SEPTEMBER 2004
WEEK ENDING SEPTEMBER 4
PRODUCT
Red Blood Cells, Leukoreduced.
CODE
Unit 30187-5584.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fargo, ND.
REASON
Blood products, collected from a donor whose medical history screening was incomplete,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ND.
PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Cryoprecipitated AHF.
CODE
a) and b) Unit: 30187-4485
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Fargo, ND.
Manufacturer: United Blood Services, Bismarck, ND.
REASON
Blood products, collected from a donor whose medical history screening was incomplete,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
ND and CA.
PRODUCT
Source Plasma.
CODE
Units 148DK195B, 148DK337B, 148DK448B, 148DK553B, 148DK820B, 148DK976B, 148DL065B,
148DL194B, 148DL406B, 148G8081B, 148G8221B, 148G8263B, 148G8398B, 148G8461B,
148G8613B, 148G8641B, 148G8765B, 148G8946B, 148W8883B, 148W9303B, 1494U012B,
1494U059B, 1494U254B, 1494U386B, 1494U455B, 1498E593B, 1498E626B, 1498E785B,
1498E889B, 1498E932B, 1498F070B, 1498F272B, 1498F319B, 1498F465B, 1498FI09B,
149CK232B, 149CK281B, 149CK452B, 149CK530B, 149CK618B, 149CK719B, 149CK811B,
149CK896B, 149CL000B, 149CL095B, 149CL216B, 149CL318B, 149CL409B, 149CL512B,
149CL590B, 149CL701B, 149CL796B, 149CL896B, 149CL984B, 149EX576B, 149EX683B,
149EX787B, 149EX878B, 149EX999B, 149LL135B, 149LL268B, 149LL319B, 149LL405B,
149LL496B, 149LL702B, 149LL883B, 149LM082B, 149LM305B, 149LM806B, 149LM887B,
149NB587B, 149NB762B, 149NC144B, 149NC287B, 149NC335B, 149NC457B, 149YT035B,
149YT147B, 149YT221B, 149YT324B, 149YT402B, 14CHBZMGB, 14CHBZVQB, 14CHBZYSB,
14CHCBFRB, 14CHCBJCB, 14CHCBPYB, 14CHCBSFB, 14CHCBYWB, 14CHCCBYB, 14CHCCKNB,
14CHCCRMB, 14CHCCTRB, 14CHCCZWB, 14CHCDCJB, 14CHCDJNB, 14CHCDMYB, 14CHCDXNB,
14CHCFBPB, 14CHCFGPB, 14CHCFKTB, 14CHCFQVB, 14CHCFZDB, 14CHFHJBB, 14CHFHNBB,
14CHFHSFB, 14CHFJCLB, 14CHFJFRB, 14CHFJLFB, 14CHFJNTB, 14CHFJWDB, 14CHFJYDB,
14CHKLPZB, 14CHKLQHB, 14CHKLTGB, 14CHKLTSB, 14CHKLWFB, 14CHKLXJB, 14CHKLYVB,
14CHKMCJB, 14CHKMCMB, 14CHKMDJB, 14CHKTVVB, 14CHKVBDB, 14CHKVDPB, 14CHKVPLB,
14CHKVWJB, 14CHKVZNB, 14CHKWFYB, 14CHLVZGB, 14CHLWCMB, 14CHLWFWB, 14CHLXBMB,
14CHLXDRB, 14CHLXGPB, 14CHLXJVB, 14CHLXMDB, 14CHLXNTB, 14CHLXSSB, 14CHLXTRB,
14CHLXXHB, 14CHLXYJB, 14CHLYBZB, 14CHLYDGB, 14CHLYGRB, 14CHLZHPB, 14CHLZPTB,
14CHLZQVB, and 14W8958B.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Minneapolis, MN..
REASON
Blood products, which tested initially reactive for an infectious disease on
an invalidated test run but subsequently tested negative on a single repeat
run, were distributed.
VOLUME OF PRODUCT IN COMMERCE
149 units.
DISTRIBUTION
IL, Germany and Switzerland.
PRODUCT
Source Plasma.
CODE
Unit 79273374.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Dallas, TX.
REASON
Source Plasma, collected from a donor who tested positive for hepatitis B surface
antigen (HbsAg) by PCR testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit K39505.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Rapids, MI.
REASON
Blood product, corresponding to Platelets that were contaminated with Streptococcus
agalactiae, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit.
DISTRIBUTION
MI.
PRODUCT
a) Plasma, Frozen.
b) Cryoprecipitated AHF.
c) Recovered Plasma.
CODE
a) Unit number: 11GR34665;
b) and c) Unit number: 11GZ36568.
RECALLING FIRM/MANUFACTURER
American Red Cross, Missouri-Illinois Region, St. Louis, MO.
REASON
Blood products, collected from an unsuitable donor due to a history of residing
in an area considered at increased risk for variant Creutzfeldt-Jakob Disease
(vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MO and Switzerland.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number 04G56432.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus
(anti-HCV),
but were collected from an ineligible donor based on the subsequent disclosure
of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA, and MA.
PRODUCT
Red Blood Cells, Leukocytes Reduced. .
CODE
Units 40FG47029, 40FG47335.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Heart of America Region,.
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
IL.
PRODUCT
Source Plasma.
CODE
Unit numbers G-05363-018, G-06599-018, G-07063-018, G-07865-018,
G-08354-018, G-09151-018, G-09534-018, G-11511-018, G-11944-018,
G-12817-018, G-13273-018, G-14104-018, G-14485-018, G-17025-018,
G-24172-018, G-25509-018, G-26696-018, G-27484-018, G-28080-018,
G-28777-018, G-30076-018, G-31158-018, G-31738-018, G-32388-018,
G-33077-018, G-33648-018, G-34329-018, G-34937-018, G-35669-018,
G-36411-018, G-36895-018, G-37951-018, G-38728-018, G-39157-018,
G-39979-018, G-40470-018, G-41206-018, G-41656-018, G-42535-018,
G-42803-018, G-43705-018, G-44014-018, G-44947-018, G-45210-018,
G-46183-018, G-46414-018, G-47269-018, G-47545-018, G-48409-018,
G-48636-018, G-49600-018, G-49901-018, G-50855-018, G-51156-018,
G-51990-018, G-52454-018, G-53114-018, G-53580-018, G-54266-018,
G-54753-018, G-55483-018, G-55899-018, G-56627-018, G-57053-018,
G-57768-018, G-58249-018, G-58947-018, G-59409-018, G-60144-018,
G-60580-018, G-61380-018, G-61780-018, G-62416-018, G-62923-018,
G-63585-018, G-64057-018, G-64738-018, G-65207-018, G-65912-018,
G-66470-018, G-67564-018, G-68215-018, G-68689-018, G-69341-018,
G-69812-018, G-70537-018, G-70996-018, G-71696-018, G-81895-018,
G-82437-018, G-83584-018, G-83668-018, G-84131-018, G-84381-018,
G-84774-018, G-84833-018, G-85165-018, G-85702-018, G-85766-018,
G-86109-018, G-86389-018, G-86586-018, G-87055-018, G-87116-018,
G-87677-018, G-88418-018, G-88947-018, G-89698-018, G-90186-018,
G-90956-018, G-91487-018, G-92177-018, G-92811-018, G-93534-018,
G-93928-018, G-94657-018, G-95231-018, G-95884-018, G-96914-018,
G-97297-018, G-98251-018, G-98786-018, G-99452-018, N-65795-018, and N-65811-018.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alpha Therapeutic Corp, Bakersfield, CA.
Manufacturer: Alpha Therapeutic Corporation, Fresno, CA.
REASON
Blood products, that tested negative for viral markers, but were collected from
an ineligible donor due to intravenous (IV) drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
125 units.
DISTRIBUTION
CA, NC, Spain, Switzerland, and the United Kingdom.
PRODUCT
Red Blood Cells, Leukocytes Reduced. .
CODE
Unit numbers 12GM86253, 12GM86286, 12GM86255, and 12GM86317.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Carolinas Region, Charlotte, NC.
REASON
Blood products, manufactured in a manner that may have compromised the sterility
of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
NC.
PRODUCT
Human Tissue for Transplantation, Femoral-Popliteal Artery SG.
CODE
Model number SGR020, serial number 7966894.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA.
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
1 tissue.
DISTRIBUTION
CA.
PRODUCT
a)
Cryoprecipitated AHF.
b)
Fresh Frozen Plasma.
c)
Plasma, Cryoprecipitate Reduced.
CODE
a) and c) Unit number 20T42372;
b) Unit numbers 20K68084, 20S54835, 20S55086, and 20S58380.
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Lewis and Clark Region, Boise,
ID.
Manufacturer: The American National Red Cross, Salt Lake City, UT. .
REASON
Blood products, associated with a unit of Red Blood Cells that contained clots,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
UT and CA.
PRODUCT
Source Plasma.
CODE
Unit numbers: 9VG914 O, 91V437 O, 91V706 O, 91W012 O, 91W159 O, 91W566 O, 91W778
O, 97R050 O, 97R254 O, 91X052 O, 91X215 O, 97S095 O, 97S847 O, 97S998 O, BSCYPD
O, BSCZZN O, BSDBTH O, BSDCDW O, BSFGPL O, BSFGWF O, BSFHTQ O.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., St. Paul, MN.
REASON
Blood products, collected from an ineligible donor who had been permanently
deferred due to drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units.
