JUNE 2010

WEEK ENDING JUNE 26

PRODUCT Source Plasma. 

REASON Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION CA

PRODUCT Source Plasma. 

REASON Blood products, collected from a donor who did not receive a complete physical examination, were distributed.

VOLUME OF PRODUCT IN COMMERCE 5 units

DISTRIBUTION Germany, IL

PRODUCT Red Blood Cells Leukocytes Reduced.

REASON Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION TN

REASON Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION TN

2) Units: W227709390798, W227708313034

RECALLING FIRM/MANUFACTURER

REASON Blood products, collected from a donor with a history of high risk behavior, were distributed.

VOLUME OF PRODUCT IN COMMERCE 5 units

DISTRIBUTION TN

PRODUCT Source Plasma. 

REASON Blood products, collected from a donor who did not receive a complete physical examination, were distributed.

VOLUME OF PRODUCT IN COMMERCE 10 units

DISTRIBUTION Austria

REASON Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION SC, NC

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION TN, IL

PRODUCT Cryoprecipitated AHF, Pooled. 

REASON Blood products, which were labeled with extended expiration dates, were distributed.

VOLUME OF PRODUCT IN COMMERCE 5 units

DISTRIBUTION WI, IA

REASON Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION FL

PRODUCT Fresh Frozen Plasma (Apheresis). 

REASON Blood product, which did not meet quality control specifications, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION TX

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 53KL69878

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 MD

PRODUCT Red Blood Cells Leukocytes Reduced.

CODE Unit: W149509304234

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 CA

PRODUCT Source Plasma. 

CODE Units: 6240193930, 6240182085

REASON Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION IL

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 53KG12737

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 DC

PRODUCT Source Plasma. 

REASON Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.

VOLUME OF PRODUCT IN COMMERCE 14 units

DISTRIBUTION IL

PRODUCT Plasma Frozen within 24 hours (FP24). 

CODE Unit: 041FL14369

REASON Blood product, collected from a donor whose scheduled physical exam was incomplete, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION AL

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 53FN41556

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 MD

PRODUCT Human Cornea Tissue.

REASON Human Corneas, recovered from an ineligible donor, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 corneas

DISTRIBUTION IL, MI

PRODUCT

1) Red Blood Cells. 

REASON Blood products, collected from a donor taking the medication Proscar, were distributed.

VOLUME OF PRODUCT IN COMMERCE 4 units

DISTRIBUTION OH

REASON Blood products, collected from a donor who was taking the medication finasteride, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION OH

REASON Blood products, which were not quarantined after receiving information concerning donor suitability, were distributed.

VOLUME OF PRODUCT IN COMMERCE 3 units

DISTRIBUTION KY, Austria

PRODUCT Red Blood Cells Leukocytes Reduced Irradiated. 

CODE Unit: W067109067876

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 LA

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 24KS98469

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 IN

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced.

CODE Unit: W051509101095 (2 units)

REASON Blood products, with a low hemoglobin level, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION WI

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: W038109025323

REASON Blood product, which was not tested for HIV/HCV NAT, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION FL

PRODUCT Platelets Pheresis Leukocytes Reduced. 

CODE Unit: W036909219876 (2 units)

REASON Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION NJ

PRODUCT Platelets Pheresis Leukocytes Reduced.

CODE Unit: W053509075286 (2 units)

REASON Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION NJ

PRODUCT Plasma Frozen within 24 hours (FP24). 

CODE Unit: 9526249

REASON Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION FL

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 024KR46612

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 KY

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: W042208002560D

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 LA

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 MO, AR

PRODUCT Platelets Pheresis Leukocytes Reduced. 

CODE Unit: 72N429870

REASON Blood product, with a low platelet count, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION AL

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 TN

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 53FJ09097

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 MD

PRODUCT Platelets Pheresis Leukocytes Reduced. 

CODE Units: W288609005745 (2 units)

REASON Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION IL

PRODUCT Platelets Pheresis Leukocytes Reduced. 

