SEPTEMBER 2005

WEEK ENDING SEPTEMBER 3

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit number: 027LW47648
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Johnstown, PA
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Cryoprecipitated AHF, 
CODE Unit number: FV10195
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Blood product, which was collected from a whole blood unit in which the associated Red Blood Cells and component contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Human Cornea For Transplant Tissue, 
CODE Tissue 05-0940-100
RECALLING FIRM/MANUFACTURER Rocky Mountain Lions Eye Bank, Aurora, CO
REASON Human Tissue, procured from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue
DISTRIBUTION CO

PRODUCT Source Plasma
CODE Unit numbers: 370044259, 370035534, 370031700, 370031219, 370030380
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Toledo, OH
REASON Source Plasma, collected from a previously deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION Spain

PRODUCT Source Plasma
CODE Unit numbers: 370044674, 370043691, 370043326, 370042636, 370042310, 370041074, 370039859, 370039531, 370038574, 370038255, 370036110, 370034856, 370034313, 370033823, 370033399, 370007539, 370007130, 370006195, 370005829, 370005335, 370004818
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Toledo, OH
REASON Source Plasma, collected from a previously deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units
DISTRIBUTION Spain

PRODUCT Recovered Plasma
CODE Unit number: A139963
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
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 Source Plasma
CODE Unit numbers: N71143020, N71184020, G95802020, G09926020, G10374020, G10732020, G11273020, G14795020, G15112020, G17165020, G17662020, G18066020, G18428020, G18783020, F00313020, F00665020, F01120020, F01703020, and F07705020
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, McAllen, TX
REASON Blood products, which were collected from a donor who provided post donation information regarding to having engaged in multiple high risk behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE 19 units
DISTRIBUTION NC, CA, and Switzerland

PRODUCT Red Blood Cells Leukoreduced
CODE Unit number: G142574
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
REASON Blood product, which was collected from a donor who had traveled to an area endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WA

PRODUCT
a) Red Blood Cells
b) Platelets
CODE a) and b) Unit number: R164706
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
REASON Blood product, which was collected from a donor who had traveled to an area endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION WA

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 04KM58966
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA
REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION VT

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers: P10-20475A and P10-20475B
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Inc., Trenton, NJ
REASON Platelets Pheresis with elevated platelet counts were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NJ

PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated,
b) Platelets
c) Fresh Frozen Plasma
CODE a), b) and c) Unit number: 4689834
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK.
REASON Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION TX and OK

PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated,
b) Buffy Coat
c) Recovered Plasma
CODE a), b) and c) Unit number: 4539511
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION FL, OK, and NB

PRODUCT Source Plasma
CODE Unit numbers: 370024563, 370024248, 370017309, 370017101, 370016582, 370016231
RECALLING FIRM/MANUFACTURER Biomat USA Inc., Toledo, OH
REASON Blood products, collected from a donor who was previously permanently deferred, were distributed
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION Spain

PRODUCT Red Blood Cells Leukocyte Reduced
CODE Unit number: R12-00521
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Trenton, NJ
REASON Blood product, collected from a donor who had previously been implicated in a case of post-transfusion hepatitis transmission, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT
a) Red Blood Cells Leukoreduced, 
b) Recovered Plasma, 
CODE a) and b) Unit numbers: 55Z44548, 55Z45007, 55Z45537
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR
REASON Blood products, collected from a donor with a history of Multiple Sclerosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION AR, AL, CA, and D.C.

PRODUCT
a) Red Blood Cells Leukoreduced
b) Fresh Frozen Plasma
CODE a) and b) Unit numbers: 55FK38567
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR
REASON Blood products, collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AR

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets
c) Fresh Frozen Plasma
d) Recovered Plasma
CODE
a) Unit numbers: 4855895, and 4801967;
b) and c) Unit numbers: 4855895;
d) Unit number: 4801967
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION OK, MI, VA, and Switzerland

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit number: 12FZ40918
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC
REASON Blood product, which was collected from a donor who had travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Recovered Plasma
CODE a) and b) Unit numbers: 4624350, and 4707130
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION OK, and Switzerland

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Recovered Plasma
CODE a) and b) Unit numbers: 4758589
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OK, and Switzerland

PRODUCT
a) Red Blood Cells, Leukocytes Reduced
CODE Unit number: 4800698
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OK

PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated
b) Recovered Plasma
CODE a) and b) Unit numbers: 4859848
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OK, and Switzerland

PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Recovered Plasma
CODE a) and b) Unit numbers: 4776367
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood products, which were collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NC, and Switzerland

PRODUCT
Red Blood Cells
CODE Unit number: 3154136
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center, San Francisco, CA
REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Source Plasma
CODE Unit number: AY0486356
RECALLING FIRM/MANUFACTURER Yale Blood Plasma, LLC, Albuquerque, NM
REASON Blood product, which was untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION England

PRODUCT Source Plasma
CODE Unit numbers: AY0482676, AY0485027
RECALLING FIRM/MANUFACTURER Yale Blood Plasma, LLC, Albuquerque, NM
REASON Blood product, which was untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION England

PRODUCT Source Plasma
CODE Unit numbers: AY0481990, AY0482200, AY0482802, AY0483144, AY0483443, AY0483914, AY0484118, AY0484559, AY0485078, AY0485320
RECALLING FIRM/MANUFACTURER Yale Blood Plasma, LLC, Albuquerque, NM
REASON Blood product, which was untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION England

PRODUCT Red Blood Cells
CODE Unit number: 55H54673
RECALLING FIRM/MANUFACTURER American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AR.
REASON Blood product, which tested negative for antibody to hepatitis B core antigen (anti-HBc), but was collected from a donor who tested repeat reactive for anti-HBc on two previous occasions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AR

PRODUCT Platelets
CODE Unit number: FC20-11062
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Inc., Trenton, NJ
REASON Blood product, which was untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets
c) Platelets Pheresis, Leukocytes Reduced,
d) Fresh Frozen Plasma
e) Fresh Frozen Plasma [Apheresis],
f) Recovered Plasma
CODE
a) and b) Unit numbers: 4651063, 4649807, 4746914, and 4803426;
c) Unit numbers: 4583634 (2 split products), 4757152 (2 split products), 4620181 (3 split units);
d) Unit number: 4803426;
e) Unit number: 4619525
f) Unit numbers: 4651063, 4649807, and 4746914
RECALLING FIRM/MANUFACTURER

