DECEMBER 2004

WEEK ENDING DECEMBER 4

PRODUCT
a) Red Blood Cells. 
b) Recovered Plasma. 
CODE a) and b) Unit KS08907.
RECALLING FIRM/MANUFACTURER Inova Health Care Services, Blood Donor Services, Annadale, VA.
REASON Blood products, collected from a donor who disclosed a previous positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD and NJ.

PRODUCT Source Plasma. 
CODE Unit 70082463.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma Services, Inc., Kansas City, MO.
REASON Source Plasma, with an elevated ALT level, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma. 
CODE Units 50636655, 41164570, 41150375, 41147368, 41115633, 41113127,
41127872, 28529132, 526872.
RECALLING FIRM/MANUFACTURER ZLB Bioplasma Services, Inc., Kansas City, MO.
REASON Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 9 units.
DISTRIBUTION CA

PRODUCT Human Corneal Tissue. 
CODE SL04-05-048R1 & SL04-05-048L1.
RECALLING FIRM/MANUFACTURER Mid-America Transplant Services, Olivette, MO.
REASON Tissue, procured from a donor who engaged in high-risk activity, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION Mexico.

PRODUCT
a) Red Blood Cells, Leukocytes Removed, Irradiated. 
b) Fresh Frozen Plasma.   
CODE a) and b) Unit number: 224292744.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Las Vegas, NV.
REASON Blood products, collected from an ineligible donor due to the use of the medication, Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NV.

PRODUCT
a) Platelets Pheresis, Leukocytes Reduced. 

b) Platelets Pheresis, Leukocytes Reduced, Irradiated. Recall # B-0270-5;  

