APRIL 2006

WEEK ENDING APRIL 1

PRODUCT Achilles Tendon with Bone, Frozen, Irradiated
CODE Tissue 040484-018
RECALLING FIRM/MANUFACTURER Community Blood Center, dba Community Tissue Services, Portland, OR
REASON Human tissue, positive for Propionibacterium acnes on final culture after processing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue
DISTRIBUTION Korea

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 20FZ22044
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Lewis and Clark Region, Boise, ID
Manufacturer: American National Red Cross, Missoula, MT.
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 MT

PRODUCT
a) Red Blood Cells
b) Cryoprecipitated AHF, Pooled,
c) Recovered Plasma
CODE a), b), and c) Unit number: 0633536
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH
REASON Blood products, collected from an ineligible donor due to a history of intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION IN and OH

PRODUCT
a) Red Blood Cells
b) Platelets
c) Cryoprecipitated AHF
CODE a), b), and c) Unit number: 12H21309
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION MD, NC, and PR

PRODUCT Red Blood Cells
CODE Unit number: 040GN08023
RECALLING FIRM/MANUFACTURER American National Red Cross, Heart of America, Peoria, IL
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 Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 9050706
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc., Greenville, SC,
REASON Platelets, with a platelet count above the firmís specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION SC

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 36M71122
RECALLING FIRM/MANUFACTURER American National Red Cross, South Carolina Region, Columbia, SC
REASON Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION SC

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 003LY14844
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON Platelets Pheresis, with an elevated platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT Platelets Pheresis
CODE Unit number: 03KN18640
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON Platelets, inappropriately prepared by splitting the product into two storage bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 12W96818 (Part 1)
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, collected in an apheresis collection kit that exceeded the acceptable time period for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Red Blood Cells, Irradiated
CODE Unit number: 9306695
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced, Irradiated
c) Cryoprecipitated AHF
d) Fresh Frozen Plasma
e) Plasma, Frozen
f) Recovered Plasma
CODE
a) Unit numbers: 03GS32813, 03GH28032;
b) Unit number: 03LM79071;
c) Unit number: 03GH28032;
d) Unit number: 03GS32813;
e) Unit number: 03GH28032;
f) Unit number: 03LM79071
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA,
REASON Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION CA, GA, and Switzerland

PRODUCT Platelets, Leukocytes Reduced
CODE Unit number: 49GW24633
RECALLING FIRM/MANUFACTURER American National Red Cross, Southwest Region, Tulsa, OK.
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT
a) Red Blood Cells, Washed
b) Recovered Plasma
CODE a) and b) Unit number: KC69321
RECALLING FIRM/MANUFACTURER HCSC-Blood Center, Bethlehem, Pa
REASON Blood products, collected from a donor who was previously deferred for a history of intravenous (IV) drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NJ and PA

PRODUCT Platelets Pheresis, Leukocytes Reduced, Irradiated
CODE Unit number: 6879943
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, TX
REASON Blood product, which was incorrectly labeled as having been irradiated, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Recovered Plasma
CODE
a) Unit numbers: 1411853, 1410232;
b) Unit number: 1410232
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, TX
REASON Blood products, which tested negative for hepatitis, but were collected from a donor with a history of Hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION NJ, TN, and TX

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets Pheresis, Leukocytes Reduced,
c) Recovered Plasma
CODE
a) Unit numbers: 49LF64408, 49LF65369;
b) Unit numbers: 49LP11951, 49LP12030, 49LP12791;
c) Unit numbers: 49LF64408, 49LF65369
RECALLING FIRM/MANUFACTURER American National Red Cross, Southwest Region, Tulsa, OK
REASON Blood products, collected from a donor who provided post donation information regarding multiple high-risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units
DISTRIBUTION CA, OK, TX, and Switzerland

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated
b) Platelets Pheresis, Leukocytes Reduced, Irradiated
CODE
a) Unit number: 6906034;
b) Unit number: 1410768
RECALLING FIRM/MANUFACTURER Coffee Memorial Blood Center, Inc., Amarillo, TX
REASON Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION TX

PRODUCT Red Blood Cells,
CODE Unit numbers: 3026275, 5502066
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL
Manufacturing Firm: LifeSource Hyde Park Donor Center, Chicago, IL,
REASON Blood products, collected from an ineligible donor due to use of the medication Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION IL

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 027LW50207
RECALLING FIRM/MANUFACTURER American National Red Cross, Greater Alleghenies Region, Johnstown, PA
REASON Blood product, collected from a donor that did not answer one of the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KY

PRODUCT Platelet Pheresis, Leukocytes Reduced
CODE Unit number: 6697433
RECALLING FIRM/MANUFACTURER Suncoast Communities Blood Bank, Sarasota, FL
REASON Blood product, possibly contaminated with several skin contaminants, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 04710
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ
Manufacturer: Blood Systems Inc., Albuquerque, NM
REASON Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NM

PRODUCT Plasma
CODE Unit number: 4705440
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX
REASON Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NJ

