MAY 2003

WEEK ENDING MAY 3

PRODUCT Blood-Pack_ Units with PL 732 Transfer Pack.
CODE Product Code 4R3431NM: Lots M03A09014, M03A09014A.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corporation/Fenwal Division, Deerfield, IL

Baxter Healthcare Corporation/Fenwal Division, Maricao, Puerto Rico.
REASON PL732 Platelet Containers that may split during component preparation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 lots, 16,890 units.
DISTRIBUTION Nationwide.

PRODUCT Platelets.
CODE Unit number F52894.
RECALLING FIRM/MANUFACTURER Central Illinois Community Blood Bank, Springfield, IL,

REASON Blood product collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IL.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 03K21952.
RECALLING FIRM/MANUFACTURER American National Red Cross, Southern Region, Atlanta, GA,

REASON Blood product collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 18N83004.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI,

REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 18FX38619.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI,

REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Plasma, Cryoprecipitate Reduced.
d) Fresh Frozen Plasma.
e) Platelets for further manufacture.
f) Recovered Plasma.
CODE
a) Unit numbers 18FQ74621, 18FQ74622, 18FQ74631, 18FQ74634, 18FQ74635, 18FQ74636, 18FQ74643, 18FQ74645, 18FQ74646,
18FQ74647, 18FQ74648, 18FQ74651, 18FQ74652, 18FQ74653, 18FQ74655, 18FQ74656, 18FQ74658, 18FQ74659, 18FQ74661,
18FQ74662, 18FQ74666, 18FQ74669, 18FQ74671, 18FQ74673, and 18FQ74674;
b) Unit numbers 18FQ74611, 18FQ74614, 18FQ74615, 18FQ74616, 18FQ74618, 18FQ74624, 18FQ74628, 18FQ74633, 18FQ74636,
18FQ74637, 18FQ74639, 18FQ74640, and 18FQ74641;

c) Unit numbers 18FQ74643, 18FQ74646, 18FQ74647, 18FQ74666, 18FQ74667, and 18FQ74674;
d) Unit numbers 18FQ74628 and 18FQ74651;
e) Unit numbers 18FQ74617, 18FQ74619, 18FQ74623, and 18FQ74634.
f) Unit numbers 18FQ74616, 18FQ74642, 18FQ74648, 18FQ74650, 18FQ74653, 18FQ74654, 18FQ74655, 18FQ74658, 18FQ74660,
18FQ74661, 18FQ74663, and 18FQ74664.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI,.
REASON Blood products, collected from donors whose health history screening were inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 25 units;
b) 13 units;
c) 6 units;
d) 2 units;
e) 4 units;
f) 12 units;
DISTRIBUTION MI, CA, MA, and Switzerland.

PRODUCT Red Blood Cells, Leukocytes Reduced. .
CODE Unit KC77022.
RECALLING FIRM/MANUFACTURER BloodSource, Sacramento, CA,
REASON Blood product, that did not have the additive solution included within the time frames specified by the manufacturer's instructions, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA

WEEK ENDING MAY 10

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit 71W808286-8.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Gainesville, FL,

REASON Platelets, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION AL.

PRODUCT
a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
d) Cryoprecipitate AHF.
CODE a) 7720116, 7720118, 1230097, 7708821, 7708822, 6630305, 6630306, 6630307, 6630308, 6630309, 6630311, 6630312, 6630313, 6630314, 6630315, 7720121, 7720122, 7720124, 7720125, 7720126, 1230101, 1230102, 1230103, 1230104, 1230105, 7741283, 0021048, 7720127, 7720128, 1230108, 6617470, 6617474, 6617476, 6617480, 6617481, 6617490, 6616500, 6616502, 6616505, 6616517, 6616521, 6670039, 6670045, 7720131, 7720133, 1230109, 1230110, 1230111, 7741307, 7741309, 7741312, 7730191, 7709099, 1700062, 1240016, 6670261, 1207014, 1207015, 1207017, 1207018, 1207019;
b) 6617470, 6617474, 6617476, 6617480, 6617481, 6616500, 6616502, 6616505, 6670261;
c) 6616500, 6616502, 6670261, 6616505, 7741307, 7741309;

d) 6630305, 6630306, 6630307, 6630308, 6630309 6630313, 6630314, 6630315, 0021048 ,6616517 6616521, 6670039, 6630312.
RECALLING FIRM/MANUFACTURER Suncoast Communities Blood Bank, Inc., Sarasota, FL,

REASON Blood products, collected in a manner that compromises the sterility of the collection system, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 61 units;
b) 9 units;
c) 6 units;
d) 13 units.
DISTRIBUTION FL, and MA.

PRODUCT Source Plasma for Further Manufacture of Injectables.
CODE F-00520-046; F-00492-046; F-00420-046; F-00376-046; F-00283-046; VP-33553; VP-33503; VP-33481; VA-109024; VA-108959;
VA-108697; VA-108597; VA-108343; VA-108249; VA-108033; VA-107966; VA-107755; VA-107695; VA-107447; VA-107125;
VA-107033; VA-105592; VA-103419; VP-35309; VP-35243; VP-35220; VP-35124; VP-35099; VP-35023; VP-34983; VP-34912, VP-34886; VP-34723; VP-34677, VP-34622; VP-34583; VP-34543; VP-34608; VP-34458; VP-34419; VP-34382; VP-34342; VP-34305; VP-34259; VP-34223; VP-34169, VP-34146; VP-33881; VP-33844; VP-33819; VP-33785; VP-33750; VP-33723; VP-33669; VP-33642; VP-33587; VA-107370.
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA,
REASON Blood products, collected from a donor whose name was found on the state deferral registry, were distributed.
VOLUME OF PRODUCT IN COMMERCE 57 units.
DISTRIBUTION NJ, CA, IL, and Austria.

