AUGUST 2006
WEEK ENDING AUGUST 5
PRODUCT
Platelets Pheresis
Leukocytes Reduced,
CODE Unit
003P59114
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern Region, Atlanta, GA,
REASON Platelets, which were possibly
contaminated with Corynebacterium species, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit
12GS37972
RECALLING FIRM/MANUFACTURER American National Red Cross,
Carolinas Region, Charlotte, NC,
REASON Blood product, collected from
a donor who had lived in an area designated as endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NC
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets, Leukocytes Reduced,
CODE a) and b) Unit 11GL79280
RECALLING
FIRM/MANUFACTURER American Red Cross Blood Services, Missouri-Illinois
Region, St. Louis, MO,
REASON Blood
products, collected from a donor who reported travel to an area designated as
endemic for malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION MO and KY
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit
2598508
RECALLING FIRM/MANUFACTURER South Texas Blood & Tissue
Center, San Antonio, TX,
REASON Blood product, collected from a donor
who reported travel to an area designated as endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION TX
PRODUCT Corneas,
CODE
Unit 06710501 and 06710502
RECALLING
FIRM/MANUFACTURER Northeast Pennsylvania Lions Eye Bank, Inc., Allentown, PA
REASON
HCT/Ps, which were collected from a
donor who tested repeatedly reactive for the antibody to the hepatitis B core
antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION Saudi Arabia
PRODUCT Platelets Pheresis
Leukocytes Reduced Irradiated,
CODE Unit
FM24078
RECALLING FIRM/MANUFACTURER Sacramento Medical Foundation,
Sacramento, CA,
REASON Blood product, which was collected in a manner
that may have compromised the sterility of the collection system, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells,
b) Fresh Frozen Plasma,
c) Platelets,
CODE
a) and c) Units 1006510, 1015600 and 1025208;
b)
Unit 1025208
RECALLING FIRM/MANUFACTURER Walter L. Shepeard
Community Blood Center, Inc., Augusta, GA,.
REASON Blood products, collected
from an ineligible donor due to use of the medication Lanoxin, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION GA
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit
03F17704
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern Region, Atlanta, GA,
REASON Blood product,
which was inappropriately distributed in a single storage bag, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit
11LE19573
RECALLING FIRM/MANUFACTURER American National Red Cross,
Missouri-Illinois Region, St. Louis, MO,
REASON Blood product, collected from a donor who had
traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MO
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Platelets,
CODE a) and b) Unit: 11GN22366
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois
Region, St. Louis, MO
REASON Blood products,
collected from a donor who traveled to a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION GA
PRODUCT Source Plasma,
CODE
Units: 0200349151, 0200348943, 0200347688,
0200347429, 0200346417, 0200346158, 0200345435, 0200344129,
0200344008
RECALLING FIRM/MANUFACTURER ZLB Bioplasma Inc., Norman,
OK,
REASON Blood products, collected from an ineligible
donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9
units
DISTRIBUTION NC
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
9705331
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO,
REASON Blood product, collected from a donor who traveled
to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
6922130
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO,
REASON Blood product, collected from a donor who traveled
to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Units: 9025985 (Split
product)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO,
REASON Blood products, collected from a donor who
traveled to an area endemic for malaria, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL and MN
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
11GL75089
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Missouri-Illinois Region, St. Louis, MO
REASON Blood product, collected from a donor who traveled
to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION MO
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
2485597
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue
Center, San Antonio, TX
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
2554978
RECALLING FIRM/MANUFACTURER South Texas Blood and Tissue
Center, San Antonio, TX
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX
PRODUCT Platelet Pheresis
Leukoreduced,
CODE Unit:
04GR33513
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
REASON Blood product, possibly contaminated with
micrococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MA
PRODUCT Platelet Pheresis
Leukoreduced,
CODE Unit:
04GJ20511
RECALLING FIRM/MANUFACTURER The American National Red
Cross, New England Region, Dedham, MA
REASON Blood product, possibly contaminated with
micrococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MA
PRODUCT Platelets Pheresis
Leukocytes Reduced,
CODE Unit:
03FK39386
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Southern Region, Atlanta, GA,
REASON Blood product, possibly
contaminated with bacillus species, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT
a) Platelets Pheresis
Leukocytes Reduced,
b) Fresh Frozen Plasma Pheresis,
CODE
a) Units: 7785664- 1, 7785664- 2, 7785850-
1, 7785850- 2,
5111003- 1, 5111003- 2, 7785329, 7785260, 7785414, 7785392-
1,
7785392- 2, 7784468, 7785425;
b) Unit: 7785537
RECALLING
FIRM/MANUFACTURER Life Source, Glenview, IL
REASON Blood
products, collected in an open system and not given an expiration time of 24
hours, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14
units
DISTRIBUTION IL
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Red Blood Cells Pheresis,
Leukocytes Reduced,
c) Red Blood Cells, Leukocytes
Reduced, Irradiated,
CODE
a) Unit: 10046-7501;
b) Units: 10046-0189 (Parts 1 & 2), 10046-0195 (Parts 1 & 2),
10046-5913 (Parts 1 & 2), 10046-6395, 10046-7496, 10046-7511
(Parts
1 & 2), 10046-7519 (Parts 1 & 2), 10046-7524 (Parts 1 & 2),
10046-8222, 10047-0276 (Parts 1 & 2), 10047-0281, 10046-8225,
10046-6376 (Parts 1 & 2), 10046-9988;
c) Unit: 10046-7501 (Part
2)
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ
REASON
Blood products, which lacked assurance of
sterility due to improper use of the Sterile Connecting Device, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 24
units
DISTRIBUTION AZ
PRODUCT Platelets Pheresis
Leukocytes Reduced
CODE Unit:
04FP80337
RECALLING FIRM/MANUFACTURER American Red Cross Blood
Services, Dedham, AL