PRODUCT Platelets
CODE Unit number: GP80277
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Blood product, inadvertently contaminated with Optisol (AS-5), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: G47666, G47671, J06012, J06070, L53552, L53567, S37262, S37337, S37397
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Center, Springfield, IL
REASON Blood products, mislabeled as leukocytes reduced, were distributed
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION IL

PRODUCT
a) Red Blood Cells
b) Red Blood Cells, Leukocytes Reduced,
CODE
a) Unit numbers: J02977, J03004, J02984, J02991;
b) Unit number: J02997
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Center, Springfield, IL
REASON Blood products, collected on a trip scale that was incorrectly calibrated, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION IL

PRODUCT Fresh Frozen Plasma
CODE Unit numbers: L53131, L53142, S35408
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Center, Springfield, IL.
REASON Blood products, which lacked assurance of proper shipping temperatures due to inaccurate documentation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION IL

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Recovered Plasma
CODE a) and b) Unit number: 36LP23987
RECALLING FIRM/MANUFACTURER American National Red Cross, South Carolina Region, Columbia, SC
REASON Blood products, collected from an ineligible donor due to receipt of the hepatitis B vaccination, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA and SC

PRODUCT Red Blood Cells
CODE Unit number: 6443076
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood product, manufactured without the entire quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: LH33536
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., Dba Rhode Island Blood Center, Providence, RI
REASON Blood product, manufactured without the entire quantity of additive solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NY

PRODUCT Red Blood Cells
CODE Unit number: FH24943
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL
Manufacturing Firm: Heartland Blood Centers Dekalb, Dekalb, IL.
REASON Blood product, collected from an ineligible donor due to the use of an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT
a) Platelets Pheresis Leukocytes Reduced,
b) Platelets Pheresis Leukocytes Reduced Irradiated
CODE a) and b) Unit number: 38FX01910
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN
REASON Blood products, possible contaminated with coagulase-negative staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MI

PRODUCT Platelets, Leukocytes Reduced
CODE Unit number: H18610, H18611, H18617, H18619, C67297
RECALLING FIRM/MANUFACTURER South Bend Medical Foundation, South Bend, IN
REASON Blood products, which were incorrectly tested for the antibody to the human T-lymphotropic virus (anti-HTLV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION IN

PRODUCT Source Plasma
CODE Unit number: SH047021
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Harrisburg, PA
REASON Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION France

WEEK ENDING APRIL 8

PRODUCT Human Corneas for Transplantation Tissues
CODE Tissues: 05-0191-100 and 05-0191-200
RECALLING FIRM/MANUFACTURER Mid South Eye Bank for Sight Restoration, Inc., Memphis, TN.
REASON Human tissues for transplantation, recovered from a donor who was subsequently found to have tested positive for the hepatitis C virus by both NAT and antibody testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues
DISTRIBUTION NY

PRODUCT Source Plasma
CODE Unit numbers: N-37471-097, N-37494-097, G-91707-097, G-91940-097, G-92659-097, G-92907-097, G-93645-097, G-93924-097, G-95831-097, G-96149-097, G-97647-097, G-98705-097, G-99010-097, G-05826-097, G-06673-097, G-07071-097, G-08072-097, G-08749-097, G-09126-097, G-09719-097, G-10033-097, G-10970-097, G-11232-097, G-12389-097, G-12716-097, G-13674-097, F-00078-097, F-00367-097, F-01024-097, F-01399-097, F-02473-097
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., San Diego, CA
REASON Blood products, collected from a donor who had engaged in multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 31 units
DISTRIBUTION CA and Spain

PRODUCT Source Plasma
CODE Unit numbers: SP-20158, SP-20620, SP-20633, SP-20714, F-00335-044, F-00455-044, F-00483-044, F-00670-044, F-00706-044, F-00828-044, F-00872-044, F-01171-044, F-01273-044, F-01315-044
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, San Diego, CA
REASON Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a history of hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units
DISTRIBUTION CA and Austria

PRODUCT Source Plasma
CODE Unit numbers: G-05988-072, F-00081-072, F-01523-072, F-02979-072, F-19651-072, F-21287-072, F-22556-072, F-23698-072
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Long Beach, CA
REASON Blood products, collected from a donor who had a tattoo applied within twelve months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION NC

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 06LR01358
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Pomona, CA
REASON Blood product, which tested negative for the antibody to the human T-lymphotropic virus type 1 (anti-HTLV-1), but was collected from a donor who previously tested repeatedly reactive for anti-HTLV-1, Western blot positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Platelets Pheresis Leukocytes Reduced
CODE Units (2 units) 004KC33387 -- parts 1 and 2
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, New England Region, Dedham, MA
REASON Platelets, possibly contaminated with bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION VT and MA

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 113431788
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX
REASON Blood product, which tested initially non-reactive for West Nile Virus (WNV) when tested in a pool of 16 donations, but was not tested individually for WNV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Human Corneas for Transplantation
CODE Tissues 0078-06-01, 0078-06-02
RECALLING FIRM/MANUFACTURER North Carolina Eye Bank, Dorham, NC
REASON Human tissues for transplantation, that tested negative for hepatitis prior to distribution, but were subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues
DISTRIBUTION NC and TX

