JUNE 2005

JUNE 2005

WEEK ENDING JUNE 4

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 4586774.
RECALLING FIRM/MANUFACTURER
Recalling firm: Oklahoma Blood Institute, Oklahoma City, OK
Manufacturer: Oklahoma Blood Institute, Ardmore, OK.
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 OK.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit J10702.
RECALLING FIRM/MANUFACTURER Costal Bend Blood Center, Corpus Christi, TX
REASON Blood product, corresponding to a unit of Platelets that was possibly contaminated with gram-positive cocci, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Source Plasma.
CODE Unit: 390005380.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX
REASON Blood product, released with incomplete testing but later found to have an elevated ALT, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit: 18236-8849.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ
Manufacturer: Blood Systems Inc., Cheyenne, WY. .
REASON Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION WY.

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced.
CODE Unit: 246320206 (split unit).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ
Manufacturer: Blood Systems Inc., Rapid City, SD.
REASON Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION SD and MS.

PRODUCT Platelets, Pheresis ‚ split product.
CODE Unit: 19GL14515.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN.
REASON Blood products, collected from a donor who reported a history of a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN.

PRODUCT Immucor-Gammaís Alseverís Solution, 250 mL (Modified by Gamma for Suspending and Preserving Red Blood Cells).
CODE Lot # ALS843-2, Expiration 9/16/2005.
RECALLING FIRM/MANUFACTURER Gamma Biologicals, Inc., Houston, TX
REASON Alseverís Solution, possibly contaminated with mold species, was distributed.
VOLUME OF PRODUCT IN COMMERCE 482 bottles.
DISTRIBUTION Nationwide and Japan.

PRODUCT Sorvall Cellwasher 2 (DA-12 rotor arm assembly); Model Number 04500.
CODE Serial numbers: R28O-155736-SO, S11O-155794-SO, S11O-155795-SO, S17O-155835-SO, S24O-155869-SO, S24O-155870-SO, T07O-155911-TO, T14O-155953-TO, T14O-155954-TO, U12O-156092-UO, U19O-156114-UO, U19O-156115-UO, U26O-156156-UO, U26O-156157-UO, V03O-156216-VO, V03O-156218-VO, V09O-156247-VO, V09O-156253-VO, V09O-156254-VO, V09O-156261-VO, V09O-156262-VO, V09O-156263-VO, V09O-156264-VO, V09O-156265-VO, V09O-156266-VO, V16O-156330-VO, W140-156453-WO, W14O-156447-WO, W14O-156451-WO, W23O-156496-WO, W23O-156506-WO, and X14N-109222-XN.
RECALLING FIRM/MANUFACTURER Kendro Laboratory Products, Asheville, NC
REASON Blood Bank cellwashers, containing an out of specification rotor arm assembly, were distributed.
VOLUME OF PRODUCT IN COMMERCE 32 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Source Plasma.
CODE Unit numbers ST257873, ST257015, ST256794, ST254334, ST253699, ST253096, ST252706, ST251877, ST251064, ST250725, ST244231, ST243848, ST243198, ST232355, ST231966, ST230734, ST229955, ST229479, ST228537, ST228167, ST226338, ST226046, ST224666, ST214759, ST214422, ST213858, ST213604, ST212969, ST212635, ST211772, ST211236, ST210739, ST210129, ST209822, ST209076, ST208557, ST208172, ST207555, ST204946, ST204370, ST203654, ST202367, ST201361, ST201134, ST200216, ST200072, ST198752, ST198099, ST197677, ST197093, ST196573, ST196082, ST195518, ST195008, ST194027, ST193318, ST192837, ST191478, ST190745, ST182325, ST180913, ST174141, ST173781, ST172858, ST172468, ST171752, ST170665, ST170151, ST169744, ST169240, ST168773, ST166650, ST163819, ST163237, ST162468, ST161778, ST160923, ST160392, ST159817, ST158962, ST158152, ST157885, ST157131, ST156231, ST155668, ST154557, ST154241, ST153565, ST152904, ST152416, ST151525, ST151116, ST150302, ST189958, ST189103, ST186491, and ST183949.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., San Antonio, TX
REASON Blood products, that tested negative for viral markers, but were collected from a donor that was subsequently determined to have multiple risk factors for increased incidence of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 97 units.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE a) and b) Unit number 4661784.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
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 OK and TX.

PRODUCT Source Plasma. .
CODE Unit numbers 01SMNB9766 and 01SMNC0321.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., St. Cloud, MN
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Austria.

PRODUCT Source Plasma.
CODE Unit numbers 00SMNC1623, 00SMNB9630, 00SMNC7533, and 00SMNC1229.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., St. Cloud, MN
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION MI and Austria.

PRODUCT Source Plasma.
CODE Unit numbers 00PWIB5991, 00PWIB6289, 00PWIB4557, 00PWIB4197, and 00PWIB3586.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Stevens Point, WI
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MI and Austria.

PRODUCT Source Plasma.
CODE Unit numbers SX064773, SX064445, SX064289, SX063463, SX063291, AND SX063023.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., San Marcos, TX
REASON Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Unit numbers SX009379, SX008942, SX008487, SX008087, SX007611, SX007312, SX007164, SX006951, SX006636, SX006440, SX006213, SX005815, SX005711, SX005461, SX005352, SX005121, SX005036, SX004854, and SX004750.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., San Marcos, TX
REASON Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to body piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 19 units.
DISTRIBUTION MA

PRODUCT Source Plasma. .
CODE Unit number 330020328.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Seattle, WA
REASON Blood product, that tested negative for viral markers, but was not properly quarantined after the receipt of deferral information related to body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Spain.

PRODUCT
a) Cryoprecipitated AHF.
b)Plasma, Cryoprecipitate Reduced.
CODE a) and b) Unit number 1377521.
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL
REASON Blood products, collected from an unsuitable donor due to use of the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC

PRODUCT Recovered Plasma.
CODE Unit number 1407113.
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL
REASON Blood product 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).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria

PRODUCT Recovered Plasma.
CODE Unit number 8476060.
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL
REASON Blood product, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but was collected from a donor that subsequently reported a previous reactive test for anti-HIV, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 4917527A.
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc. Orlando, FL
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 2269211.
RECALLING FIRM/MANUFACTURER Floridaís Blood Centers Inc., Orlando, FL
REASON Blood product tested positive for antibodies to red blood cell antigen D (anti-D) but was not labeled anti-D positive.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NC.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 3022277.
RECALLING FIRM/MANUFACTURER Floridaís Blood Centers Inc., Orlando, FL
REASON Blood product, collected from a donor who had received Human Chorionic Gonadatropin (HCG) injections, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Source Plasma.
CODE Unit numbers 00JWIB3650, 00JWIB4063.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P. Janesville, WI
REASON Blood products, which were not properly quarantined after receiving post donation information concerning high-risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Austria.

