June 23, 2004
04-25
_______________________________
PRODUCT
Trail Mix, Net Wt. 4.5 oz. (127.58 g), packaged in a rigid plastic container.
Recall # F-254-4.
CODE
SELL BY 11/6/2004.
RECALLING FIRM/MANUFACTURER
KorAm Distributor, Inc., Long Island City, NY, by letters on February 4, 2004.
New York State initiated recall is complete.
REASON
The product contained undeclared sulfites (290 ppm) based on sampling &
analysis by New York State Dept. of Agriculture & Markets (NYSDAM).
VOLUME OF PRODUCT IN COMMERCE
All products on the market at the time the recall was initiated.
DISTRIBUTION
NY and NJ.
_______________________________
PRODUCT
a) Moose Tracks Ice Cream, packaged in pint, half gallon
and 3 gallon containers. Recall # F-255-4;
b) After Dinner Mint Ice Cream, packaged in half gallon
containers. Recall # F-256-4.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Purity Dairies, Inc., Nashville, TN, by press release and telephone on April
27, 2004. Firm initiated recall is complete.
REASON
Ice Cream contains undeclared egg.
VOLUME OF PRODUCT IN COMMERCE
531,638 units.
DISTRIBUTION
TN, AL, KY.
_______________________________
PRODUCT
a) Raw Fresh Yellowtail (Hamachi) Fillets, vacuum packed in
flexible plastic bags, each bag weighing approx. 4-4.5
lbs. Each styrofoam carton contains 6 bags. Product is
unlabeled and not frozen. Recall # F-250-4;
b) Raw Fresh Amberjack (Kanpachi) Fillets, vacuum packed in
flexible plastic bags, each bag weighing approx. 4-4.5
lbs. Each styrofoam carton contains 6 bags. Product is
unlabeled and not frozen. Recall # F-251-4.
CODE
Uncoded.
RECALLING FIRM/MANUFACTURER
Nishimaru, Inc., Brooklyn, NY, by letters on February 18, 2004. FDA initiated
recall is complete.
REASON
Product subject to Import Alert # 16-125 and entry was partially distributed.
VOLUME OF PRODUCT IN COMMERCE
7 cartons (6 bags per carton).
DISTRIBUTION
NY and Canada.
_______________________________
PRODUCT
a) The Vitamin Shoppe brand ìAmerican Ginseng 648mgî
capsules, 100 hard gelatin capsule bottle.
Recall # F-252-4;
b) The Vitamin Shoppe brand ìGinseng Complexî capsules, 100
and 300 hard gelatin capsule bottles, American Ginseng
200mg; Korean Ginseng 200mg; Red Chinese Ginseng 200mg;
Eleuthero 200mg; Royal Jelly Extract 57mg/capsule.
Recall # F-253-4.
CODE
a) Product code: VS-2064, 1071847;
b) Product codes: VS-2076, 1072392 -- 100 capsule bottles;
VS-2077, 1072392 -- 300 capsule bottles; VSU-6066,
1132710 -- Kosher, Vegicaps, 100 capsule bottles.
RECALLING FIRM/MANUFACTURER
Vitamin Shoppe Industries, Inc., North Bergen, NJ, by e-mails on February
6, 2004. FDA initiated recall is complete.
REASON
Capsules contain pesticide contaminants.
VOLUME OF PRODUCT IN COMMERCE
21.084 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Peanut Butter & Strawberry Jam Combo, 26030, 200, 2.12oz, 0074 (4) B,
Boca Grande Foods, Duluth, GA 30096. Product in packed in flexible cellophane
pouches with the creamy peanut butter separated by a perforation from the
strawberry jam portion. Recall # F-258-4.
CODE
Product code: 26030, Lot number 0074 (Julian date).
RECALLING FIRM/MANUFACTURER
Boca Grande Foods, Duluth, GA, by telephone and e-mail on January 16, 2004.
Firm initiated recall is complete.
REASON
Product contains elevated levels of Aflatoxin.
VOLUME OF PRODUCT IN COMMERCE
159 cases (200/2. 12 oz. pouches per case).
DISTRIBUTION
CA.
_______________________________
PRODUCT
American Ginseng, Jarrow Formulas, 7% Ginsenosides, 50 and 100 capsules, 500
mg, 12 bottles per case. Recall # F-259-4.
CODE
a) For the 50 capsules per bottle - When customers are ordering this product,
the name code is AMG and the number code is 14017. Two bottling productions
resulting in codes that are either Lot # Best Used Before: 16994L2 12/2004
or Lot # Best Used Before: 12113C3 03/2005;
b) For the 100 capsules per bottle ‚ When customers are ordering his product,
the name code is AMGS and the number code is 14018. Two productions resulting
in codes that are either Lot # Best Used Before: 1972B3 07/2005 or Lot # Best
Used Before: 1324H2 08/2004.
RECALLING FIRM/MANUFACTURER
Jarrow Formulas, Inc., Los Angeles, CA, by telephone on November 21, 2003.
FDA initiated recall is complete.
REASON
Ginseng capsules contain pesticide contaminants.
VOLUME OF PRODUCT IN COMMERCE
1.730 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Bratz Funky Fashion Makeover Kit. Recall # F-260-4.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
MGA Entertainment, North Hills, CA, by telephone on August 11, 2003. Firm
initiated recall is complete.
REASON
The product contains unapproved color additive Rhodamine B (formerly certifiable
as FD&C Red # 19).
VOLUME OF PRODUCT IN COMMERCE
3,608 kits.
DISTRIBUTION
Nationwide
_______________________________
PRODUCT
a) Hannaford Fresh Frozen Sliced Strawberries, 16 oz.
package. Recall # F-248-4;
b) Hannaford Fresh Frozen Sliced Strawberries, 10 oz.
package. Recall # F-249-4.
CODE
a) All lots remaining at the wholsale level which included:
376058, 376059, 376081, 376082, 376083, 376084, 376086,
376087, 376088, 376089, 376090, and 376120;
b) All lots remaining at the wholsale level which included:
376029, 376030, and 376031.
RECALLING FIRM/MANUFACTURER
VIP Sales Co., Tulsa, OK., by visit and by letter on February 18, 2004. Firm
initiated recall is complete.
REASON
a) Incorrect labeling. Calories are incorrectly listed as
50 whereas they should be 150;
b) Incorrect labeling. Servings per container are
misprinted as 3. The correct number of servings is 2
per container.
VOLUME OF PRODUCT IN COMMERCE
8,971 cases.
DISTRIBUTION
NY, ME, MA, VT, and NH.
_______________________________
PRODUCT
Jewel Chefís Kitchen Turkey and Cheese Sandwich (Wedge Type), Keep Refrigerated,
item number 57356, Net Wt. 7.0 oz. Recall # F-257-4.
CODE
Sell By 03/25/04.
RECALLING FIRM/MANUFACTURER
Flying Food Group, Chicago, IL, by telephone and fax on March 24, 2004. Firm
initiated recall is complete.
REASON
Sandwiches contain undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
236 sandwiches.
DISTRIBUTION
IL, and IN.
_______________________________
PRODUCT
a) Zyprexa Tablets, (olanzapine), 15 mg, 60 count bottle,
Rx only. Recall # D-184-4;
b) Zyprexa Tablets, (olanzapine), 20 mg, 60 count bottle,
Rx only. Recall # D-185-4.
