Enforcement Report

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

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November 29, 2006
06-48

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS II

______________________________
PRODUCT
Tetracaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 12 x 0.7 mL Single use containers, Sterile, Rx only, NDC 59390-181-07, Recall # D-401-7
CODE
Lot: 05368, Exp. 09/07
RECALLING FIRM/MANUFACTURER
Altaire Pharmaceuticals, Inc., Aquebogue, NY, by letter dated November 7, 2006. Firm initiated recall is ongoing.
REASON
Subpotent
VOLUME OF PRODUCT IN COMMERCE
35,664 single use units
DISTRIBUTION
CA and MI

______________________________
PRODUCT
Neaclear Liquid Oxygen Scar Advantage, Hydrocortisone 0.5%, 1.0 oz (30 ml) bottles, Recall # D-402-7
CODE
Lots: 6994 and 8050
RECALLING FIRM/MANUFACTURER
Diversified Manufacturing Corp, Newport, MN, by telephone on July 27, 2007. Firm initiated recall is ongoing.
REASON
Defective container
VOLUME OF PRODUCT IN COMMERCE
20,000 bottles estimated
DISTRIBUTION
IL

______________________________
PRODUCT
Acetaminophen caplets, 500 mg, packaged in bottles of 24, 50, 65, 100, 250 and 500 caplets under the following brand names: American Fare Extra Strength Pain Relief Made for Kmart Corporation, NDC 49738-484-78;
Berkley & Jensen Extra Strength Pain Relief, Dist. by BJWC;
Best Yet Extra Strength Non-Aspirin, Dist. by Fleming;
Brite-Life Extra Strength Pain Reliever, Dist. by AmerisourceBergen, NDC 24385-484-71;
Brooks Acetaminophen Extra Strength, Dist. by Maxi Drug, Inc. d/b/a/ Brooks Pharmacy;
CareOne Pain Relief Extra Strength, Dist. by American Sales Company;
Extra Strength CounterAct Pain, Dist by Melaleuca, Inc.;
CVS Pharmacy Extra Strength Pain Relief, Dist. by CVS Pharmacy, Inc.;
DG Guarantee Extra Strength Pain Relief, Dist. by Dolgencorp, Inc.;
Eckerd Extra Strength Non-Aspirin Pain Relief, Dist. by Eckerd Drug Co., NDC 19458-5013-2;
Equaline Extra Strength Pain Relief, Dist. By Albertsons Inc., NDC 41163-484-78;
Equate Extra Strength Pain Reliever, Dist. by Wal-Mart Stores, Inc., NDC 49035-484-78;
Family Pharmacy Extra Strength Pain Reliever, Dist. by Family Pharmacy, NDC 52735-710-12;
Food Lion Pain Relief, extra strength, Dist. By Food Lion LLC, NDC 55316-484-78;
FormuCare Pain Relief, Extra Strength, Dist. by Access Business Group International LLC;
Good Neighbor Pharmacy Extra Strength Pain Reliever, Dist by AmerisourceBergen, NDC 24385-484-78;
GoodSense Extra Strength Pain Relief, Dist by Perrigo Co, NDC 0113-0484-78;
H-E-B Pain Relief, Extra Strength, Dist. by H-E-B, NDC 37808-484-78;
Hannaford Pain Reliever, extra strength, Dist. by Hannaford Bros. Co., NDC 41268-484-78;
