DECEMBER 2007

WEEK ENDING DECEMBER 1

PRODUCT
a) Red Blood Cells Leukocytes Reduced, 
b) Cryoprecipitated AHF, 
CODE a) and b) Unit: LH56079
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., Providence, RI, 
REASON Blood products, which were collected from a donor who was taking Finasteride (Proscar), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MA and RI

PRODUCT Red Blood Cells Leukocytes Reduced, 
CODE Unit: LM34518
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., Providence, RI,
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 MA

PRODUCT
a) Red Blood Cells, 
b) Platelets,
CODE a) and b) Unit: 6343553
RECALLING FIRM/MANUFACTURER Lifesource, Glenview, IL,
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 IL

PRODUCT
a) Red Blood Cells Leukocytes Reduced, 
b) Platelets Leukocytes Reduced,
CODE a) and b) Unit: LG54585
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., Providence, RI, 
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 RI

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit: 2228963
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 Fresh Frozen Plasma, 
CODE Unit: 71T582695
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON Blood product, associated with a red cell unit that had a broken port, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL 

PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 30GX96227
RECALLING FIRM/MANUFACTURER American Red Cross, Northeastern, Ashley, PA, 
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 and CA

PRODUCT Platelets Pheresis Leukocytes Reduced, 
CODE Unit: 71X528310
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, 
CODE Unit: FN05662
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA, 
REASON Blood product, which was manufactured from a whole blood unit in which the associated blood product contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Red Blood Cells,
CODE Unit: 027GM11524
RECALLING FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA
REASON Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MD

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: 2030638
RECALLING FIRM/MANUFACTURER Indiana Blood Center, Indianapolis, IN, 
REASON Blood product, which tested initially reactive for the hepatitis C virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IN

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced,
CODE Unit: 035FC71476 (2 units)
RECALLING FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA, 
REASON Blood products, collected using equipment that had not been validated, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION WV

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit: 71X529982
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: 71X529539
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: 71X44158X
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: 71X527546
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 Red Blood Cells, Leukocytes Reduced, 
CODE Unit: 71T379620
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON Blood product, associated with a plasma unit that contained fibrin strands, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: 71T175309
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL
REASON Blood product, associated with a plasma unit that contained fibrin strands, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Red Blood Cells, 
CODE Unit: V47743
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA,
REASON Blood product, associated with a Fresh Frozen Plasma unit that was possibly contaminated with Staphylococcus epidermidis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Units: 71X448371 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON Blood products, which did not have the required plasma volume to support the platelet concentration, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AL

PRODUCT
a) Platelets, 
b) Red Blood Cells, Leukocytes Reduced, 
CODE a) and b) Unit: 5960602
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, 
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: 2665477
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, 
REASON Blood product, collected from a donor taking the medication Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX and Switzerland

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced,
CODE Unit: 2795316 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
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 TX

PRODUCT Platelets, 
CODE Unit: 1957545
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, 
REASON Blood product, for which the sterility may have been compromised during collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced, 
CODE Unit: 2794257
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: W045007018451
RECALLING FIRM/MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City, MO
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 MO

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: LG48137
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., Providence, RI,
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 RI

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Units: W045007905707; W045007906231; W045007903967; W045007902739; and W045007902229
RECALLING FIRM/MANUFACTURER Community Blood Center of Greater Kansas City, Kansas City, MO
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION MO and KS

PRODUCT
a) Fresh Frozen Plasma, 
b) Red Blood Cells Leukocytes Reduced, 
c) Recovered Plasma, 
CODE
a) Unit: 2151334;
b) Units: 2151334, 2244695;
c) Unit: 2244695
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN,
REASON Blood products, collected from a donor who was taking the medication Enbrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION TN and FL

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Units: FW95994, GW08070
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Blood products, which may have reached an unacceptable temperature during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION WI

PRODUCT Recovered Plasma,
CODE Unit: 30GX96227
RECALLING FIRM/MANUFACTURER American Red Cross, Northeastern, Ashley, PA,
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 and CA

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated Washed, 
CODE Unit: 71T544549
RECALLING FIRM/MANUFACTURER Lifesouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL
REASON Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Fresh Frozen Plasma, 
CODE Unit: 1614910
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, 
REASON Blood product, which tested negative for hepatitis, but was collected from a donor who subsequently tested repeat reactive for antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Recovered Plasma, 
CODE Unit: 2665477
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood product, collected from a donor taking the medication Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX and Switzerland

PRODUCT Platelets Pheresis Leukocytes Reduced, 
CODE Unit: GR62062
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Blood product, which may have been shipped under unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced, 
CODE Unit: 1996792 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, 
REASON Blood products, collected from a donor who had received an MMR vaccine, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated, 
b) Platelets, 
CODE a) and b) Unit: 1462507
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were complete.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX

WEEK ENDING DECEMBER 8

PRODUCT
a) Fresh Frozen Plasma, 
b) Red Blood Cells, Leukocytes Reduced, 
CODE
a) Unit: 36KP15846;
b) Units: 36KP15848; 36KP15846
RECALLING FIRM/MANUFACTURER American National Red Cross, Columbia, SC,
REASON Blood products, collected from donors whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION SC