CODE
a) Unit numbers: 150258768 (Parts 1 & 2);
b) Unit number: 150258768.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX.
REASON Blood products, collected from a donor who did not have a complete medical history interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. 
b) Platelets, Leukocytes Reduced. 
CODE a) and b) Unit number 0982259.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH.
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 OH.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Unit numbers 15025-1722 (distributed as two split products) and 15025-2418.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX.
REASON Blood products, collected from donors whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT
a) Whole Blood, Leukocytes Reduced. 
b) Red Blood Cells. 
c) Red Blood Cells, Leukocytes Reduced. 
d) Red Blood Cells (Apheresis), Leukocytes Reduced. 
e) Platelets. 
f) Platelets, Pooled 
g) Platelets Pheresis, Leukocytes Reduced. 
h) Cryoprecipitated AHF. 
i) Cryoprecipitated AHF, Pooled. 
j) Fresh Frozen Plasma. 
k) Fresh Frozen Plasma (Apheresis). 
l) Plasma, Cryoprecipitate Reduced. 
CODE
a) Unit numbers KZ66299, KZ69840, and KZ68404;
b) Unit numbers KZ65297, KZ66104, KZ66496, KZ66503, KZ66524, KZ68568, KZ68718, KZ69426, KZ69429, KZ69432, KZ69437, KZ69440, KZ69460, KZ69490, KZ69532, KZ69538, KZ70043, KZ70056, LP41656, and LP41662;
c) Unit numbers GR27116, GR27918, GR29059, KA69384, KZ65237, KZ65377, KZ65392, KZ65396, KZ65399, KZ65456, KZ65471, KZ65534, KZ65623, KZ65751, KZ65770, KZ65793, KZ65803, KZ65826, KZ65886, KZ65902, KZ65922, KZ65971, KZ66011, KZ66170, KZ66178, KZ66182, KZ66191, KZ66197, KZ66199, KZ66216, KZ66242, KZ66243, KZ66249, KZ66265, KZ66269, KZ66273, KZ66276, KZ66282, KZ66286, KZ66287, KZ66288, KZ66326, KZ66332, KZ66334, KZ66345, KZ66348, KZ66359, KZ66362, KZ66368, KZ66370, KZ66375, KZ66401, KZ66403, KZ66405, KZ66406, KZ66415, KZ66417, KZ66431, KZ66433, KZ66435, KZ66449, KZ66450, KZ66451, KZ66457, KZ66459, KZ66464, KZ66465, KZ66467, KZ66493, KZ66494, KZ66497, KZ66509, KZ66549, KZ66559, KZ66561, KZ66571, KZ66578, KZ66598, KZ66603, KZ66050, KZ66607, KZ66621, KZ66622, KZ66628, KZ66636, KZ66637, KZ66660, KZ66688, KZ66809, KZ66814, KZ66822, KZ66827, KZ66829, KZ66839, KZ66840, KZ66844, KZ66852, KZ66856, KZ66858, KZ66860, KZ66868, KZ66873, KZ66888, KZ66896, KZ66929, KZ66967, KZ66979, KZ66982, KZ66996, KZ67010, KZ67016, KZ67027, KZ67035, KZ67041, KZ67053, KZ67078, KZ67080, KZ67141, KZ67148, KZ67157, KZ67199, KZ67238, KZ67259, KZ67277, KZ67310, KZ67410, KZ67428, KZ67431, KZ67436, KZ67438, KZ67443, KZ67459, KZ67462, KZ67477, KZ67486, KZ67499, KZ67503, KZ67529, KZ67600, KZ67637, KZ67650, KZ67716, KZ67718, KZ67721, KZ67723, KZ67724, KZ67747, KZ67771, KZ67782, KZ67825, KZ67840, KZ67853, KZ67896, KZ67904, KZ67910, KZ67916, KZ67918, KZ67919, KZ67931, KZ67937, KZ68118, KZ68126, KZ68127, KZ68129, KZ68149, KZ68179, KZ68180, KZ68195, KZ68201, KZ68207, KZ68257, KZ68275, KZ68276, KZ68314, KZ68316, KZ68319, KZ68329, KZ68340, KZ68362, KZ68367, KZ68369, KZ68394, KZ68411, KZ68412, KZ68429, KZ68452, KZ68518, KZ68532, KZ68556, KZ68561, KZ68599, KZ68615, KZ68623, KZ68624, KZ68625, KZ68675, KZ68677, KZ68702, KZ68712, KZ68719, KZ68724, KZ68725, KZ68729, KZ68732, KZ68736, KZ68741, KZ68747, KZ68770, KZ68782, KZ68835, KZ68836, KZ68844, KZ68847, KZ68857, KZ68889, KZ68922, KZ68940, KZ68976, KZ68986, KZ68992, KZ69006, KZ69039, KZ69051, KZ69061, KZ69073, KZ69074, KZ69076, KZ69079, KZ69091, KZ69143, KZ69190, KZ69193, KZ69200, KZ69211, KZ69229, KZ69243, KZ69268, KZ69298, KZ69306, KZ69342, KZ69366, KZ69373, KZ69383, KZ69401, KZ69408, KZ69412, KZ69562, KZ69639, KZ69647, KZ69663, KZ69746, KZ69768, KZ69829, KZ69842, KZ69844, KZ69847, KZ69854, KZ69863, KZ69882, KZ69897, KZ69939, KZ70114, KZ70133, KZ70137, LC15638, LE43800, LE43806, LE44451, LE45643, LE45645, LE45933, LE45942, LE45988, LE46000, LN54025, LN54033, LN54049, LN54514, LN54517, LN54520, LN54874, LN54884, LN54893, LN54894, LN55356, LN55373, LN55813, LN55817, LN55820, LN55824, LN55837, LN56255, LN56260, LN56267, LN56456, LN56671, LN56677, LN56683, LN56693, LN56729, LN58173, LN58188, LP44159, and T97635; and the following units were distributed as multiple split products. Units KZ66384, KZ67897, and LN55834 were distributed as three split products each, and unit KZ69402 was distributed as six split products;
d) Unit numbers KZ67073, KZ67246, KZ67542, KZ67838, KZ68331, KZ68344, KZ68389, KZ68620, KZ68637, KZ68698, KZ68727,
KZ68906, KZ69002, LN56249, and LN56662 (all units distributed as two split products);
e) Unit numbers LN54033, LN54049, KZ66249, KZ66288, LN55813, KZ68624, and KZ69342;
f) Pool numbers P18357, P18456, P18492, P24827, P24858, P24861, P21772, P21898, P24750, P21700, P21735, P18210, P24583,
P24584, P24670, P24727, P24735, P21548, P21561, P21611, P21624, P21727, P17562, P17664, P17709, P18168, P18242, P18261, P18376, P18423, P24773, P24802, P24831, P24863, P24897, P24927, P21755, P20011, P20018, P21659, P21512, P18358, P24829, P24839, P18007, P21520, P24553, P24654, P21672, P21740, P18028, P21570, P21675, P17574, P17545, P21638, P18333, and P24837;
g) Unit numbers KZ67764, KZ69860, KZ69263, and KZ66488; and unit number LH61515 was distributed as two split products;
h) Unit numbers KZ66888 and KZ66269;
i) Pool numbers P15517, P15578, P15615, P15654, P15717, P15733, P19165, P19222, P22355, P22356, P22367, P22408, P22460, P23604, P23622, P23663, P23675, P23683, and P27234;
j) Unit numbers KZ65297, KZ65534, KZ66929, KZ66637, KZ68319, KZ65392, and KZ65399;
k) Unit numbers KZ65936 and KZ66296, and units KZ65203, KZ65311, KZ65323, KZ65429, and KZ65666 were each distributed as three split products
l) unit numbers KZ66896, KZ67918, KZ68195, KZ68518, KZ68783, and KZ69091.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI.
REASON Blood products, collected from donors that did not answer a medical history question concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 495 units.
DISTRIBUTION WI, VA, NY, LA, MS, FL, and IL.

