ENFORCEMENT REPORT FOR June 4, 2003

JUNE 2003

WEEK ENDING JUNE 7

PRODUCT Red Blood Cells.
CODE Unit number 0147668.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells. .
CODE Unit number 0161448.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT
a) Platelets.
b) Cryoprecipitated AHF.
c) Fresh Frozen Plasma.
CODE
a) and c) Unit number 7506170;
b) Unit number 7618557.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, manufactured from a unit of Whole Blood that had an extended collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE a) and b) Unit number 5379485.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, manufactured from a unit of Whole Blood that had a discrepant collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit number 5358384.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, collected from an ineligible donor due to a history of colitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, and MI.

PRODUCT Cornea.
CODE ID number 03-097-1
RECALLING FIRM/MANUFACTURER Utah Lions Eye Bank, Salt Lake City, UT,
REASON Cornea that was collected from a donor who was found to test repeatedly reactive for Hepatitis B Core antibody (HBcAb) subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION UT.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.

CODE a) and b) 50LG75346.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH,
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units,
DISTRIBUTION OH, and IN.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Platelets, Pheresis, Leukocytes Reduced. Recall # B-1050-3.
CODE a) Unit numbers 20030-0136, 20407-7092, 21608-4302; b) Unit number 17199-2305.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen, TX,
REASON Blood products, possibly exposed due unacceptable shipping temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX.

PRODUCT Source Plasma.
CODE Unit numbers G-15328-113, and DLG004449.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Beaumont, TX,
REASON Blood products, collected from a donor whose arm inspection was documented as unacceptable, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION KY, and CA.

PRODUCT Source Plasma.
CODE Unit number DLG005475.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Beaumont, TX,
REASON Blood product, collected from a donor whose arm inspection was documented as unacceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number DLG012653.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Beaumont, TX,
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number WSG007612.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number WSG007388.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

WEEK ENDING JUNE 14

PRODUCT Human Tissues for transplantation:
a) Achilles Tendon.
b) Tibialis Tendon.
c) Hemi Patellar Tendon.
d) Saphenous veins.
e) Semi-quadriceps Tendon.
CODE
a) Donor #60084, Serial #7785332;
b) Donor #60084, Serial #7785274;
c) Donor #60084, Serial #7785289;
d) Donor #57455, Serial #7442784; Donor #57455, Serial #7315085; Donor #57455, Serial #7442794; Donor #55139, Serial #7238163;
e) Donor #42926, Serial #6643867.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA,
REASON Human tissues for transplantation, collected from donors whose companion sample, from a different site, was positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION CO, MI, NH, NJ, TX, and Canada.

PRODUCT Human Tissues for transplantation:
a) Saphenous Vein.
b) Femoral Artery.
CODE
a) Donor # 49120, Serial # 6874115;
b) Donor # 49120, Serial # 6855223.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA,

REASON Human tissues for transplantation, collected from donors whose companion sample, from a different site, was positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION SC, and FL.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 7416085.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Platelets.
CODE Unit 7548295.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells.
b) Platelets.
CODE a) and b) Unit 7454109.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Platelets, Pheresis.

CODE Unit 0352423.
RECALLING FIRM/MANUFACTURER Florida Blood Services, Inc., St. Petersburg, FL.
REASON Platelets, labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT a) Platelets, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 19GN88726.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN.
REASON Blood products, collected under conditions where the sterility of the products may have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TN, and VA.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 12Q58828.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC.
REASON Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC, and CA.

PRODUCT a) Red Blood Cells.

b) Fresh Frozen Plasma.
CODE a) and b) Unit 20284-6039.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc, Scottsdale, AZ.
Manufacturer: Blood Systems, Inc, Lafayette, LA.
REASON Blood products, collected from a donor taking the drug Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NC, and LA.

PRODUCT Fresh Frozen Plasma.
CODE Unit 19GN94456.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN.
REASON Blood product, corresponding to a unit of Red Blood Cells, that was implicated in a transfusion reaction and found to be contaminated with Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TN.