CODE
a) Lot Numbers-Expiration Dates: 7EJ36A-NOV 1, 2005;
7EJ38A-NOV 1, 2005; 7EJ40A-NOV 1, 2005; 7EJ43A-NOV 1,
2005; 7EG61A-SEP 1, 2005; 7EG63A-SEP 1, 2005 7EG65A -SEP
1, 2005;
b) Lot Numbers-Expiration Dates: 7EJ34A-NOV 1, 2005;
7EJ28A-NOV 1, 2005; 7EJ32A-NOV 1, 2005; 7EJ33A-NOV 1,
2005; 7EF40A-AUG 1,2005; 7ED85A-JUL 1, 2005; 7EF41A-AUG
1, 2005.
RECALLING FIRM/MANUFACTURER
Burlington Drug Company, Milton, VT, by letter on May 10, 2004. Firm initiated
recall is ongoing.
REASON
Counterfeit.
VOLUME OF PRODUCT IN COMMERCE
238 bottles.
DISTRIBUTION
ME, NH, NY, MA and VT
_______________________________
PRODUCT
a) Colgate Fluoride Toothpaste, Maximum Cavity Protection,
(Sodium Monofluorophosphate 0.76% (1000ppm F) and Sodium
Fluoride 0.1% (450ppm F)), packaged in 100-ml tubes, net
wt. 5 oz., Regular Flavour. Recall # D-186-4.
b) Colgate Fluoride Toothpaste Triple Action, (1.10% Sodium
Monofluorophosphate and 0.20% Triclosan) packaged in
100-ml. tubes, net wt. 5-oz. Rcall # D-187-4;
c) Mentadent P, Fluoride Toothpaste, (0.74% Sodium Mono-
Fluorophosphate), packaged in 100-ml. tubes, Net Wt 5
oz. Recall # D-188-4;
d) Colgate Fluoride Toothpaste, Herbal, (1.10% Sodium
Monofluorophosphate, packaged in 100-ml. tubes, NET WT 5
oz. Recall # D-189-4;
e) Aquafresh Fluoride Toothpaste, (Sodium
Monofluorophosphate 0.76% w/w), packaged in 100-ml.
tubes, 5 OZ. Recall # D-190-4.
CODE
a) All Lots: South African labeling SKU: 458976;
b) All Lots: South African labeling SKU: 445077;
c) All Lots: South African labeling SKU: 458977;
d) All Lots: South African labeling SKU: 460361;
e) All Lots: South African labeling SKU: 418030.
RECALLING FIRM/MANUFACTURER
Deals Nothing Over A Dollar, Earth City, MO, by letters on March 3, 2004 and
email on March 11, 2004. Firm initiated recall is complete.
REASON
Misbranded; labeling is not in compliance with regulations.
VOLUME OF PRODUCT IN COMMERCE
Approximately 50,000 tubes.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Prozac Pulvules (Fluoxetine Hydrochloride) Equiv. To 20 mg, 2,000 count bottles,
Rx Only. Recall # D-191-4.
CODE
Lot 7AA93P; Exp. March 1, 2006.
RECALLING FIRM/MANUFACTURER
Lilly, Eli & Co., Indianapolis, IN, by letter dated May 20, 2004. Firm
initiated recall is ongoing.
REASON
Labeling: missing lot number and/or expiration date.
VOLUME OF PRODUCT IN COMMERCE
1,697 bottles.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Zyprexa Tablets (Olanzapine) 5 mg, 1000 count bottles, Rx only. Recall # D-192-4.
CODE
Lot 7AA35S; Exp. February 1, 2005.
RECALLING FIRM/MANUFACTURER
Lilly, Eli & Co., Indianapolis, IN, by letter dated May 18, 2004. Firm
initiated recall is ongoing.
REASON
Labeling: missing lot number and/or expiration date.
VOLUME OF PRODUCT IN COMMERCE
2,526 bottles.
DISTRIBUTION
Nationwide.
*****CORRECTION*****
ENFORCEMENT REPORT 04-22, JUNE 2, 2004, CLASS II ‚ SOURCE PLASMA, RECALL # B-1365-4, THE UNIT NUMBER OT23522 IS INCORRECT. THE CORRECT UNIT NUMBER IS OT235322.
_______________________________
PRODUCT
a) Red Blood Cells, Leukoreduced. Recall # B-1011-4;
b) Recovered Plasma. Recall # B-1012-4.
CODE
a) Units: 29GL69199, 29GP76599, 29GV55112, 29GW40655,
29GW41130, 29GX82435, 29GY23438, 29GY23439, 29GY23685,
29KC55640, 29KC55645, 29KC56997, 29KE37537;
b) Units: 29GL69199, 29GP76599, 29GW40655, 29GX82435,
29GY23438, 29GY23439, 29GY23685, 29KC55640, 29KC55645,
29KC56997, 29KE37537.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Mid-Atlantic Region, Norfolk, VA, by telephone
on October 17, 2003, and by letter on October 22, 2003 and November 17, 2003.
Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised sterility,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units.
DISTRIBUTION
NC, VA, CA, and Switzerland.
_______________________________
PRODUCT
a) Platelets Pheresis. Recall # B-1335-4;
b) Platelets Pheresis, Leukocytes Reduced.
Recall # B-1336-4;
c) Platelets Pheresis, Irradiated. Recall # B-1337-4;
d) Platelets Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1338-4.
CODE
a) Unit numbers: 31132-7918 (2 units), 31132-8819 (2
units), 31132-9070 (2 units), 31133-0253 (2 units),
31133-0319, 31133-0547 (2 units), 31133-0600 (2 units),
31133-1635 (2 units), 31133-1672 (2 units), 31133-1769
(2 units), 31133-1779 (2 units), 31133-2252 (2 units),
31133-2387 (2 units), 31133-3096 (2 units), 31133-4034
(2 units), 31133-4185 (2 units), 31133-4426 (2 units),
31133-4515 (2 units), 31133-5281 (2 units), 31133-5336
(2 units), 31132-1504, 31123-6156, 31123-6612, 31123-
6668, 31123-6711, 31123-6721, 31123-8473, 31123-8543,
31123-8555, 31123-8577, 31123-8581, 31123-9001, 31123-
9125, 31123-9159, 31123-9161, 31124-0245, 31124-0281,
31124-0296, 31124-0324, 31124-0342, 31124-0809, 31124-
0890, 31124-0907, 31124-0950, 31124-0960, 31124-1689,
31124-2611, 31124-2628, 31124-2635, 31124-2658, 31124-
2778, 31124-3543, 31124-3576, 31124-4286, 31124-4321,
31124-5216, 31124-5217, 31124-5334, 31124-5343, 31124-
5368, 31124, 6491, 31124-6513, 31124-6586, 31124-6584,
31124-7402, 31124-7480, 31124-7543, 31124-7544,
31124-7545, 31124-7560, 31124-7592, 31124-8823,
31124-8869, 31124-8888, 31124-8897, 31124-9447, 31124-
9466, 31124-9493, 31125-0021, 31125-0136, 31125-0161,
31125-0164, 31125-0526, 31125-0527, 31125-0569, 31125-
1212, 31125-1315, 31125-1371, 31125-2427, 31125-2462,
31125-2488, 31125-2511, 31125-2539, 31125-3226, 31125-
3252, 31125-3276, 31125-3347, 31125-4222, 31125-4249,
31125-4280, 31125-4288, 31125-4353, 31125-4370, 31125-
5227, 31125-5229, 31125-5260, 31125-5342, 31125-6647,
31125-6768, 31125-6786, 31125-7812, 31125-7835, 31125-
7962, 31125-7963, 31125-7974, 31125-8952, 31125-8967,