PRODUCT Antihemophilic Factor/von Willebrand Factor Complex (Human), Dried, Pasteurized Humate-P. The box is shipped in a box containing the following: 1 glass vial of Antihemophilic Factor/von Willebrand Factor Complex (Human); 1 glass vial of Sterile Diluent for Humate-P; 1 transfer needle for reconstitution; 1 disposable filter; 2 alcohol swabs; and directions for use. NDC numbers 0053-7620-05, NDC number 0053-7620-10, NDC number 0053-7620-20, NDC number 0053-7615-05, NDC number 0053-7615-10, NDC number 0053-7615-20,
CODE
Lot number 39466611E exp 15/04/07;
Lot numbers 41166611A exp 28/06/07; 41566611A exp07/08/07; 41666611A exp 07/08/07; 41966611A exp 07/08/07;
Lot numbers 37566611G exp 03/12/06; 41366611A exp 31/08/07; 41466611A exp 01/09/07; 41766611A exp 08/09/07; 41866611A exp 09/09/07; 42166611A exp 27/09/07; 42266611A exp 04/10/07; and 42466611A exp 05/10/07;
Lot numbers 00166811A exp 22/06/06; 00466811A exp 16/07/06; 01766811A exp 08/11/07; 03166811A exp 09/12/07; 06166811A exp 09/05/08; 06166811B exp 09/05/08;06266811A exp 16/05/08; 06366811A exp 17/05/08; 08066811A exp 03/08/08; 08066811B exp 03/08/08; 09566811A exp 25/11/08; and 11366811A exp 13/01/09;
Lot numbers 00266811A exp 13/07/06, 00966811A exp 06/10/07, 01066811A exp 06/10/07, 01866811A exp 06/10/07, 02866811A exp 06/10/07, 02966811A exp 06/10/07, 03066811A exp 08/12/07, 03266811A exp 24/01/08, 03366811A exp 25/01/08, 04066811A exp 09/02/08, 04566811A exp 28/02/08, 05266811B exp 28/03/08, 05366811B exp 29/03/08 05466811A exp 04/04/08, 05566811A exp 05/04/08, 05666811A exp 11/04/08, 05766811A exp 12/04/08, 06066811A exp 27/04/08, 06066811B exp 27/04/08, 07166811A exp 15/06/08, 07266811A exp 16/06/08, 07366811A exp 24/06/08, 07666811A exp 21/07/08, 07766811A exp 22/07/08, 08166811A exp 19/09/08, 08266811A exp 20/09/08, 08766811A exp 12/10/08, 08766811B exp 12/10/08, 08866811A exp 13/10/08, 09366811A exp26/10/08, 09466811A exp 25/11/08, 10866811A exp 23/01/09, 10966811A exp 24/01/09, 11466811A exp 10/02/09, 12466811A exp 17/03/09;
Lot numbers 01166811A exp 27/10/07, 01266811A exp 28/10/07,
01366811A exp 01/11/07, 01466811A exp 02/11/07, 01566811A exp 03/11/07, 01666811A exp 04/11/07, 01966811A exp 10/11/07, 02066811A exp 11/11/07, 02166811A exp 15/11/07, 02266811A exp 16/11/07, 02366811A exp 17/11/07, 02466811A exp 18/11/07, 02566811A exp 22/11/07, 02666811A exp 23/11/07, 02766811A exp 24/11/07, 03466811A exp 26/01/08, 03566811A exp 27/01/08, 03766811A exp 01/02/08, 03866811A exp 07/02/08, 03966811A exp 08/02/08, 04166811A exp 15/02/08, 04266811A exp 16/02/08, 04366811A exp 17/02/08, 04466811A exp 17/02/08, 04666811A exp 01/03/08, 04766811A exp 02/03/08, 04866811B exp 07/03/08, 04966811B exp 08/03/08, 05066811B exp 14/03/08, 05166811B exp 15/03/08, 05866811A exp 25/04/08, 05966811A exp 26/04/08, 06466811A exp 23/05/08, 06566811A exp 07/06/08, 06666811A exp 08/06/08, 06766811A exp 09/06/08, 06866811A exp 10/06/08, 06966811A exp 13/06/08, 07066811A exp 14/06/08, 07466811A exp 14/07/08, 07566811A exp 15/07/08, 07866811A exp 01/08/08, 07966811A exp 02/08/08, 08366811A exp 30/09/08, 08466811A exp 30/09/08, 08566811A exp 10/10/08, 08666811A exp 11/10/08, 08966811A exp 17/10/08, 09066811A exp 18/10/08, 09166811A exp 24/10/08, 09266811A exp 25/10/08, 09666811A exp 28/11/08, 09766811A exp 29/11/08, 09866811A exp 30/11/08, 09966811A exp 01/12/08, 10166811A exp 09/12/08, 10266811A exp 12/12/08, 10366811A exp 13/12/08, 10466811A exp 22/12/08, 10566811A exp 22/12/08, 10666811B exp 12/01/09, 10766811B exp 12/01/09, 11066811A exp 12/01/09, 11166811A exp 12/01/09, 11266811A exp 12/01/09, 11566811A exp 12/01/09, 11666811A exp 12/01/09, 11766811A exp 12/01/09, 11866811A exp 12/01/09, 11966811A exp 12/01/09, 12066811A exp 12/01/09, 12166811A exp 12/01/09, 12366811A exp 12/01/09, 12566811A exp 10/03/09, 12966811A exp 24/03/09, 13466811A exp 05/04/09, and 13566811A exp 06/04/09;
RECALLING FIRM/MANUFACTURER Csl Behring Llc, King of Prussia, PA,
REASON Humate-P, with possible damage to the blister (plastic film) packaging of the transfer sets, was distributed.
VOLUME OF PRODUCT IN COMMERCE 205,671 vials
DISTRIBUTION Nationwide, Canada and Germany

PRODUCT Teruflex®CPDA-1 Blood collection System with Blood Sampling Arm®, containing 63mL CPDA-1 anticoagulant, 450 mL (whole blood fill) volume, 
CODE
Lot #: 070417GY Exp 2009-09
070418GV Exp 2009-09
070530GX Exp 2009-10
070531GV Exp 2009-10
070628GX Exp 2009-11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Terumo Medical Corp., Elkton, MD, 
Manufacturer: Fujinomiya Factory Of Terumo Corp., Shizuoka, Japan. 
REASON Blood collection system is mislabeled for expiration date.
VOLUME OF PRODUCT IN COMMERCE 5 lots
DISTRIBUTION PA, LA and FL

PRODUCT AUSAB Quantitation Panel, List Number 1459-05, 
CODE Lot 46399M100
RECALLING FIRM/MANUFACTURER Abbott Laboratories MPG, Abbott Park, IL, 
REASON The AUSAB Quantitation Panel was found to read preparations of the W.H.O. reference material up to 61% higher when using Procedure A and up to 84% higher when using Procedure B for Lot Number 46399M100.
VOLUME OF PRODUCT IN COMMERCE 1 panel
DISTRIBUTION Nationwide, Canada and Germany

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE FW84186
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI, b
REASON Blood product, collected from an unsuitable donor who had traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: GN21681
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
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 WI

PRODUCT Red Blood Cells,
CODE Unit: 6760121
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO  

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: 4811469
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute – Sylvan N Goldman Center, Oklahoma City, OK, 
Manufacturer: Oklahoma Blood Institute, Ardmore, OK. 
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 NY and Switzerland

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: 2334882
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN,
REASON Blood product, collected from a donor who had sexual contact with a person who traveled to an HIV Group O risk area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TN 

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit: 2294873, Part A and Part B.
RECALLING FIRM/MANUFACTURER Blood Bank of Delmarva, Inc., Newark, DE,
REASON Blood products, which were labeled with incorrect platelet counts and product volumes, were distributed. Firm initiated recall is complete.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION DE

PRODUCT eQueTM Automated Interview and Assessment, 
CODE Version 1.2.1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haemonetics Corp., Braintree, MA, 
Manufacturer: Fifth Dimension Info Systems, Edmonton, Canada. .
REASON Blood Donor Self Interview may not result in assessment of the donors suitability
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA, WI and NJ

PRODUCT Fresh Frozen Plasma, 
CODE Unit: 71S962694
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Birmingham, AL
REASON Blood product, associated with a Red Blood Cell unit that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Abbott COMMANDER Flexible Pippetting Center (FPC); List #3A46; 510(k) #K894069, 
CODE All
RECALLING FIRM/MANUFACTURER Abbott Laboratories, Inc., Irving, TX, 
REASON Blood device pippetor with arms that may be out of specification, resulting in samples potentially not being drawn and dispensed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 438 units
DISTRIBUTION Nationwide, Canada and Japan