DISTRIBUTION
IL, and Switzerland.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit numbers: 4710054, 3723225.
RECALLING FIRM/MANUFACTURER
LifeSource Blood Services, Glenview, IL.
REASON
Blood products, failing to meet quality control requirements, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelet.
CODE
a) Units 4610489, 4502323;
b) Unit 4610489.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX..
REASON
Blood products, collected from a donor with a history of cancer, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells.
CODE
Unit number: 6026373.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, Alaska..
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
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit numbers: 004GC09671P1, 004GC09671P2, 004GC09675, 004GC09684, 004GC09693,
004GC09702, 004GC09722, 004GC09738, 004GC09746, 004GC09750, 004GC09753, 004GC09756,
004GC09763, 004GC09768, 004GC09770, 004GC09774, 004GC09776P1, 004GC09776P2,
004GJ10173, 004GJ10174, 004GJ10186, 004GJ10199P1, 004GJ10199P2, 004GJ10203,
004GJ10207P1, 004GJ10207P2, 004GJ10213, 004GJ10216, 004GJ10218P1, 004GJ10218P2,
004GJ10220, 004GJ10237P1, 004GJ10237P2, 004GJ10241, 004GJ10242P1, 004GJ10242P2,
004GJ10243, 004GJ10244, 004GJ10245, 004GJ10251, 004GJ10260, 004GR18125P1, 004GR18125P2,
004GR18146P1, 004GR18146P2, 004GR18155P1, 004GR18155P2, 004GR18192, 004GR18203,
004GR18213, 004GR18214, 004GR18215, 004GR18218, 004GR18221, 004GR18232, 004GR18249,
004GR18250, 004GR18251P1, 004GR18251P2, 004GR18255, 004GR18256P1, 004GR18256P2,
004GR18257, 004GR18258, 004GR18260, 004GR18266P1, 004GR18266P2, 004GR18267,
004GR18272, 004GR18282, 004GR18283, 004GR18284, 004GR18285, 004GR18287, 004GR18290,
004GR18297P1, 004GR18297P2, 004GR18298, 004GR18300P1, 004GR18300P2, 004GR18301P1,
004GR18301P2, 004GR18303, 004GR18308P1, 004GR18308P2, 004GR18309, 004GR18313P1,
004GR18313P2, 004GR18317P1, 004GR18317P2, 004GR18327P1, 004GR18327P2, 004GR18340,
004GR18365, 004GR18377, 004GR18394, 004GR18400, 004GR18403, 004GR18408, 004GR18409,
004GR18421, 004GR18427, 004GR18437, 004GR18438, 004GR18439.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA.
REASON
Platelet pheresis products, lacking monthly quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
105 units.
DISTRIBUTION
MA.
PRODUCT
Recovered Plasma.
CODE
Units 7016575, 7015305.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE.
REASON
Blood products, collected from a donor who disclosed a history of testing positive
for hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 71 W50715-6 (split unit).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL.
REASON
Platelets, prepared with an insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL, and FL.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Units 71 W49499-2 (split unit).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL..
REASON
Platelets, prepared with an insufficient plasma volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.
PRODUCT
a) Platelets.
b) Fresh Frozen Plasma.
CODE
a) and b) Units 71W50187-1.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Suwanne Valley Region, Lake City, FL.
REASON
Blood products were collected in a manner that may compromise the sterility
of the products.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL, and AL.
PRODUCT
Red Blood Cells.
CODE
Unit number 6001173.
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Erie, PA.
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
PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 04C83537.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA..
REASON
Blood product was not properly quarantined after a report that the donor had
possibly been exposed to hepatitis A.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NY.
PRODUCT
Recovered Plasma.
CODE
Unit 30187-5584.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fargo, ND.
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
Recovered Plasma.
CODE
Unit: 30187-4485.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Fargo, ND..
Manufacturer: United Blood Services, Bismarck, ND..
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, Leukoreduced.
CODE Unit: 40FT17276.
REASON
Blood product, with an unacceptably high hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
a) Source Leukocytes.
b) Recovered Plasma.
CODEa) and b) Unit 4502323.
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX..
REASON
Blood products, collected from a donor with a history of cancer, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
PRODUCT
a) Platelet Pheresis, Leukoreduced.
b) Platelet Pheresis, Leukoreduced, Irradiated. .
CODE
a) Units: 21FP16494, 21FP16498, 21KP43312, 21KP43324, 21KP43368,
21KP43399, 21KP43401, 21KP43403 (2 units), 21KP43407, 21KP43409,
21KP43410 (2 units), 21KP43417, 21KP43419, 21KP43420 (2 units),
21KP43421, 21KP43422, 21KP43423, 21KP43426 (2 units), 21KP43436,
21KP43438, 21KP43440, 21KP43442, 21LQ05649 (2 units), 21LQ05675,
21LQ05676, 21LQ05677, 21LQ05680, 21LQ05681, 21LQ05684, 21LQ05686
(2 units), 21LQ05687, 21LQ05691;
b) Units: 21KP43364, 21KP43409, 21KP43428, 21KP43431 (2 units),
21lQ05675, 21LQ05685.
REASON
Blood products that were exposed to unacceptable temperatures during shipping
were distributed.
VOLUME OF PRODUCT IN COMMERCE
45 units.
DISTRIBUTION
WA, and OR.
PRODUCT
Red Blood Cells. .
CODE
Unit number 71L40707-9.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
WEEK ENDING SEPTEMBER 11
PRODUCT
a) Whole Blood.
b) Red Blood Cells.
c) Red Blood Cells, Leukocytes Reduced.
d) Red Blood Cells, Leukocytes Reduced, Irradiated.
e) Platelets.
f) Platelets, Irradiated.
g) Fresh Frozen Plasma.
h) Cryoprecipitated AHF.
CODE
a) Unit numbers: 24FC19939, 24FC19981, 24FC20405,
24FC20850, 24FC21029, 24FC21033, 24FC21035, 24FC21053,
24FC21438, 24FC21442, 24FC21456, 24FC21473;
b) Unit numbers: 24FC18821, 24FC18878, 24FC18973,
24FC18974, 24FC18978, 24FC18989, 24FC19023, 24FC19039,
24FC19278, 24FC19309, 24FC19315, 24FC19380, 24FC19925,
24FC19959, 24FC19975, 24FC20016, 24FC20817, 24FC20826,
24FC20839, 24FC21037, 24FC21184, 24FC21199, 24FC21206,
24FC21301, 24FC21440, 24FC21466
c) Unit numbers: 24FC18818, 24FC18822, 24FC18824,
24FC18826, 24FC18829, 24FC18848, 24FC18852, 24FC1885
24FC18860, 24FC18864, 24FC18865, 24FC18901, 24FC18920,
24FC18923, 24FC18925, 24FC18931, 24FC18963, 24FC18972,
24FC18982, 24FC18995, 24FC18998, 24FC19005, 24FC19010,
24FC19012, 24FC19013, 24FC19289, 24FC19290, 24FC19293,
24FC19295, 24FC19296, 24FC19297, 24FC19299, 24FC19313,
24FC19314, 24FC19326, 24FC19327, 24FC19328, 24FC19330,
24FC19390, 24FC19392, 24FC19393, 24FC19394, 24FC19409,
24FC19412, 24FC19414, 24FC19930, 24FC19961, 24FC19972,
24FC19992, 24FC19993, 24FC20001, 24FC20012, 24FC20013,
24FC20014, 24FC20023, 24FC20024, 24FC20026, 24FC20028,
24FC20037, 24FC20042, 24FC20043, 24FC20044, 24FC20048,
24FC20050, 24FC20054, 24FC20067, 24FC20068, 24FC20069,
24FC20074, 24FC20075, 24FC20090, 24FC20092, 24FC20094,
24FC20096, 24FC20358, 24FC20360, 24FC20377, 24FC20378,
24FC20386, 24FC20388, 24FC20520, 24FC20539, 24FC20540,
24FC20544, 24FC20700, 24FC20735, 24FC20987, 24FC20988,
24FC21002, 24FC21003, 24FC21116, 24FC21131, 24FC21132,
24FC21133, 24FC21135, 24FC21147, 24FC21149, 24FC21183,
24FC21185, 24FC21196, 24FC21292, 24FC21300, 24FC21312,
