933, 2429936, 2429938, 2429941, 2429942,
2429943, 2429945, 2429948, 2429949, 2429951, 2429954, 2429955, 2429956, 2429958,
2429960, 2429961, 2429962, 2429963, 2429965, 2429967, 2429968, 2429970, 2429971,
2429977, 2429979, 2429980, 2429981, 2429982, 2429985, 2429986, 2429988, 2429989,
2429991, 2429993, 2429994, 2430351, 2430353, 2430357, 2522969, 2522971, 2522972,
2522977, 2522979, 2522981, 2522984, 2522986, 2522988, 2522990, 2522993,
2522994;
b) Units: 2140476, 2230878, 2334929, 2334945, 2429771, 2429821, 2429937, 2429952;
c) Units: 2140494, 2230845, 2230848, 2230849, 2230851, 2230857, 2230870,
2230872, 2230875, 2230878, 2230881, 2230884, 2230885, 2230890, 2230894, 2334634,
2334640, 2334643, 2335101, 2335105, 2335185, 2335252, 2335255,
2335099
RECALLING FIRM/MANUFACTURER Medic, Inc.,
Knoxville, TN
REASON Blood products, collected from donors
whose body temperature and pulse were not taken, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 224
units
DISTRIBUTION KY and TN
PRODUCT
a) Platelets,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit:
033GR98228
RECALLING FIRM/MANUFACTURER Firm: American
National Red Cross, Connecticut Region, Farmington, CT
REASON
Blood products, manufactured from a unit
of Whole Blood with a discrepant collection time, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CT
WEEK ENDING JANUARY 27
PRODUCT
Human Tissue for
Transplantation:
a) Achilles Tendon Frozen;
b) Tibialis Anterior Tendon,
Frozen,
CODE
a) 03-0168302
b) 03-0168303,
03-0168304
RECALLING FIRM/MANUFACTURER DCI Donor Services Tissue
Services Division, Nashville, TN
REASON Human tissue, which was either implicated
in a post-transplant bacterial infection, or was processed in the same manner as
tissue that was implicated in a post-transplant bacterial infection, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 3 tissue allografts
DISTRIBUTION New Mexico, TN
PRODUCT
Human Tissue for
Transplantation:
a) Achilles Tendon Frozen;
b) Patellar Ligament Hemi,
Frozen;
c) Cartilage in Saline Vacuum;
d) Tibialis Anterior Tendon,
Frozen
e) Tibialis Tendon Frozen;
f) Tibialis Tendon Posterior
Frozen;
g) Fascia Lyo 101-150 sq cm;
h) Pericardium Lyo 26-50 sq
cm;
i) ) Semitendonosus / Gracilis Frozen;
j) Patella Ligament Whole
Frozen,
CODE
a) 03-0178792, 03-0173682,
03-0168103, 03-0168104, 03-0162640, 03-0168841, 03-0181591, 03-0179205,
03-0181592, 03-0042572, 03-0155372, 03-0182234, 03-0032401, 03-0174931,
03-0155371, 03-0161144, 03-0182782, 03-0182623, 03-0181628, 03-0182051,
03-0032400, 03-0168301, 03-0147962, 03-0173822, 03-0182235, 03-0181627,
03-0128130, 03-0162639, 03-0182783, 03-0182624, 03-0161143, 03-0182052,
03-0151503, 03-0147961, 03-0042571, 03-0179206, 03-0172621, 03-0135831,
03-0174932, 03-0173821,
03-0173681, 03-0172251, 03-0178791, 03-0173841,
03-0173842;
b) 03-0168842, 03-0181593, 03-0135832, 03-0181595, 03-0182781, 03-0178796, 03-0182625, 03-0182626, 03-0168844, 03-0173823,
03-0173825,
03-0179203, 03-0173826, 03-0182011, 03-0182049, 03-0179202, 03-0042574,
03-0139081, 03-0151502, 03-0147967,
03-0168102, 03-0162641, 03-0161142,
03-0128132, 03-0042575, 03-0168101, 03-0172618, 03-0181594, 03-0162643,
03-0168843, 03-0181438, 03-0172252, 03-0181596, 03-0178793, 03-0178794, 03-0032405, 03-0139084, 03-0179204, 03-0182047, 03-0181212,
03-0172620,
03-0182048, 03-0172617, 03-0172619, 03-0042573, 03-0042576, 03-0178795,
03-0139082, 03-0162644, 03-0173824, 03-0181213, 03-0172253, 03-0182050,
03-0151501, 03-0179201, 03-0181436, 03-0181437, 03-0032402, 03-00324404,
03-0162642,
03-0128131, 03-0128133, 03-0147968, 03-0181211;
c)
03-0014874, 03-0014871, 03-0014878, 03-0014875, 03-0014876, 03-0014877;
d)
03-0182053, 03-0182054, 03-0181621, 03-0179207, 03-0179208,
03-0181600,
03-0181599, 03-0155375, 03-0173846, 03-0173847, 03-0181622;
e) 03-0042582,
03-0042580, 03-0042581, 03-0178797, 03-0178798,
03-0178799, 03-0147963,
03-0147964, 03-0147965, 03-0147966;
f) 03-0155377, 03-0173845, 03-0182055,
03-0181623, 03-0155376,
03-0181598, 03-0181624, 03-0179209, 03-0181597,
03-0179210;
g) 03-0182237, 03-0182238, 03-0168105;
h) 03-0168845,
03-0173684, 03-168846, 03-0174935, 03-0174936, 03-0173683;
i)
03-0147971;
j) 03-0182232, 03-0182233, 03-0155373, 03-0155374, 03-0179281,
03-0111812, 03-0174933, 03-0161141, 03-0173844, 03-0181625,
03-0173843
RECALLING FIRM/MANUFACTURER DCI Donor Services Tissue
Services Division, Nashville, TN
REASON Human tissue, which was either implicated in a
post-transplant bacterial infection, or was processed in the same manner as
tissue that was implicated in a post-transplant bacterial infection, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 167 tissue allografts
DISTRIBUTION TN, CA, NV, AR and New Mexico
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit: 032KM30370
RECALLING
FIRM/MANUFACTURER American National Red Cross, Badger-Hawkeye Region,
Madison, WI
REASON Blood products, collected from a donor that tested
negative for antibody to Hepatitis B core antigen (anti-HBcore), but previously
tested repeatedly reactive for anti-HBcore on two occasions.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION WI
PRODUCT Red Blood Cells
CODE
Unit: 0209555
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON Blood product,
collected from a donor whose donor suitability was not adequately determined,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
22GQ15801
RECALLING FIRM/MANUFACTURER American National Red Cross,
Penn-Jersey Region, Philadelphia, PA,