PRODUCT Red Blood Cells, Leukocytes Reduced
CODE Unit number 4617514.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
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 OK.

PRODUCT Platelets.
CODE Unit number 3926998.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK.
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 TX.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets.
CODE a) and b) Unit number 4674432.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK.
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 OK and TX.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Platelets
CODE a) and b) Unit number 4558173.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center
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 OK and TX.

PRODUCT Platelets.
CODE Unit number: KK75374.
RECALLING FIRM/MANUFACTURER Central Blood Bank, Pittsburgh, PA
REASON Blood product, which did not meet the specifications for manufacturing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT
a) Red Blood Cells, Irradiated.
b) Platelets.
c) Recovered Plasma.
CODE a), b), and c) Unit number 4191363.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products collected a donor whose suitability determination was inadequately performed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OK, TX and Switzerland.

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit number 11LV27257.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Missouri-Illinois Region, St. Louis, MO
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MO and CA.

PRODUCT Platelets, Leukocytes Reduced.
CODE Unit number 5317426.
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc. Orlando, FL
REASON Blood product, that tested negative for viral markers, but was collected from an ineligible donor due to a history of possible blood and body fluid exposure, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number E17710.
RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank, Inc., Rockford, 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 Red Blood Cells.
CODE Unit number T04153.
RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank, Inc., Rockford, 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
a) Platelets.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number L88116.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI
REASON Blood products, associated with a unit of Red Blood Cells that contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number S81045.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Saginaw, MI, REASON Blood products, corresponding to a unit of Platelets that tested positive for Staphylococcus epidermidis bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 12KE81932
RECALLING FIRM/MANUFACTURER American Red Cross , Carolinas Region, Charlotte, NC.
REASON Blood product, untested for human immunodeficiency virus (HIV) and hepatitits C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION NC.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers: 9033166 (Parts 1 & 2).
RECALLING FIRM/MANUFACTURER The Blood Connection, Inc., Greenville, SC,
REASON Platelets, collected on an instrument that had not been validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Units.
DISTRIBUTION SC.

PRODUCT Red Blood Cells, Leukocytes Reduced. .
CODE Unit number 4666179.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
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 MS

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a)and b) Unit number 4616567.
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).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OK and Switzerland.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Recovered Plasma.
CODE a), b) and c) Unit number 4705045.
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).
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OK, TX and Switzerland.

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit number 6530948
RECALLING FIRM/MANUFACTURER BloodNet USA, Inc., Lakeland, FL
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).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL and Switzerland.

PRODUCT Source Plasma.
CODE Unit number HP120496.
RECALLING FIRM/MANUFACTURER Interstate Blood Bank, Inc. of Chicago, Chicago, IL, REASON Blood product, that tested elevated for alanine aminotransferase (ALT), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit numbers 3452773 and 3451520.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource Blood Services, Glenview, IL
Manufacturer: LifeSource, Gurnee Donor Center, Gurnee, IL.
REASON Blood products, that 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 2 units.
DISTRIBUTION IL.

PRODUCT Fresh Frozen Plasma [Apheresis].
CODE Unit number T17375.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Centers, Traverse City, MI
REASON Blood product, collected using automated equipment that had not been validated, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells.
CODE Unit number 01KK98700.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New York-Penn Region
REASON Blood product, corresponding to a unit of Platelets that tested positive for coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Plasma.
CODE
a) Unit numbers 01FW19307, 01KX80274, 01Q71880, and 01Y52914.
b) Unit numbers 01FW19307, 01FW19319, 01KX80274, 01Q71880, and 01Y52914.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New York-Penn Region
REASON Blood products, corresponding to units of Platelets that were pooled and possibly contaminated with coagulase negative Staphylococcus sp. bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION NY.

PRODUCT Red Blood Cells.
CODE Unit number 6035916.
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK,,
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 AK.

PRODUCT Red Blood Cells.
CODE Unit number 6705129.
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK
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 AK.

PRODUCT Red Blood Cells.
CODE Unit number 6705310.
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK
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 AK.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 4467500.
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).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OK and Switzerland.

PRODUCT Platelets, Leukocytes Reduced. .
CODE Unit numbers 22GE79947, 22GE79957, 22GE79963, 22GE79966, 22GE79967, 22GH04791, 22GH04794, 22GH04800, 22GH04813, and 22KW58769.
RECALLING FIRM The American National Red Cross,Penn-Jersey Region, Philadelphia, PA, REASON Blood products were manufactured in bags that may have contained leaks.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION PA.

PRODUCT Source Plasma. .
CODE Unit numbers DZMMBT and DZMMJB.
RECALLING FIRM
Recalling Firm: Aventis Bio-Resources, Inc., Knoxville, TN
Manufacturer: International BioResources, LLC, Eugene, OR.
REASON Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN.

PRODUCT Source Plasma.
CODE Unit numbers FQDQHJ and FQDQCL.
RECALLING FIRM Aventis Bio-Resources, Inc., Knoxville, TN
REASON Blood products, collected from a donor that was not tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN.

PRODUCT Source Plasma. .
CODE Unit number FQDVRL.
RECALLING FIRM Aventis Bio-Resources, Inc., Knoxville, TN
REASON Blood product, collected from a donor that was not tested for syphilis, was distributed
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 22KV74611.
RECALLING FIRM The American National Red Cross,Penn-Jersey Region, Philadelphia, PA, REASON Blood product, corresponding to a unit of Platelets that tested positive for coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Source Plasma. .
CODE Unit number 02BMTC2170.
RECALLING FIRM Biolife Plasma Services L.P., Deerfield, IL
REASON Blood product collected from an ineligible donor due to recent dental surgery.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Source Plasma.
CODE Unit number FQDMQW.
RECALLING FIRM Aventis Bio-Resources, Inc., Knoxville, TN
MANUFACTURER International Bio-Resources, LLC, Salem, OR.
REASON Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT Source Plasma.
CODE Unit number FQDKYH.
RECALLING FIRM Aventis Bio-Resources, Inc. Knoxville, TN
REASON Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT Source Plasma.
CODE Units 92020610, 91484918, 91484956, 91484222, 91484017.
RECALLING FIRM Biomat USA, Inc., Colorado Springs, CA
REASON Blood products, which were untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION CA and Spain.