24FC21313, 24FC21317, 24FC21322, 24FC21324, 24FC21325,
24FC21458, 24FC21474, 24FC21484, 24FC20565, 24FC20572,
24FC20574, 24FC20577, 24FC20584, 24FC20820, 24FC20829,
24FC20830, 24FC20833, 24FC20834, 24FC20837, 24FC20848,
24FC20859, 24FC20860, 24FC20861, 24KG56510, 24KG58159,
24KG58162, 24KG58163, 24KG58175, 24KG58176, 24KH95846,
24KH95847, 24KH95848, 24KH95851, 24KH95871, 24KH95875,
24KH95877, 24KH95878, 24KH95881, 24KH95882, 24KH96472,
24KJ69126, 24KJ69127, 24KJ69129, 24KJ69142, 24KJ69143,
24KJ69146, 24KJ70003, 24KJ70004, 24KJ70050, 24KJ70051,
24KJ70052, 24KJ70054, 24KJ70058, 24KJ70073, 24KJ70078,
24KJ70090, 24KJ70091, 24KJ70092, 24KJ70093, 24KJ70106,
24KJ70108, 24KJ70113, 24KJ70114, 24KJ70128, 24KJ70129,
24KJ70130, 24KJ70140, 24KJ70316, 24KJ70320, 24KJ70325,
24KJ70339, 24KJ70340, 24KJ70341, 24KJ70343, 24KJ70346,
24KJ70349, 24KJ70351, 24KJ70353, 24KM83399, 24KM83400,
24KM83406, 24KM83411, 24KM83414, 24KM83467, 24KM83469,
24KM83474, 24KM83475, 24KQ56116, 24KQ56117, 24KQ56132,
24KQ56133, 24KQ56142, 24KQ56146, 24KR21873, 24KR21874,
24KR21880, 24KR21881, 24KR21882, 24KR21884, 24KR21885,
24KR21890, 24KR21891, 24KR21892, 24KR21895, 24KR21896,
24KR21900, 24KR21902, 24KS56066, 24KS56067, 24KS56068,
24KS56071, 24KS56074, 24KS56075, 24KS56077, 24KS56078,
24KS56081 24FC18636, 24FC19021, 24FC19022, 24FC19040,
24FC19041, 24FC19051, 24FC19053, 24FC19259, 24FC19260,
24FC19261, 24FC19270, 24FC19272, 24FC19273, 24FC19345,
24FC19347, 24FC19356, 24FC19358, 24FC19360, 24FC19379,
24FC19381, 24FC19385, 24FC19731, 24FC19751, 24FC19752,
24FC19758, 24FC19767, 24FC19768, 24FC19776, 24FC19778,
24FC19779, 24FC19913, 24FC19924, 24FC19937, 24FC19944,
24FC19945, 24FC19947, 24FC19948, 24FC19956, 24FC19962,
24FC19963, 24FC20097, 24FC20149, 24FC20151, 24FC20153,
24FC20631, 24FC20635, 24FC20657, 24FC20659, 24FC20670,
24FC20672, 24FC20674, 24FC20677, 24FC20682, 24FC21021,
24FC21026, 24FC21051, 24FC21056, 24FC21057, 24KC33488,
24KC33489, 24KC33490, 24KC33492, 24KC33495, 24KC33504,
24KC33505, 24KH93842, 24KH93844, 24KH93846, 24KH93849,
24KH93851, 24KH93859, 24KH94851, 24KH94852, 24KH94853,
24KH94854, 24KH94861, 24KH95010, 24KH95450, 24KH95451,
24KH95453, 24KH95459, 24KH95467, 24KH95492, 24KH95494,
24KH95498, 24KH96442, 24KH96444, 24KJ70008, 24KJ70016,
24KJ70019, 24KJ70020, 24KJ70032, 24KJ70033, 24KJ70034,
24KJ70039, 24KJ70040, 24KJ70043, 24KJ70046, 24KJ70049,
24KL65170, 24KL65171, 24KL65173, 24KL65184, 24KL65185,
24KM83145, 24KM83148, 24KM83154, 24KM83160, 24KM83163,
24KM83164, 24KM83172, 24KQ56162, 24KQ56482, 24KQ56501;
d) Unit numbers: 24FC20566, 24FC20573, 24FC19036,
24FC19037, 24FC20099, 24FC20630, 24FC20632, 24KC33486,
24KH95009, 24FC18912, 24FC18928, 24FC18983, 24FC19312,
24FC19966, 24FC20000, 24FC20045, 24FC20401, 24FC20714,
24FC21004, 24FC21118, 24FC21120, 24FC21146, 24FC21210,
24FC21461, 24FC21475;
e) Unit numbers: 24FC19021, 24FC19036, 24FC19037,
24FC19050, 24FC19051, 24FC19345, 24FC19347, 24FC19379,
24FC19385, 24FC19731, 24FC19767, 24FC19768, 24FC19776,
24FC19778, 24FC19913, 24FC19924, 24FC19937, 24FC19944,
24FC19945, 24FC19947, 24FC19956, 24FC19962, 24FC20632,
24FC20657, 24FC20659, 24FC20670, 24FC20672, 24FC20674,
24FC20677, 24FC20682, 24FC21026, 24FC21051, 24FC21052,
24FC21057, 24KC33486, 24KC33489, 24KC33505, 24KH93846,
24KH93849, 24KH93851, 24KH93859, 24KH94851, 24KH94852,
24KH94861, 24KH95451, 24KH95453, 24KH95467, 24KH95494,
24KH95498, 24KH96442, 24KJ70016, 24KJ70020, 24KJ70032,
24KJ70033, 24KJ70034, 24KJ70039, 24KJ70040, 24KJ70046,
24KL65170, 24KL65173, 24KL65184, 24KL65185, 24KM83148,
24KM83154, 24KM83160, 24KM83163, 24KM83164, 24KQ56162,
24KQ56499, 24KQ56501;
f) Unit numbers: 24FC19948, 24FC19963, 24KC33488,
24KC33490, 24KC33492, 24KH93842, 24KH93844, 24KH95010,
24KM83145;
g) Unit numbers: 24FC19021, 24FC19024, 24FC19036,
24FC19037, 24FC19041, 24FC19050, 24FC19051, 24FC19053,
24FC19345, 24FC19347, 24FC19356, 24FC19358, 24FC19359,
24FC19360, 24FC19379, 24FC19381, 24FC19385, 24FC19731,
24FC19752, 24FC19758, 24FC19776, 24FC19778, 24FC19779,
24FC19913, 24FC19924, 24FC19937, 24FC19944, 24FC19945,
24FC19947, 24FC19948, 24FC19956, 24FC19962, 24FC19963,
24FC20151, 24FC20153, 24FC20572, 24FC20630, 24FC20632,
24FC20635, 24FC20657, 24FC20659, 24FC20670, 24FC20672,
24FC20674, 24FC20677, 24FC20682, 24FC20833, 24FC20834,
24FC20848, 24FC20859, 24FC20860, 24FC20861, 24FC21021,
24FC21026, 24FC21051, 24FC21052, 24FC21056, 24FC21057,
24FC21062, 24KC33486, 24KC33488, 24KC33489, 24KC33490,
24KC33492, 24KC33495, 24KC33505, 24KG58159, 24KG58161,
24KG58162, 24KG58163, 24KG58175, 24KG58176, 24KH93842,
24KH93844, 24KH93846, 24KH93849, 24KH93851, 24KH93859,
24KH94852, 24KH94853, 24KH94854, 24KH95010, 24KH95451,
24KH95459, 24KH95467, 24KH95494, 24KH95498, 24KH96442,
24KH96444, 24KH96472, 24KJ69126, 24KJ69127, 24KJ69142,
24KJ69143, 24KJ69146, 24KJ70078, 24KJ70129, 24KL65170,
24KL65171, 24KL65173, 24KL65184, 24KL65185, 24KM83160,
24KM83163, 24KM83164, 24KQ56162, 24KQ56499, 24KQ56501;
h) Unit numbers: 24KH95875, 24KH95877, 24KH95878,
24KM83467, 24KM83474, 24KM83475.
RECALLING FIRM/MANUFACTURER
American Red Cross, River Valley Region, Louisville, KY.
REASON
Blood products, collected from a donor whose arm preparations were not adequately
prepared, were distributed.
VOLUME OF PRODUCT IN COMMERCE
589 units.
DISTRIBUTION
Nationwide.
PRODUCT
Source Plasma.
CODE
Unit numbers: 7G2898, 8MW310, 8MW498, 95D691, 95D796, 95D967, 95E040, 95E289,
95E349, 95E539, 95E578, 95E716, 95F464, 9NS158, 9NS265, 9NS594, 9SW771, 9SW999,
9V5741, 9V5801, BJBZNC, BJCDLK.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Oklahoma City, OK.
REASON
Blood products, collected from an ineligible donor who had been permanently
deferred due to drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units.
DISTRIBUTION
IL, and Germany.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 04KM46478.
RECALLING FIRM/MANUFACTURER
American 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
VT.
PRODUCT
Red Blood Cells (Apheresis), Leukoreduced.
CODE
Units 301878101, 301878107, 301878159.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Fargo, ND.
Manufacturer: United Blood Services, Bismarck, ND.
REASON
Blood products, collected in a manner that may have compromised their sterility,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units from 3 doubles.
DISTRIBUTION
CA, NJ, and ND.
PRODUCT
Platelet Pheresis, Leukoreduced.
CODE
Units: 5479032A, 5479032B, 5479032C, 5479080A, 5479080B, 5479080C.
RECALLING FIRM/MANUFACTURER
Coral Blood Services Inc. Bangor, ME.
REASON
Blood products, collected from a donor who was taking the medication Proscar,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
ME.
PRODUCT
Source Plasma.
CODE
Units DPDCDL, DPDCGV, DPDCWT, DPDDCZ, DPDDXW, DPDDRY.
RECALLING FIRM/MANUFACTURER
International Bio Resources, LLC, Milwaukee, WI..
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
IL.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number: G98916.
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL..
REASON
Blood product, contaminated with coagulase-negative Staphylococcus, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
PRODUCT
a) Platelets.
b) Platelets, Leukocytes Removed.
c) Platelets, Irradiated.
d) Fresh Frozen Plasma.
e) Plasma, Frozen.
CODE
a) Unit numbers: 49Y67247, 49F97629, 49F97919, 49S74852,
49Y46256, 49L86761, 49GF08210, 49L86831, 49G75024, 49S77099, 49S78483, 49LJ36776,
49Y66975, 49Y68019, 49LR07035, 49M29798, 49LF47660, 49S88013, and 49G97186;
b) Unit numbers: 49LR25697, 49GF65893, 49M40747, 49GF66168,
49GF66163, 49GG08274, 49GG08288, 49Y83947, 49LR23218,
49LR23574, 49GG07218, 49LR26552, 49Y88280, 49M43638, and
49GG08308;
c) Unit number: 49GG06960;
d) Unit numbers: 49LW09875, 49LR25697, 49M40654, 49GF65893,
49M40747, 49GF65928, 49LW10123, 49GF66168, 49GF66163,
49Y86783, 49Y86768, 49GF66283, 49GG08274, 49GG08308,
49GG08288, 49GF66711, 49Y43034, 49G67557, 49GF02183,
49GF02368, 49S74472, 49GF12916, 49S77778, 49LJ36776,
49LG35118, 49GF32092, 49Y68019, 49LR05986, 49X74064,
49S88013, 49Y70271, 49GF44164, 49M33702, 49GF59138,
49GF59374, 49GG03425, 49Y83947, 49M37476, 49GF62809,
49LR23218, 49LR23574, 49M38005, 49M37999, 49M37998,
49GF64155, 49GG06960, 49S97285, 49GG07218, 49GG07494,
49GG07480, 49W37522, 49M40192, 49Y88280, 49GF68833,
49M43638, 49GF70875, 49Y89926, 49GF71467, 49GF72747, and
49GN14868;
e) Unit numbers: 49LJ41837.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK.
REASON
Blood products, corresponding to a unit of clotted Red Blood Cells, were distributed.
VOLUME OF PRODUCT IN COMMERCE
96 units.
DISTRIBUTION
UT, IL, OK, and TX.
PRODUCT
Source Plasma.
CODE
Units 9NS964, 82P211, 82O863, 82O161, 82N548, 82J462, 82J334, 82J270, 82I921,
82I853, 8ZI158, 8ZH186, 8ZH080, 8ZG902, 8ZG807, 8ZG379, 8ZG293, 8ZG021, 8ZF932,
8ZE634, 8I5722, 8I5566, 8I5394, 8I5140, 8I5037, 8I4627, 8I3735, 8I3603, 8I3444,
8I2822, 8I2768, 8I2552, 8I2381, 8I2166, 8I2025, 8I1615, 8I1499, 8I1080, 71A482,
71A387, 709879, 709421, 7CY967, 7CY849, 7CY746, 6CV867, 6CV756, 6CV552, 6CU454,
6CU311, 6CU227, 6CU008, 6CT900, 6CT664, 6CT570, 6CS303, 6CR529, 6CQ220, 04L394,
04L213, 04L106, 04K740, 04K379, 04K012, 04J363, 04J165, 04J055, 04I723, 04I429,
04H960, 04H848, 04H498, 04H324, 04H196, 04G627, 04G323, 04D951, 04D774, 04D053,
04C584, 04C404, 04C326, 04C054, 04B922, 04B810, 04B691, 04B571, 04B493, 04B223,
04B170, 04A989, 04A918, 04A386, 04A140, 04A070, 038429, 038146, YFU655, YFU568,
YFU336, YFU148, YFU022, YFQ795, YFQ662, YFQ439, YFQ249, YFQ048, YFT956, YFO756,
YFN863, YFN721, YFM886, YFM745, YFL980, V07334, V07175, V06914, V06763, V06332,
V06010, V05370, V05239, V04958, V04820, V04566, V04463, V03972, V03858, V03596,
V00914, UG0107, UGZ800, UGZ578, UGZ364, UGY603, UGY517, RLS382, RLS104, RLR352,
RLR151, RLQ885, RLQ566, RLQ451, RLP664, UGT030, UGS796, UGS671, UGS399, UGS232,
UGS006, UGR245, UGQ309, RLP223, RLP117, RLO745, RLO595, S3P848, S3N929, S3N666,
S3N371, S3N146, S3M426, S3M215, S3M018, S3L422, S3L285, S3K939, S3K134.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Oklahoma City, OK.
REASON
Source Plasma, collected from a donor who engaged in high-risk behavior, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
168
DISTRIBUTION
NC, France, and Germany.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers: 38H84546, 38FE77835.
RECALLING FIRM/MANUFACTURER
American Red Cross, Indiana-Ohio Region, Fort Wayne, IN.
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
IN.
PRODUCT
Red Blood Cells, Leukocytes Reduced. .
CODE
Unit 21K21241.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Portland, OR.
REASON
Blood product, which was collected from a donor who had an unacceptable hemoglobin
at the time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
WA.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit 20GR16226.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Boise, ID.
REASON
Blood product, which was collected from a donor who had received the typoid
vaccination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MT.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit numbers 23149-4917 (distributed as two split units) and 23149-4931.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Billings, MT.
REASON
Blood products, for which documentation of irradiation was incomplete, were
distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MT.
PRODUCT
Platelets.
CODE
Units 4229844, 4229846, 4229850, 4229880.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK.
REASON
Blood products, which yielded a platelet count that was below the acceptable
limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
AK.
PRODUCT
Red Blood Cells Frozen.
CODE Unit 71Z69719-8
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Gainesville, FL.
REASON
Blood product, which was manufactured using expired glycerol solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.
PRODUCT
a) Red Blood Cells
b) Platelets
c) Fresh Frozen Plasma.
CODE
a) Units 11GK17618 and 11GK11191;
b) Unit 11GK17618;
c) Units 11GK17618 and 11GK11191.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO.
REASON
Blood products, which were collected from a donor who admitted to engaging in
multiple high risk behaviors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MO, and CA.
PRODUCT
Recovered Plasma.
CODE
Unit 11GQ51677.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO.
REASON
Blood product, which was collected from a donor who was at increased risk for
Creuztfeldt Jakob Disease (CJD) due to having lived in Europe between 1984 -
1987, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number 04FP70069.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA.
REASON
Blood product, collected in an apheresis collection kit that had exceeded the
acceptable time period for use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Recovered Plasma.
CODE
a), b), and c) unit number 33GE80466.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Connecticut Region, Farmington, CT.
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
CT, and CA.
PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number 4227074.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK.
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
AK.
PRODUCT
Fresh Frozen Plasma. .
CODE
Unit number KC51510.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Miller Memorial Blood Center, Bethlehem, PA.
REASON
Blood product, associated with an unit of Red Blood Cells that contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE
a) and b) Unit number 11GJ26528.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Missouri-Illinois Region, St. Louis, MO.
REASON
Blood products, that tested negative for hepatitis, but were collected from
an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL, and PR.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced,
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
CODE
a) Unit 49FF51189;
b) Unit 49FF50655.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Southwest Region, Tulsa, OK.
Manufacturing Firm: American Red Cross Blood Services,
Southwest Region, College Station, 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
OK, and TX.
PRODUCT
Source Plasma.
CODE
Units FLHSHK , FLDRWN, FLDRVJ, FLDRQG, FLDRPH , FLDRBK, FLDQLL, FLDQJX, FLDQHY
, FLDQGB, FLDQDM, FLDPSC, FLDPRC, FLCPTM, FLCPRV, FLCPRC, FLCPBM, and FLCNWF.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Waco, 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
18 units.
DISTRIBUTION
IL.
PRODUCT
Human Corneal Tissue.
CODE
2004-040OS, 2004-040OD.
RECALLING FIRM/MANUFACTURER
Great Plains Lions Eye Bank, Inc., Lubbock, TX.
REASON
Human tissues for transplantation, procured from a donor whose next of kin was
not asked multiple questions regarding high-risk behavior questions during the
Medical/Social History Interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
MO.
PRODUCT
Red Blood Cells.
CODE
Unit number: 49LF47704.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK.
REASON
Blood products, corresponding to a unit of clotted Red Blood Cells, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells Leukocytes Reduced.
CODE
a) Unit 2421944401;
b) Unit 242192958.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Rapid City, SD.
REASON
Blood products, which were incorrectly tested for the presence of red cell antigens,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WY.
PRODUCT
Source Plasma.
CODE
Unit XG0013823.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX.
REASON
Blood product, which was collected from a donor whose health history screening
was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
PRODUCT
Source Plasma.
CODE
Unit XN0002165.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX.
REASON
Blood product, which was collected from a donor whose health history screening
was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
PRODUCT
Source Plasma,
CODE
Unit number XG0019114.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX.
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.
PRODUCT
Source Plasma..
CODE
Unit number XA0002443.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX.
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.
PRODUCT
Source Plasma.
CODE
Unit number XA0002340.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX.
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.
PRODUCT
Source Plasma.
CODE
Unit number XG0011720.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Port Arthur, TX.
REASON
Blood product, collected from a donor whose arm inspection was not documented,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Spain.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit number 04GR22891 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA.
REASON
Blood products, that were labeled leukoreduced but were not tested to determine
the white blood cell count as required in the firm's standard operating procedures,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MA.
PRODUCT
Platelets.
CODE
Unit number 6034421.
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK.
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
MI.
WEEK ENDING SEPTEMBER 18
PRODUCT Red Blood Cells.
CODE Unit number: 6703829.
RECALLING FIRM/MANUFACTURER Blood Bank of Alaska, Inc., Anchorage, AK.
REASON Blood product, untested for CMV, but labeled as CMV negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AK.
PRODUCT Platelets.
CODE Unit number: LJ75284.
RECALLING FIRM/MANUFACTURER Mid-South Regional Blood Center, Memphis,
TN.
REASON Blood products, collected from a donor whose spouse engaged in 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 1 unit.
DISTRIBUTION TN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Reduced, Irradiated.
c) Platelets, Leukocytes Reduced.
d) Fresh Frozen Plasma.
e) Recovered Plasma.
CODE
a) Units 38C11045, 38C11047, 38C11048, 38C11072, 38C11073, 38C11081, 38E05749, 38E05751, 38E05754, 38E05756, 38E05758, 38E05770, 38E05772,
38E05957, 38E05969, 38FH20830, 38FH20838, 38FH20839, 38FH20842, 38FH20848, 38FK29656,
38FK29658, 38FK29662, 38FK29663, 38FK29676, 38FV09255, 38FV09262, 38FV09266,
38FV09268, 38FV09286, 38FV09294, 38FV09296, 38FV09339, 38FV09341, 38FV09355,
38FV09358, 38FV09365, 38FV09366, 38FV09375, 38FV09378, 38FV09851, 38FV09852,
38FV09858, 38FV09862, 38FV09873, 38FV09880, 38FV09882, 38FV09888, 38FV09889,
38FV09894, 38FV09926, 38FV09928, 38FV09932, 38FV09945, 38FV09951, 38FV09960,
38FV09962, 38FV09982, 38FV09991, 38FV09992, 38FV09997, 38FV10004, 38FV10005,
38FV10008, 38FV10009, 38FV10010, 38FV10014, 38FV10027, 38FV10029, 38FV10031,
38FV10051, 38FV10074, 38KT09820, 38KT09827, 38KT09828, 38KT09831, 38KT09838,
38KT09874, 38KT09885, 38KT09891, 38KT09896, 38KT09898, 38KT09936, 38KT09945,
38KT09948, 38KT09951, 38KT09955, 38KT09985, 38KT09992, 8KT10028, 38KT10036,
38KT10052, 38KT10055, 38KT10695, 38KT10698, 8KT10727, 38KT10733, 38KT10735,
38KT10740, 38KT10762, 38KT10764, 8KT10766, 38KT10778, 38LC69698, 38LC69705,
38LC69730, 38LC69733, 38LC69736, 38LC69737, 38LC69755, 38LC69759, 38LC69761,
38LC69763, 38LC69779, 38LC69818, 38LC69821, 38LC69824, 38LC69829, 38LC69834,
38LC69836, 38LC69853, 38LC69858, 38LC69861, 38LC69866, 38LC69887, 38LC69896,
38LC70135, 38LC70138, 38LC70163, 38LC70170, 38LC70171, 38LC70191, 38LC70196,
38LC70197, 38LC70340, 38LC70343, 38LC70347, 38LC70351, 38LC70391, 38LC70394,
38LC90432, 38LC70456, 38LC70469, 38LC70537, 38LC70544, 38LC70547, 38W31284,
38W31285, 38W31288, 38W31289, 38W31290, 38W31291, 38W31295, 38W31300, 38LC69894;
b) Unit 38FV10036;
c) Units 38C11045, 38C11047, 38C11072, 38FV09962, 38FV09982, 38FV09991, 38FV09992, 38FV09997, 38FV10004,
38FV10005, 38FV10008, 38FV10009, 38FV10010, 38FV10027, 38FV10029, 38FV10031, 38FV10036, 38KT09843, 38KT10052,
38KT10055, 38KT10695, 38KT10698, 38KT10727, 38KT10733, 38LC69705;
d) Units 38C11045, 38C11047, 38C11048, 38C11073, 38E05761, 38FV09962, 38FV09982, 38FV10005, 38FV10008, 38FV10010,
38FV10031, 38FV10036, 38FV10051, 38KT09820, 38KT09828, 38KT09831, 38KT09843, 38KT09987, 38KT10028, 38KT10036,
38KT10052, 38KT10055, 38KT10698, 38KT10733, 38KT10735, 38KT10740, 38LC69698, 38LC69705, 38LC69829, 38W31295,
38W31300;
e) Units 38C11072, 38C11081, 38E05749, 38E05750, 38E05751, 38E05754, 38E05756, 38E05758, 8E05770, 38E05772,
38E05957, 38E05969, 38FH20830, 38FH20838, 38FH20839, 38FH20842, 38FH20848, 38FK29656, 38FK29658, 38FK29662,
38FK29663, 38FK29676, 38FV09255, 38FV09262, 38FV09266, 38FV09268, 38FV09286, 38FV09294, 38FV09296, 38FV09339,
38FV09341, 38FV09355, 38FV09358, 38FV09365, 38FV09366, 38FV09375, 38FV09851, 38FV09852, 38FV09858, 38FV09862,
38FV09873, 38FV09880, 38FV09882, 38FV09888, 38FV09889, 38FV09894, 38FV09926, 38FV09928, 38FV09932, 38FV09945,
38FV09951, 38FV09960, 38FV09991, 38FV09992, 38FV09997, 38FV10009, 38FV10014, 38FV10029, 38FV10074, 38KT09827,
38KT09838, 38KT09874, 38KT09885, 38KT09891, 38KT09896, 38KT09898, 38KT09936, 38KT09945, 38KT09948, 38KT09951,
38KT09955, 38KT09985, 38KT09992, 38KT10695, 38KT10727, 38KT10762, 38KT10764, 38KT10766, 38KT10778, 38LC69730,
38LC69733, 38LC69736, 38LC69737, 38LC69755, 38LC69759, 38LC69761, 38LC69763, 38LC69779, 38LC69818, 38LC69821,
38LC69824, 38LC69834, 38LC69836, 38LC69853, 38LC69858, 38LC69861, 38LC69866, 38LC69887, 38LC69896, 38LC70129,
38LC70135, 38LC70138, 38LC70163, 38LC70171, 38LC70191, 38LC70196, 38LC70197, 38LC70340, 38LC70343, 38LC70347,
38LC70351, 38LC70391, 38LC70394, 38LC70456, 38LC70458, 38LC70466, 38LC70469, 38LC70535, 38LC70537, 38LC70544,
38LC70547, 38W31284, 38W31285, 38W31288, 38W31289, 38W31290, 38W31291, 38LC69894.
RECALLING FIRM/MANUFACTURER American National Red Cross, Indiana-Ohio Region, Fort Wayne,
IN..
REASON Blood products, collected in a manner where the sterility of the products may
have been compromised, were distributed.
VOLUME OF PRODUCT IN COMMERCE 340 units.
DISTRIBUTION Nationwide.
PRODUCT NucliSensÆ Automated Isolation Reagents.
CODE Lot number: 04031904.
RECALLING FIRM/MANUFACTURER
Recalling Firm: bioMÈrieux, Inc., Durham, NC.
Manufacturer: bioMÈrieux bv, Boxtel, Netherlands.
REASON Components of the NucliSensÆ Automated Isolation reagents, containing a raw
material, which affected the sensitivity and accuracy of down stream assays,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 46 units.
DISTRIBUTION NY, FL, DC, and CA.
PRODUCT In-vitro Diagnostic Tests of the following type:
a) MTS Anti-IgG CardTM ;
b) MTS A/B/D Monoclonal and Reverse Grouping CardTM.
CODE
a) Lot 082203001-14, Expiration 15 July 04 (Microtube #1 from left to right with the barcode facing
forward);
b) Lot 111903037-11, Expiration 23 Oct 04 (Anti-D Microtube);
RECALLING FIRM/MANUFACTURER Micro Typing Systems, Inc., Pompano Beach,
Florida.
REASON In-vitro diagnostic test cards, which may contain a microtube without any gel,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 1,124 boxes, each containing 48 cards.
DISTRIBUTION Nationwide and Canada.
PRODUCT Reagent Red Blood Cells, 0.8% SELECTOGEN.
CODE Lot # 8S243, exp. 1/13/2004.
RECALLING FIRM/MANUFACTURER Ortho Clinical Diagnostics, Inc, Raritan,
NJ.
REASON Reagent Red Blood Cells, manufactured with cell concentrations that were out
of specification, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1,883.
DISTRIBUTION Nationwide and Internationally.
PRODUCT
a) ACF Spacer;
b) C/C Chips 1.7-10mm 30cc;
c) Cancellous Chips 1.7-10mm 15cc;
d) Cancellous chips;
e) Dowel 13mm (Diam)
f) Fascia Lata (medium);
g) Iliac Crest Wedge;
h) Ilium Tricortical Strip;
i) Patella Wedge;
j) Achilles Tendon w/Calc.;
k) Femoral head 44mm;
l) Demin. Cort. Powder.
CODE
a) Unit numbers: 007333011001, 007333011002, 007333011003, 007333011004, 007333011005, 007333011006, 007333011007,
007333011008, 007333011009, 007333011010, 007333011011, 007333011012, 007333011014, 007333011015, 007333011016,
007333011017, 007333011018, 007333011019, 007333011020;
b) Unit numbers: 5007333010063, 007333010064, 007333010065, 007333010066, 007333010067;
c) Units 00733310033, 00733310034, 00733310035, 00733310036, 00733310037, 00733310038, 00733310039,
00733310040, 00733310041, 00733310042, 00733310043, 00733310044, 00733310045, 00733310046, 00733310047;
d) Units: 007333010031, 007333010032;
e) Units: 007333010049, 007333010050;
f) Units: 007333010005, 007333010006;
g) Units: 007333010059, 007333010060, 007333010061, 007333010062;
h) Units: 007333010053, 007333010054;
i) Units: 007333010068, 007333010069;
j) Units: 007333010007, 007333010008;
k) Units: 007333010029, 007333010030;
l) Units: 007333010502.
RECALLING FIRM/MANUFACTURER Musculoskeletal Transplant Foundation, Edison,
NJ.
REASON Human tissues for transplantation, procured from a donor who tested negative
for antibody to Hepatitis C virus (anti-HCV), but was subsequently found to
be reactive using HCV RNA (TMA) testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 192 units.
DISTRIBUTION Nationwide.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 33GK38931, 33LQ33988, 33GS36753.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Connecticut Region, Farmington,
CT.
REASON Blood products, corresponding to Platelets that were implicated in a transfusion
reaction and found to be contaminated with Streptococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CT.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Units 33GY69919, 33GH69987, 33GS43398, 33GS43397.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Connecticut Region, Farmington,
CT.
REASON Blood products, corresponding to Platelets that were implicated in a transfusion
reaction and found to be contaminated with Staphylococcus, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CT.
PRODUCT Human Tissue for Transplantation, Corneas.
CODE Tissue numbers IA-2003-01-021R1 and IA-2003-01-021L1.
RECALLING FIRM/MANUFACTURER Iowa Lions Eye Bank, Iowa City, IA.
REASON Human tissue for transplantation, that tested negative for hepatitis, but was
procured from a donor that previously tested reactive for hepatitis, was distributed
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION IA, and NJ.
PRODUCT Source Plasma.
CODE Unit numbers: 4VI065 O, 4VI101 O, VI129 O, 4VI169 O,
4VI201 O, 4VI234 O, 4VI258 O, 4VI284 O, 4VI311 O, 4VI365 O,
4VI398 O, BSGNDM O, BSGNGJ O, BSGNHZ O, BSGNKY O, BSGNMH O, BSGNPC O, BSGNRW O, 97S233 O, 97S376 O, 97S619 O, 97S773 O, BSCJKM O, BSCJSW
O, BSCKLZ O, BSCKWM O, BSCQMQ O, BSCQQX O, BSCRKR O, BSCRTS O, BSCSQF O, BSCSYD
O, BSCTPS O, BSCTZZ O, BSCVLQ O, BSCWCH O, BSGNTX O, BSGPGZ O, BSGPKC O, BSGPLZ
O, BSGPPJ O, BSGPRF O, BSGPSS O, BSGPVH O, BSFNNC O, BSFNXN O, BSFPPN O, BSFPVX
O, and BSFQMN O.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, St. Paul, MN.
REASON Blood products, collected from an ineligible donor due to previous incarceration,
were distributed.
VOLUME OF PRODUCT IN COMMERCE 49 units.
DISTRIBUTION IL, and Germany.
PRODUCT
a) Platelets Pheresis, Leukocytes Reduced.
b) Platelets Pheresis, Leukocytes Reduced, Irradiated.
CODE
a) Unit numbers: 9181266 (2 units), 6950880 (2 units), 6950881 (2 units), 6951100 (2 units), 4802472, 4802476,
4802674 (2 units), 4802676, and 4802707;
b) Unit number: 4803017.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis,
IN.
REASON Blood products, labeled leukoreduced but were not tested to determine the white
blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 15 Units.
DISTRIBUTION IN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Red Blood Cells, Leukocytes Removed, Irradiated.
c) Platelets, Leukocytes Removed.
CODE
a) Unit number: 49GN26214;
b) Unit number: 49GE04511;
c) Unit numbers: 49GN26214, 49GE04511.
RECALLING FIRM/MANUFACTURER American Red Cross, Southwest Region, Tulsa,
OK.
REASON Blood products, collected from an unsuitable donor who had lived in an area
designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION TX, and OK.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 49LH47809.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross, Southwest Region, Tulsa, OK.
Manufacturer: American Red Cross, Southwest Region, College Station, TX.
REASON Blood products, collected from an unsuitable donor who had lived in an area
designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit 182348827.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY.
REASON Blood product, collected from a donor who did not have a complete medical history
interview, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.
PRODUCT Source Plasma.
CODE Unit numbers: 0040996, 0041273. 0041657, and 0042031.
RECALLING FIRM/MANUFACTURER DCI Biologicals Bryant, LLC, Bryan, TX.
REASON Blood products, which were collected from a donor who had received a body piercing
within twelve months of the donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NY.
PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number: 40LS21668.
RECALLING FIRM/MANUFACTURER American Red Cross, Heart of America Region, Peoria,
IL.
REASON Blood product, collected from a donor who provided a history of non-Hodgkin's
lymphoma, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.
PRODUCT
Fresh Frozen Plasma.
CODE
Unit 030GF43641.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Ashley, PA.
REASON
Blood product, which was collected from a donor who was taking the medication
Coumadin, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Cryoprecipitated AHF. .
CODE
Unit 030GJ35956.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Ashley, PA.
REASON
Blood products, which were collected from a donor who tested negative for the
antibody to hepatitis B core antigen (anti-HBc) but tested repeatedly reactive
for anti-HBc on two previous occasions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
PA.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 49KM05621.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross, Southwest Region, Tulsa, OK.
Manufacturer: American Red Cross, Southwest Region, Farmers Branch, TX.
REASON
Blood product, collected from a donor in which donor suitability was not adequately
determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers 004FV31913 and 004FR73871.
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
2 units.
DISTRIBUTION
NY, and ME.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE
Unit numbers 004GL67386 and 004KE41974 (both units distributed as two split
products).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood
cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MA, and NY.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers U00076667 and U00085610.
RECALLING FIRM/MANUFACTURER
York Hospital Donor Center, York, 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
Human Tissue for Transplantation, Corneas.
CODE
Tissue number 03-1099.
RECALLING FIRM/MANUFACTURER
Lions Eye Bank of Central Texas, Manor, TX.
REASON
Human tissue for transplantation, that tested reactive for antibodies to hepatitis
B core antigen (anti-HBc), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 tissue.
DISTRIBUTION
TX.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Red Blood Cells (Apheresis), Leukocytes Reduced.
d) Fresh Frozen Plasma.
e) Fresh Frozen Plasma (Apheresis).
CODE
a) Unit number 31134-4265 (distributed as three split
products);
b) Unit numbers 31134-1230, 31134-1231, 31134-1233, 31134-
1239, 31134-1240, 31134-1243, 31134-1247, 31134-1255,
31134-1260, 31134-1263, 31134-1275, 31134-1277, 31134-
1279, 31134-1281, 31134-1285, 31134-1286, 31134-1288,
31134-1292, 31134-1296, 31134-1299, 31134-1301, 31134-
1303, 31134-1308, 31134-1310, 31134-1312, 31134-1313,
31134-1315, 31134-1316, 31134-1317, 31134-1320, 31134-
1321, 31134-1322, 31134-1325, 31134-1331, 31134-1333,
31134-1343, 31134-1347, 31134-1351, 31134-1357, 31134-
1359, 31134-1362, 31134-2040, 31134-2046, 31134-2053,
31134-2054, 31134-2060, 31134-2062, 31134-2063, 31134-
2164, 31134-2168, 31134-2173, 31134-2177, 31134-2179,
31134-2183, 31134-2189, 31134-2193, 31134-2198, 31134-
2784, 31134-2787, 31134-2789, 31134-2800, 31134-2831,
31134-2899, 31134-2901, 31134-2909, 31134-2910, 31134-
2916, 31134-2920, 31134-2922, 31134-2995, 31134-2997,
31134-3274, 31134-3277, 31134-3279, 31134-3285, 31134-
3288, 31134-3290, 31134-3296, 31134-3298, 31134-3300,
31134-3304, 31134-3307, 31134-3315, 31134-3318, 31134-
3321, 31134-3609, 31134-3612, 31134-3614, 31134-3620,
31134-3621, 31134-3625, 31134-3626, 31134-3631, 31134-
3663, 31134-3667, 31134-3671, 31134-3675, 31134-3687,
31134-3688, 31134-3693, 31134-3694, 31134-3702, 31134-
3703, 31134-3704, 31134-3746, 31134-4101, 31134-4104,
31134-4106, 31134-4116, 31134-4120, 31134-4129, 31134-
4131, 31134-4133, 31134-4135, 31134-4136, 31134-4142,
31134-4147, 31134-4149, 31134-4154, 31134-4156, 31134-
4169, 31134-4176, 31134-4179, 31134-4182, 31134-4220,
31134-4222, 31134-4263, 31134-4449, 31134-4469, 31134-
4470, 31134-4472, 31134-4963, 31134-4966, 31134-5037,
31134-5039, 31134-5046, 31134-5050, 31134-5054, 31134-
5060, 31134-5071, 31134-5075, 31134-5077, 31134-5079,
31134-5612, 31134-5617, 31134-5618, 31134-5621, 31134-
5628, 31134-5630, 31134-5693, 31134-5698, 31134-5703,
31134-5866, 31134-5870, 31134-5873, 31134-5874,
c) Unit numbers 31134-2791, 31134-2905, 31134-2906,
31134-3317, 31134-4224, and 31134-4272; and the following units were distributed
as two split products: unit numbers 31134-2913, 31134-1228, 31134-1242, 31134-1250,
31134-1290, 31134-1294, 31134-1306, 31134-1314, 31134-1318, 31134-1337, 31134-1345,
31134-1352, 31134-1354, 31134-1363, 31134-1398, 31134-2036, 31134-2042, 31134-2047,
31134-2050, 31134-2169, 31134-2186, 31134-2999, 31134-3251, 31134-3266, 31134-3306,
31134-3601, 31134-3689, 31134-4117, 31134-4127, 31134-4138, 31134-4155, 31134-4184,
31134-4189, 31134-4270, 31134-4453, 31134-5088, 31134-5091, 31134-5601, 31134-5627,
31134-5691, 31134-5871, 31134-5930, 31134-5931, and 31134-5943;
d) Unit numbers 31132-1374, 31132-1383, 31132-1750,
31132-3252, 31132-4103, 31132-4401, 31132-4444, 31132-4986, 31132-4989, 31132-5075,
31132-6214, 31132-6402, 31132-6449, 31132-6451, 31132-6456, 31132-6458, 31132-6461,
31132-7528, 31132-7533, 31132-7540, 31132-8328, 31132-8330, 31132-8335, 31132-8886,
31132-8888, 31132-8899, 31133-0048, 31133-0366, 31133-0368, 31133-0371, 31133-0376,
31133-0381, 31133-0388, 31133-0392, 31133-3737, 31133-3740, 31133-3748, 31133-5305,
31133-5433, 31133-5449, 31133-5455, 31133-5665, 31133-5682, 31133-5691, 31133-5693,
31133-5796, 31133-8417, 31133-8418, 31133-8419, 31133-8422, 31133-8423, 31133-8425,
31133-8427, 31133-9042, 31133-9045, 31133-9050, 31133-9054, 31133-9066, 31133-9071,
31133-9073, 31133-9307, 31134-0147, 31134-0149, 31134-0150, 31134-0154, 31134-0155,
31134-0156, 31134-0159, 31134-0161, 31134-0164, 31134-0165, 31134-0305, 31134-0311,
31134-0322, 31134-0554, 31134-0562, 31134-0564, 31134-0570, 31134-0575, 31134-0577,
31134-0579, 31134-0752, 31134-0753, 31134-0754, 31134-0755, 31134-1986, 31134-1987,
31134-2217, 31134-2219, 31134-2221, 31134-2410, 31134-2413, 31134-2417, 31134-2421,
31134-2429, 31134-2432, 31134-2434, and 31134-2436;
e) Unit number 31134-2906; and the following units were
distributed as two split products: unit numbers 31132-
7993, 31133-4048, 31133-4054, 31133-4063, 31133-9867,
and 31134-0764.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturer: Blood Systems, Inc., Tupelo, MS.
REASON
Blood products, collected from donors who were improperly questioned concerning
the use of certain medications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
370 units.
DISTRIBUTION
MS, AL, and TX.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
CODE
a) Unit 11GX76525;
b) Units 11GX76319, 11FJ10350, 11GP14939, 11FJ10239,
11FJ10296.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO.
REASON
Blood products, possibly collected from unreliable donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
MO.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
c) Cryoprecipitated AHF, Pooled.
d) Platelets.
e) Plasma, Cryoprecipitate Reduced.
f) Fresh Frozen Plasma.
g) Recovered Plasma.
CODE
a) Units 18FK79385, 18FK79392, 18FS76888, 18FS76898,
18FS76901, 18FS76908, 18FW45920, 18FW45925, 18FW45930, 18FW45941, 18FY11086,
18FY11092, 18FY11097, 18FY11108, 18GC12460, 18GC12464, 18GC12473, 18GC12476,
18GM02367, 18GM02370, 18GM02374, 18GM02404, 18GM02571, 18GM02572, 18GM02581,
18GM02588, 18GM02589, 18N88571, 18N88572, 18N88576, 18N88580, 18N88582;
b) Unit 18GM02370;
c) Unit 18GM02367;
d) Units 18GM02409, 18GM02571, 18GM02572, 18GM02581,
18GM02588;
e) Unit 18GM02367;
f) Units 18FS76901, 18FS76908, 18GM02570, 18GM02571,
18GM02572, 18GM02581, 18GM02588;
g) Units 18FK79392, 18FS76888, 18FS76898, 18FW45920,
18FW45925, 18FW45930, 18FW45941, 18GC12460, 18GC12464,
18GC12473, 18GM02370, 18GM02374, 18GM02404, 18GM02409,
18N88571.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI.
REASON
Blood products, collected from donors whose arm scrubs were incorrectly performed,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
62 units.
DISTRIBUTION
CA, MI, NY, and Switzerland.
PRODUCT
a) Red Blood Cells.
b) Plasma.
c) Recovered Plasma.
CODE
a) Units 011LY33525 and 011LY21015;
b) Unit 011LY33525;
c) Unit 011LY21015.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO.
REASON
Blood products, which were collected from a donor who had a history of testing
positive for the hepatitis C virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MO, IL, and Switzerland.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units 2100823 and 2500696.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, which were collected from a donor who had traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE
a) Units 9071342 and 9066889;
b) Unit 9066889.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, which were collected from a donor who had traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units 2403776 and 2409074.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, which were collected from a donor who had traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Units 9547222 and 2101429.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, which were collected from a donor who had traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
CODE
a) and b) Unit 9527509.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, which were collected from a donor who had traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit 2304597.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood product, which were collected from a donor who was taking the medication
Methotrexate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Platelets Pheresis Leukocytes Reduced.
CODE
Units 2026683, 2024471, 2016775, and 2015315.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, which were collected from a donor who had traveled to a malarial
endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TN.
PRODUCT
Source Plasma.
CODE
Unit numbers: 9WY598, 9WY602, 9WY612, 9WY618, FLBTMJ, FLBTMR, FLBTNH, FLBTNL,
FLBTQN, FLBTVF, FLBTVG, FLBTVR, FLBTWG, FLBTWL, FLBTXB, FLBTXH, FLCJHC, FLCJJX,
FLCJKC, FLCJKQ, FLCJKY, FLCJLX, FLCJNB, FLCJNK, FLCJNX, FLCJPK, FLCJQP, FLCJQW,
FLCJRQ, FLCJSW, FLCJSY, FLCJWR, FLCJWV, FLCJXC, FLCJXG, FLCJXM, FLCJXV, FLCJXX,
FLCJYH, FLCJYM, FLCJYS, and FLCJYZ.
RECALLING FIRM/MANUFACTURER
Aventis Bio-Services, Inc., Waco, TX.
REASON
Blood products, collected from an ineligible donor who had been permanently
deferred due to drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
42 units.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2023959.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, collected from an unsuitable donor based on travel to an area
considered endemic for malarial, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Source Plasma.
CODE
Units 0141107409, 0141108210, 0141108897, and 0141109503.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Tulsa, OK.
REASON
Blood products, collected from a donor who was at increased risk of exposure
to new variant Creutzfeldt Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
FL.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: KE89063.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA..
REASON
Blood product, which were collected from a donor in which donor suitability
was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2411148.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
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
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2304597.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
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
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2315645.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
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
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2022659.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN..
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
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2602476.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
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
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number 2200237.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
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
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit numbers 2507390, 2504211, and 2010137.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
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
3 units.
DISTRIBUTION
TN.
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE
Unit number 2022036A.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE
Unit number 2025315A.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE
Unit number 2028718.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, that were labeled leukoreduced but had an elevated white blood
cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Liquid Plasma.
CODE
a), b), and c) Unit number 7769415.
RECALLING FIRM/MANUFACTURER
Department of the Air Force, 59th Medical Wing/MTLLB, Lackland AFB, TX.
REASON
Blood products, which tested negative for hepatitis, but were collected from
an ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
PA, and TX.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets, Leukocytes Reduced.
c) Plasma.
CODE
a), b), and c) Unit number 011GR32159.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Missouri-Illinois Region, St. Louis, MO.
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 subsequently
reported a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MO, and PR.
PRODUCT
Source Plasma. Recall # B-1991-4.
CODE
Unit numbers 00156875, 00156646, 00149990, and 00146876.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Lansing, MI.
REASON
Blood products, collected from a donor that tested reactive for hepatitis C
virus (HCV) by the polymerase chain reaction (PCR) assay, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CA.
PRODUCT
a) Diptheria and Tetanus Toxoids Adsorbed.
b) Albumin (Human) 25%.
c) Albumin 25% for diagnostic use only.
CODE
a) Lot number DT4177;
b) Lot number HA1215;
c) Lot number HA1208.
RECALLING FIRM/MANUFACTURER
BioPort Corporation, Lansing, MI.
REASON
Products were manufactured during a period where microbiological control of
the manufacturing operation could not be assured.
VOLUME OF PRODUCT IN COMMERCE
3 lots.
DISTRIBUTION
FL, MA, and MI.
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) and b) Unit number 31134-1727.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale.
Manufacturer: Blood Systems, Inc., Tupelo, MS.
REASON
Blood products, that tested negative for viral markers, but were collected from
an unsuitable donor due to the application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MS, and Switzerland.
PRODUCT
a) Cryoprecipitated AHF.
b) Recovered Plasma.
CODE
a) Unit 1794010;
b) Unit 4015236.
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX..
REASON
Blood products, collected from a donor who was at an increased risk for variant
Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX, and FL.
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE
Unit number 16KF41945.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH.
REASON
Platelets with a decreased platelet count were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
PRODUCT
IMOVAX Rabies, Rabies Vaccine, (Human Diploid Cell), Single Dose Vial (1mL).
Recall # B-1675-4.
CODE
Lots W1419-2, W1419-3, X0667-2, X0667-3.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Aventis Pasteur, Inc. Swiftwater, Pennsylvania.
Manufacturer: Aventis Pasteur SA, 69007 Lyon Cedex, France.
REASON
IMOVAX Rabies Vaccine, manufactured during the same campaign as a bulk lot (not
distributed) that failed the test for inactivation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
4 lots. 45,161 doses.
DISTRIBUTION
Nationwide.
PRODUCT
Baxter ALYX Component Collection System.
CODE
Product code: 4R5707, 4R5707R (refurbished).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corporation, Deerfield, IL.
Manufacturing Firm: Baxter Healthcare Corporation, Largo, FL.
REASON
Automated Blood Cell Separator (ALYX Component Collection System), designed
to collect red blood cells by centrifugation, may spin uncommanded after the
centrifuge door is opened.
VOLUME OF PRODUCT IN COMMERCE
174 instruments.
DISTRIBUTION
Nationwide.
PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Deglycerolized.
CODE
a) Units 03K03660, 03K03767, 03K03844;
b) Unit 03K03826.
RECALLING FIRM/MANUFACTURER
National Institutes of Health, Warren Grant Magnuson Clinical Center, Bethesda,
MD.
REASON
Blood products, incorrectly tested for Hepatitis B surface antigen (HBsAg) and
for the antibody to Hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MD.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE
Unit number: 49KC05145.
RECALLING FIRM/MANUFACTURER
American Red Cross, Southwest Region, Tulsa, OK.
REASON
Blood product, labeled leukoreduced but failed quality control testing due to
an elevated white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Recovered Plasma.
CODE
Unit 182348827.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ.
Manufacturing Firm: Blood Systems, Inc., Cheyenne, WY.
REASON
Blood products, collected from a donor who did not have a complete medical history
interview, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
PRODUCT
Source Plasma.
CODE
Unit number OG0019078.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Amarillo, 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
Spain.
PRODUCT
Source Plasma.
CODE
Unit number OG0019372.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Amarillo, 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
Spain.
PRODUCT
Platelets Pheresis.
CODE
Unit numbers 030GP32669, 030GP32679, 030GP32681, 030GP32684, 030GP32696, 030GP32716,
030GP32724, 030GP32726, 030GP32731, 030GP32758, 030GP32760, 030GP32771, 030GP32774,
030GP32776, 030GP32786, 030GP32794, 030GP32797, 030GP32799, 030GP32815, 030GP32825,
030GP32826, 030GP32830, 030GP32834, 030GP32885, 030GP32899, 030GP32919, 030GP32936,
030GP32949, 030GP33082, 030GP33104, 030GP33113, 030GP33118, 030GP33125, 030GP33131,
030GP33148, 030GP33175, 030GP33214, 030GP33275, and 030GP33288; and the following
units were distributed as two split products: unit numbers 030GP33111, 030GP32664,
030GP32698, 030GP32708, 030GP32763, 030GP32785, 030GP32811, 030GP32852, 030GP32952,
030GP32981, 030GP32996, 030GP33079, 030GP33085, 030GP33099, 030GP33100, 030GP33127,
030GP33141, 030GP33189, 030GP33219, 030GP33246, 030GP33282, and 030GP33298.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA.
REASON
Blood products, collected during a period when quality control testing was not
performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
83 units.
DISTRIBUTION
PA.
PRODUCT
Recovered Plasma.
CODE
Unit 2037977.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood products, which were collected from an autologous donor but was labeled
for allogeneic use, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
PRODUCT
Recovered Plasma.
CODE
Unit 2304597.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood product, which was collected from a donor who was taking the medication
Methotrexate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Switzerland.
PRODUCT
Red Blood Cells.
CODE
Unit numbers 030GF43777, 030GF43784, and 030GF43792.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA.
REASON
Blood products, that were not tested for hematocrit as required by the firm's
specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
NY.
PRODUCT
Recovered Plasma.
CODE
Unit number: KE89063.
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA.
REASON
Blood products, which were collected from a donor in which donor suitability
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
Unit number 2606708.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated.
CODE
Unit number 2017118.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
a) Platelets, Leukocytes Reduced.
b) Fresh Frozen Plasma. .
CODE
a) and b) Unit 16GJ24707.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Ohio Region, Columbus, OH.
REASON
Blood products, which were prepared from a whole blood unit with a discrepant
collection time, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.
PRODUCT
Source Plasma.
CODE
Unit numbers 470000121 and 470000165.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX.
REASON
Blood products, collected from a donor that did not answer all medical history
questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY.
PRODUCT
Source Plasma.
CODE
Unit number DSKZCG.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ.
Manufacturer: International BioResources, LLC, Tuscaloosa, AL.
REASON
Blood product, collected from a donor that did not answer the medical history
questions, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
PRODUCT
Source Plasma.
CODE
Unit numbers FGFDJR and FGFDCH.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ZLB Bioplasma, Boca Raton, FL.
Manufacturer: Aventis Bio-Services, Inc., Montgomery, AL.
REASON
Blood products, collected from a donor whose arm inspection was not documented,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
PRODUCT
Platelets Pheresis, Irradiated.
CODE
Unit numbers 42KF11846, 42KF11852, and 42KW20978.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Central Ohio Region, Columbus, OH.
REASON
Blood products that were removed from controlled storage for more than allowed
were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
OH.
PRODUCT
Platelets Pheresis.
CODE Unit number: W0013 03 200069.
RECALLING FIRM/MANUFACTURER
Department of the Air Force, 59th Medical Wing/MTLLB, Lackland AFB, TX.
REASON
Blood product, with a decreased platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TX.
PRODUCT
Red Blood Cells.
CODE Unit number: W90796.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Traverse City, MI.
REASON
Blood product, in which the corresponding Platelets were possibly
contaminated with bacteria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE Unit number: 11LL10029A.
RECALLING FIRM/MANUFACTURER
American Red Cross, Missouri-Illinois Region, St. Louis, MO.
REASON
Blood product, corresponding to Platelets Pheresis, Leukocytes Reduced
that were possibly contaminated with coagulase-negative, Staphylococcus
sp., was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MO.
PRODUCT
Platelets Pheresis, Leukocytes Reduced.
CODE Unit number: 2038237.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN.
REASON
Blood product, possibly contaminated with coagulase-negative, Staphylococcus
warneri, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.
PRODUCT
Source Plasma.
CODE Unit numbers: BSDLKJA, BSDLPZA, BSDMCPA, BSDMPNA, BSDNHYA, BSDNMTA,
BSDNWLA, BSDPDMA, BSDPQKA, BSDPWNA, BSDQKKA, BSDRDRA.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc. St. Paul, MN.
REASON
Blood products, collected from an ineligible donor who had been
permanently deferred due to drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
IL.
PRODUCT
Red Blood Cells Leukocytes Reduced,
CODE Units 16GQ17699 and 16GQ17705.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Columbus, OH.
REASON
Blood products, which were collected from a donor whose hematocrit
was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH.
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated.
CODE Units 027GH18885 and 027LQ16774.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA.
REASON
Blood products, which had no documentation that irradiation was
adequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WV.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 027LK13192.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA.
REASON
Blood products, which were collected from a donor who was at risk
for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WV.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 027LK12322.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA.
REASON
Blood products, which were collected from a donor who was at risk
for Creutzfeldt-Jakob Disease (CJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WV, and Switzerland.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 027LC27348.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA.
REASON
Blood products, which were collected from a donor in which donor
suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA and CA.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 027LC26720.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA.
REASON
Blood products, which were collected from a donor in which donor
suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WV, and CA.
PRODUCT
Recovered Plasma.
CODE Unit 027LQ11229.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA.
REASON
Blood product, which was collected from a donor in which donor suitability
was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
a) Red Blood Cells Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit 027LW24603.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Johnstown, PA Ohio and California.
REASON
Blood products, which were collected from a donor in which donor
suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
OH, and CA.
PRODUCT
Red Blood Cells.
CODE Unit KR11466.
RECALLING FIRM/MANUFACTURER
ITXM Clinical Services, Pittsburgh, PA.
REASON
Blood product, which was positive for the Kell antigen but was labeled
negative for the Kell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Platelets Pheresis Irradiated.
CODE Unit E75912.
RECALLING FIRM/MANUFACTURER
HCSC Blood Center, Bethlehem, PA.
REASON
Blood product, which had no documentation that irradiation was adequately
performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.
PRODUCT
Source Plasma.
CODE Unit: 77832405
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank Inc. of Wisconsin, Milwaukee, WI.
REASON
Blood product, collected from a donor whose medical history screening
was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
PRODUCT
Source Plasma.
CODE Unit numbers: BGXHTB, BGXHJB, BGXGRP, BGXGDV, and BGTRNG.
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Knoxville, TN..
REASON
Blood products, which tested negative for all infectious diseases,
but were collected from a donor in which donor suitability was not
adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
IL, and Germany.
PRODUCT
Platelets Leukocytes Reduced.
CODE Unit 042GE12940.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Cleveland, OH.
REASON
Blood product, which was quarantined due to a discrepant collection
time, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
PRODUCT
Red Blood Cells, Leukocytes Reduced.
CODE Units 150217090, 150216933, 150216924, 150217087.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lubbock, TX.
REASON
Blood products, incorrectly tested for HIV/HCV NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
TX, and New Mexico.
PRODUCT
Blood Cells Leukocytes Reduced Irradiated.
CODE Units 71L191227, 71L025932, 71L317916, and 71L173406.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL.
REASON
Blood products, which were labeled with an incorrect expiration
date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
FL.