MARCH 2010
WEEK ENDING MARCH 27
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 2594131
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY,
REASON
Blood product, collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 6846521
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida’s Blood Centers, Inc., Orland, FL,
Manufacturer: Florida’s Blood Centers, Inc., Winter Springs, FL.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated.
CODE
Unit: W071209040570
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN,
REASON
Blood product, collected from a donor who provided a history of travel to a
malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Units: W088409000550 (double collection); 1736861 (double collection);
W088409000706; 1704195 (double collection); 1703897 (double collection)
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii,
REASON
Blood products, collected from a donor who provided a history of travel to a
malarial risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
HI
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Unit: W088409000989
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii,
REASON
Blood product, collected from a donor who provided a history of travel to a
malarial area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
HI
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Unit: 9010157, 9010664
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA,
REASON
Blood products, collected from a donor who visited a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
PRODUCT
1) Red Blood Cells.
2) Red Blood Cells Leukocytes Reduced.
3) Platelets Pooled Leukocytes Reduced.
CODE
1) Unit: W120609260582;
2) Unit: W120609261319;
3) Units: W120609380817, W120609382134
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI,
REASON
Blood products, collected from a donor who had traveled to areas that are
endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MI
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated.
2) Red Blood Cells (Apheresis)
Leukocytes Reduced.
CODE
1) Unit: W047009226621A;
2) Units: W047009361053A, W047009361053B, W047009371142, W047009226621B
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY,
REASON
Blood products, which did not meet the minimum requirement for red blood cell
recovery and were not tested for residual white blood cell count, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NY
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: W071209040517
RECALLING FIRM/MANUFACTURER
Medic Inc, Knoxville, TN,
REASON
Blood product, which was incorrectly tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: W141609433256
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA,.
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA.
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
WA
PRODUCT
1) Red Blood Cells.
2) Recovered Plasma.
3) Red Blood Cells Leukocytes Reduced. ;
4) Fresh Frozen Plasma.
CODE
1) Units: W126907242485, W126907245107, W126908244746, W126908246493,
W126909261093, W126909242843;
2) Units: 2429775, W126907242485, W126908244746, W126908246493, W126909261093, W126909242843;
3) Units: 2429775, W126908247162;
4) Unit: W126908247162
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL,
REASON
Blood products, collected from a donor with a history of exposure to an
individual with hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
GA, FL, Austria
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets Leukocytes Reduced.
CODE
1) and 2) Unit: 72L32546X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL
REASON
Blood products, collected from a donor who was previously deferred for a history
of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated.
2) Fresh Frozen Plasma.
CODE
1) and 2) Unit: 024KW66716
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Louisville, KY
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
KY, IN
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: W118809301433, W118809420817, W118809420799, W118809420804
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., Jacksonville, FL,
REASON
Blood products, which were leukoreduced by filtration beyond the allowable time
limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA, FL
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Platelets Pooled Leukocytes Reduced.
3) Fresh Frozen Plasma.
CODE
1), 2), and 3) Unit: 033GM43188
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT,
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
CT
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 09FK81518
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
NJ
PRODUCT
Source Plasma.
CODE
Unit: 0411423854
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Oak Park, MI,
REASON
Blood product, collected from a donor who did not receive a complete physical
examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 024KR40984
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Louisville, KY
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 Leukocytes Reduced.
CODE
Unit: 017GN51518
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN,
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
NJ
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 50Y22377
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, 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
OH
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 041FN78294
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL,
Manufacturer: American Red Cross Blood Services Alabama Region, Huntsville, 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
FL
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: 2326534, 2528224
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY
REASON
Blood products, collected from a donor who was taking the medication
mercaptopurine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
PRODUCT
Surround System software.
CODE
Surround software versions 4.1, 4.2, 4.2.1, 4.2.2, 4.4, 4.5, 4.6 and 4.7
RECALLING FIRM/MANUFACTURER
Haemonetics Software Solutions, Rosemont, IL,
REASON
Software, with a defect or glitch, was distributed.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
DC, FL, HI, IL, IN, IA, LA, MI, MN, MO, NJ, NC, OH, OR, PA, RI, SC, TN, TX, WA,
Canada, Hong Kong, PRC
PRODUCT
Source Plasma.
CODE
Units: SQ092956, SQ092940
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Wisconsin, Madison, WI,
REASON
Source plasma, collected from a donor who subsequently tested negative for HCV
and HIV NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 4351667
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute – Sylvan N Goldman Center, Oklahoma City, OK,
REASON
Blood product, collected from a previously deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
PRODUCT
Recovered Plasma.
CODE
Unit: 09FK81518
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
CA
PRODUCT
Recovered Plasma.
CODE
Unit: 024KR40984
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Louisville, KY,
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: 017GN51518
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN,
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: 50Y22377
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, 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: 041FN78294
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL,
Manufacturer: American Red Cross Blood Services Alabama Region, Huntsville, 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
WEEK ENDING MARCH 20
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Unit: 72H95739-X
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
AL
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 55R75265
RECALLING FIRM/MANUFACTURER
American National Red Cross, Little Rock, AR,
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR
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
AR
PRODUCT
1) Red Blood Cells.