PRODUCT Source Plasma.
CODE Units 330021509, 330021712, 330022059, 330022272, 330022697, 330022922, 330023312, 330023676, 330024154, 330024391, 330024767, 330024976, 330025347, 330025593, 330025974.
RECALLING FIRM Biomat USA, Inc., Colorado Springs, CA
REASON Blood products, collected from a donor who was previously deferred for being an unreliable historian, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 units.
DISTRIBUTION Spain.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Removed.
c) Fresh Frozen Plasma.
d) Recovered Plasma.
CODE
a), b) and c) Unit numbers: 33GR68578, 33GJ66433.
d) Unit numbers: 33GE75845, 33GT23988.
RECALLING FIRM American Red Cross, Connecticut Region, Farmington, CT
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 8 units.
DISTRIBUTION CA and CT.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit number 231467988.
RECALLING FIRM
Recalling Firm: Blood Systems, Inc, Scottsdale, AZ,
Manufacturer: Blood Systems, Inc, Billings, MT.
REASON Blood products, which were collected from a donor who was taking the medication Methadone HCL, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MT.

PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) Unit numbers: 4635622 (Part 1), 4627584 (Part1), 4654056 (Parts 1 & 2);
b) Unit numbers: 4627584 (Part 2), 4635622 (Part 2).
RECALLING FIRM
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK,
REASON Blood products, collected from a donor that who was taking Sulfasalazine, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION OK, TX, and AR.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
c) Recovered Plasma.
CODE a), b), and c) Unit number FV02486.
RECALLING FIRM Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI
REASON Blood products, collected from a donor who had undergone surgery and had received blood transfusions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CT, MA, and Switzerland.

PRODUCT Recovered Plasma.
CODE Unit number 5734369.
RECALLING FIRM Floridaís Blood Centers, Inc, Orlando, FL
REASON Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to recent body piercing, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit LG12219.
RECALLING FIRM Healthcare Provider Services, dba Rhode Island Blood Center, Providence, RI
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 MA.

PRODUCT Red Blood Cells, Irradiated.
CODE Unit 3042021.
RECALLING FIRM Ogden Medical Center, Inc., Ogden, UT
REASON Blood product, collected from a therapeutic donor with a history of polycythemia, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION UT.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma, for manufacturing injectable products.
CODE a) and b) Unit number: 4508467.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
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 NY and Switzerland.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number: 4483825.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, which tested negative for hepatitis, but were collected from a donor who disclosed a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OK, and Austria.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Fresh Frozen Plasma. .
CODE a), b) and c) Unit number: 4685689.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, collected from a donor who previously made a therapeutic donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION AR, OK, and TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 4582546.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, collected from a donor who was at increased risk for variant Creutzfeldt Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OK.

PRODUCT Platelets.
CODE Unit 4804882.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, which was collected from a donor who had taken aspirin within 3 days of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT
a) Cryoprecipitated AHF.
b) Recovered Plasma.
CODE a) and b) Unit 4350370.
RECALLING FIRM/MANUFACTURER Floridaís Blood Centers, Inc., Orlando, FL
REASON Blood products, which were collected from a donor who admitted to risk factors for variant Creuztfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL and Austria.

PRODUCT Fresh Frozen Plasma (Apheresis). .
CODE Unit number: 4506318.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood product, collected from a donor who had an elevated alanine aminotransferease (ALT), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OK.

PRODUCT Baxter Fenwal Amicus Separator Apheresis Device.
CODE Product Codes: 4R4580 and 4R4580R. All serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Fenwal Division, Deerfield, IL,
Manufacturer: Baxter Healthcare Corporation, Largo, FL.
REASON Apheresis Devices, in which the polycarbonate window on the centrifuge door may develop cracks and fissures if ammonia or ammonia based cleaners are used on it, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2,221 units.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Leukotrap RC - Whole Blood Collection, Filtration and Storage System with the New Pall RC2D Leukocyte Reduction Filter.
CODE Affected Leukotrap RC Systems Lot Numbers: 0400198, 0400161, 0301733, 0301615, 0300039, 0300898, 0300038, RE 1827, 0400317, 0400232, 0400278, 0400234, 0400200, 0400199, 0400282;
Affected RC2D Filter Lot Numbers: 231517, 231917, 232217, 303617, 304917, 330717, 330817, 331417, 402220, 402420, 402620, 402720, 403320.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pall Biomedical Products Corp., East Hills, NY
Filter Manufacturer: Pall Biomedical, Inc., Fajardo, PR.
System Manufacturer: Pall Medical, Covina, CA.
REASON Leukoreduction Filters, associated with reports of air down stream of the filter and quality control failures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 30,888 units.
DISTRIBUTION IA, FL, TX, and MD.

PRODUCT Human Tissue for Transplantation, Corneas.
CODE Numbers NY-05-04-017-R1 and NY-05-04-017-L1.
RECALLING FIRM/MANUFACTURER Sight Society of Northeastern New York, Albany, NY.
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 2 tissues.
DISTRIBUTION PA and SD.

PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit number 0063204.
RECALLING FIRM/MANUFACTURER Suncoast Communities Blood Bank, Sarasota, 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 2 units.
DISTRIBUTION FL.

PRODUCT Source Plasma.
CODE Unit numbers 87346237, 87344066, 87338089, 87334494, 87329667, 87326307, 87320916, 87318029, 87311501, 87309249, 87303667, 87301144, 87295726, 87293463, 87288131, 87285369, 87280005, 87276978, 87265903, 87263299, 87256277, 87248746, 87246612, 87241785, 87238648, 87233506, 87231939, 87226195, 87216219, 87213782, 87208795, 87204674, 87201635, 87197945, 87193657, 87287922, 87185041, 87179613, 87176520, 87171556, 87168129, 87162226, 87153811, 87152630, 70439915, 70437386, 70432190, 70427929, 70422429, 70420333, 70412109, 70408317, 70402643, 70399455, 70393859, 70390957, 70385922, 70382716, 70377200, 70374247, 70368796, 70365832, 70361483, 70357424, 70352238, 70349528, 70341584, 70338669, 70333008, 70330359, 70624983, 70322545, 70317558, 70314977, 70310771, 70307566, 70301090, 70298468, 70292695, 70290134, 70284911, and 70281781.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., Dallas, TX
REASON Blood products, that tested negative for viral markers, but were collected from a donor that was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE 82 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit number 04DILD3390.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., DeKalb, IL
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 CA.

PRODUCT Source Plasma.
CODE Unit numbers 65931R and 01347T.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Lakeland, FL
REASON Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to a recent tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC.

PRODUCT
a) Red Blood Cells,
b) Fresh Frozen Plasma.
CODE a) and b) Unit number B169359.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA.
REASON Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to a recent tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced Irradiated.
b) Platelets, Pooled.
CODE
a) Unit number E166030;
b) Pool number HP10816.
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center and Program, Seattle, WA.
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 1 unit; 1 pool.
DISTRIBUTION WA.