CODE Units: 032KP55224 Part A; 032KP55224 Part B

REASON Blood products, which did not meet the acceptable product specifications for release, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION MI

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 17KW97332

REASON Blood product, which was collected from a donor who traveled to a malaria endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION MA

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Units: 17GZ58716, 17KM70536

REASON Blood products, which tested positive for red cell antibodies, but were missing antibody identification labels, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION MN, WI

REASON Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION MN, MA

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Units: 17FL83961, 17GK25208

REASON Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION NJ, MA

PRODUCT Platelets Pheresis Leukocytes Reduced. 

CODE Units: 032KZ03636 Part A ;032KZ03636 Part B

REASON Blood products, for which the quality control testing was incomplete, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION WI

PRODUCT Platelets Pheresis Leukocytes Reduced. 

CODE Unit: 032GP41916

REASON Blood product, with a low platelet count, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION WI

PRODUCT Red Blood Cells Leukocytes Reduced. 

CODE Unit: 53G07729

REASON Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION MD

PRODUCT Source Plasma. 

CODE Units: 3260000142, 3260000173, 3260004707, 3260005722

REASON Blood products, which reached unacceptable temperatures during storage, were distributed.

VOLUME OF PRODUCT IN COMMERCE 4 units

DISTRIBUTION NC

REASON Blood products, collected from a donor with a history of high risk behavior, were distributed.

VOLUME OF PRODUCT IN COMMERCE 2 units

DISTRIBUTION TN

PRODUCT Recovered Plasma. 

CODE Unit: 53KL69878

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 CA

PRODUCT Recovered Plasma. 

CODE Unit: 53KG12737

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 CA

PRODUCT Source Plasma. 

CODE Units: 4010407937, 4010407906, 4010407944, 4010407922

RECALLING FIRM/MANUFACTURER

REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.

VOLUME OF PRODUCT IN COMMERCE 4 units

DISTRIBUTION IL

PRODUCT Recovered Plasma. 

CODE Unit: 53FN41556

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 CA

PRODUCT Recovered Plasma. 

CODE Unit: W067109067876

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 Switzerland

PRODUCT Recovered Plasma. 

CODE Unit: 24KS98469

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, River Valley Region, Louisville, KY, by electronic notification on February 17, 2010 and by letters dated February 17, 2010 and February 19, 2010. Firm initiated recall is complete.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION CA

PRODUCT Recovered Plasma. 

CODE Unit: 024KR46612

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

PRODUCT Recovered Plasma. 

CODE Unit: W042208002560D

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 Switzerland

PRODUCT Platelets. 

CODE Unit: W035210058676W

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 TX

PRODUCT Recovered Plasma. 

CODE Unit: 53FJ09097

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

PRODUCT Platelets Pheresis Leukocytes Reduced. 

CODE Unit: 9403172

REASON Blood product, which was not stored under continuous agitation and controlled temperature, was distributed.

VOLUME OF PRODUCT IN COMMERCE 1 unit

DISTRIBUTION OH

WEEK ENDING JUNE 19

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M595038
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc - Birmingham Region, Birmingham, AL
REASON Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Red Blood Cells Leukocytes Reduced. 
CODE Unit: 03GE22792
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, 
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 IL, GA  

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M644166
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, 
REASON Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M742080
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, 
REASON Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Source Plasma. CODE Unit: 2920272565
RECALLING FIRM/MANUFACTURER
PlasmaCare, Inc., Pittsburgh, PA, 
REASON Blood product, collected from a donor who received a tattoo within 12 months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Red Blood Cells Leukocytes Reduced. 
CODE Units: 2524419, 2537768
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, 
REASON Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION KY

PRODUCT 
1) Platelets. 
2) Red Blood Cells Leukocytes Reduced. 
CODE
1) and 2) Unit: 2534283
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, 
REASON Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION KY

PRODUCT Red Blood Cells Leukocytes Reduced. 
CODE Units: 2538674A, 2538674B, 2440841, 2461015A, 2461015B
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, 
REASON Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION KY

PRODUCT Red Blood Cells Leukocytes Reduced. 
CODE Units: 2495246, 2566894  
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, REASON Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION KY

PRODUCT Red Blood Cells Leukocytes Reduced. 
CODE Units: 238852, 2439038, 2455159, 2499047
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, 
REASON Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION KY

PRODUCT 
1) Platelets. 
2) Red Blood Cells. 
3) Red Blood Cells Leukocytes Reduced. 
CODE
1) and 3) Unit: 0754322;
2) Units: 0845494, 0787632
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, 
REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units  
DISTRIBUTION TX, MN