2) Fresh Frozen Plasma.
3) Platelets.
CODE
1) Units: LV84211, LV84218, LV84219, LV84222, LV84236, LV84238;
2) Units: LV84211, LV84218, LV84236;
3) Unit: LV84236
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA,
REASON
Blood products, collected from donors for whom donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
PA, FL
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated.
2) Red Blood Cells Leukocytes Reduced.
3) Plasma Frozen.
CODE
1) Unit: 003KF34108;
2) and 3) Unit: 003S43365
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA,
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
GA
PRODUCT
Source Plasma.
CODE
Units: 384070392 and 384069982
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Phenix City, AL,
REASON
Blood products, collected from a donor who was previously deferred for a tattoo,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: 003LR99165, 003LR99172 and 003KX29116
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA,
Manufacturer: The American National Red Cross – Southern Region, Douglasville,
GA.
REASON
Blood products, which was not leukoreduced within the appropriate time period
after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 026KJ52776
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA,
Manufacturer: The American National Red Cross – Southern Region, Douglasville,
GA.
REASON
Blood product, which may have had an inadequate volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: 003LF39354, 003LF39367
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Atlanta, GA,
Manufacturer: The American National Red Cross – Southern Region, Douglasville,
GA.
REASON
Blood products, collected in a manner that may have compromised the sterility of
the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
PRODUCT
Platelets Pheresis Leukocytes Reduced, Irradiated.
CODE
Unit: 9953890
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL,
REASON
Blood product, which was inappropriately distributed in a single storage, was
distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Unit: 9917413
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL,
REASON
Blood product, which was inappropriately distributed in a single storage bag,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
PRODUCT
Fresh Frozen Plasma.
CODE
Unit: 5391172
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, 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
Austria
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Unit: 9896718
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL,.
REASON
Blood product, labeled leukoreduced without the assurance that it met the
criteria for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 03KH40513
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red, Douglasville, GA,
Manufacture: The American National Red Cross – Southern Region, Douglasville,
GA.
REASON
Blood product, collected from ineligible donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
PRODUCT
1) Platelets.
2) Red Blood Cells Leukocytes Reduced.
3) Plasma Frozen.
CODE
1), 2), and 3) Units: 028FL04785, 028FL06551 and 028FY03633
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA,
REASON
Blood products, collected from a donor who was previously deferred for testing
positive for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
CA, MI
PRODUCT
Red Blood Cells.
CODE
Unit: W287709000318
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lifesource, Glenview, IL,
Manufacturer: Lifesource Mundelein, Mundelein, IL.
REASON
Blood product, collected from a donor with unacceptably low hemoglobin, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
PRODUCT
1) Cornea.
2) Sclera.
CODE
1) Units: 20080297 (2); 20080423 (2); 20080457 (2); 20080517 (2); 20080549 (2);
20080553 (2); 20080601 (2); 20080805 (2); 20080835 (2); 20080899 (2); 20080921
(2); 20080925 (2);
2) Units: 20080457 (8 pieces); 20080601
(2 pieces); 20080805 (8 pieces)
RECALLING FIRM/MANUFACTURER
Transplant Services Center UT Southwestern Medical Center, Dallas, TX,
REASON
1) Tissue products, collected from donors whose suitability to donate was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 corneas and 18 pieces of sclera
DISTRIBUTION
TX, Venezuela
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: W087608043352; W087608043403
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA,
REASON
Blood products, labeled leukoreduced, which had not undergone leukoreduction,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 35V91549
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA,
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
MO
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 27S95141
RECALLING FIRM/MANUFACTURER
ARC Greater Alleghenies, Johnstown, PA,
REASON
Blood product, phenotypically mislabeled, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 9864575
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Lake Charles, LA,
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
LA
PRODUCT
Cornea.
CODE
Corneas: IN2007040861, IN2007040862
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN,.
REASON
Tissue, tested for viral markers using a sample that was possible diluted, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NM, SC
PRODUCT
Cornea.
CODE
Corneas: 09343OSCN, 090343ODCN
RECALLING FIRM/MANUFACTURER
Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN,
REASON
Tissue, tested for viral markers using a sample that was possible diluted, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
IN
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated.
CODE
Unit: 21KT52445
RECALLING FIRM/MANUFACTURER
American National Red Cross, Portland, OR,
REASON
Blood product, for which there was incomplete documentation of the irradiation
process, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR
PRODUCT
Red Blood Cells.
Plasma Frozen.
CODE
1) and 2) Unit: 35FX29611
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA,
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
VA, D.C.
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 53GQ50455
RECALLING FIRM/MANUFACTURER
American National Red Cross-Greater Chesapeake & Potomac Region, Baltimore,
MD,
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
MD
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated.
2) Platelets Pheresis Leukocytes Reduced.
CODE
1) Unit: W047009065340;
2) Unit: W047009054586; W047009054707; W047009065340
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Westbury, NY,
REASON
Blood products, collected from a donor who reported travel to a malarial endemic
area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NJ, NY
PRODUCT
Red Blood Cells.