PRODUCT a) Red Blood Cells.
b) Platelets.
c) Recovered Plasma.
CODE a), b), and c) Unit 19KW12321.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN.
REASON Blood products, collected from an unsuitable donor due to behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV) or the hepatitis B virus (HBV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TN.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Irradiated.
b) Fresh Frozen Plasma.
c) Recovered Plasma.
CODE
a) Units 0882793, 0847776;
b) Unit 084776;
c) Unit 0882793.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH.
REASON Blood products, collected from a donor who took the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION OH, and FL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 29FJ48235.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA.
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 NC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 29FN44316.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA.
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 VA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 035GC20849.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Appalachian Region, Roanoke, VA.
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 WV.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit KT00769.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA.
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 VA.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit KC09262.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Tri-Counties Blood Bank, Inc, Santa Barbara, CA.
REASON Platelets, Pheresis, which did not have a white blood cell determination, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Corneas (two tissues).
CODE Tissue number 03-159 R and 03-159 L.
RECALLING FIRM/MANUFACTURER Cincinnati Eye Bank for Sight Restoration, Inc, Cincinnati, OH.
REASON Human corneas, collected from a donor who subsequently tested positive for antibody to the Hepatitis B core antigen (Anti-Hbcore) by another tissue procurement organization, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION Taiwan.

PRODUCT a) Platelets, Pheresis, Leukocytes Reduced.
b) Platelets, Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) 0893057(part 2); 0882561 (parts 1 & 2);
b) 0893057 (part 1).
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, Cincinnati, OH.
REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION KY, and OH.

PRODUCT Platelets.
CODE 9750024, 9750025, 9750035, 9750042, 9750052, 9750053, 9750058, 9750059, 9750060, 9750061, 9750062, 9750086, 9750093, 9750242, 9750245, 9750246, 9750247, 9750248, 9750249, 9750250, 9750251, 9750252, 9750253, 9750254, 9750255, 9750256, 9750257, 9750258, 9750260, 9750262, 9750263, 9750264, 9750269, 9750272, 9750274, 9750277, 9750278, 9750279, 9750280, 9750285, 9750287, 9750289, 9750290, 9750291, 9750292, 9750297, 9750300, 9750301, 9750303, 9750305, 9750308, 9750309, 9750310, 9750313, 9750314, 9750315, 9750316, 9750317, 9750318, 9750319, 9750320, 9750321, 9750322, 9750323, 9750326, 9750328, 9750329, 9750330, 9750332, 9750333, 9750334, 9750335, 9750338, 9750340, 9750341, 9750345, 9750347, 9750348, 9750349, 9750351, 9750354, 9750355, 9750356, 9750357, 9750358, 9750359, 9750360, 9750361, 9750363, 9750364, 9750367, 9750368, 9750369, 9750370, 9750373, 9750374, 9750375, 9750376, 9750377, 9750378, 9750380, 9750385, 9750387, 9750388, 9750391, 9750392, 9750393, 9750394, 9750395, 9750396, 9750398, 9750399, 9750400, 9750405, 9750406, 9750407, 9750408, 9750410, 9750411, 9750412, 9750413, 9750414, 9750415, 9750417, 9750418, 9750419, 9750421, 9750422, 9750425, 9750426, 9750427, 9750428, 9750430, 9750431, 9750432, 9750434, 9750436, 9750437, 9750438, 9750439, 9750440, 9750442, 9750445, 9750446, 9750450, 9750451, 9750452, 9750453, 9750454, 9750455, 9750456, 9750457, 9750459, 9750460, 9750462, 9750464, 9750467, 9750468, 9750469, 9750471, 9750472, 9750473, 9750474, 9750475, 9750476, 9750477, 9750478, 9750480, 9750481, 9750482, 9750483, 9750484, 9750485, 9750488, 9750489, 9750490, 9750492, 9750495, 9750496, 9750497, 9750500, 9750501, 9750502, 9750503, 9750609, 9750610, 9750615, 9750628, 9750630, 9750631, 9750632, 9750634, 9750635, 9750636, 9750637, 9750640
RECALLING FIRM/MANUFACTURER HemaCare Corp., Coral Blood Services, Inc, Albany, NY.
REASON Platelets, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 196 units.
DISTRIBUTION NY.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 04KF56285.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA.
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 04KL72175, 04KW18455, and 04KL66071.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA.
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 MA, and VT.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) unit number 19GH34831.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN.
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 TN, and CA.

PRODUCT Platelets, Leukocytes Reduced.
CODE Unit numbers 19LW23807, 19LW23765, 19LW23790, 19LW23776, 19LW23774, 19LW23772, 19LW23786, 19LW23777, and 19LW23799.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Tennessee Valley Region, Nashville, TN.
REASON Blood products, collected from donors whose health history screening were inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION TN.

PRODUCT Red Blood Cells.
CODE Unit number FJ55294.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI.
REASON Blood product, that tested negative for viral markers, but was collected from an ineligible donor due to intravenous drug use, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION RI.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Cryoprecipitated AHF.
d) Plasma, Cryoprecipitate Reduced.
e) Fresh Frozen Plasma.
CODE
a), b), and e) Unit number FG41412;
a), c), and d) Unit number FG54186.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI.
REASON Blood products, that tested negative for viral markers, but was collected from an ineligible donor due to intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION RI, MA, and TX.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Fresh Frozen Plasma.
CODE
a), and b) Unit numbers FG37970, FG22663, and FJ54319;
c) Unit numbers FG37970 and FJ54319.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI.