Healthy Generations extra strength non-aspirin Pain Relief, Dist. by Supervalu Inc., NDC 38045-484-78;
HyVee Extra Strength non-aspirin Pain Relief, Dist. by Hy-Vee, Inc.;
Kroger Pain Relief, Extra Strength, Dist. by the Kroger Co., NDC 30142-484-78;
Longs Wellness Extra Strength Pain Relief, Dist. by Longs Drugs, NDC 12333-9058-1;
Medic Extra Strength Acetaminophen, Dist. by Winn Dixie Stores, Inc.;
Meijer Pain Relief, Extra Strength, Dist. by Meijer Distribution, Inc., NDC 41250-484-78;
Pathmark Extra Strength Acetaminophen, Dist. by Pathmark Stores, Inc.,
Publix Extra Strength Pain Relief, Dist. by Publix Super Markets, Inc., NDC 56062-484-78;
Roundy’s Quality Extra Strength Pain Reliever, Dist. by Roundy’s Inc.;
Safeway Extra Strength non-aspirin Acetaminophen, Dist. by Safeway, Inc., NDC 21130-484-78;
ShopRite Extra Strength Non-Aspirin, Dist. by Wakefern Food Corp.;
Sunmark Pain Relief, Extra Strength, Dist by McKesson, NDC 49348-042-10;
Swan Extra Strength Pain Reliever/Fever Reducer, Dist. by Cumberland Swan, NDC 0869-9484-71;
The Medicine Shoppe Extra Strength Medi-Tabs, Dist. by Medicine Shoppe International, Inc., NDC 49614-123-78;
Today's Health Extra Strength Pain Reliever, Dist. by Warehouse Concepts, Inc., NDC 38309-484-78 and
TopCare Extra Strength Pain Relief, Dist. by Topco Associates LLC, NDC 36800-484-78, Recall # D-403-7
CODE
Lots 5CE0507, exp. 11/06; 5CE0333, exp. 11/06; 5CE0347, exp. 11/06; 5CE0348, exp. 11/06; 5CE0350, exp. 12/06; 5CE0461, exp. 12/06; 5CE0601, exp. 12/06; 5CE0602, exp. 12/06; 5CE0606, exp. 01/07; 5CE0607, exp. 01/07; 5CE0608, exp. 12/06; 5CE0874, exp. 01/07; 5CE0876, exp. 01/07; 5CE0877, exp. 01/07; 5CE0878, exp. 01/07; 5CE0879, exp. 01/07; 5CE1022, exp. 01/07; 5CE1023, exp. 01/07; 5CE1024, exp. 01/07; 5CE1025, exp. 01/07; 5CE1026, exp. 01/07; 5CE1088, exp. 09/06; 5CE1089, exp. 12/06; 5DE0121, exp. 01/07; 5DE0122, exp. 01/07; 5DE0322, exp. 01/07; 5DE0464, exp. 01/07; 5DE0465, exp. 01/07; 5DE0466, exp. 01/07; 5DE0476, exp. 01/07; 5DE0477, exp. 01/07; 5DE0746, exp. 02/07; 5DE0867, exp. 02/07; 5DE0868, exp. 02/07; 5DE0913, exp. 02/07; 5DE0982, exp. 02/07; 5DE0983, exp. 02/07; 5EE0055, exp. 02/07; 5EE0056, exp. 02/07; 5EE0057, exp. 02/07; 5EE0381, exp. 12/06; 5EE0382, exp. 01/07; 5EE0383, exp. 12/06; 5EE0384, exp. 01/07; 5EE0385, exp. 02/07; 5EE0386, exp. 02/07; 5EE0416, exp. 02/07; 5EE0417, exp. 02/07; 5HE0455, 5HV0249, 5JE0105, exp. 05/07; 5JE0142, exp. 04/07; 5JE0467, exp. 06/07; 5JE0469, exp. 07/07; 5JE0471, exp. 07/07; 5JE0472, exp. 04/07; 5JE0474, exp. 07/07; 5JE0582, exp. 07/07; 5JE0610, exp. 07/07; 5JE0713, exp. 06/07; 5JE0714, exp. 07/07; 5JE0723, exp. 04/07; 5JE0731, exp. 07/07; 5JE0936, exp. 07/07; 5JE0937, exp. 08/07; 5JE0938, exp. 08/07; 5JE0939, exp. 08/07; 5JE0939, exp. 08/07; 5JE0940, exp. 07/07; 