REASON Blood product,
which was contaminated with a Staphlyococcus coagulase negative organism, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Cryoprecipitated, AHF
CODE
Unit: LY04724
RECALLING
FIRM/MANUFACTURER Healthcare Provider Services, Inc., Dba Rhode Island
Blood Center, Providence, RI,
REASON Blood product, which was
collected from a donor with a history of erythrocytosis, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MA
PRODUCT Platelet Pheresis
Leukoreduced Irradiated,
CODE Unit:
F206787
RECALLING FIRM/MANUFACTURER Paget Sound Blood Center,
Seattle, WA
REASON Blood product, labeled as leukoreduced, but which
did not meet the requirements for a leukoreduced product, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WA
PRODUCT Red Blood Cells,
CODE
Unit: 9607861
RECALLING
FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK,
REASON Blood
product, collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT Platelets Pheresis
Leukocyte Reduced Irradiated,
CODE Units:
21LQ13666, 21KP62024
RECALLING FIRM/MANUFACTURER Legacy Emanuel
Hospital and Health Center, Portland, OR
REASON Blood products, labeled with
extended expiration dates, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION OR
PRODUCT
a) Red blood Cells,
b) Red Blood Cells Leukocytes Reduced,
c) Platelets,
d) Platelets
Leukoreduced,
e) Cryoprecipitated AHF,
f) Plasma,
g) Fresh Frozen Plasma,
h) Plasma
Frozen Cryoprecipitated Reduced,
i) Recovered Plasma,
CODE
a) Units: 18S90190, 18FX00898, 18R98468,
18FQ28948, 18R91485, 18R89139, 18E93288, 18E91572, 18FK05922, 18R63592,
18FC51274, 18X63058, 18E54611, 18X53332;
b) Units: 18FV64233, 18FK80793,
18FZ38543, 18FX48755, 18GC03612, 18FZ28245, 18FQ65458, 18FW09271, 18FS36649;
c) Units: 18S90190, 18FX00898, 18R98468, 18FQ28948, 18R89139, 18FK05922;
d) Units: 18GC03612, 18FZ28245, 18FW09271;
e) Units:
18FV64233, 18FZ38543, 18GC03612, 18FQ65458, 18R91485;
f) Unit:
18R91485;
g) Units: 18FX48755, 18FZ28245, 18FW09271, 18R98468, 18R89139,
18E54611;
h) Units: 18FV64233, 18FZ38543, 18GC03612, 18FQ65458;
i) Units:
18FK80793, 18R63592, 18FC51274
RECALLING FIRM/MANUFACTURER The
American National Red Cross, Great Lakes Region, Lansing, MI
REASON Blood products, collected from a donor whose
sexual partner tested reactive for hepatitis B, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 51 units
DISTRIBUTION CA, CT, FL, MD,
MI, OH and UT
PRODUCT
a) Red Blood Cells,
b) Cryoprecipitated
AHF,
c)
Recovered Plasma,
CODE a), b) and c) Unit:
2016719
RECALLING FIRM/MANUFACTURER Walter Shepeard Community Blood
Center, Inc., Augusta, GA
REASON Blood products, which were collected from a
donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD),
were distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION GA and Germany
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit: 2443595
RECALLING
FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX,
REASON
Blood products, which were collected from a donor
who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT
a) Red Blood Cells
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit: 2545596
RECALLING
FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX
REASON
Blood products, which were collected from a donor
who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION TX
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
6707887
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KY
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
9700180
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Unit:
9071834
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood
Center, Denver, CO
REASON Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells, Recall #
B-1597-6
CODE Unit: 6962628
RECALLING
FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON
Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO
PRODUCT
a) Red Blood Cells,
b) Platelets,
c) Fresh Frozen
Plasma,
CODE
a) Units: 4015161, 2012773;
b)
Unit: 4015161;
c) Unit: 2012773
RECALLING
FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc.,
Augusta, GA,
REASON Blood products, collected from a donor taking
Topamax, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION GA and SC
PRODUCT Human Tissue for
Transplantation, :
a) CryoVein, CryoPatch Allografts,
Pulmonary Hemi-Artery;
b) CryoVein, CryoPatch Allografts, Saphenous Vein
CODE
a) Serial #: 8491819;
b) Serial #s: 8491622,
8491613
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA
REASON
Human Tissue, collected from a donor with a
history of IV drug use, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 tissues
DISTRIBUTION MI and IN
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
003GF24857
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern Region, Atlanta, GA
REASON Blood product, which lacked assurance of sterility
due to improper use of the Sterile Connecting Device, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells,
b)
Platelets
CODE
a)
Units: 3022290, 3115201, 4015438;
b) Unit: 3115201
RECALLING
FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc.,
Augusta, GA,
REASON Blood products, collected from a donor who
reported travel to an area designated as endemic for malarial, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION GA
PRODUCT Red Blood Cells,
CODE
Unit: 2016727
RECALLING
FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc.,
Augusta, GA
REASON Blood products, collected from a donor who
reported travel to an area designated as endemic for malarial, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 003L69383,
003L69365, 003L69368
RECALLING FIRM/MANUFACTURER American National
Red Cross, Southern Region, Atlanta, GA,
REASON Blood products, collected on a trip scale that was
incorrectly calibrated, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION GA
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Units: 7024204,
7024196
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc.,
Anchorage, AK,
REASON Blood products, with an unacceptably low red cell
recovery rate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION AK
PRODUCT Red Blood Cells,
Leukocytes Reduced Irradiated
CODE Units:
21LC19328, 21KL84140, 21KW29232, 21LC19308, 21LJ04897,21KL83906
RECALLING
FIRM/MANUFACTURER Providence Portland Medical Center, Portland, OR
REASON
Blood products, labeled with extended expiration
dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6
units
DISTRIBUTION OR
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
027LR48002
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Alleghenies Region, Johnstown, PA
REASON Red Cells, mislabeled for the Fyb antigen, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT Red Blood Cells
CODE
Unit: G153410
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center,
Seattle, WA,.