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 55P46462
RECALLING FIRM/MANUFACTURER American National Red Cross, Greater Ozarks-Arkansas Region, Little Rock, AR,
REASON Platelets, which were possibly contaminated with Staphylococcus epidermidis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AR

PRODUCT Cryoprecipitated AHF
CODE Unit number: 5650054
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
REASON Blood product, corresponding to a unit of red cells that was possibly contaminated with coagulase-negative Staphylococcus and implicated in an adverse transfusion reaction, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT Fresh Frozen Plasma
CODE Unit number: 22GL27322
RECALLING FIRM/MANUFACTURER American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON Blood product, in which the corresponding Platelets were possibly contaminated with coagulase-negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Human Saphenous Vein
CODE Tissue number: 8306257
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA
REASON Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue
DISTRIBUTION MA

PRODUCT Cryoprecipitated AHF
CODE Unit number: 16GW44163
RECALLING FIRM/MANUFACTURER American National Red Cross, Central Ohio Region, Columbus, OH
REASON Blood product, corresponding to a unit of red cells that was implicated in a transfusion reaction and was possibly contaminated with Aeromonas hydrophilia, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

PRODUCT Human Cornea Tissue for Transplantation
CODE Tissue number: 05-1136 OD
RECALLING FIRM/MANUFACTURER Northwest Lions Eye Bank, Seattle, WA
REASON Human Cornea, placed in an expired viewing chamber, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue
DISTRIBUTION Japan

PRODUCT Platelets Pheresis Leukocytes Reduced
CODE Unit numbers: 40P06964-P1, 40P06964-P2
RECALLING FIRM/MANUFACTURER The American National Red Cross, Heart of America Region, Peoria, IL.
REASON Blood products, collected in an apheresis collection kit after the acceptable time period for use was exceeded, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION IL

PRODUCT Platelets Pheresis, 
CODE Unit number: 03F16197
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON Blood product, collected from a donor that did not answer one of the medical history questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT
a) Red Blood Cells
b) Platelets, 
c) Fresh Frozen Plasma, 
d) Recovered Plasma, 
CODE
a) Unit numbers: 12V06564, 12P80910, 12C81080, 12X37662, 12X35755;
b) Unit number: 12X37662;
c) Unit number: 12X37662;
d) Unit numbers: 12C81080, 12P80910, 12V06564, 12X35755
RECALLING FIRM/MANUFACTURER American National Red Cross, Asheville, NC.
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previously positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units
DISTRIBUTION NC and CA

PRODUCT Baxter ALYX Red Kit, For Collection of Two Leukoreduced Red Blood Cell Products by Centrifugation, For Use with the ALYX Instrument; sterile single use unit consisting of a separation chamber, an umbilicus, a cassette, 1 container 0.9% sodium chloride, 1 container ACD-A anticoagulant, 1 container Adsol Red Cell Preservative Solution, 3 blood component containers, 2 red cell storage containers, 1 18 gauge needle and 1 Sepacell leukoreduction filter
CODE All lot numbers starting with H04J, H04K, H04L, H05A, H05B, H05C, H05D, H05E, H05F, H05G and H05H, except those lots suffixed with "A" (H05I02028A, H05I13041A and H05I19071A)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL
Manufacturer: Baxter Healthcare Corporation, Mountain Home, AR
REASON Apheresis kits, manufactured with potential for leaks from the cassette of the disposable kit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 122,676 kits representing 67 lots
DISTRIBUTION Nationwide and Internationally

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 06LE31558
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Pomona, CA
REASON Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Red Blood Cells Pheresis, Leukocytes Reduced
CODE Unit numbers: 12645-8676 (split unit)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, 
Manufacturer: Blood Systems, Inc., Albuquerque, NM, 
REASON Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NM

PRODUCT Red Blood Cells
CODE Unit number: 6029974
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON Blood product, which tested negative for hepatitis, but was collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit numbers: 2120513, 2116438
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY,
REASON Blood products, associated with units of Cryoprecipitated AHF that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION KY

PRODUCT Platelets
CODE Unit number: 2166218
RECALLING FIRM/MANUFACTURER Central Kentucky Blood Center, Inc., Lexington, KY
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION KY

PRODUCT Red Blood Cells
CODE Unit number: 36FQ28150
RECALLING FIRM/MANUFACTURER American National Red Cross, South Carolina Region, Columbia, SC
REASON Blood product, which was not quarantined after receiving information regarding a post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION SC

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 06GC13649
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Pomona, CA
REASON Blood product, which was incorrectly labeled as being negative for unexpected antibodies, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers: 004GR31489 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER American National Red Cross, New England Region, Dedham, MA
REASON Platelets, which were possibly contaminated with coagulase negative Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NY

PRODUCT Platelets Pheresis, Irradiated
CODE Unit number: 06KR35274
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Pomona, CA
REASON Blood product, with elevated platelet counts, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 1249550
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON Platelets, with a low yield, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