31125-8998, 31125-9434, 31125-9446, 31125-9498, 31125-
9520, 31125-9528, 31125-9549, 31126-0664, 31126-0768, 31126-1473, 31126-1487,
31126-1546, 31126-1547, 31126-1549, 31126-2351, 31126-2372, 31126-2378, 31126-3480,
31126-3497, 31126-3534, 31126-3573, 31126-4220, 31126-4258, 31126-4272, 31126-4291,
31126-4654, 31126-4760, 31126-5842, 31126-5961, 31126-5993, 31126-7934, 31126-9173,
31126-9182, 31127-0290, 31127-0325, 31127-0354, 31127-0836, 31127-0844, 31127-0892,
31127-0898, 31127-0910, 31127-2205, 31127-2224, 31127-2626, 31127-2657, 31127-2712,
31127-3288, 31127-3333, 31127-3334, 31127-3345, 31127-3362, 31127-3397, 31127-4331,
31127-4354, 31127-4380, 31127-4394, 31127-5047, 31127-5074, 31127-5077, 31127-5102,
31127-5158, 31127-5179, 31127-6222, 31127-6232, 31127-6258, 31127-6293, 31127-6329,
31127-6356, 31127-6358, 31127-7201, 31127-7221, 31127-7269, 31127-7324, 31127-7362,
31127-7367, 31127-7379, 31127-7392, 31127-7400, 31127-7463, 31127-8900, 31127-8907,
31127-8909, 31127-8912, 31127-8928, 31127-8945, 31127-9869, 31127-9870, 31127-9886,
31127-9889, 31127-9894, 31127-9909, 31127-9994, 31128-1042, 31128-1047, 31128-1051,
31128-1059, 31128-1087, 31128-1116, 31128-2009, 31128-2039, 31128-2147, 31128-2178,
31128-2188, 31128-3005, 31128-3008, 31128-3037, 31128-3074, 31128-3084, 31128-3089,
31128-3093, 31128-3108, 31128-3151, 31128-3179, 31128-3964, 31128-4247, 31128-4340,
31128-4358, 31128-5276, 31128-5356, 31128-5382, 31128-5390, 31128-5397, 31128-6124,
31128-6132, 31128-6727, 31128-6798, 31128-7521, 31128-7524, 31128-7525, 31128-7565,
31128-7586, 31128-8319, 31128-8350, 31128-9022, 31128-9093, 31128-9135, 31128-9143,
31129-0237, 31129-0260, 31129-0296, 31129-0382, 31129-1435, 31129-1447, 31129-1492,
31129-1534, 31129-1540, 31129-1542, 31129-2625, 31129-2649, 31129-2740, 31129-2746,
31129-2785, 31129-3430, 31129-3433, 31129-3525, 31129-3529, 31129-3530, 31129-4232,
31129-4288, 31129-4377, 31129-4607, 31129-5022, 31129-5060, 31129-5175, 31129-5501,
31129-5526, 31129-6022, 31129-6023, 31129-6052, 31129-6123, 31129-6147, 31129-6161,
31129-6230, 31129-6241, 31129-6268, 31129-6816, 31129-6979, 31129-6993, 31129-6999,
31129-8249, 31129-8296, 31129-8302, 31129-9251, 31129-9305, 31129-9827, 31129-9840,
31129-9899, 31129-9911, 31129-9921, 31129-9992, 31129-9998, 31130-0804, 31130-0831,
31130-0944, 31130-1146, 31130-2003, 31130-2129, 31130-2132, 31130-2175, 31130-2679,
31130-2680, 31130-2769, 31130-3631, 31130-3635, 31130-3637, 31130-3684, 31130-3752,
31130-4112, 31130-4131, 31130-4806, 31130-4865, 31130-5404, 31130-5432, 31130-5438,
31130-5491, 31130-5820, 31130-5840, 31130-5882, 31130-5950, 31130-6472, 31130-6473,
31130-6580, 31130-7018, 31130-7041, 31130-7063, 31130-7122, 31130-7460, 31130-7476,
31130-7496, 31130-7524, 31130-7549, 31130-8224, 31130-8319, 31130-8350, 31130-8361,
31130-8391, 31130-8868, 31130-8990, 31130-8996, 31130-9803, 31130-9827, 31130-9948,
31130-9951, 31131-0003, 31131-0021, 31131-0072, 31131-0115, 31131-0163, 31131-1030,
31131-3402, 31131-3462, 31131-3471, 31131-3581, 31131-4447, 31131-4500, 31131-4509,
31131-4521, 31131-5603, 31131-5626, 31131-5639, 31131-5648, 31131-5727, 31131-5739,
31131-5772, 31131-6004, 31131-6081, 31131-6122, 31131-6148, 31131-6169, 31131-6192,
31131-6199, 31131-7080, 31131-7083, 31131-7122, 31131-7853, 31131-7879, 31131-8046,
31131-8052, 31131-8064, 31131-8616, 31131-8645, 31131-8761, 31131-9538, 31131-9565,
31132-0027, 31132-0071, 31132-0124, 31124-0174, 31132-0901, 31132-0914, 31132-0955,
31132-0967, 31132-0979, 31132-1409, 31132-1522, 31132-1540, 31132-2046, 31132-3236,
31132-3266, 31132-3337, 31132-4115, 31132-4447, 31132-5427, 31132-5448, 31132-5518,
31132-5585, 31132-6220, 31132-6244, 31132-6257, 31132-7202, 31132-7258, 31132-7903,
31132-8917, 31132-9087, 31133-0236, 31133-0251, 31133-0369, 31133-0422, 31133-0475,
31133-0497, 31133-0610, 31133-0696, 31133-1626, 31133-1664, 31133-2352, 31133-2388,
31133-3004, 31133-3011, 31133-3022, 31133-3037, 31133-4088, 31133-4546, 31133-5261,
31128-2169, 31132-5591, 31123-6758-01, 31123-6758-02, 31123-9051-01, 31123-9051-02,
31124-1786-01, 31124-1786-02, 31124-3448-01, 31124-3575-01, 31124-3575-02,
31124-4303-01, 31124-6553-01, 31124-6553-02, 31124-7542-01, 31124-7542-02,
31124-7546-01, 31124-7546-02, 31124-7572-01, 31124-6553-02, 31124-8976-01,
31124-7542-02, 31124-9518-01, 31124-9518-02, 31125-0570-01, 31125-0570-01,
31125-0570-02, 31125-1382-01, 31125-1382-02, 31125-2510-01, 31125-2510-02,
31125-2559-01, 31125-2559-02, 31125-4266-02, 31125-4348-01, 31125-4348-02,
31125-5320-01, 31125-5320-02, 31125-5393-01, 31125-5939-02, 31125-6609, 31125-6632-01,
31125-6632-02, 31125-6751-01, 31125-6751-02, 31125-6785-01, 31125-6785-02,
31125-7913-01, 31125-7913-02, 31125-8815-01, 31125-8815-02, 31125-8950-01,
31125-8950-02, 31125-9403-01, 31126-0700-01, 31126-0700-02, 31126-1097, 31126-1449-01,
31126-1449-02, 31126-1453-01, 31126-1453-02, 31126-2394-01, 31126-2394-02,
31126-3557-01, 31126-3557-02, 31126-3596-01, 31126-3596-02, 31126-4383-01,
31126-4383-02, 31126-4709-01, 31126-4709-02, 31126-4787-01, 31126-4787-02,
31126-4963-01, 31126-4963-02, 31126-5809-01, 31126-5809-02, 31126-6801, 31126-6977-02,
31126-7808-01, 31126-7828-02, 31126-7838-01, 31126-7838-02, 31126-7855-01,
31126-7855-02, 31126-7879-01, 31126-7879-02, 31126-7953-01, 31126-7953-02,
31126-9072-01, 31126-9106-01, 31126-9106-02, 31126-9182, 31127-0354, 31127-0844,
31127-0898, 31127-0910, 31127-2205, 31127-2224, 31127-2717, 31127-3288, 31127-3362,
31127-3397, 31127-4354, 31127-5047, 31127-5158, 31127-6222, 31127-6232, 31127-6258,
31127-6293, 31127-6329, 31127-6358, 31127-7201, 31127-7362, 31127-7367, 31127-7379,
31127-7400, 31127-8900, 31127-8909, 31127-8928, 31127-8945, 31127-9197, 31127-9870,
31127-9886, 31127-9894, 31127-9994, 31128-1047, 31128-1051, 31128-1059, 31128-1087,
31128-1116, 31128-2175, 31128-2178, 31128-2188, 31128-3005, 31128-3008, 31128-3034,
31128-3074, 31128-3084, 31128-3089, 31128-3093, 31128-3108, 31128-3167, 31128-3179,
31128-4247, 31128-5250, 31128-5356, 31128-5382, 31128-5390, 31128-5397, 31128-6124,
31128-6132, 31128-6798, 31128-7521, 31128-7524, 31128-7525, 31128-7565, 31128-7586,
31128-8319, 31128-9093, 31128-9135, 31128-9143, 31129-0237, 31129-0260, 31129-0296,
31129-0382, 31129-1435, 31129-1492, 31129-1534, 31129-2649, 31129-2740, 31129-2746,
31129-3529, 31129-3530, 31129-4232, 31129-4288, 31129-4607, 31129-5022, 31129-5175,
31129-6052, 31129-6055, 31129-6161, 31129-6230, 31129-6241, 31129-6816, 31129-6993,
31129-8249, 31129-8302, 31129-9251, 31129-9305, 31129-9827, 31129-9840, 31129-9868,
31129-9899, 31130-0804, 31130-0831, 31130-0944, 31130-2003, 31130-2132, 31130-2175,
31130-2679, 31130-2769, 31130-3631, 31130-3635, 31130-3637, 31130-3684, 31130-4079,
31130-4112, 31130-4131, 31130-4865, 31130-5404, 31130-5432, 31130-5820, 31130-5882,
31130-6472, 31130-6580, 31130-7211, 31130-7476, 31130-7496, 31130-7524, 31130-8319,
31130-8350, 31130-8361, 31130-8990, 31130-8996, 31131-0072, 31131-0163, 31131-3402,
31131-3462, 31131-3581, 31131-5639, 31131-6004, 31131-6008, 31131-6081, 31131-6169,
31131-6192, 31131-6199, 31131-7122, 31131-7853, 31131-7879, 31131-7985, 31131-8052,
31131-8616, 31132-0027, 31132-0124, 31132-0174, 31132-1409, 31132-1438, 31132-1522,
31132-2046, 31132-3246, 31132-3266, 31132-5448, 31132-6244, 31132-7202, 31132-7903;
b) Unit numbers: 31119-7457, 31119-7506, 31119-7513, 31119-7595, 31119-8620,
31119-8657, 31119-8726, 31119-8771, 31119-8774, 31119-9871, 31120-0425-01,
31120-0425-02, 31120-0507, 31120-0510, 31120-0528, 31120-0549, 31120-0597,
31120-1252, 31120-1276, 31120-1279, 31120-1317, 31120-1344, 31120-1375, 31120-2225,
31120-2310, 31120-2389, 31120-3027, 31120-3051-01, 31120-3051-02, 31120-3098-01,
31120-3098-02, 31120-3192, 31120-3200, 31120-4340, 31120-5216, 31120-5353,
31120-6143, 31120-6195, 61120-6610, 61120-6643, 31120-6679, 31120-6775-01,
31120-6775-02, 31120-7078, 31120-7135, 31120-7696, 31120-7768, 31120-7771,
31120-7800, 31120-8673, 31120-8701-01, 31120-8701-02, 31121-0801, 31121-0884-01,
31121-0884-02, 31121-0919, 31121-0934-01, 31121-0934-02, 31121-0938, 31121-0975,
31121-0983-01, 31121-0983-02, 31121-1522-01, 31121-1522-02, 31121-1531-01,
31121-1531-02, 31121-1550, 31121-1572, 31121-1593-01, 31121-1593-02, 31121-2438,
31121-2465, 31121-2519-01, 31121-2519-02, 31121-2532-01, 31121-2532-02, 31121-2560,
31121-2592, 31121-3424, 31121-3452, 31121-3501, 31121-3516, 31121-3552, 31121-3562,
31121-3569-01, 31121-3569-02, 31121-3584, 21121-4453-01, 21121-4453-02, 31121-4488-01,
31121-4488-02, 31121-4517, 31121-4570, 31121-5033, 31121-5159, 31121-5807,
31121-5874, 31121-5942, 31121-5957, 31121-6812, 31121-6996, 31121-7046, 31121-7179,
31121-8240, 31121-8342, 31121-8385, 31121-9349, 31121-9829, 31121-9929, 31121-9953,
31122-0440, 31122-0506, 31122-0590, 31122-1339, 31122-1367, 31122-1388, 31122-1947,
31122-2102-01, 31122-2102-02, 31122-3606, 31122-3738, 31122-3739, 31122-4673-01,
31122-4673-02, 31122-4688, 31122-6400, 31122-6808, 31122-6870, 31122-7442,
31122-7496, 31122-8761, 31122-9391, 31123-0327, 31123-0378, 31123-1030, 31123-1031,
31123-1094-01, 31123-1094-02, 31123-1131, 31123-1163, 31123-1182, 31123-1192-01,
31123-1192-02, 31123-2007, 31123-2070, 31123-2112-01, 31123-2112-02, 31123-2910,
31123-2945-01, 31123-294502, 31123-3832-01, 31123-3832-02, 31123-3884, 31123-3906,
31123-3968, 31123-3991, 31123-3992, 31123-5201, 31123-5210, 31123-5352, 31123-5372,
31123-6056, 31124-0924-01, 31124-0924-02, 31125-0128, 31125-0572, 31125-1226-01,
31125-1226-02, 31125-1347, 31125-3255, 31125-4297-01, 31125-4297-02, 31125-4350-01,
31125-4350-02, 31126-3436, 31126-4748-01, 31126-4748-02, 31127-0311, 31126-7258,
31127-0311, 31127-7258, 31127-8883;
c) Unit numbers: 31124-1604, 31119-9890, 31121-4433-01, 31121-4433-02, 31121-7018;
d) Unit numbers: 31123-6125-01, 31123-6125-02, 31124-4303, 61126-6801, 31124-1772,
31124-3525, 31124-4369, 31129-9868, 31132-2139.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by letters, dated February
11, 2003 and April 4, 2003.
Manufacturing Firm: Blood Systems, Inc., Tupelo, MS. Firm initiated recall
is complete.
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
921 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1444-4.
CODE
Unit number: 6014589.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Newark, DE, by letter, dated September 12, 2003. Firm
initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the medication, Avodart,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
DE.
_______________________________
PRODUCT
Red Blood Cells, Leukoreduced. Recall # B-1461-4.
CODE
Unit number: 3012601.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., Newark, DE, by letter, dated October 23, 2003.
Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication, Avodart,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.
_______________________________
PRODUCT
Source Plasma. Recall # B-1463-4.
CODE
Unit numbers: 528484, 529357, 529583, 533674, and 587296.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International BioResources, LLC, Scottsdale, AZ, by facsimile
on September 25, 2003, and by telephone on March 30, 2004.
Manufacturing Firm: International BioResources, LLC, Monroe, LA. Firm initiated
recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
NC, and IL.
_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-1464-4.
CODE
Unit FG82764.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., Rhode Island Blood Center, Providence,
RI, by telephone on November 14, 2003. Firm initiated recall is complete.
REASON
Blood product, corresponding to red cells that were implicated in a transfusion
reaction and were possibly contaminated, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
RI.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1465-4;
b) Fresh Frozen Plasma. Recall # B-1466-4.
CODE
a) and b) Unit number: 9160291.
RECALLING FIRM/MANUFACTURER
Vermont Blood Center, Williston, VT, by telephone on June 17, 2003, and by
letter, dated August 5, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of Addisonís disease,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
VT.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1467-4;
b) Platelets, Leukocytes Removed. Recall # B-1468-4.
CODE
a) and b) Unit number: LE62765.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc., dba Rhode Island Blood Center, Providence,
RI, by telephone on November 17, 2003. Firm initiated recall is complete.
REASON
Blood products, in which the corresponding blood component was possibly contaminated
with Staphylococcus sp. bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
RI, and MA.
_______________________________
PRODUCT
Platelets. Recall # B-1472-4.
CODE
Unit numbers: 2064559, 2064575.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter, dated April
2, 2004, and by email on April 27, 2004. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of whole blood that were collected
from donors who had ingested aspirin-like medication, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1473-4;
b) Red Blood Cells, Leukocytes Reduced. Recall # B-1474-4.
CODE
a) Units 004KF69927, 004KF72652;
b) Unit 004KF66468.
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by facsimile
on March 1, 2004 and by letters dated March 3, 2004 and March 24, 2004. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MA, NH, and VT,
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Removed. Recall # B-1475-4.
CODE
Unit 004GS10797.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, New England Region,
Dedham, MA, by telephone on February 17, 2004 and letter dated February 18,
2004. Firm initiated recall is complete.
REASON
Platelets, were inappropriately distributed in one platelet bag instead of
two.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes ReducedRecall # B-1476-4.
CODE
Units: 042KW16118 042KW16119 042KW16120 042KW16161 042KW16365 042KW16421 042KW16422
042KW16429 042KW16244 042KW16281 042KW16295 042KW16237 042KW16241 042KW16249
042KW16313 042KW16315 042KW16264 042KW16305 042KW16061 042KW16166 042KW16349
042KW16375 042KW16394 042KW16334 042KW16336 042KW16049 042KW16068 042KW16154
042KW16395 042KW16478 042KW16192 042KW16195 042KW16205 042KW16232 042KW16233
042KW16256 042KW16069 042KW16075 042KW16079 042KW16084 042KW16128 042KW16128
042KW16166 042KW16377 042KW16381 042KW16414 042KW16430 042KW16431 042KW16467
042KW16481 042KW16482 042KW16071 042KW16072 042KW16168 042KW16302 042KW16190
042KW16196 042KW16200 042KW16198 042KW16198 042KW16233 042KW16247 042KW16247
042KW16302 042KW16303 042KW16313 042KW16318 042KW16081 042KW16082 042KW16084
042KW16087 042KW16116 042KW16116 042KW16119 042KW16123 042KW16126 042KW16156
042KW16152 042KW16158 042KW16159 042KW16160 042KW16362 042KW16366 042KW16405
042KW16408 042KW16434 042KW16438 042KW16441 042KW16446 042KW16207 042KW16047
042KW16075 042KW16120 042KW16156 042KW16209 042KW16257 042KW16260 042KW16041
042KW16087 042KW16138 042KW16152 042KW16264 042KW16287 042KW16238 042KW16281
042KW16288 042KW16295 042KW16049 042KW16056 042KW16353 042KW16491 042KW16189
042KW16203 042KW16251 042KW16260 042KW16280 042KW16305 042KW16323 042KW16336
042KW16045 042KW16063 042KW16064 042KW16065 042KW16072 042KW16078 042KW16106
042KW16121 042KW16123 042KW16126 042KW16157 042KW16154 042KW16129 042KW16181
042KW16356 042KW16363 042KW16391 042KW16402 042KW16402 042KW16407 042KW16412
042KW16440 042KW16442 042KW16446 042KW16460 042KW16460 042KW16487 042KW16491
042KW16139 042KW16145 042KW16368 042KW16417 042KW16250 042KW16065 042KW16067
042KW16383 042KW16385 042KW16403 042KW16195 042KW16206 042KW16243 042KW16270
042KW16318 042KW16321 042KW16045 042KW16159 042KW16178 042KW16363 042KW16421
042KW16471 042KW16474 042KW16479 042KW16484 042KW16485 042KW16397 042KW16206
042KW16254 042KW16201 042KW16310 042KW16335 042KW16339 042KW16137 042KW16368
042KW16484 042KW16485 042KW16235 042KW16271 042KW16294 042KW16308 042KW16317
042KW16073 042KW16107 042KW16107 042KW16145 042KW16131 042KW16163 042KW16172
042KW16172 042KW16174 042KW16373 042KW16431 042KW16082 042KW16425 042KW16109
042KW16387 042KW16194 042KW16057 042KW16350 042KW16412 042KW16271 042KW16400
042KW16400 042KW16189 042KW16204 042KW16205 042KW16232 042KW16243 042KW16249
042KW16254 042KW16261 042KW16274 042KW16291 042KW16310 042KW16322 042KW16331
042KW16342 042KW16054 042KW16054 042KW16056 042KW16073 042KW16085 042KW16112
042KW16112 042KW16113 042KW16114 042KW16150 042KW16133 042KW16133 042KW16162
042KW16167 042KW16176 042KW16180 042KW16350 042KW16351 042KW16353 042KW16356
042KW16358 042KW16366 042KW16371 042KW16372 042KW16397 042KW16405 042KW16407
042KW16411 042KW16419 042KW16425 042KW16479 042KW16482 042KW16489 042KW16197
042KW16299 042KW16071 042KW16134 042KW16390 042KW16221 042KW16259 042KW16303
042KW16320 042KW16058 042KW16129 042KW16162 042KW16167 042KW16173 042KW16177
042KW16358 042KW16375 042KW16379 042KW16381 042KW16385 042KW16387 042KW16389
042KW16391 042KW16408 042KW16415 042KW16472 042KW16218 042KW16434 042KW16427
042KW16438 042KW16194 042KW16223 042KW16229 042KW16238 042KW16256 042KW16273
042KW16286 042KW16298 042KW16298 042KW16325 042KW16330 042KW16330 042KW16339
042KW16042 042KW16043 042KW16052 042KW16076 042KW16078 042KW16106 042KW16108
042KW16109 042KW16137 042KW16146 042KW16130 042KW16131 042KW16158 042KW16161
042KW16175 042KW16177 042KW16186 042KW16188 042KW16188 042KW16345 042KW16351
042KW16395 042KW16417 042KW16309 042KW16320 042KW16057 042KW16067 042KW16085
042KW16355 042KW16424 042KW16432 042KW16461 042KW16461 042KW16469 042KW16228
042KW16252 042KW16273 042KW16274 042KW16299 042KW16322 042KW16335 042KW16173
042KW16389 042KW16390 042KW16414 042KW16430 042KW16439 042KW16471.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Northern Ohio Region, Cleveland, OH, by
facsimile dated December 26, 2003, and by letter dated January 2, 2004. Firm
initiated recall is complete.
REASON
Platelets, collected using an apheresis instrument that had not been validated
for use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
349 units.
DISTRIBUTION
OH, and MI.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1479-4;
b) Recovered Plasma. Recall # B-1480-4.
CODE
a) and b) Units 004H23182, 004N18918.
RECALLING FIRM/MANUFACTURER
American National Red Cross, New England Region, Dedham, MA, by facsimile
on February 4, 2004 and letters dated February 6, 2004. Firm initiated recall
is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from
an ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CA, MA, and NY.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1481-4;
b) Recovered Plasma. Recall # B-1482-4.
CODE
a) and b) Units 24KE48643, 24KJ71315.
RECALLING FIRM/MANUFACTURER
American National Red Cross, River Valley Region, Louisville, KY, by telephone
or the Logic system on March 26, 2004 and by letters dated April 19, 2004.
Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from
an ineligible donor due to a subsequent disclosure of previous positive hepatitis
testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
CA, IL, and KY.
_______________________________
PRODUCT
Red Blood Cells Pheresis. Recall # B-1484-4.
CODE
Units 13FV27924 and 13 FV28086.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Detroit, MI, by telephone on October 30,
2003, and by letter dated November 18, 2003. Firm initiated recall is complete.
REASON
Blood products, which were determined to have low actual RBC volume resulting
in the failure to meet acceptable quality control criteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1485-4.
CODE
Unit number: 02LG24761.
RECALLING FIRM/MANUFACTURER
American Red Cross, Central Plains Region, Wichita, KS, by letter, dated July
18, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area
considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KS.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced Irradiated.
Recall # B-1486-4;
b) Recovered Plasma. Recall # B-1487-4.
CODE
a) Units 004J54932 and 004L54784;
b) Unit 004L54784.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Dedham, MA, by telephone on February 2,
2004 and by letter dated February 6, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of hepatitis,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MA and CA.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1488-4.
CODE
Unit 36P58864.
RECALLING FIRM/MANUFACTURER
American National Red Cross, South Carolina Region,
Columbia, SC, by letter dated December 29, 2000. 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
SC.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1489-4.
CODE
Unit number: 02FJ89793.
RECALLING FIRM/MANUFACTURER
American Red Cross, Central Plains Region, Wichita, KS, by letter, dated August
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, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1490-4.
CODE
Unit numbers: 02LC08572, 02FC97190.
RECALLING FIRM/MANUFACTURER
American Red Cross, Central Plains Region, Wichita, KS, by letter, dated April
22, 2002. Firm initiated recall is 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
KS and CA.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1491-4;
b) Cryoprecipitated AHF. Recall # B-1492-4.
CODE
a) and b) Unit FK90502.
RECALLING FIRM/MANUFACTURER
Healthcare Provider Services, Inc. Providence,
RI, by telephone and by letter dated March 26, 2004. Firm initiated recall
is complete.
REASON
Blood products, which tested negative for the antibody to the human t-lymphotropic
virus type I (anti-HTLV-I) but were collected from a donor who previously
tested repeatedly reactive for anti-HTLV-I, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX and NY.
_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced. Recall # B-1493-4;
b) Recovered Plasma. Recall # B-1494-4.
CODE
a) and b) Unit number: 02FE08982.
RECALLING FIRM/MANUFACTURER
American Red Cross, Central Plains Region, Wichita, KS, by telephone on September
4, 2002, by facsimile on September 9, 2002, and by letter, dated September
10, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on a history of residing
in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob
Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KS and CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1495-4.
CODE
Unit 12LN26128.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Carolinas Region, Winston-Salem, by letter
dated April 12, 2001. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had lived in an area designated
as endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1496-4.
CODE
Units 02FZ12897, 02FZ12209.
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Wichita, KS, by letter
dated January 10, 2003.
Manufacturing Firm: American National Red Cross, Central Plains Region, Hays,
KS. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had lived in an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA and KS.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1498-4.
CODE
Units 02FJ90559, 02LG27677.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Central Plains Region, Wichita, KS, by letter
dated May 2, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area designated
as endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KS.
_______________________________
PRODUCT
Recovered Plasma. Recall # B-1501-4.
CODE
Unit 11GN56565.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Missouri-Illinois Region, St. Louis, MO, by facsimile
on May 29, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to a history of travel
to 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
Switzerland.
_______________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-1502-4.
CODE
Unit number: 24FH35934.
RECALLING FIRM/MANUFACTURER
American Red Cross, River Valley Region, Louisville, KY, by telephone on January
8, 2004, and by letter, dated January 13, 2004. Firm initiated recall is complete.
REASON
Blood product, collected using equipment that had not been validated, was
distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
OH.
_______________________________
PRODUCT
Source Plasma. Recall # B-1505-4.
CODE
Unit 527582.
RECALLING FIRM/MANUFACTURER
International BioResources, LLC., Monroe, LA, by facsimile on March 26, 2002.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had an unexplained weight
loss, was collected.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-1506-4.
CODE
Unit 528431.
RECALLING FIRM/MANUFACTURER
International BioResources, LLC., Monroe, LA, by facsimile on March 30, 2002.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had an unexplained weight
loss, was collected.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-1507-4.
CODE
Units 535402 and 535770.
RECALLING FIRM/MANUFACTURER
International Bio Resources, LLC., Monroe, LA, by facsimile on June 4, 2002.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had an unexplained weight
loss, was collected.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1508-4.
CODE
Unit W045003011051.
RECALLING FIRM/MANUFACTURER
Community Blood Center of Greater Kansas City, Kansas City, MO, by letter
dated November 4, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking Dexamethasone at the
time of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KS.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1509-4.
CODE
Unit 4634060.
RECALLING FIRM/MANUFACTURER
Department of the Navy, Naval Hospital, Great Lakes, IL, by telephone on September
3, 2003. Firm initiated recall is complete.
REASON
Red Blood Cells, which tested positive for West Nile Virus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced. Recall # B-1510-4.
CODE
Units 1537595-parts 1&2.
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Jacksonville, FL, by telephone on September
10, 2003, and by facsimile dated October 16, 2003. Firm initiated recall is
complete.
REASON
Platelets, inappropriately prepared by splitting the product into two storage
bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TX.
_______________________________
PRODUCT
a) Red Blood Cells Leukocytes Reduced. Recall # B-1512-4;
b) Recovered Plasma. Recall # B-1513-4.
CODE
a) and b) Unit 11FE90803.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO, by telephone on December
4, 2003, and by letter dated December 17, 2003. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody for the human immunodeficiency
virus (anti-HIV) but were collected from a donor who had previously tested
positive for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
MO and CA.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1516-4;
b) Fresh Frozen Plasma. Recall # B-1517-4.
CODE
a) Units S39303, S35827;
b) Unit S35827.
RECALLING FIRM/MANUFACTURER
Delta Blood Bank, Stockton, CA, by letter dated August 6, 2002. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor taking Nitrofurantoin, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1518-4.
CODE
Unit number 38FV13753.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Indiana-Ohio Region, Fort Wayne, IN, by telephone
on March 12, 2004. Firm initiated recall is complete.
REASON
Blood product, manufactured from an overweight unit of Whole Blood, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
_______________________________
PRODUCT
Plasma, Cryoprecipitate Reduced. Recall # B-1519-4.
CODE
Unit number 18FW47910.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Great Lakes Region, Lansing, MI, by telephone
on March 22, 2004, and by letter on March 23, 2004. Firm initiated recall
is complete.
REASON
Blood product, associated with an unit of Red Blood Cells that contained clots,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MI.
_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-1521-4;
b) Recovered Plasma. Recall # B-1522-4.
CODE
a) and b) Unit 11C54266.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Missouri-Illinois Region,
St. Louis, MO, by facsimile on January 22, 2003 or letter dated January 30,
2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who engaged in high risk 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
2 units.
DISTRIBUTION
CA and Switzerland.
_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-1339-4.
CODE
Unit 2052278-split 1.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by telephone on November
10, 2003. Firm initiated recall is complete.
REASON
Platelets, in which the corresponding Platelets tested positive for the presence
of Lactobacillus bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Irradiated. Recall # B-1351-4.
CODE
Unit numbers: 18GJ84736, 18GK34397, 18GH98299, 18GH98298, 18FZ43315, 18FQ93859,
18FZ43266, 18FV57584, 18GH98207, 18GH97519, 18GG64092, 18GH98312.
RECALLING FIRM/MANUFACTURER
American National Red Cross, Great Lakes Region, Lansing, MI, by telephone
on February 27, 2004, and by letter dated March 5, 2004. Firm initiated recall
is complete.
REASON
Blood products, mislabeled with the incorrect volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
MI.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed, Irradiated. Recall # B-1452-4.
CODE
Unit numbers: 93Y03240, 93Y03242, and 93Y03261.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by telephone on February
3, 2004. Firm initiated recall is complete.
REASON
Blood products, labeled with the incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
MA.
_______________________________
PRODUCT
Source Plasma. Recall # B-1459-4.
CODE
Unit number: DSKPLS.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Bio Resources, LLC, Scottsdale, AZ, by facsimile
on October 20, 2003.
Manufacturing Firm: International Bio Resources, LLC, Tuscaloosa, AL. Firm
initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not performed,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.
_______________________________
PRODUCT
Source Plasma. Recall # B-1460-4.
CODE
Unit numbers: DSPLPV, DSNFJS.
RECALLING FIRM/MANUFACTURER
Recalling Firm: International Bio Resources, LLC, Scottsdale, AZ, by letter
dated November 24, 2003, and by telephone on March 30, 2004.
Manufacturing Firm: International Bio Resources, LLC, Tuscaloosa, AL. Firm
initiated recall is complete.
REASON
Blood products, collected from a donor whose health history screenings were
inadequately performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
a) Fresh Frozen Plasma, Apheresis. Recall # B-1477-4;
b) Cryoprecipitated AHF. Recall # B-1478-4.
CODE
a) Unit 24FH32595;
B) 24FC16988.
RECALLING FIRM/MANUFACTURER
American National Red Cross, River Valley Region, Louisville, KY, by telephone
on June 19, 2003 and by letter dated June 20, 2003. Firm initiated recall
is complete.
REASON
Blood products, which were incorrectly labeled with an extended expiration
date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
KY.
_______________________________
PRODUCT
Red Blood Cells, Rejuvenated. Recall # B-1483-4.
CODE
Unit 0642661.
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific, Irwin Center, San Francisco, CA, by letter dated
May 15, 2002. Firm initiated recall is complete.
REASON
Blood product, which was not approved for immediate transfusion following
rejuvenation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
_______________________________
PRODUCT
Human Tissue for Transplantation:
a) CryoVein, Saphenous Vein;
b) CryoGraft, Pulmonary Trunk Patch.
Recall # B-1497-4.
CODE
a) Serial # 8081525;
b) Serial # 8080033.
RECALLING FIRM/MANUFACTURER
CryoLife, Inc., Kennesaw, GA, by letter dated
March 2, 2004. Firm initiated recall is complete.
REASON
Human tissue, processed using an expired anti-microbial solution (AMS), was
distributed.
VOLUME OF PRODUCT IN COMMERCE
2 tissues.
DISTRIBUTION
MO and SC.
_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-1499-4.
CODE
Unit number: 04V07558.
RECALLING FIRM/MANUFACTURER
American Red Cross, New England Region, Dedham, MA, by letter, dated March
11, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to the use of the antibiotic,
Keflex, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MA.
_______________________________
PRODUCT
Platelets. Recall # B-1500-4.
CODE
Unit number: 36K84706.
RECALLING FIRM/MANUFACTURER
American Red Cross, South Carolina Region, Columbia, SC, by telephone on April
7, 2000. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to the use of an antibiotic,
was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
SC.
_______________________________
PRODUCT
Source Plasma. Recall # B-1503-4.
CODE
Unit 077786.
RECALLING FIRM/MANUFACTURER
International Bio Resources, LLC, Monroe, LA, by facsimile on July 24, 2002.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability
was not adequately determined, was collected.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Source Plasma. Recall # B-1504-4.
CODE
Unit 005947.
RECALLING FIRM/MANUFACTURER
International Bio Resources, LLC, Monroe, LA, by facsimile on April 22, 2002.
Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which the arm inspection
was not performed prior to phlebotomy, was collected.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NC.
_______________________________
PRODUCT
Platelets, Pheresis, Leukocytes Reduced, Irradiated.
Recall # B-1511-4.
CODE
Units: G83057.
RECALLING FIRM/MANUFACTURER
Northern Illinois Blood Bank, Inc., Rockford, IL, by telephone on November
6 and 7, 2003. Firm initiated recall is complete.
REASON
Plateletpheresis products, with an unusual odor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.
_______________________________
PRODUCT
a) Platelets, Pheresis, Leukocytes Reduced. Recall # B-
1514-4
b) Fresh Frozen Plasma. Recall # B-1515-4.
CODE
a) and b) Unit number LZ16658.
RECALLING FIRM/MANUFACTURER
Dartmouth-Hitchcock Medical Center, One Medical Center Drive, Lebanon, NH,
by telephone in June 2002, and by letter dated October 16, 2003. Firm initiated
recall is complete.
REASON
Blood products, collected from a donor with a history of Polymyalgia Rheumatica
(PMR), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NH.
_______________________________
PRODUCT
Red Blood Cells. Recall # B-1520-4.
CODE
Unit number: 2012558.
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc., Lexington, KY, by letter on February
1, 2004. Firm initiated recall is complete.
REASON
Blood product, that may have contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.
_______________________________
PRODUCT
COBAS Gui software interface between the Cobas AMPLICOR instrument and the
Tecan clinical workstation (Tecan Genesis 150/8 front end COBAS), Roche catalog
number 04498984001. Recall # Z-1021-04.
CODE
All units (serial numbers 6178, 7629, 7698, 7744, 7753, 7754, 7755 and 7768.
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp, Indianapolis, IN, by letter dated May 5, 2004 and
press release on May 7, 2004. Firm initiated recall is ongoing.
REASON
The Roche COBAS interface driver for the Tecan software may assign sample
results to the wrong patient.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
CA, CT, IL, MA, PA, TX and WI.
_______________________________
PRODUCT
Tecan Clinical Workstations with Robonet software. Recall # Z-1022-04.
CODE
PN 10-410 Tecan Genesis 150/8 Back End Configuration, PN 10-415 Tecan Genesis
150/8 Front End Configuration, PN 10-309 Tecan Genesis 200/8 Workstation,
PN 10-307 Tecan Genesis 150/8 Workstation, PN 10-043A Tecan Genesis RSP 150/8,
PN 10-040A Tecan Genesis RSP 100/4, PN 10-401A Tecan Genesis RSP 100/8,
RECALLING FIRM/MANUFACTURER
Tecan US Inc., Durham, NC, by letter on May 3, 2004. Firm initiated recall
is ongoing.
REASON
Tecan software has the potential to match the patient with a different patientís
test results.
VOLUME OF PRODUCT IN COMMERCE
44 units (Hardware), 33 units (Software).
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
X-ray systems, model numbers: P200R24 and P200R40. Recall # Z-0985/0986-04.
CODE
None supplied.
RECALLING FIRM/MANUFACTURER
MinXray, Inc., Northbrook, IL, by telephone beginning on June 9, 2004. Firm
initiated recall is ongoing.
REASON
The units user manual had missing or inadequate information.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Radionics Head and Neck Localizer (HNL), Version B. Recall # Z-1020-04.
CODE
Serial Numbers: 032610023, 0326100023, 32690010, 041200023.
RECALLING FIRM/MANUFACTURER
Radionics, Inc., Burlington, MA, by telephone and letters dated May 25, 2004.
Firm initiated recall is complete.
REASON
Software may provide inaccurate coordinates and cause mistreatment.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
Canada, Germany, and Greece.
_______________________________
PRODUCT
Cardio Respiratory Monitor with Oximax technology with software version 5.0,
Model 511. Recall # Z-1023-04.
CODE
Serial Numbers: 0351320- through 0351369, 0413101through 0413107, 0413109,through
0413117, 0413119 through 0413125, 0413188, 0413452 through 0413501 through
0414477.
RECALLING FIRM/MANUFACTURER
CAS Medical Systems, Inc., Branford, CT, by telephone and letter dated May
24, 2004. Firm initiated recall is ongoing.
REASON
Device may not alarm for %SpO2 value limit violations if a specific feature
is enabled.
VOLUME OF PRODUCT IN COMMERCE
146 units.
DISTRIBUTION
Nationwide, Canada, and Taiwan.
_______________________________
PRODUCT
NC Stormer Zipper MX Balloon Dilation Catheter, a Percutaneous Transluminal
Coronary Angioplasty system in sterile pouch. Recall # Z-1024-04.
CODE
Not supplied.
RECALLING FIRM/MANUFACTURER
Medtronic Vascular, Santa Rosa, CA, by letter and telephone on June 8, 2004.
Firm initiated recall is ongoing.
REASON
Medical device for which sterility may be compromised because of improper
seal.
VOLUME OF PRODUCT IN COMMERCE
193 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Hitachi Ascension PIP instrument tray base. Recall # Z-1025-04.
CODE
All trays in the marketplace at the time the recall was initiated.
RECALLING FIRM/MANUFACTURER
Ascension Orthopedics, Inc., Austin, TX, by letter beginning in October 2003.
Firm initiated recall is complete.
REASON
Cracks in the tray due to excessive use can cause perforations in the outer
wrap used to maintain instrument tray sterility.
VOLUME OF PRODUCT IN COMMERCE
107 trays.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Synchron Systems Acetaminophen Reagent, part No. 472169. Recall # Z-1026-04.
CODE
All lots.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on September 4, 2003.
REASON
Firm shortened calibration frequency to 7 days from 14 days.
VOLUME OF PRODUCT IN COMMERCE
Unknown.
DISTRIBUTION
Nationwide and Canada.
_______________________________
PRODUCT
DL 2000 Data Manager. Recall # Z-1027-04.
CODE
Version 6.2.
RECALLING FIRM/MANUFACTURER
Beckman Coulter, Inc., Brea, CA, by letters on February 14, 2003. Firm initiated
recall is complete.
REASON
Software defect. The type of results affected were replicate type results
for a single sample transmitted within the same data stream.
VOLUME OF PRODUCT IN COMMERCE
231 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Trolley for Intera/NT MRI System. Recall # Z-1028-04.
CODE
The firm uses site numbers instead of serial numbers: Site Numbers: 105313,
104340, 105929, 84700, 103811, 103904, 504899, 102157, 103592, 85500, 87355,
86404, 103247, 87604, 505682, X1595, 101595, 87062, 103215, 86012, 103620,
101070, 104897, 105486, 83306, 86184, 100826, 84899, 100629, 87527, 84820,
100786, 86085, X1649, 504412, 504741, 87365, 102786, 104886, 103688, 86570,
102095, 103665, 100459, 103611, 102353, 104102, 100462, 103101, 103540, 85158,
103450, 102671, 102896, 102698, 83080, 103782.
RECALLING FIRM/MANUFACTURER
Philips Medical Systems Sales & Service Region No. America, Bothell, WA,
by letter on May 13, 2004. Firm initiated recall is ongoing.
REASON
Patient and MRI tabletop may fall if the tabletop is not positioned correctly
on the MRI trolley.
VOLUME OF PRODUCT IN COMMERCE
57 units.
DISTRIBUTION
Nationwide.
______________________________
PRODUCT
a) Circle CÆ Dual Lumen Acute Hemodialysis/Apheresis
Catheter Surgical Tray, DLC-600TEC, 12 Fr. x 15.2cm,
Sterile. The product is a clear rigid plastic surgical
tray containing components required for implantation.
Components of the inner tray are in a separate sterile
pouch. The tray and components are then sealed in an
outer clear plastic pouch. Catalog #DLC600-64C. Recall
# Z-1029-04;
b) Circle CÆ Dual Lumen Acute Hemodialysis/Apheresis
Catheter Surgical Tray, DLC-600TEC, DCL-800TEC 12 Fr. x
20.3cm. The product is a clear rigid plastic surgical
tray containing components required for implantation.
Components of the inner tray are in a separate sterile
pouch. The tray and components are then sealed in an
outer clear plastic pouch. Recall # Z-1030-04.
CODE
a) Lot Numbers 335418 and 356778;
b) Lot Numbers 3538781, 356779 & 342251.
RECALLING FIRM/MANUFACTURER
Horizon Medical Products, Inc., Manchester, GA, by letter on May 28, 2004.
Firm initiated recall is ongoing.
REASON
The products have a potential defective seal that closes the productís OUTER
POUCH. The surface of the INNER TRAY may no longer be sterile.
VOLUME OF PRODUCT IN COMMERCE
621 Units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Computed Tomography, Models TSX-101A and TSZ-021A. Recall # Z-1031-04.
CODE
All Codes.
RECALLING FIRM/MANUFACTURER
Toshiba American Med System, Inc., Tustin,
CA, by letters on March 17, 2004. Firm initiated recall is ongoing.
REASON
Erroneous patient data is entered. Previous patientís demographics are recorded.
VOLUME OF PRODUCT IN COMMERCE
552 units.
DISTRIBUTION
Nationwide.
_______________________________
PRODUCT
Monarc Subfascial Hammock With Tensioning Suture, Product Number 72403830/1.
Recall # Z-1019-04.
CODE
Lot/serial number 372128/001-030 (domestic) and 374329/001-032 (international).
RECALLING FIRM/MANUFACTURER
American Medical Systems, Minnetonka, MN, by telephone on July 28, 2003. Firm
initiated recall is complete.
REASON
Insertion needles from the former version of the product were packaged with
the new sling with dilator that is different than the old version and not
compatible with the old needles.
VOLUME OF PRODUCT IN COMMERCE
62 kits.
DISTRIBUTION
CT, IN, MI, NC, OH, TX, and Belgium.
_______________________________
PRODUCT
Sprout Chick Starter Grower Medicated Crumble with Active Drug Ingredients Amprolium
at 0.0125% and Ethopabate at 0.0004%, in 50 pound bags. The product is distributed
by Mills Fleet Farm. Recall # V-149-4.
CODE
Production codes: 4NR097, 4NR098, 4NR111, NR113, 4NR117, and 4NR118.
RECALLING FIRM/MANUFACTURER
Cargill, Inc., Animal Nutrition Division, New Richland, MN, by telephone and
e-mail on April 28, 2004. Firm initiated recall is ongoing.
REASON
The product did not contain Ethopabate declared as an active ingredient on the
label.
VOLUME OF PRODUCT IN COMMERCE
1090/50 lb. bags.
DISTRIBUTION
IA, MN, ND, and WI.
END OF ENFORCEMENT REPORT FOR JUNE 23, 2004
###
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