PRODUCT ID-MTS (Micro Typing System) Impact Pipettor.
CODE Serial Numbers: 182192 182193 182232 182238 182241 182243 182247 182259 182261 182265 182273 182275 182276 182277 182290 182292 182293 182297 182300 182304 182308 182311 182313 182314 182369 182370 182373 182374 182380 182382 182383 182384 182386 182387 182388 182393 182415 182422 182424 182430 182433 182434 182439 182442 182444 182445 182451 182455 182456 182458 182459 182462 182477 182483 182485 182487 182488 182490 182491 182492 182493 182495 182496 182498 182509 182511 182512 182513 182515 182516 182518 182519
182520 182521 182524 182525 182526 182528 182529 182530 182531 182532 282624 282626 282627 282629 282630 282631 282632 282633 282634 282635 282636 282638 282639 282640 282641 282642 282643 28264 282645 282646 282648 282650 282651 282653 282654 282656 282658 282659 282660 282661 282662 282663 282664 282665 282668 282669 282670 282671 282672 282673 282675 282676 282677 282678 282680 282682 282689 282692 282696 100383801 100383802 100383804 100383805 100383806 100383807 100383808 100383811 100383813 100383814 100576800 100576801 100576802 100576803 100576804 100576806 100576807 100576808 100576809 100576811 100576812 100576813 100576814 100576815
100576816 100576817 100576818 100576819 100576820 100576821 100576822 100677800 100677801 100677802 100677803 100677804 100677805 100677806 100677807 100677808 100677809 100677810 100677811 100677812 100677813 100677814 100677815 100677817 100677818 100677819 100677820 100677821 100677822 100677824 100677825 100956301 100956305 100956306 100956307 100956308 100956309 100956310 100956312 100956313 100956314 100956315 100956316 100956317 100956318 100956319 100956320 100956321 100956323 100956324 100984803.
RECALLING FIRM/MANUFACTURER Matrix Technologies Corporation, Hudson, NH,

REASON Pipettor motor system failure may result in inaccurate test results.
VOLUME OF PRODUCT IN COMMERCE 206 units.
DISTRIBUTION FL.

PRODUCT Red Blood Cells.
CODE Unit 084LP14176.
RECALLING FIRM/MANUFACTURER American National Red Cross, Northern California Region, Oakland, CA,

REASON Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells. .
CODE Unit number 9361824.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON Blood product, collected from a donor whose body temperature was not determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Red Blood Cells.
CODE Unit number 9307871.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA,
REASON Blood product, collected from a donor whose body temperature was not determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Platelets Pheresis.
CODE Unit number 38P78444 (distributed as two split units).
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN,

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

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 38H96509.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN,

REASON Blood products, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA and IN.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 7762501.
RECALLING FIRM/MANUFACTURER Central Indiana Regional Blood Center, Indianapolis, IN,
REASON Blood product, collected by a phlebotomy method that may have compromised the sterility of the product, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT
a) Red Blood Cells.
b) Fresh Frozen Plasma.
CODE a) and b) 5078113 and 5078181.
RECALLING FIRM/MANUFACTURER Coral Blood Services, Inc., Eastern Maine Medical Center, Bangor, ME,

REASON Blood products, that tested repeatedly reactive for the antibodies to human T lymphotropic virus, types I and II (anti-HTLV-I/II), were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION ME.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE
a) 03LC14396, 03LL26216, and 03GL66895;
b) 03LC14396, 03GL66895.
RECALLING FIRM/MANUFACTURER American National Red Cross, Atlanta, GA,

REASON Blood products, collected from a donor with a history of hepatitis A, were distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION GA.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Cryoprecipitated AHF.
c) Cryoreduced Plasma.
CODE a) b) and c) Units 12FQ56126, 12FQ54507, and 12FQ52349.
RECALLING FIRM/MANUFACTURER American Red Cross, Carolinas Blood Services Region, Charlotte, NC,

REASON Blood products, that tested negative for 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 9 units.
DISTRIBUTION NC, TN, and GA.

PRODUCT Red Blood Cells.
CODE Unit 1278459.
RECALLING FIRM/MANUFACTURER Houchin Blood Service, Bakersfield, CA,
REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells.
CODE Unit 4108465.
RECALLING FIRM/MANUFACTURER Walter L Shepeard Community Blood Center, Inc., Augusta, GA

REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION GA.

PRODUCT Red Blood Cells.
CODE Unit 2763423.
RECALLING FIRM/MANUFACTURER Houchin Blood Services, Bakersfield, CA,
REASON Blood product, collected from a donor who reported travel to an area designated as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Units BYDQMT, BYDRZM, BYDSGM, BYDSTG, BYDTBM, BYDVHQ, BYDVST, BYDWGB, BYDWNL, BYDXBY, BYDXKK, BYDZYF, BYFBKD, BYFBYK.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Charlotte, NC,

REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 14 units.
DISTRIBUTION IL and Germany.

PRODUCT Red Blood Cells.
CODE Unit 6000742.
RECALLING FIRM/MANUFACTURER Houchin Blood Services, Bakerfield, CA,.
REASON Blood product, collected from a donor who engaged in high-risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Platelets Pheresis.
CODE Unit number 38P76062.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN,
REASON Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.

PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 38W22069.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, In,

REASON Blood products, collected from an ineligible donor due to medication with the drug Imuran, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION IN and CA.

PRODUCT
a) Platelets Pheresis.
b) Platelets Pheresis Irradiated.
c) Platelets Pheresis Leukocytes Reduced.
d) Platelets Pheresis Leukocytes Reduced Irradiated.
CODE
a) Unit numbers C07319, C07422, C07461, C07533, C08620, C08628, C08954, C09279, C09290, R36553, R36827, R36863, R37483, R39006, R40047, R40131, R40508, R41488, W65559, W65590, W65958, W66010, W66215, W66327, W66530, W66581, and W66693; and the following units were distributed as two split products: R40132, R40196, R40345, and W66476;
b) Unit numbers C09167, R36863, R40508, R40884, R41025, R41051, R41177, W65335, and W66518;