Recalling Firm: Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
Manufacturer: Oklahoma Blood Institute, Midwest City Donor Center, Midwest City, OK. 
REASON Blood products collected from an unsuitable donor due to a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD) were distributed.
VOLUME OF PRODUCT IN COMMERCE 20 units
DISTRIBUTION OK, TX, MI, AR, and Switzerland

PRODUCT
a) Red Blood Cells
b) Platelets
CODE
a) Unit numbers: 7872863 and 9206095;
b) Unit number: 7872863
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood products, collected from unsuitable donors based on travel to areas considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION IL

PRODUCT
a) Red Blood Cells
b) Platelets
CODE
a) Unit numbers: 6375547 and 6387786;
b) Unit number: 6387786
RECALLING FIRM/MANUFACTURER BloodNet USA, Inc., Lakeland, FL
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION FL

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 16-41235
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Inc., Trenton, NJ
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT
a) Platelets
b) Fresh Frozen Plasma
CODE a) and b) Unit number: 71N950416
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Suwanne Valley Region, Lake City, FL
REASON Blood products, associated with a unit of Red Blood Cells, that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL

PRODUCT Fresh Frozen Plasma
CODE Unit numbers: 55C75463, 55C75526, 55C75615, 55C75687, 55C75963, 55C76073, 55E45023, 55E46468, 55E46514, 55FK31220, 55FS14315, 55FS14328, 55FS14337, 55FS14340, 55W43364, 55W43413, and 55C82553
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Ozarks -- Arkansas Region, Little Rock, AR
REASON Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 17 units
DISTRIBUTION TN, MO, and AR

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Recovered Plasma
CODE a) and b) Unit number: 4917920
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, collected from an ineligible donor due to use of the medication Phenobarbital, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OK and Switzerland

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Recovered Plasma
CODE a) and b) Unit number: 4624925
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, collected from an ineligible donor due to use of the medication Phenobarbital, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NY and Switzerland

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: W16-37925
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Inc., Trenton, NJ
REASON Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to a recent tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets
c) Recovered Plasma
CODE
a) Unit numbers: 4857801, 4712387, 4673791, 4636376, 4566323, and 4446787;
b) Unit numbers: 4673791 and 4636376;
c) Unit numbers: 4857801, 4712387, 4673791, 4636376, and 4446787
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, collected from an unsuitable donor due a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units
DISTRIBUTION OK, TX, MS, NJ, NY and Switzerland

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets
c) Recovered Plasma
CODE
a) and c) Unit numbers: 4642576, 4729391, 4807247;
b) Unit number: 4642576;
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, collected from an unsuitable donor due a history of travel to an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION OK, TX, and Switzerland

PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
c) Platelets
d) Fresh Frozen Plasma
e) Recovered Plasma
CODE
a) Unit numbers: C00-99918, C00-98970, and V15-04860;
b) Unit numbers: FC20-02625 and FC20-04002;
c) Unit numbers: FC20-02625, C00-99918, and V15-04860;
d) Unit numbers: FC20-02625, C00-99918, C00-98970, and V15-04860;
e) Unit number: FC20-04002
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Inc, Trenton, NJ
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 units
DISTRIBUTION PA and NJ

PRODUCT Red Blood Cells
CODE Unit number: 9904017
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA
REASON Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION LA

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Plasma Cryoprecipitate Reduced
CODE a) and b) Unit number: 8163182
RECALLING FIRM/MANUFACTURER Florida Blood Centers, Inc., Lake Park, FL
REASON Blood Products, collected from a door whose health history screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL and SC

PRODUCT Six-Part Barcode Labels for Use with COBAS AmpliScreen System Roche M/N 03261549001; Computype M/N 1004639
CODE Batch Numbers 028868 and 029213 - Barcode Human Readable D26DT through D5KLG (inclusive)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Molecular Systems, Inc., Somerville, NJ
Manufacturer: Computype, Saint Paul, MN. 
REASON Barcode labels, containing duplicate numbers that could lead to mismatched test results and sample ID numbers, were distributed.
VOLUME OF PRODUCT IN COMMERCE 100 rolls
DISTRIBUTION CA, FL, IA,MN,MO, NJ, WA, Canada, Spain, and Sweden

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 6945030 and 6945038
RECALLING FIRM/MANUFACTURER Central Jersey Blood Center, Shewsbury, NJ
REASON Blood products, which failed acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NJ

PRODUCT Fresh Frozen Plasma Apheresis
CODE Unit numbers: 6931901, 6931939, 6931903, 6943667, 6932274, 6932273, 6943827, 6931222, and 6931910
RECALLING FIRM/MANUFACTURER Central Jersey Blood Center, Shewsbury, NJ
REASON Blood products, which were not frozen within six hours of collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION NJ

PRODUCT Platelets
CODE Unit number: 4815205
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood product, which did not have a documented time of collection for the associated whole blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit number: 6936177
RECALLING FIRM/MANUFACTURER Central Jersey Blood Center, Shewsbury, NJ
REASON Blood product, which failed acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT Platelets
CODE Unit number: 4815206
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood product, which did not have a documented time of collection for the associated whole blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Platelets
CODE Unit number: 5256401
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood product, which did not have a documented time of collection for the associated whole blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated
CODE Unit number: 6970592
RECALLING FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ
REASON Blood product, which was not quarantined after receiving information regarding post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT Platelets
CODE Unit number: 4837007
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, prepared from a unit of Whole Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Platelets
CODE Unit number: 4821327
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK.
REASON Blood product, prepared from a unit of Whole Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Platelets
CODE Unit number: 4809330
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, prepared from a unit of Whole Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Platelets
CODE Unit number: 4845888
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, prepared from a unit of Whole Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Platelets
CODE Unit number: 4844784
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK.
REASON Blood product, prepared from a unit of Whole Blood lacking phlebotomy documentation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Platelets
CODE Unit number: 4844810, 4844935
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, prepared from a units of Whole Blood with a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MI and TX