CODE
Unit: W126909242270
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, 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
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 2542471
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY,
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
KY
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 2533178
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY,
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
KY
PRODUCT
Recovered Plasma.
CODE
Units: W087908654400; W087909651903; W087909652963; W087909654017; W087909650769
RECALLING FIRM/MANUFACTURER
Recalling Firm: Community Blood Bank of Lancaster County Medical Society,
Lincoln, NB
Manufacturer: Community Blood Bank of Lancaster County, Lincoln, NB.
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
5 units
DISTRIBUTION
Austria
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Fresh Frozen Plasma.
CODE
1) and 2) Unit: W221609603461
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood & Tissue Center, Austin, TX
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
VA, TX
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: W036509108156
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA,
REASON
Blood product, labeled “leukoreduced”, but which had not undergone
leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Recovered Plasma.
CODE
1) and 2) Units: GC48895; GC27593
RECALLING FIRM/MANUFACTURER
Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA,
REASON
Blood products, collected from a donor who resided in a HIV Group O risk area,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Austria, CA
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 003KY45445
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA,
Manufacturer: The American National Red Cross – Southern Region, Douglasville,
GA.
REASON
Blood product, collected in a manner that may compromise the sterility of the
product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
PRODUCT
Source Plasma.
CODE
Unit: NG0226370
RECALLING FIRM/MANUFACTURER
DCI Biologicals Nacogdoches, LLC, Nacogdoches, TX,
REASON
Blood product, collected from a donor who received ear piercings within 12
months of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UK
PRODUCT
Source Plasma.
CODE
Unit: WN0177327
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wilmington, Inc., Wilmington, NC, .
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
PA
PRODUCT
Source Plasma.
CODE
Units: HS0204796; HS0205007; HS0205666
RECALLING FIRM/MANUFACTURER
DCI Biologicals Hot Springs, Inc., Hot Springs, AR
REASON
Blood products, collected from a donor who reported non-sexual exposure to
Hepatitis C, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
UK
PRODUCT
1) Recovered Plasma.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) and 2) Unit: 2326023
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA,
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
Austria, CA
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Units: 0354165, 0354135, 0354138
RECALLING FIRM/MANUFACTURER
Blood Center of the St. Johns, Inc., St Augustine, FL,
REASON
Blood products, with platelet count below the specified minimum requirement,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units: 0569297, 0569616, 0569922
RECALLING FIRM/MANUFACTURER
Blood Center of the St. Johns, Inc., St Augustine, FL,
REASON
Blood products, collected from a donor who visited a malarial endemic area, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL, TX
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 0136077
RECALLING FIRM/MANUFACTURER
Blood Center of the St. Johns, Inc., St Augustine, FL
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
PRODUCT
1) Red Blood Cells.
2) Platelets Pheresis Leukocytes Reduced.
CODE
1) and 2) Unit: 1818783
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL,
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
FL
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Units: 9954025 (part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL,
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
PRODUCT
Platelets Pheresis 7-d Leukocytes Reduced.
CODE
Unit: 9956590 ( part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL,
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
PRODUCT
Platelets Pheresis-7 d Leukocytes Reduced.
CODE
Unit: 9954034 (part 1, 2, and 3)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL,
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
PRODUCT
Platelets Pheresis-7 d Leukocytes Reduced.
CODE
Units: 9955180 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL,
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
PRODUCT
Platelets Pheresis 7d Leukocytes Reduced.
CODE
Unit: 9912799
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL,
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Units: 8994037(part 1 and 2) 1946346(part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL,
REASON
Blood products, with unacceptable qc results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Cryoprecipitated AHF.
3) Fresh Frozen Plasma.
CODE
1) Units: 3234138, 3224073;
2) Unit: 3234138;
3) Unit: 3224073
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL,
REASON
Blood products, collected from a therapeutic donor and not labeled to indicate
the type of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units: 18FV8399, 18GW20186, 18FV85432, 18FG30990, 18FY66419, 18GR35712,
18GR36237, 18FF24878, 18FY60491, 18FY60240, 18FG31008, 18GR35290, 18FJ95274,
18GW18849, 18GT33406, 18GF69440, 18FG30985, 18FG30053, 18FY60233, 18GR35251,
18GW19433, 18FG27582, 18GR35270, 18FY66454, 18FY60497, 18GC62586, 18GW20097,
18GR35566, 18FG29985, 18FY61277 and 18FG28705
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI,
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
AZ, MD, MI, NJ, PA
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Units 18FJ93535, 18FJ93552, 18GD58657, 18GC58988, 18GR33983, 18GR32659,
18GC58751, 18GC58610, 18GW18105, 18GR38950, 18GW20234, 18FG26685, 18GW18136,
18FY66025, 18FG29271 and 18FG23249
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI,
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
AZ, MI, NJ, NY, PA
PRODUCT
Source Plasma.
CODE
Units: 08BINA6632, 08BINA6272, 08BINA5693, 08BINA5363, 08BINA2801, 08BINA2194,
08BINA1611, 08BINA1231, 08BINA0740, 08BINA0371, 07BINE2632, 07BINE2000,
07BINE1705, 07BINE1128, 07BINE0364, 07BIND9904, 07BIND9112, 07BIND8528,
07BIND8381, 07BIND7827, 07BIND7469, 07BIND6735, 07BIND6397, 07BIND5813,
07BIND5492 and 07BIND4515
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P, Bloomington, IN,
REASON
Blood products, which was collected from an unsuitable donor based on risk
factors for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units
DISTRIBUTION
IL
PRODUCT
Source Plasma.