Manufacturer: Puget
Sound Blood Center, Renton, WA.
REASON Blood product, which was manufactured from a unit
of whole blood more than eight hours after collection, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION WA
PRODUCT Red Blood Cells,
Leukocytes Reduced, Irradiated,
CODE Units:
GF29645, LE46222
RECALLING FIRM/MANUFACTURER Sacramento Medical
Foundation, Sacramento, CA,
REASON Blood products, which were out
of controlled storage for more than 30 minutes during irradiation, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION CA
PRODUCT
a) Red Blood Cells,
b) Fresh Frozen Plasma,
c)
Platelets,
CODE a), b), and c) Units: 5107239,
5107917, 5109832
RECALLING FIRM/MANUFACTURER Walter L. Shepeard
Community Blood Center, Inc., Augusta, GA
REASON Blood products, which tested
negative for Hepatitis B surface antigen (HBsAg) and for the antibody to
Hepatitis B core antigen (anti-HBc), but were collected from a donor who
previously tested positive for HBsAg, were distributed.
VOLUME OF PRODUCT
IN COMMERCE 9 units
DISTRIBUTION GA and SC
WEEK ENDING AUGUST 12
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit:
LP00299
RECALLING FIRM/MANUFACTURER Central Blood Bank,
Pittsburgh, PA,
REASON Platelets, which tested negative for the
antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected
from a donor who previously tested repeatedly reactive for HIV, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Source Plasma,
CODE
Unit:
NG0057019
RECALLING FIRM/MANUFACTURER DCI Biologicals
Nacogdoches, LLC, Nacogdoches, TX,
REASON Blood
product, which tested negative for hepatitis B surface antigen (HbsAg), but was
collected from a donor who subsequently tested positive for HbsAg, was not
properly quarantined and was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION KY
PRODUCT Unprocessed,
cadaveric tissue,
CODE LA05-018
RECALLING
FIRM/MANUFACTURER Life Alaska Donor Services, Anchorage, AK
REASON
Unprocessed, cadaveric tissue that was
subsequently found to test repeatedly reactive for antibodies to Hepatitis B
Core Total (IgM/lgG) by a different facility was distributed.
VOLUME
OF PRODUCT IN COMMERCE 1
tissue
DISTRIBUTION TX, GA, and NJ
PRODUCT
a) Red Blood
Cells, Leukocytes Reduced,
b) Platelets,
c) Fresh Frozen Plasma,
d) Cryoprecipitated
AHF,
CODE
a) Units: 2597240, 2597085,
2596321, 2596720, 2629130, 2599098, 2600915, 2630350, 2630082,
2628579;
b) Unit: 2630350;
c) Units: 2597085, 2600915, 2629130,
2630350;
d) Units: 2597240, 2630082
RECALLING
FIRM/MANUFACTURER South Texas Blood & Tissue Center, San
Antonio, TX,
REASON Blood products, collected from
donors whose suitability to donate had not been adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 17
units
DISTRIBUTION TX, WI, Austria and Switzerland
PRODUCT Decavac
Vaccine, 10 x 1 UD Syringe, NDC number: 49281-291-10,
CODE Lot number: U1703AA, Expiration date:
7/11/07
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Amerisource Bergen, Chesterbrook, PA,
Manufacturer: Sanofi Pasteur,
Inc., Swifterwater, PA.
REASON Vaccines, that were stored under
unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 300 units
DISTRIBUTION TX
PRODUCT
a) Red Blood
Cells, Leukocytes Reduced,
b) Plasma Frozen,
CODE
a) Units: 04KK14463 and 04KK14471;
b)
Unit: 04KK14456
RECALLING FIRM/MANUFACTURER American Red
Cross Blood Services, Dedham, MA
REASON Blood products, which were collected in
a manner that may have compromised the sterility of the collection system, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 3
units
DISTRIBUTION NH and VT
PRODUCT Cryoprecipitated
AHF,
CODE Units: 0980870, 0980879,
0980882, 0980893, 0990389, and 0990406
RECALLING
FIRM/MANUFACTURER Bergen Community Regional Blood Center, Paramus, NJ
REASON
Blood products, which did not meet
acceptable product specifications, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 6
units
DISTRIBUTION NJ
PRODUCT Red Blood
Cells, Leukocytes Reduced,
CODE Unit:
13FC61595
RECALLING FIRM/MANUFACTURER American Red Cross
Blood Services, Detroit, MI
REASON Blood product, which was collected from
a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MI
PRODUCT Cryoprecipitated
AHF,
CODE Unit:
1851268
RECALLING FIRM/MANUFACTURER Central Indiana
Regional Blood Center, Indianapolis, IN
REASON Blood
product, which was manufactured from a whole blood unit in which the associated
blood component contained clots, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1
unit
DISTRIBUTION IN
PRODUCT
a) Fresh Frozen
Plasma,
b) Platelets,
CODE a) and b) Unit:
3015049
RECALLING FIRM/MANUFACTURER Walter L. Shepeard
Community Blood Center, Inc., Augusta, GA
REASON Blood products,
possibly contaminated with Staphylococcus, were distributed.
VOLUME
OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION SC and GA
PRODUCT Red Blood Cells
(Apheresis),
CODE Unit:
S85997
RECALLING FIRM/MANUFACTURER HCSC Blood Center,
Bethlehem, PA
REASON Blood
product, which did not meet acceptable product specifications, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT
a) Red Blood
Cells,
b) Platelets,
c)
Cryoprecipitated AHF,
d) Recovered Plasma,
CODE
a) and d) Units: 1029180 and 3105267;
b)