5KE0060, exp. 07/07; 5KE0061, exp. 08/07; 5KE0066, exp. 08/07; 5KE0260, exp. 07/07; 5KE0306, exp. 07/07; 5KE0308, exp. 07/07; 5KE0396, exp. 08/07; 5KE0427, exp. 08/07; 5KE0428, exp. 07/07; 5KE0488, exp. 08/07; 5KE0489, exp. 08/07; 5KE0530, exp. 08/07; 5KE0531, exp. 08/07; 5KE0532, exp. 08/07; 5KE0579, exp. 08/07; 5KE0838, exp. 08/07; 5KE0955, exp. 04/07; 5KE0988, exp. 08/07; 5KE1063, exp. 08/07; 5KV0623, exp. 08/07; 5KV0624, exp. 08/07; 5LE0074, exp. 08/07; 5LE0075, exp. 09/07; 5LE0076, exp. 09/07; 5LE0264, exp. 09/07; 5LE0309, exp. 07/07; 5LE0329, exp. 09/07; 5LE0330, exp. 09/07; 5LE0399, exp. 09/07; 5LE0400, exp. 09/07; 5LE0419, exp. 09/07; 5LE0522, exp. 09/07; 5LE0612, exp. 09/07; 5LE0736, exp. 09/07; 5LE0791, exp. 09/07; 5LE0793, exp. 09/07; 5LE0794, exp. 09/07; 5LE0843, exp. 09/07; 5LE0853, exp. 09/07; 5LV0537, exp. 08/07; 5ME0011, exp. 09/07; 5ME0012, exp. 10/07; 5ME0031, exp. 09/07; 5ME0065, exp. 09/07; 5ME0180, exp. 10/07; 5ME0181, exp. 10/07; 5ME0265, exp. 10/07; 5ME0266, exp. 10/07; 5ME0269, exp. 10/07; 5ME0375, exp. 10/07; 5ME0379, exp. 10/07; 5ME0380, exp. 10/07; 5ME0403, exp. 11/07; 5ME0458, exp. 10/07; 5ME0459, exp. 09/07; 5ME0488, exp. 10/07; 5ME0603, exp. 10/07; 5ME0669, exp. 10/07; 5ME0685, exp. 10/07; 5ME0688, exp. 11/07; 5ME0694, exp. 09/07; 5ME0783, exp. 10/07; 5ME0786, exp. 09/07; 5ME0788, exp. 079/07; 5ME0822, exp. 09/07; 5ME0825, exp. 09/07; 5ME0829, exp. 10/07; 5ME0920, exp. 11/07; 5MV0309, exp. 09/07; 5MV0515, exp. 09/07; 5MV0565, exp. 09/07; 5MV0566, exp. 09/07; 5MV0568, exp. 10/07; 5MV0571, exp. 10/07; 6AE0008, exp. 11/07; 6AE0009, exp. 10/07; 6AE0017, exp. 11/07; 6AE0071, exp. 10/07; 6AE0144, exp. 11/07; 6AE0183, exp. 10/07; 6AE0199, exp. 11/07; 6AE0277, exp. 09/07; 6AE0278, exp. 10/07; 6AE0279, exp. 11/07; 6AE0280, exp. 11/07; 6AE0281, exp. 11/07; 6AE0314, exp. 10/07; 6AE0324, exp. 11/07; 6AE0506, exp. 11/07; 6AE0507, exp. 10/07; 6AE0567, exp. 11/07; 6AE0568, exp. 11/07; 6AE0569, exp. 12/07; 6AE0708, exp. 11/07; 6AE0712, exp. 11/07; 6AE0719, exp. 11/07; 6AE0726, exp. 11/07; 6AE0834, exp. 12/07; 6AE0835, exp. 12/07; 6AE0847, exp. 11/07; 6AV0092, exp. 08/07; 6AV0093, exp. 10/07; 6BE0068, exp. 11/07; 6BE0086, exp. 11/07; 6BE0087, exp. 11/07; 6BE0120, exp. 11/07; 6BE0160, exp. 11/07; 6BE0162, exp. 12/07; 6BE0168, exp. 12/07; 6BE0201, exp. 12/07; 6BE0279, exp. 12/07; 6BE0378, exp. 12/07; 6BE0395, exp. 12/07; 6BE0466, exp. 11/07; 6BE0535, exp. 12/07; 6BE0581, exp. 12/07; 6CE0064, exp. 12/07; 6CE0065, exp. 12/07; 6EV0392, exp. 11/07; 6FE0051, exp. 04/09; 6FE0182, exp. 04/09; 6FE0305, exp. 04/09; 6FE0377, exp. 04/09; 6FE0478, exp. 04/09; 6FE0479, exp. 04/09; 6FE0659, exp. 04/09; 6FV0404, exp. 04/09; 6FV0435, exp. 04/09; 6GE0108, exp. 04/09; 6GE0303, exp. 05/09; 6GE0436, exp. 05/09; 6GE0438, exp. 