PRODUCT
a) Cryoprecipitated AHF, 
b) Red Blood Cells, 
c) Red Blood Cells Leukocytes Reduced, 
d) Plasma Frozen, 
e) Red Blood Cells Leukocytes Reduced Irradiated, 
f) Fresh Frozen Plasma, 
CODE
a) Units: 40FR29652, 40FR29654, 40FR29656, 40FR29661, 40FR29663, 40FR29665, 40FR29669, 40FW38020, 40FW38026, 40FW38032, 40FW38040, 40FW38048, 40FW38052, 40GF77726, 40GF77727, 40GF77730, 40GF77731, 40GF77733, 40GF77740, 40GF77742, 40GF77743, 40GF77744, 40GF77755, 40GF77756, 40GF77758, 40GF77762, 40GF77765, 40GF77766, 40GF77768, 40GL11341, 40GL11343, 40GL11349, 40GL11353, 40GL11356, 40GL11361, 40GL11400, 40GL11403, 40GL11407, 40GL11414, 40GL11415, 40GN17192, 40GN17194, 40GN17198, 40GN17201, 40GN17204, 40GN17205, 40GN17213, 40GN17214, 40GN17215, 40GN17223, 40GN17226, 40GN17227, 40GN17230, 40GN17231, 40GN17233, 40GN17234, 40GS86453, 40GS86462, 40GS86463, 40GS86473, 40GS86478, 40GS86482, 40GS86483, 40GS86487, 40GS86710, 40GS86719, 40GS86731, 40GS86739, 40GS86753, 40GS86758, 40GS86766, 40GS86770, 40GS86772. 40KE67669, 40KE67671, 40KE67674, 40KE67677, 40KE67679, 40KE67687, 40KE67691, 40KE67693, 40KE67700, 40KE67704, 40KE67707, 40KE67717, 40KE67718, 40KE67723, 40KE67724, 40KE67728, 40KE67729, 40KE67733, 40KE67737, 40KE67738, 40KE67859, 40KG09485, 40KG09486, 40KG09489, 40KG09493, 40KG09496, 40KG09500, 40KG09503, 40KG09504, 40KG09507, 40KG09508, 40KG09509, 40KG09512, 40KJ01035, 40LZ24794, 40LZ24801, 40LZ24807, 40LZ24811, 40LZ24814, 40LZ24816, 40LZ24819, 40LZ24821, 40LZ24823, 40LZ24824, 40LZ24825;

b) Units: 40 FF61065, 40FF61066, 40FF61069, 40FF61071, 40FF61073, 40FF61077, 40FF61083, 40FF61086, 40FF61088, 40FF61090, 40FF61093, 40FF61100, 40FR29663, 40FR29665, 40FW38012, 40GF77726, 40GF77727, 40GF77733, 40GF77740, 40GF77742, 40GF77743, 40GF77744, 40GF77755, 40GF77756, 40GF77758, 40GF77762, 40GF77765, 40GF77766, 40GF77768, 40GH77269, 40GH77287, 40GH77619, 40GJ65488, 40GJ65495, 40GJ65498, 40GJ65506, 40GJ65512, 40GJ65517, 40GL11343, 40GL11353, 40GL11356, 40GL11382, 40GN17192, 40GN17196, 40GN17198, 40GN17201, 40GN17204, 40GN17205, 40GN17208, 40GN17213, 40GN17215, 40GN17227, 40GN17229, 40GN17234, 40GR84905, 40GS86473, 40GS86478, 40GS86482, 40GS86739, 40GS86758, 40KE67669, 40KE67671, 40KE67674, 40KE67677, 40KE67679, 40KE67687, 40KE67691, 40KE67693, 40KE67695, 40KE67700, 40KE67704, 40KE67717, 40KE67718, 40KE67729, 40KE67733, 40KE67737, 40KE67867, 40LH26851, 40LH26867, 40LV11644, 40LV11646, 40LZ24807, 40LZ24816, 40LZ24821, 40LZ24824;

c) Units: 40FF61061, 40FF61063, 40FF61082, 40FF61085, 40FF61092, 40FF61096, 40FF61097, 40FR29646, 40FR29647, 40FR29650, 40FR29652, 40FR29654, 40FR29656, 40FR29661, 40FR29668, 40FR29669, 40FR29675, 40FR29678, 40FR29679, 40FW38015, 40FW38020, 40FW38026, 40FW38032, 40FW38048, 40FW38052, 40FW38056, 40GF77731, 40GH77271, 40GH77276, 40GH77309, 40GH77311, 40GH77314, 40GH77317, 40GH77324, 40GH77328, 40GH77598, 40GH77602, 40GH77615, 40GH77621, 40GH77643, 40GH77645, 40GH77657, 40GH77661, 40GH77664, 40GH77669, 40GH77676, 40GJ65490, 40GJ65500, 40GJ65502, 40GJ65504, 40GJ65509, 40GJ65514, 40GJ65518, 40GJ65581, 40GJ65586, 40GJ65588, 40GJ65591, 40GJ65593, 40GJ65594, 40GJ65603, 40GJ65605, 40GJ65609, 40GJ65613, 40GJ65614, 40GJ65616, 40GL11341, 40GL11349, 40GL11374, 40GL11378, 40GL11388, 40GL11393, 40GL11394, 40GL11400, 40GL11403, 40GL11407, 40GL11414, 40GL11415, 40GM05848, 40GN17210, 40GN17214, 40GN17223, 40GN17226, 40GN17230, 40GN17231, 40GN17233, 40GR84868, 40GR84879, 40GR84881, 40GR84895, 40GR84897, 40GR84909, 40GR84910, 40GR84914, 40GR84919, 40GR84929, 40GR84940, 40GR84941, 40GR84956, 40GR84957, 40GR84985, 40GR85004, 40GR85010, 40GS86451, 40GS86453, 40GS86462, 40GS86466, 40GS86471, 40GS86477, 40GS86487, 40GS86688, 40GS86706, 40GS86710, 40GS86719, 40GS86725, 40GS86731, 40GS86733, 40GS86753, 40GS86766, 40GS86770, 40GS86772, 40KC16416, 40KC16418, 40KC16425, 40KC16432, 40KC16437, 40KC16448, 40KC16455, 40KC16464, 40KC16472, 40KC16478, 40KC16484, 40KC16486, 40KE67707, 40KE67723, 40KE67724, 40KE67728, 40KE67738, 40KE67834, 40KE67850, 40KE67854, 40KE67858, 40KE67859, 40KE67860, 40KE67866, 40KG09325, 40KG09485, 40KG09486, 40KG09489, 40KG09493, 40KG09496, 40KG09500, 40KG09503, 40KG09504, 40KG09507, 40KG09508, 40KG09509, 40KG09512, 40KG09802, 40KG09814, 40KJ01035, 40LH26853, 40LH26857, 40LH26865, 40LH26868, 40LH26872, 40LH26874, 40LH26875, 40LV11638, 40LV11641, 40LV11653, 40LV11655, 40LV11657, 40LV11659, 40LV11661, 40LV11663, 40LV11665, 40LV11670, 40LV11671, 40LV11675, 40LV11679, 40LV11683, 40LW31117, 40LW31119, 40LW31122, 40LW31123, 40LW31125, 40LW31129, 40LW31134, 40LW31135, 40LW31136, 40LW31137, 40LW31166, 40LW31168, 40LW31171, 40LW31177, 40LW31182, 40LW31184, 40LW31191, 40LW31193, 40LW31196, 40LW31200, 40LW31206, 40LW31209, 40LW31214, 40LW31217, 40LW31220, 40LW31319, 40LW31321, 40LW31325, 40LW31327, 40LW31334, 40LW31335, 40LW31336, 40LW31341, 40LW31343, 40LW31345, 40LW31347, 40LW31350, 40LW31352, 40LW31358, 40LW31360, 40LW31362, 40LZ24793, 40LZ24794, 40LZ24801, 40LZ24811, 40LZ24823, 40LZ24825, 40KE67843;