PRODUCT Red Blood Cells
CODE Unit number: 6956071
RECALLING FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ
REASON Blood products, collected from a donor whose temperature was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT Source Plasma
CODE Unit numbers: AY0483857, AY0483900, AY0483993, AY0486531, AY0486532, AY0486533, AY0486534, AY0486535, AY0486536, AY0486537, AY0486539, AY0486540, AY0486541, AY0486542, AY0486543, AY0486544, AY0486545, AY0486546, AY0486547, AY0486548, AY0486549
RECALLING FIRM/MANUFACTURER Yale Blood Plasma, LLC, Albuquerque, NM
REASON Blood products, which were untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units
DISTRIBUTION England

PRODUCT Source Plasma
CODE Unit numbers: AY0489088, AY0492764, AY0492785, AY0492804, AY0493751
RECALLING FIRM/MANUFACTURER Yale Blood Plasma, LLC, Albuquerque, NM
REASON Blood products, which were untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION England

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 03KH16750 and 03KH16752
RECALLING FIRM/MANUFACTURER The American National Red Cross, American Red Cross Blood Services, Daytona Beach, FL.
REASON Blood products, that were collected in a manner that may compromise the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION GA

PRODUCT Red Blood Cells
CODE Unit numbers: 9977479, 9977480, 9977481, 9977482, 9977485
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA
REASON Blood products, collected from donors whose body temperature determinations may have been inaccurate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION LA, MI, and OH

PRODUCT Platelets
CODE Unit number: 16-38411
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Inc., Trenton, NJ
REASON Blood product, which was untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced Irradiated
CODE Unit number: 9454315
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA
REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION LA

PRODUCT Fresh Frozen Plasma
CODE Unit number: FG55250
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL
REASON Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 40GN09195
RECALLING FIRM/MANUFACTURER The American National Red Cross, Hearth of America Region, Peoria, IL
REASON Blood product, that did not have the complete amount of additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Red Blood Cells, Leukocytes Reduced Irradiated
CODE
a) Unit numbers: 03KC15795, 03KC15796, 03KC15798, and 03KC15799;
b) Unit number: 03KC15797
RECALLING FIRM/MANUFACTURER The American National Red Cross, American Red Cross Blood Services, Daytona Beach, FL.
REASON Blood products, that were collected in a manner that may compromise the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION GA

WEEK ENDING SEPTEMBER 10

PRODUCT Source Plasma
CODE Unit numbers: NF168058, NF167915, NF167568, NF167161, NF167035, NF166687, NF166036, NF165892, NF160612, NF160119, NF159987, NF159731, NF159582, NF159071, NF158849, NF157986, NF157674, NF157405, NF157292, NF157003, NF156836,
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P
REASON Blood products, collected from a donor who disclosed a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 21 units
DISTRIBUTION NC

PRODUCT Red Blood Cells
CODE Unit number: 7135927
RECALLING FIRM/MANUFACTURER Florida Blood Services, Inc., Bradenton, FL
REASON Blood product, with incomplete anti-HTLV-1 testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Fresh Frozen Plasma
CODE Unit number: FC2010145
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Trenton, NJ
REASON Blood product, prepared from whole blood with an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

WEEK ENDING SEPTEMBER 17

PRODUCT Red Blood Cells
CODE Unit number: 6933779
RECALLING FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ
REASON Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT Red Blood Cells
CODE Unit number: 6981627
RECALLING FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ
REASON Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT
a) Red Blood Cells, Leukoreduced
b) Recovered Plasma,
CODE a) and b) Unit numbers: 4638263, 4568044
RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK,
REASON Blood products, collected from a donor considered to be at increased risk for exposure to variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION NY, CA, OK, and Switzerland

PRODUCT
a) Red Blood Cells, Leukoreduced, 
b) Recovered Plasma, 
CODE a) and b) Unit numbers: 55L34605, 55V15093
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AR
REASON Blood products, collected from a donor who had previously tested positive for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION AR, CA, and Switzerland

PRODUCT
a) Red Blood Cells, Leukoreduced, 
b) Red Blood Cells (Apheresis) Leukocytes Reduced,
c) Platelets,
d) Fresh Frozen Plasma, 
e) Fresh Frozen Plasma Apheresis,
CODE
a) Unit numbers: 261153610, 261153639, 261153614, 261153621, 261153694, 261153909, 261153700,
261153917, 261153710, 261153941, 261153952, 261154139, 261154163, 261154141, 261154784,
261154144, 261154788, 261154149, 261154791, 261154156, 261154793, 261154157, 261154794,
261154159, 261154796, 261154799, 261155451, 261155840, 261156132, 261156395, 261156152,
261156160, 261156610, 261156677, 261156613, 261156618, 261156623, 261156806, 261156632,
261156811, 261156636, 261156815, 261156639, 261156817, 261156642, 261156819, 261156646,
261156821, 261156836, 261156897, 261156838, 261156842, 261157041, 261157099, 261157045,
261157112, 261157114, 261157116, 261157133, 261157119, 261157134, 261157180, 261157382,
261157184, 261157384, 261157193, 261157196, 261161094, 261161214, 261161109, 261161116,
261161295, 261161347, 261161329, 261161501, 261161617, 261161504, 261161507, 261161520,
261161737, 261161743, 261161821, 261161756, 261161832, 261161761, 261161835, 261161764,
261161839, 261161774, 261161785, 261161885, 261161947, 261161896, 261161963, 261161898,
261161900, 261162321, 261162918, 261162324, 261162919, 261162327, 261162329, 261164486,
261164581, 261164490, 261164491, 261164492, 261164494, 261164632, 261164657, 261164633,
261164659, 261164635, 261164662, 261164636, 261164665, 261164637, 261164670, 261164639,
261164641, 261164643, 261164697, 261164644, 261164645, 261164646, 261164647, 261164648,
261164649, 261164650, 261164800, 261164818, 261164801, 261164821, 261164802, 261164827,
261164807, 261164829, 261164811, 261164833, 261164812, 261164834, 261164814, 261164839,
261164815, 261164817, 261164904, 261165490, 261164906, 261165494, 261164911, 261165497,
261165501, 261165612, 261165745, 261165616, 261165759, 261165626, 261165762, 261165629,
261165764, 261165634, 261165768, 261165640, 261165771, 261165646, 261165772, 261165654,
261165659, 261165674, 261165679, 261165837, 261165879, 261165842, 261165882, 261165845,
261165884, 261165855, 261165886, 261165856, 261165888, 261165858, 261165892, 261165860,
261165894, 261165864, 261165898, 261165866, 261165868, 261165870, 261165877, 261165878,
261165905, 261167218, 261165908, 261167221, 261165909, 261167232, 261165914, 261165916,
261165917, 261168006, 261165919, 261168011, 261165922, 261168015, 261165923, 261168019,
261165924, 261165926, 261165927, 261168207, 261165928, 261168209, 261168218, 261168219,
261168449, 261168521, 261168457, 261168524, 261168474, 261168533, 261168483, 261168487,
261168491, 261174713, 261174738, 261174801, 261175308, 261175418, 261175850, 261175420,
261175862, 261175423, 261175868, 261175424, 261175426, 261175428, 261175429, 261175431,
261175433, 261175435, 261175438, 261175440, 261175442, 261175445, 261175446, 261175448,
and 261175455;
b) Unit numbers: 261153612, 261164485, 261164624, 261164626 (2 units), 261164631, 261164804 (2 units), 261164908 (2 units), 261164914 (2 units), 261165499, 261165650 (2 units), 261165669 (2 units), 261165671 (2 units), 261165848 (2 units), 261165890 (2 units), 261165904 (2 units), 261165913 (2 units), 261167228, 261168420, and 261168454;
c) Unit numbers: 261168204, 261168207, 261168209, 261168217, 261168218, 261168220, and 261168222;
d) Unit numbers: 261153610, 261153614, 261153621, 261153622, 261153639, 261153641, 261153658,
61153660, 261153664, 261153694, 261153698, 261153700, 261153708, 261153710, 261153909,
261153917, 261153922, 261153925, 261153941, 261153944, 261153952, 261154139, 261154141,
261154144, 261154149, 261154152, 261154156, 261154157, 261154159, 261154163, 261154784,
261154788, 261154791, 261154793, 261154794, 261154796, 261154797, 261154799, 261155451,
261156083, 261156085, 261156087, 261156093, 261156099, 261156121, 261156132, 261156147,
261156152, 261156156, 261156160, 261156172, 261156175, 261156610, 261156395, 261156613,
261156618, 261156623, 261156630, 261156677, 261156632, 261156636, 261156639, 261156680,
261156642, 261156646, 261156806, 261156836, 261156808, 261156838, 261156809, 261156839,
261156811, 261156842, 261156813, 261156845, 261156815, 261156817, 261156890, 261156819,261156891, 261156821, 261156897, 261156823, 261156898, 261156900, 261156907, 261157027, 261157032, 261157031, 261157040, 261157041, 261157045, 261157099, 261157133, 261157101, 261157134, 261157104, 261157136, 261157112, 261157138, 261157114, 261157140, 261157115, 261157143, 261157116, 261157146, 261157118, 261157119, 261157120, 261157121, 261157180, 261157380, 261157184, 261157382, 261157193, 261157383, 261157196, 261157384, 261161094, 261157994, 261161109, 261161347, 261161116, 261161135, 261161249, 261161214, 261161259, 261161272, 261161295, 261161329, 261161501, 261161617, 261161504, 261161507, 261161511, 261161730, 261161520, 261161737, 261161742, 261161821, 261161743, 261161825, 261161748, 261161831, 261161756, 261161832, 261161761, 261161835, 261161764, 261161839, 261161774, 261161842, 261161785, 261161847, 261161852, 261161854, 261161885, 261161918, 261161890, 261161894, 261161896, 261161947, 261161898, 261161963, 261161900, 261162321, 261162799, 261162324, 261174801, 261162327, 261174814, 261162329, 261162917, 261164486, 261162918, 261162919, 261162920, 261164645, 261162923, 261164646, 261162926, 261164659, 261165674, 261165855, 261165914, 261165868, 261165877, 261168027, 261168217, 261168029, 261174546, 261174591, 261174669, 261174713, 261174714, 261174738, 261175305, 261175308, 261175418, 261175850, 261175420, 261175861, 261175424, 261175862, 261175426, 261175868, 261175428, 261175431, 261175438, 261175939, 261175445, and 261175946;
e) Unit numbers: 261153612 and 261153644
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR
REASON Blood Products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 499 units
DISTRIBUTION TX, AR, AZ, MS, NV, OK, and Switzerland

PRODUCT
a) Cryoprecipitated AHF,
b) Recovered Plasma, 
CODE a) and b) Unit number: FE53870
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL
REASON Blood products, collected from a donor who received insulin of unknown origin for gestational diabetes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION IL and Switzerland

PRODUCT Source Plasma,
CODE Unit numbers 0016712, 0016918, 0017083, 0017353, 0017574, and 0017759
RECALLING FIRM/MANUFACTURER DCI Biologicals LLC, Nacogdoches, TX
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION KY

PRODUCT Source Plasma
CODE Unit numbers NG0049992, NG0050553, NG0050599, and NG0051159
RECALLING FIRM/MANUFACTURER DCI Biologicals LLC, Nacogdoches, TX
REASON Blood products, that tested negative for viral markers, but were collected from an donor that was not adequately screening regarding recent tattoos, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION KY

PRODUCT
Human tissue for transplantation of the following types:
a) Femoral Hemi Condyle Lateral Left - FS/A;
b) Femoral Hemi Condyle Lateral Right - FS/A;
c) Talus Right - FS/A;
d) Meniscus Medial Right - FS/A;
e) Cancellous Chips 4-9.5 15cc - FZ/A;
f) Cancellous Chips 4-9.5 30cc - FZ/A;
g) Cancellous Crushed 1-4 15cc - FZ/A;
h) Dowel Without Cartilage 14mm Diameter;
i) Achilles Tendon - FZ/A;
j) Tibialis Tendon Posterior - FZ/A;
k) Tibialis Tendon Anterior - FZ/A;
l) Patellar Ligament Hemi - FZ/A;
m) Tendon Double Bundle Semitendinosus/Gracilis - FZ/I
CODE
a) Part 32147002, number 044630-001;
b) Part 32147001, number 044630-003;
c) Part 32647001, number 044630-004;
d) Part 28225001, number 044630-005;
e) Part 27616015, numbers 044630-115 and 044630-117;
f) Part 27616030, numbers 044630-119, 044630-120, 044630-121, 044630-122, 044630-123, 044630-124, 044630-125, and 044630-126;
g) Part 27716015, number 044630-129;
h) Part 14211014, numbers 044630-130, 044630-131, 044630-132, and 044630-133;
i) Part 10016000, numbers 044630-162 and 044630-163;
j) Part 41616000, numbers 044630-164 and 044630-165;
k) Part 41516000, numbers 044630-166, 044630-167;
l) Part 17816000, numbers 044630-168, 044630-169, 044630-170, and 044630-171;
m) Part 44217002, numbers 044630-172 and 044630-173
RECALLING FIRM/MANUFACTURER AlloSource, Inc., Centennial, CO
REASON Human tissue for transplantation was incorrectly tested for viral markers in that the blood sample used for testing was hemodiluted.
VOLUME OF PRODUCT IN COMMERCE 31 units
DISTRIBUTION MN, CA, CO, IL, MA, MO, NC, and WI

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers: 55P42733, 55P42740, 55P42750, 55P42758, 55P42759, 55P42762, 55P42767, 55P42775, 55P42776, 55P42780, 55P42781, 55P42784, 55P42788, 55P42790, 55P42796, 55P42806, 55P42815, 55P42821, 55P42838, 55P42840, 55P42845, 55P42850, 55P42852, 55P42860, 55P42866, 55P42976, 55P42985, 55P42990, 55P43045, 55P43099, 55P43119, 55P43135, 55P43146, 55P43149, 55P43169, 55P43174, 55P43175, 55P43179, 55P43181, 55P43183, 55P43189, 55P43191, 55P43193, 55P43197, 55P43200, 55P43207, 55P43227, 55P43231, 55P43242, 55P43243, 55P43249, 55P43251, 55P43255, 55P43265, 55P43270, 55P43271, 55P43281, 55P43284, 55P43297, 55P43298, 55P43301, 55P43303, 55P43313, 55P43315, 55P43316, 55P43321, 55P43326, 55P43331, 55P43338, 55P43387, 55P43395, 55P43411, 55P43412, 55P43418, 55P43428, 55P43441, 55P43448, 55P43459, 55P43465, 55P43471, 55P43477, 55P43485, 55P43497, 55P43506, 55P43507, and 55P43514; and the following units were distributed as two split products: units 55P42731, 55P42743, 55P42792, 55P42803, 55P42839, 55P42876, 55P42970, 55P43108, 55P43163, 55P43201, 55P43214, 55P43215, 55P43222, 55P43228, 55P43253, 55P43261, 55P43264, 55P43277, 55P43289, 55P43304, 55P43308, 55P43328, 55P43339, 55P43349, 55P43352, 55P43357, 55P43380, 55P43397, 55P43403, 55P43420, 55P43423, 55P43429, 55P43489, 55P43491, and 55P43499
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Ozarks- Arkansas Region, Little Rock, AR
REASON Blood products, collected during a period when quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 156 units
DISTRIBUTION AR, and TN

PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Platelets Pheresis Leukocytes Reduced,
c) Fresh Frozen Plasma,
CODE a), b), and c) Unit 55P43135
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Little Rock, AR
REASON Blood products, which, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION AR

PRODUCT Source Plasma
CODE Unit numbers: 04MUSA0982, 04MUSA1123, 04MUSA1241, 05MUSA0408, 05MUSA2732, 05MUSA4642, 07324321, 07325328, 07327414, 07329098, 09880955, 09883086, 09884694, 09886346, 09887794, 09889361, 10010655, 10012512, 10014264, 10016190, 10017746, 10019030, 10020173, 19041940, 19042749, 19044842, 19046068, 19047867, 19049052, 19770741, 19772301, 19890999, 19891910, 19893587, 19896113, 19899596, 19901640, 19904139, 19904931, 19907192, QP034346, QP034424, QP034476, QP034503, QP034515, QP034538, QP034549, QP034568, QP034575, QP034607, QP034655, QP034667, QP034690, QP034717, QP034740, QP034766, QP034779, QP034805, QP034821, QP034842, QP034855, QP034883, QP034908, QP034928, QP034956, QP034995, QP035014, QP035036, and QP043804 [69 units]
RECALLING FIRM/MANUFACTURER Bio-Blood Components, Inc., Muskegon, MI
REASON Blood products, which were collected from a donor who had engaged in high risk behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE 69 units
DISTRIBUTION CA and Germany

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 6597209, 6593686, and 6590896
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6590986
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated
CODE Unit number: 4276718
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Inc., Indianapolis, IN
REASON Blood product, which was labeled as irradiated with no documentation that the irradiation process was adequate, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IN

PRODUCT Cornea
CODE Unit number: IN200410111
RECALLING FIRM/MANUFACTURER Indiana Lions Eye and Tissue Transplant Bank, Indianapolis, IN
REASON Human tissue, which was collected from a donor who had discordant test results for hepatitis B surface antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Source Plasma
CODE Unit number: VP182095
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Source Plasma
CODE Unit number: VP182166
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Recovered Plasma
CODE Unit numbers: 261156896, 261156973, 261157106, 261157108, 261157117, 261157128, 261157130, 261157187, 261157396, 261157397, 261157339, 261157462, 261157466, 261157469, 261157475, 261157479, 261157986, 261157998, 261161210, 261161381, 261161384, 261161444, 261161458, 261161462, 261161466, 261161471, 261161476, 261161484, 261161601, 261161628, 261161629, 261161633, 261161634, 261161642, 261161651, 261161684, 261161687, 261161691, 261161726, 261161731, 261161853, 261161875, 261161879, 261161881, 261161906, 261161910, 261161915, 261161970, 261161974, 261164650, 261164800, 261165616, 261165634, 261165640, 261165645, 261165762, 261165888, 261165892, 261165898, 261165908, 261165922, 261174589, 261174642, 261174651, 261174656, 261174657, 261174658, 261174663, 261174675, 261174680, 261174682, 261174698, 261175429, 261175433, 261175911, 261161302, 261161434, 261161533, 261161769, 261162392, 261165879, 261155882, 261165884, 261165886, 261175455, and 261175915
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR
REASON Blood Products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 86 units
DISTRIBUTION TX, AR, AZ, MS, NV, OK, and Switzerland

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 40LE18972 and 40LE18984
RECALLING FIRM/MANUFACTURER The American National Red Cross, Heart of American Region, Peoria, IL
REASON Blood products, which were collected from donors in which Copper Sulfate QC was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION IL

WEEK ENDING SEPTEMBER 30

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit numbers: 0759500, 075200
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO

PRODUCT
a) Red Blood Cells, Leukoreduced, 
b) Frozen Plasma, 
CODE
a) Unit numbers: 004FJ63475, 004FJ67669;
b) Unit number: 004FJ84238
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA
REASON Blood products, collected from a donor who was taking the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION MA and VT

PRODUCT Source Plasma
CODE Unit number: 04TTXC5260
RECALLING FIRM/MANUFACTURER Plasma Center -- Tyler, Inc., Tyler, TX
REASON Source Plasma, which tested positive for hepatitis B surface antigen (HbsAg), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Source Plasma
CODE Unit numbers: AY0492741, AY0493023, AY0493506, AY0493750
RECALLING FIRM/MANUFACTURER Yale Blood Plasma, LLC, Albuquerque, NM
REASON Blood products, which were untested for human immunodeficiency virus (HIV) by the nucleic acid test (NAT) method, but subsequently tested positive for hepatitis C virus (HCV) by NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION England

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit number: 6577256
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was leukoreduced twice, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT
a) Red Blood Cells, 
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit number: 6580297;
b) Unit number: 6583543
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit numbers: 6951227, 7043123
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO and IL

PRODUCT
a) Red Blood Cells,
b) Red Blood Cells, Leukocytes Reduced, 
CODE
a) Unit number: 6867816;
b) Unit numbers: 6873283, 6864770, 6861183
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukoreduced
CODE Unit number: 55FH62443
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AK
REASON Blood product, which initially tested positive for West Nile Virus (WNV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AK

PRODUCT Red Blood Cells
CODE Unit numbers: 19GS18400, 19GM08233
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN
REASON Red Cells, collected from donors with a history of a positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TN

PRODUCT Red Blood Cells
CODE Unit number: 4762386
RECALLING FIRM/MANUFACTURER Department of the Army, Brooke Army Medical Center, Fort Sam Houston, TX
REASON Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 20039-2515, 20726-3809
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Lafayette, LA.
REASON Red Blood Cells, collected from ineligible donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION LA

PRODUCT Human Corneas for Transplantation, 
CODE Tissues 05341OD and 05341OS
RECALLING FIRM/MANUFACTURER Upstate NY Transplant Svc, Inc, Buffalo, NY
REASON Human Corneas, procured from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues
DISTRIBUTION NY and PA

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets,
c) Recovered Plasma, 
CODE a), b), and c) Unit number: 4738645
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION TX and NY

PRODUCT Human Corneas for Transplant, 
CODE Tissue 05-0992-200
RECALLING FIRM/MANUFACTURER Rocky Mountain Lions Eye Bank, Aurora, CO
REASON Corneal tissue was distributed before eligibility screening was complete.
VOLUME OF PRODUCT IN COMMERCE 1 tissue
DISTRIBUTION HI

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced,
CODE Unit numbers: W16-36079A, W16-36079B
RECALLING FIRM/MANUFACTURER Community Blood Council of New Jersey, Inc., Trenton, NJ, 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 NJ

PRODUCT
a) Red Blood Cells, 
b) Red Blood Cells, Leukocytes Reduced, 
CODE
a) Unit number: 6640999;
b) Unit number: 6651361
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NC and PA

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit numbers: 6656388, 3912090, 6632022
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION CO, IL, and KS

PRODUCT Red Blood Cells
CODE Unit number: 6628444
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT
a) Red Blood Cells, ;
b) Red Blood Cells Leukoreduced,;
c) Platelets Pheresis Leukocytes Reduced, 
CODE
a) Unit numbers: K13692, K13702, K22932, K32087, K32088, K32089;
b) Unit numbers: K13700, K13696;
c) Unit numbers: K13709-P1, K13709-P2
RECALLING FIRM/MANUFACTURER Regional Health Resource Center, Urbana, IL
REASON Blood products, tested for anti-HBc using an expired reagent, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION IL

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit number: 6891510
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells
CODE Unit number: 6646981
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelet Pheresis, Leukocytes Reduced,
CODE
a) Unit numbers: 0750307, 0758893, and 0761465;
b) Unit numbers: 0755255 and 0753664
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION CO, NB, NC, and FL

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit numbers: 6950016, 6952526
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION IL and MA

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 6910443, 6419944
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO and IL

PRODUCT
Recall # B-2248-5;
b) Red Blood Cells, Leukocytes Reduced, Irradiated,
CODE
a) Unit number: 6952525;
b) Unit number: 6950014
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit number: 4954252
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood product, which failed Red Blood Cell QC testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 5560077
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood product, which failed Red Blood Cell QC testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Recovered Plasma
CODE a) and b) Unit number: 01FC35421
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, West Henrietta, NY
REASON Blood products, which were collected from a donor who had medical history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NY and CA

PRODUCT Red Blood Cells
CODE Unit numbers: 3938002, 3938016, and 3938017
RECALLING FIRM/MANUFACTURER New York Blood Center, Inc., New Brunswick, NJ
REASON Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION NY

PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit number: 6416207;
b) Unit number: 6418103
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL and CO

PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit number: 6589572;
b) Unit number: 6583197
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NY and CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6871943
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 6891542, 6637553
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 6578044, 6572683
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from a donor who traveled to an area endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6571556
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells
CODE Unit number: 6612228
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT
a) Red Blood Cells, Leukocytes, Reduced,
b) Cryoprecipitated AHF, Pooled;
c) Recovered Plasma
CODE
a) and c) Unit numbers: 3165611 and 3148673;
b) Unit number: 3165611
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center, San Francisco, CA, REASON Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION CA and Switzerland

PRODUCT
a) Red Blood Cells, Leukocytes, Reduced,
b) Platelet
c) Recovered Plasma,
CODE a), b), and c) Unit number: 20032-3450
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Lafayette, LA.
REASON Blood products, which were collected from a donor who had a non-confidential health history screening, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION LA and Switzerland

PRODUCT Platelets Pheresis
CODE Unit number: N23627
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Saginaw, MI
REASON Blood product, which did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI

PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes Reduced
c) Red Blood Cells Leukocytes Reduced Irradiated, 
d) Red Blood Cells (Apheresis) Leukocytes Reduced,
e) Platelets
f) Fresh Frozen Plasma,
CODE
a) Unit numbers: 38FS14735, 38FS14736, 38J52385, 38J52386, 38J52387 and 38LV00284;
b) Unit numbers: 38FM89525, 38FM89526, 38FM89531, 38FM89532, 38FM89538, 38FM89539, 38FM89541, 38FM89545, 38FV35418, 38FV35420, 38FV35421, 38FV35422, 38FV35424,
38FV35425, 38FV35426, 38FV35427, 38FV35428, 38FV35429, 38FV35431, 38FV35432, 38FV35433, 38FV35434, 38FV35437, 38FV35441, 38FV35442, 38FV35443, 38FV35444, 38FV35445, 38FV35446, 38FV35449, 38FV35450, 38FV35451, 38FV35452,
38FV35453, 38FV35455, 38FV35456, 38FV35457, 38FV35458, 38FV35459, 38FV35460, 38FV35461, 38FV35463, 38FV35464, 38FV35465, 38FV35466, 38FV35467, 38FV35468, 38FV35469, 38KT28641, 38KT28647, 38KT28648, 38KT28649, 38KT28650,
38KT28656, 38KT28659, 38KT28660, 38KT28665, 38KT28666, 38KT28669, 38KT28675, 38KT28679, 38L92590, 38L92593, 38L92594, 38L92595, 38L92597, 38L92599, 38L92601,
38L92605, 38L92608, 38L92611 (2 units), 38L92612, 38L92613, 38L92614, 38L92616 (2 units), 38L92617, 38L92618, 38L92619, 38LC94178, 38LC94181, 38LC94182, 38LC94183, 38LC94184, 38LC94185, 38LC94186, 38LC94187, 38LC94188, 38LC94189, 338LC94197, 38LC94199, 38LC94200, 38LC94204, 38LC94205, 38LC94206, 38LC94207, 38LC94209, 38LC94212, 38LC94213, 38LC94214, 38LC94217, 38LC94218, 38LC94220, 38W39131, 38W39135, 38W39139, 38W39144, and 38W39145;
c) Unit number: 38LV00283;
d) Unit numbers: 38FV35448 (2 units), 38FV35454 (2 units) and 38FV35462 (2 units);
e) Unit numbers: 38FS14735, 38FS14736, 38J52385, 38J52386, 38J52387, and 38LV00284;
f) Unit numbers: 38FV35428
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Fort Wayne, IN
REASON Blood products, which were untested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 129 units
DISTRIBUTION IN, KY, and MI

PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Fresh Frozen Plasma
CODE a) and b) Unit number: 13FR67969
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Detroit, MI
REASON Blood products, which were collected from a donor who had taken the medication Avodart, were collected.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MI

PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Platelets
c) Recovered Plasma,
CODE
a) and c) Unit numbers: 18FK60222 and 18FX24650;
b) Unit number: 18FX24650
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Lansing, MI
REASON Blood products, which were collected from a donor who had engaged in multiple high behavior activities, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION CA, MA, and MI

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6910559
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit number: 6837455
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Red Blood Cells
CODE Unit number: 6842323
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells
CODE Unit number: 7018627
RECALLING FIRM/MANUFACTURER HemaCare Corporation, Sherman Oaks, CA,
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit number: 2125000
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc, Lexington, KY
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KY

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 2128372
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc, Lexington, KY
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KY

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets
CODE a) and b) Unit number: 2140358
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc, Lexington, KY
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION KY and NY

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Unit number: 4817563
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1unit
DISTRIBUTION TX

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Recovered Plasma
CODE a) and b) Unit numbers: 3138491, 3117542, 1212487
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, San Francisco, CA
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION CA and Switzerland

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit number: 6833936
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from a donor whose arm scrub may have been incorrectly performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers: 6947151, 6945920, and 6942247
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6611946
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6531221
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells
CODE Unit number: 6863871
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6625804
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 6834619
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTIONCO

PRODUCT
a) Platelets Pheresis, Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes Reduced Irradiated,
CODE a) and b) Unit number: 04GH13188
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA
REASON Blood products, that tested positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MA

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Unit numbers: 04GH13152P1 and 04GH13152P2
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA
REASON Blood products, that tested positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION PA

PRODUCT Red Blood Cells
CODE Unit number: 7018470
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit number: 6415050
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT
a) Red Blood Cells, 
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit number: 6603207;
b) Unit number: 7031297
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, which were collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6871175
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6869677
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6868779
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 6888296
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells
CODE Unit number: 6617893
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Platelet Pheresis Leukoreduced
CODE Unit number: 6833578
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, with incomplete irradiation documentation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 12LV27754
RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected from a donor who lived in an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 12GM96685
RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 12FZ31792
RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected from a donor who traveled to an area endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Red Blood Cells Leukocytes Reduced, 
CODE Unit number: 0752551
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Recovered Plasma,
CODE a) and b) Unit number: 7037679
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, which were collected from a donor who had received acupuncture therapy and had come into contact with someone else's blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION IL and Switzerland

PRODUCT Red Blood Cells,
CODE Unit number: 6943114
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells Leukocytes Reduced,
CODE Unit number: 7025863
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Red Blood Cells, 
CODE Unit number: 6417490
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AL

PRODUCT Source Plasma
CODE Unit numbers: SP-152026, SP-151399, SP-151455, SP-151565, SP-151637, SP-151764, SP-151297, SP-151944, SP-153215, SP-152140, SP-152790, SP-152867, SP-152982, SP-153043, SP-153137, and SP-151839
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, San Diego, CA
REASON Blood products, collected from an unsuitable donor based on an unexplained weight loss, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units
DISTRIBUTION Australia

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 71X089578 (Part 2)
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Center, Gainesville, FL
REASON Platelets Pheresis, with an unacceptably low volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Red Blood Cells Leukoreduced
CODE Unit number: 10041-8973
RECALLING FIRM/MANUFACTURER Blood Systems Inc, Scottsdale, AZ,
REASON Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AZ

PRODUCT Red Blood Cells, Leukoreduced, 
CODE Unit number: 10042-9924
RECALLING FIRM/MANUFACTURER Blood Systems, Inc, Scottsdale, AZ
REASON Blood product, not prepared in accordance with specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AZ

PRODUCT Red Blood Cells, Leukoreduced, 
CODE Unit number: 027GV85498
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies Region, Johnstown, PA
REASON Blood product, which tested positive for the S-antigen but was labeled as S-antigen negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WV

PRODUCT
a) Red Blood Cells, Leukoreduced,
b) Recovered Plasma
CODE a) and b) Unit numbers: 4684850, 4685490, 4800231, 4800825, 4570579, 4684028
RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood products, collected from a donor who was taking the antibiotic ampicillin, were distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units
DISTRIBUTION OK, VA and Switzerland

PRODUCT
a) Red Blood Cells, Leukoreduced,
b) Recovered Plasma, 
CODE a) and b) Unit number: 4836994
RECALLING FIRM/MANUFACTURER Sylvan N. Goldman Center, Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood products, collected from a donor who was taking the drug Aygestin, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OK and Switzerland

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Recovered Plasma, 
CODE a) and b) Unit number: 1645152
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX
REASON Blood products, collected from a donor whose arm inspection was not documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX and Switzerland

PRODUCT
a) Red Blood Cells, Leukoreduced,
b) Fresh Frozen Plasma,
c) Recovered Plasma,
CODE
a) Unit numbers: 1098552, 1069139, 1078831;
b) Unit number: 1078831;
c) Unit number: 1069139
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH
REASON Blood products, collected from a donor who was taking the medication Embrel, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION OH and Switzerland

PRODUCT Platelets
CODE Unit number: 4865390
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Platelets, manufactured from whole blood units that were collected while the mobile site temperature was out of range, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Platelets
CODE Unit number: 4841779
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood product, manufactured from a unit of Whole Blood that had an incorrectly documented collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Platelets
CODE Unit number: 4865255
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood product, manufactured from a unit of Whole Blood that had an incorrectly documented collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells, Leukocytes, Reduced
CODE Unit number: 200381688
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Lafayette, LA.
REASON Blood product, collected on a trip scale that was incorrectly calibrated, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION LA

PRODUCT Red Blood Cells, Leukocytes Reduced, 
CODE Unit numbers: 38FV35807 (2 units), 38FV35834 (2 units), 38LLC94134 (2 units), and 37LC94139 (2 units)
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Fort Wayne, IN
REASON Blood products, which were not tested for white blood cell counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION IN

PRODUCT Platelets
CODE Unit number: 4840802
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood product, lacking documented collection times, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NY

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated,
CODE Unit number: 6876703
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, which was out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Granulocytes Pheresis, 
CODE Unit number: 49GP20305
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK
REASON Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT
a) Red Blood Cells
b) Platelets, 
CODE a) and b) Unit number: 1681754
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX
REASON Blood products, which were collected from a donor in which donor stability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Red Blood Cells, 
CODE Unit number: 20726-8578
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, 
Manufacturer: Blood Systems, Inc., Lafayette, LA. 
REASON Blood product, which was untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION LA

PRODUCT Source Plasma,
CODE Unit number: VA-113100
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON Blood product, collected from a donor whose arm inspection was not acceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Source Plasma,
CODE Unit number: VA-182763
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Source Plasma,
CODE Unit number: SP-21257
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, San Diego, CA
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Source Plasma, 
CODE Unit number: YA-134557
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, San Diego, CA
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Source Plasma, 
CODE Unit number: CH-100149
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Colton, CA
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT Source Plasma
CODE Unit number: VP-180016
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Source Plasma
CODE Unit number: VP-191194
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Source Plasma,
CODE Unit number: VA-126685
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON Blood product, collected from a donor for whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Source Plasma
CODE Unit number: VA-125877
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON Blood product, collected from a donor whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Source Plasma
CODE Unit number: VP-186141
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON Blood product, collected from a donor whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Austria

PRODUCT Source Plasma
CODE Unit number: F-00895-046
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA
REASON Blood product, collected from a donor whom there was no documentation on the donor record of an arm inspection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Unit number: 0754572 (distributed as two split products)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, collected in an expired collection bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Unit number: 6835267
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO,
REASON Blood product, that was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Platelets Pheresis, Leukocytes Reduced,
CODE Unit number: 6579639 (distributed as two split units)
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, that were labeled leukoreduced but was not tested to determine the white blood cell count as required in the firm's standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CO

PRODUCT Red Blood Cells Leukoreduced Irradiated, 
CODE Unit numbers: 6886219, 6946572, 6946610, 6613476, 6866337, 6833642, 6417254, 6631268, 0754967, 6417284, 6417643, 6579952, 6620964, 6620039, 6886646
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood products, labeled with extended expiration dates, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units
DISTRIBUTION CO and WY

PRODUCT
a) Platelet Pheresis Leukocytes Reduced,
b) Platelets Pheresis Leukocyte Reduced Irradiated,
CODE Unit number: 6402624
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, IN
REASON Blood products, labeled as "Leukocyte Reduced" but which failed to meet the criteria for leukoreduced units, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION IN

PRODUCT Platelet Pheresis Leukocytes Reduced, 
CODE Unit number: 6579278
RECALLING FIRM/MANUFACTURER Belle Bonfils Memorial Blood Center, Denver, CO
REASON Blood product, labeled as leukoreduced but which was not tested for White Blood Cell count as required, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CO

PRODUCT Recovered Plasma
CODE Unit number: 10041-8973
RECALLING FIRM/MANUFACTURER Blood Systems Inc, Scottsdale, AZ
REASON Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Switzerland