and c) Unit: 1029180
RECALLING FIRM/MANUFACTURER Walter
L. Shepeard Community Blood Center, Inc., Augusta, GA.
REASON
Blood
products, which were collected from a donor who may be at increased risk for
HIV-1 Group O infection, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 6 units
DISTRIBUTION GA and
Germany
PRODUCT Source Plasma,
CODE
Units: 83906770,
83900587
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc.,
Spokane Valley, WA
REASON Source Plasma, collected from a donor
that tested reactive for hepatitis C virus (HCV), by the polymerase chain
reaction (PCR) assay, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION CA
PRODUCT Platelets
Pheresis Leukocytes Reduced,
CODE Unit:
LW12875
RECALLING FIRM/MANUFACTURER Central Blood Bank,
Pittsburgh, PA
REASON Blood product, with platelet yield below
the firm’s specified minimum requirement, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Fresh Frozen
Plasma,
CODE Units: 3006637,
3005136
RECALLING FIRM/MANUFACTURER South Texas Blood and
Tissue Center, San Antonio, TX
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 2 units
DISTRIBUTION TX
PRODUCT Red Blood
Cells,
CODE Unit:
7003531
RECALLING FIRM/MANUFACTURER Walter L. Shepeard
Community Blood Center, Inc., Augusta, GA
REASON Blood product,
collected from a donor who reported travel to an area designated as endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Red Blood
Cells,
CODE Unit:
2018616
RECALLING FIRM/MANUFACTURER Walter L. Shepeard
Community Blood Center, Inc., Augusta, GA
REASON Blood product,
collected from a donor who reported travel to an area designated as endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT
a) Red Blood
Cells,
b) Platelets,
CODE a) and b) Unit:
1030740
RECALLING FIRM/MANUFACTURER Walter L. Shepeard
Community Blood Center, Inc., Augusta, GA
REASON Blood product,
collected from a donor who reported travel to an area designated as endemic for
malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION GA
PRODUCT
a) Platelets
Pheresis, Leukocytes Reduced,
b) Platelets Pheresis,
Leukocytes Reduced, Irradiated,
CODE
a) Units: 04FP64617P1, 04FP64617P2,
04FP64707, 04FP64901P1, 04FP64901P2, 04FP64957, 04FP64965, O4FP64996P1, O4FP64996P2, 04FP65015, 04FP65040P1, 04FP65040P2,
04FP65068, 04FP65103,
04FP65153, 04FP65314P1, 04FP65314P2, 04FP65329P, 04FP65361, 04FP65371P1,
04FP65371P2, 04FP65374P2, 04FP65385P1, 04FP65385P2, 04FP65422, 04FP65460, 04FP65483, 04FP65672, 04FP65691, 04FP65760,
04FP65784,
04FP65804, 04FP65916P1, 04FP65916P2, 04FP65967P1, 04FP65967P2, 04FP65969,
04FP65987, 04FP66080P1, 04FP66080P2, 04FP66093, 04FP66111P1, 04FP66111P2, 04FP66175P1, 04FP66175P2, 04FP66230,
04FP66288,
04FP66357P1, 04FP66357P2, 04FP66360P1, 04FP66360P2, 04FP66492P1,
04FP66492P2, 04FP66493P1, 04FP66493P2, 04FP66509P1, 04FP66509P2,
04FP66532P1,
04FP66532P2, 04FP66548P1, 04FP66548P2, 04FP66572, 04FP66586P1, 04FP66586P2, 04FP66587P1, 04FP66587P2,
04FP66599P1,
04FP66599P2, 04FP66662, 04FP66706P1, 04FP66706P2, 04FP66712, 04FP66728P1,
04FP66728P2, 04FP66797, 04FP66799, 04FP66902P1, 04FP66902P2, 04FP66905P2,
04FP66933P1, 04FP66933P2, 04FP66935P1, 04FP66935P2, 04FP66936P1,
04FP66936P2, 04FP66950, 04FP66986P1, 04FP66986P2, 04FP67005, 04FP67018P1, 04FP67018P2, 04FP67030, 04FP67069P1, 04FP67069P2,
04FP67074,
04FP67121P1, 04FP67121P2, 04FP67122P1, 04FP67122P2, 04FP67123P2, 04FP67171,
04FP67190, 04FP67347P1, 04FP67347P2, 04FP67383P1, 04FP67383P2, 04FP67415P1, 04FP67415P2, 04FP67416, 04FP67556P1,
04FP67556P2,
04FP67559, 04FP67580P1, 04FP67580P2, 04FP67595P1, 04FP67595P2, 04FP67652,
04FP67663, 04FP67702P1, 04FP67702P2, 04FP67774P1,
04FP67774P2, 04FP67804P1, 04FP67804P2, 04FP67806P1, 04FP67806P2, 04FP67821, 04FP67833P1, 04FP67833P2, 04FP67857P1,
04FP67857P2,
04FP67858P1, 04FP67858P2, 04FP67939P1, 04FP67939P2, 04FP67941P1,
04FP67941P2, 04FP67968, 04FP68032, 04FP68067, 04FP68153P1, 04FP68153P2, 04FP68173, 04FP68272P1, 04FP68272P2, 04FP68291P1,
04FP68291P2,
04FP68311P1, 04FP68311P2, 04FP68387P1, 04FP68387P2, 04FP68390P1,