REASON Blood product, collected
from a donor who donation record was incomplete, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells
Leukocytes Reduced
CODE Units: 5242996,
4982587
RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Center,
Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood products, collected from
a donor who visited a malarial endemic area, were distributed
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION AL
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Units: 8309271
(triple-split product)
RECALLING FIRM/MANUFACTURER Florida's Blood
Centers Inc., Orlando, FL
REASON Blood products, with platelet yields below the
specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION FL
PRODUCT Platelets,
CODE
Unit: 1334632
RECALLING
FIRM/MANUFACTURER New York Blood Center, Inc., Westbury, NY,
REASON
Blood product, collected from a donor who had
taken aspirin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Units: 4723660, 4492802
RECALLING
FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute,
Oklahoma City, OK
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 4
units
DISTRIBUTION OK, MI, NB, and Switzerland
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Platelets Leukocytes Reduced,
CODE a) and b) Unit: LL35485
RECALLING
FIRM/MANUFACTURER Healthcare Provider Services, DBA Rhode Island Blood
Center, Providence, RI
REASON Blood products, collected from a donor who visited
a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION RI
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Platelets Leukocytes Reduced,
CODE a) and b) Unit: LL30489
RECALLING
FIRM/MANUFACTURER Healthcare Provider Services, DBA Rhode Island Blood
Center, Providence, RI
REASON Blood products, collected from a donor who visited
a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN
COMMERCE2 units
DISTRIBUTION MA, and FL
PRODUCT Red Blood Cells
CODE
Unit: 0430525
RECALLING
FIRM/MANUFACTURER Community Blood Bank of Erie County, Erie, PA
REASON
Blood product, collected from a donor who was at
increased risk for new variant Creutzfeldt-Jakob Disease (vCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red Blood Cells,
CODE
Unit: C61443
RECALLING
FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA
REASON Blood product, collected from a donor with an
unacceptable hemoglobin/hematocrit result, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
5889460
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product,
collected from a donor with an elevated body temperature, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Recovered Plasma
CODE
Unit: 0209555
RECALLING
FIRM/MANUFACTURER The Blood Center, New Orleans, LA
REASON Blood product,
collected from a donor whose donor suitability was not adequately determined,
was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION LA
PRODUCT Red Blood Cells (Apheresis) Irradiated,
CODE
Units: 71Q340990,
71Q340873
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Inc., Birmingham, AL
REASON Blood products, labeled with extended
expiration dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AL
PRODUCT Buffy Coat,
CODE
Unit: 4492802
RECALLING
FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute,
Oklahoma City, OK
REASON Blood product, collected from a donor considered
to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK, MI, NB, and Switzerland
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit: 5274880
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N.
Goldman Center, Oklahoma City, OK
REASON Platelets, possibly
contaminated with Bacillus sp., was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION OK
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit: 5274799
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N.
Goldman Center, Oklahoma City, OK
REASON Blood product, which was
identified as being contaminated by the BacT/ALERT system, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WI
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Unit: 5411212
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N.
Goldman Center, Oklahoma City, OK
REASON Platelets,
possibly contaminated with Bacillus sp., was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit:
5651322
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute,
Sylvan N. Goldman Center, Oklahoma City, OK
REASON Platelets,
which were possibly contaminated with coagulase negative Staphylococcus, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OK
PRODUCT Red Blood Cells Pheresis,
Leukocytes Reduced,
CODE Units 033GC03567 (2
units), 033GQ01653 (2 units)
RECALLING FIRM/MANUFACTURER American
National Red Cross, Connecticut Region, Farmington, CT
REASON Blood products, for which documentation of the
apheresis procedure was incomplete, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 4 units
DISTRIBUTION CT
PRODUCT Red Blood Cells,
CODE
Unit: KJ87643
RECALLING
FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA,
REASON
Blood
product, manufactured without the additive solution added, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 030GM30971,
030GM30978, 030GM30983
RECALLING FIRM/MANUFACTURER American
National Red Cross, Northeastern Pennsylvania Region, Ashley, PA
REASON
Blood
products, collected on a trip scales for which documentation of the daily
quality control testing was incomplete, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 3 units
DISTRIBUTION NY