05/09; 6GE0654, exp. 05/09; 6GE0655, exp. 04/09; 6GE0657, exp. 05/09; 6GE0659, exp. 05/09; 6GE0660, exp. 05/09; 6GV0258, exp. 05/09; 6GV0260, exp. 05/09; 6HE0051, exp. 04/09; 6HE0091, exp. 06/09; 6HE0404, exp. 04/09; 6HE0422, exp. 04/09; 6HE0536, exp. 04/09; 6HE0566, exp. 07/09; 6HE0567, exp. 05/09; 6HE0568, exp. 05/09; 6HE0639, exp. 07/09; 6HE0640, exp. 07/09; 6HE0641, exp. 07/09; 6HE0673, exp. 05/09; 6HE0741, exp. 07/09; 6HE0742, exp. 07/09; 6HE0744, exp. 04/09; 6HE0823, exp. 07/09; 6HE0824, exp. 07/09; 6HV0167, exp. 04/09; 6HV0168, exp. 04/09; 6HV0170, exp. 04/09; 6HV0171, exp. 05/09; 6HV0226, exp. 04/09; 6HV0277, exp. 05/09; 6HV0278, exp. 06/09; 6HV0442, exp. 07/09; 6HV0453, exp. 07/09; 6HV0455, exp. 07/09; 6JE0016, exp. 07/09; 6JE0095, exp. 07/09; 6JE0096, exp. 07/09; 6JE0116, exp. 08/09; 6JE0346, exp. 07/09; 6JE0483, exp. 07/09; 6JE0484, exp. 07/09; 6JE0485, exp. 07/09; 6JE0680, exp. 08/09; 6JE0681, exp. 08/09; 6JE0682, exp. 07/09; 6KE0101, exp. 08/09; 6KE0106, exp. 08/09; 6KE0107, exp. 08/09; 6KE0108, exp. 08/09; 6KE0231, exp. 08/09; 6KE0252, exp. 08/09; 6KE0270, exp. 04/09; 6KE0271, exp. 07/09; 6KE0272, exp. 08/09; 6KE0274, exp. 08/09; 6KE0276, exp. 08/09; 6KE0364, exp. 08/09; 6KE0527, exp. 08/09; 6KE0529, exp. 08/09; 6KE0538, exp. 08/09; 6KE0562, exp. 08/09 and 6KE0722, exp. 08/09;
plus retailer display case overwrap lots 5CV0082, 5CV0251, 5CV0259, 5CV0336, 5CV0404, 5CV0471, 5DV0189, 5DV0293, 5DV0343, 5DV0347, 5DV0399, 5DV0431, 5DV0445, 5EV0148, 5EV0310, 5EV0313, 5FV0144, 5FV0302, 5HV0249, 5KV0157, 5KV0301, 5KV0622, 5LV0190, 5LV0393, 5LV0394, 5LV0396, 5LV0397, 5LV0170, 5LV0458, 5LV0506, 5MV0491, 6AV0118, 6AV0123, 6AV0125, 6AV0126, 6AV0279, 6AV0403, 6AV0404, 6AV0405, 6AV0406, 6AV0407, 6AV0409, 6AV0411, 6AV0412, 6AV0414, 6AV0460, 6AV0461, 6AV0462, 6AV0463, 6AV0464, 6AV0465, 6AV0466, 6AV0467, 6AV0468, 6AV0491, 6AV0494, 6AV0496, 6AV0504, 6AV0520, 6AV0521, 6AV0522, 6AV0523, 6AV0535, 6AV0538, 6AV0539, 6AV0540, 6AV0543, 6AV0544, 6AV0545, 6AV0614, 6BV0114, 6BV0115, 6BV0116, 6BV0117, 6BV0118, 6BV0119, 6BV0120, 6BV0208, 6BV0354, 6CV0149, 6CV0536, 6DV0180, 6DV0181, 6DV0182, 6DV0183, 6DV0185, 6DV0186, 6DV0188, 6DV0217, 6DV0366, 6EV0196, 6EV0262, 6EV0274, 6EV0276, 6EV0286, 6EV0287, 6EV0316, 6EV0320, 6EV0334, 6EV0335, 6EV0388, 6EV0395, 6FV0405, 6GV0139, 6GV0264, 6GV0272, 6GV0316, 6JV0320, 6JV0398, 6JV0399, 6JV0400, 6KV0122, 6KV0127, 6KV0221, 6KV0232, 6KV0234, 6KV0262, 6KV0282, 6KV0284, 6KV0291 and 6KV0309
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan, MI, by press release and letters on November 9, 2006. Firm initiated recall is ongoing.
REASON
Presence of foreign substance; Caplets may have small pieces of metal imbedded within them.
VOLUME OF PRODUCT IN COMMERCE
11,112,836 bottles
DISTRIBUTION
Nationwide