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M741396
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M873473
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc - East Alabama Region, Opelika, AL
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M884266
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc – Birmingham Region, Birmingham, AL
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M983822
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL,
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M689080
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, 
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M990677
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, 
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72N245952
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, 
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M588256
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT 
1) Red Blood Cells. 
2) Fresh Frozen Plasma. CODE
1) and 2) Unit: 6136713
RECALLING FIRM/MANUFACTURER
Hemacare Corp., Van Nuys, CA, 
REASON Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA

PRODUCT Red Blood Cells Leukocytes Reduced. 
CODE Unit: 12FG42121
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC, 
Manufacturer: American Red Cross Blood Services, Durham, NC. 
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 NC 

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72N103163
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M94932X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M633557
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M972868
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M912706
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M871873
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers – Wiregrass Region, Dothan, AL, 
REASON Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M877472
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc – Birmingham Region, Birmingham, AL
REASON Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72N296269
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Mobile, AL
REASON Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL 

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M868451
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Mobile, AL,
REASON Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72M606856
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc – Birmingham Region, Birmingham, AL
REASON Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72N29680X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL,
REASON Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE
Unit: W038109026624
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, 
Manufacturer: Florida's Blood Centers, Inc., Sebring, FL. 
REASON Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Platelets Pheresis Leukocytes Reduced. R
CODE Unit: 151209789
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc - Lubbock Center, Lubbock, TX 
REASON Blood product, contaminated with P. acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 151208932
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, Manufacturer: Blood Systems, Inc - Lubbock Center, Lubbock, TX. 
REASON Blood product, contaminated with P. acnes, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Source Plasma. CODE
Units: I56009010, I56008001, I56013568, I56013220, I56013070, I56014727, I56014536, I56012710, I56012406, I56012202, I56011624, I56011538, I56010643, I56010603, I56010081, I56009601, I56009421, I56009163, 392024806, 392024519,392024360,392023993, 392023885, 392023528, 392023302, 392023025, 392022863, 392022497, 392022309, 392022055, 392021901, 392021628, 392021438, 392020289, 392020152, 392019787, 392019536, 392019354, 392019045, 392018894, 392018605, 392018502, 392018181, 392017941, 392017713, 392017543, 392017310, 392016846, 392016698, 392016353, 392016190, 392015892, 392015684, 392015443, 392015300, 392014971, 392014887, 392014474, 392014367, 392013471, 392013288, 392012960, 392012794, 392012569, 392012368, 392012034, 392011306, 392010624, 392011896, 392010184, 392010022, 392009293, 392008544, 392008340, 392007488, 392007312, 392007029, 392006423, 392006114, 392002497, 392002254, 392002087, 392001836, 392001729, 392001459, 392001325, 392001123, 392000963, 392000739, 392000576, I56024163, I56024048, I56023511, I56023407, I56023247, I56023130, I56022945, I56022832, I56022613, I56021894, I56021805, I56021598, I56021541, I56021369, I56021266, I56021106, I56020827, I56020729, I56020361, I56020168, I56019995, I56019837, I56019618, I56019423, I56019365, I56019172, I56019129, I56018840, I56018751, I56018595, I56018515, I56018300, I56018049, I56017918, I56017753, I56015596, I56015529 and I56014261
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources Inc., Research Triangle Park, NC, Manufacturer: Talecris Plasma Resources Inc., Rockford, IL. 
REASON Blood products, collected from a donor who was previously permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE 128 units
DISTRIBUTION NC and Austria

PRODUCT Red Blood Cells Leukocytes Reduced. 
CODE Unit: 53GN82348
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Reg., Baltimore, MD, 
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 MD

PRODUCT 
1) Fresh Frozen Plasma. 