REASON Blood products, that tested negative for viral markers, but was collected from an ineligible donor due to intravenous drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION RI, and MA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b) and c) Unit numbers FG35335 and FM34726.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI.
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to self-injected drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION RI, and MA

PRODUCT Red Blood Cells.
CODE Unit number 5301557.
RECALLING FIRM/MANUFACTURER Department of the Navy, Naval Medical Center, Portsmouth, VA.
REASON Blood product, collected using a phlebotomy method that may have compromised the sterility of the products, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT a) Platelets Pheresis, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) Unit number 035P39424 (distributed as two split products);
b) Unit number 035P39424.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Appalachian Region, Roanoke, VA.
REASON Blood products, untested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NJ, and VA.

PRODUCT Menomune A/C/Y/W-135, Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W-135 Combined, single-dose vials (including single-dose in five dose packaging).
CODE Lots UB040AA, UB040AB, UB070AA, UB096AA.
RECALLING FIRM/MANUFACTURER Aventis Pasteur, Swiftwater, PA.
REASON Product failed to meet potency specification during stability testing at twelve months.
VOLUME OF PRODUCT IN COMMERCE 4 lots.
DISTRIBUTION Nationwide, Argentina, Australia, Singapore, Thailand, Canada, and India.

PRODUCT Red Blood Cells.
CODE Unit 5304584.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Source Plasma.
CODE Unit number WSG009471.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX.

REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number WSN001397.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX.

REASON Blood product, collected from a donor that did not answer medical history 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 KY.

PRODUCT Source Plasma.
CODE Unit number WSG009639.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX.
REASON Blood product, collected from a donor that did not answer medical history 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 KY.

PRODUCT Source Plasma.
CODE Unit number WSG009015.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX.
REASON Blood product, collected from a donor that did not answer medical history 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 KY.

PRODUCT Source Plasma.
CODE Unit number XA0002596.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Port Arthur, TX.
REASON Blood product, collected from a donor that did not answer medical history 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 IN.

PRODUCT Source Plasma.
CODE Unit number SS-9309.
RECALLING FIRM/MANUFACTURER Pyramid Biological Corp., Las Vegas, NV.
REASON Blood product, collected from a donor that did not answer medical history 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 NJ.

PRODUCT Platelets.
CODE Unit 5361361.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.

PRODUCT Corneas.
CODE ID numbers 01020738OS, 01020738OD.
RECALLING FIRM/MANUFACTURER Old Dominion Eye Foundation, Inc., Richmond, VA.
REASON Corneas that were collected from a donor who was found to test repeatedly reactive for Human Immunodeficiency Virus (HIV) 1/2 subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION VA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a), and b) Unit number M74238.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.
REASON Blood products, collected from an ineligible donor due recent administration of the measles, mumps, and rubella (MMR) vaccine, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA, and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 13FW01800.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON Red Blood Cells, possibly mislabeled for the Fyb antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

WEEK ENDING JUNE 21

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Recovered Plasma.
CODE a) and b)Unit number 35FV06069.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Appalachian Region, Roanoke, VA.
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 2 units.
DISTRIBUTION WV, and MA.

PRODUCT a) Red Blood Cells. b) Platelets, Irradiated. c) Recovered Plasma.
CODE a), b), and c) unit number T92524.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.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 3 units.
DISTRIBUTION VA, and Switzerland.

PRODUCT a) Red Blood Cells. b) Recovered Plasma.
CODE a), and b) unit number LC22449.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA.
REASON Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA, and NJ.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Fresh Frozen Plasma.
CODE a), and b) unit number FE82326.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annandale, VA.
REASON Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Recovered Plasma.
CODE a) and b)Unit number 38FM47100.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN.
REASON Blood products, collected from an ineligible donor due to medication with the drug Imuran, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN, and NC.

PRODUCT Recovered Plasma.
CODE Units 18FQ81523, 18FW26005, and 18FK57162.
RECALLING FIRM/MANUFACTURER American Red Cross/Great Lakes Region, Lansing, MI.
REASON Blood products, collected from a donor who previously tested reactive for the antibody to hepatitis C virus (anti-HCV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NC, and Switzerland.