PRODUCT Source Plasma. 
CODE Unit numbers CS0196618, CS0196815, CS0197266, CS0197481, CS0197946, CS0198192, CS0198601, CS0198845, CS0199280, CS0199485, CS0199899, CS0200158, CS0200569, CS0200802, CS0201186, and CS0201392.
RECALLING FIRM/MANUFACTURER Westgate Biologicals, LLC, College Station, TX.
REASON Blood products, collected from an ineligible donor due to recent surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE 16 units.
DISTRIBUTION NC.

PRODUCT Source Plasma. 
CODE Unit numbers CS0187466, CS0187895, CS0188275, CS0188657, CS0189089, CS0189434, CS0189903, CS0190273, CS0191103, CS0191504, CS0197565, CS0198006, CS0198267, CS0198685, CS0198925, CS0199427, CS0199640, CS0200867, and CS0201262.
RECALLING FIRM/MANUFACTURER Westgate Biologicals, LLC, College Station, TX.
REASON Blood products, collected from an ineligible donor due to recent surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE 19 units.
DISTRIBUTION NC.

PRODUCT
a) Platelets Pheresis, Leukocytes Reduced (2 units). 
b) Fresh Frozen Plasma [Apheresis)..
CODE
a) Unit number 1035847 (distributed as two split products);
b) Unit number 1035847.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH.
REASON Blood products, collected from an unsuitable donor due to use of the medication Propecia, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH.

PRODUCT Fresh Frozen Plasma [Apheresis]. 
CODE Unit numbers 15025-4907 and 15025-4922.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock, TX.
REASON Blood products, possibly frozen more than eight hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 Units.
DISTRIBUTION TX.