CODE
Unit: 09MMTB3720
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Missoula, MT,
REASON
Blood product, collected from a donor in deferral status, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE
Unit: 003LM31567
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA,
Manufacturer: The American National Red Cross – Southern Region, Douglasville,
GA.
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
GA
PRODUCT
Source Plasma.
CODE
Unit: LC0603366
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, NM,
REASON
Blood product, collected from a donor who may have received a tattoo within
twelve months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
Units: 266822741 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR,
Manufacturer: United Blood Services - Hot Springs, Hot Springs, AR.
REASON
Blood products, for which the documentation of the apheresis procedure was
incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AR
PRODUCT
Recovered Plasma,
CODE
Unit: 55R75265
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Little Rock, AR,
Manufacturer: American National Red Cross, Greater Ozark-Arkansas Region, Little
Rock, AR.
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
Units: LV84219, LV84222, LV84238
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA,
REASON
Blood products, collected from donors for whom donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CA
PRODUCT
Recovered Plasma.
CODE
Unit: 003KF34108
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA,
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
1) Platelets Pheresis Leukocytes Reduced.
2) Red Blood Cells Leukocytes Reduced.
3) Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
1) Unit: 003KR16641;
2) Unit: 003KY31572;
3) Unit: 003S33443 (Parts 1 and 2)
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA,
REASON Blood products, collected from an unsuitable donor based
on travel to an area considered endemic for Leishmaniasis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA
PRODUCT
Source Plasma.
CODE
Unit: 08FIND6543
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fort Wayne, IN,
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
1) Platelets Pheresis Leukocytes Reduced Irradiated.
2) Platelets Pheresis Leukocytes Reduced.
CODE
1) Units: 003F25635, 003F25636, 003F25639, 003F25634, 003F25637;
2) Units: 003F25634, 003F25635,
003F25636, 003F25637, 003F25638 (Parts 1 & 2), 003F25639
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA,
REASON
Blood products, which may have reached an unacceptable temperature during
storage, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
GA
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Units: 041GM68991 (3 units)
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA,
REASON
Blood products, for which a platelet count was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AL, GA
PRODUCT
Fresh Frozen Plasma.
CODE
Units: 1881980, 1881993, 1882008, 1882963, 1882980, 1886244, 1886268, 1886272,
1886274, 1886278, 1886284, 1886304, 1886349, 1886614, 1886618, 1886622, 1886629
RECALLING FIRM/MANUFACTURER
Recalling Firm: Department of the Army, Augusta, GA, .
Manufacturer: D. D. Eisenhower Army Med. Ctr. - Blood Bank, Fort Gordon, GA.
F
REASON
Blood products, which may have reached an unacceptable temperature during
storage, were distributed
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
NJ
PRODUCT
1) Recovered Plasma.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) and 2) Unit: 003KF33846
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA,
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA.
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
CA, GA
PRODUCT
Recovered Plasma.
CODE
Unit: 028FY00831
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA,
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
CA
PRODUCT
Recovered Plasma.
CODE
Unit: 35V91549
RECALLING FIRM/MANUFACTURER
American National Red Cross, Roanoke, VA,
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
1) Red Blood Cells Leukocytes Reduced.
2) Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
1) Units: W03940941524300, W03940941524500, W03940941524900,
2) Units: W03940941525200 (2 units)
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL,
REASON
Blood products, collected using equipment for which the quality control testing
was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
FL
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Units: 038GP42314; 038GP42324; 038GP42328; 038LJ06630; 038LJ06631 (split
product)
RECALLING FIRM/MANUFACTURER
American National Red Cross – Indiana-Ohio Region, Fort Wayne, IN,
REASON
Blood products, in transit for more than 24 hours and without continuous
agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
OH
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Fresh Frozen Plasma.
3) Platelets Pheresis Leukocytes Reduced
4) Granulocytes.
5) Red Blood Cells Leukocytes Reduced Irradiated.
6) Plasma Frozen.
7) Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
1) Units: 55C36777, 55C36782, 55C36785, 55C36786, 55C36788, 55C36805, 55E59641,
55E59642, 55E59648, 55E59652, 55E59657, 55E59660, 55FK60213, 55FK60215,
55FK60216, 55FK60217, 55FK60219, 55FK60222, 55FK60224, 55FK60226, 55FK60227,
55FK60228, 55FK60233, 55FK60234, 55FR67578, 55FR67579, 55FR67580, 55FR67583,
55FR67585, 55FR67592, 55FR67593, 55FR67596, 55FR67598, 55FR67604, 55FR67605,
55FR67610, 55FR67611, 55FR67614, 55FR67616, 55FR67617, 55FR67619, 55FR67620,
55FR67622, 55FR67624, 55FR67626, 55FR67627, 55FR67628, 55FR67629, 55FS35415,
55FS35417, 55FS35418, 55FS35420, 55FS35421, 55FS35426, 55FS35430, 55FS35431,
55FS35434, 55FS35438, 55FS35439, 55FS35441, 55FS35444, 55FS35446, 55FS35451,
55FS35454, 55FS35455, 55FS35457, 55FS35458, 55FS35463, 55FS35464, 55FS35465,
55FS35467, 55FS35471, 55FS35485, 55FS35487, 55H15750, 55H15751, 55H15766,
55H15769, 55H15773, 55H15774, 55H15779, 55H15780, 55H15784, 55H15787, 55H15789,
55H15794, 55H15795, 55H15797, 55H15798, 55K63476, 55K63477, 55K63479, 55K63486,
55K63488, 55K63495, 55K63496, 55K63497, 55K63498, 55K63501, 55K63502, 55K63503,
55K63504, 55K63506, 55K63507, 55K63508, 55L71155, 55L71158, 55L71161, 55L71162,
55L71164, 55L71165, 55L71169, 55L71171, 55L71174, 55R73547, 55R73548, 55R73549,
55R73550, 55S62860, 55S62862, 55S62864, 55S62865, 55S62866, 55S62869, 55S62870,
55S62873, 55S62874, 55S62875, 55S62876, 55S62878, 55S62879, 55S62884, 55S62886,
55S62887, 55S62891, 55Y36405, 55Y36406, 55Y36407, 55Y36425, 55Y36426, 55Y36427,
55Y36430, 55Y36431, 55Y36433, 55Y36435, 55Y36437, 55Y36441, 55Y36445, 55Y36447,
55Y36449, 55Y36450, 55Y36451, 55Y36453, 55Y36454, 55Y36465, 55Y36466, 55Y36468,
55Y36469, 55Y36471, 55Y36472, 55Y36477, 55Y36478, 55Y36480, 55Y36482, 55Y36483,
55Y36485, 55Y36487, 55Y36488, 55Y36491, 55Y36492, 55Y36494, 55Y36496, 55Y36498,
55Z69781;
2) Units: 55C36787, 55C36788, 55C36791, 55C36794, 55C36797, 55C36799, 55C36802, 55C36807, 55E59640, 55E59641, 55E59648, 55E59649, 55E59653, 55E59654, 55E59655, 55E59656, 55E59660, 55FK60221, 55FK60224, 55FK60233, 55FR67600, 55FR67603, 55FR67605, 55FR67614, 55FR67618, 55FR67619, 55FR67620, 55FR67622, 55FR67626, 55FR67629, 55FS35434, 55FS35455, 55FS35465, 55FS35478, 55FS35487, 55K63487, 55K63492, 55K63495, 55K63497, 55K63498, 55K63501, 55L71170, 55R73550, 55S62875, 55S62876, 55S62884, 55S62888, 55Y36458, 55Y36466, 55Y36468, 55Y36469, 55Y36475, 55Y36477, 55Y36481, 55Y36482, 55Y36483, 55Y36489, 55Y36491, 55Y36492, 55Y36498;
3) Units: 55FT09890 (Parts 1 & 2), 55FT09891 (Parts 1 & 2), 55FT09892 (Parts 1 & 2), 55FT09893 (Parts 1 & 2), 55FT09894 (Parts 1 & 2), 55P54494 (Part 1), 55P54495 (Parts 1 & 2), 55P54499 (Parts 1 & 2), 55P54500 (Parts 1 & 2), 55P54501 (Parts 1 & 2), 55P54502 (Parts 1 & 2), 55Q29248 (Parts 1, 2, & 3), 55Q29249 (Part 1), 55Q29252 (Part 1), 55Q29253 (Part 1), 55Q29254 (Part 1);
4) Unit: 55C36806;
5) Unit: 55C36808 (Part 1);
6) Units: 55FK60216, 55FR67579, 55FR67580, 55FR67592; 55H15762, 55H15768, 55H15770, 55H15780, 55K63480, 55S62863, 55Y36411, 55Y36416, 55Y36434, 55Y36444;
7) Units: 55FS35422 (Bags 1 & 2),
55FS35423 (Bags 1 & 2), 55FS35424 (Bags 1 & 2), 55FS35425 (Bag 2),
55FS35436 (Bags 1 & 2), 55FS35442 (Bags 1 & 2), 55FS35448 (Bags 1 &
2), 55Y36408 (Bags 1 & 2), 55Y36417 (Bags 1 & 2)
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Little Rock, AR,
REASON
Blood products, which were incorrectly tested for West Nile virus (WNV), were
distributed.
VOLUME OF PRODUCT IN COMMERCE
295 units
DISTRIBUTION
AR, TN, TX, MD, MO, CA, OK
PRODUCT
Source Plasma.