2) Red Blood Cells. 
CODE
1) and 2) Units: 004F42060
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, 
REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NY, ME

PRODUCT 
Plasma Frozen within 24 hours (FP24). 
CODE Unit: 7375617
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Melbourne, FL
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 FL

PRODUCT  Source Plasma. CODE
Units: 4920198227, 4920196062, 4920195831, 4920194386, 4920193638, 4920192943, 4920191433, 4920191141, 4920189989, 4920189137, 4920188652, 4920187523, 4920187285, 4920185930, 4920185134, 4920183956, 4920180532, 4920180153, 4920178805, 4920178007, 4920177050, 4920176808, 4920175479, 4920174944, 4920169659, 4920168711, 4920168121, 4920167283, 4920165983, 4920165243, 4920163932, 4920163439, 4920162391, 4920162154, 4920161170, 4920160166, 4920159830, 4920158652, 4920158163, 4920157419, 4920157098
RECALLING FIRM/MANUFACTURER
Recalling Firm: CSL Plasma. Boca Raton, FL
Manufacturer: CSL Plasma, Springfield, OH. 
REASON Blood products, collected using an abbreviated screening process for which the donor was not eligible, were distributed.
VOLUME OF PRODUCT IN COMMERCE 41 units
DISTRIBUTION IL, Germany, Switzerland

PRODUCT  Source Plasma. CODE
Units: 4080244491, 4080241784, 4080241086, 4080238994, 4080237396, 4080236451
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Inc., Boca Raton, FL. 
Manufacturer: ZLB Bioplasma Inc., Dayton, OH. 
REASON Blood products, collected from a donor whose scheduled physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION IL

PRODUCT  Source Plasma. CODE Unit: 4030250588
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma Inc., Boca Raton, FL, 
Manufacturer: ZLB Bioplasma Inc., Louisville, KY. 
REASON Blood product, untested for Hepatitis B surface antigen (HBsAg), and the antibodies to the human immunodeficiency virus type 1/2 (anti-HIV-1/2), Hepatitis C virus encoded antigen (anti-HCV), Hepatitis B core antigen (anti-HBc), and Syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT  Red Blood Cells Leukocytes Reduced. 
CODE Unit: W038309136793
RECALLING FIRM/MANUFACTURER
Mississippi Valley Reg Building Center, Davenport, IA,
REASON Blood product, which did not have red cell preservative solution added but which was labeled AS-5, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IA

PRODUCT  Recovered Plasma. 
CODE Unit: 03GE22792
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, 
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 IL, GA

PRODUCT  Recovered Plasma. 
CODE Units: 0845494, 787632, 0754322
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN,
REASON Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION Switzerland

PRODUCT  Recovered Plasma. 
CODE Unit: 12FG42121
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Carolinas Region, Charlotte, NC,
Manufacturer: American Red Cross Blood Services, Durham, NC. .
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

PRODUCT  Recovered Plasma. 
CODE Unit: 20Z15664
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT
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 MI

PRODUCT  Red Blood Cells. 
CODE
Units: W012009011421; W012009011423; W012009011422
RECALLING FIRM/MANUFACTURER
Department of Army US Army Blood Bank Center, Fort Hood, TX,
REASON Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION NJ

PRODUCT  Red Blood Cells Leukocytes Reduced. 
CODE Unit: 6899621
RECALLING FIRM/MANUFACTURER
BloodNetUSA, Inc., Lakeland, FL,
REASON Blood product, leukoreduced after the specified post collection time limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT  Red Blood Cells Leukocytes Reduced. 
CODE Unit: W071209052232
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, 
REASON Blood product, with an unacceptably low red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TN

WEEK ENDING JUNE 12

PRODUCT  Source Plasma. CODE Unit:  0141473269
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Tulsa, OK, 
REASON
Blood product, collected from a donor who did not have an acceptable physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Switzerland

PRODUCT 
1) Red Blood Cells Leukocytes Reduced. 
2) Plasma Frozen. 
CODE
1) and 2) Unit: 50LC29816
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, 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  Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72K733014
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT  Platelets Pheresis Leukocytes Reduced. 
CODE Unit: 72J389876
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, 
REASON Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT 
1) Platelets Pooled Leukocytes Reduced Irradiated. 
2) Red Blood Cells. 
CODE
Unit: 1) and 2) W141609375213
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle WA, 
Manufacturer: Puget Sound Blood Center and Program, Federal Way, WA, 
REASON Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION WA

PRODUCT  Red Blood Cells Leukocytes Reduced. 
CODE Unit: 012KQ74758
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, 
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 NC  