PRODUCT
a) Fresh Frozen Plasma
b) Recovered Plasma
CODE
a) Unit number 4835787;
b) Unit number 4642919
RECALLING FIRM/MANUFACTURER Floridaís Blood Centers, Inc., Orlando, FL
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 FL

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit number: 3178210
RECALLING FIRM/MANUFACTURER LifeSource, Glenview, IL
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 IL

PRODUCT Source Plasma
CODE Unit numbers: G20953014, G21541014, G21942014, G22813014, G23670014, G24004014, G25274014, G25494014, G26751014, G26999014, and G27681014
RECALLING FIRM/MANUFACTURER Alpha Therapeutics Corporation, National City, CA, REASON Blood products, which were collected from a donor who was previously deferred for high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 11 units
DISTRIBUTION Spain

PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Platelets Pheresis, Leukocytes Reduced
CODE
a) Unit number: 40FY44368;
b) Unit number: 40FP22168
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Peoria, IL
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 IL

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: LW12295
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT
a) Red Blood Cells Pheresis, Leukocytes Reduced
b) Platelets Pheresis, Leukocytes Reduced
CODE
a) Unit numbers: 18238-5378, 18238-7088, 18238-7097;
b) Unit numbers: 18238-6876, 18238-7088
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Cheyenne, WY,
REASON Blood products, collected in apheresis collection kits that may have exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION WY

PRODUCT Platelets
CODE Unit number: L94697
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI

PRODUCT Platelets
CODE Unit number: N25356
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI
REASON Blood product, associated with a unit of Red Blood Cells that contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MI

PRODUCT Red Blood Cells
CODE Unit number: S84804
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Saginaw, MI
REASON Blood product, labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION FL

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 04FJ43633
RECALLING FIRM/MANUFACTURER American National Red Cross, New England Region, Dedham, MA
REASON Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who was subsequently determined to have previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION MA

PRODUCT Red Blood Cells
CODE Unit number: 4167724
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON Blood product, collected from a donor who did not have a hematocrit test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

PRODUCT Red Blood Cells
CODE Unit numbers: 18X74361, 18X74362, 18X74363
RECALLING FIRM/MANUFACTURER American National Red Cross, Great Lakes Region, Lansing, MI
REASON Blood products, for which the storage temperature of the donor thermometers exceeded the acceptable limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION MI

PRODUCT
a) Red Blood Cells
b) Recovered Plasma
CODE a) and b) Unit numbers: 03GK31284, 03LR49415
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION GA

PRODUCT Red Blood Cells
CODE Unit number: S47299
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Bethlehem, PA
REASON Blood product, untested for the antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION PA

PRODUCT Platelets Pheresis, Leukocytes Reduced, Irradiated
CODE Unit numbers: 16KF48433
RECALLING FIRM/MANUFACTURER American National Red Cross, Central Ohio Region, Columbus, OH
REASON Blood products, for which platelet cross-match testing was incorrectly performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH

PRODUCT Fresh Frozen Plasma (Apheresis)
CODE Unit number: 36N05072
RECALLING FIRM/MANUFACTURER American National Red Cross, South Carolina Region, Columbia, SC
REASON Fresh Frozen Plasma, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION SC

PRODUCT Six Bag Aliquot System with piercing pin and injection site; Size 150 mL, 
CODE Product Code T2186; Lot 109851
RECALLING FIRM/MANUFACTURER Charter Medical Limited, Winston Salem, NC
REASON Transfer packs, mislabeled with an incorrect bag volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1,464 units
DISTRIBUTION CA, FL, IL, and OH

PRODUCT Red Blood Cells
CODE Unit number: 06FS93865
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Pomona, CA
REASON Blood product, collected in an expired collection bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Red Blood Cells
CODE Unit numbers: 06FM23362, 06FM23387
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Pomona, CA,
REASON Blood products, collected in expired collection bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AZ and CA

PRODUCT Red Blood Cells Pheresis, Leukocytes Reduced
CODE Unit number: 33GN02171
RECALLING FIRM/MANUFACTURER American National Red Cross, Connecticut Region, Farmington, CT.
REASON Blood product, which was labeled leukoreduced but was not tested to determine the white blood cell count as required in the firmís standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CT

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 211FM47855 -- split product
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Pomona, CA
REASON Platelets, possibly contaminated with Bacillus sphaericus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA

PRODUCT Platelets Pheresis, Leukocyte Reduced
CODE Unit numbers: 211FM37798 -- split unit
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Pomona, CA
REASON Platelets, possibly contaminated with Bacillus species, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated
CODE Unit number: FH02840
RECALLING FIRM/MANUFACTURER Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL
REASON Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION IL

PRODUCT Recovered Plasma, 
CODE Unit number: 04FJ43633
RECALLING FIRM/MANUFACTURER American National Red Cross, New England Region, Dedham, MA
REASON Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who was subsequently determined to have previously tested positive for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Switzerland

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated,
CODE Unit number: 1253053
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON Blood product, which was irradiated twice, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