______________________________
PRODUCT
Xigris® (Drotrecogin alfa, activated), lyophilized powder for intravenous use, 5 mg vial, Rx only, NDC 0002-7559-01, Lilly item code VL7559, Recall # D-408-7
CODE
Lot: A10242, Exp. 2/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eli Lilly and Company, Indianapolis, IN, by letter dated November 1, 2006.
Manufacturer: DSM Pharmaceuticals, Inc., Greenville, NC. Firm initiated recall is ongoing.
REASON
The vial stopper may generate particulates or collapse during reconstitution of the drug.
VOLUME OF PRODUCT IN COMMERCE
322/5 mg vials
DISTRIBUTION
AZ, CA, CO, and WA

______________________________
PRODUCT
Oxygen, Compressed USP, medical gas in aluminum cylinder, sizes D, E, DA, EA, M4, M6, M9, M22, Recall # D-409-7
CODE
WT02T226B, WT03T236I, WT01T250K, WT04T262D, WT05T270Q, WT00T282P, WT02T226I , WT04T240B, WT01T250N, WT04T262F, WT05T271B, WT00282N, WT02T226M, WT04T240F, WT01T250P, WT04T263K, WT05T271I , WT01T283A, WT02T227F, WT04T240K, WT01T251G, WT04T263M, WT05T271K, WT01T283D, WT02T227J, WT04T241C, WT02T254A, WT04T263N, WT05T271O, WT01T283I, WT02T229A, WT04T241F, WT02T254C, WT04T263O, WT05T272C, WT01T283M, WT02T229D, WT04T241L, WT02T254L, WT047263P, WT06T272F, WT01T283P, WT02T229E, WT04T241M, WT02T255B, WT04T264D, WT00T275D, WT03T230A, WT04T242D, WT02T255C, WT04T264M, WT00T275H, WT03T233F, WT04T242G, WT02T255F, WT04T264O, WT00T278A, WT03T233G, WT05T243B, WT02T255G, WT04T265D, WT00T278B, WT03T234B, WT05T243D, WT03T257I, WT04T265F, WT00T278C, WT03T234F, WT01T249B, WT03T257N, WT04T266A, WT00T278D, WT03T234H, WT01T249D, WT03T258D, WT04T268B, WT00T278H, WT03T235B, WT01T249E, WT03T258I, WT04T268D, WT00T279B, WT03T236A, WT01T249G, WT03T261A, WT04T269C, WT00T279C, WT03T236B, WT01T249J, WT03T261F, WT04T269E, WT00T279E, WT03T236K, WT01T250B, WT03T261I, WT04T269G, WT00T279F, WT03T236M, WT01T250D, WT03T261J, WT04T269H, WT00T282H, WT03T236F, WT01T250F, WT04T262B, WT04T269L, WT00T282J
RECALLING FIRM/MANUFACTURER
Airgas South, Inc., Albany, GA, by letter on October 17, 2006. Firm initiated recall is ongoing.
REASON
Rinse water from external cleaning may have contaminated product resulting in residual odor of cleaning solution.
VOLUME OF PRODUCT IN COMMERCE
2,774 cylinders
DISTRIBUTION
GA