PRODUCT  Red Blood Cells Leukocytes Reduced. 
CODE Unit: W039808005862
RECALLING FIRM/MANUFACTURER
North Colorado Medical Center BB, Greeley, CO,
REASON Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT 
1) Cryoprecipitated AHF, Pooled. 
2) Recovered Plasma. 
CODE
Unit: W036309244038X
RECALLING FIRM/MANUFACTURER
Recalling Firm: BloodCenter of Wisconsin, Inc., Milwaukee, WI, 
Manufacturer: BloodCenter of Wisconsin, Inc., Brown Deer, WI. 
REASON Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION WI, Switzerland

PRODUCT  Red Blood Cells. CODE Unit: 9165678
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Port Charlotte, FL,
REASON Blood product, contaminated by air during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT  Platelets Pheresis Leukocytes Reduced. 
CODE Units: 17FP10692 (2 units), 17FP10693
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN
REASON Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION MN

PRODUCT  Source Plasma. CODE Unit: TQ055151
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN,
REASON Source Plasma, collected from a donor who subsequently tested negative for HIV and HCV NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT  Recovered Plasma. 
CODE Unit: 012KQ74758
RECALLING FIRM/MANUFACTURER
American Red Cross Carolinas Blood Services Region, Charlotte, NC, 
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 CA

PRODUCT  Red Blood Cells Leukocytes Reduced. 

CODE Units: 6750586, 6751153, 6757510, W116509100809
RECALLING FIRM/MANUFACTURER
Ogden Medical Center, Inc., Ogden, UT, 
REASON Blood products, with an unacceptably low red cell recovery rate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION UT

PRODUCT  Platelets Leukocytes Reduced. 
CODE Unit: 032KS30549
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, 
REASON Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

WEEK ENDING JUNE 5

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Unit: 024FF07722 (2 units)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO,
REASON
Blood products, for which quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION KY

PRODUCT Source Plasma. CODE
Units: 6120217900, 6120217310, 6120219544
RECALLING FIRM/MANUFACTURER
CSL Plasma, Inc., Columbia, SC,
REASON Blood products, for which physical examination was undocumented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION Switzerland; IL

PRODUCT 
1) Fresh Frozen Plasma.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: 012FW39248;
2) Units: 012FW39248, 012FQ86654
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC,
Manufacturer: American Red Cross Blood Services, Durham, NC.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units   
DISTRIBUTION NC    

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: 09GX52608
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Omaha, NB,
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 MD

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: 16LK44602
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH,
REASON Blood product, which was labeled as negative for the Fyb antigen, but was collected from a donor who subsequently tested positive for the Fyb antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: 2818492
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH
REASON Blood products, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: 6177584
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX,
REASON Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Source Plasma. CODE
Units: 381065814, 381065549, 381064763, 381065401, 381065185, 381063964, 381063762, 381063478, 381063186, 381062919, 381062406, 381062067, 381061315, 381061003, 381060233, 381059864, 381059613, 381059147, 381058284, 381058056, 381057760, 381057225, 381056814, 381055669, 381055407, 381054468, 381054275, 381047019, 381046821, 381046387, 381046166, 381043967, 381043739, 381043297, 381043068, 381041480, 381037532 and 381037503
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Peoria, IL,
REASON Blood products, collected from a donor who provided unreliable information regarding application of tattoos, were distributed.
VOLUME OF PRODUCT IN COMMERCE 38 units
DISTRIBUTION NC

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit: 71X267861
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL,  REASON Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Source Plasma. CODE
Unit: TA2018966; TA2019245; TA2020000; TA2020261; TA2020593; TA2020742; TA2055913; TA2058976; TA2061324; TA0008168; TA0012574; TA2003530; TA2017954; TA2018305; TA2018497; TA2018840
RECALLING FIRM/MANUFACTURER
Recalling Firm: DCI Biologicals Texarkana LLC, Gallup, NM,
Manufacturer: DCI Biologicals Texarkana, LLC, Texarkana, AR.
REASON Blood products, collected from a donor who provided unreliable information regarding application of tattoos and piercings, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units
DISTRIBUTION NC, VA

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit # 1690684
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center University of Cincinnati Medical Center, Cincinnati, OH,
REASON Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

