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 firmís 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