04FP68390P2, 04FP68406, 04FP68412P2, 04FP68429P1, 04FP68429P2, 04FP68527P1, 04FP68527P2, 04FP68529P1, 04FP68529P2, 04FP68584P1,
04FP68584P2,
04FP68601P1, 04FP68601P2, 04FP68613, 04GP53958P1, 04GP53958P2, 04GP53988P1,
04GP53988P2, 04GP54167P1, 04GP54167P2, 04GP54196P1, 04GP54196P2, 04GP54579P1, 04GP54579P2, 04GP54618P1, 04GP54618P2,
04GP54678P1,
04GP54678P2, 04P50398, 04P50504P1, 04P50504P2, 04P50580, 04P50655,
04P51092P1, 04P51092P2, 04P51299P1, 04P51299P2, 04P51428P1, 04P51428P2,
04P51442P1, 04P51442P2, 04P51477P1, 04P51477P2, 04P51478P1, 04P51478P2, 04P51540P1, 04P51540P2, 04P51624P1, 04P51624P2, 04P51766P1,
04P51766P2,
04P51958, 04P52007P1, 04P52007P2, 04P52094P1, 04P52094P2, 04P52135P1,
04P52135P2, 04P52375, 04P52652, 04P52738P1, 04P52738P2, 04P52772,
04FP64831P1, 04FP64831P2;
b) Units: 04FP65329P1, 04FP67020, 04FP67859P1,
04FP67859P2, 04FP67123P1, 04P52750, 04FP65374P1, 04FP65851, 04P52027P1, 04P52027P2, 04P52241P1, 04P52241P2, 04FP64962, 04FP66905P1,
04FP67734,
04FP68412P1
RECALLING FIRM/MANUFACTURER American Red
Cross, New England Region, Dedham, MA
REASON Platelets, collected in apheresis
collection kits that may have exceeded their acceptable period for use, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 233
units
DISTRIBUTION GA, MA, PA, ME, NH, VA, and VT
PRODUCT Platelets
Pheresis, Leukocytes Reduced,
CODE Units: 22KG91790
RECALLING
FIRM/MANUFACTURER American National Red Cross, Penn-Jersey Region,
Philadelphia, PA
REASON Platelets, possibly contaminated with
Corynebacterium species, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION PA and NJ
PRODUCT Source Plasma,
CODE
Units: ST0870889, ST0872003,
ST0872145, ST0872414, ST0872737, and ST0873021
RECALLING
FIRM/MANUFACTURER Stillwater Plasma Center LLC, Stillwater, OK
REASON
Source Plasma, which had not been tested
for HIV NAT, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 6 units
DISTRIBUTION UK
PRODUCT
a) Red Blood
Cells,
b) Red Blood Cells, Leukocytes Reduced,
c) Plasma Frozen,
CODE
a)
Units: 12LL21379, 12LL21380, 12LL21382, 12LL21383, and 12LL21384;
b)
Units: 12GL83396, 12GL83397, 12GL83398, 12GL83400, 12GL83401, 12GL83402,
12GL83403, 12GL83404, 12GL83405, 12GL83407, 12GL83408, 12GL83409, 12GL83410,
12GL83411, 12GL83412, 12GL83413, 12GM09065, 12GM09066, 12GM09067, 12GM09068, 12GM09069, 12GM09070, 12GM09072, 12GM09073,
12GM09074,
12GM09075, 12GM09076, 12GM09077, 12GM09078, 12GM09079, 12GM09080, 12GM09082,
12GM09083, 12GM09084, 12GM09085, 12GM09086, 12GM09087, 12GM09088, 12GN92999, 12GN93000, 12GN93002, 12GN93003, 12GN93004, 12GN93005,
12GN93006,
12GN93007, 12GN93008, 12GN93009, 12GN93010, 12GN93011, 12GN93012, 12GN93013,
12GN93014, 12GN93015, 12GN93016, 12GN93017, 12GN93019, 12GN93020, 12GN93021, 12GN93022, 12GN93023, 12GN93024, 12GN93025, 12GN93026,
12GN93027,
12GN93028, 12GN93029, 12GN93030, 12GN93031, 12GN93032, 12GN93033, 12GN93034,
12GN93035, 12GN93036, 12GN93037, 12GN93039, 12GN93040, 12GN93041, 12GN93042, 12GN93043, 12GN93044, 12GN93045, 12KP90079, 12KP90080,
12KP90081,
12KP90083, 12KP90084, 12KP90085, 12KP90086, 12KP90088, 12KP90089, 12KP90090,
12KP90093, 12KP90094, 12KP90095, 12KP90096, 12KP90097, 12KP90098, 12KP90099, 12KP90100, 12KP90101, 12KP90102, 12KP90103, 12KP90104,
12KP90105,
12KP90106, 12KP90107, 12KP90108, 12KP90109, 12KP90110, 12KP90111, 12KP90119,
12KP90120, 12KP90121, 12KP90122, 12KP90123, 12KP90124, 12KP90125, 12KP90127, 12KP90128, 12KP90129, 12KP90130, 12KP90132, 12KP90134,
12KP90135,
12KP90136, 12LJ63210, 12LJ63211, 12LJ63212, 12LJ63214, 12LJ63215, 12LJ63216,
12LJ63217, 12LJ63218, 12LJ63219, 12LJ63220, 12LJ63221, 12LJ63222, 12LJ63223, 12LJ63225, 12LJ63227, 12LJ63228, 12LJ63229, 12LJ63231,
12LJ63232,
12LJ63233, 12LJ63234, 12LJ63235, 12LJ63236, 12LJ63237, 12LJ63238, 12LJ63239,
12LJ63240, 12LK69114, 12LK69115, 12LK69116, 12LK69117, 12LK69118, 12LK69119, 12LK69120, 12LK69121, 12LK69123, 12LK69124, 12LK69125,
12LK69126,
12LK69127, 12LK69129, 12LK69130, 12LK69131, 12LL21381, and 12LL21385.
c)
Units: 12GL83398, 12GM09066, 12GM09075, 12GN93001, 2GN93012, 2LJ63231 and
12LJ63238.