d) Units: 40FF61061, 40FF61065, 40FF61082, 40FF61085, 40FF61086, 40FF61092, 40FF61096, 40FF61097, 40KC16464, 40LV11659, 40LV11671, 40LV11675, 40LV11679, 40LW31117, 40LW31177, 40LW31196, 40LW31220;

e) Units: 40FF61076, 40GL11372, 40GR84870, 40GS86458, 40KE67847, 40KE67856, 40KE67861, 40LW31332;

f) Units: 40GH77269, 40GH77271, 40GH77276, 40GH77287, 40GH77290, 40GH77309, 40GH77311, 40GH77615, 40GH77619, 40GH77621, 40GJ65488, 40GJ65490, 40GJ65495, 40GJ65498, 40GJ65500, 40GJ65502, 40GJ65504, 40GJ65506, 40GJ65509, 40GJ65512, 40GJ65514, 40GJ65517, 40GJ65518, 40GJ65594, 40GJ65603, 40GJ65609, 40GJ65613, 40GJ65614, 40GR84868, 40GR84870, 40GR84905, 40GR84909, 40GR84910, 40GR84919, 40KC16416, 40KC16418, 40KC16425, 40KC16432, 40KC16437, 40KE67843, 40LH26851, 40LH26857, 40LH26868, 40LH26872, 40LH26875, 40LW31125, 40LW31129, 40LW31134, 40LW31135, 40LW31136, 40LW31137, 40LW31319, 40LW31321, 40LW31335, 40LW31336, 40LW31343, 40LW31345, 40LW31347, 40LW31350, 40LW31352, 40LW31358, 40LW31360, 40LW31362 units 40LW31332 - parts 1, 2, 3 and 4, and 40LW31334 - parts 1, 2, 3 and 4;
RECALLING FIRM/MANUFACTURER American National Red Cross HOA Blood Services Region, Peoria, IL
REASON Blood products, collected in a manner that may compromise the sterility of the product, were distributed.
VOLUME OF PRODUCT IN COMMERCE 529 units
DISTRIBUTION PA, NY, WI, MA, MO, NE and IL

PRODUCT
a) Platelets, 
b) Red Blood Cells, Leukocytes Reduced, 
CODE a) and b) Unit: 5960602
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: 2665477
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood product, collected from a donor taking the medication Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX and Switzerland

PRODUCT Red Blood, 
CODE Unit: FK62860
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Blood Centers, Aurora, IL, 
Manufacturer: Heartland Blood Centers – Tinley Park, Tinley Park, IL. 
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 IL

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Unit: FK87327
RECALLING FIRM/MANUFACTURER Heartland Blood Centers, Aurora, IL, 
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 IL

PRODUCT Misys Laboratory" Blood Bank and Blood Donor Modules V6.0.1,
CODE Blood Bank/Blood Donor 6.0.1 Blood Bank/Blood Donor is distributed with Misys Laboratory Version 6.1 and Version 6.2
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems dba Misys Hospital Systems, Tucson, AZ, 
REASON Misys identified that under certain scenarios the count for tests with unacceptable results is inaccurate. This could lead to: The QA failure, "Unit status updated to inventory with unacceptable results on file", in Blood Product Testing Review (BTR) not being displayed. - This could result in a unit being released into inventory inappropriately if no active donor deferral(s) are on file (Misys Blood Donor). If the unit is inappropriately released into inventory, the QA failure, "Unacceptable Result on File", does not display in the following functions: - Blood Order Processing (BOP), Blood Product Issue (BPI), Blood Component Preparation (BCP), Blood Status Correction (BSC), or Blood Status Update (BSU).
VOLUME OF PRODUCT IN COMMERCE 252 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Red Blood Cells, 
b) Platelets, 
CODE a) and b) Unit: 5943902
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL,
REASON Blood products, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION IL

PRODUCT Fresh Frozen Plasma, 
CODE Unit: 71S17420X
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center, Inc., Gainesville, GA, 
REASON Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Plasma Frozen, 
CODE a) and b) Unit: 012FR01026
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services, 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 2 units
DISTRIBUTION NC

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Plasma Frozen, 
CODE a) and b) Unit: 003FV96175
RECALLING FIRM/MANUFACTURER American National Red Cross, Douglasville, GA, by telephone on September 29, 2006 and by letter dated October 9, 2006. Firm initiated recall is complete.
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 GA

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Units: 003GF31326, 003GP83001, 003GX37433, 003GZ86205, 003H40073
RECALLING FIRM/MANUFACTURER American National Red Cross, Douglasville, GA
REASON Blood products, collected from donors who traveled to areas considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION GA

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: 2655238
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, which was labeled as leukoreduced, but was not tested to verify the White Blood Cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Platelets, 
CODE Unit: 1983766
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, associated with a red cell unit that was contaminated with Staphylococcus aureus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT
a) Platelets, 
b) Recovered Plasma, 
CODE a) and b) Unit: 2758544
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, collected from a donor who had received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX and Switzerland

PRODUCT Misys Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2,
CODE Misys Laboratory Blood Bank and Blood Donor Modules v6.0.1 and v6.0.2 distributed with Misys Laboratory v6.1, v6.2 and v6.3
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems dba Misys Hospital Systems, Tucson, AZ, 
REASON Software, with a defect or glitch, was distributed.
VOLUME OF PRODUCT IN COMMERCE 260 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Units: 012LJ72060, 012LJ69569
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, 
Manufacturer: American Red Cross Blood Services, Asheville, NC. 
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 NC and CA

PRODUCT
a)Cryoprecipitated AHF, 
b) Fresh Frozen Plasma, 
c) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit: 012FF47499;
b) Unit: 012FF45625;
c) Unit: 012FF45625; 012FF47499
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services, Charlotte, NC,
REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION NC

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: 003FJ94461
RECALLING FIRM/MANUFACTURER American National Red Cross, 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 and CA