CODE
Units: 377051574, 377051655, 377051658, 377051664, 377051693, 377051696,
377051703, 377051706, 377051710, 377051725, 377051746, 377051754, 377051763,
377051797, 377051798, 377051807, 377051830, 377051842, 377051843, 377051844,
377051845, 377051848, 377051849, 377051852, 377051855, 377051858, 377051863,
377051864, 377051865, 377051867, 377051895, 377051896, 377051900, 377051909,
377051911, 377051914, 377051916, 377051993, 377052034, 377052376, 377052380,
377052384, 377052386, 377052592, 377052594, 377052596, 377052603, 377052617,
377052619, 377052621, 377052625, 377052655, 377052686, 377052842, 377052857,
377052871, 377052872, 377052879, 377052887, 377052889, 377052890, 377052896,
377052898, 377052900, 377052907, 377052914, 377052927, 377052933, 377052946,
377052950, 377053016, 377053066, 377053089, 377053104, 377053113, 377053121,
377053144, 377053145, 377053150, 377053163, 377053173, 377053185, 377053187,
377053208, 377053215, 377053218, 377053225, 377053235, 377053239, 377053242,
377053245, 377053271, 377053280, 377053298, 377053326, 377053343, 377053349,
377053362, 377053420, 377053422, 377053426, 377053429, 377053452, 377053454,
377053459, 377053467, 377053470, 377053475, 377053492, 377053500, 377053518,
377053524, 377053525, 377053552, 377053563, 377053577, 377053590, 377053599,
377053623, 377053628, 377053630, 377053632, 377053644, 377053649, 377053690,
377053714, 377053716, 377063747, 377053759, 377053760, 377053766, 377053780,
377053789, 377053803, 377053806, 377053863, 377053878, 377053923, 377053938,
377053957, 377053958, 377053962, 377053968, 377053973, 377054632, 377054642,
377054648, 377054665, 377054669, 377054672, 377054677, 377054690, 377054696,
377054697, 377054704, 377054713, 377054723, 377054742, 377054743, 377054768,
377054773, 377054776, 377054780, 377054781, 377054783, 377054784, 377054814,
377054816, 377054829, 377054839, 377054847, 377054849, 377054878, 377054888,
377054898, 377054901, 377054909, 377054914, 377054919, 377054937, 377054952,
377054954, 377054955, 377054957, 377054960, 377054981, 377054983, 377054987,
377054994, 377054997, 377055003, 377055019, 377055045, 377055273, 377055288,
377055290, 377055305, 377055310, 377055318, 377055331, 377055339, 377055355,
377055356, 377055360, 377055403, 377055407, 377055408, 377055410, 377055413,
377055423, 377055427, 377055436, 377055443, 377055457, 377055460, 377055461,
377055477, 377055497, 377056237, 377056276, 377056288, 377056295, 377056305,
377056318, 377056359, 377056372, 377506405, 377056424, 377056431, 377056440,
377056441, 377056445, 377056489, 377056497, 377056501, 377056507, 377056518,
377056525, 377056527, 377056541, 377056547, 377056612, 377056613, 377056616,
377056625, 377056631, 377056632, 377056641, 377056642, 377056645, 377056678,
377056750, 377056762, 377056787, 377056834, 377057006, 377057002, 377057022,
377057028, 377057034, 377057048, 377057050, 377057056, 377057060, 377057067,
377057075, 377057086, 377057089, 377057287, 377057290, 377057327, 377057345,
377057349, 377057366, 377057372, 377057386, 377057397, 377057403, 377057527,
377057722, 377057744, 377057749, 377057753, 377057761, 377057773, 377057780,
377057784, 377057796, 377057812, 377057816, 377057853, 377057854, 377057864,
377057895, 377057904, 377057905, 377057911, 377057928, 377057945, 377057975,
377057992, 377058017, 377058020, 377058053, 377058070, 377058075, 377058117,
377058120, 377058123, 377058140, 377058145, 377058148, 377058161, 377058163,
377058166, 377058170, 377058175, 377058206, 377058209, 377058221, 377058233,
377058242, 377058246, 377058258, 377058417, 377058420, 377058422, 377058428,
377058438, 377058439, 377058452, 377058472, 377058475, 377058491, 377058497,
377058519, 377058524, 377058544, 377058549, 377058551, 377058553, 377058555,
377058561, 377058563, 377058572, 377058574, 377058579, 377058599, 377058615,
377058619, 377058621, 377058832, 377058872, 377058873, 377058887, 377058940,
377058952, 377058956, 377058959, 377058976, 377058981, 377058982, 377058985,
377060003, 377060011, 377060020, 377060022, 377060031, 377060045, 377060054,
377060057, 377060066, 377060069, 377060077, 377060106, 377060124, 377060127,
377060128, 377060131, 377060139, 377060140, 377060158, 377060167, 377060172,
377060180, 377060182, 377060208, 377060227, 377060240, 377060241, 377060243,
377060249, 377060255, 377060257, 377060259, 377060266, 377060283, 377060294,
377060297, 377060312, 377060313, 377060316, 377060325, 377060371, 377060437,
377060471, 377060473, 377060487, 377060490, 377060497, 377060500, 377060507,
377060513, 377060516, 377060526, 377060534, 377060544, 377060547, 377060573,
377060608, 377060613, 377060615, 377060626, 377060631, 377060635, 377060641,
377060646, 377060657, 377060666, 377060681, 377060685, 377060686, 377060726,
377061195, 377061198, 377061207, 377061209, 377061230, 377061234, 377061241,
377061245, 377061444, 377061458, 377061470, 377061475, 377061477, 377061487,
377061528, 377061529, 377061566, 377061576, 377061607, 377061608, 377061610,