c) Unit numbers C07514, C06847, C06336, C06794, C06830, C06847, C06942, C06969, C07039, C07147, C07232, C07246, C07279, C07307, C07308, C07327, C07338, C07356, C07405, C07451, C07467, C07468, C07479, C07486, C07493, C07497, C07499, C07532, C07547, C07564, C07565, C07575, C07582, C07584, C07585, C07605, C07611, C07627, C07637, C07638, C07676, C07678, C07684, C07692, C07702, C07709, C07747, C07754, C07775, C07785, C07786, C07791, C08003, C08019, C08036, C08038, C08060, C08084, C08094, C08098, C08112, C08119, C08120, C08122, C08147, C08171, C08178, C08199, C08282, C08293, C08297, C08325, C08329, C08330, C08333, C08334, C08341, C08353, C08366, C08371, C08375, C08395, C08403, C08404, C08409, C08410, C08416, C08419, C08421, C08427, C08429, C08441, C08442, C08448, C08454, C08472, C08475, C08486, C08491, C08492, C08493, C08499, C08516, C08518, C08529, C08553, C08555, C08556, C08564, C08565, C08568, C08572, C08574, C08589, C08592, C08600, C08611,
C08624, C08631, C08634, C08635, C08638, C08667, C08674, C08675, C08676, C08688, C08691, C08694, C08723, C08725, C08734, C08745, C08750, C08758, C08762, C08763, C08785, C08798, C08805, C08811, C08821, C08827, C08828, C08847, C08848, C08850, C08879, C08883, C08893, C08910, C09002, C09018, C09031, C09061, C09069, C09080, C09099, C09124, C09136, C09138, C09139, C09149, C09196, C09204, C09207, C09232, C09233, C09240, C09243, C09248, C09253, C09256, C09258, C09270, C09280, C09285, C09301, C09303, CO8316, CO8454, R37425, R36015, R36093, 36188, R36191, R36200, R36208, R36253, R36277, R36441, R36485, R36590, R36645, R36701, R36840, R36874, R36932, R36936, R37031, R37039, R37164, R37212, R37284, R37304, R37313, R37366, R37415, R37425, R37438, R37460, R37509, R37542, R37992, R38013, R38355, R38373, R38378, R38379, R38383, R38392, R38419, R38422, R38433, R38480, R38590, R38708, R38714, R38861, R38888, R38970, R38982, R39015, R39052, R39085, R39104,
R39136, R39167, R39387, R39493, R39539, R39570, R39618, R39626, R39634, R39719, R39787, R39800, R39815, R39866, R39894, R39958, R40060, R40086, R40298, R40326, R40353, R40787, R40905, R41031, R41066, R41070, R41074, R41172, R41258, R41265, W47209, W47530, W47887, W48239, W48336, W48811, W48831, W49829, W49891, W49893, W49936, W65228, W65244, W65284, W65288, W65350, W65395, W65401, W65415, W65434, W65469, W65479, W65535, W65569, W65573, W65575, W65577, W65578, W65584, W65602, W65615, W65618, W65688,
W65704, W65729, W65740, W65753, W65766, W65780, W65795, W65822, W65834, W65866, W65917, W65964, W65967, W65975, W66012, W66016, W66021, W66034, W66069, W66097, W66115, W66119, W66124, W66143, W66150, W66158, W66196, W66205, W66218, W66221, W66235, W66237, W66241, W66244, W66248, W66263, W66289, W66292, W66313, W66325, W66332, W66361, W66365, W66369, W66399, W66415, W66417, W66421, W66424, W66433, W66434, W66456, W66502, W66513, W66521, W66531, W66534, W66540, W66546, W66557, W66561, W66575, W66591, W66602, W66623, W66632, W66635, W66654, W66655, W66669, W66672, W66678, W66701, and W66706; and the following units were distributed as two split products: C06783, C06841, C07247, C07313, C07336, C07342, C07387, C07409, C07437, C07456, C07476, C07480, C07504, C07510, C07518, C07532, C07556, C07574, C07588, C07593, C07622, C07735,C07756, C07761, C07765, C07769, C07772, C07779, C07781, C08021, C08023, C08055, C08093, C08133, C08181, C08205, C08326, C08390, C08420, C08425, C08497, C08513, C08524,
C08530, C08559, C08562, C08577, C08593, C08605, C08642, C08643, C08649, C08650, C08673, C08776, C08796, C08814, C08837, C08842, C08858, C08869, C08929, C09014, C09146, C09172, C09213, C09223, C09224, C09244, C09249, C09265, C09268, R36073, R36417, R36731, R36764, R36836, R37046, R37319, R37347, R37464, R37472, R37586, R37838, R38356, R38509, R38618, R38734, R38774, R38778, R38878, R39039, R39049, R39084, R39106, R39157, R39171, R39193, R39240, R39366, R39505, R39607, R39705, R39786, R39854, R39862, R39874, R39968, R40014, R40084, R40450, R40461, R40466, R40485, R40725, R40748, R40782, R40906, R41268, R41365, R41413, W47522, W47949, W48856, W48947, W49114, W49568,
W49866, W65272, W65413, W65461, W65594, W65630, W65663, W65665, W65713, W65714, W65738, W65746, W65970, W65977,W65983, W66022, W66090, W66191, W66214, W66257, W66293, W66319, W66333, W66380, W66407, W66497, W66541, W66639, W66714, and W66715
d) Unit numbers C05969, C06122, C06830, C06942, C07039, C07085, C07232, C07246, C07301, C07304, C07327, C07399, C07443, C07451, C07467, C07475, C07486, C07503, C07565, C07577, C07579, C07611, C07619, C07671, C07677, C07705, C07786, C08025, C08053, C08064, C08102, C08112, C08113, C08119, C08131, C08159, C08179, C08282, C08285, C08307, C08312, C08329, C08333, C08347, C08375, C08389, C08400, C08410, C08416, C08437, C08452, C08455, C08472, C08475, C08504, C08511, C08531, C08545, C08550, C08565, C08575, C08581, C08586, C08600, C08614, C08615, C08624, C08625, C08666, C08675, C08678, C08681, C08693, C08716, C08723, C08732, C08750, C08755, C08763, C08798, C08806, C08809, C08821, C08834, C08847, C08882, C08889, C08918, C08942, C09002, C09013, C09019, C09029, C09034, C09061, C09063, C09069, C09123, C09124, C09133, C09135, C09140, C09166, C09171, C09233, C09262, C09275, C09286, C09303, CO8314, C08744, R37373, R36015, R36093, R36200, R36241, C36253, R36287, R36322, R36689, R36712, R36813, R36943, R36996, R37031, R37045, R37272, R37313, R37431, R37438, R37462, R37506, R37914, R37925, R37935, R37947, R37987, R38341, R38419, R38435, R38459, R38463, R38502, R38861, R38918, R38970, R38982, R39015, R39189, R39526, R39538, R39578, R39618, R39634, R39813, R39815, R39819, R39833, R39846, R39866, R39891, R39894, R39924, R39958, R40070, R40108,
R40353, R40489, R40501, R40971, R41027, R41074, R41157, R41258, R41359, R39819, W48336, W48612, W49638, W65225, W65232, W65336, W65389, W65401, W65415, W65467, W65553, W65569, W65570, W65573, W65578, W65584, W65615, W65618, W65648, W65688, W65707, W65708, W65721, W65740, W65752, W65753, W65766, W65780, W65795, W65801, W65855, W65882, W65896, W65897, W65918, W65966, W65972, W65973, W66012,W66029, W66039, W66060, W66119, W66154, W66175, W66205, W66233, W66266, W66317, W66332, W66335, W66353, W66372, W66403, W66406, W66409, W66417, W66424, W66495, W66524, W66525, W66534, W66535, W66546, W66561, W66591, W66609, W66613, W66645, W66660, W66683, W66706, W66713, W66717, W66735, W66742, W66746, and W66779; and the following
units were distributed as two split products: C07324, C07787, C08047, C08306, C08340, C08443, C08551, C08596, C08684, C08685, C08705, C08779, C08826, C08956, C09006, C09121, C09219, R36751, R37084, R37501, R38764, R39591, R39825, R40024, R40228, R40425, R41347, R41398,
R41404, R41500, W48897, W49490, W49992, W65254, W65481, W65719, W65758, W65771, W65788, W66164, W66326, W66481,
W66528, W66595, and W65555.
RECALLING FIRM/MANUFACTURER Virginia Blood Services, Richmond, VA

REASON Blood products were collected during a period of instrument validation but no monthly quality control checks for pH and white blood cell count were performed as required by the validation.
VOLUME OF PRODUCT IN COMMERCE
a) 35 units;
b) 9 units;
c) 687 units;
d) 344 units.
DISTRIBUTION VA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit numbers 8000827A and 8000827B.
RECALLING FIRM/MANUFACTURER Houchin Blood Services, Bakersfield, CA,

REASON Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Platelets.
CODE a) and b) Unit number 13FY68108.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI,

REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Platelets.
CODE a) and b) Unit number 13GM64244.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI

REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Platelets.
CODE a) and b) Unit number 13FH89671.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI

REASON Blood products, collected from an unsuitable donor based on living in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MI.

PRODUCT a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets.
d) Fresh Frozen Plasma.
e) Platelets for further manufacture.
f) Recovered Plasma.
CODE a), c) and f) Unit number 18Q88193;
b) Unit numbers 18FT61803 and 18Q85936;
d) and e) Unit number 18FT61803.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI

REASON Blood products, collected from a donor whose health history screening was inadequately performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE 7 units.
DISTRIBUTION MI, CA, and NC.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit number 18FQ57263.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI,

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 3 units.
DISTRIBUTION MI.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 16358-6319.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., Scottsdale, AZ,

Manufacturer: Blood Systems, Inc., Meridian, MS. Firm initiated recall is complete.
REASON Blood product, that was labeled leukoreduced but 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 MS.

PRODUCT Source Plasma.
CODE Unit number CNA002283.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma for Further Manufacture of Non-Injectables Units.
CODE VA-106788; VA-106710; VA-106491; VA-106423; VA-106219; VA-106112; VA-105925; VA-105826; VA-105512; VA-105308;
VA-105221; VA-105019; VA-104929; VA-104694; VA-104609; VA-104409; VA-104322; VA-104114; VA-104053; VA-103789; VA-103709;

VA-103508; VA-103190; VA-103125; VA-102860; VA-102795; VA-102541; VA-102475; VA-101913; VA-101788; VP-35463.
RECALLING FIRM/MANUFACTURER Pyramid Biological Corporation, Van Nuys, CA,
REASON Blood products, collected from a donor whose name was found on the state deferral registry, were distributed.
VOLUME OF PRODUCT IN COMMERCE 31 units.
DISTRIBUTION NJ, CA, IL, and Austria.

PRODUCT Source Plasma (For manufacturing use only).
CODE Unit number DLG008068.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Beaumont, TX,
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Platelet, Pheresis.
CODE Unit 084M10518.
RECALLING FIRM/MANUFACTURER American National Red Cross, Northern California Region, Oakland, CA,

REASON Blood product, which was not stored under continuous agitation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Frozen Plasma.
CODE Unit 084Q60162.
RECALLING FIRM/MANUFACTURER American National Red Cross, Northern California Region, Oakland, CA,

REASON Blood product, manufactured from a unit of Whole Blood with a discrepant collection time, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells.
CODE Unit number 9300714.
RECALLING FIRM/MANUFACTURER The Blood Center, New Orleans, LA,

REASON Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Recovered Plasma.
CODE Unit number 38H96428.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN,

REASON Blood products, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA and IN.

PRODUCT Source Plasma.
CODE Unit DLN000867.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Beaumont, TX,

REASON Blood product, collected from a donor whose arm inspection was noted to be unacceptable, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit N-58729-113.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Beaumont, TX,

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

PRODUCT Source Plasma.
CODE Unit number JG0062029.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior know to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number JG0085366.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior know to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number JA0005089.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior know to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number JG0082144.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior know to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number JA0007790.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior know to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number JG0058645.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior know to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number JG0066393.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior know to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number JG0078951.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,.
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior know to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

WEEK ENDING MAY 17

PRODUCT Human Tissues for transplantation:
a) Pericardium.
b) Femoral Vein with Valve.
c) Tibialis Tendon.
d) Achilles Tendon.
e) Semitendinosus Gracilis Tendon.
f) Femoral Popliteal Artery.
g) Semitendinosus Tendon.
h) Saphenous Vein. .
CODE
a) Donor #29037, Serial number 6170005;
b) Donor #29976, Serial #6212697, Donor #58520, Serial #7368056,Donor #58520, Serial #7368044;
c) Donor #43211, Serial #4294430, Donor #43211, Serial #4294449, Donor #57681, Serial #7443417;
d) Donor #57681, Serial #7443400;
e) Donor #43211, Serial #4294453, Donor #52896, Serial #7069071;
f) Donor #51562, Serial #7094319;
g) Donor #52896, Serial #7068882;
h) Donor #57681, Serial #7440351, Donor #57681, Serial #7440369, Donor #58398, Serial #7357499, Donor #58398, Serial #7357520,
Donor #58398, Serial #7357868.
RECALLING FIRM/MANUFACTURER CryoLife, Inc., Kennesaw, GA,

REASON Human tissues for transplantation, collected from donors whose companion sample, from a different site, was positive for microorganisms, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 1 unit;
b) 3 units;
c) 3 units;
d) 1 unit;
e) 2 units;
f) 1 unit;
g) 1 unit;
h) 5 units.
DISTRIBUTION Nationwide.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 16GM22225.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Central Ohio Region, Columbus, OH,
REASON Blood product, collected from an unsuitable donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT Red Blood Cells, Leukocytes Reduced. .
CODE Unit number 30GH95330.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, 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 18FT36209.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing MI,

REASON Blood product, collected from an ineligible donor due to a reported history of aplastic anemia, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Reduced.

CODE Unit number 11326-7701.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, 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 Corneas.
CODE ID numbers IA-2003-02-034R1, IA-2003-02-034L1.
RECALLING FIRM/MANUFACTURER Iowa Lions Eye Bank, Iowa City, IA, .
REASON Human corneas, collected from a donor with discordant Hepatitis C Virus antibody (anti-HCV) test results, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION NC and AZ.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 30GN50964.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA,
REASON Blood product, collected from a donor whose health history screening was not adequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA and CA.

PRODUCT Source Plasma. .
CODE Unit numbers JN0009003, JN0009107, JG0091589, and JG0091837.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood products, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD).
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit numbers 92240940, 92244160, 92248960, and 92293205.
RECALLING FIRM/MANUFACTURER Interstate Blood Bank, Inc. of Chicago, Chicago, IL,
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to illegal drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit numbers 0530324809, 0530324422, 0530324023, 0530323312, 0530322558, 0530321415, 0530320676, 0530320083, 0530318966, 0530318127, 0530316346, 0530315867, 0530315504, 0530315051, 0530312728, 0530307015, 0530306213, and 0530305109.
RECALLING FIRM/MANUFACTURER Recalling Firm: ZLB Bioplasma, Inc., Boca Raton, FL,
Manufacturer: ZLB Bioplasma, Inc., Lexington, KY. Firm initiated recall is complete.
REASON Blood products, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 18 units.
DISTRIBUTION NC.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 04FR61614 and 04FJ45965.
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 MA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 04FC01107, 04FC98968, and 04FC96980.
RECALLING FIRM/MANUFACTURER The American National Red Cross, New England Region, Dedham, MA,

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

PRODUCT a) Red Blood Cells. b) Frozen Plasma.
CODE a) and b) units 6957825 and 6957830.
RECALLING FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ,
REASON Blood products, which tested negative for anti-HIV-1, HbsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NJ.

PRODUCT a) Platelets.
b) Fresh Frozen Plasma.
CODE a) and b) Unit 30GN49418.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northeastern Pennsylvania Region, Ashley, PA

REASON Blood products, which were collected from a donor who was diagnosed with Porphyria Cutanea Tarda, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA and NY.

PRODUCT Red Blood Cells Leukocytes Removed.
CODE Units 30GN58272 and 30GH88941.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Northeastern Pennsylvania Region, Ashley, PA,

REASON Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA.

PRODUCT Human Tissues for Transplantation Corneas.
CODE Serial # 01-1383, 01-1384.
RECALLING FIRM/MANUFACTURER Lions Eye Bank of Central Texas, Manor, TX,

REASON Corneas, collected from a donor who had dura mater transplantation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MD and Argentina.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.

CODE 20404-4451 (split product), 20404-4458.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc, Scottsdale, AZ,
REASON Platelets, that were not tested for pH as required by the firm's specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION LA.

PRODUCT Counterfeit EpogenÒ (Epoetin Alfa) labeled as 40,000 U/ ml vials in ten pack boxes.
CODE Lot number P002970; expiration 7/03.
RECALLING FIRM/MANUFACTURER Tradewinds Trading Co., Inc., Leander, TX,
REASON Counterfeit drug products, with a concentration of active ingredient less than labeled, were distributed.
VOLUME OF PRODUCT IN COMMERCE 335 boxes.
DISTRIBUTION OH and CA.

PRODUCT Red Blood Cells Leukocytes Removed.

CODE Unit 30GS28441.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA,

REASON Blood products, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA, and NJ.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 20403-0435.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,

Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON Blood product, collected from an ineligible donor due to medication with the drug Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA and CA.

PRODUCT Whole Blood, Leukocytes Reduced Irradiated.
CODE Unit number 20400-7357.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,

Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON Blood product, that tested negative for viral markers, but was collected from an unsuitable donor due to application of a tattoo, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 20400-7369 (distributed as two split units).
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON Blood products, that were labeled leukoreduced but had an elevated white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION LA.

PRODUCT
a) Red Blood Cells.
b) Red Blood Cells, Leukocytes Reduced.
c) Platelets Pheresis, Leukocytes Reduced.
d) Red Blood Cells for Manufacture.
e) Recovered Plasma.
CODE a) Unit numbers 20402-7968, 20402-7972, 20402-4062, 20402-7966, 20402-7965, 20402-7976, 20402-7971, 20402-7960, 20402-7964, 20402-4060, 20402-7977, 20402-7974, 20402-7969, and 20402-7967; and the following unit was distributed as two split products:unit number 20402-7963;
b) Unit numbers 20402-7957, 20402-7970, and 20402-7962;
c) Unit number 20402-3998;
d) Unit number 20402-7973;
e) Unit numbers 20402-7957, 20402-7968, 20402-7972, 20402-4062, 20402-7965, 20402-7976, 20402-7971, 20402-7973, 20402-7960, 20402-6842, 20402-7964, 20402-7970, 20402-7974, 20402-7969, and 20402-7967.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,

Manufacturer: Blood Systems, Inc., Lafayette LA. Firm initiated recall is complete.
REASON Blood products, incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 16 units;
b) 3 units;
c) 1 unit;
d) 1 unit;
e) 15 units.
DISTRIBUTION LA, CA, NV, NY, and Switzerland.

PRODUCT
a) Red Blood Cells, Leukoreduced.
b) Fresh Frozen Plasma.
c) Platelets.
CODE a), b), and c) Unit 113301635.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., El Paso, TX,

REASON Blood product, collected from a donor who had surgery within twelve months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX and New Mexico.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit numbers 0598766, 0752277, 0750275, and 0746294; and the following units were distributed as three split products: unit numbers 1149724 and 1148319.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center, San Francisco, CA

REASON Blood products that were possibly out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced Irradiated.
CODE Unit numbers 13FC32327, 13FW02021, 13FW02037, 13FW02018, 13FQ15383, and 13FW02217.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI,

REASON Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION MI.

PRODUCT a) Red Blood Cells, Leukocytes Reduced Irradiated.
b) Platelets Pheresis, Irradiated.
CODE
a) Unit numbers 13GV33943, 13GV33899, 13GV33952, 13GV33917, and 13GV33904;
b) Unit numbers 13P90664, 13P90657, and 13P90640.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Southeastern Michigan Region, Detroit, MI,

REASON Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE 8 units.
DISTRIBUTION MI.

PRODUCT Platelets.
CODE Unit numbers 18FW30736, 18FW30746, and 18FW30747.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI,

REASON Blood products, exposed to unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION MI.

PRODUCT Source Plasma. .
CODE Unit JG0091065.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, which was collected from a donor in which the results of the arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit JG0089762.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, which was collected from a donor in which the results of the arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit CNA002888.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit CNG002553.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, which was collected from a donor in which the results of the arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit JG0089393.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, which was collected from a donor in which the results of the arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit CNA005603.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit CNA000019.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit CNA003690.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit JA0009721.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit JG0054154.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit JG0083828.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 18FK74463.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Great Lakes Region, Lansing, MI,

REASON Blood product possibly exposed to unacceptable shipping temperatures, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MI.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 16364-0706 and 16363-7777.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Meridian, MS.
REASON Blood products, that did not have the additive solution included in the time frames established by the manufacturer, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION AL, and MS.

PRODUCT Red Blood Cells.
CODE Unit number 16363-7727.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Meridian, MS.
REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MS.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit numbers 30LE03287 and 30GN53626.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA,
REASON Blood products, that were found to be out of specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION PA.

PRODUCT Platelets.
CODE Unit numbers 30GL27842, 30GL27894, 30GL27896, 30GL27897, 30GL27888, 30GL27890, 30GL27898, 30GL27899, 30GL27880, 30GL27882, 30GL27883, 30GL27887, 30GL27851, 30GL27852, 30GL27853, 30GL27838, 30GL27846, 30GL27847, 30GL27850, 30GL27845, 30GL27892, 30GL27893, 30GL27878, 30GL27891, 30GT11350, 30GT11347, 30GT11348, 30GL27833, 30GL27836, 30GL27837, 30GL27844, 30GK04587, 30GL27831, 30GT11340, 30GT11337, 30GT11333, 30GL27867, 30GL27868, 30GL27866, 30GL27855, 30GL27857, 30GL27858, 30GL27861, 30GL27859, 30GL27854, 30GL27834, 30GL27871, 30GK04593, 30GK04594, 30GK04586, 30GT11331, 30GT11326, 30GT11327, 30GT11323, 30GT11324, 30GT11325, and 30GT11321.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA,

REASON Blood products, that exceeded the firm's specification for the time without agitation, were distributed.
VOLUME OF PRODUCT IN COMMERCE 57 units.
DISTRIBUTION PA, and NY.

PRODUCT Source Plasma.
CODE Unit number JG0090593.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number JG0096967.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number JG0055640.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number JG0089269.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor that did not answer medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Fresh Frozen Plasma.
CODE Unit number 30GW23296.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA,
REASON Blood product, that tested negative for the antibody to hepatitis C virus (anti-HCV), but was not properly quarantined after the receipt of subsequent repeatedly reactive anti-HCV results for the donor of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA.

PRODUCT Recovered Plasma.
CODE Unit 30GS28441.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA,
REASON Blood products, which tested negative for anti-HIV-1, HBsAg, anti-HCV, anti-HBc, anti-HTLV-I, and syphilis, but was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION PA, and NJ.

PRODUCT Source Plasma.
CODE Unit number JG0050286.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number JG0080420.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number CNA006265.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number CNA002181.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Source Plasma.
CODE Unit number CNA001940.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc., Houston, TX,
REASON Blood product, collected from a donor whose responses to the health history screening questions were not recorded properly, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Recovered Plasma.
CODE Unit number 20403-0435.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Lafayette LA

REASON Blood product, collected from an ineligible donor due to medication with the drug Aricept, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA and CA.

PRODUCT Platelets.
CODE Unit numbers 20399-5233, 20399-5235, 20399-5236, 20399-5237, 20399-5238, 20399-5240, 20399-5241, 20399-5244, 20399-5249, and 20399-5251.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON Blood products, manufactured from units of Whole Blood stored at incorrect temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE 10 units.
DISTRIBUTION LA.

PRODUCT Whole Blood.
CODE Unit number 20400-7357.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Lafayette LA.
REASON Blood product, labeled with the incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Source Plasma.
CODE Unit number 62480888.
RECALLING FIRM/MANUFACTURER Aventis Bio-Services, Inc., Lakewood, WA,
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Red Blood Cells. .
CODE Unit number 1159676.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center, San Francisco, CA,
REASON Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Cryoprecipitated AHF.
CODE Unit number 21KZ08403 (included in pool #6851).
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR,
REASON Blood product, manufactured from a unit of Whole Blood that should have been designated as a traumatic collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OR.

WEEK ENDING MAY 24

PRODUCT a) Platelets Pheresis Leukocytes Reduced.
b) Platelets Pheresis Leukocytes Reduced Irradiated.
CODE a) Unit number 21KP33410;
b) Unit number 21KP34490.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR,
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 OR.

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit number 21KP28086.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR,
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OR.

PRODUCT a) Red Blood Cells, Leukocytes Reduced.
b) Recovered Plasma.
CODE a) and b) Unit number 21GE19877.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR,
REASON Blood products, collected from an ineligible donor due to medication with the drug Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WA, and CA.

PRODUCT a) Plasma.
b) Recovered Plasma.
CODE a) Unit number 21KM34985;
b) Unit numbers 21KM31477 and 21KM21942.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR,
REASON Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OR, and CA.

PRODUCT Source Plasma.
CODE Unit number 70473445.
RECALLING FIRM/MANUFACTURER Nabi, Scranton, PA, by letter on October 4, 2002. Firm initiated recall is complete.
REASON Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

PRODUCT Human Tissues for Transplantation Corneas.
CODE Serial # 2003-03-6057.
RECALLING FIRM/MANUFACTURER Heartland Lions Eye Bank, Columbia, MO,
REASON Human cornea, collected from a donor with discordant Hepatitis B Virus test result, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION MO.

PRODUCT Source Plasma.
CODE Unit number 70491463 and 70493177.
RECALLING FIRM/MANUFACTURER Nabi, Scranton, PA,
REASON Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Source Plasma.
CODE Unit number 70481266, 70483093, 70484540, 70486667, and 70488449.
RECALLING FIRM/MANUFACTURER Nabi, Scranton, PA,

REASON Blood product, collected from a donor whose medical history screening did not include questioning regarding risk factors for new variant Creutzfeldt-Jacob disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 5 units.
DISTRIBUTION CA.

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

CODE a) and b) Unit number 21KZ03364.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Pacific Northwest Region, Portland, OR,
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION WA, and CA.

PRODUCT a) Red Blood Cells.
b) Platelets.
c) Fresh Frozen Plasma.
CODE a), b), and c) Unit number 0596224.
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center, San Francisco, CA,
REASON Blood products, collected from a donor whose body temperature was not determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION CA.

PRODUCT Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE Unit number 0833444 (distributed as 2 split products).
RECALLING FIRM/MANUFACTURER Blood Centers of the Pacific, Irwin Center, San Francisco, CA,
REASON Blood products, collected from an ineligible donor due to recent ingestion of aspirin, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION CA.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 01Y43255.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY,
Manufacturer: American Red Cross Blood Services, Fairport, NY. .
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 NY.

PRODUCT Recovered Plasma.
CODE Unit number 01FF47133.
RECALLING FIRM/MANUFACTURER Recalling Firm: The American National Red Cross, New York-Penn Region, West Henrietta, NY,
Manufacturer: American Red Cross Blood Services, Binghamton, NY. Firm initiated recall is complete.
REASON Blood product, collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to new variant Creutzfeldt-Jakob Disease (nvCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION CA.

WEEK ENDING MAY 31

PRODUCT a) Red Blood Cells. b) Cryoprecipitated AHF. c) Recovered Plasma.
CODE a), b), and c) Unit number 50H93583.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Western Lake Erie Region, Toledo, OH,
REASON Blood products, that tested negative for hepatitis, but were collected from an ineligible donor due to a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION OH, and Switzerland.

PRODUCT a) Cryoprecipitated AHF. b) Recovered Plasma.
CODE a) and b) Unit 21GY79013.
RECALLING FIRM/MANUFACTURER American Red Cross Blood Services, Portland, OR,
REASON Blood products, corresponding to Red Blood Cells that showed evidence of air contamination, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OK.

PRODUCT Red Blood Cells.
CODE Unit 5421504.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,

REASON Blood product, manufactured from an overweight whole blood unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells. b) Plasma.
CODE a), and b) Unit number 0369085.
RECALLING FIRM/MANUFACTURER Central Jersey Blood Center, Shrewsbury, NJ,
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to previous self-exclusion, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION NJ.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 0892003.
RECALLING FIRM/MANUFACTURER Hoxworth Blood Center, University of Cincinnati Medical Center, Cincinnati, OH,
REASON Blood product, collected from an ineligible donor due to a decreased hematocrit value, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION OH.

PRODUCT a) Red Blood Cells, Leukocytes Reduced. b) Platelets, Leukocytes Reduced.
CODE a) and b) Unit number 0872313.
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, and KY.

PRODUCT Red Blood Cells.
CODE Unit number 0828877.
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 1 unit.
DISTRIBUTION IN.

PRODUCT Red Blood Cells. Platelets.
CODE a) and b) unit number 7567431.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells. Cryoprecipitated AHF. Plasma, Cryoprecipitate Reduced.
CODE a), b), and c ) Unit number 5294074.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT Platelets.
CODE Unit number 5293879.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood product, collected from a donor that did not answer one of the history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells.b)Platelets. c) Fresh Frozen Plasma.
CODE a), b), and c) Unit number 7544446.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, collected from a donor whose body temperature was not determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE 3 units.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells. b) Fresh Frozen Plasma.
CODE a) and b) Unit 7445273.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, which were collected from a donor who had received the MMR vaccine within 2 weeks of the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT a) Platelets Pheresis, Leukocytes Reduced. b) Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE a) and b) Unit number 7567283.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, collected from a donor that did not answer the history questions concerning behavior know to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.
CODE Unit number 0180199.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX, and Switzerland.

PRODUCT Red Blood Cells.Platelets. Recall # B-1026-3.
CODE a) Unit numbers 5352685, 7727575, and 7696671; b) Unit number 5352685.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, 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 4 unit.
DISTRIBUTION TX.

PRODUCT a) Platelets Pheresis, Leukocytes Reduced. b) Platelets Pheresis, Leukocytes Reduced Irradiated.
CODE a) Unit numbers 7579961, 7579742, 7579586, 7578589, 7578369, 7578112, 7577931, 7577767, 7576909, 7576740, and 7576499, and the following unit was distributed as two split products: unit number 7577505.
b) Unit number 7579360.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, 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 a) 13 units; b) 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.
CODE Unit number 7896204.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells. b) Recovered Plasma.
CODE a) and b) Unit numbers 12LJ32126 and 12LS52686.
RECALLING FIRM/MANUFACTURER The American National Red Cross, Carolinas Region, Charlotte, NC,
REASON Blood products, collected from an ineligible donor due to a history of a previous positive test for hepatitis and jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE 4 units.
DISTRIBUTION NC, CA, and Switzerland.

PRODUCT Red Blood Cells.
CODE Unit number 5280714.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood product, collected from a donor that did not have a hematocrit or hemoglobin test during the donor screening process, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT a) Red Blood Cells. b) Fresh Frozen Plasma.
CODE a) and b) Unit number 7427886.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to previous reactive viral marker testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Carticel (Autologous Cultured Chondrocytes).
CODE Lot number CC07818.
RECALLING FIRM/MANUFACTURER Genzyme Tissue Repair, Cambridge, MA,
REASON Autologous product from a different individual was distributed with labeling that incorrectly identified the intended recipient.
VOLUME OF PRODUCT IN COMMERCE 1 lot.
DISTRIBUTION GA.

PRODUCT Corneas.
CODE ID numbers 2002-05-3291, 2002-05-3292.
RECALLING FIRM/MANUFACTURER Central Florida Lions Eye and Tissue Bank, Tampa, FL,
REASON Corneas that were collected from donors who were found to test repeatedly reactive for Human Immunodeficiency Virus (HIV) 1/2 subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE 2 tissues.
DISTRIBUTION WI, FL, Egypt, Mexico, Guatemala, and Singapore.

PRODUCT Platelets, Pheresis, Leukocytes Reduced.
CODE Unit number 17198-3460.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen, TX,
REASON Blood products, collected by automated equipment that was not validated for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.
CODE Unit number 71E17879-0.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Gainesville, FL,
REASON Blood product, collected from an ineligible donor based on living in an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Red Blood Cells.
CODE Unit number 7836820.
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 Red Blood Cells, Leukocytes Reduced.
CODE Unit number 8395025.
RECALLING FIRM/MANUFACTURER South Florida Blood Banks, Inc., West Palm Beach, FL,
REASON Blood product, collected from an ineligible donor due to a decreased hematocrit value, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit number 71W22217-5.
RECALLING FIRM/MANUFACTURER LifeSouth Community Blood Centers, Gainesville, FL,
REASON Platelets with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION FL.

PRODUCT Platelets Pheresis Leukocytes Reduced.
CODE Unit number 17200-5229.
RECALLING FIRM/MANUFACTURER Blood Systems, Inc., McAllen, TX, .
REASON Platelets Pheresis with elevated platelet counts, were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Source Plasma.
CODE Unit number WSN001430.
RECALLING FIRM/MANUFACTURER Biomat USA, Inc, Houston, TX,
REASON Blood product tested negative for viral markers but was collected from an ineligible donor due to risk factors for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION KY.

PRODUCT Red Blood Cells, Leukocytes Reduced.
CODE Unit number 16361-5068 (distributed as two split units).
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Meridian, MS.
REASON Blood products, collected on an apheresis machine where there was no documentation of evaluation of the filter assemblies as required, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION MS.

PRODUCT Platelets.
CODE Unit 5410357.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,

REASON Blood product, prepared from a donation that had discrepant start and stop collection times documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT a) Platelets. b) Fresh Frozen Plasma.
CODE a) and b) Unit number 5459713.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, prepared from a donation that had discrepant start and stop collection times documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT a) Platelets. b) Fresh Frozen Plasma.
CODE a) and b) Unit 5417303.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, prepared from a donation that had discrepant start and stop collection times documented, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.
CODE Units 5292920 (split unit).
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION TX.

PRODUCT Red Blood Cells.
CODE Unit number 20404-1793.
RECALLING FIRM/MANUFACTURER Recalling Firm: Blood Systems, Inc., Scottsdale, AZ,
Manufacturer: Blood Systems, Inc., Lafayette, LA.
REASON Blood product, that was found to be out of specification for red blood cell volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION LA.

PRODUCT Platelets Pheresis, Leukocytes Reduced.
CODE Unit number 5293829.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,.
REASON Blood product, collected from a donor with an elevated body temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX.

PRODUCT Recovered Plasma.
CODE Unit number 0180199.
RECALLING FIRM/MANUFACTURER Carter BloodCare, Bedford, TX,
REASON Blood products, collected from a donor that did not answer the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION TX, and Switzerland.

PRODUCT Corneas.
CODE ID numbers 2002-06-3375, 2002-06-3376, 2002-06-3501, 2002-06-3502, 2002-06-3505, 2002-06-3506.
RECALLING FIRM/MANUFACTURER Central Florida Lions Eye and Tissue Bank, Tampa, FL,
REASON Corneas that were collected from donors who were found to test repeatedly reactive for Human Immunodeficiency Virus (HIV) 1/2 subsequent to distribution.
VOLUME OF PRODUCT IN COMMERCE 6 tissues.
DISTRIBUTION WI, FL, Egypt, Mexico, Guatemala, and Singapore.