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: 012Z69024
RECALLING FIRM/MANUFACTURER American Red Cross Carolinas Blood Services Region, Charlotte, NC
REASON Blood product, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA and TN

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, 
b) Recovered Plasma, 
CODE a) and b) Unit: 4355028
RECALLING FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ,
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 2 units
DISTRIBUTION NJ and CA

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit; 12F79666
RECALLING FIRM/MANUFACTURER American Red Cross Carolinas Blood Services Region, Charlotte, NC,
REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA and NC

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: 012Z70816
RECALLING FIRM/MANUFACTURER American Red Cross Carolinas Blood Services Region, Charlotte, NC
REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC and CA

PRODUCT Platelets, 
CODE Unit: KP14078
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA, 
REASON Blood product, associated with a red cell component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit 2792754
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, 
REASON Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX and Switzerland

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit: 71X41440X
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL.
REASON Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit: 71X15322X
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL
REASON Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit: 71X15756
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Birmingham Region, Birmingham, AL. 
REASON Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Fresh Frozen Plasma,
CODE Unit: FV17650
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA, 
REASON Blood product, associated with a red cell component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit: FQ85903
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI,
REASON Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced, 
CODE Units: LP72132, (Split unit), KC33150 (Split unit)
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI,
REASON Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION WI

PRODUCT a) Platelets, 
b) Red Blood Cells, 
CODE a) and b) Unit: 6731609
RECALLING FIRM/MANUFACTURER LifeShare Community Blood Services, Elyria, OH
REASON Blood products, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH 

PRODUCT
a) Red Blood Cells, 
b) Platelets, 
CODE a) and b) Unit: 4183281
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH
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 OH

PRODUCT
a) Red Blood Cells, 
b) Cryoprecipitated AHF, 
CODE a) and b) Units: 6730567
RECALLING FIRM/MANUFACTURER LifeShare Community Blood Services, Elyria, OH
REASON Blood products, collected from a donor who provided post donation information regarding a previous positive test for the Hepatitis C virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH 

PRODUCT Red Blood Cells Apheresis, Leukocytes Reduced,
CODE Unit: 182348794 (2 units)
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Cheyenne, WY
REASON Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION WY

PRODUCT Red Blood Cells (Apheresis) Leukocyt4s Reduced,
CODE Unit: 2786777 (Split unit)
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX 

PRODUCT
a) Platelets, 
b) Fresh Frozen Plasma, 
CODE a) and b) Unit: 2775376
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood products, which were collected fro a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX

PRODUCT Robotic Disposable Tip (DiTi) Rack for use with the Abbott m2000sp (List 9K14-01) and m1000 (List 4J72-01) Automated Sample Preparation System. The racks are sold as a component of the instruments as well as replacement components. Each system contains two 200 microliter DiTi racks, two 1000 microliter ASPS reuse racks and nine 1000 microliter DiTi racks, and three racks are included in the m1000/M2000 Upgrade Kit, part 09K13-01. The individual replacement DiTi racks are sold one per carton: Robotic DiTi 200 Rack - Tecan Art. Nr. 613089, Abbott LN Nr 04J72-30; Robotic DITi 1000 Rack - Tecan Ref 613090, Abbott LN Nr 04J72-32; and Robotic DiTi Reuse 1000 ASPS Rack - Tecan Ref 613091, Abbott Ln Nr 04J72-34, 
CODE Part numbers: 9K14-01, 4J72-01, 9K13-01, 4J72-30, 4J72-32, 4J72-34
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Molecular, Des Plaines, IL,.
Manufacturer: Tecan Schweiz Ag, Mannedorf Zuerich, Switzerland. 
REASON The spring clips on the Disposable Tips (DiTi) Racks may have sharp protruding corners which may cause instrument user injury. The DiTi Racks were shipped with or independent of the m2000sp Instrument or the m1000 Instrument.
VOLUME OF PRODUCT IN COMMERCE 22 instruments in U.S.; 308 instruments, 111 racks internationally
DISTRIBUTION Nationwide and Internationally

PRODUCT Pall Acrodose PL System, Pool and Store Set for Leukocyte -Reduced Platelets with a 1.5 Liter CLX HP Extended Storage Bag for Pooled Leukocyte-Reduced Platelets. This extended Storage Bag is not labeled properly. The Storage Bag has a white stick-on label labeled in part "*** LEUOKOCYTES REDUCED -- ___mL -- Number of units in pool ___. -- From CP2D Whole Blood -- Store at 20-24C. *** 12064 *** VOLUNTEER DONOR *** LOT REO2131 *** Pall Corporation -- East Hills, NY 11548, NY ***". --- The actual label should read "*** PLATELETS POOLED - 5d LEUKOCYTES REDUCED *** ___mL -- Number of units in pool ___. -- From CP2D Whole Blood -- Store at 20-24C. *** 12064 *** VOLUNTEER DONOR *** LOT REO2131 *** The Storage Bag also contains a section where the unit number and expiry date can be placed. This system is packages in a Tyvek header bag and includes one (1) system per unit pouch. There is also unit package insert which includes instructions for use. --- 510K # BR050074, 
CODE Lot Number: REO2131; Expiration Date: December 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pall Biomedical Products Corp., East Hills,  NY, 
Manufacturer: Ensatec, S.A. de C.V. Fraccionamineto El Florido, Tijuana/Tecate  
Mexico. 
REASON The product name "PLATELETS POOLED -5d" does not appear on the label as required.
VOLUME OF PRODUCT IN COMMERCE 2,880 units
DISTRIBUTION CT, OH

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: 4026169
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Blood Connection, Inc., Piedmont, SC, 
REASON Blood product, documented as being out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION SC

PRODUCT
a) Fresh Frozen Plasma, 
b) Red Blood Cells, Leukocytes Reduced, 
c) Recovered Plasma, 
CODE
a) Unit: 2151334;
b) Units: 2151334, 2244695;
c) Unit: 2244695
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN, by telephone on October 30, 2006
REASON Blood products, collected from a donor who was taking the medication Enbrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION TN and FL

PRODUCT Recovered Plasma,
CODE Unit: 2665477
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, collected from a donor taking the medication Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX and Switzerland

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit: FW97994
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Blood product, which may have been shipped under unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: GW07035
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, W
REASON Blood product, which may have been stored under unacceptable storage conditions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX\

PRODUCT Cryoprecipitated AHF, 
CODE Unit: KQ66955
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Blood product, which may have been stored under unacceptable storage conditions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated,
CODE Units: 71S016651, 71S016663, and 71S126434
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody, GA
REASON Blood products, which were incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION GA

PRODUCT Red Blood Cells, 
CODE Unit: 71T459146
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody, GA
REASON Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: 003H36514
RECALLING FIRM/MANUFACTURER American National Red Cross, Douglasville, GA,
REASON Blood product, which was not manufactured in accordance with the manufacturer’s instructions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit: 8464482 (split unit)
RECALLING FIRM/MANUFACTURER Atlanta Blood Services, Atlanta, GA.
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION GA