PRODUCT Red Blood Cells.
CODE Unit number FG02482.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL
Manufacturer: Heartland Blood Centers, Elgin Donor Center, Elgin, IL.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distribted.
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 40P03881.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Heart of America Region, Peoria, IL
REASON Blood products, collected in an apheresis collection kit that had exceeded the acceptable time period for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IL.

PRODUCT Recovered Plasma.
CODE Unit: 18235-4611.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
REASON Blood product, collected from a donor whose medical history screening was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number: 7833910.
RECALLING FIRM/MANUFACTURER Southeastern Community Blood Center, Tallahassee, FL
REASON Blood products, collected from an unsuitable donor due to the use of erythromycin, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL, and Switzerland.

PRODUCT Baxter Fenwal Sepacell PLS-5A Leukocyte Reduction Administration Set For Platelet Transfusion. Product Code 4C2496.
CODE Lot Number A04I08265.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Fenwal Division, Deerfield, IL
Manufacturer: Baxter Healthcare Corporation, Parque Industrial Itabo, Haina, Dominican Republic.
REASON Platelet Bedside Filters, containing an inverted pre-filter, were distributed.
VOLUME OF PRODUCT IN COMMERCE 493
DISTRIBUTION VA, WA, HA, D.C.

PRODUCT Platelets, Leukocytes Reduced.
CODE Unit numbers 33GV65820, 33GV65882, 33GV65783, 33GV65784, 33GV65799, 33GV65790, 33GV65809, 33GV65819, 33GV65832, 33GV65805, 33GV65850, 33GV65862, 33GV65749, 33GY89268, 33GY89247, 33GY89248, 33GV65787, 33GV65789, 33GV65771, 33GV65768, 33GV65775, 33GL44543, 33GL44517, 33GY89294, 33GV65837, 33GV65879, 33GL44548, 33GL44515, 33GV65875, 33GV65877, 33GR76215, 33GV65773, 33GV65778, 33GV65842, 33GV65848, 33GL44547, 33GV65828, 33GY89301, 33GY89281, 33GY89289, 33GV65884, 33GV65769, 33GV65776, 33GV65774, 33GV65838, 33GV65847, 33GL44540, 33GY89239, 33GL44561, 33GL44550, 33GL44555, 33GR76210, 33GV65878, 33GY89302, 33GY89306, 33GR76208, 33GR76218, 33GR76238, 33GV65804, 33GV65797, 33GV65801, 33GY89323, 33GL44534, 33GV65826, 33GV65830, 33GY89308, 33GY89275, 33GV65885, 33GV65883, 33GV65786, 33GV65785, 33GV65792, 33GV65793, 33GV65791, 33GV65767, 33GV65788, 33GV65777, 33GV65835, 33GV65839, 33GV65843, 33GL44546, 33GL44523, 33GY89266, 33GY89256, 33GY89307, 33GY89309, 33GL44514, 33GY89312, 33GL44531, 33GY89322, 33GR76199, 33GL44516, 33GY89349, 33GY89246, 33GV65833, 33GL44507, 33GL44505, 33GL44541, 33GL44519, 33GL44549, 33GY89346, 33GY89347, 33GY89343, 33GY89331, 33GY89332, 33GY89314, 33GY89324, 33GY89244, 33GY89321, 33GR76227, 33GY89290, 33GY89292, 33GY89252, 33GY89253, 33GY89251, 33GY89304, 33GY89257, 33GY89259, 33GY89262, 33GV65881, 33GY89313, 33GV65861, 33GY89320, 33GY89264, 33GY89240, 33GL44510, 33GL44560, 33GV65831, 33GL44512, 33GL44532, 33GV65858, 33GV65752, 33GV65755, 33GV65765, 33GY89296, 33GV65823, 33GV65870, 33GV65866, 33GV65864, 33GY89274, 33GR76231, 33GV65867, 33GR76202, 33GR76196, 33GR76236, 33GV65796, 33GY89241, 33GV65757, 33GV65876, 33GR76206, 33GY89276, 33GR76230, 33GV65800, 33GY89329, 33GV65871, 33GV65872, 33GR76200, 33GR76213, 33GL44539, 33GV65816, 33GV65868, 33GV65865, 33GV65753, 33GV65873, 33GV65762, 33GR76201, 33GV65760, 33GR76216, 33GV65886, 33GR76232, 33GR76229, 33GR76233, 33GR76237, 33GV65811, 33GV65825, 33GV65798, 33GV65803 33GV65802 33GV65807 33GV65845, and 33GV65860.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Connecticut Region, Farmington, CT
REASON Platelets, not stored under continuous agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 181 units.
DISTRIBUTION CT, and MA.