WEEK ENDING APRIL 15

PRODUCT Human Tissue for Transplantation, 
a) Alloquent CC allograft (8, 9, & 10 mm) Amended to include 5, 6, and 7 mm;
b) Achilles Tendon; 
c) Cancellous, 4-10 mm (15 cc & 30 cc);
d) Patella Tendon-Hemi;
e)  Tibialis Tendon; 
f)  Iliac Crest Wedge (14-17mm, 11-13 mm, <10 mm and 18+mm);
CODE
a) Product Code:  BS30-4008, ID# : GL2005-180-001, GL2005-180-002, GL2005-180-003, GL2005-180-004, GL2005-180-005, GL2005-180-006, GL2005-180-007, GL2005-180-008, GL2005-180-009; Amended to include: ID# : GL2005-139-013, GL2005-139-014, GL2005-176-001, GL2005-176-002, GL2005-176-003, GL2005-179-001, GL2005-179-002, GL2005-179-003, GL2005-179-004, GL2005-183-001, GL2005-183-002, GL2005-183-003, GL2005-183-004
Product Code: BS30-4009, ID#: GL2005-180-010; Amended to include: GL2005-127-015, GL2005-139-015, GL2005-143-012, GL2005-176-004, GL2005-176-005, GL2005-176-006, GL2005-176-007, GL2005-176-008, GL2005-176-009, GL2005-176-010, GL2005-179-007, GL2005-179-008, GL2005-179-009, GL2005-183-005, GL2005-183-006, GL2005-183-007, GL2005-183-008, GL2005-183-009, GL2005-183-010
Product Code: BS30-4010, ID#: GL2005-147-020, L2005-147-021, GL2005-161-017, GL2005-161-018, GL2005-164-013, GL2005-164-014, GL2005-165-015, GL2005-167-013, GL2005-167-014, GL2005-167-015, GL2005-167-016, GL2005-167-017, GL2005-168-013, GL2005-168-014, GL2005-168-015, GL2005-168-016; Amended to include: GL2005-139-016, GL2005-127-016, GL2005-143-013, GL2005-159-013, GL2005-181-018
Amended to include: Product Code BS30-4005, ID#: GL2005-133-005, GL2005-139-010, GL2005-143-008;
Product Code: BS30-4006, ID#: GL2005-127-010, GL2005-133-006, GL2005-133-007, GL2005-143-009, GL2005-143-010;
Product Code: BS30-4007, ID#: GL2005-127-011, GL2005-127-012, GL2005-127-013, GL2005-127-014, GL2005-133-008, GL2005-133-009, GL2005-139-011, GL2005-139-012, and GL2005-143-011

b) Product Code: LATM, ID#: GL2005-107-001, GL2005-108-001, GL2005-108-002, GL2005-109-001, GL2005-109-002, GL2005-114-002, GL2005-116-002, GL2005-118-001, GL2005-119-001, GL2005-119-002, GL2005-124-002, GL2005-130-001, GL2005-115-002, GL2005-116-001, GL2005-114-001, GL2005-120-003, GL2005-118-002, GL2005-124-001, and GL2005-115-001

c) Product Code: LCIPM, ID#: GL2005-107-003, GL2005-111-004, GL2005-113-004, GL2005-114-004, GL2005-115-004, GL2005-116-004, GL2005-122-004, T2005-034-005, T2005-049-014, T2005-064-003, T2005-078-005, T2005-057-002, T2005-072-003, GL2005-139-009
Product Code: LCISM, ID#: T2005-040-013, T2005-040-014, T2005-040-015, T2005-040-016, GL2005-108-003, GL2005-109-003, GL2005-111-003, GL2005-114-003, T2005-034-003, T2005-034-004, T2005-039-003, T2005-039-004, T2005-039-005, T2005-040-007, T2005-040-017, T2005-041-008, T2005-041-009, T2005-041-010, T2005-041-011, T2005-041-012, T2005-041-017, T2005-043-005, T2005-043-006, T2005-043-007, T2005-045-008, T2005-045-009, T2005-045-010, T2005-045-011, T2005-045-012, T2005-045-017, T2005-048-008, T2005-048-009, T2005-048-010, T2005-048-011, T2005-048-012, T2005-048-013, T2005-049-009, T2005-049-012, T2005-051-001, T2005-052-001, T2005-053-003, T2005-054-003, T2005-055-003, T2005-056-001, T2005-059-002, T2005-059-003, T2005-060-001, T2005-061-004, T2005-062-001, T2005-062-002, T2005-063-003, T2005-064-001, T2005-064-002, T2005-065-001, T2005-066-001, T2005-067-001, T2005-068-003, T2005-069-003, T2005-075-003, T2005-078-003, T2005-078-004, GL2005-107-002, GL2005-109-004, GL2005-110-004, GL2005-113-003, GL2005-115-003, GL2005-116-003, GL2005-117-003, GL2005-117-004, GL2005-118-003, GL2005-118-004, GL2005-120-001, GL2005-120-002, GL2005-122-003, GL2005-123-003, GL2005-123-004, GL2005-123-005, GL2005-124-003, GL2005-124-004, GL2005-127-007, GL2005-130-003, GL2005-139-007, GL2005-139-008, T2005-038-003, T2005-040-008, T2005-045-013, T2005-045-014, T2005-045-015, T2005-045-016, T2005-045-018, T2005-045-019, T2005-046-010, T2005-046-011, T2005-046-013, T2005-047-016, T2005-047-017, T2005-049-010, T2005-049-013, GL2005-119-003, GL2005-119-004, T2005-038-004, T2005-040-009, T2005-040-010, T2005-040-011, T2005-040-012, T2005-044-014, T2005-044-015, T2005-047-011, T2005-047-012, T2005-047-013, T2005-047-014, T2005-047-015, T2005-048-007, T2005-048-014, T2005-070-001, T2005-071-001, T2005-073-001, T2005-074-003, T2005-043-016, T2005-044-009, T2005-057-001, T2005-058-001, T2005-059-001, T2005-012-003, T2005-012-004, T2005-012-005, T2005-012-006, T2005-014-001, T2005-014-002, T2005-014-003, T2005-014-004, T2005-014-005, T2005-014-006, T2005-015-001, T2005-015-002, T2005-015-003, T2005-015-004, T2005-015-005, T2005-016-001, T2005-016-002, T2005-016-003, T2005-016-004, T2005-016-005, T2005-016-006, T2005-016-007, T2005-019-001, T2005-019-002, T2005-019-003, T2005-019-004, T2005-020-001, T2005-020-002, T2005-020-003, T2005-020-004, T2005-020-005, T2005-020-006, T2005-021-001, T2005-021-002, T2005-021-003, T2005-021-004, T2005-021-005, T2005-021-006, T2005-022-003, T2005-022-004, T2005-022-005, T2005-022-006, T2005-022-007, T2005-022-008, T2005-022-009, T2005-022-010, T2005-023-003, T2005-023-004, T2005-023-005, T2005-023-006