RECALLS AND FIELD CORRECTIONS: DRUGS -- CLASS III

______________________________
PRODUCT
Doxepin Hydrochloride Capsules, USP, 25 mg, Rx only, 1000 count bottles, NDC 0591-5630-10, Recall # D-407-7
CODE
Lot: L6G0879, Exp. 8/31/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Watson Laboratories, Inc., Corona, CA, by letters dated November 8, 2006.
Manufacturer: Watson Laboratories, Inc., Carmel, NY. Firm initiated recall is ongoing.
REASON
Defective containers (loose caps)
VOLUME OF PRODUCT IN COMMERCE
167/1000 count bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS -- CLASS II

______________________________
PRODUCT
BD Procount Progenitor Cell Enumeration Kit, Part Number: 340498, Recall # B-0051-7
CODE
Lot Number: 45602
RECALLING FIRM/MANUFACTURER
BD Biosciences, San Jose, CA, by letter dated August 10, 2006. International customers were notified by telephone and e-mail the week ending August 11, 2006. Firm initiated recall is ongoing.
REASON
Progenitor Cell Enumeration Kits, which may produce false results, were distributed.
VOLUME OF PRODUCT IN COMMERCE
799 kits
DISTRIBUTION
Nationwide and Internationally

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0212-7
CODE
Unit: 71P126152
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile dated May 5, 2005. Firm initiated recall is complete.
REASON
Red Cells, mislabeled as to the Rh antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0219-7;
b) Plasma, Recall # B-0220-7
CODE
a) Units: 53GJ28938, 53KN29412;
b) Unit: 53GJ28938
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Chesapeake & Potomac Region, Baltimore, MD, by telephone on February 9, 2006 and by letters dated February 10 and 13, 2006, and March 13, 2006. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the antibody to the human immunodeficiency virus (anti-HIV-1/2), but were collected from a donor who provided post donation information regarding having a prior false positive test for HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
MD and D.C.

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0365-7
CODE
Unit: 261215931
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone on May 26, 2004, and by letter dated June 15, 2004. 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
AK

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0394-7;
b) Red Blood Cells, Recall # B-0395-7
CODE
a) Units: 11FJ09817, 11LC60924, 11LC62210, 11LC63383, 11LC64773,
11LC75829, 11LC76977, 11LC78281, 11LC79571, 11LC81747;
b) Units: 11LC42821, 11LV96347, 11LY34374
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Missouri-Illinois Region, Saint Louis, MI, by telephone beginning February 13, 2004, and by letter dated February 27, 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
13 units
DISTRIBUTION
IL, MO, GA, MD, PA, and SC

______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0396-7
CODE
Unit: 11GT46514
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Missouri-Illinois Region, Saint Louis, MI, by telephone on September 13, 2003, and by letter dated September 23, 2003. 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
IL

______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0397-7;
b) Red Blood Cells, (Apheresis) Leukocytes Reduced, Recall # B-0398-7
CODE
a) Unit: 268357972;
b) Units: 268347619 -- parts 1 and 2
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by telephone and letter dated December 9, 2005. 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
AK and OK