PRODUCT Recovered Plasma. 
CODE Unit numbers LN54520, LN58188, KZ66170, KZ69268, KZ66191, KZ67931, KZ66216, KZ68421, KZ66242, LE45988, KZ66269, KZ69538, KZ66273, KZ66287, LP44159, KZ66288, KZ66282, KZ66345, KZ66359, KZ66362, KZ66370, KZ66375, KZ66379, KZ66401, LE45645, KZ65405, KZ66493, KZ68568, GR27918, KZ68624, KZ66243, KZ68712, KZ66660, KZ68724, KZ68729, KZ68732, KZ68736, KZ68747, KZ66766, KZ68836, LE43806, KZ68847, KZ66868, KZ65377, KZ67010, KZ68889, KZ66104, KZ68912, KZ68922, KZ68940, KZ68986, KZ66967, KZ68992, LN55824, LN55837, LC15638, KZ67477, KZ67486, KZ65793, KZ67499, KZ65786, KZ67503, KZ69401, KZ67600, KZ69829, KZ67637, KZ67721, KZ65770, KZ67723, KZ67747, KZ67771, KZ65471, KZ67842, LN56255, LN56260, LN56267, LN54520, LN58188, KZ67896, KZ67904, KZ67910, KZ68675, KZ69200, LN55356, LN55373, KZ66982, KZ67010, KZ68889, KZ67016, KZ69229, KZ67035, KZ65237, KZ67078, KZ67080, KZ69143, KZ67259, KZ69639, KZ67277, KZ67428, KZ67436, KZ67438, KZ67443, KZ69408, LN54025, LN55813, LN58173, LN55817, LN55820, KZ66406, KZ66417, KZ66418, KZ66431, KZ66433, KZ68275, KZ66435, KZ69476, KZ66450, KZ68257, KZ66451, KZ66457, KZ66459, KZ68725, LE45942, KZ66464, KZ66467, KZ66494, KZ66496, KZ68770, T97635, KZ66524, KZ66525, KZ66527, LN54884, LN56729, LN54893, KZ67141, KZ69006, LN56683, KZ69073, KZ66888, KZ69076, KZ69079, KZ67199, LP41656, KZ69193, KZ69211, KZ66688, KZ69243, KZ66549, KZ69373, KZ65751, KZ69383, KZ69412, KZ69426, KZ65456, KZ67310, KZ69429, KZ66852, KZ65826, KZ67529, LE44451, KZ69647, KZ67916, KZ68126, KZ68129, KZ66249, KZ68179, KZ66183, KZ68209, KZ68198, KZ66050, KZ68207, KZ68314, KZ68316, KZ66524, KZ66345, KZ66011, KZ68329, KZ68340, KZ68343, LE43800, LN54033, T93980, LN54049, LN56693, KZ68394, KZ65623, KZ68452, KZ67157, KZ69651, KZ69768, LN58198, KZ67027, KZ69844, KZ66979, KZ69847, KZ67044, KZ69849, KZ67782, KZ69854, KZ66334, KZ68127, KZ67459, KZ67716, KZ67724, KZ67650, LP41662, KZ67937, LN54894, KZ66561, KZ66571, KZ68380, KZ69051, KZ68392, KZ66603, KZ66607, KZ69074, GR29059, KZ68429, LE45933, KZ66639, KZ66809, KZ69061, KZ66814, KZ66827, KZ66829, KZ68976, LE46000, KZ66839, KZ66844, KZ66850, KZ66856, KZ68677, KZ66858, and KZ66860.
RECALLING FIRM/MANUFACTURER The Blood Center of Southeast Wisconsin, Inc., Milwaukee, WI.

REASON Blood products, collected from donors that did not answer a medical history question concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 235 units.
DISTRIBUTION Switzerland.

WEEK ENDING DECEMBER 11

PRODUCT Red Blood Cells. 
CODE Units 1636581, 1636583, 1636573, 1636585, 1636587, and 1636557.
RECALLING FIRM/MANUFACTURER Department of the Army, Madigan Army Medical Center , Tacoma , WA.
REASON Red Cells, incorrectly tested for HIV/HCV by NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION WA.

PRODUCT Human Tissue for Transplantation. 
a) Femoral Head;
b) Patellar Bone with attachments;
c) Femoral Condyles.
CODE
a) ID number: 031229010;
b) ID number: 031229008;
c) ID number: 031229001.
RECALLING FIRM/MANUFACTURER AlloSource, Inc., Denver , CO.
REASON Human tissue for transplantation was incorrectly tested for viral markers in that the blood sample used for testing was likely hemodiluted.
VOLUME OF PRODUCT IN COMMERCE 3 Tissues.
DISTRIBUTION CA.

PRODUCT
a) Red Blood Cells. 
b) Platelets. 
c) Recovered Plasma. 
CODE a), b), and c) Unit KT06478.
RECALLING FIRM/MANUFACTURER Innova Health Care Services, Blood Donor Services, Annandale , VA.
REASON Blood products, collected from a donor considered to be at increased risk of exposure to Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION VA and NJ.