d) Product Code: LPTHM (Amended from LTTM), ID#: GL2005-147-003

e) Product Code: LTTM, ID#: GL2005-180-015, GL2005-183-014, GL2005-146-004, GL2005-133-014, GL2005-139-004, GL2005-139-005, GL2005-143-005, GL2005-143-006, GL2005-146-003, GL2005-161-003, GL2005-161-004, GL2005-164-003, GL2005-164-004, GL2005-167-003, GL2005-167-004, GL2005-168-004, GL2005-176-013, GL2005-176-015, GL2005-176-016, GL2005-179-012, GL2005-179-013, GL2005-179-015, GL2005-180-013, GL2005-180-014, GL2005-183-013, GL2005-183-016, Amended to include: ID#.GL2005-158-003, GL2005-158-004, GL2005-159-004

f) Product Code: LIWLM, ID#: T2005-034-008, T2005-038-005, T2005-010-009, T2005-019-010, T2005-020-010, T2005-021-014, T2005-022-019, T2005-022-020, T2005-023-011, T2005-023-012, T2005-038-009;
Product Code: LIWMM, ID#: T2005-021-010, T2005-021-011;
Product Code: LIWSM, ID#: T2005-010-002, T2005-015-006;
Product Code: LIWXLM, ID#: T2005-034-007, T2005-045-023, T2005-045-024, T2005-045-022, T2005-034-006, T2005-045-020
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Lost Mountain Tissue Bank, Kennesaw, GA
Manufacturer:  Biomedical Tissue Services, Ltd., Fort Lee, NJ.
REASON Human tissues, procured from donors without adequate donor eligibility determinations, were distributed.
VOLUME OF PRODUCT IN COMMERCE 337 tissues
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Recovered Plasma
CODE a) and b) Unit numbers: 06FW75154, and 06FW78487
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern California Region, Pomona, CA
REASON Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent disclosure of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION CA

PRODUCT
a) Red Blood Cells, Irradiated
b) Platelets
CODE a) and b) Unit number: 4127145
RECALLING FIRM/MANUFACTURER Community Blood Center, Dayton, OH
REASON Blood products, collected from an unsuitable donor who had traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OH

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit numbers:  9040689, 9041609, and 9041611
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc., Greenville, NC
REASON Platelets, not manufactured according to firm specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION NC

PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Recovered Plasma
CODE a) and b) Recall # 12FN59020
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NC and MA

PRODUCT BacT ALERT Classic 120 System and 240 System
CODE All Models
RECALLING FIRM/MANUFACTURER bioMerieux, Inc., Durham, NC
REASON BacT/ALERT Classic Systems, with a software glitch or defect, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3,531 units
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Fresh Frozen Plasma
CODE a) and b) Unit number: 12FG08634
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC, 
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 NC

PRODUCT  Red Blood Cells, Leukocytes Reduced
CODE Unit number: 12LW87797
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC, 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 NC

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit number: 12Y52574
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC, 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 NC 

PRODUCT Platelets Pheresis Leukocytes Reduced
CODE Unit number:  R84677
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Community Blood Center of the Carolinas, Charlotte, NC
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 NC

PRODUCT Plasma, Frozen
CODE Unit numbers: 003FJ79310, 003GZ61817, and 003GZ61830
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON Blood products, associated with units of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION GA 