RECALLING FIRM/MANUFACTURER American National
Red Cross, Carolinas Region, Charlotte, NC
REASON Blood products, for which shipping
conditions were undocumented, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 183 units
DISTRIBUTION GA, NE, NC,
VA, SC, and TN
PRODUCT Source Plasma
CODE
Units: ST0870666,
ST0870893
RECALLING FIRM/MANUFACTURER Stillwater Plasma
Center LLC, Stillwater, OK
REASON Source Plasma, which had not
been tested for HIV NAT, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION UK
PRODUCT Recovered
Plasma,
CODE Unit: 2597240, 2596321,
2596720, 2599098, 2630082, 2628579, 2601579
RECALLING
FIRM/MANUFACTURER South Texas Blood & Tissue Center, San
Antonio, TX
REASON Blood products, collected from
donors whose suitability to donate had not been adequately determined, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION TX, WI, Austria and Switzerland
PRODUCT Red Blood
Cells, Leukocytes Reduced,
CODE Units:
03LR76868, 03GR10492, 03GF10441, 03GF10582, 03GF10619, 03KM31460, 03LE25494,
03GF10435, 03GF11098, 03GF10869, 03K 31892, 03FJ78587, 03FJ78751, 03GF11087,
03GF10809, 03FG42813, 03LR77069, 03GF11145, 03GF10507, 03GF10440, 03GX31757,
03LX30116, 03LR76902, 03FF78312, 03LE26546, 03LE26532, 03GX32043, 03V 35328,
03LE26442, 03LR76881, 03GF11298, 03GF10630, 03GF10430, 03GF10537, 03GG11828,
03GP63149, 03GZ62987, 03LE26223, 03LX30001, 03GF11362, 03GC18782, 03LR76870,
03FV90781, 03FY06900, 03GG11872, 03FJ78610
RECALLING
FIRM/MANUFACTURER American National Red Cross, Southern Region,
Atlanta, GA
REASON Red Cells,
mislabeled as to M antigen phenotype, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 46
units
DISTRIBUTION GA
PRODUCT Platelets
Pheresis, Leukocytes Reduced, Irradiated,
CODE Unit: A226093
RECALLING
FIRM/MANUFACTURER Puget Sound Blood Center Program, Seattle, WA
REASON
Platelets, untested for infectious
disease markers, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION WA
PRODUCT Red Blood
Cells, Leukocytes Reduced,
CODE Unit:
22KE08954
RECALLING FIRM/MANUFACTURER American National
Red Cross, Penn-Jersey Region, Philadelphia, PA
REASON Red Cells, mislabeled as to the C
antigen phenotype, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION PA
PRODUCT Red Blood
Cells, Leukocytes Reduced, Irradiated,
CODE Unit: 027LL12902
RECALLING
FIRM/MANUFACTURER The American National Red Cross, Greater
Alleghenies Region, Johnstown, PA
REASON Blood product, out of controlled storage
for an undocumented length of time, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red Blood
Cells,
CODE Unit:
22KV02633
RECALLING FIRM/MANUFACTURER American National
Red Cross, Penn-Jersey Region, Philadelphia, PA
REASON Red Cells, mislabeled as to unexpected
antibodies, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION PA
WEEK ENDING AUGUST 19
PRODUCT Source Plasma,
CODE
Units: 0421074947, 0421074114, 0421073373,
0421071954 and 0421068618.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Lansing,
MI
REASON Blood products, which were collected from an
unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5
units
DISTRIBUTION IL
PRODUCT Red Blood Cells,
CODE
Unit: KJ68156
RECALLING
FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA,
REASON Blood product,
mislabeled as to CMV status, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION PA
PRODUCT
a) Red Blood Cells,
b) Cryoprecipitated
AHF,
CODE a) and b) Unit: KC92360
RECALLING
FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Blood product,
mislabeled as to CMV status, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION PA
PRODUCT Recovered Plasma,
CODE
Unit: 2505256
RECALLING
FIRM/MANUFACTURER South Texas Blood and Tissue Center, San Antonio, TX,
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 Switzerland
PRODUCT Galileo Automated Blood
Bank Analyzer,
CODE Galileo CMV Assay 1.02
(20MAY04)
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA
REASON
Galileo Blood Bank Analyzer, loaded with the wrong
version of CMV Assay, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 25 units
DISTRIBUTION Nationwide
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets, Leukocytes, Reduced,
CODE
a) Units: LH39588, LH34329;
b) Unit:
LH39588
RECALLING FIRM/MANUFACTURER Healthcare Provider Services,
Inc., Dba Rhode Blood Center, Providence, RI,
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 RI and MA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Platelets, Leukocytes, Reduced,
CODE a) and b) Unit: 1006206
RECALLING
FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH
REASON Blood
products, collected from a donor who reported travel to an area designated as
endemic for malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION FL and OH
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
28LT5494
RECALLING FIRM/MANUFACTURER American National Red Cross,
South Carolina Region, Columbia, SC.
REASON Blood product, collected from
a donor who reported travel to an area designated as endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT
a) Red Blood Cells,
b) Recovered Plasma, Recall #
B-1675-6
CODE a) and b) Unit: 12GE40856
RECALLING
FIRM/MANUFACTURER American National Red Cross, Carolinas Region,
Charlotte, NC
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 NC and Switzerland
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
22FZ20136
RECALLING FIRM/MANUFACTURER American National Red Cross,
Penn-Jersey Region, Philadelphia, PA
REASON Blood product, which a platelet yield that may
have been below the acceptable limit, was distributed.
VOLUME OF PRODUCT
IN COMMERCE 1 unit
DISTRIBUTION PA
PRODUCT Source Plasma
CODE
Units: 0040133218, 0041033488, 0041034165,
0041034500, 0041035451, 0041035739, 0041036480, 0041036905, 0041037382,
0041037818, 0041038386, 0041038975, 0041039435, 0041040092, 0041040409,
0041041157, 0041041681, 0041042188, 0041042671, 0041043279, 0041050545,
0041044310, 0041044763, 0041045352, 0041045769, 0041046323, 0041046781,
0041047381, 0041047845, 0041048475, 0041048895, 0041049865, 0041049943,
0041050854, 0041051274, 0041051821, 0041052296, 0041052813, 0041053336,
0041053873, 0041054464, 0041055416, 0041055948, 0041056329, 0041056906,
0041057494
RECALLING FIRM/MANUFACTURER Nabi Biopharmaceuticals,
Gainesville, FL
REASON Source Plasma, collected from a donor who had
received a piercing within 12 months of donation, was distributed.