PRODUCT
a) Red Blood Cells, Leukoreduced. 
b) Fresh Frozen Plasma. 
CODE a) and b) Unit KS16926
RECALLING FIRM/MANUFACTURER Innova Health Care Services, Blood Donor Services, Annandale , VA.
REASON Blood products, collected from a donor considered to be at increased risk of exposure to Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION VA.

PRODUCT Platelets Pheresis, Leukocytes Reduced. 
CODE Unit number: K57645.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond , VA.
REASON Blood product, possibly contaminated with Micrococcus sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Source Plasma. 
CODE Unit numbers: 57862750, 57749242, 57743479, 56818079, 56813869, and 56810844.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, Richmond , VA..
REASON Blood products, collected from a donor who was permanently deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION CA.

PRODUCT Source Plasma. 
CODE Units 96912577, 96919484, 96896099, 96891483, 96886854, 96873878, 96869758, 96859926, 96853344, 96849873, 96832844, 96829110.
RECALLING FIRM/MANUFACTURER ZLB Plasma Services, Inc., Kansas City , MO.
REASON Source Plasma, collected from a donor who did not answer the CJD questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 12 units.
DISTRIBUTION CA.

PRODUCT Source Plasma. 
CODE Unit BHQYPQ.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc. Davenport , IA.
REASON Source Plasma, untested for viral markers, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Source Plasma. 
CODE Units BHNLNK, BHNKZC, BHMBFN, BHLZHY, BHLYXN, BHLYFB.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Davenport , IA.
REASON Source Plasma, collected from a donor who had a tattoo applied within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION IL.

PRODUCT Platelets. 
CODE Unit V18099.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond , VA.
REASON Blood Product, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION VA.

PRODUCT Platelets Pheresis, Leukocytes Reduced. 
CODE Unit number: 150262186.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock , TX.
REASON Blood product, associated with a positive bacterial culture, which identified coagulase negative, Staphylococcus sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Human Tissue for Transplantation, Cornea. 
CODE Number 00404344.
RECALLING FIRM/MANUFACTURER East Tennessee Lions Eye Bank, Knoxville , TN.
REASON Human tissue for transplantation, that tested negative for hepatitis and human immunodeficiency virus (HIV) prior to distribution, but was subsequently found to test repeatedly reactive for antibodies to hepatitis B core antigen (anti-HBc) and anti-HIV by a different facility, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 tissue.
DISTRIBUTION TN.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Unit number 7193855.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeShare Blood Centers , Shreveport , LA .
Manufacturer: LifeShare Blood Centers , Alexandria , LA. 
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Unit number 7193215.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeShare Blood Centers , Shreveport , LA.
Manufacturer: LifeShare Blood Centers , Alexandria , LA. 
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 LA.

PRODUCT Red Blood Cells, Leukocytes Reduced. .
CODE Unit number 8355537.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeShare Blood Centers , Shreveport , LA .
Manufacturer: LifeShare Blood Centers , Alexandria , LA. 
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 LA.

PRODUCT Source Plasma. 
CODE Unit number XF261748.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services L.P., New Orleans , LA.
REASON Blood product was collected from an ineligible donor based on previous reactive testing for syphilis.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Germany.

PRODUCT Red Blood Cells, Irradiated. 
CODE Unit number E88786.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA.
REASON Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Red Blood Cells, Irradiated. 
CODE Unit number E71962.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA.
REASON Blood product, for which documentation of the time of irradiation was not in accordance with specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Unit number 4144864.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford , TX.
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 Platelets..
CODE Unit number 3016988.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford , TX.
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 Platelets. 
CODE Unit number 3011303.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford , TX.
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 Platelets. 
CODE Unit number 4153097.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford , TX.
REASON Blood product, that tested reactive for the antibody to hepatitis B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells. 
CODE Units 1636543, 1636544, 1636545, 1636546, 1636548, 1636549, 1636550, 1636551, 1636552, 1636554, 1636555, 1636556, 1636558, 1636559, 1636560, 1636561, 1636562, 1636563, 1636567, 1636568, 1636569, 1636571, 1636572, 1636575.
RECALLING FIRM/MANUFACTURER Department of the Army, Madigan Army Medical Center , Tacoma , WA.
REASON Red Cells, incorrectly tested for HIV/HCV by NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE 24 units.
DISTRIBUTION WA.