PRODUCT a) Red Blood Cells. b) Platelets.
CODE a) Units 13R06522, 13R02468, 13R98495; b) Units 13R06522, 13R02468.
RECALLING FIRM/MANUFACTURER American National Red Cross, Detroit, MI.
REASON Blood products, collected from a donor taking the drug Ridaura, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MI.

PRODUCT a) Red Blood Cells. b) Recovered Plasma.
CODE a), and b) Unit 1747017.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, IN.
REASON Blood products, collected from a donor taking the drug Proscar, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN, and Switzerland.

PRODUCT a) Red Blood Cells, Leukoreduced. b) Recovered Plasma.
CODE a), and b) Unit 38W22069.
RECALLING FIRM/MANUFACTURER American National Red Cross, Fort Wayne, IN.
REASON Blood products, collected from a donor taking the drug Imuran, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN, and NC.
PRODUCT a) Red Blood Cells, Leukocytes Reduced, Irradiated. b) Platelets, Pheresis, Leukocytes Reduced, Irradiated.
CODE a) Units 50Z08325, 50Z08329; b) Unit 50P34773 – part 1.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH.
REASON Blood products, possibly exposed to inadequate irradiation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 22KM81294.
RECALLING FIRM/MANUFACTURER American Red Cross, Penn Jersey, Musser Blood Center, Philadelphia, PA.
REASON Blood product, corresponding to a pool of platelets that was implicated in a transfusion reaction and found to be contaminated with Serratia marcescens, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.

DISTRIBUTION PA.

WEEK ENDING JUNE 28

PRODUCT Cornea.
CODE ID number 03-097-1.
RECALLING FIRM/MANUFACTURER Utah Lions Eye Bank, Salt Lake City, UT.
REASON Cornea that was collected from a donor who was found to test repeatedly reactive for Hepatitis B Core antibody (HbcAb) subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION UT.

PRODUCT a) Red Blood Cells, Leukoreduced.
b) Recovered Plasma.
CODE a) and b) Unit number 50E24218.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH.

REASON Blood products, collected from a donor who provided post donation information regarding having tested positive for hepatitis, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OH, and Switzerland.

PRODUCT Recovered Plasma.
CODE Unit 04C64041.
RECALLING FIRM/MANUFACTURER American Red Cross, New England Region, Dedham, MA.
REASON Blood product, collected from a donor with a history of having tested positive for hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit number 13FM77147.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON Blood products, collected from an ineligible donor due to medication with the drug Imuran, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI.

PRODUCT a) Red Blood Cells, Leukocytes Reduced Irradiated.
b) Platelets, Irradiated.
CODE a) Unit numbers 13FM88958, 13FM88928, 13FM88948, and 13FM88956;
b) Unit number 13GM76657.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON Blood products were not irradiated but were distributed with labeling that indicated that the units had been irradiated.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 13T96271.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI.
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 MI.

PRODUCT a)Red Blood Cells, Leukocytes Reduced.

b)Platelets.
CODE a) and b) Unit number 22KT44570.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
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 PA.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
CODE a), and b) unit number 22FV93238.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Units.
DISTRIBUTION PA, and NJ.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Recovered Plasma.
CODE a), b) and c) Unit number 22FJ71665.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
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 3 units.
DISTRIBUTION PA, VA, and CA.

PRODUCT Platelets.
CODE Unit number 22KM75770.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA.
REASON Blood products, that 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 VA.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit number 04L42295.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA.
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, Leukocytes Reduced.
CODE Unit numbers 04KL72173 and 04KL66070.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA.
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 2 units.
DISTRIBUTION VT.

PRODUCT a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit number 04GK27366.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA.
REASON Blood products tested negative for viral markers but were collected from an ineligible donor due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NY, and CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 50LJ50599.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Western Lake Erie Region, Toledo, OH.
REASON Blood product, collected using a phlebotomy method that may compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT a) Red Blood Cells.
b) Recovered Plasma.
CODE a) and b) Unit number LL75668.
RECALLING FIRM/MANUFACTURER Blood Bank of the Redwoods, Santa Rosa, CA.
REASON Blood products, collected from a donor who had a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Platelets..
CODE a), and b) Unit number 4108271.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX

REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, and NY.

PRODUCT a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
CODE
a) Unit number 4100696; b), and c) Unit number 4288465.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX

REASON Blood products, collected from a donor who reported travel to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Platelets..
CODE a) and b) Unit number 4284534.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX

REASON Blood products, collected from a donor who had not completed the CJD/nvCJD increased risk questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma..
CODE a), and b) Unit number 18230-1151.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ

REASON Blood products, collected from a donor who was at increased risk for new variant Creutzfeldt Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WY, and Switzerland.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Fresh Frozen Plasma.
d) Cryoprecipitated AHF
CODE a), b), c), and d) Unit number 3787166.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX

PRODUCT Source Plasma.
CODE Unit numbers 0020754322, 0020754729, 0020755051, 0020755442, 0020755775, 0020756164, 0020756588, and 0020757359.
RECALLING FIRM/MANUFACTURER Nabi, Norfolk, VA.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION NC.