377061611, 377061620, 377061622, 377061623, 377061625, 377061645, 377061651,
377061654, 377061689, 377061690, 377061707, 377061714, 377061740, 377061744,
377061764, 377061777, 377061789, 377061769, 377061805, 377061807, 377061813,
377061814, 377061823, 377061884, 377061899, 377061913, 377061916, 377061931,
377061973, 377061981, 377061984, 377062008, 377062022, 377062034, 377062039,
377062062, 377062092, 377062105, 377062110, 377062122, 377062126, 377062134,
377062140, 377062146, 377062153, 377062155, 377062162, 377062171, 377062179,
377061828, 377062180, 377062212, 377062232, 377062253, 377062261, 377062282,
377062297, 377062302, 377062303, 377062310, 377062313, 377062317, 377062328,
377062331, 377062334, 377062375, 377062379, 377062381, 377062383, 377062409,
377062420, 377062438, 377062439, 377062446, 377062492, 377062497, 377062514,
377062516, 377062521, 377062537, 377062538, 377062545, 377062554, 377062556,
377062557, 377062559, 377062567, 377062569, 377062571, 377062771, 377062787,
377062805, 377062820, 377062825, 377062826, 377062831, 377062870, 377062885,
377062984, 377062911, 377062986, 377062996, 377062997, 377063034, 377063030,
377063045, 377063047, 377063049, 377063064, 377063069, 377063071, 377063075,
377063081, 377063083, 377063088, 377063103, 377063108, 377063132, 377063134,
377063136, 377063137, 377063156, 377063158, 377063160, 377063179, 377063191,
377063206, 377063207, 377063211, 377063217, 377063220, 377063244, 377063246,
377063255, 377063256, 377063260, 377063264, 377063273, 377063278, 377063279,
377063283, 377063284, 377063286, 377063291, 377063293, 377063294, 377063300,
377063306, 377063308, 377063310, 377063315, 377063319, 377063321, 377063323,
377063329, 377063330, 377063335, 377063336, 377063337, 377063350, 377063375,
377063387, 377063404, 377063422, 377063449, 377063474, 377063479, 377063485,
377063524, 377063533, 377063541, 377063544, 377063454, 377063547, 377063550,
377063552, 377063560, 377063562, 377063567, 377063571, 377063578, 377063601,
377063620, 377063622, 377063791, 377063808, 377063812, 377063841, 377063852,
377063865, 377063867, 377063894, 377063907, 377063913, 377063937, 377063967,
377063978, 377063979, 377063986, 377063993, 377063998, 377064002, 377064006,
377064007, 377064009, 377064038, 377064041, 377064049, 377064055, 377064059,
377064080, 377064099, 377064102, 377064123, 377064132, 377064119, 377064134,
377064135, 377064136, 377064186, 377064209, 377064215, 377064217, 377064223,
377064230, 377064231, 377064234, 377064252, 377064258, 377064265, 377064276,
377064257, 377064287, 377064347, 377064350, 377064365, 377064372, 377064402,
377064421, 377064354, 377064371, 377064443, 377064758, 377064764, 377064772,
377064775, 377064782, 377064790, 377064845, 377064855, 377064891, 377064905,
377064917, 377064919, 377064928, 377064932, 377064945, 377064949, 377064952,
377064970, 377065026, 377065049, 377065053, 377065060, 377065074, 377065093,
377065150, 377065159, 377065193, 377065205, 377065209, 377065211, 377065251,
377065253, 377065260, 377065266, 377065294, 377065322, 377065323, 377065343,
377065355, 377065365, 377065366, 377065378, 377065541, 377065560, 377065578,
377065588, 377065593, 377065603, 377065615, 377065618, 377065640, 377065651,
377065655, 377065656, 377065658, 377065662, 377065667, 377065687, 377065706,
377065761, 377065786, 377065841, 377065846, 377065854, 377065863, 337065877,
377065930, 377065900, 377066586, 377066587, 377066589, 377066592, 377066784,
377066793, 377066796, 377066800, 377066813, 377066819, 377066837, 377066852,
377066859, 377066868, 377066869, 377066874, 377066878, 377066884, 377066888,
377066889, 377066890, 377066891, 377066896, 377067003, 377067018, 377067213,
377067224, 377067235, 377067241, 377067250, 377067278, 377067322, 377067362,
377067366, 377067421, 377067425, 377067504, 377067532, 377067557, 377067558,
377067562, 377067568, 377067614, 377067628, 377067633, 377067697, 377067699,
377067717, 377067720, 377067743, 377067808, 377067837, 377067839, 377067921,
377067922, 377067970, 377068002, 377068004, 377068029, 377068031, 377068036,
377068041, 377068064, 377068110, 377068113, 377068128, 377068540, 377068553,
377068560, 377068568, 377068573, 377068587, 377068623, 377068637, 377068638,
377068641, 377068676, 377068677, 377068681, 377068698, 377068713, 377068719,
377068749, 377068755, 377068764, 377068813, 377068814, 377068815, 377068877,
377068889, 377068915, 377068950, 377068954, 377068960, 377068968, 377069049,
377069212, 377069294, 377069117, 377069328, 377069580, 377069603, 377069606,
377069608, 377069789, 377069806, 377069884, 377069897, 377069916, 377069958,
377069960 and 377069967
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Anderson, IN,
REASON
Blood products, collected from a donor in which donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
876 units
DISTRIBUTION
NC
PRODUCT
Red Blood Cells
CODE
Unit: 5359563
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL,
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
FL
PRODUCT
Recovered Plasma.