PRODUCT Plasma Frozen, 
CODE Units: 012FC93282, 012LF22170, 012LF22169
RECALLING FIRM/MANUFACTURER American Red Cross Carolinas Blood Services Region, Charlotte, NC,
REASON Blood products, which may have been out of controlled storage for longer than the acceptable time limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION NC

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced 
CODE Unit: 1995841 (2 units)
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, .
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 TX

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced, 
CODE Unit: 1979795 (2 units)
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX, 
REASON Blood products, collected from a donor with an elevated body temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX

PRODUCT Blood and Blood Products for Reprocessing, 
CODE Units: 012LJ72060, 012LJ69569
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, 
Manufacturer: American Red Cross Blood Services, Asheville, NC. 
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 NC and CA

PRODUCT Recovered Plasma, 
CODE Unit: 003FJ94461
RECALLING FIRM/MANUFACTURER American National Red Cross, Douglasville, GA, 
REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA and CA

PRODUCT Blood and Blood Products for Reprocessing,
CODE Unit: 012Z69024
RECALLING FIRM/MANUFACTURER American Red Cross Carolinas Blood Services Region, Charlotte, 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 and TN

PRODUCT Blood and Blood Products for Reprocessing, 
CODE Unit; 12F79666
RECALLING FIRM/MANUFACTURER American Red Cross Carolinas Blood Services Region, Charlotte, 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 and NC

PRODUCT Blood and Blood Products for Reprocessing,
CODE Unit: 012Z70816
RECALLING FIRM/MANUFACTURER American Red Cross Carolinas Blood Services Region, Charlotte, 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 and CA

PRODUCT Red Blood Cells, 
CODE Unit: 71S451992
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Dunwoody, GA
REASON Blood product associated with a unit of Cryoprecipitated AHF that contained clots was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced,
CODE Unit: 71T10470
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers – Wiregrass Region, Dothan, AL
REASON Blood product, which was manufactured from an associated blood component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: 71Q521069
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION  AL 

PRODUCT Red Blood Cells (Apheresis) 
CODE Unit: LR96407
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA, by fax on May 30, 2007. 
REASON Blood product, associated with a red cell component that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 split unit
DISTRIBUTION PA

WEEK ENDING DECEMBER 15

PRODUCT
a) Baxter Closed System Apheresis Kit with PL 3014 Plastic Platelet Storage Containers; an Rx disposable sterile fluid pathway for platelet and plasma collection; catalog  number 4R2180T, 
b) Baxter Fenwal Open System Apheresis Kit; an Rx disposable sterile fluid pathway  for blood component collection; catalog number 4R2210T, 
c) Baxter Fenwal Closed System Apheresis Kit with restrictor tubing; an Rx disposable sterile fluid pathway for platelet and plasma collection; catalog number R4R2230T  (multi-language label), 
d) Baxter Fenwal Open System Apheresis Kit with restrictor tubing; an Rx disposable sterile fluid pathway for blood component collection; catalog number R4R2210T,
CODE
a) Lot numbers N06D17034, N06D24022, N06D26027, N06E16025, N06E22023,  N06F12022, N06F15017, N06H17027, N06H29022, N06I01029, N06I05020,  N06I11028, N06I14014, N016I25028, N06J05011, N06J09021, N06J18022,  N06J24012, N06J30019, N06K02024, N06K20026, N06K27039, N06L01024,  N06L13029, N06L20016, N07A22013, N07A24027, N07B07020, N07B13028,
N07C07028, N07C09016, N07C23025, N07D18015 *** N06A26023 ***;
b) Lot numbers N0521023, N05C01031, N05C06020, N05D12028, N05D15021,  N05D20021N05E23022, N05E26025, N05F06017, N05F08021, N05F10027,  N05G12021, N05G15024, N05J27024, N06A11025, N06A13021, N06A18020, N06B02022, N06B06023, N06B08029, N06B16022, N06C01022, N06C06021,  N06C20022, N06C23026, N06C27027, N06D10021, N06E04021, N06E08022,
N06F05018, N06G22029, N06G27028, N06G28034, N07A09010, N07B22011, N07C19023, N07C30020, N07D26018, N07D30010, N07E03014, N07E07023,  N07E10027, N07E14037;
c) Lot numbers: N06A30017, N06C29023, N06F21023, N06G19025, N06H03027,  N06H09024, N06J03024, N06K08021, N07B15015, N07B19025, N07D11010;
d) Lot numbers: N05F22022, N06I21027, N06K13039, N07B21013, N07D13016
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fenwal Inc., Round Lake, IL, 
Manufacturer: Baxter Healthcare Corporation of Puerto Rico, San German, PR. 
REASON Some of the CS3000 apheresis kits may have the ACD (anticoagulant) and saline lines misassembled. The reversed bag connections may not be visually apparent and could result in excessive ACD infusion and severe injury, including death, to the donor.
VOLUME OF PRODUCT IN COMMERCE 92,761 kits
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Red Blood Cells, 
b) Red Blood Cells, Leukocytes Reduced, 
c) Blood and Blood Products for Reprocessing,
CODE
a) Unit: 4056551;
b) Units: 0237016; 4030291;
c) Units: 4056551; 0237016; 4030291
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc., Piedmont, SC
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 6 units
DISTRIBUTION FL, NC, SC, and AL

PRODUCT
a) Platelets, 
b) Fresh Frozen Plasma,
CODE a) and b) Units: LR70489
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA,
REASON Blood product, collected from a donor who provided post donation information regarding multiple high-risk behaviors, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION PA

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit: 71X453577
RECALLING FIRM/MANUFACTURER Lifesouth Community 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: 71X391743
RECALLING FIRM/MANUFACTURER Lifesouth Community Centers, Wiregrass Region, Dothan, AL
REASON Blood product, which did not meet the acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: 003LJ38759
RECALLING FIRM/MANUFACTURER American National Red Cross, Douglasville, GA
REASON Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets, Leukocytes Reduced,
CODE a) and b) Unit: 027KJ21267
RECALLING FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA
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, NC, and CA

PRODUCT Recovered Plasma, 
CODE Unit: 027KJ21267
RECALLING FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA,
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, NC, and CA

WEEK ENDING DECEMBER 22

PRODUCT Red Blood Cells, 
CODE Unit: 039E08083
RECALLING FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA
REASON Blood product, collected from a donor whose sexual partner was positive for hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WV

PRODUCT
a) Fresh Frozen Plasma, 
b) Red Blood Cells Leukocytes Reduced, 
CODE a) and b) Units: 22KC93265
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA
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 PA

PRODUCT
a) Cryoprecipitated AHF, 
b) Red Blood Cells, Leukocytes Reduced,
c) Platelets Leukocytes Reduced, 
CODE
a) Unit: 22KF66401;
b) Unit: 22KF66401, 22GL34395;
c) Unit: 22GL34395
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA
REASON Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 Units
DISTRIBUTION CA, NJ, PA, and PR