VOLUME
OF PRODUCT IN COMMERCE 46 units
DISTRIBUTION NC and
Korea
PRODUCT Source Plasma
CODE
Units: 0440483542, 0440482567, 0440477493,
0440476789, 0440476223, 0440475800, 0440475308, 0440474504, 0440474280,
0440473571, 0440472434
RECALLING FIRM/MANUFACTURER ZLB Bioplasma,
Inc., Charleston, SC
REASON Blood products, collected from a donor who
provided post donation information regarding multiple high-risk behaviors, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 11
units
DISTRIBUTION NC
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
003E59603
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern Region, Atlanta, GA
REASON Blood product,
collected from a donor whose documentation of a hematocrit test during the donor
screening process was discrepant, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
003LJ38321
RECALLING FIRM/MANUFACTURER American National Red Cross,
Southern Region, Atlanta, GA
REASON Blood product, collected from a donor who did not
have a hematocrit test during the donor screening process, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION GA
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit:
71X348833
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Inc., Dunwoody, GA,
REASON Blood product, which yielded a platelet
count that was below the acceptable limit, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Galileo Automated Blood
Bank Analyzer, Immediate Spin Crossmatch (IS_XM) Assay,
CODE Units: 00064999, 00064997
RECALLING
FIRM/MANUFACTURER Immucor, Inc, Norcross, GA
REASON Blood Bank Analyzers, which may not give expected
compatibility results, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 75 units
DISTRIBUTION Nationwide, Canada and
Japan
PRODUCT Becton Dickinson CMV scan
Card Test Kit,
Catalog No. 255205, Catalog No. 255001, and
Catalog No. 255126
CODE
Lot No. 6095886; Exp. 8/31/2006;
Lot
No. 6095884; Exp. 8/31/2006;
Lot No. 6114596; Exp.
10/31/2006;
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Becton Dickinson & Co., Sparks, MD
Manufacturer: Becton Dickinson Caribe LTD,
Cayey, PR.
REASON CMV Test Kits, which may
produce false positive test results when testing some plasma specimens, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 393 test
kits
DISTRIBUTION Nationwide, Canada, Australia, and Bermuda
PRODUCT Fresh Frozen Plasma
CODE
Unit: KJ84399
RECALLING
FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
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 PA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
36M69917
RECALLING FIRM/MANUFACTURER American National Red Cross,
South Carolina Region, Columbia, SC,
REASON Blood product, collected from
a donor who reported travel to an area designated as endemic for malaria, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION SC
PRODUCT
a) Red Blood Cells,
b) Fresh Frozen Plasma, Recall #
B-1690-6
CODE a) and b) Unit: 28LJ10623
RECALLING
FIRM/MANUFACTURER American National Red Cross, South Carolina Region,
Columbia, SC,
REASON Blood products, which tested negative for
hepatitis, but were collected from a donor with a history of Hepatitis A, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION SC
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
7036900
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON
Blood product, collected from an ineligible donor
due to use of the medication Finasteride (Proscar), was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced
b) Platelets, Leukocytes Reduced,
CODE a) and b) Unit: 16KJ11127
RECALLING
FIRM/MANUFACTURER American National Red Cross, Central Ohio Region,
Columbus, OH
REASON Blood products,
collected from a donor for whom donor suitability was not adequately determined,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 2
units
DISTRIBUTION OH
PRODUCT
a) Red Blood Cells,
b) Platelets,
c) Fresh Frozen
Plasma,
CODE a), b) and c) Unit:
4173807
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON
Blood products, which tested negative for
hepatitis, but were collected from a donor who had a history of non-sexual
exposure to Hepatitis B, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 3 units
DISTRIBUTION OH
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Units: 1611885 (split
unit)
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center,
Cincinnati, OH
REASON Blood products, which were inappropriately
distributed in single storage bags, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION OH
PRODUCT Source
Plasma
CODE Units: 4120006824, 4120006814, 4120006834,
4120006815, 4120006823, 4120006833, 4120006838, 4120006846, 4120006835,
4120006844, 4120006841, 4120006840, 4120006839, 4120006837, 4120006830,
4120006832, 4120006829, 4120006825, 4120006826, 4120006827, 4120006828,
4120006842, 4120006843, 4120006847, 4120050462, 4120050466, 4120050463,
4120050460, 4120050454, 4120050469, 4120050468, 4120050449, 4120050455,
4120050467, 4120050459, 4120050236, 4120050237, 4120050240, 4120050239,
4120050229, 4120050213, 4120050223, 4120050227, 4120050225, 4120050224,
4120050220, 4120050226, 4120050211, 4120050214, 4120050218, 4120050221,
4120050228, 4120050233, 4120050241, 4120050238, 4120050464, 4120050452,
4120050232, 4120050230, 4120050216, 4120050217, 4120050235, 4120050422,
4120050457
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc.,
Indianapolis, IN
REASON Blood products, which were possibly exposed to
unacceptable storage temperatures, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 64 units
DISTRIBUTION IL and Switzerland
PRODUCT Fresh Frozen Plasma
CODE
Units: 22LW81325 (4 units), 22GS16769 (2
units)
RECALLING FIRM/MANUFACTURER American National Red Cross,
Penn-Jersey Region, Philadelphia, PA
REASON Blood products, which were not frozen within the
appropriate time frame following collection, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 6 units
DISTRIBUTION PA
PRODUCT Source Plasma,
CODE
Units: 0041063949, 0041063461, 0041063061,
0041062209, 0041061707, 0041061226, 0041060760, 0041059964, 0041059467,
0041058867, 0041057900, 0041057600, 0041056282, 0041055560, 0041054928,
0041054453, 0041053415, 0041052782, 0041052384, 0041051569, 0041051030,
0041050545, 0041049884, 0041049550, 0041048850, 0041048267, 0041047778,
0041046765, 0041046359, 0041045363, 0041044788, 0041043710, 0041042672,
0041042564, 0041041647, 0041041564, 0041040416, 0041039497, 0041038730,