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced. 
CODE Unit numbers 15024-8397, 15025-2982, 15025-2945, and 15025-2969; and the following units were distributed as two split products, unit numbers 15025-2956, 15025-2922, and 15025-2971.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Lubbock , TX.
REASON Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION TX and NM.

PRODUCT Platelets. 
CODE Unit number 3008046.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford , TX.
REASON Blood product, manufactured from a unit of Whole Blood that had a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Fresh Frozen Plasma. 
CODE Unit 0174576.
RECALLING FIRM/MANUFACTURER Marquette General Hospital, Inc., Marquette, MI.
REASON Blood product, which was collected from a donor who was taking the drug Desmopressin, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells. 
b) Red Blood Cells Leukocytes Reduced. 
c) Platelets, 
d) Platelets Leukocytes Reduced. 
e) Fresh Frozen Plasma, R
f) Recovered Plasma, 
CODE
a) and c) Units 042X38219, 042X25534, 042K01884, 042FP10993, 042X36285, 042X13288, 042W62587, 042G81622 and 042L75294;
b) and d) Unit 042X76460;
e) Units 042X38219 and 042X13288;
f) Units 042X76460, 042X25534, 042K01884, 042FP10993, 042X36285, 042W62587, 042G81622 and 042L75294.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Cleveland, OH.
REASON Blood products, which were collected from a donor who had close contact with an individual that had a history of a positive test for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 30 units.
DISTRIBUTION OH and NY.

PRODUCT Source Plasma. 
CODE Unit G-29028-093.
RECALLING FIRM/MANUFACTURER Alpha Therapeutic Corporation, Brownsville, TX..
REASON Source Plasma, collected from a donor who had a tattoo applied within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Spain.

PRODUCT Platelets Pheresis, Leukocytes Reduced. 
CODE 

RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeShare Blood Centers, Shreveport, Louisiana.
Manufacturer:  LifeShare Blood Centers, Alexandria, Louisiana. 
REASON Platelets, prepared with an insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Source Plasma. 
CODE Units HM056710, HM056377, HM056227, HM056067, HM055930, HM055779, HM055662, HM055211, HM055062, HM054335, HM054052, HM039752, HM039448. 
RECALLING FIRM/MANUFACTURER BioLife Plasma Services LP,   Houma, Louisiana..
REASON Source Plasma, collected from a donor who had tattoos applied within the past 12 months, were distributed.
VOLUME OF PRODUCT IN COMMERCE 13 UNITS.
DISTRIBUTION NC.

PRODUCT Human Corneal Tissue for Transplantation. 
CODE MSN-2003-0461 & MSN-2003-0462.
RECALLING FIRM/MANUFACTURER The Lions Eye Bank of Wisconsin, Inc., Madison, WI.
REASON Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly reactive for anti-hepatitis C virus (anti-HCV) and antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2) by a different facility, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION WI.

PRODUCT Red Blood Cells (Apheresis), Leukocytes Reduced. 
CODE Unit number 4182338 (distributed as two split products).
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from an ineligible donor due to recent dental surgery, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Unit number 01GN75532.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY.
Manufacturer: American Red Cross Blood Services, Syracuse, NY. 
REASON Blood product, collected from a donor whose medical history interview did not have documentation of answers to the medical history questions related to risk factors for Creutzfeldt-Jacob disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.

PRODUCT
a) Red Blood Cells, 
b) Recovered Plasma, 
CODE a) and b) Unit number 31K76559.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY.
Manufacturer: American Red Cross Blood Services, Buffalo, NY. 
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 2 units.
DISTRIBUTION CA, and Switzerland.

PRODUCT Platelets Pheresis, Leukocytes Reduced, 
CODE Unit numbers LE81108, LE98489, and FG99732.
RECALLING FIRM/MANUFACTURER Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence, RI.
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 RI, NY, and MA.