PRODUCT Fresh Frozen Plasma, Irradiated.
CODE Unit number: 0058515.
RECALLING FIRM/MANUFACTURER Community Blood Centers of South Florida, Lauderhill, FL
REASON Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells Pheresis, Leukocytes Reduced.
c) Red Blood Cells, Leukocytes Reduced, Irradiated.
d) Red Blood Cells Pheresis, Leukocytes Reduced, Irradiated.
e) Red Blood Cells, Leukocytes Reduced, Washed.
f) Platelets Pheresis, Leukocytes Reduced.
g) Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE a) Units 6158665, 6280982, 2936980, 6173056, 6157828, 6149107, 6283062, 2879340, 0172683, 6227592, 6233165, 6165618, 6161628, 2936979, 2884028, 6150003, 2917063, 2917061, 6146654, 6157827, 6215115, 6258946, 6260317, 6260316, 6250216, 6283012, 2923046, 0096640, 6215114, 0099358, 6249123, 6258961, 0176452, 0166294, 2976917, 6150002, 6237643, 6227594, 6270548, 2906478, 6207506, 0088076, 6162020, 6162019, 6161630, 6161626, 6161624, 6161204, 6161203, 2904669, 6283133, 6263378, 6177155, 2917062, 5460852, 2978760, 6191779, 6157045, 6245621, 6238501, 2940567, 6158666, 6276236, 6165608, 6161629, 2936982, 2936976, 6215667, 6258948, 5461811, 6209918, 6245628, 6215120, 6283063, 0096985, 0095730, 2949151, 6215121, 6215118, 6244382, 0089927, 2081778, 2916555, 6245203, 6265714, 6139302, 0095480, 6140482, 6149428, 6139303, 6196672, 6238833, 2929494, 6196786, 6245202, 6173751, 6182666, 6149429, 0146605, 2906220, 6167275, 6160579, 6156241, 2906839, 6174692, 6213577, 6195084, 6201425, 6165297, 6142891 (2 splits), 0100223, 5451155, 6172091, 2905693, 2896543, 2914517, 2860747, 2958346, 2898210, 6145855, 6264243, 6138325, 2863720, 2917438, 2914217, 2906697, 2905095, 6143215, 6204602, 6213581, 6218343, 6218699, 6165946, 6228094, 0094742, 2926563, 6164804, 6140310, 2907775, 6168635, 6147114, 6230329, 2937219, 2929444, 6151090, 6242715, 2864095, 2877141, 2863666, 2861679, 2979707, 6150863, 6149232, 6139026, 6136621, 6161200, 6167274, 6153690, 6143479, 6179242, 6242716, 6228087, 6201393, 6237932, 2083686, 0115630, 0112327, 6235464, 5446817, 5454886, 0185871, 0178793, 2875678, 2872637, 0142866, 2878153, 0179697, 2940840, 2861676, 2889543, 2910417, 2862328, 2906385, 6164957, 6164851, 6150489, 2906652, 6163637, 6141404, 2939378, 2905094, 6176129, 6168630, 6151374, 6172090, 6154505, 6146707, 6145170, 6142774, 6157604, 2927019, 6167272, 6160576, 6153697, 2906838, 6182330, 6168185, 6211724, 6245697, 6165844, 6254363, 6270729, 6283973, 6168633, 5451154, 2949154, 2961617, 6235471, 6283131, 0175302, 0176454, 2931633, 2957478, 2895962, 0186435, 6152715, 6284758, 6279530, 6265472, 6255178, 0096989, 2867366, 0185879, 0185241, 0179763, 0165439, 0132046, 2909693, 2904929, 6139120, 2908106, 6164846, 2906643, 2906642, 2927094, 6149081, 6146254, 6142737, 6141144, 6143471, 6157830, 6157829, 6214470, 6218695, 6228093, 6265670, 6235465, 5458009, 0133930, 0186716, 0179046, 2875682, 2931634, 6197318, 2905489, 2895971, 2925476, 2909698, 2906219, 2906218, 2904914, 2896630, 6149872, 6164914, 6164911, 2914176, 6157717, 6144210, 6172096, 6172092, 6168632, 6178433, 6178432, 6178424, 6171603, 6171600, 6207237, 6241971, 2080617, 0127172, 0087059, 6136293, 6172094, 6223328, 6200483, 5461797, 0164306, 2914216, 6157602, 6153694, 6147141, 2927034, 2905692, 2869512, 6164960, 6145456, 6142773, 6143714, 6160203, 6143418, 6256629, 2860788, 5443398, 5456940, 0186440, 0178799, 2913725, 2953228, 2993348, 2858677, 2895974, 6156883, 6154090, 6151161, 6142250, 6142219, 6141335, 2904670, 6156995, 6149073, 6149072, 6157614, 6171672, 6160315, 2961630, 2867369, 0185878, 2966463, 6178427, 6216922, 5438558, 6148608, 2934239, 2975833, 2925640, 6164807, 6270051, 6274085, 0085548, 5451016, 2884057, 2916951, 6146610, 6228049, 0185874, 2869514, 2967524, 6164216, 6262354, 0098156, 2080343, 2875680, 2875679, 2875675, 0179044, 0179043, 6151135, 6151250, 0186443, 0175301, 0179041, 2963814, 6165046, 6141399, 6162016, 6151262, 6145204, 6142247, 6141337, 6140672, 6176824, 6143475, 6143474, 6143461, 6165846, 6249668, 6279732, 6272740, 0149185, 2867403, 2867370, 2867365, 0185882, 0185880, 0185877, 0185872, 0185869, 2871358, 2886448, 2981919, 6150896, 2934087, 2934083, 2929314, 2908104, 6154088, 6142221, 6137395, 2914195, 6146938, 6223257, 6250781, 6276301, 6237929, 5436285, 2945523, 6260814, 6225790, 0185883, 6186695, 6247267, 6247266, 6241214, 0143457, 6172089, 6148604, 6149229, 2934090, 2934086, 6150889, 2917457, 5445501, 0185366, 2858691, 0157927, 0109765, 2921024, 5443452, 5446794, 0147707, 0186441, 0185876, 2881413, 0142594, 0170919, 2931643, 2955586, 2897035, 2934348, 2919313, 2896545, 6153696, 6143473, 6273494, 2867972, 2889550, 2940074, 2940065, 2963807, 6164910, 6164853, 2914174, 6146547, 6143809, 6154138, 2882527, 2867402, 2869507, 0185365, 2859475, 2863783, 2982406, 2961861, 2916952, 2898072, 6164849, 6154086, 6140627, 6137715, 6136912, 2939357, 6178423, 6171426, 5466757, 2895973, 2895969, 2925461, 2909699, 2934322, 2909700, 2885676, 6164918, 6146590, 0097730, 0098241, 2925639, 2915743, 6168132, 0112316, 6248326, 5457685, 2982403, 2973942, 6160427, 6138567, 6202102, 5443451, 2876806, 0185460, 6257235, 6180063, 6151354, 6160202, 6160200, 6153691, 2993879, 2897494, 6146939, 6160577, 6172921, 2966925, 2961628, 2924851, 2876666, 2907546, 5431346, 2988291, 2979622, 2974507, 2895970, 2914175, 2906650, 6165058, 6161206, 6141403, 6136282, 2904665, 2904664, 6160429, 6252408, 2084306, 0096796, 0127012, 0098155
b) Units 6152011, 6265790, 6152001, 6136973, 6278267, 6232344, 6245203, 6225710, 6225707, 6171964, 2090736, 6152014, 6240240, 2939410, 6152013, 0122872, 6255545,
6272734, 6178145, 6272547, 6178666;
c) Units 0096984, 0088078, 5443397, 6164847, 2925464, 2937994, 6144313, 2895672, 6153628;
d) Unit 6245201;
e) Units 0158718, 2895961, 6238506, 6215113, 2938748;
f) Units 6182923 (8 splits), 0102301, 6272174, 0155141, 0107804 (2 splits), 6232304, 0171418, 2958942, 2979100 (2 splits), 6264155 (3 splits), 0162199, 0152046, 2894267, 0155167, 6191146, 6182954 (2 splits), 6244681, 5437558, 0133268, 2960124, 2862628 (2 splits), 2957930, 2969659, 6191324, 6219913, 5466665, 2892668, 2951670, 6182961, 6183021, 6262504, 0147517 (2 splits), 2860181 (2 splits), 2983819, 2984030, 6200605, 6247557, 6193028 (2 splits), 0084750 (3 splits), 0139898, 5456811, 2867774 (2 splits), 0142454, 2964840, 0155003 (2 splits), 6229846, 0086047, 2084874, 0107789 (2 splits), 2991366, 2964816 (2 splits), 0158192 (2 splits), 2869647 (2 splits), 7426717 (3 splits),
6185456, 6193079, 0124953, 5437560, 0183441, 0160173 (3 splits), 2923849, 2980937, 6144436, 6154435 (2 splits), 6210980, 6263851 (3 splits), 0102672, 0107781 (2 splits), 0150466, 2921933, 2975301, 2934958, 0155186, 6236023, 6244713, 6232317 (3 splits),
6262595, 2922041, 6211081, 2921887, 0149416, 0139891, 5465962, 0180195, 2877895, 2943681 (2 splits), 2935344, 6181476 (2 splits), 6252223, 6266043, 5454984, 2921999,
0177684, 5437459, 2867687, 0150445, 6235331, 5442653, 0177856, 6240129, 6235586, 0084277, 6206579, 2921912, 2979595, 2948975, 0098923 (3 splits), 5437410, 0181161,
6264200 (2 splits), 0084077 (2 splits), 2942386, 0115810 (3 splits), 6266369, 0107733 (3 splits);
g) Units 6210918, 7426372, 6229846, 6220357, 6266369, 6247517, 0148502 (2 splits), 2923878, 2921912, 6191472, 2085507, 2854321, 0084277, 0187747, 2970754, 6264200, 6262595, 0162199, 0189390 (2 splits), 2921999, 2867774, 6244681, 0124953,
2942386, 0181161.
RECALLING FIRM/MANUFACTURER Carter Blood Care, Bedford, TX
REASON Blood products, which were labeled leukoreduced, but had an unacceptable white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 767 units.
DISTRIBUTION CA, FL, GA, IL, MS, NC, NJ, NY, TN, and TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units: 21609-6076, 21609-6083, 21609-6084, 21609-6275.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ
Manufacturer: Blood Systems Inc., Fargo, ND.
REASON Blood products, possibly out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION SD.