PRODUCT Source Plasma. CODE
Units: 2040083641, 2040083417, 2040080677, 2040080432, 2040077653, 2040077393, 2040068825, 2040066383, 2040052816, 2040052582, 2040051758, 2040051398, 2040050802, 2040050247, 2040049341, 2040048657
RECALLING FIRM/MANUFACTURER
Recalling Firm: PlasmaCare, Inc., Cincinnati, OH,
Manufacturer: PlasmaCare Inc., Columbus, OH. .
REASON Blood products, collected from a donor whose physical exam was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units
DISTRIBUTION NC, CA

PRODUCT Source Plasma. CODE
Units: TA2002497; TA2002724; TA2003225; TA2004361; TA2143790; TA2144131; TA2145043; TA2145477; TA2146044; TA2146285; TA2146888; TA2147459; TA2148579
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana LLC, Texarkana, AR,
REASON Blood products, collected from a donor with high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units
DISTRIBUTION NC, England

PRODUCT 
1) Red Blood Cells Leukocytes Reduced.
2) Plasma Frozen.
CODE
1) and 2) Unit: W117009320905
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA
Manufacturer: Blood Centers of The Pacific - North Bay Center, Fairfield, CA. .
REASON Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit: 72M71087X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Inc., Gainesville, GA,
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT Red Blood Cells. CODE Unit: W088409027667
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI,
REASON Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION HI

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: W227709341682
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN,
REASON Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TN

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE
Unit: 004GZ05862 (Parts 1, 2, & 3)
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA,
REASON Blood products, which were labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION MA

PRODUCT 
1) Red Blood Cells.
2) Plasma Frozen within 24 hours (FP24).
CODE
1) Units: KL26509, W088609300606, W088609303912;
2) Units: KL26509, W088609303912
RECALLING FIRM/MANUFACTURER
Providence Health System Southern California, Burbank, CA,
REASON Blood products, collected from a donor who was previously deferred for high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION CA

PRODUCT Source Plasma. CODE Unit: 0650400015
RECALLING FIRM/MANUFACTURER
CSL Plasma, Racine, WI,
REASON Blood product, for which physical examination was undocumented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: W117009337904
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Blood Centers of the Pacific - Irwin Center, San Francisco, CA,
Manufacturer: Blood Centers of the Pacific - North Bay Center, Fairfield, CA,
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 CA

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: W0352100074914
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX,
REASON Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria, TX

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE
Units: W117009223294, W117009223294, W11700922552, W117009226998, W117009226998, W117009226998, W117009225527 and W117009225527
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA,
Manufacturer: Blood Centers of the Pacific - Shasta Blood Center, Redding, CA.
REASON Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION CA

PRODUCT Source Plasma. CODE
Units:  0360038200, 0360034032, 0360032192, 0360031470, 0360030857, 0360030527, 030028617, 0360028249, 0360027393 and 0360027156
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., South Bend, IN,
REASON Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION Spain

PRODUCT Source Plasma. CODE
Units: 7030617976; 7030617474; 7030616311; 7030615662
RECALLING FIRM/MANUFACTURER
ZLB Plasma Services, San Antonio, TX, .  
REASON Blood products, collected from a donor who did not receive a required annual physical, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION IN

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: 2441650
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY
REASON Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KY

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: W118809502610
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., Jacksonville, FL,
REASON Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Source Plasma. CODE Unit: 09MMTH7388
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Missoula, MT,
REASON Blood product, collected from a donor who had not had an annual physical performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Source Plasma. CODE Unit: 09GNDH1815
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Grand Forks, ND,   
REASON Blood product, collected from a donor who had not had an annual physical performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: W038309031505
RECALLING FIRM/MANUFACTURER
Mississippi Valley Reg. Bld. Center, Davenport, IA, .
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 LA

PRODUCT 
1) Platelets Pheresis Leukocytes Reduced Irradiated.
2) Platelets Pheresis Leukocytes Reduced.
CODE
1) and 2) Unit: W038309062147
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Building Center, Davenport, IA,
REASON Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE2 units
DISTRIBUTION NY, CA

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE
Units: W051509146805 and W051509146805
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN,
REASON Blood products, which were labeled leukoreduced, but had an unacceptable white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH

PRODUCT 
1) Red Blood Cells Leukocytes Reduced.
2) Recovered Plasma.
CODE
1) and 2) Unit: 016KG36090
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Central Ohio Region, Columbus, OH,
REASON
Blood products, which were not quarantined after receiving post donation information concerning an illness following donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH, CA

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: 16GR56012
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, 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 PA  

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: 026FW26508
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL,
Manufacturer: The American National Red Cross, Mobile, AL.
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 AL   

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: 29KE67178
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA,
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 VA 

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: W090709018777
RECALLING FIRM/MANUFACTURER
Blood Bank Of The Redwoods, Santa Rosa, CA,
REASON Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Switzerland and CA

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: 6312464
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX,
REASON Blood product, collected from a donor who was taking the medication finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria, TX

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit: 72K963089 (Parts 2 & 3)
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA,
REASON Platelets, inappropriately prepared by splitting the product into three storage bags instead of two, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION GA

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit: 72M595604
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit # 72M465914
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL,.
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit: 72M066208
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL,
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Fenwal PL 2410 Storage Container, 1000 mL with Tubing Leads; a sterile, nonpyrogenic fluid path and container for storage of up to a maximum of 4.7 x 10-11th platelets; 4 containers per pouch, 7 pouches per case; product code 4R2350.
CODE Lot number FA10A26035, expiration January, 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fenwal Inc., Lake Zurich, IL,
Manufacturer: Baxter Fenwal Division, Haina, Dominican Republic.
REASON Amicus Ancillary PL2410 Plastic Storage Containers, associated with reports of leaks on the heat seals at the end of the tubing leads, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3,052 units
DISTRIBUTION AL, AZ, CA, FL, GA, IL, MI, MN, NJ, NY, OK, PA, TN WA, WI

PRODUCT Bone.
CODE
Units: 094240301, 094240302, 094240303, 094240304, 094240305, 094240306, 094240307, 094240308, 094240314, 094240315, 094240328, 094240329, 094240330, 094240331, 094240332, 094240334, 094240335, 094240336, 094240337, 094240338, 094240339, 094240340, 094240341, 094240342
RECALLING FIRM/MANUFACTURER
Allosource, Centennial, CO,
REASON Human tissue allografts, with positive pre-processing cultures for group D Enterococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 24 grafts
DISTRIBUTION PA, NJ, CA

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit: 72M250257
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL,
REASON Blood product, which was not manufactured in accordance to the manufacturer's instructions for leukocyte reduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit: 72M554959
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit: 72M581231
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Mobile, AL,
REASON Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT 
1) Platelets Pheresis Leukocytes Reduced.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) and 2) Unit: 17FE08229
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN,
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MN, PA

PRODUCT 
1) Red Blood Cells Leukocytes Reduced.
2) Fresh Frozen Plasma.
CODE
1) and 2) Units: 55E55829 and 55E56335
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR
REASON Blood products, collected from a donor for which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION AR, MO

PRODUCT 
1) Influenza A (H1N1) 2009 Monovalent Vaccine, No Preservative 0.50 ml.

2) Influenza A (H1N1) 2009 Monovalent Vaccine, No Preservative Pediatric Dose 0.25 ml.
CODE
1) Unit: UT037AA exp 4/26/2011;

2) Units: UT023AA exp 3/28/2011, UT023BA exp 3/30/2011, UT023CA exp 4/1/2011, UT023EA exp 4/3/2011, and UT023FA exp 4/5/2011
RECALLING FIRM/MANUFACTURER
Sanofi Pasteur, Inc., Swiftwater, PA,
REASON
Influenza A (H1N1) 2009 Monovalent Vaccine, with antigen content lower than the specification limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 960,295 doses
DISTRIBUTION Nationwide

PRODUCT Recovered Plasma. Unit:
CODE Unit: 012FQ86654
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC,
Manufacturer: American Red Cross Blood Services, Durham, NC.
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

