May 7, 2003
03-19
_______________________________
PRODUCT
Mexican pastries:
a) Pan Heuvo. Recall # F-360-3;
b) Pan Fino. Recall # F-361-3;
c) Cupcakes. Recall # F-362-3.
Any of the above products may be packed in a clear plastic bag labeled in part: "PAN DULCE JUANITA'S. The labeling on the back of the package lists each product followed by the ingredients for each product. This "generic" bag is used for 5 different pastry items. Products are packed 6/bag and 8/bag.
CODE
Products coded with a date code of 11/30/02 and prior.
RECALLING FIRM/MANUFACTURER
Dominguez Family Enterprises dba Juanita's Fine Foods Hood River, OR, by letter dated October 30,2002. FDA initiated recall is complete.
REASON
Undeclared certified colors as follows: a & b) yellow 5 & 6, red 3 & 40; c)
yellow 5 & 6.
VOLUME OF PRODUCT IN COMMERCE
a) 300 cases/18 pkg per case/6 count;
b) 392 ctns/12/8 count;
c) 368 cases/12 pkg6 count.
DISTRIBUTION
WA, OR, ID, CA, TX, and UT.
_______________________________
PRODUCT
Mexican pastries:
Ojos. Recall # F-363-3.
The products may be packed in a clear plastic bag labeled in part: "PAN DULCE JUANITA'S. The labeling on the back of the package lists each product followed by the ingredients for each product. This "generic" bag is used for 5 different pastry items. Products are packed 6/bag and 8/bag.
CODE
Products coded with a date code of 11/30/02 and prior.
RECALLING FIRM/MANUFACTURER
Dominguez Family Enterprises dba Juanita's Fine Foods Hood River, OR, by letter dated October 30,2002. FDA initiated recall is complete.
REASON
Undeclared certified colors, red 3 & 40, blue 1.
VOLUME OF PRODUCT IN COMMERCE
38 cases/18 pkg/6 count.
DISTRIBUTION
WA, OR, ID, CA, TX, and UT.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-0667-3.
CODE
Unit 71W808286-8.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Gainesville, FL, by e-mail dated May 30, 2002. Firm initiated recall is complete.
REASON
Platelets, with a decreased platelet count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
AL.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0668-3;
b) Platelets. Recall # B-0669-3;
c) Fresh Frozen Plasma. Recall # B-0670-3;
d) Cryoprecipitate AHF. Recall # B-0671-3;
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, by letters dated October 13, and October 26, 2000. Firm initiated recall is complete.
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. Recall # B-0759-3.
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, by facsimile dated September 25, 2002. Firm initiated recall is complete.
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. Recall # B-0804-3.
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, by letter dated November 11, 2002. Firm initiated recall is ongoing.
REASON
Pipettor motor system failure may result in inaccurate test results.
VOLUME OF PRODUCT IN COMMERCE
206 units.
DISTRIBUTION
FL.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-0817-3.
CODE
Unit 084LP14176.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern California Region, Oakland, CA, by letter dated June 24, 2000 and July 22,2000. Firm initiated recall is ongoing.
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. Recall # B-0825-3.
CODE
Unit number 9361824.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on April 25, 2002. Firm initiated recall is complete.
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. Recall # B-0826-3.
CODE
Unit number 9307871.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on February 1, 2002. Firm initiated recall is complete.
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. Recall # B-0827-3.
CODE
Unit number 38P78444 (distributed as two split units).
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on December 12, 2002. Firm initiated recall is complete.
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. Recall # B-0828-3.
CODE
Unit number 38H96509.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on December 5, 2002 and by facsimile on December 6, 2002. Firm initiated recall is complete.
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. Recall # B-0830-3.
CODE
Unit number 7762501.
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by telephone on January 29, 2003. Firm initiated recall is complete.
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. Recall # B-0831-3;
b) Fresh Frozen Plasma. Recall # B-0832-3.
CODE
a) and b) 5078113 and 5078181.
RECALLING FIRM/MANUFACTURER
Coral Blood Services, Inc., Eastern Maine Medical Center, Bangor, ME, by letters on December 17 and December 19, 2002. Firm initiated recall is complete.
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. Recall # B-0833-3;
b) Recovered Plasma. Recall # B-0834-3.