PRODUCT a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
CODE a) Unit numbers C46090 and KQ29143; b) Unit number C40796.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA.

REASON Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from an ineligible donor due to a subsequent report of a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA, and TX.

PRODUCT a) Red Blood Cells.
b) Recovered Plasma
CODE a), and b) Unit numbers 35FH46064, 35FH52457, and 35GC00421.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Appalachian Region, Roanoke, VA

PRODUCT Recovered Plasma.
CODE Unit number 53GL13129.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region.,

REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Switzerland.

PRODUCT a) Red Blood Cells, Leukocytes Reduced . b) Plasma. Recall # B-1228-3.
CODE a), and b) Unit number 29FS84448.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA

REASON Blood products, collected from an ineligible donor due to use of the medication Arava, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 29GF31819.

RECALLING FIRM/MANUFACTURER The American National Red Cross, Mid-Atlantic Region, Norfolk, VA

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 NC.

PRODUCT a) Red Blood Cells, Leukocytes.
b) Recovered Plasma.
CODE a), and b) Unit number 27GX40430.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Greater Alleghenies Region, Johnstown, PA

PRODUCT Red Blood Cells, Leukocytes Reduced.

CODE Unit number 53GH57572.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD., 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 MD.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Platelets.
CODEa) Unit numbers 4207948 and 4181168; b) Unit number 4181168.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.,

REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Platelets..
CODE a), and b) Unit number 4229251.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX

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 TX.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Platelets.

CODE a), and b) Unit number 4275066.

RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.,

PRODUCT Platelets Pheresis.

CODE Unit number 4328690 (distributed as two split products).
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX

REASON Blood product, manufactured in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced.

CODE Unit number 4251163.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.,

REASON Blood product, that was below the firm's specification for red blood cell volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells. b) Recovered Plasma.
CODE a) and b) Unit numbers 6850866, 5433676, 5702938, and 5245809.
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Lake Charles, LA

REASON Blood products, that tested negative for antibodies to human immunodeficiency virus (anti-HIV), but were collected from a donor that previously tested repeatedly reactive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION LA, TX, FL, CA, and NY.

PRODUCT Source Plasma.
CODE Unit numbers G-94172-070, G-93996-070, G-93558-070, G-93297-070, G-92935-070, G-92569-070, G-92302-070, G-91960-070, G-91657-070, G-90078-070, G-89735-070, G-89482-070, G-89123-070, G-88896-070, G-88574-070, G-88329-070, G-87972-070, G-87464-070, G-87263-070,

G-86844-070, G-86632-070, G-86176-070, G-85964-070, G-85604-070, G-85357-070, G-84973-070, G-84731-070, G-84307-070, G-84120-070,

G-83707-070, G-83511-070, G-83161-070, G-82968-070, G-81309-070, G-80615-070, G-80359-070, G-79944-070, G-79633-070, G-79049-070,

G-78830-070, G-78370-070, G-78045-070, G-77651-070, G-77381-070, G-77010-070, G-76656-070, G-76297-070, G-75895-070, G-75633-070,

G-75246-070, G-74847-070, G-72379-070, G-71954-070, G-71759-070, G-71320-070, G-71033-070, G-70559-070, and G-69553-070.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corp., Vancouver, WA.
REASON Blood products, tested negative for viral markers but were collected from an ineligible donor due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 58 units.

DISTRIBUTION CA, Spain, and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced..
CODE Unit number 22KQ67825.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Penn-Jersey Region, Philadelphia, PA

REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.

PRODUCT Source Plasma.

CODE Unit number 57561622.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Danville, VA.,
REASON Blood product, collected from a donor that did not answer medical history 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 Platelets Pheresis.
CODE 53LP37152, 53GK27517, 53GK27513, 53LP37147, 53LF69115, and 53GK27518; and the following unit was distributed as two split products: unit number 53GK27514.

RECALLING FIRM/MANUFACTURER The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD

REASON Blood products, exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION MD, and Washington, D.C.

PRODUCT Platelets.

CODE Unit numbers 4391691 and 4391692.
RECALLING FIRM/MANUFACTURER Gulf Coast Regional Blood Center, Houston, TX.
REASON Blood products, manufactured from units of Whole Blood possibly collected and/or stored at incorrect temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX, and TN.