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets, Leukocytes Reduced,
CODE a) and b) Unit: 22KT88518
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA
REASON Blood products, which tested negative for the Human Immunodeficiency Virus (HIV), but were collected from a donor who previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION PA, NC

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets, Leukocytes Reduced, 
CODE a) and b) Unit: 22LW89838
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA
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 PA

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Unit: 71X391398
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Wiregrass Region, Dothan, AL.
REASON Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit: 71X447896
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL
REASON Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Source Plasma, 
CODE Units: 4120052997, 4120041309, 4120050379, 4120049362, 4120048885, 4120047943, 4120046261, 4120045848, 4120042317, 4120041954, 4120034592 and 4120033517
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Indianapolis, IN
REASON Blood products, which were collected from a donor who had received a tattoo within 12 months of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units
DISTRIBUTION IL, Germany and Switzerland

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit: 2752585
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT
a) Red Blood Cells, 
b) Red Blood Cells, Leukocytes Reduced
CODE
a) Unit: 9408666;
b) Unit: 9410736
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, which was collected from a donor who had traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO, NJ

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: 2090219
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Platelets
CODE Unit: 2737912
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells, Apheresis Leukocytes Reduced
CODE Units: 22FM11946, 22GH37802
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA
REASON Blood products, for which the quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION PA

PRODUCT Plasma,, Frozen,
CODE Unit: 2807831
RECALLING FIRM/MANUFACTURER Indiana Blood Center, Terre Haute, IN
REASON Blood product, associated with a red blood cell unit that was found to contain clots during leukoreduction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IN

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Unit: 71X422908
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Unit: 71X392715
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL
REASON Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, 
b) Recovered Plasma, 
CODE a) and b) 02FV12222
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Wichita, KS, 
REASON Blood product, which was collected from a donor who had received a tattoo within 12 months of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX, KY

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: 5996701
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit: 2660665
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit: 1620483
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center UC Medical Center, Cincinnati, OH
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit: 1653674
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center UC Medical Center, Cincinnati, OH
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

PRODUCT
a) Red Blood Cells (Apheresis), Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes Reduced
CODE
a) Unit: 1956079;
b) Unit: 1956079 (split unit)
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION TX

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit: LP77077
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
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 WI

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit: 2201594
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY,
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KY

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Units: 2084395 and 2122752
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION KY

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit: 2136288
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KY

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit: 2620567
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,

REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit: 71X199362
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL, 
REASON Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit: 71X298468
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL
REASON Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit: 71X299557 (split unit)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL,
REASON Blood product, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AL

PRODUCT
a) Platelets Pooled, Irradiated, 
b) Platelets Pheresis, Leukocytes Reduced Irradiated
c) Platelets Pheresis, Leukocytes Reduced, 
CODE
a) LC70068 and FQ85764;
b) LJ34952;
c) LJ35065, KF07689, and GW12136
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Blood products, which were labeled with an incorrect expiration date or time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION WI

PRODUCT Platelets, 
CODE Unit: 2641333
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT
a) Red Blood Cells, 
b) Fresh Frozen Plasma, 
c) Red Blood Cells, Leukocytes Reduced, 
CODE
a) Unit: LJ34298;
b) Unit: LJ34298, LC69203;
c) Unit: LC69203
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Blood products, which were collected from a donor in which Donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION WI, VA

PRODUCT
a) Red Blood Cells (Apheresis), Leukocytes Reduced,
b) Red Blood Cells, Leukocytes Reduced, 
CODE
a) Units: KL08388 and KL08286;
b) Unit: GR67720
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Blood products, which may have been stored under unacceptable storage conditions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION WI

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated
CODE Unit: FQ84669
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Blood products, which may have been stored under unacceptable storage conditions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI

PRODUCT Fresh Frozen Plasma, 
CODE Unit: M20693
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI,
Manufacturer: Michigan Community Blood Centers, Bay City, MI. REASON Blood product, which was collected from an unsuitable donor based on risk factors for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Unit: 3838744
RECALLING FIRM/MANUFACTURER Indiana Blood Center, Terre Haute, IN,
REASON Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IN

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: Q06478
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI, 
Manufacturer: Michigan Community Blood Centers, Bay City, MI. REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI

PRODUCT Platelets, 
CODE Unit: N59944
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Grand Rapids, MI
REASON Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI

PRODUCT Platelets, 
CODE Unit: N92515
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Grand Rapids, MI
REASON Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI

PRODUCT Platelets, 
CODE Unit: E24509
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Rapids, MI, 
Manufacturer: Michigan Community Blood Centers, Saint Joseph, MI. REASON Blood product, which was manufactured from a whole blood unit in which an associated blood
component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI

PRODUCT Platelets, Leukocytes Reduced Irradiated,
CODE Unit: W89836
RECALLING FIRM/MANUFACTURER Costal Bend Blood Center, Corpus Christi, TX
REASON Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Recovered Plasma, 
CODE Unit: 22KF66401, 22GL34395
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA
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 CA, NJ, PA, and PR

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Units: 71R82459X and 71R827308
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL
REASON Blood products, which were not manufactured in accordance with the manufacturers instructions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AL

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit: 004KE55956 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER ARC Blood Services, New England Region, Dedham, MA,
REASON Blood products, collected from a donor who received a shingles vaccine, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MA

PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated
b) Red Blood Cells Leukocytes Reduced Irradiated
CODE
a) Units: 2754393, 2751665 (1), and 2751665 (2);
b) Units: 2760187, 1760683, 2766956, 760182, 2767003, 2766990, 2753370, 1728091, 2760188, 2754283, 2750680, 2761509, 2758530, 2767097, 2766987
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, which were incorrectly labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units
DISTRIBUTION TX

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit: 2081541
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON Blood product, which was collected from an autologous donor with a history of hepatitis but was not labeled with a Biohazard label, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TN

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Units: 22GQ06569, 22LY95697
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA
REASON Blood products, which were incorrectly labeled as negative for the anti-C Red Blood Cell antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION PA

PRODUCT Fresh Frozen Plasma, 
CODE Units: 71R54116X and 71R82547X
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Inc., Huntsville, AL
REASON Blood products, which were not manufactured in accordance to current Good Manufacturing Practices, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AL

PRODUCT
a) Red Blood Cells, 
b) Red Blood Cells, Leukocytes Reduced, 
CODE
a) Unit: 4009694;
b) Units: 0227576; and 4014451
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc., Piedmont, SC,
REASON Blood products, which were manufactured from a whole blood unit in which an associated blood component contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units 
DISTRIBUTION AL, GA, SC

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced,
CODE Units: 71S639774 (split unit); 71S624693 (split unit); 71S62408X (split unit) ;71S639590 (split unit); and 71S623623 (split unit)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers – Montgomery Region, Montgomery, AL
REASON Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION AL

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced
CODE Unit: 71S040073 (split unit)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL
REASON Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AL