PRODUCT Recovered Plasma.
CODE Unit: 18236-8849.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ
Manufacturer: Blood Systems Inc., Cheyenne, WY.
REASON Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT Red Blood Cells, Leukocyte Reduced, Irradiated.
CODE Unit number: 4705192.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, labeled as "Leukocyte Reduced" but which failed quality control testing due to an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OK.

PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) Unit number 9144974;
b) Unit number 1368467.
RECALLING FIRM/MANUFACTURER Floridaís Blood Centers, Inc., Orlando, FL
REASON Blood products, collected from an unsuitable donor due to use of the medication Aricept, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL.

PRODUCT Source Plasma.
CODE Unit numbers 00PWIA4592, 00PWIA4939, 00PWIA5590, 00PWIA5973, 00PWIA6671, 00PWIA7072, and 00PWIA7746.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Stevens Point, WI
REASON Blood products, collected from a donor who disclosed a recent measles vaccination, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION Austria.

PRODUCT Recovered Plasma.
CODE Unit number: 8462882.
RECALLING FIRM/MANUFACTURER Floridaís Blood Centers, Inc., Orlando, FL
REASON Blood product, collected from an unsuitable donor due to use of the medication Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number: 4921392A.
RECALLING FIRM/MANUFACTURER Floridaís Blood Centers, Inc., Orlando, FL
REASON Blood product, that was labeled leukoreduced but had an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells.
CODE Unit number: 6723076.
RECALLING FIRM/MANUFACTURER Floridaís Blood Centers, Inc., Orlando, FL
REASON Blood product tested positive for antibodies to red blood cell antigen D and C (anti-D and anti-C) but was not labeled anti-D and anti-C positive.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 6537982.
RECALLING FIRM/MANUFACTURER BloodNet USA, Inc., Lakeland, FL
REASON A unit of Recovered Plasma for manufacturing use was distributed as Fresh Frozen Plasma for transfusion.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 6515203.
RECALLING FIRM/MANUFACTURER BloodNet USA, Inc., Lakeland, FL
REASON A unit of Recovered Plasma for manufacturing use was distributed as Fresh Frozen Plasma for transfusion.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 6542349.
RECALLING FIRM/MANUFACTURER BloodNetUSA, Inc., Lakeland, FL
REASON A unit of Recovered Plasma for manufacturing use was distributed as Fresh Frozen Plasma for transfusion.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 6525316.
RECALLING FIRM/MANUFACTURER BloodNet USA, Inc., Lakeland, FL
REASON A unit of Recovered Plasma for manufacturing use was distributed as Fresh Frozen Plasma for transfusion.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit number N11806.
RECALLING FIRM/MANUFACTURER Michigan Community Blood Center, Grand Rapids, MI
REASON Blood products, collected from an ineligible donor due to a history of a human tissue transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI.

PRODUCT Source Plasma.
CODE Unit number FQDQKX.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Resources, Inc., Knoxville, TN
Manufacturer: International Bio-Resources, LLC, Salem, OR.
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 Red Blood Cells, Leukocytes Reduced.
CODE Unit number 5019232.
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK
REASON Blood product, that tested out of specification for hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AK.

PRODUCT Source Plasma.
CODE Unit number FQCZNL.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Resources, Inc., Knoxville, TN.
Manufacturer: International Bio-Resources, LLC, Salem, OR.
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 FQDLYZ.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Bio-Resources, Inc., Knoxville, TN
Manufacturer: International Bio-Resources, LLC, Salem, OR.
REASON Blood product, collected from a donor whose donor suitability determination was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT Source Plasma.
CODE Unit number: 92710412.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson, TN.
REASON Blood product, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers 04974468, 04849803, 04841777, 04840824, 05821426, 04489771, and 04488828.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson, TN
REASON Blood products, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE Unit number: 1150250.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, San Francisco, CA
REASON Blood product, which remained out of controlled storage for more than 30minutes, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers 05828715, 05824496, and 04489795.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson, TN
REASON Blood products, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers 04847090 and 05822249.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson, TN
REASON Blood products, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers 04850267, 05827782, 05821860, and 04489252.
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson, TN
REASON Blood products, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 3867695.
RECALLING FIRM/MANUFACTURER Floridaís Blood Centers, Inc., Orlando, FL
REASON Blood product, collected from an ineligible donor due to a history of a human tissue transplant, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 8310540 (distributed as two split units.
RECALLING FIRM/MANUFACTURER Floridaís Blood Centers, Inc., Orlando, FL
REASON Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL.

PRODUCT Recovered Plasma.
CODE Unit numbers: 6818791, 6817789, 3362390.
RECALLING FIRM/MANUFACTURER Floridaís Blood Centers, Inc., Orlando, FL
REASON Blood products, collected from a donor who gave a history of ulcerative colitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION Austria and Switzerland.