PRODUCT Platelets Pheresis, Leukocytes Reduced. 
CODE Unit number 1670933 (distributed as two split products).
RECALLING FIRM/MANUFACTURER Blood Center of New Jersey, Inc., East Orange, NJ.
REASON Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ.

PRODUCT Red Blood Cells, Leukocytes Reduced,
CODE Unit number 13FF46327.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region,Detroit, MI.
REASON Blood product, corresponding to a unit of Platelets that was possibly contaminated with coagulase negative Staphylococcus sp. bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, 
CODE Unit number 13LC78722.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI. 

REASON Blood product, that tested elevated for alanine aminotransferase (ALT), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Irradiated, 
CODE Unit number 6854283.
RECALLING FIRM/MANUFACTURER Blood Center of New Jersey, Inc.,  East Orange, NJ.
REASON Blood product, for which documentation of irradiation was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NJ.

WEEK ENDING DECEMBER 25

PRODUCT Platelets Pheresis Leukocytes Reduced. 
CODE Unit 7157494 (split product).
RECALLING FIRM/MANUFACTURER LifeShare Blood Centers, Lake Charles, LA.
REASON Blood product, which did not meet the acceptable product specifications for a leukocyte reduced product but was labeled as leukoreduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA.

PRODUCT Source Plasma. 
CODE Unit numbers 02GWIF6657 and 02GWIF8108.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., Green Bay, WI.
REASON Blood products, that tested negative for viral markers, but were collected from a donor whose routine physical examination was inadequately documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION Austria.

PRODUCT Red Blood Cells, Leukocytes Reduced. 
CODE Unit KC59412.
RECALLING FIRM/MANUFACTURER HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA.
REASON Blood product, corresponding to a unit of plasma that was hemolyzed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced. 
b) Fresh Frozen Plasma. 
c) Platelets for further manufacture. 
CODE a), b), and c) Unit number 2045871.
RECALLING FIRM/MANUFACTURER Blood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark, DE.
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 DE, and NJ.

PRODUCT Platelets Pheresis, Leukocytes Reduced. 
CODE Unit number 9076067.
RECALLING FIRM/MANUFACTURER Blood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark, DE.
REASON Blood product, that was not tested for pH as required by the firmís specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION DE.

PRODUCT Source Plasma. 
CODE Unit numbers 02GWID4417, 02GWIF1798, 02GWID5096, 02GWID9113, 02GWID9790, 02GWIE1924, 02GWIE2598, 02GWIF1167, 02GWID6021, 02GWID6685, 02GWID7577, 02GWID8245, 02GWIE0737, 02GWIE1351, 02GWIE3445, 02GWIE4162, 02GWIE5014, 02GWIE5674, 02GWIE6534, 02GWIE7206, 02GWIE8090, 02GWIE8778, 02GWIE9664, 02GWIF0317, and 02GWIF2576.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., Green Bay, WI.
REASON Blood products collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE 25 units.
DISTRIBUTION CA, and Austria.

PRODUCT Source Plasma. 
CODE Unit numbers 03GWIA5967, 03GWIA6818, 03GWIA9816, 03GWIB2809, 03GWIB5853, 03GWIC0294, 03GWID4754, 03GWIB4448, 03GWIB6571, 03GWIB7421, 03GWIC3313, 03GWIC5003, 03GWID0105, 03GWID0981, 03GWID1594, 03GWID2480, 03GWID3156, 03GWID4054, 03GWID6241, 03GWID7087, 03GWID7768, 03GWID8744, 03GWID9280, 03GWIE0571, 03GWIE2079, 03GWIE2908, 03GWIE3601, 03GWIE5125, 03GWIE6079, 03GWIE6793, and 03GWIE7671.
RECALLING FIRM/MANUFACTURER Biolife Plasma Services L.P., Green Bay, WI.
REASON Blood products, that tested negative for viral markers, but were collected from a donor whose routine physical examination was inadequately documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 31 units.
DISTRIBUTION CA, and Austria.

PRODUCT Platelets Pheresis, Leukocytes Reduced. 
CODE Unit number 13P89758.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI.
REASON Blood product, that was labeled leukoreduced but was collected on an apheresis device undergoing validation and was not tested to determine the white blood cell count as required in the firm's standard operating procedures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Platelets. 
CODE nit 0602748.
RECALLING FIRM/MANUFACTURER LifeShare, Inc., Elyria, OH.
REASON Blood product, which was manufactured from a whole blood unit in which the associated red blood cells was found to contain clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Source Plasma. 
CODE Unit 03OWIC0313.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, LP, Oshkosh, WI.
REASON Blood product, which was collected in a manner that may have compromised the sterility of the collection system, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Source Plasma. 
CODE Unit 02OWIF0474.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, LP, Oshkosh, WI.
REASON Blood product, which was collected from a donor whose suitability was not adequately determined for risk factors for Creutzfeldt-Jakob Disease (CJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION Austria.

PRODUCT Source Plasma. 
CODE Units 02GWIE4630, 02GWIE7096, 02GWIE8241, 02GWIE8944, 02GWIE4922, 02GWIE5585, and 02GWIE6316.
RECALLING FIRM/MANUFACTURER BioLife Plasma Services, LP, Green Bay, WI.
REASON Blood products, which were collected from a donor in which donor suitability for risk factors for Creutzfeldt-Jakob Disease (CJD) were not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION Austria.

PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Red Blood Cells Leukocytes Reduced Irradiated. 
CODE
a) Units 102951014, 102951019, 102951034, 102951035, 102951087, 102951156, 102954685, 102954746, 102955945, 102955953, 102955982, 102956025, 102956032, 102956035, 102956065, 102956081, 102956086, 102956103, 102956116, 102956121, 102956131,
102960028, 102960047, 102960097, 102960113, 102960132, 102960181, 102964583, 102964585, 102964588, 102978801, 102978807, 102978870, 102978885, 102978930, 102978977, 102978981, 102978998, 102982471, and 102982479;
b) Units 102955945 and 102956131.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ.
REASON Blood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE 42 units.
DISTRIBUTION AZ.

PRODUCT Red Blood Cells (Apheresis) Leukocytes Reduced. 
CODE Unit 107589332 (split unit).
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ.
REASON Blood products, which were collected from a donor with a history of multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units,
DISTRIBUTION AZ.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF. 
c) Recovered Plasma. 
CODE a), b), and c) Unit 6277903.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX.
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX, and Switzerland.

PRODUCT
a) Platelets. 
b) Fresh Frozen Plasma. 
CODE a) and b) Unit number 6725887.
RECALLING FIRM/MANUFACTURER Blood Center of New Jersey, Inc., East Orange, NJ.
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 NJ, and NY.

PRODUCT
a) Red Blood Cells. 
b) Cryoprecipitated AHF. 
c) Plasma, Cryoprecipitate Reduced.
CODE a), b), and c) Unit number 1612234.
RECALLING FIRM/MANUFACTURER Blood Center of New Jersey, Inc., East Orange, NJ.
REASON Blood products, collected from an ineligible donor due to a history of Idiopathic Thrombocytopenic Purpura (ITP), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION NJ, CA, and TN.

PRODUCT Fresh Frozen Plasma. 
CODE Unit numbers 19242-7922, 19242-7932, 19244-3412, and 19247-4381.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Reno, NV.
REASON Blood products, whose freeze time exceeded the firm's specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NV.

PRODUCT Fresh Frozen Plasma. 
CODE Unit number 19250-3253.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Reno, NV.
REASON Blood product, whose freeze time exceeded the firm's specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NV.

PRODUCT Platelets Pheresis, Leukocytes Reduced. 
CODE Unit number 7796973.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, IN.
REASON Blood product, that was labeled leukoreduced but there was insufficient documentation to confirm that the product was actually leukoreduced, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT Red Blood Cells Leukocytes Reduced. .
CODE Unit 192514107.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Reno, NV.
REASON Blood product, which may have been stored at unacceptable temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 Unit.
DISTRIBUTION NV.

PRODUCT Red Blood Cells Leukocytes Reduced. .
CODE Units F98309, F98310, and F98311.
REASON Blood products, which were labeled incorrectly as having had additive solution added, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.