CODE
a) 03LC14396, 03LL26216, and 03GL66895;
b) 03LC14396, 03GL66895.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Atlanta, GA, by letter dated March 5, 2002, and a "Questionable Plasma Inquiry" on February 15, 2002. Firm initiated recall is complete.
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. Recall # B-0835-3;
b) Cryoprecipitated AHF. Recall # B-0836-3;
c) Cryoreduced Plasma. Recall # B-0837-3.
CODE
a) b) and c) Units 12FQ56126, 12FQ54507, and 12FQ52349.
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by letter dated August 23, 2002. Firm initiated recall is ongoing.
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. Recall # B-0840-3.
CODE
Unit 1278459.
RECALLING FIRM/MANUFACTURER
Houchin Blood Service, Bakersfield, CA, by letter dated June 27, 2002. Firm initiated recall is complete.
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. Recall # B-0841-3.
CODE
Unit 4108465.
RECALLING FIRM/MANUFACTURER
Walter L Shepeard Community Blood Center, Inc., Augusta, GA, by facsimile dated December 4, 2002. Firm initiated recall is complete.
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. Recall # B-0842-3.
CODE
Unit 2763423.
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by letter dated April 18, 2002. Firm initiated recall is complete.
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. Recall # B-0850-3.
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, by letter on or about May 31, 2002. Firm initiated recall is complete.
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. Recall # B-0851-3.
CODE
Unit 6000742.
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakerfield, CA, by fax dated May 10, 2002. Firm initiated recall is complete.
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. Recall # B-0852-3.
CODE
Unit number 38P76062.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by letter on October 28, 2002. Firm initiated recall is complete.
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. Recall # B-0853-3;
b) Recovered Plasma. Recall # B-0854-3.
CODE
a) and b) Unit number 38W22069.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, In, by letter and facsimile on December 4, 2002, and January 7, 2003. Firm initiated recall is complete.
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. Recall # B-0855-3;
b) Platelets Pheresis Irradiated. Recall # B-0856-3;
c) Platelets Pheresis Leukocytes Reduced.
Recall # B-0857-3;
d) Platelets Pheresis Leukocytes Reduced Irradiated.
Recall # B-0858-3.
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, R36188, 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, R36253,
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, by letter and email on April 4, 2002. Firm initiated recall is complete.
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. Recall # B-0873-3.
CODE
Unit numbers 8000827A and 8000827B.
RECALLING FIRM/MANUFACTURER
Houchin Blood Services, Bakersfield, CA, by facsimile on September 27, 2002. 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
CA.
______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0874-3;
b) Platelets. Recall # B-0875-3.
CODE
a) and b) Unit number 13FY68108.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated September 26, 2002. Firm initiated recall is complete.
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. Recall # B-0876-3;
b) Platelets. Recall # B-0877-3.
CODE
a) and b) Unit number 13GM64244.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letter dated November 2 and November 5, 2002. Firm initiated recall is complete.
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. Recall # B-0878-3;
b) Platelets. Recall # B-0879-3.
CODE
a) and b) Unit number 13FH89671.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Southeastern Michigan Region, Detroit, MI, by letters on September 18, 2002, and October 28, 2002. Firm initiated recall is complete.
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. Recall # B-0896-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0897-3;
c) Platelets. Recall # B-0898-3;
d) Fresh Frozen Plasma. Recall # B-0899-3;
e) Platelets for further manufacture. Recall # B-0900-3;
f) Recovered Plasma. Recall # B-0901-3.
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, by telephone, electronic mail, and letter between September 6, 2002, and October 15, 2002. Firm initiated recall is complete.
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. Recall # B-0902-3;
b) Platelets. Recall # B-0903-3;
c) Fresh Frozen Plasma. Recall # B-0904-3.
CODE
a), b), and c) Unit number 18FQ57263.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by letter on December 10, 2002. Firm initiated recall is complete.
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. Recall # B-0908-3.
CODE
Unit number 16358-6319.
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AZ, by telephone on August 1, 2001, and by letter on August 9, 2001.
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. Recall # B-0699-3.
CODE
Unit number CNA002283.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile dated December 19, 2001. Firm initiated recall is complete.
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. Recall # B-0760-3.
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, by facsimile dated September 25, 2002. Firm initiated recall is complete.
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). Recall # B-0816-3.
CODE
Unit number DLG008068.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Beaumont, TX, by letter and fax on November 26, 2001. Firm initiated recall is complete.
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. Recall # B-0818-3.
CODE
Unit 084M10518.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern California Region, Oakland, CA, by letter dated May 10, 2000. Firm initiated recall is complete.
REASON
Blood product, which was not stored under continuous agitation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
______________________________
PRODUCT
Frozen Plasma. Recall # B-0819-3.
CODE
Unit 084Q60162.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Northern California Region, Oakland, CA, by telephone on May 4, 2000, and by letter dated May 23, 2000. Firm initiated recall is complete.
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. Recall # B-0824-3.
CODE
Unit number 9300714.
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on March 13, 2002. Firm initiated recall is complete.
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. Recall # B-0829-3.
CODE
Unit number 38H96428.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone on December 12, 2002. Firm initiated recall is complete.
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. Recall # B-0838-3.
CODE
Unit DLN000867.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Beaumont, TX, by letter dated November 20, 2001. Firm initiated recall is complete.
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. Recall # B-0839.3.
CODE
Unit N-58729-113.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Beaumont, TX, by facsimile transmission dated November 19, 2001. Firm initiated recall is complete.
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. Recall # B-0843-3.
CODE
Unit number JG0062029.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 4, 2001. Firm initiated recall is complete.
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. Recall # B-0844-3.
CODE
Unit number JG0085366.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on February 22, 2002. Firm initiated recall is complete.
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. Recall # B-0845-3.
CODE
Unit number JA0005089.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 18, 2001. Firm initiated recall is complete.
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. Recall # B-0846-3.
CODE
Unit number JG0082144.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 5, 2001. Firm initiated recall is complete.
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. Recall # B-0847-3.
CODE
Unit number JA0007790.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 12, 2001. Firm initiated recall is complete.
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. Recall # B-0848-3.
CODE
Unit number JG0058645.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 18, 2001. Firm initiated recall is complete.
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. Recall # B-0849-3.
CODE
Unit number JG0066393.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 5, 2001. Firm initiated recall is complete.
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. Recall # B-0859-3.
CODE
Unit number JG0078951.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Houston, TX, by facsimile on December 4, 2001. Firm initiated recall is complete.
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
TransportAir, Accessory to an Air Bed, Auxiliary Blower Unit. Recall # Z-0718-03.
CODE
Serial numbers 0550037 through 0559399.
RECALLING FIRM/MANUFACTURER
Kinetic Concepts, Inc., San Antonio, TX, by service representative, from November
1997 through March 1998. Firm initiated recall is complete.
REASON
Battery out-gassing due to battery over charging and/or secondary failure mode
of deep-discharge.
VOLUME OF PRODUCT IN COMMERCE
4,264 Units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Boston Scientific/Microvasive Open End Ureteral Catheter
(4 Fr x 70 cm) Product Number: 400-200.
Recall # Z-0734-03;
b) Boston Scientific/Microvasive Open End Ureteral Catheter
(5 Fr x 70 cm) Product Number: 400-201.
Recall # Z-0735-03;
c) Boston Scientific/Microvasive Open End Ureteral Catheter
(7 Fr x 70 cm) Product Number: 400-2003.
Recall # Z-0736-03;
d) Boston Scientific/Microvasive Cone Tip Ureteral Catheter
(5 Fr x70 cm) Product Number: 400-211.
Recall # Z-0737-03;
e) Boston Scientific/Microvasive Cone Tip Ureteral Catheter
(6 Fr x70 cm) Product Number: 400-212.
Recall # Z-0738-03;
f) Boston Scientific/Microvasive Open End Ureteral Catheter
(7 Fr x 70 cm) Product Number: 400-213.
Recall # Z-0739-03;
g) Boston Scientific/Microvasive Open End Ureteral Catheter
(6 Fr x 70 cm) Product Number: 400-202.
Recall # Z-0740-03.
CODE
a) Lot Numbers: 5178407 5202076 5275909 5309468 5337024;
b) Lot Numbers: 5178078 5180218 5195624 5198454 5202074
5205547 5208877 5215596 5218848 5225787 5228124 5229087
5230642 5238639 5241768 5243189 5243190 5246163 5252047
5252048 5252049 5253538 5256810 5259786 5269989 5291570
5303658 5315933 5315934 5326181 5326182 5327127 5331373
5334828 5337025 5337026 5344010 5345288 5355951 5358877;
c) Lot Numbers: 5225786 5303820 5312170 5340602;
d) Lot Numbers: 5178119 5188905 5192526 5192527 5194308
5198455 5202075 5205549 5208875 5208878 5225910 5226327
5229088 5235251 5235252 5235253 5258360 5258361 5269990
5270281 5286299 5288682 5291571 5291572 5315936
5327922 5331374 5334829 5334830 5337023 5344015 5363071
5366442 5366443 5375808 5381688;
e) Lot Numbers: 5180479 5188907 5222243 5253537 5296860
5309467 5345287 5369860;
f) Lot Numbers: 5218586 5303655 5312172 5348155;
g) Lot Numbers: 5161012 5174860 5174861 5180481 5185487
5218431 5221729 5243192 5252957 5296861 5296862 5303657
5327920 5327921 5345290 5348157 5355947.
RECALLING FIRM/MANUFACTURER
Boston Scientific Corporation, Natick, MA, by letter on March 17, 2003. Firm
initiated recall is ongoing.
REASON
Warning flag may be detached from the tip protector on the catheter and result
in the tip protector advancing through the catheter during use.
VOLUME OF PRODUCT IN COMMERCE
715 boxes.
DISTRIBUTION
Nationwide, Singapore, Japan, Korea, Canada, and Africa.
______________________________
PRODUCT
Easypump LT 6024 Easypump InfusionPump (60 ml x 22 ml/hr). Recall # Z-0741-03.
CODE
Lot numbers 04434366/2A2469 and 04434367/2A2470.
RECALLING FIRM/MANUFACTURER
I-Flow Corporation, Lake Forest, CA, by email on March 18, 2003. Firm initiated
recall is ongoing.
REASON
Overinfusion due to misassembly.
VOLUME OF PRODUCT IN COMMERCE
2,638 units.
DISTRIBUTION
France.
______________________________
PRODUCT
a) Tandem-Cath Hemodialysis Cuffed Catheter with side holes
10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #: 8888-
219226. Recall # Z-0742-03;
b) Tandem-Cath Hemodialysis Cuffed Catheter with side holes
10 Fr 23 cm Arterial Cuff/26cm Venous Cuff Code #: 8888-
223266. Recall # Z-0743-03;
c) Tandem-Cath Hemodialysis Cuffed Catheter with side holes
10 Fr 28 cm Arterial Cuff/31cm Venous Cuff Code #: 8888-
228316. Recall # Z-0744-03;
d) Tandem-Cath Hemodialysis Cuffed Catheter with no side
holes 10 Fr 19 cm Arterial Cuff/22cm Venous Cuff Code #:
8888-219220. Recall # Z-0745-03;
e) Tandem-Cath Hemodialysis Cuffed Catheter with no side
holes 10 Fr 23 cm Arterial Cuff/26 cm Venous Cuff Code
#: 8888-223260. Recall # Z-0746-03;
f) Tandem-Cath Hemodialysis Cuffed Catheter with no side
holes 10 Fr 28 cm Arterial Cuff/31cm Venous Cuff Code #:
8888-228310 Recall # Z-0747-03.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Tyco Healthcare/Kendall, Mansfield, MA, by letter on March 20, 2003. Firm initiated
recall is ongoing.
REASON
Tandem Hemodialysis Catheter may have splits in the catheter shaft below the
extension adapter.
VOLUME OF PRODUCT IN COMMERCE
1,077 units.
DISTRIBUTION
Nationwide and Internationally.
_________________________
PRODUCT
a) TriaDyne I and TriaDyne II Powered Adjustable Hospital
Beds. Recall # Z-0748-03;
b) KinAir IV TheraPaulse II AC-Powered Adjustable Hospital
Beds. Recall # Z-0749-03;
c) BariAir AC-Powered Adjustable Hospital Beds.
Recall # Z-0750-03.
d) PediDyne AC-Powered Adjustable Hospital Beds.
Recall # Z-751-03;
e) TransportAir Auxiliary Blower Unit. Recall # Z-0752-03.
CODE
All Serial Numbers.
RECALLING FIRM/MANUFACTURER
Kinetic Concepts, Inc., San Antonio, TX, by Technical Bulletin on April 11,
and September 11, 2000, and by letter in October, 2002. Firm initiated recall
is ongoing.
REASON
Battery Failure/Outgassing.
VOLUME OF PRODUCT IN COMMERCE
a) 915 units;
b) 381 units;
c) 237 units;
d) 244 units;
e) 9,399 units.
DISTRIBUTION
Nationwide.
_________________________
PRODUCT
Custom surgical packs for a variety of surgical applications. Each pack is custom
assembled and contains a variety of components including blades, gowns, needles,
sponges, towels, syringes, gloves, etc. All products could have the WINDSTONE
MEDICAL INC. label or the CARDIO-PAK label.
a) Major Pack. Recall # Z-0753-03;
b) RJT&A Pack. Recall #Z-0754-03;
c) T & A Pack. Recall # Z-0755-03;
d) Back Pack. Recall # Z-0756-03;
e) Arthroscopy Pack. Recall # Z-0757-03;
f) Cloward Pack. Recall # Z-0758-03;
g) Dr Desai's Pack. Recall # Z-0759-03;
h) Abdominal Gyn Pack. Recall # Z-0760-03;
i) Shoulder Pack. Recall # Z-0761-03;
j) Knee Pack. Recall # Z-0762-03;
k) Craniotomy Pack. Recall # Z-0763-03;
l) Laminectomy Pack. Recall # Z-0764-03;
m) Knee Arthroscopy Pack. Recall # Z-0765-03;
n) Shoulder Arthroscopy. Recall # Z-0766-03;
o) Lami Lap Pack. Recall # Z-0767-03;
p) Band Bag W/Fastener. Recall # Z-0768-03;
q) Band Bag. Recall # Z-0769-03;
r) Pick Up Pack. Recall # Z-0770-03;
s) Penrose Ace Bandage. Recall # Z-0771-03;
t) Subclavian Procedure Tray. Recall # Z-0772-03;
u) Isolation Gown Pack. Recall # Z-0773-03;
v) Valve Accessory Pack. Recall # Z-0774-03;
CODE
a) Catalog number 002117-000 Lot numbers 000006595
000006895;
b) Catalog number 002142-000 Lot numbers 000006010,
000005754;
c) Catalog number 002612-000 Lot numbers 000006693,
000006858;
d) Catalog number 002199-000 Lot numbers 000005267,
000006020, 000006280;
e) Catalog number 002238-000 Lot number 000006601;
f) Catalog number CPA-2374 Lot numbers 007253692,
000000329, 000000644, 000001197, 000001988, 000002422,
000002854, 000003293, 000003400, 000004000, 000004498,
000004845, 000005665, 000005763, 000005783, 000006309,
000006530, 000006766;
g) Catalog number CPA-3064 Lot numbers 000005461,
000005613, 000005829, 000005854, 000006093, 000006210,
000006226, 000006427;
h) Catalog number CPA-2378 Lot numbers 000002809,
000003401, 000003647, 000004421, 000004844, 000005838,
000006012;
i) Catalog Number 002617-000 Lot number 000006848;
j) Catalog number 002618-000 Lot numbers 000006700,
000006897;
k) Catalog number CPA-2382 Lot numbers 000000344,
000000612, 000001469, 000002199, 000003462, 000003952,
000004570, 000005078, 000005597, 000005879, 000005852,
000006499, 000006505;
l) Catalog Number CPA-2390 Lot Numbers 007253617,
007253618, 000000151, 000000426, 000000536, 000001201,
000001517, 000001772, 000001961, 000002108, 000002109,
000002409, 000002588, 000002589, 000002907, 000002908,
000003429, 000003430, 000003738, 000003739, 000004355,
000004356, 000004802, 000004803, 000005460, 000005506,
000005825, 000005786, 000006248, 000006410, 000006532;
m) Catalog Number CPA-3398 Lot Number 000005563, 000005677,
000005875, 000005974, 000006112, 000006232;
n) Catalog Number CPA-3400 Lot Numbers 000005595,
000005706, 000005927, 000006113;
o) Catalog Number CPA-3557 Lot Numbers 000006892,
000006893;
p) Catalog Number CPA-50009 Lot numbers 000000875,
000000876, 000000877, 000000878, 000000879, 000000880,
00000881, 000000882, 000000883, 000000884, 000000885,
000000886, 000000887, 000000888, 000000889, 000000890,
000000891, 000000892, 000000893, 000000894, 000001235,
000001236, 000002011, 000002012, 000003160, 000003161,
000003162, 000005535, 000005939, 000006004;
q) Catalog Number CPA-50025 Lot Numbers 007253627,
007253628, 007253629, 007253630, 007253631, 007253632,
007253633, 007253634;
r) Catalog Number CPA-3410 Lot Numbers 000005222,
000005442, 000005223, 000005224, 000006330, 000006294;
s) Catalog Number CPA-3294 Lot Numbers 000000819,
000000820, 00001431, 000001432, 000002405, 000002533,
000002755, 000003124, 000003125, 000004077, 000004189,
000004657, 000004658, 000005472, 000005979;
t) Catalog Number CPA-1069 Lot Numbers 000000668,
000000669, 000000670, 000000672, 000000673, 000000674,
000000676, 000000677, 000000671, 000000675, 000000678,
000000679, 000000681, 000000682, 000000683, 000000684,
000000692, 000000693, 000000694, 000000695, 000000696,
000000697, 000000698, 000000699, 000000709, 000000713,
000000716, 000000717, 000000720, 000000724, 000000725,
000000728, 000000732, 000000733, 000000734, 000000735,
000000736, 000000737, 000000680, 000000685, 000000686,
000000687, 000000688, 000000689, 000000690, 000000691,
000000700, 000000701, 000000702, 000000703, 000000704,
000000705, 000000706, 000000707, 000000708, 000000710,
000000711, 000000712, 000000714, 000000715, 000000718,
000000719, 000000721, 000000722, 000000723, 000000726,
000000727, 000000729, 000000730, 000000731, 000005001,
000005002, 000005003, 000005004, 000005005, 000005006,
000005007, 000005008, 000005009, 000005010, 000005014,
000005015, 000005016, 000005021, 000005022, 000005025,
000005026, 000005027, 000005029, 000005030, 000005031,
000005032, 000005011, 000005012, 000005013, 000005017,
000005018, 000005019, 000005020, 000005023, 000005024,
000005028, 000005033, 000005034, 000005035;
u) Catalog Number CPA-1431 Lot Numbers 000000848,
000000849, 000002055, 000002828, 000002829, 000004637,
000004638;
v) Catalog Number CPA-3648 Lot Numbers 000004282,
000005469, 000005896, 000005639, 000006725.
RECALLING FIRM/MANUFACTURER
Windstone Medical Inc., Billings, MT, by telephone and letter on March 25, 2003.
Firm initiated recall is ongoing.
REASON
Product has latex free symbol on package, yet contains latex components.
VOLUME OF PRODUCT IN COMMERCE
7,958 packs.
DISTRIBUTION
CO, IN, MI, MN, MT, UT, and WA.
_________________________
PRODUCT
Guidant Multi-Link Vision Coronary Stent System. Catalog Numbers: 30 different
catalog numbers have been listed. Recall # Z-0775-03.
CODE
All lots are included in the action.
RECALLING FIRM/MANUFACTURER
Guidant Corporation ACS, Temecula, CA, by facsimile on April 1, 2003. FDA initiated
recall is ongoing.
REASON
Complaints that the stents are being dislodged from the delivery system.
VOLUME OF PRODUCT IN COMMERCE
Estimated 7 to 9 thousand units.
DISTRIBUTION
Internationally.
______________________________
PRODUCT
a) Boston Scientific Scimed Radius Monorail 4.0 mm Stent
Systems, Catalog Number H74917485400.
Recall # Z-0776-03;
b) Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-
Expanding Coronary Stent with Over-the-Wire Delivery
System, Catalog Number H74917500301.
Recall # Z-0777-03;
c) Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-
Expanding Coronary Stent with Over-the-Wire Delivery
System, Catalog Number H74917500401.
Recall # Z-0778-03.