CODE
Unit: 003LM31567
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA,
Manufacturer: The American National Red Cross – Southern Region, Douglasville,
GA.
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: 4770795
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL,
REASON
Blood product, found to be contaminated with Propionbacterium acnes using the
BacT ALERT System, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
WEEK ENDING MARCH 6
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE Units: 9918275 (Part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL,
REASON Blood products, labeled leukoreduced without the
assurance that it met the criteria for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE Units: 9889041 (Part 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL,
REASON Blood products, with a pH lower than the acceptance
criteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION FL
PRODUCT
Source Plasma, For Manufacturing Use Only.
CODE
Units: FD0444932, FD0445789, FD0446135, FD0446756, FD0447890, FD0449492,
FD0449919, FD0450405, FD0451143, FD0451693, FD0453645, FD0454288, FD0454953,
FD0455660, FD0456150, FD0442184, FD0442481, FD0444818, FD0456596, FD0457591,
FD0458662, FD0461186, FD0461717, FD0463325, FD0463896, FD0464748, FD0465386,
FD0465967, FD0466792, FD0467948, FD0468848, FD0469342, FD0469814
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Farmington, NM,
REASON Blood products, collected from a donor who received a
tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE 33 units
DISTRIBUTION NY and UK
PRODUCT
1) Platelets Pooled Leukocytes Reduced Irradiated.
2) Red Blood Cells.
CODE
1) Unit: W120609382354;
2) Unit: W120609231709
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Saginaw, MI,
Manufacturer: Michigan Community Blood Centers, Bay City, MI.
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 MI
PRODUCT
Plasma Frozen Cryoprecipitate Reduced.
CODE Unit: W0363082878431
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Center of Wisconsin, Inc., Milwaukee, WI,
Manufacturer: Blood Center of Wisconsin, Inc. Marshfield, WI. 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 WI
PRODUCT
1) Recovered Plasma.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: W0410090934641;
2) Units: W041009127044Q, W0410090934641
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., dba United Blood Services, Scottsdale, AZ,
REASON Blood products, collected from a donor who received a
tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION Switzerland, AZ
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated.
2) Red Blood Cells (Apheresis) Leukocytes
Reduced.
3) Red Blood Cells.
4) Platelets.
CODE
1) and 2) Unit: W227709060639;
3) and 4) Unit: W227709060908
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN
REASON Blood products, collected from a donor who traveled to
an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION TN
PRODUCT
1) Platelets Pooled Leukocytes Reduced.
2) Red Blood Cells Leukocytes Reduced.
CODE
1) Unit: W051709803382;
2) Unit: W051709625148
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI,
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 RI, MI
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. CODE Unit:
W037909154486 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA,
REASON Blood products, collected from a donor with a history of
high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE Unit: W071209020921
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, 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
Source Plasma.
CODE Units: 4590020795, 4590020646
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Jacksonville, FL,
REASON Blood products, collected from a donor who did not
receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION Austria
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE Unit: W117009119803
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific – Irwin Center, San Francisco, CA
REASON Blood product, which was not quarantined after receiving
post donation information concerning an illness following donation, was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA
PRODUCT
Recovered Plasma. CODE Units: W090708027007, W090709012548,
W090708022595
RECALLING FIRM/MANUFACTURER
Blood Bank Of The Redwoods, Santa Rosa, 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 3 units
DISTRIBUTION Switzerland
PRODUCT
Red Blood Cells Leukocytes Reduced.
CODE Unit: 50E56076
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, 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 OH
PRODUCT
Platelets Pooled Leukocytes Reduced.
CODE Unit: W120609184065
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI
REASON Blood product, with a low platelet yield was
distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. CODE Unit:
W037909163713 (2 units)
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA,
REASON Blood products, for which quality control testing was
not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION IA
PRODUCT
1) Red Blood Cells Leukocytes Reduced.
2) Recovered Plasma.
CODE 1) and 2) Unit: W036309306241M
RECALLING FIRM/MANUFACTURER
Blood Centers of Wisconsin, Inc, Milwaukee, WI,
REASON Blood products, collected from a donor who was deferred
after disclosing application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION Switzerland, WI
PRODUCT
Source Plasma.
CODE Unit: TQ025292
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma, Corp., Knoxville, TN,
REASON Blood product was tested for HIV and HCV by Nucleic Acid
Testing (NAT), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC
PRODUCT Red Blood
Cells. CODE Unit: W141609171504
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA,
Manufacturer: Puget Sound Blood Center and Program, Olympia, WA. 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 WA
PRODUCT Recovered
Plasma. CODE Unit: 50E56076
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, 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