PRODUCT Influenza A (H1N1) 2009 Monovalent Vaccine, Live, Intranasal. The product is shipped in cartons containing 2 trays each tray contains 5 syringes. NDC 66019-200-01.
CODE
Lot numbers: 500751P, 500754P, 500756P, 500757P, 500758P, 500759P, 500760P, 500761P, 500762P, 500763P, 500764P, 500765P, 500776P
RECALLING FIRM/MANUFACTURER
Recalling Firm: MedImmune, LLC, Gaithersburg, MD,
Manufacturer: MedImmune, LLC, Philadelphia, PA.
REASON
Influenza A (H1N1) 2009 Monovalent Vaccine, with antigen content lower than the specification limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4,818,740 units
DISTRIBUTION Nationwide

PRODUCT Cornea.
CODE
Units: 12770901, 12770902
RECALLING FIRM/MANUFACTURER
Northeast Pa Lions Eye Bank, Inc., Bethlehem, PA,
REASON Human corneas, recovered from a donor whose donor eligibility was incomplete and subsequently determined to be suitable, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 corneas
DISTRIBUTION CT, PA

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE
Unit: W142809405927, W142809405931, W142809405924, W142809405925, W142809405922, W142809405939
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-Counties Blood Bank dba UBS- Central Coast, Santa Barbara, CA
Manufacturer: Tri-Counties Blood Bank dba Community Blood Bank, Inc., Rancho Mirage, CA.
REASON
Blood products, which were incorrectly labeled as being collected from volunteer donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION CA

PRODUCT Red Blood Cells Leukocytes Reduced Irradiated.
CODE Unit: 004E37435
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA,
REASON Blood product, manufactured without the additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NY

PRODUCT Recovered Plasma.
CODE
Unit: W0352100074914
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX,
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria, TX

PRODUCT Recovered Plasma.
CODE Unit: 16GR56012
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, 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

PRODUCT Recovered Plasma.
CODE Unit: 026FW26508
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL,
Manufacturer: The American National Red Cross, Mobile, AL.
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

PRODUCT Recovered Plasma.
CODE Unit: 29KE67178
RECALLING FIRM/MANUFACTURER
American National Red Cross Mid Atlantic Region, Norfolk, VA,
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

PRODUCT Recovered Plasma.
CODE
Unit: W090709018777
RECALLING FIRM/MANUFACTURER
Blood Bank Of The Redwoods, Santa Rosa, CA,
REASON
Blood product, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Switzerland and CA

PRODUCT Recovered Plasma.
CODE Unit: 6312464
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX,.
REASON Blood product, collected from a donor who was taking the medication finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria, TX

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE
Units: W039709150101M, W039709150103I  
RECALLING FIRM/MANUFACTURER
Heartland Blood Centers, Aurora, IL,
REASON Blood products, collected in expired collections bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MS

PRODUCT Source Plasma. CODE
Units: HS0221865, HS0222190, HS0223067, HS0223952, HS0224548, HS0225666
RECALLING FIRM/MANUFACTURER
DCI Biologicals Hot Springs, Inc., Hot Springs, AR,.
REASON Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION United Kingdom

PRODUCT 
Prevnar. Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM 197 Protein), 0.5 mL single dose pre-filled syringe (10 per package), NDC 0005-1970-50 (10s) and NDC 0005-1970-49 (Singles). NDC 0005-1970-50 - Prevnar Pneumococcal 7-valent Conjugate Vaccine- 1 carton contains 10 single dose (0.5 mL) pre-filled syringes. NDC 0005-1970-49 - Prevnar Pneumococcal 7-valent Conjugate Vaccine- 1 single dose (0.5 mL) pre-filled syringe. Unit size: 10 x 1 (0.5 mL) single dose pre-filled syringes per carton. Shipping Unit Size: 45 cartons of 10 x 1 (0.5 mL) single dose pre-filled syringes per shipper. US License # 3, 103905.
CODE
Lots: E25197 (EXP 10/13), E28211 (EXP 10/13), E37556 (EXP 10/13), E38749 (EXP 11/13)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals Inc., Philadelphia, PA,   
Manufacturer: Wyeth Pharmaceuticals, Inc., Pearl River, NY.
REASON Prevnar, with a potential for syringes with a rubber formulation in the tip caps that was not approved for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
46,155 (cartons of 10)
DISTRIBUTION Nationwide, Puerto Rico and Guam

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE Unit: 7165382
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX,
REASON A blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Units: 6060146; 6060167; 6060291; 6060242
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX,
REASON
Blood products, which did not meet the acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION TX