PRODUCT Cryoprecipitated AHF.
CODE Units: 4460247, 4615317.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, prepared from plasma that was not frozen within 6 hours of collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OK.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Recovered Plasma.
CODE a), b), and c) Unit 4191475.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NY, TX, and Switzerland.

PRODUCT Red Blood Cells.
CODE Unit 04LE57305.
RECALLING FIRM/MANUFACTURER American National Red Cross, New England Region, Dedham, MA
REASON Blood product, collected from an autologous donor with a history of seizures, but not labeled with a biohazard label, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Recovered Plasma, for manufacturing non-injectable products.
CODE Unit number: 4508467.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
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 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit number 027GM98403.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies Region, Johnstown, PA.
REASON Blood product exposed to unacceptable shipping temperatures was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 5285064.
RECALLING FIRM/MANUFACTURER Ogden Medical Center, Inc., Columbia Ogden Medical Center, Ogden, UT
REASON Blood product, manufactured from a unit of Whole Blood that had an extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION UT.

PRODUCT Fresh Frozen Plasma.
CODE Unit numbers: 4584729 and 4560714.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood products, whose freeze time exceeded the firmís specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OK.

PRODUCT Baxter Fenwal Blood-Pack Unit, Product Code 4R1247MC.
CODE Lots M02I26046, M02I26046A, M02J10064, M02J10064A, M02K18032, M02K30029, M03A31067, M03B14038, M03B14038A, M03B28053, M03C21056, M03E28056, M03K06051, M04A17032, M04C26039 and M04E07034.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Round Lake, IL
Manufacturer: Baxter Healthcare Corporation, Transfusion Therapies Division, Maricao, PR.
REASON The Samplink access device included in the cases with the Blood-Pack Units may be expired while the Blood-Pack Units are still within expiration.
VOLUME OF PRODUCT IN COMMERCE 16 lots, 1,991 cases.
DISTRIBUTION Nationwide and Germany.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) Unit number 4543571;
b) Unit number 4543571 (two units distributed).
RECALLING FIRM/MANUFACTURER Recalling firm: Oklahoma Blood Institute, Sylvan N. Goldman Center), Oklahoma City, OK
Manufacturer: Oklahoma Blood Institute, Northwest Oklahoma Blood Institute, Enid, OK.
REASON Blood products, collected from an ineligible donor due to a history of a human tissue transplant, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OK, FL, and CA.

PRODUCT Source Plasma.
CODE Unit numbers 15796929, 15795687, 15793966, 15793058, 15791238, 14560217, 14558429, 14557422, 14555756, 14554513, 14552557, 14551802, 15469496 and 15468758.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Clearwater, FL
REASON Blood products, collected from an unsuitable donor due to use of the medication Propecia, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION MI.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 26173-6759.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR,
REASON Blood product, that was labeled as leukoreduced but failed quality control testing due to as elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AR

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 26173-2206, 26173-2200, 26173-2192, 26173-2191, 26173-2188, 26173-2187, 26173-2195, and 26173-2196.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR
REASON Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION AR.

WEEK ENDING JUNE 18

PRODUCT Source Plasma.
CODE Unit numbers: 6270233812, 6270233343, 6270232575, 6270231874, 6270231253, 6270230437, 6270230043, 6270229405, 6270228572, 6270226633, 6270216031, 6270213965, 6270213347, 6270212674, 6270212027, 6270211322, 6270211084, 6270210632, 6270210412, 6270209843.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma, Inc., South Salt Lake City, UT
REASON Blood products, collected from an unsuitable donor based on previous deferral for IV drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 20 units.
DISTRIBUTION NC.

PRODUCT Source Plasma.
CODE Units 2518A, 2218AY, 01683T, 01269T, 00753T, 00406T, 99907R, 99561R, 99245R, 98712R, 98209R, 53812T, 53324T, 52980T, 52481T, 52120T, 51672T, 51231T, 65820R, 65435R, 64928R, 64534R, 64170R, 63878R, 63381R, 62981R, 62420R, 62164R, 65512N, 65283N, 64658N, 64391N, 63889N, 63426N, 62877N, 62491N, 62076N, 67546H, 67142H, 66671H, 66266H, 65661H, 65012H, 64480H, 64110H, 59618H, 59353H, 58861H, 58657H, 58158H, and 57835H.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., Lakeland, FL
REASON Blood products, which were collected from a donor who had previously tested repeatedly reactive for the antibody to human immunodeficiency virus types 1 and 2 (anti-HIV-1/2), were distributed.
VOLUME OF PRODUCT IN COMMERCE 51 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells.
CODE Unit numbers: F139536, F137949, F136288.
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
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 WA.

PRODUCT Red Blood Cells.
CODE Unit number: P128645.
RECALLING FIRM/MANUFACTURER Puget Sound Blood Center, Seattle, WA
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 1 unit.
DISTRIBUTION WA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells (Apheresis), Leukocytes Reduced.
c) Red Blood Cells.
d) Platelets.
CODE
a) and d) Unit number: 4126710;
b) Unit number: 4304813;
c) Unit number: 4050736.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Oklahoma Blood Institute, Oklahoma City, OK
Manufacturer: Oklahoma Blood Institute, East Central Oklahoma Blood Institute, Ada, OK.
REASON Blood products, collected from a donor who had a history of malaria, and donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION OK and MO.

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit 4569970.
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
REASON Blood product, which was collected from a donor who was taking medication for an upper respiratory infection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OK.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 2287278.
RECALLING FIRM/MANUFACTURER Florida's Blood Centers, Inc., Orlando, FL
REASON Blood products, which were collected from a donor who admitted to risk factors for variant Creuztfeldt Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION FL, and Austria.

PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1304-5;
b) Red Blood Cells (Apheresis) Leukocytes Reduced.
CODE
a) Unit numbers: 18228-6240, 18228-6267;
b) Unit number: 18228-6239.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products, collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION NB

PRODUCT Red Blood Cells Leukocytes Reduced.
CODE Unit number: T35787
RECALLING FIRM/MANUFACTURER Tacoma-Pierce County Blood Bank, Tacoma, WA
REASON Blood product, collected from a donor whose medical history screening was incomplete regarding risk factors for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WA

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
CODE
a) and b) Unit number: 21KJ72224
RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Region, Portland, OR
REASON Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OR, AL, and Switzerland

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit numbers 23147-2334 and 23147-6230
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ

Manufacturer: Blood Systems, Inc., Billings, MT.
REASON Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that was subsequently determined to have a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units
DISTRIBUTION MO. and WY

PRODUCT Red Blood Cells..
CODE Unit number R24576
RECALLING FIRM/MANUFACTURER Tacoma-Pierce County Blood Bank, Tacoma, WA
REASON Blood product, collected from a donor whose health history screening was inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WA

PRODUCT Source Plasma.
CODE Unit numbers 10429075, 10427989, 10425930, 10423363, 10422397, 09079984, 09077614, 09076716, and 09074262
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson, TN
REASON Blood products, that tested negative for viral markers, but were not properly quarantined after the receipt of deferral information related to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units
DISTRIBUTION CA

PRODUCT Source Plasma.
CODE Unit numbers 76268144 and 76266966
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a subsequent determination of previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION CA

PRODUCT
a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit number 21GV05733
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to previous positive hepatitis testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION OR, and Switzerland

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b)Unit number M13398
RECALLING FIRM/MANUFACTURER Northern Illinois Blood Bank, Inc, Rockford, IL
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a possible history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION IL and CA

PRODUCT Source Plasma.
CODE Unit numbers OJ094123, OJ093796, OJ092869, OJ092507, OJ091787, OJ091080, OJ090764, OJ089973, OJ089620, OJ088637, OJ088493, OJ087193, OJ086641, OJ086280, OJ085775, OJ085346, OJ085034, OJ084503, OJ084142, OJ083500, OJ083199, OJ081583, OJ081496, OJ080277, OJ079976, OJ079442, OJ078683, OJ078374, OJ077235, OJ076531, OJ076225, OJ075673, OJ075293, OJ074870, OJ074522, OJ073985, OJ073516, OJ073125, and OJ072769
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., Jacksonville, FL
REASON Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that was subsequently determined to have a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 39 units
DISTRIBUTION UK

PRODUCT Fresh Frozen Plasma, [Apheresis]. .
CODE Unit number 18228-8366 (distributed as three split units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ
Manufacturer: Blood Systems, Inc., Cheyenne, WY.
REASON Blood products were collected in a manner that may compromise the sterility of the products.
VOLUME OF PRODUCT IN COMMERCE 3 units
DISTRIBUTION NE

PRODUCT Source Plasma.
CODE Unit numbers: 77395863, 58164105, 41702642, 27381465, 77404510, 47422209, 47113961, 47367395, 47431454, 41710074, 41708897, and 41703540
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN
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 12 units
DISTRIBUTION CA

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 027P72224
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Alleghenies Region, Johnstown, PA
REASON Blood product was manufactured in a bag that may have leaks and was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WV

PRODUCT Source Plasma. .
CODE Unit BNBXTP
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomat USA, Inc., Baton Rouge, LA
Manufacturing Firm: Biomat USA, Inc., Clarksville, TN.
REASON Blood product, mislabeled as testing negative for HIV, HBV, and HCV by NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION Germany

PRODUCT Platelets.
CODE Unit 238849
RECALLING FIRM/MANUFACTURER Aultman Hospital Blood Bank, Canton, OH
REASON Blood product, collected from a donor who was previously deferred for a history of intravenous (IV) drug use, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit 4513820
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Oklahoma City, OK
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 OK

PRODUCT Source Plasma.
CODE Unit number: 04844303
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc, Jackson, TN
REASON Blood product, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Source Plasma.
CODE Unit number: 04846321
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson, TN
REASON Blood product, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Source Plasma.
CODE Unit numbers: 05829620, 05828821, 05822645, 05820528, 04489733, and 04488170
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson, TN
REASON Blood product, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units
DISTRIBUTION CA

PRODUCT Platelets.
CODE Unit number: 4725408
RECALLING FIRM/MANUFACTURER Oklahoma Blood Institute, Sylvan N. Goldman Center, Oklahoma City, OK
REASON Blood product, which may have been prepared from a Whole Blood unit with and extended collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION TX

PRODUCT Recovered Plasma. .
CODE Unit number: 21KJ72224
RECALLING FIRM/MANUFACTURER American Red Cross, Pacific Northwest Region, Portland, OR
REASON Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OR, AL, and Switzerland

PRODUCT Source Plasma.
CODE Unit number: 91443465
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN
REASON Blood product, collected from a donor that was not asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Source Plasma.
CODE Unit number: 90623141
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Memphis, TN
REASON Blood product, collected from a donor that was not asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Red Blood Cells.
CODE Unit number V54855
RECALLING FIRM/MANUFACTURER Tacoma-Pierce County Blood Bank, Tacoma, WA
REASON Blood product, that was not properly quarantined after the receipt of post donation information concerning medication with an antibiotic, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION WA

PRODUCT Source Plasma.
CODE Unit number 04DILD5716
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, L.P., DeKalb, IL
REASON Blood product, collected from an unsuitable donor due to recent antibiotic use, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

WEEK ENDING JUNE 25

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced.
CODE Unit: 246320206 (split unit)

RECALLING FIRM/MANUFACTURER

Recalling Firm: Blood Systems Inc., Scottsdale, AZ
Manufacturing Firm: Blood Systems Inc., Rapid City, SD.
REASON Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION SD and MS

PRODUCT Human Tissue for Transplantation, Corneas.
CODE Tissue numbers NY-05-04-017-R1 and NY-05-04-017-L1
RECALLING FIRM/MANUFACTURER Sight Society of Northeastern New York, Albany, NY
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 2 tissues
DISTRIBUTION PA and SD

PRODUCT Source Plasma.
CODE Unit numbers 65931R and 01347T
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., Lakeland, FL,
REASON Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to a recent tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION NC

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number B169359
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA,
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA.
REASON Blood products, that tested negative for viral markers, but were collected from an unsuitable donor due to a recent tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units
DISTRIBUTION WA

PRODUCT Red Blood Cells.
CODE Unit number FG02482.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aurora Blood Bank, Heartland Blood Centers, Aurora, IL,.
Manufacturer: Heartland Blood Centers, Elgin Donor Center, Elgin, 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.
CODE Unit number 238849.
RECALLING FIRM/MANUFACTURER Aultman Hospital Blood Bank, Canton, OH,\
REASON Blood product, collected from a donor who was previously deferred for a history of intravenous (IV) drug use, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION OH

PRODUCT Source Plasma.
CODE Unit number 04844303
RECALLING FIRM/MANUFACTURER Plasma Biological Services, Inc., Jackson, TN
REASON Blood product, collected from a donor that was not properly asked the medical history questions, including those questions concerning behavior known to increase risk of infection with the human immunodeficiency virus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION CA

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 26173-6759
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Fort Smith, AR,
REASON Blood product, that was labeled as leukoreduced but failed quality control testing due to an elevated white blood cell
count, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AR

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 6705757
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc, Anchorage, AK
REASON Blood product, which was not leukoreduced within the appropriate time period after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit
DISTRIBUTION AK