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced,
CODE Unit: 71S043929 (split unit)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL
REASON Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AL

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced,
CODE Unit: 71S040374 (split unit)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL,
REASON Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AL

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Unit: LK24212
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Blood product, which may have been stored under unacceptable storage conditions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI

PRODUCT Red Blood Cells, 
CODE Unit: 2180949
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY
REASON Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KY

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: W89836
RECALLING FIRM/MANUFACTURER Costal Bend Blood Center, Corpus Christi, TX
REASON Blood product, which was manufactured from a whole blood unit in which an associated blood component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

WEEK ENDING DECEMBER 29

PRODUCT
a) Red Blood Cells (Apheresis) Leukocytes Reduced, 
b) Fresh Frozen Plasma (Apheresis), 
CODE a) and b) Units: 4821861
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute - Sylvan N Goldman Center, Oklahoma City, OK, 
Manufacturer: Oklahoma Blood Institute, Ponca City, OK
REASON Blood products, collected from a donor whose suitability to donate were not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION OK

PRODUCT Data Innovations Instrument Manager Software versions 7.04.0001 through 8.04.03.01, 
CODE Software versions 7.04.0001 through 8.04.03.01
RECALLING FIRM/MANUFACTURER Data Innovations, Inc., South Burlington, VT
REASON Software, with a defect or glitch, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1,500 units
DISTRIBUTION Nationwide and Canada

PRODUCT Red Blood Cells Leukocytes Reduced, 
CODE Units: GR57222; FQ68938
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc, Milwaukee, WI,
REASON Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION WI

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit: 2793646
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, which possibly contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced,
CODE LL28574 (double unit)
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., Providence, RI
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 RI and MA

PRODUCT
a) Red Blood Cells Leukocytes Reduced
b) Whole Blood Leukocytes Reduced,
CODE
a) Unit: LS89596;
b) Unit: LJ05544
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc, Milwaukee, WI
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 WI

PRODUCT Platelets Pooled Irradiated,
CODE Unit: KR10771
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc, Milwaukee, WI,
REASON Blood product, with incomplete documentation of the irradiation process, was distributed
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced,
CODE Units: 027GG27506, 027GG27510, 027KJ24564 and 027KJ24564
RECALLING FIRM/MANUFACTURER ARC Greater Alleghenies, Johnstown, PA
REASON Blood products, collected using equipment that had not been validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION WV and PA

PRODUCT Red Blood Cells Leukocytes Reduced Irradiated, 
CODE Units: 22FR08010, 22FR08004
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA, complete.
REASON Blood products, for which there was incomplete documentation of the irradiation process, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION PA

PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: FN14699
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc, Milwaukee, WI
REASON Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI

PRODUCT
a) Cryoprecipitated AHF, 
b) Red Blood Cells Leukocytes Reduced, 
c) Plasma Cryoprecipitated Reduced, 
CODE
a) and b) Units: 22FN85220, 22FN80893;
c) Unit: 22FN85220
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA,
REASON Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION NJ, PA and WV

PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: FW93528
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Blood product, returned due to possible hemolysis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI

PRODUCT Fresh Frozen Plasma, 
CODE Unit: 22GH42185
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA,
REASON Blood product, associated with a platelet unit that was contaminated with Streptococcus pyogenes, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Red Blood Cells Leukocytes Reduced, Irradiated,
CODE Unit: 36LX14580
RECALLING FIRM/MANUFACTURER American National Red Cross, Columbia, SC,
REASON Blood product, for which the documentation of irradiation was discrepant, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION SC

PRODUCT Red Blood Cells Leukocytes Reduced, Irradiated, 
CODE Unit: 1585560
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, collected from a donor who had a rash, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX, Switzerland

PRODUCT
a) Red Blood Cells Leukocytes Reduced, Irradiated
b) Platelets, 
CODE a) and b) Unit: 2604483
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood product, collected from a donor who traveled to a malaria endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX

PRODUCT
a) Cryoprecipitated AHF, 
b) Red Blood Cells Leukocytes Reduced,
c) Plasma Cryoprecipitated Reduced, 
CODE a), b) and c) Units: 22GG03416
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA,
REASON Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION PA and CA

PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 2133205
RECALLING FIRM/MANUFACTURER Medic, Inc., Knoxville, TN
REASON Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TN

PRODUCT Platelets, 
CODE Unit: 2658652
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood product, collected from a donor who had received the oral typhoid vaccine, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Ortho Assay Software (OAS) Version 2.0.1. There is no product code for the OAS. OAS software is pre-loaded on the OAS workstation. The workstation on which the software is loaded has two product codes: Product Code 936415 - April 4, 1999 to April 24, 2007 Product Code 936415F- Oct 26, 2005 to April 9, 2007 (F denotes refurbished), 
CODE Version 2.0.1
RECALLING FIRM/MANUFACTURER Ortho Clinical Diagnostics, Inc., Raritan, NJ
REASON The Sample Omission Monitoring (SOM) Calculations can be erroneous under very specific circumstances in which the Ortho Summit Sample Handling System (Summit) does not dispense Specimen Diluent into the A1 microwell of the assay plate.
VOLUME OF PRODUCT IN COMMERCE 230 units
DISTRIBUTION Nationwide

PRODUCT Platelets Pheresis Leukocytes Reduced
CODE Unit: LK17622
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc, Milwaukee, WI
REASON Blood product, lacking assurance of having been maintained at an acceptable temperature during shipping, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced, 
CODE Units: 1955576 (split unit)
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
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 TX

PRODUCT Red Blood Cells Leukocytes Reduced, 
CODE Unit: FW96100
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc, Milwaukee, WI
REASON Blood product, with an unacceptably low red cell recovery rate, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WI

PRODUCT
a) Plasma Cryoprecipitated Reduced,
b) Fresh Frozen Plasma, 
CODE
a) Unit: FQ80563;
b) Units: LP72328; KL00077
RECALLING FIRM/MANUFACTURER Blood Center of Wisconsin, Inc., Milwaukee, WI
REASON Blood products, for which storage conditions and shipment information were undocumented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION WI

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit: 22KP88763
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA,
REASON Blood product, which was labeled as negative for the C red cell antigen, but was collected from a donor who subsequently tested positive for C antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Units: 22KJ59008, 22KK56829, 22GX95607
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA
REASON Blood products, which were labeled as negative for the Fyb red cell antigen, but were collected from a donor who subsequently tested positive for Fyb antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION NJ and PA

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit: 2194024
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY
REASON Blood product, which may have reached an unacceptable temperature during shipment, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KY

PRODUCT Recovered Plasma,
CODE Unit: 1585560
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood product, collected from a donor who had a rash, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX, Switzerland

PRODUCT Platelets, 
CODE Unit: 9821739
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, which was collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit: 22LP26438
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn Jersey Region, Philadelphia, PA
REASON Blood product, manufactured from a unit of whole blood more than eight hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA