February 5, 2003
03-06
_____________________________
PRODUCT
Cellos packages labeled as Pumpkin Bread, 18 oz., actually contained Maple Zucchini Artichoke Bread, 20 ounce loaf in a foil pan. Recall # F-169-3.
CODE
Lot 3085500599, Sell by 10/25/02
RECALLING FIRM/MANUFACTURER
Sutton Place Gourmet, Bethesda, MD, by telephone on October 25, 2002. Firm initiated recall is complete.
REASON
Undeclared walnuts-packages labeled as Pumpkin Bread actually contain Maple Zucchini Artichoke bread with walnuts.
VOLUME OF PRODUCT IN COMMERCE
18 loaves.
DISTRIBUTION
CT.
_____________________________
PRODUCT
Powdered Infant Formula packaged under the following
labels: Recall # F-171-3.
Albertson's
*Baby Basics by Albertson's Soy Infant Formula with Iron
2 LB (908g)
*Baby Basics by Albertson's Soy Infant Formula with Iron
1 LB (454g)
Amway
*Kozy Kids Infant Formula with Iron 16 oz (454g)
*Kozy Kids Soy Infant Formula with Iron 16 oz (454g)
HEB
*Hill Country Fare Infant Formula with Iron 32 oz (2 LB)
908g
*Hill Country Fare Infant Formula with Iron 16 oz (1 LB)
454g
*Hill Country Fare Soy Infant Formula with Iron 32 oz
(2 LB) 908g
*Hill Country Fare Soy Infant Formula with Iron 16 oz
(1 LB) 454g
K-Mart
*American Fare Little Ones Infant Formula with Iron 2 LB
(908g)
*American Fare Little Ones Soy Infant Formula with Iron
2 LB (908g)
Preferred Products Inc. (SuperValue)
*HomeBest Soy Infant Formula with Iron 2 LB. (908 g)
Safeway
*Safeway Select Infant Formula with Iron 2 LB (908g)
*Walgreens Infant Formula with Iron 16 oz (454g)
Walmart
*Parent's Choice Infant Formula with Iron 2 LB (908g)
*Parent's Choice Infant Formula with Iron 16 oz (454g)
*Parent's Choice Soy Infant Formula with Iron 2 LB (908g)
*Parent's Choice Soy Infant Formula with Iron 35oz (1 kg)
Product sold in Wyeth Company Store in PA only:
Perfect Choice Infant Formula (454g) with Use by 08 28 05
can codes: L10NTJ, L11NTJ.
Sold in Mexico:
NURSOY: Day Codes: K16NVF, K17NVL, K17NVE, K18NVE, K18NVF, K19NVF, L09NVF
CODE
The products are coded with expiration/use by dates of 07 28 05, 08 28 05, and
09 28 05. They are also coded with six-digit lot numbers embossed on the bottom
of the cans. The first four characters of the six-digit lot numbers are K12N
through K19N; L07N through L30N; and N03N through N25N.
RECALLING FIRM/MANUFACTURER
Recalling Firm: WYETH Nutrition St., Davids, PA, by withdrawal notification
on October 25, 2002, press release on November 1, 2002, email and registered
letter on November 5, 2002 and notification via the intranet on November 8,
2002.
Manufacturer: WYETH, Georgia, VT. Firm Initiated recall is complete.
REASON
Products may be contaminated with Enterobacter sakazakii.
VOLUME OF PRODUCT IN COMMERCE
1,470,132 cans.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
The product is sold under the following brands:
a) South Mill brand Porcini & Sun Pasta Blend;
b) Phillips Mushrooms Farms brand Dried Wild Pasta Blend
Mushrooms;
c) Elite Mushroom Company brand Dried Wild Pasta Blend
Mushrooms.
Recall # F174-3.
CODE
All Products on the market at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Kaolin Mushroom Farms, Inc., Kennett Square, PA, by press release on April 11, 2002 and by letter on April 12, 2002. State initiated recall complete.
REASON
The product sold under 3 different brands contained undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
5846 packages.
DISTRIBUTION
PA, MA, MI, and FL.
_____________________________
PRODUCT
Powdered Infant Formula packaged under the following
labels: Recall # F-172-3.
Albertson's
*Baby Basics by Albertson's Formula for older infants with iron 1 LB. 15.7 oz (900g)
K-Mart
*American Fare Little Ones Formula for Older Infants with Iron & Calcium 1 LB 15.7 (900g)
Target
*Healthy Baby Formula for Older Infants with Iron 1 LB 15.7 oz. (900g)
Walmart
*Parent's Choice 2 Infant Formula with Iron 1 LB 15.7 oz (900g)
Sold in Hong Kong:
Enercal Plus Vanilla (Adult Use). Recall # F-173-3.
CODE
F-172-3: The products are coded with expiration/use by dates of 07 28 05, 08 28 05, and 09 28 05. They are also coded with six-digit lot numbers embossed on the bottom of the cans. The first four characters of the six-digit lot numbers are K12N through K19N; L07N through L30N; and N03N through N25N.
F-173-3: Codes N05NTC and N06NTD.
RECALLING FIRM/MANUFACTURER
Recalling Firm: WYETH Nutrition St., Davids, PA, by withdrawal notification on October 25, 2002, press release on November 1, 2002, email and registered letter on November 5, 2002 and notification via the intranet on November 8, 2002.
Manufacturer: WYETH, Georgia, VT. Firm Initiated recall is complete.
REASON
Products may be contaminated with Enterobacter sakazakii.
VOLUME OF PRODUCT IN COMMERCE
1,470,132 cans.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0429-3;
b) Fresh Frozen Plasma. Recall # B-0430-3.
CODE
a) and b) Unit R66525.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc, Richmond, VA., by telephone on August 6, 2002, and by letter dated September 3, 2002.
Firm initiated recall complete.
REASON
Blood products, collected from a donor who may have had sexual contact with an individual who lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-0431-3;
Platelets, Irradiated. Recall # B-0432-3.
CODE
a) and b) Unit M97648.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA., by letter dated September 23, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor who may have had sexual contact with an individual who lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VA.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-0468-3;
Recovered Plasma. Recall # B-0469-3.
CODE
a) and b) unit number 8727990.
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New Brunswick, NJ., by telephone and letter on or about June 5, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor that did not answer one of the medical history questions, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NY and Switzerland.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0470-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0471-3;
c) Red Blood Cells, Leukocytes Reduced Irradiated.
Recall # B-0472-3;
d) Cryoprecipitated AHF. Recall # B-0473-3;
e) Platelets. Recall # B-0474-3;
f) Platelets Irradiated. Recall # B-0475-3;
g) Fresh Frozen Plasma. Recall # B-0476-3;
h) Plasma. Recall # B-0477-3;
i) Source Leukocytes. Recall # B-0478-3;
j) Red Blood Cells for further manufacture.
Recall # B-0479-3;
k) Platelets for further manufacture. Recall # B-0480-3;
l) Recovered Plasma. Recall # B-0481-3.
CODE
a) unit numbers 1530719, 1530723, 1530731, 1531172,
1531173, 1531174, 1531175, 1531178, 1531179, 1531814,
1532478, 1532481, 1532484, 1532488, 1532491, 1532493,
1532496, 1532502, 1532503, 1532507, 1532508, 1532512,
1532513, 1532514, 1648032, 1648037, 1648040, 1648043,
1648052, 1648053, 1648077, 1648078, 1648083, 1648099,
1648100, 1648165, 1648167, 1648173, 1648174, 1648178,
1648183, 1648184, 1648191, 1648197, 1648201, 1648204,
1648281, 1648282, 1648289, 1648300, 1648314, 1648320,
1648325, 1648326, 1648333, 1648334, 1648340, 1648345,
2568058, 2568063, 2568066, 2568073, 2568076, 2568079,
2568083, 2568084, 2568089, 2568311, 2568650, 2568652,
2568656, 2568659, 2568662, 2568663, 2568667, 2568670,
2568671, 2568680, 2569353, 2569361, 2569437, 2569467,
2569595, 2569601, 2569630, 2569666, 2569678, 2569716,
2569778, 2569790, 2569858, 2569877, 2569928, 2570060,
2570115, 2570944, 2590949, 2570951, 2570962, 2571478,
2571479, 2571484, 2571486, 2571488, 2571490, 2571492,
2571494, 2571495, 2571501, 2571600, 2571601, 2571602,
2571605, 2571613, 2571616, 2571618, 2571620, 2573502,
2573512, 2573529, 2573530, 2573540, 2573541, 2573690,
2574004, 2574564, 2574568, 2574571, 2574574, 2574578,
2574581, 2574583, 2574585, 2574589, 2574591, 2574696,
2574756, 2574758, 2574764, 2574766, 2575067, 2575075,
2575079, 2575086, 2575095, 2575098, 2575102, 2575109,
2575113, 2575126, 2575131, 2575135, 2575136, 2575140,
2575145, 2575153, 2665812, 2665815, 2665816, 2665819,
2665820, 2665822, 2665830, 2665831, 2665832, 2665989,
2665995, 2665996, 2665997, 2666177, 2666180, 2666181,
2666184, 2666187, 2666192, 2666193, 2666196, 2666199,
2666201, 2666534, 2666578, 2666580, 2666581, 2666583,
2666586, 2666587, 2666589, 2666590, 2668244, 2668246,
2668247, 2730772, 2730773, 2730774, 2730775, 2730776,
2730777, 2730778, 2730780, 2730782, 2730783, 2730784,
3417975, 3417976, 3417977, 3417978, 3417979, 3417980,
3417981, 3417982, 3417984, 3417986, 3417987, 3417988,
3417989, 3417990, 3417991, 3417992, 3418168, 3418192,
3418193, 3824480, 3824481, 3824487, 3824488, 3824491,
3824492, 3825671, 3825679, 3825778, 3825788, 3827064,
3827067, 3827068, 3827071, 3827080, 3827092, 3827103,
3827107, 3827725, 4130006, 4130007, 4130010, 4130013,
4130014, 4130016, 4130017, 4130450, 4130452, 4130453,
4131270, 4131656, 4131657, 4131658, 4131713, 4131714,
4218908, 4219390, 4219399, 4219400, 4219404, 4219407,
4220123, 4220140, 4220153, 4220154, 4221346, 4221349,
4221351, 4221357, 4221358, 4221359, 4221363, 4221373,
4221375, 4221379, 4221388, 4222216, 4222221, 4222228,
4222235, 4222242, 4222245, 4222254, 4222255, 4222262,
4222275, 4222276, 4222283, 4222304, 4223025, 4223027,
4223029, 4223034, 4223035, 4223038, 4223042, 4223044,
4223050, 4223053, 4223055, 4223057, 4223059, 4224403,
4224406, 4224411, 4224414, 4224415, 4224419, 4224889,
4224948, 4224949, 4224954, 4224958, 4224960, 4224961,
4225161, 4225173, 4225229, 4225230, 4225232, 4225233,
4225237, 4225239, 4225240, 4225356, 4225358, 4225365,
4225367, 4225369, 4225372, 4225377, 4225384, 4225394,
4225399, 4225404, 4225411, 4225417, 4225418, 4225421,
4225424, 4225427, 4225429, 4225434, 4225456, 4225458,
4225465, 4225470, 4225472, 4225475, 4225479, 4718843,
4718846, 4718849, 4718855, 4718856, 4718861, 4718863,
4718867, 4718868, 4718872, 4718874, 6541772, 6541774,
6541784, 6541801, 6541815, 6541825, 6541826, 6541832,
6541835, 6541837, 6541859, 6541869, 6541871, 6547639,
6547645, 6547650, 6547652, 6547650, 6547652, 6547656,
7802323, 7802325, 7802326, 7802327, 7802328, 7802330,
7802331, 8218470, 8218476, 8218485, 8218491, 8218509,
8218515, 8219462, 8219465, 8219497, 8219511, 8219768,
8219769, 8219776, 8219777, 8219779, 8219781, 8219782,
8219786, 8219787, 8219789, 8219790, 8219821, 8219971,
8219972, 8219974, 8219983, 8219997, 8220000, 8220006,
8220041, 8220045, 8220046, 8220051, 8220058, 8220097,
8220100, 8220101, 8220105, 8220106, 8220109, 8220110,
8220218, 8220316, 8220323, 8220333, 8220334, 8220342,
8220370, 8220381, 8220398, 8220416, 8220428, 8220429,
8220451, 8220454, 8220459, 8220495, 8220516, 8220599,
8220600, 8220611, 8220642, 8220647, 8220654, 8220659,
8220669, 8220674, 8220729, 8220730, 8220742, 8220746,
8220759, 8220767, 8220774, 8220775, 8221136, 8221143,
8221145, 8221253, 8221256, 8222273, 8222281, 8222591,
8222598, 8222604, 8222615, 8222641, 8222642, 8222644,
8222645, 8222646, 8222649, 8222650, 8223572, 8223574,
8223711, 8224200, 8224203, 8224210, 8224224, 8224228,
8224231, 8224526, 8224550, 8224552, 8224571, 8224575,
8224576, 8224586, 8224922, 8224923, 8224925, 8224927,
8408397, 8409132, 8409137, 8409138, 8409344, 8409348,
8409349, 8409352, 8409355, 8409356, 8409357, 8409359,
8409363, 8409364, 8409366, 8409369, 8411254, 8411258,
8411260, 8411261, 8411264, 8411266, 8411271, 8411273,
8411274, 8411276, 8411278, 8412090, 8412092, 8412096,
8412099, 8412102, 8412104, 8412105, 8412112, 8412114,
8412116, 8412127, 8412137, 8412142, 8412154, 8412167,
8412170, 8412281, 8412282, 8412285, 8412291, 8412293,
8412294, 8412296, 8412299, 8412300, 8412302, 8412304,
8412312, 8412343, 8412346, 8412349, 8412353, 8412355,
8412356, 8412360, 8412363, 8412364, 8412366, 8412373,
8412375, 8412377, 8412602, 8412608, 8412609, 8412613,
8412615, 8412619, 8412779, 8413013, 8413022, 8413023,
8412024, 8413029, 8413032, 8413040, 8413051, 8413053,
8413056, 8413061, 8413066, 8413073, 8413074, 8413077,
8413079, 8413081, 8413086, 8413171, 8413176, 8413181,
8413184, 8413194, 8413203, 8413204, 8413210, 8413217,
8413224, 8413225, 8413233, 8413235, 8413236, 8413244,
8413245, 8413249, 8413251, 8413264, and 8413265
b) Unit numbers 1529951, 1529953, 1529955, 1529956,
1529959, 1529961, 1529963, 1529968, 1529969, 1530720,
1530721, 1530722, 1530724, 1530733, 1530735, 1530736,
1531117, 1531118, 1531119, 1531120, 1531121, 1531123,
1531124, 1531126, 1531127, 1531176, 1531177, 1531181,
1531182, 1531260, 1531261, 1531262, 1531263, 1531264,
1531266, 1531267, 1531268, 1531270, 1531271, 1531330,
1531332, 1531334, 1531336, 1531801, 1531804, 1531819,
1532497, 1648020, 1648023, 1648026, 1648054, 1648061,
1648294, 1648297, 1648313, 1648351, 1648356, 2568070,
2568302, 2569473, 2569502, 2569520, 2569549, 2570003,
2570004, 2570466, 2570469, 2570472, 2570479, 2570481,
2570483, 2570496, 2570498, 2570501, 2570506, 2570508,
2570511, 2570515, 2570519, 2570524, 2570531, 2570533,
2570822, 2570825, 2570827, 2570828, 2570830, 2570834,
2570836, 2570837, 2570841, 2570844, 2570848, 2570853,
2570855, 2570971, 2570975, 2570977, 2570979, 2570986,
2570989, 2570993, 2570999, 2571011, 2571498, 2571611,
2571622, 2572808, 2572810, 2572812, 2572817, 2572818,
2572820, 2572821, 2572826, 2572828, 2573310, 2573313,
2573314, 2573315, 2573318, 2573319, 2573321, 2573325,
2573326, 2574018, 2574035, 2574059, 2574088, 2574098,
2574099, 2574121, 2574127, 2574142, 2574143, 2574150,
2574157, 2574166, 2574175, 2574176, 2574185, 2574688,
2574693, 2665240, 2665245, 2665247, 2665248, 2665251,
2665825, 2665827, 2665828, 2666070, 2666071, 2666072,
2666073, 2666074, 2666075, 2666076, 2666078, 2666079,
2666330, 2666516, 2666519, 2666522, 2666524, 2666526,
2666528, 2666531, 2666579, 2666671, 2666673, 2666675,
2666677, 2666678, 2666680, 2666682, 2666686, 2666688,
2666691, 2666692, 2666695, 2666699, 2666701, 2667973,
2667993, 2667996, 2667999, 2668239, 2668242, 2668253,
2668254, 3416647, 3416648, 3416651, 3416652, 3416654,
3416655, 3416658, 3416659, 3416660, 3416661, 3416662,
3416767, 3416779, 3416782, 3416785, 3417451, 3417453,
3417455, 3417457, 3417459, 3417464, 3417468, 3417472,
3417474, 3417476, 3417983, 3417985, 3418161, 3418165,
3418172, 3418174, 3418177, 3418178, 3418180, 3418183,
3418188, 3823579, 3823580, 3823582, 3823584, 3823585,
3823796, 3823797, 3823799, 3823801, 3823802, 3823804,
3823805, 3823806, 3825638, 3825640, 3825642, 3825643,
3825644, 3825647, 3825650, 3825651, 3825655, 3825657,
3825660, 3825665, 3825675, 3825782, 3825784, 3825786,
3825893, 3825894, 3825895, 3825896, 3825897, 3825898,
3825899, 3825900, 3825901, 3825902, 3825903, 3825904,
3827074, 3827077, 3827083, 3827084, 3827086, 3827087,
3827089, 3827094, 3827096, 3827102, 3827481, 3827483,
3827485, 3827699, 3827700, 3827702, 3827704, 3827706,
3827707, 3827709, 3827712, 3827713, 3827715, 3827716,
3827721, 3827724, 3827727, 4129590, 4129591, 4129592,
4129593, 4129594, 4129595, 4129598, 4129599, 4129600,
4129601, 4130018, 4130020, 4130022, 4130025, 4130026,
4130027, 4130028, 4130700, 4130701, 4130702, 4130703,
4130704, 4130705, 4130706, 4130708, 4130710, 4131243,
4131245, 4131246, 4131247, 4131248, 4131249, 4131250,
4131251, 4131252, 4131253, 4131255, 4131256, 4131258,
4131602, 4131603, 4131604, 4131716, 4131718, 4131719,
4218903, 4218906, 4219386, 4219395, 4219409, 4219415,
4219418, 4219579, 4219582, 4219584, 4219590, 4219602,
4219606, 4219607, 4220410, 4220962, 4220966, 4220975,
4220983, 4220992, 4220996, 4221002, 4221003, 4221013,
4221027, 4221365, 4221674, 4221675, 4221681, 4221688,
4221693, 4221703, 4221704, 4221705, 4221975, 4221977,
4221983, 4221986, 4221990, 4221992, 4221995, 4222001,
4222004, 4222009, 4222010, 4223443, 4223444, 4223447,
4223451, 4223452, 4223455, 4223458, 4223459, 4223462,
4223465, 4223467, 4223470, 4223471, 4223473, 4223476,
4223477, 4223479, 4223481, 4223483, 4223484, 4224173,
4224390, 4224391, 4224395, 4224399, 4224884, 4224891,
4224893, 4224897, 4224900, 4224902, 4224905, 4224909,
4224951, 4225162, 4225178, 4225184, 4225202, 4225288,
4225291, 4225293, 4225294, 4225296, 4225297, 4225300,
4225301, 4225305, 4225308, 4225313, 4225316, 4225318,
4225320, 4225445, 6541783, 6541791, 6541806, 6541807,
6547666, 6547673, 6547674, 6547681, 7802324, 7802659,
7802660, 7802661, 7802662, 7802663, 7802664, 7802665,
7802666, 7802669, 7802670, 7802671, 7802672, 7802673,
7802676, 8218258, 8218495, 8218501, 8218523, 8218525,
8218868, 8218869, 8218873, 8219277, 8219279, 8219384,
8219463, 8219467, 8219469, 8219470, 8219512, 8219514,
8219516, 8219520, 8219521, 8219579, 8219584, 8219586,
8219609, 8219613, 8219735, 8219737, 8219747, 8219751,
8219756, 8219757, 8219761, 8219762, 8219976, 8219979,
8219982, 8219986, 8219987, 8219991, 8219992, 8219995,
8219996, 8220001, 8220010, 8220049, 8220230, 8220231,
8220241, 8220246, 8220247, 8220250, 8220257, 8220267,
8220272, 8220273, 8220289, 8220290, 8220299, 8220307,
8220308, 8220483, 8220489, 8220498, 8220505, 8220509,
8220510, 8220521, 8220855, 8221140, 8222235, 8222254,
8222259, 8222263, 8222320, 8222321, 8222408, 8222416,
8222418, 8222587, 8222588, 8222589, 8222595, 8222614,
8222647, 8223084, 8223085, 8223088, 8223559, 8223563,
8223565, 8223568, 8223712, 8223717, 8224220, 8224223,
8224528, 8224530, 8224532, 8224534, 8224536, 8224541,
8224542, 8224544, 8224546, 8224573, 8225115, 8225117,
8408800, 8408801, 8408802, 8408810, 8408814, 8408816,
8408821, 8408825, 8409380, 8409385, 8409386, 8409912,
8409916, 8409920, 8409922, 8409925, 8411256, 8411267,
8412109, 8412287, 8412288, 8412307, 8412309, 8412316,
8412317, 8412318, 8412771, 8412775, 8412776, 8412777,
8412786, 8412790, 8413010, 8413016, 8413037, 8413042,
8413097, 8413211, 8413215, 8413229, 8413271, 8413278,
8413336, 8413340, 8413343, 8413346, 8413354, 8413356,
8413358, 8413359, 8413362, 8413363, 8413367, 8413368,
and 8413371
c) Unit numbers 1648060, 3827482, 3827722, 3828180,
4131254, 4131257, 4131715, 4131717, 4221696, 4225450,
and 7802668
d) Unit numbers 1531124,
1648032, 1648054, 1648061, 1648077, 2569595, 2569678,
2570466, 2570472, 2570496, 2570498, 2570501, 2570504,
2570506, 2570508, 2570822, 2570825, 2570827, 2570828,
2570834, 2570843, 2570853, 2570949, 2570951, 2570962,
2570971, 2571611, 2571618, 2571622, 2574098, 2574583,
2666074, 2666678, 2730777, 3824488, 3825904, 3827077,
3827709, 3827712, 3827713, 3827716, 3827727, 4130703,
4130704, 4130705, 4130706, 4130708, 4130709, 4131246,
4131255, 4131257, 4219418, 4221674, 4221675, 4221681,
4221688, 4221690, 4221693, 4221696, 4222242, 4222254,
4222262, 4224884, 6541784, 6541806, 6541869, 8219463,
8219465, 8219467, 8219511, 8219737, 8219761, 8220001,
8222281, 8222591, 8222595, 8222647, 8224220, 8224223,
8408802, 8408825, 8409356, 8409386, 8412343, 8412353,
8412366, 8412777, and 8412786;
e) Unit numbers 1529953, 1531126, 1531178, 1531801,
1531804, 1531814, 1530819, 1530819, 1532478, 1532481,
1532484, 1532488, 1532491, 1532496, 1532502, 1532507,
1532512, 1532514, 1648037, 1648043, 1648052, 1648053,
1648060, 2568650, 2568652, 2568656, 2568659, 2568662,
2568667, 2570469, 2570479, 2570481, 2570483, 2570490,
2570515, 2570944, 2571602, 2571605, 2573312, 2573314,
2573315, 2573318, 2573321, 2573325, 2573502, 2573512,
2573529, 2573530, 2573540, 2573541, 2574018, 2574059,
2574088, 2574143, 2574166, 2574175, 2574185, 2574568,
2574571, 2574578, 2574756, 2574758, 2574764, 2574766,
2575075, 2575079, 2575086, 2575098, 2575102, 2575109,
2575113, 2575126, 2575131, 2575135, 2575136, 2575156,
2665245, 2665247, 2665248, 2665827, 2665832, 2666069,
2666071, 2666072, 2666073, 2666076, 2666079, 2666578,
2666673, 2666675, 2666677, 2666680, 2666682, 2667973,
2667993, 2667999, 2668242, 2668247, 2668254, 2730772,
2730773, 2730774, 2730775, 2730780, 2730782, 3417451,
3417453, 3417455, 3417457, 3417459, 3417474, 3417476,
3417975, 3417976, 3417978, 3417979, 3417980, 3417983,
3417986, 3417988, 3417990, 3417991, 3418163, 3418174,
3418183, 3418184, 3418185, 3418188, 3418193, 3418195,
3823585, 3824480, 3824481, 3824491, 3824492, 3825643,
3825650, 3825660, 3825665, 3825675, 3825893, 3825894,
3825899, 3825901, 3827064, 3827067, 3827068, 3827071,
3827074, 3827083, 3827084, 3827086, 3827089, 3827094,
3827096, 3827102, 3827482, 3827485, 3827699, 3827700,
3827704, 4129590, 4129598, 4131248, 4131258, 4131602,
4131604, 4131656, 4131657, 4131658, 4219412, 4220090,
4220098, 4220109, 4220123, 4220140, 4221351, 4221358,
4221359, 4221363, 4221371, 4221373, 4221375, 4221379,
4221975, 4221977, 4221979, 4221986, 4221992, 4221995,
4222001, 4222004, 4222009, 4222013, 4222216, 4222235,
4223443, 4223447, 4224399, 4224403, 4224406, 4224411,
4224414, 4224415, 4224419, 4224889, 4224893, 4224902,
4224958, 4225184, 4225202, 4225229, 4225230, 4225232,
4225233, 4225237, 4225239, 4225240, 4225289, 4225293,
4225297, 4225300, 4225308, 4225309, 4225310, 4225314,
4225316, 4225361, 4225365, 4225367, 4225372, 4225373,
4225377, 4225378, 4225383, 4225405, 4225440, 4225443,
4225445, 4225450, 4225456, 4225464, 4225465, 4225472,
4225475, 4225479, 6541774, 6541783, 6541791, 6541801,
6541807, 6541815, 6541825, 6541826, 6541835, 6541837,
6541852, 6541871, 8218258, 8219469, 8219470, 8219971,
8219972, 8219976, 8219979, 8219982, 8219986, 8219987,
8219991, 8219992, 8219995, 8219996, 8220498, 8220505,
8220521, 8221253, 8221256, 8222273, 8222604, 8222614,
8222615, 8222642, 8222645, 8222646, 8223085, 8224550,
8224923, 8224927, 8408397, 8408800, 8408801, 8408821,
8409138, 8409380, 8409912, 8409913, 8411258, 8411260,
8411261, 8411264, 8411266, 8411271, 8411276, 8412092,
8412096, 8412099, 8412102, 8412104, 8412116, 8412127,
8412167, 8412170, 8412281, 8412287, 8412291, 8412294,
8412296, 8412298, 8412299, 8412300, 8412302, 8412304,
8412316, 8412602, 8412609, 8412613, 8412619, 8413181,
8413184, 8413194, 8413203, 8413204, 8413210, 8413211,
8413217, 8413229, 8413235, 8413236, 8413244, 8413245,
8413249, 8413251, 8413264, 8413265, 8413272, 8413340,
8413344, 8413348, and 8413362
f) Unit numbers 2665825, 26666070, 4131253, 8219747,
8412090, 8412154, 8412285, 8412293, and 8412615
g) Unit numbers 1530719, 1530720, 1530721, 1530722,
1530724, 1530726, 1531117, 1531118, 1531121, 1531177,
1531182, 1531259, 1531261, 1531266, 1531804, 1530819,
1532478, 1532481, 1532488, 1532491, 1532496, 1532507,
1532512, 1532514, 1648023, 1648026, 1648040, 1648043,
1648052, 1648053, 1648085, 2568302, 2570511, 2570533,
2571602, 2572812, 2572821, 2572828, 2573312, 2573314,
2573315, 2573318, 2573325, 2573502, 2573529, 2573530,
2573540, 2573690, 2574018, 2574143, 2574166, 2574175,
2574176, 2574185, 2574578, 2574766, 2575075, 2575098,
2575109, 2575136, 2575153, 2575156, 2665812, 2665815,
2665819, 2665820, 2665825, 2665827, 2665832, 2666330,
2666331, 2666516, 2666530, 2666673, 2666675, 2666677,
2666680, 2666682, 2667973, 2667993, 2667996, 2667999,
2668237, 2668242, 2668246, 2668254, 2730774, 2730775,
2730778, 2730780, 2730784, 3416782, 3417453, 3417457,
3417459, 3417474, 3417979, 3417980, 3417981, 3417989,
3825782, 3825784, 3825786, 3825896, 3825897, 3825898,
3825899, 3825900, 3825901, 3827067, 3827074, 3827080,
3827083, 3827084, 3827086, 3827089, 3827107, 3827482,
3828180, 4130006, 4130010, 4130013, 4130014, 4130016,
4130017, 4130018, 4130020, 4130026, 4130028, 4130453,
4130710, 4131248, 4131249, 4131251, 4131252, 4131253,
4131254, 4131256, 4131258, 4131270, 4131602, 4131603,
4219399, 4219400, 4219404, 4219407, 4219409, 4219412,
4220966, 4220996, 4221002, 4221013, 4221351, 4221357,
4221358, 4221359, 4221363, 4221977, 4221979, 4221992,
4222255, 4222276, 4223443, 4223447, 4223451, 4223467,
4223470, 4223471, 4223479, 4223481, 4224391, 4224406,
4224414, 4224900, 4224905, 4224909, 4224949, 4224961,
4225161, 4225173, 4225181, 4225202, 4225229, 4225230,
4225237, 4225405, 4718843, 4718846, 4718867, 4718868,
6541774, 6541791, 6541807, 6541815, 6541832, 6541837,
6541859, 6547639, 6547650, 6547652, 6547666, 6547681,
7802323, 7802324, 7802326, 7802327, 7802328, 7802329,
7802330, 8218485, 8219277, 8219279, 8219384, 8219462,
8219469, 8219470, 8219584, 8220218, 8222254, 8222259,
8222263, 8222273, 8222414, 8222604, 8222614, 8222615,
8222642, 8222645, 8222646, 8222649, 8223084, 8223559,
8223565, 8223568, 8223574, 8223711, 8224526, 8224530,
8224532, 8224533, 8224541, 8224542, 8224544, 8224550,
8224575, 8224576, 8224586, 8224923, 8408814, 8408816,
8409912, 8409920, 8409922, 8409924, 8411254, 8411256,
8411258, 8411260, 8411266, 8411271, 8411274, 8411276,
8411278, 8412104, 8412114, 8412137, 8412142, 8412170,
8412285, 8412291, 8412298, 8412302, 8412346, 8412356,
8412364, 8412369, 8412372, 8412373, 8412375, 8412377,
8412608, 8412609, 8412613, 8412615, 8412619, 8413010,
8413016, 8413017, 8413022, 8413040, 8413045, 8413053,
8413056, 8413061, 8413066, 8413073, 8413074, 8413079,
8413081, 8413171, 8413176, 8413271, 8413272, and
8413278;
h) Unit numbers 1532503, 1648061, 2569595, 2569678,
2570466, 2570472, 2570496, 2570501, 2570504, 2570506,
2570828, 2571618, 2573319, 2574098, 2574127, 2666074,
3824488, 3827709, 3827712, 3827713, 3827716, 3827724,
3827727, 4130705, 4130706, 4130708, 4131246, 4131255,
4131257, 4219418, 4225356, 8219465, 8219467, 8219511,
8219737, 8219761, 8220001, 8224220, 8224224, 8224552,
8224925, 8408802, 8408825, 8409356, 8409386, 8412343,
8412349, and 8412366;
i) Unit numbers 8219462, 8220494, 8220495, 8223559, and
8224526;
j) Unit number 8412372;
k) Unit numbers 8413336, 8413354, and 8413368;
l) Unit numbers 1529953, 1529955, 1529956, 1529959,
1529961, 1529963, 1529968, 1529969, 1530723, 1530728,
1530731, 1530735, 1530736, 1531119, 1531120, 1531123,
1531126, 1531172, 1531173, 1531174, 1531175, 1531176,
1531178, 1531179, 1531814, 1532484, 1532493, 1532497,
1532502, 1532508, 1532513, 1648020, 1648032, 1648054,
1648078, 1648083, 1648167, 1648173, 1648174, 1648178,
1648183, 1648184, 1648191, 1648197, 1648201, 1648204,
1648281, 1648282, 1648289, 1648294, 1648297, 1648300,
1648306, 1648313, 1648314, 1648320, 1648326, 1648333,
1648340, 1648345, 1648351, 1648356, 2568058, 2568063,
2568066, 2568070, 2568073, 2568076, 2568079, 2568083,
2568084, 2568089, 2568311, 2568650, 2568652, 2568659,
2568662, 2568663, 2568667, 2568670, 2568671, 2568680,
2569353, 2569473, 2569502, 2569520, 2569549, 2569601,
2569630, 2569666, 2569716, 2569752, 2569778, 2569790,
2569831, 2569832, 2569858, 2569877, 2569928, 2570003,
2570004, 2570042, 2570060, 2570115, 2570469, 2570479,
2570481, 2570483, 2570490, 2570498, 2570508, 2570515,
2570519, 2570524, 2570531, 2570821, 2570822, 2570825,
2570827, 2570830, 2570834, 2570836, 2570837, 2570841,
2570844, 2570848, 2570944, 2570949, 2570960, 2570962,
2570971, 2570977, 2570979, 2570986, 2570989, 2570993,
2570999, 2571011, 2571479, 2571483, 2571484, 2571486,
2571488, 2571490, 2571492, 2571494, 2571495, 2571498,
2571500, 2571501, 2571600, 2571601, 2571605, 2571611,
2571613, 2571616, 2571622, 2572808, 2572810, 2572817,
2572818, 2572820, 2572826, 2573310, 2573321, 2573326,
2574004, 2574035, 2574121, 2574150, 2574564, 2574568,
2574571, 2574581, 2574585, 2574589, 2574693, 2574696,
2574756, 2574764, 2575140, 2665240, 2665245, 2665247,
2665248, 2665251, 2665816, 2665822, 2665828, 2665830,
2665831, 2665988, 2665989, 2665991, 2665992, 2665993,
2665994, 2665995, 2665996, 2665997, 2665999, 2666069,
2666070, 2666071, 2666072, 2666073, 2666075, 2666076,
2666077, 2666078, 2666079, 2666177, 2666180, 2666181,
2666182, 2666184, 2666187, 2666192, 2666193, 2666196,
2666199, 2666201, 2666517, 2666519, 2666522, 2666524,
2666526, 2666528, 2666531, 2666534, 2666578, 2666579,
2666580, 2666581, 2666583, 2666586, 2666587, 2666589,
2666590, 2666671, 2666678, 2666686, 2666688, 2666691,
2666692, 2666695, 2666699, 2666701, 2667996, 2668000,
2668239, 2668244, 2668253, 2730772, 2730773, 2730776,
2730777, 2730782, 2730783, 3416647, 3416648, 3416651,
3416652, 3416654, 3416655, 3416658, 3416659, 3416660,
3416661, 3416662, 3416767, 3416769, 3416774, 3416779,
3416785, 3417451, 3417455, 3417464, 3417468, 3417472,
3417476, 3417982, 3417984, 3417989, 3823579, 3823582,
3823584, 3823796, 3823797, 3823799, 3823801, 3823802,
3823804, 3823805, 3823806, 3824480, 3824481, 3824487,
3824491, 3824492, 3825638, 3825640, 3825642, 3825643,
3825644, 3825646, 3825647, 3825650, 3825651, 3825655,
3825657, 3825660, 3825661, 3825665, 3825671, 3825675,
3825679, 3825778, 3825788, 3825893, 3825894, 3825902,
3825903, 3825904, 3827068, 3827077, 3827087, 3827102,
3827488, 3827704, 3827707, 3827715, 3827725, 4129590,
4129594, 4129595, 4129598, 4129599, 4129600, 4129601,
4130007, 4130022, 4130025, 4130029, 4130450, 4130452,
4130700, 4130701, 4130702, 4130703, 4130709, 4131243,
4131247, 4131250, 4131656, 4131657, 4131658, 4131713,
4131714, 4131715, 4131717, 4131718, 4131719, 4218903,
4218906, 4218908, 4219386, 4219395, 4219415, 4219572,
4219573, 4219576, 4219579, 4219582, 4219584, 4219589,
4219590, 4219595, 4219596, 4219602, 4219606, 4219607,
4220090, 4220095, 4220098, 4220109, 4220120, 4220123,
4220140, 4220153, 4220154, 4220410, 4220962, 4220975,
4220983, 4220992, 4221003, 4221027, 4221365, 4221371,
4221373, 4221375, 4221379, 4221388, 4221674, 4221675,
4221681, 4221685, 4221688, 4221690, 4221693, 4221696,
4221703, 4221704, 4221705, 4221975, 4221986, 4221990,
4221995, 4221998, 4222001, 4222004, 4222009, 4222010,
4222013, 4222216, 4222221, 4222228, 4222235, 4222242,
4222245, 4222254, 4222262, 4222283, 4223025, 4223027,
4223029, 4223032, 4223034, 4223035, 4223038, 4223042,
4223044, 4223050, 4223053, 4223055, 4223057, 4223059,
4223452, 4223458, 4223459, 4223465, 4223473, 4223476,
4223477, 4224173, 4224390, 4224399, 4224403, 4224411,
4224415, 4224419, 4224889, 4224951, 4224954, 4224955,
4224958, 4224960, 4225162, 4225178, 4225288, 4225289,
4225297, 4225300, 4225305, 4225310, 4225314, 4225318,
4225369, 4225384, 4225388, 4225434, 4225446, 4225458,
4718849, 4718855, 4718856, 4718861, 4718872, 4718874,
6541772, 6541783, 6541784, 6541801, 6541806, 6541825,
6541826, 6541835, 6541852, 6541869, 6541871, 6547645,
6547656, 6547673, 6547674, 7802325, 7802331, 7802659,
7802661, 7802662, 7802663, 7802664, 7802665, 7802666,
7802668, 7802669, 7802671, 7802672, 7802673, 7802676,
8218258, 8218470, 8218476, 8218491, 8218495, 8218501,
8218509, 8218523, 8218525, 8218868, 8218869, 8218873,
8219497, 8219512, 8219514, 8219516, 8219517, 8219520,
8219521, 8219586, 8219613, 8219735, 8219747, 8219751,
8219756, 8219757, 8219762, 8219768, 8219769, 8219776,
8219777, 8219779, 8219781, 8219782, 8219786, 8219787,
8219789, 8219790, 8219821, 8219971, 8219972, 8219974,
8219976, 8219979, 8219982, 8219983, 8219986, 8219987
8220041, 8220045, 8220046, 8220049, 8220051, 8220058,
8220097, 8220100, 8220101, 8220105, 8220106, 8220109,
8220110, 8220115, 8220230, 8220231, 8220241, 8220246,
8220247, 8220250, 8220257, 8220263, 8220267, 8220272,
8220273, 8220289, 8220290, 8220299, 8220307, 8220308,
8220316, 8220323, 8220333, 8220334, 8220342, 8220354,
8220370, 8220381, 8220398, 8220416, 8220428, 8220429,
8220445, 8220451, 8220454, 8220459, 8220483, 8220489,
8220495, 8220498, 8220505, 8220509, 8220510, 8220521,
8220599, 8220611, 8220659, 8220730, 8220855, 8220857,
8220858, 8220861, 8221135, 8221136, 8221140, 8221142,
8221143, 8221145, 8221253, 8221255, 8221256, 8222235,
8222281, 8222320, 8222321, 8222408, 8222411, 8222416,
8222418, 8222587, 8222588, 8222589, 8222591, 8222595,
8222641, 8222647, 8222650, 8223085, 8223088, 8223563,
8223712, 8223717, 8224200, 8224203, 8224210, 8224231,
8224528, 8224534, 8224536, 8224546, 8224571, 8224573,
8408397, 8408800, 8408801, 8408809, 8408810, 8408821,
8409132, 8409137, 8409138, 8409344, 8409346, 8409348,
8409349, 8409352, 8409355, 8409357, 8409359, 8409363,
8409364, 8409366, 8409369, 8409380, 8409382, 8409385,
8409913, 8411264, 8411267, 8412090, 8412092, 8412096,
8412099, 8412102, 8412105, 8412109, 8412112, 8412116,
8412127, 8412154, 8412281, 8412282, 8412287, 8412293,
8412294, 8412296, 8412300, 8412304, 8412309, 8412316,
8412317, 8412355, 8412360, 8412602, 8412775, 8412779,
8413023, 8413036, 8413042, 8413077, 8413086, 8413097,
8413336, 8413340, 8413344, 8413346, 8413348, 8413351,
8413354, 8413362, 8413363, 8413367, 8413368, and 8413371
RECALLING FIRM/MANUFACTURER
Central Indiana Regional Blood Center, Indianapolis, IN, by
letter on May 28, 2002. Firm initiated recall complete.
REASON
Blood products, collected by an employee who was observed to use a phlebotomy method that may have compromised the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 621 units;
b) 623 units;
c) 11 units;
d) 88 units;
e) 349 units;
f) 9 units;
g) 304 units;
h) 48 units;
i) 5 units;
j) 1 unit;
k) 3 units;
l) 748 units
DISTRIBUTION
IN, MI, NJ, OH, and Switzerland.
_____________________________
PRODUCT
Blood-Pack Units with PL732 Pack:
a) Product code 4R3431. Recall # B-0482-3;
b) Product code 4R3436. Recall # B-0483-3;
c) Product code 4R3446. Recall # B-0484-3;
d) Product code 4R3447. Recall # B-0485-3;
e) Product code 4R3631. Recall # B-0486-3;
f) Product code 4R3636. Recall # B-0487-3;
g) Product code 4R3637. Recall # B-0488-3.
CODE
a) Lots:
M02G18013, M02G25034 M02I10016 M02I27010
Lots:
M02A08033, M02A14015, M02A17042
b) Lots:
M02G09012, M02G15035, M02G17031,
M02G22049, M02G25042, M02G29010,
M02G29028, M02G31024, M02H01025,
M02H02015, M02H05034, M02H07022,
M02H09036, M02H14028, M02I05032
M02A10047, M02A14049, M02A14056,
M02A17034, M02A21036, M02F28048
c) Lots:
M02G18039, M02G30059;
d) Lot:
M02I09034;
e) Lot:
M02A18040, M02G10044, M02H16098;
f) Lot:
M02H19076;
g) Lot:
M02H15041.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp./Fenwal, Deerfield, IL, by letter dated November 7, 2002 and November 21, 2002. Firm initiated recall ongoing.
REASON
PL 732 Platelet Container may split during component preparation.
VOLUME OF PRODUCT IN COMMERCE
36 lots.
DISTRIBUTION
Nationwide and Puerto Rico.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0489-3.
CODE
Unit 53FM55731.
RECALLING FIRM/MANUFACTURER
American Red Cross, Chesapeake Region, Baltimore, MD., by letter on July 25, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor with a history of Multiple Sclerosis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
DC.
_____________________________
PRODUCT
Platelet, Pheresis, Leukoreduced (Split unit).
Recall # B-0503-3.
CODE
Unit 7462326
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New Brunswick, NJ., by telephone on November 14, 2001. Firm initiated recall complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the unit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ.
_____________________________
PRODUCT
Platelets, Leukoreduced. Recall # B-0504-3.
CODE
Units 18FS58532, 18FS58509, 18FS58510, 18FS58528, 18FS58552.
RECALLING FIRM/MANUFACTURER
American Red Cross/Great Lakes Region, Lansing, Michigan, by telephone on November 12, 2001. Firm initiated recall complete.
REASON
Blood products, collected in a manner that may compromised the sterility of the product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
MI.
_____________________________
PRODUCT
Platelet, Pheresis, Leukoreduced(split units).
Recall # B-0505-3.
CODE
Unit LH61941.
RECALLING FIRM/MANUFACTURER
The Blood Center of Southeastern Wisconsin, Inc., Milwaukee, WI., by telephone on March 29, 2002 and by letter dated March 26, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor who reported travel to an are designated as endemic for malaria, were istributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
WI.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0506-3
CODE
Units 53GH54579, 53GH55487, 53GH53938, 53GH53350.
RECALLING FIRM/MANUFACTURER
American Red Cross, Baltimore, MD, by letters dated January 16, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor who had traveled to an area designated as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
MD, VA and DC.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0507-3;
b) Platelets. Recall # B-0508-3;
c) Fresh Frozen Plasma. Recall # B-0509-3;
d) Recovered Plasma. Recall B-05010-3.
CODE
a) and b) Units FJ83388, FK43924;
c) Unit FK43924;
d) Unit FJ83388.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc. Providence, Rhode Island, by letter dated August 23, 2002 and by facsimile dated August 23, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor who was taking the medication Methotrexate, were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 2 units;
b) 2 units;
c) 1 unit;
d) 1 unit.
DISTRIBUTION
MA and RI.
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0511-3.
CODE
Unit 18FQ69853.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI., by telephone on July 25, 2002. Firm initiated recall complete.
REASON
Blood product, that was not properly quarantined after the donor of the product reported a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0512-3;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-0513-3;
c) Platelets. Recall # B-0514-3;
d) Cryoprecipitated AHF. Recall # B-0515-3;
e) Fresh Frozen Plasma. Recall # B-0516-3;
f) Buffy Coat for further manufacture. Recall # B-0517-3;
g) Recovered Plasma. Recall # B-0518-3.
CODE
a) unit 18Q75127;
b) unit 18FJ41749 and 18FE64623;
c) unit 18Q75127;
d) unit 18FJ41749;
e) unit 18FE64623;
f) unit 18FJ41749;
g) units 18FJ41749 and 18Q75127.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI., by telephone on June 1, 2001, facsimile on June 2, 2001, and by letters on June 5, 2001, and July 6 and 26, 2001. Firm initiated recall complete.
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
a) 1 unit;
b) 2 units;
c) 1 unit;
d) 1 unit;
e) 1 unit;
f) 1 unit;
g) 2 units.
DISTRIBUTION
MI, OH and Switzerland.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0519-3;
b) Recovered Plasma. Recall # B-0520-3.
CODE
a) and b) Unit 7026171.
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., New Brunswick, NJ, by telephone on July 26, 2001 and by Facsimile on July 30, 2001. Firm initiated recall complete.
REASON
Blood products, that tested negative for the antibody to hepatitis C virus (anti-HCV), but were collected from an ineligible donor based on the subsequent disclosure of a previous positive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NJ and Switzerland.
_____________________________
PRODUCT
Recovered Plasma. Recall # B-0521-3.
CODE
Unit 1179950.
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by facsimile on November 12, 2002. Firm initiated recall 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
Austria.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0522-3;
b) Platelets. Recall # B-0523-3.
CODE
a) and b) unit S21744.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Michigan Community Blood Centers, Grand Valley Blood Program, Grand Rapids, MI., by facsimile on October 8, 2002.
Manufacturer: Michigan Community Blood Centers, Saginaw Valley Blood Program, Saginaw, MI. Firm initiated recall complete.
REASON
Blood products, collected using a phlebotomy method that may have compromised the sterility of the products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-0535-3;
b) Recovered Plasma. Recall # B-0536-3.
CODE
a) and b) unit 53G57605.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD., by facsimile June 25, 2002, and by letters dated June 26, 2002, and September 25, 2002. Firm initiated recall complete.
REASON
Blood products, collected from an unsuitable donor due to medication with the drug Purinethol, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MD and CA.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0537-3;
b) Platelets. Recall # B-0538-3.
CODE
a) and b) unit 53FK74539.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Greater Chesapeake and Potomac Region, Baltimore, MD., by letters dated March 13, 2002, and September 12, 2002. Firm initiated recall complete.
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
MD.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0539-3;
b) Platelets. Recall # B-0540-3.
CODE
a) and b) unit G68615.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI., by facsimile on May 28, 2002. Firm initiated recall complete.
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
MI.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-0541-3;
Platelets. Recall # B-0542-3.
CODE
a) and b) unit G97684.
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Center, Grand Valley Blood Program, Grand Rapids, MI., by facsimile on September 30, 2002. Firm initiated recall complete.
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
MI.
_____________________________
PRODUCT
Red Blood Cells. Recall # B-0543-3;
Recovered Plasma. Recall # B-0544-3.
CODE
a) and b) unit 8074141.
RECALLING FIRM/MANUFACTURER
LifeSource Blood Services, Glenview, IL., by telephone on January 16, 2002, and June 13, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor who should have been deferred due to use of the medication Arthrotec, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL and Switzerland.
_____________________________
PRODUCT
a) Red Blood Cells. Recall # B-0545-3;
b) Cryoprecipitated AHF. Recall # B-0546-3;
c) Recovered Plasma. Recall # B-0547-3.
CODE
a), b) and c) unit 2187382.
RECALLING FIRM/MANUFACTURER
LifeSource Blood Services, Glenview, IL., by telephone on June 17, 2002 and July 15, 2002. Firm initiated recall complete.
REASON
Blood products, collected from a donor who should have been deferred due to use of the medication Arthrotec, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
IL and Switzerland.
_____________________________
PRODUCT
a) Red Blood Cells, Leukocytes Removed. Recall # B-0550-3;
b) Platelets. Recall # B-0551-3;
c) Recovered Plasma. Recall # B-0552-3.
CODE
a) Units 24215-5676, 24214-6871, 24214-1594, 24213-1259,
24212-6081, 24212-1121;
b) Units 24212-6081, 24212-1121;
c) Units 24215-5676, 24214-6871, 24214-1594, 24213-1259,
24212-6081, 24212-1121.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ., by telephone on June 4, 2002, or by letter dated June 26, 2002.
Manufacturer: United Blood Services, Rapid City, SD. Firm initiated recall is ongoing.
REASON
Blood products, collected from an unsuitable donor due to behavior associated with an increased risk of infection with the human immunodeficiency virus (HIV) or the hepatitis B virus (HBV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
a) 6 units;
b) 2 units;
c) 6 units.
DISTRIBUTION
SD, AR and MS.
_____________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0467-3.
CODE
Unit number 021KP32558.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone on April 11, 2002. Firm initiated recall complete.
REASON
Blood product, that exceeded the firm's specification for transit without agitation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI
_____________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced (3 units),
Recall # B-0548-3.
CODE
Unit numbers F10514, F10636, and F10698.
RECALLING FIRM/MANUFACTURER
Aurora Area Blood Bank, Heartland Blood Centers, Aurora, IL, by telephone on November 5, 2002. Firm initiated recall complete.
REASON
Blood products that were out of controlled storage for more than 30 minutes were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
Il. and IN.
_____________________________
PRODUCT
Hex-Lock Abutment, 2.5 mm Diameter. This medical device is designed for use in the firm's Sulzer Dental Implant Systems for use in edentulous mandibles or maxillae for attachment of complete denture prostheses, or as a terminal or intermediary abutment for fixed or removable bridgework, or as a free standing single tooth replacement. The abutment is screwed onto an endosseous dental implant, protrudes through the gingiva and is attached to the
prostheses or fabricated tooth. The catalog numbers affected are HLA3/4. The devices are labeled sterile.
Recall # Z-1034-02.
CODE
Lot 012239, Exp Date 7/2006
RECALLING FIRM/MANUFACTURER
Sulzer Dental Inc. Carlsbad, by telephone on July 31, 2001. Firm initiated recall complete.
REASON
Sterility
VOLUME OF PRODUCT IN COMMERCE
1
DISTRIBUTION
PA
_____________________________
PRODUCT
a) 0.9% Sodium Chloride Flush Syringe, 30 syringes per
case. Recall # Z-0456-03;
b) 10 U/mL Heparin Lock Flush Solution USP, 5mL in 12 mL
Syringe, 30 syringes per case. Recall # Z0457-3;
c) 100 U/mL Heparin Lock Flush Solution USP; 30 syringes
per case. Recall # Z-0458-03.
CODE
a) All lots within expiration date of the following pre-
filled syringes:
Code 2K0901: 2 mL in 3 mL syringe
Code 2K0903: 3 mL in 6 mL syringe
Code K0905: 5 mL in 12 mL syringe
Code 2K0906: 10 mL in 12 mL syringe
Code 2K6011: 2 mL in 3 mL syringe w/cannula
Code 2K6012: 3mL in 6 mL syringe w/cannula
Code 2K6013: 5 mL in 12 mL syringe w/cannula
Code 2K6014: 10 mL in 12 mL syringe w/cannula.
b) Code 2K6030, All lots within expiration date.
c) All lots within expiration date of the following pre-
filled syringes:
Code 2K6049: 3 mL in 12 mL syringe
Code 2K6050: 5 mL in 12 mL syringe
Code 2K6058: 5 mL in 12 mL syringe w/cannula.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL., by letter dated December 12, 2002.
Manufacturer: Baxter Healthcare Corporation, Deerfield, IL. Firm initiated recall ongoing.
REASON
Sterility questioned.
VOLUME OF PRODUCT IN COMMERCE
a) 51,052,140 syringes;
b) 388,080 syringes;
c) 727,560 syringes.
DISTRIBUTION
Nationwide, Canada, Honduras, Indonesia and Israel.
____________________________
PRODUCT
a) Zimmer Alumina ceramic femoral head; 26 mm diameter
alumina head with a 0 neck length on Co-Cr 12/14
tapers. Cat. No. 6418-26-02. Recall # Z-0459-3
b) Zimmer Alumina ceramic femoral head; 26 mm diameter
alumina head with a +3.0 neck length on Co-Cr 12/14
tapers. Cat. No. 6418-26-03. Recall # Z-0460-3.
c) Zimmer Alumina ceramic femoral head; 26 mm diameter
alumina head with a +3.5 neck length on Co-Cr tapers.
Cat. No. 6418-28-03. Recall # Z-0461-3.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by letter dated January 6, 2002. Firm initiated recall is ongoing.
REASON
Compression test results are not in accordance with device approval submission.
VOLUME OF PRODUCT IN COMMERCE
362.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Premier brand C. difficile Toxin A, diagnostic test
kits, one kit per pouch, one pouch per shipping box.
Recall # Z-0463-3.
b) Premier brand Toxins A. & B, diagnostic test kits, one
kit per pouch, one pouch per shipping box.
Recall # Z-0464-3.
c) Premier Platinum brand HpSA, diagnostic test kits, one
kit per pouch, one pouch per shipping box.
Recall # Z-0465-3.
CODE
a) Lot #601096.180, Exp Date 27 SEP 03; Kit Catalog
#601096.
b) Lot #616096.053, Exp Date 23 JUL 03; Lot #616096.055,
Exp Date 23 JUL 03; Lot #616096.056, Exp Date 23 JUL 03;
Kit Catalog #616096.
c) Lot #601348.069, Exp Date 22 SEP 03; Lot #601348.070,
Exp Date 22 SEP 03; Kit Catalog #601348.
RECALLING FIRM/MANUFACTURER
Meridian Bioscience Inc., Cincinnati, OH, by letter on December 26, 2002. Firm initiated recall is ongoing.
REASON
Due to defective packaging, the firm cannot assure product stability through the labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE
a) 1,215 kits;
b) 1,409 kits;
c) 1,020 kits.
DISTRIBUTION
Nationwide and Internationally.
_____________________________
PRODUCT
Kendall Argyle 3.7 Fr Polyurethane Umbilical Vessel Catheter. Recall # Z-0471-3.
CODE
Reference Number: 8888-160350
Lot Numbers: U14250, U15530, U15850, U16210, U16460,
U16670, 423878.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tyco Healthcare Group Lp/Kendall Mansfield, MA, by letter on October 2, 2001.
Manufacturer: Kendall, a division of Tyco Healthcare Group LP Argyle, NY. Firm initiated recall is ongoing.
REASON
Lumen of Catheter may not accomodate the designated blood gas sensor.
VOLUME OF PRODUCT IN COMMERCE
734 cases (10/case).
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Versys Hip System femoral stem, fiber metal midcoat,
collared, 12/14 neck taper, low head center, size ll,
standard body. Cat. No. 7841-11-10. Recall # Z-0472-30;
b) Versys Hip System femoral stem, fiber metal midcoat,
collared, 12/14 neck taper, low head center, size l2,
standard body. Cat. No. 7841-12-10. Recall # Z-0473-30;
c) Versys Hip System femoral stem, fiber metal midcoat,
collared, 12/14 neck taper, low head center, size l3,
standard body. Cat. No. 7841-13-10. Recall # Z-0474-30;
d) Versys Hip System femoral stem, fiber metal midcoat,
collared, 12/14 neck taper, low head center, size l4,
standard body. Cat. No. 7841-14-10. Recall # Z-0475-30;
e) Versys Hip System femoral stem, fiber metal midcoat,
collared, 12/14 neck taper, low head center, size l5,
standard body. Cat. No. 7841-15-10. Recall # Z-0476-30;
f) Versys Hip System femoral stem, fiber metal midcoat,
collared, 12/14 neck taper, low head center, size l6,
standard body. Cat. No. 7841-16-10. Recall # Z-0477-30;
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN., by letter and via e-mail on January 7, 2003. Firm initiated recall ongoing.
REASON
The femoral heads will not seat onto the taper of the hip stem, as the head impinges on the radius undercut below the taper.
VOLUME OF PRODUCT IN COMMERCE
383
DISTRIBUTION
Nationwide, Australia and Canada.
_____________________________
PRODUCT
PO2 electrode for Roche AVL OMNI Analyzers. Catalog number BP1734. Recall # Z-0438-3.
CODE
All PO2 electrodes are affected.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis, IN., by letter dated December 16, 2002. Firm initiated recall is ongoing.
REASON
Air bubbles trapped in the PO2 electrode will cause falsely elevated patient test results.
VOLUME OF PRODUCT IN COMMERCE
695.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
a) Roche/Hitachi Modular Analytics E 170 Module.
Recall # Z-0454-3;
b) Roche/Hitachi Integrated MODULAR ANALYTICS E 170 Module.
Recall # Z-0455-3.
CODE
All units of all catalog numbers [7656961, 7657009, 7657021 and 7657900].
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp., Indianapolis, IN, by letter dated October 18, 2002.
Manufacturer: Hitachi Ltd., Ibaraki-ken 312-8504, Japan. Firm initiated recall is ongoing.
REASON
Fluid leak may cause smoke/damage analyzer.
VOLUME OF PRODUCT IN COMMERCE
116.
DISTRIBUTION
Nationwide and Canada.
_____________________________
PRODUCT
ComforTEC II Single Use pH Probe Latex Free. Packaged individually. Recall # Z-0466-3.
CODE
All product models: C2NS, C2NS-P, C2NS-A, C2N5, C2N10, C2N15, C2N10-V, C2IS,
C2I5, C2I10, C2I15, C2I10-V. All lot numbers: U02314 through U021216N-15G.
RECALLING FIRM/MANUFACTURER
Sandhill Scientific, Inc., Highlands Ranch, CO, by letter on January 8, 2003. Firm initiated recall is ongoing.
REASON
Failure of the dry silver chloride reference, resulting in malfunction and a 'Lead Off' indication.
VOLUME OF PRODUCT IN COMMERCE
6678 probes.
DISTRIBUTION
Nationwide, Argentina, Canada, Chile, China, Ireland, Italy, Jordan, Malaysia, Netherlands and Spain.
_____________________________
PRODUCT
Red Rooster Booster, Super Gallo (brand), 60 capsules. Recall # V-011-3.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Thomas Laboratories, Tolleson, AZ, by letters on or about November 8, 2002. State initiated recall is ongoing.
REASON
Is not labeled "Do not feed to cattle or other ruminants" and contains a bovine tissue derivative.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.
_____________________________
PRODUCT
CATTLE FEED, Flock #999, Date: 12/5/02, Quantity 8000, Load A, Feed C205, Grower# Z001, Tag C100. Recall # V-012-3.
CODE
C-205, C-210, C-220, C-302, C-406 and all other codes manufactured and distributed by Grove River Mills, Inc.,
RECALLING FIRM/MANUFACTURER
Grove River Mills Inc., Pendergrass, GA, by telephone and letter on December 9, 2002. Firm initiated recall is ongoing.
REASON
Cattle Feed contaminated with prohibited materials.
VOLUME OF PRODUCT IN COMMERCE
235,668 lbs.
DISTRIBUTION
GA.
END OF ENFORCEMENT REPORT FOR FEBRUARY 5, 2003
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