CODE
a) Lot number 5350420;
b) Lot number 5357125;
c) Lot number 5350197.
RECALLING FIRM/MANUFACTURER
Boston Scientific Scimed, Maple Grove, MN, by letter dated March 17, 2003. Firm
initiated recall is ongoing.
REASON
A component within the manifold of the stent delivery systems was found to have
pyrogen levels above specification.
VOLUME OF PRODUCT IN COMMERCE
12 stent systems.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
Vision Hollow Fiber Oxygenator. Recall # Z-0780-03.
CODE
Lot 205200.
RECALLING FIRM/MANUFACTURER
Gish Biomedical, Inc., Rancho Santa Margarita, CA, by fax on March 31, 2003.
Firm initiated recall is ongoing.
REASON
Two reports of leakage.
VOLUME OF PRODUCT IN COMMERCE
1,749.
DISTRIBUTION
Nationwide, Austria, Canada, Japan, and Saudi Arabia.
______________________________
PRODUCT
Bulk Medicated Custom Mix Feed for Swine containing 50 g/ton carbadox. Recall
# V-048-3.
CODE
Uncoded.
RECALLING FIRM/MANUFACTURER
Riverside Grain & Feed Co., Riverside, IA, by telephone on April 9, 2003. FDA
initiated recall is complete.
REASON
Firm received zinc oxide raw material ingredient from a supplier that may have
contained elevated levels of dioxin.
VOLUME OF PRODUCT IN COMMERCE
Approx. 25 tons.
DISTRIBUTION
IA.
______________________________
PRODUCT
Phenylbutazone, USP, NDC 38779-0497-7 sold in:
a) 25 kg fiber drums;
b) 5 kg plastic bottles;
c) 1 kg plastic bottles;
d) 500 gram plastic bottles;
e) 100 gram plastic bottles. Recall # V-049-3.
CODE
a) Lot #s: P-9901006, Exp. 01/03 *** P-9901007, Exp. 01/04
*** P-9901008, Exp. 01/04 **** P-9902001, Exp. 02/04
*** P-9902002, Exp. 02/04 *** P-9902002/A Exp. 02/04
*** P-9902003, Exp. 02/04 *** P-9903003, Exp. 03/04
*** P-9903006, Exp. 03/04 *** P-9903007, Exp. 03/04
*** P-9903008, Exp. 03/04 *** P-9912013, Exp. 12/04
*** P-9912014, Exp. 12/04 *** P-9912015, Exp. 12/04;
b) P-9902003, Exp. 02/04;
c) P-9902003, Exp. 02/04;
d) P-9902003, Exp. 02/04;
e) P-9902003, Exp. 02/04.
RECALLING FIRM/MANUFACTURER
Medisca, Inc., Plattsburgh, NY, by letters dated January 29, 2003. Firm initiated
recall is complete.
REASON
Expiration dates extended and lot numbers changed.
VOLUME OF PRODUCT IN COMMERCE
5,993 kg (various size units).
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) 7224: QLF Pasture Plus 32/8 (1.25%P).
Recall # V-050-3.
b) 3433: QLF Pasture Plus 34/6 (1.0%P). Recall # V-051-3;
c) 3015: QLF Select 30. Recall # V-052-3;
d) 121: Custom Pellet Binder. Recall # V-053-3;
e) 3435: QLF Pasture Plus 34/6 (1.5%P). Recall # V-054-3;
f) 3434: QLF Pasture Plus 34/6 (1.25%P). Recall # V-055-3;
g) 7220-1: QLF Natural 8CD for further manufacture of feed.
Recall # V-056-3.
CODE
No manufacturing codes.
RECALLING FIRM/MANUFACTURER
Quality Liquid Feeds, Inc., Muskogee, OK, by letter on January 8, 2003. FDA
initiated recall is complete.
REASON
Undeclared Temulose (Hemicellulose Extract) in a non-medicated feed.
VOLUME OF PRODUCT IN COMMERCE
a) 47 tons;
b) 25 tons;
c) 23 tons;
d) 72 tons
e) 20 tons;
f) 5 tons;
g) 23 tons.
DISTRIBUTION
AR, KA, MO, and OK
END OF ENFORCEMENT REPORT FOR MAY 7, 2003
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Hypertext created by clb 2003-MAY-07.