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 003KN18899
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: GM13510
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA,
REASON Blood product, collected from a donor who had lived in an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated, 
CODE Unit number: 126456483
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Albuquerque, NM
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 NM

PRODUCT Platelets Pheresis Leukocytes Reduced
CODE Unit number: 03FK41070 (double unit)
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Atlanta, GA,  REASON Blood products, which did not meet acceptable product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION GA

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 03P51460
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA
REASON Platelets, labeled as leukoreduced, but did not meet the requirements for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT The Operatorís Manual for the Baxter Fenwal Amicus Separator Apheresis Device, Amicus Separator Accessory kits containing an Operatorís Manual: Product Code 4R2332
Product Usage: An automated apheresis device intended for the simultaneous collection of platelet concentrates, plasma and red blood cells.
- Amicus Separators (New and Refurbished) Product Codes 4R4580 and 4R4580R
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation / Fenwal, Deerfield, IL
Manufacturer: Baxter Healthcare Corporation, Largo, FL
REASON Operatorís Manuals for the Baxter Fenwal Amicus Separator Apheresis Device, containing maintenance instructions that may cause a potential for red cell hemolysis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3,412 manuals
DISTRIBUTION Nationwide and Internationally

PRODUCT
a) Red Blood Cells
b) Fresh Frozen Plasma
CODE a) and b) Unit number: R82182
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Community Blood Center of the Carolinas, Charlotte, NC
REASON Blood products, which were collected from a donor who had taken the medication Toprol, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NC

PRODUCT Red Blood Cells Pheresis, Leukocytes Reduced
CODE Unit number: 012GT31999
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood product, which was not leukoreduced within the appropriate time period after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 0887578
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc., Greenville, SC
REASON Blood product, which was out of controlled storage for more than 30 minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION SC

PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Red Blood Cells, Leukocytes Reduced, Irradiated
CODE
a) Unit numbers: GM65615, GM60829, GM92690;
b) Unit numbers: GM70168, GW42852
RECALLING FIRM/MANUFACTURER Blood Bank of San Bernardino and Riverside Counties, San Bernardino, CA
REASON Blood products, which were labeled leukoreduced, but had an unacceptable white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION CA

PRODUCT
a) Red Blood Cells Leukocytes Reduced
b) Fresh Frozen Plasma
c) Plasma
d) Cryoprecipitated AHF
CODE
a) Unit numbers: 12FP61590 and 12GS23207;
b) Unit number: 12FP65190;
c) and d) Unit number: 12GS23207
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC
REASON Blood products, which were collected from a donor who had taken an anti-viral medication, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION NC, GA, and PR

WEEK ENDING APRIL 22

PRODUCT Human Tissue for Transplantation: Corneas, 
CODE ID numbers: 05-2203, 05-2204
RECALLING FIRM/MANUFACTURER Georgia Eye Bank, Atlanta, GA
REASON Human Corneas, inadequately tested for infectious diseases in that the blood sample used for testing may have been hemodiluted, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues
DISTRIBUTION GA

PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Cryoprecipitated AHF, 
CODE a) and b) Unit number: 027X21038
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON Blood products, collected from a donor whose health history screening was not adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION WV and MD

PRODUCT Red Blood Cells
CODE Unit number: 49W47679
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK
REASON Blood products, collected from a donor whose donor screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX and CA

PRODUCT
a) Red Blood Cells Leukocytes Reduced,
b) Red Blood Cells Irradiated, ;
c) Red Blood Cells, 
d) Red Blood Cells (Apheresis), 
e) Platelets Pheresis Leukocytes Reduced Irradiated, 
f) Platelets Pheresis Leukocytes Reduced, 
CODE
a) Units: S57275, S57263, S53709, S53715, S55472, S55483, S55491, S55496,
S55499, S55945, S55953, S55967, S57240, S57262, S57266, KC87131, KC87134;
b) Unit: S52760;
c) Units: S57279, S55949, S55973;
d) Units: S57241, S57283, S55966, S57259;
e) Units: S57245, S57274, S57283, S57243, S55946, S55950;
f) Units: S55966 (split product), S57241
RECALLING FIRM/MANUFACTURER HCSC-Blood Center, Bethlehem, PA
REASON Blood products, tested for CMV with unacceptable QC results, were distributed.
VOLUME OF PRODUCT IN COMMERCE 34 units
DISTRIBUTION PA

PRODUCT Platelets Pheresis Leukocytes Reduced
CODE Unit 12W03915 (split unit)
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC
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 NC

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit 12KP91034
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC
REASON Blood product, which was collected from a donor who did not meet acceptable hemoglobin specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit 03KE25187
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Atlanta, GA, REASON Blood product, which was collected from a donor who had lived in 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 33GS66196
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Farmington, CT.
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 CT

PRODUCT Recovered Plasma
CODE Unit number: 49W47679
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southwest Region, Tulsa, OK
REASON Blood products, collected from a donor whose donor screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX and CA

PRODUCT
a) Red Blood Cells, 
b) Red Blood Cells Leukocytes Reduced, 
CODE
a) Unit 7380492;
b) Unit 0157063
RECALLING FIRM/MANUFACTURER Marquette General Hospital, Marquette, MI
REASON Blood products, which were collected from a donor who had a history of arthritis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION MI and FL