0041037590, 0041037231, 0041036356, 0041035323, 0041034698, 0041033507,
0041032992, 0041032476, 0041031772, 0041031512, 0041030760, 0041029381,
0041023311, 0041022528, 0041022137, 0041021357
RECALLING
FIRM/MANUFACTURER Nabi Biopharmaceuticals, Gainesville, FL
REASON Blood products, collected from a donor for whom
post-donation information was received regarding a previous deferral for
unacceptable viral marker test results, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 55 units
DISTRIBUTION NC and Korea
PRODUCT Red Blood Cells Pheresis,
Leukocytes Reduced,
CODE Unit:
18427-1807
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood
Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
REASON
Blood product, collected from an
ineligible donor due to a history of receiving a tissue transplant, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION MS
PRODUCT Recovered Plasma,
CODE
Unit: 16KJ11127
RECALLING
FIRM/MANUFACTURER American National Red Cross, Central Ohio Region,
Columbus, OH
REASON Blood product, collected from a donor
for whom donor suitability was not adequately determined, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA
WEEK ENDING AUGUST 26
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced,
CODE Unit:
027LR64386
RECALLING FIRM/MANUFACTURER American National Red Cross,
Greater Alleghenies Region, Johnstown, PA
REASON Red Cells, with an unacceptable volume, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION PA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
22LC26946
RECALLING FIRM/MANUFACTURER American National Red Cross,
Penn-Jersey Region, Philadelphia, PA
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 PA
PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced,
c) Recovered Plasma,
CODE
a)
Units: 03LL14732, 03FV60345;
b) Unit: 03GF59615;
c) Units: 03LL14732,
03GF59615 RECALLING FIRM/MANUFACTURER
American National Red Cross,
Southern Region, Atlanta, GA
REASON Blood products, collected from a donor who
provided post donation information relating to positive test results, were
distributed.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION GA
PRODUCT Capture-S Indicator Red
Cells
CODE Lot 28477R
RECALLING
FIRM/MANUFACTURER Immucor, Inc., Norcross, GA,
REASON One lot of Indicator
Red Cells showing weak or negative reactivity when tested with Capture-S
Reactive Control Serum, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 Lot
DISTRIBUTION Nationwide, Italy, Germany and
Portugal
PRODUCT Recovered Plasma,
CODE
Unit: 9084156
RECALLING
FIRM/MANUFACTURER Blood Bank of Delmarva Inc., Newark, DE, 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 NJ
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
027GL78845
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Greater Alleghenies Region, Johnstown, PA
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 WV
PRODUCT Red Blood Cells,
CODE
Unit: 1028731
RECALLING
FIRM/MANUFACTURER Walter L. Shepeard Community Blood Center, Inc.,
Augusta, GA,
REASON Blood product, collected from a donor who traveled
to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT
a) Red Blood Cells,
Leukocytes Reduced,
b) Fresh Frozen Plasma,
CODE a) and b) Unit: 8026713
RECALLING
FIRM/MANUFACTURER Blood Bank of Delmarva, Inc., Newark, DE, REASON Blood products, collected from a donor
who had received rabies vaccine, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION DE
PRODUCT
Platelets Pheresis
Leukocytes Reduced,
CODE Units: 22LE10597 (split
product)
RECALLING FIRM/MANUFACTURER The American National Red
Cross, Philadelphia, PA
REASON Blood
products, collected from a donor whose new variant Creutzfeldt-Jacob disease (nvCJD) questionnaire was not completed, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 2 units
DISTRIBUTION PA
PRODUCT Galileo Automated Blood
Bank Analyzer (in-vitro diagnosis testing of human blood using a microplate
platform. Assays include ABO grouping and Rh (D) typing,
detection/identification of IgG red cell antibodies and compatibility testing),
CODE
Catalog Numbers: 0064997;
0064999
RECALLING FIRM/MANUFACTURER Immucor, Inc., Norcross, GA
REASON
Blood Bank Analyzer, with a
software glitch, was distributed.
VOLUME OF PRODUCT IN COMMERCE 121
units
DISTRIBUTION Nationwide, Canada and Japan
PRODUCT
a) Red Blood Cells,
b) Platelets, Recall,
CODE
a) and b) Unit: 3103801
RECALLING
FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON Blood
products, collected from a donor who reported travel to an area designated as
endemic for malaria, were distributed.
VOLUME OF PRODUCT IN
COMMERCE 2 units
DISTRIBUTION OH
PRODUCT Platelets Pheresis,
Leukocytes Reduced,
CODE Unit
30GP43761
RECALLING FIRM/MANUFACTURER American National Red Cross,
Northeastern Pennsylvania Region, Ashley, PA
REASON Platelets, possibly contaminated with
Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NY
PRODUCT Platelets Pheresis,
Leukocytes Reduced
CODE Unit:
71X400916
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood
Centers, Inc., Dunwoody, GA
REASON Blood product, which yielded a platelet
count that was below the acceptable limit, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA
PRODUCT Red Blood Cells,
Leukocytes Reduced
CODE Unit:
1149556
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center
University, Cincinnati, OH
REASON Blood product, which was collected from
a donor who had traveled to a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION OH
PRODUCT Red Blood Cells
CODE
Unit: 0988754
RECALLING
FIRM/MANUFACTURER Bergen Community Regional Blood Center, Paramus, NJ,
REASON
Blood product, which was collected from a donor
who had traveled to a malarial endemic area, was distributed.
VOLUME OF
PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ
PRODUCT Red Blood Cells
Leukocytes Reduced,
CODE Units: 10746-4393 (split
unit), 10746-4361, 10746-5304
RECALLING FIRM/MANUFACTURER Blood
Systems, Inc., Scottsdale, AZ
REASON Blood products, out of controlled
storage for an undocumented length of time, were distributed.
VOLUME OF
PRODUCT IN COMMERCE 4 units
DISTRIBUTION AZ
PRODUCT Red Blood Cells,
Leukocytes Reduced,
CODE Unit:
LE97158
RECALLING FIRM/MANUFACTURER Sacramento Medical Foundation,
Sacramento, CA
REASON Blood product, for which the documentation of weld
acceptability for the sterile docking of the filter was incorrect, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION CA