PRODUCT Red Blood Cells Leukocytes Reduced
CODE Unit: 36GR11627
RECALLING FIRM/MANUFACTURER The American National Red Cross, South Carolina Region, Columbia, SC
REASON Blood product, collected from a donor at risk for leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION SC

PRODUCT
a) Cryoprecipitated AHF, 
b) Plasma Cryoprecipitate Reduced, 
CODE a) and b) Unit 12FG10650
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Charlotte, NC
REASON Blood products, which were not collected in accordance with standard operating procedures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION GA and NC

WEEK ENDING APRIL 29

PRODUCT Source Plasma
CODE Unit number: 0370521116
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc, Medford, OR
REASON Blood product, which was collected from a donor that subsequently was determined to have an unreported body piercing, was distributed
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Platelets Pheresis Leukocytes Reduced
CODE Unit numbers: 4232511, 4232493 (part of split product)
RECALLING FIRM/MANUFACTURER Florida Blood Services, Inc., St. Petersburg, FL
REASON Blood products, collected using equipment that had not been validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION FL

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 012GF17754
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC
REASON Red Cells, prior to completion of validation studies, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION NC

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 36FG26262
RECALLING FIRM/MANUFACTURER The American National Red Cross, South Carolina Region, Columbia, SC
REASON Blood product, collected from a donor previously diagnosed with lymphoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION SC

PRODUCT
a) Platelets Pheresis Leukocytes Reduced Irradiated
b) Platelets Pheresis Leukocytes Reduced
c) Red Blood Cells
CODE
a) Unit numbers: B212072 (split product), B21179;
b) Unit number: B21179;
c) Unit number: Z110691
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
REASON Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units
DISTRIBUTION WA

PRODUCT Fresh Frozen Plasma
CODE Unit number: 71Q93466-3
RECALLING FIRM/MANUFACTURER Life South Community Blood Center, Dunwoody, GA
REASON Blood product, corresponding to a unit of clotted red blood cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Recovered Plasma
CODE a) and b) Unit number: 12KP84231
RECALLING FIRM/MANUFACTURER American National Red Cross, Carolinas Region, Charlotte, NC
REASON Blood products, which tested negative for anti-HCV, but were collected from an ineligible donor who previously tested repeat reactive for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA and GA

PRODUCT Red Blood Cells, Leukocytes Reduced, 

CODE Unit number: 36Y75006
RECALLING FIRM/MANUFACTURER American National Red Cross, South Carolina Region, Columbia, SC
REASON Blood product, collected from an ineligible donor due to use of the medication Lupron, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION SC

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 04R34997
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Dedham, MA
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 NH

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 04LQ29358
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Dedham, MA
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 NH

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 06GF83952
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Pomona, CA, REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 102908081
RECALLING FIRM/MANUFACTURER Blood Systems, Inc, Scottsdale, AZ
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 AZ

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number: 06GV14741
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Pomona, CA
REASON Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT
a) Red Blood Cells, Leukocytes Reduced
b) Plasma Frozen
CODE a) and b) Unit number: 100485227
RECALLING FIRM/MANUFACTURER Blood Systems, Inc, Scottsdale, AZ
REASON Blood products, which were collected from a donor who may be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION AZ

PRODUCT
a) Red Blood Cells
b) Platelets
CODE a) and b) Unit number: 4356015
RECALLING FIRM/MANUFACTURER Florida Blood Services, Inc., St. Petersburg, FL
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 FL

PRODUCT Platelets Pheresis, Leukocytes Reduced
CODE Unit number: 12KG72874
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC.
REASON Platelets, mislabeled as leukoreduced, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION GA

PRODUCT
a) Red Blood Cells
b) Red Blood Cells Leukocytes Reduced
CODE
a) Unit numbers: G44413, G44415, G44417, G44418, G44420, G44422, G44424,
G44425, G44426, G44427, G44429, G44431, G44432, G44434, G44439,
G44440, G44442, G44443;
b) G44411, G44412, G44414, G44416, G44419, G44421, G44423, G44428,
G44430, G44433, G44435, G44441, G44445
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Center, Springfield, IL
REASON Blood products, collected from donors whose hematocrits were not recorded concurrently during screening, were distributed.
VOLUME OF PRODUCT IN COMMERCE 31 units
DISTRIBUTION IL and LA

PRODUCT Reagent Red Blood Cells (Referencells A1 and B), Package Size: 2 x 10mL
CODE Lot number: 27461, Expiration Date: September 2, 2005
RECALLING FIRM/MANUFACTURER Immucor, Inc, Norcross, GA
REASON Reagent Red Blood Cells, containing incorrect package inserts, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6,588 units
DISTRIBUTION Nationwide and Internationally

PRODUCT Red Blood Cells
CODE Unit numbers: 0208286; 0208288; 0208290; 0208360; 0208542; 0208552; 0209034; 0208868
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc., Greenville, SC
REASON Red cells, collected in bags that had exceed their expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units
DISTRIBUTION GA and SC