______________________________
PRODUCT
Source Plasma, Recall # B-0400-7
CODE
Units: OE649210, OE648418, OE647213, OE643893, OE643376, OE642504, OE642066, OE635257, OE634840, OE633148, OE631978, OE629871, OE629376, OE628358, OE627851, OE625979, OE625188, OE624437, OE623886, OE622759, OE622255, OE621470, OE620971, OE619874, OE619393, OE618264, OE617874, OE615737, OE615254, OE614082, OE613458, OE612866, OE612266, OE609086, OE608755, OE606669, OE605689, OE605346, OE604358, OE603875, OE602820, OE602457, OE601237, OE600896, OE599638, OE599326, OE598083, OE597845, OE596513, OE596188, OE594667, OE593446, OE593085, OE591890, OE591511, OE590288, OE589951, OE588606, OE588294, OE586955, OE586663, OE585431, OE585147, OE584031, OE583607, OE582291, OE581917, OE580652, OE579959, OE578739, OE578131, OE577073, OE576559, OE575326, OE574793
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Eagle Pass, TX, by facsimile dated October 10, 2005. Firm initiated recall is complete.
REASON
Source Plasma, was not properly quarantined after receipt of post-donation information related to recent tattoos.
VOLUME OF PRODUCT IN COMMERCE
75 units
DISTRIBUTION
NC and NY

______________________________
PRODUCT
Source Plasma, Recall # B-0401-7
CODE
Units: OE569967, OE569704, OE568497, OE568158, OE566950, OE566575, OE565377, OE563777, OE563543, OE562237, OE562038, OE560690, OE560255, OE559137, OE558656, OE557579, OE557055, OE554419, OE554115, OE552640, OE551346, OE550866, OE548242, OE547939, OE546717, OE545318, OE543926, OE543421, OE542235, OE541813, OE540572, OE540282, OE537686, OE537007, OE636240, OE535311, OE534688, OE533666, OE533334, OE532565, OE532178, OE531191, OE530791, OE529773, OE529327, OE528311, OE527875, OE526854, OE526441, OE525282, OE524863, OE523640, OE523191, OE522053, OE521626, OE520517, OE520076, OE519010, OE518642, OE516540, OE515089, OE514575, OE513641, OE513107, OE512142, OE511624, OE510653, OE510131, OE509192, OE508630, OE507667, OE507143, OE506171, OE505633, OE504680, OE504131, OE503060, OE502516, OE501577, OE501079, OE500172, OE499333, OE498761, OE498119, OE497464, OE496839, OE496406, OE495741, OE495000, OE494346
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Eagle Pass, TX, by facsimile transmission dated April 14, 2004. Firm initiated recall is complete.
REASON
Source Plasma, was not properly quarantined after receipt of post-donation information related to recent piercing.
VOLUME OF PRODUCT IN COMMERCE
90 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS II

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PRODUCT
Abbott AxSYM Matrix Cells--Product List No: 8A73-02, sold in boxes of 100, Recall # Z-0117-2007
CODE
Lot # 37618Q100 Expiration Date 12/05/2006
RECALLING FIRM/MANUFACTURER
Abbott Diagnostic International, Ltd., BarcelonetaPR, by letter on September 8, 2006. Firm initiated recall is ongoing.
REASON
Increase in complaints regarding controls out of range, calibration errors, and discrepant patient results with the AxSYM Troponin-I ADV assay.
VOLUME OF PRODUCT IN COMMERCE
2,355 boxes
DISTRIBUTION
Nationwide, Hawaii, and PR
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PRODUCT
Modularis URO urological table, Model number 5531012, Recall # Z-0168-2007
CODE
Serial numbers 01001 to 01345
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on October 19, 2006.
Manufacturer: Siemens Medical Solutions, Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Potential pinch point with the patient table
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
Nationwide

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PRODUCT
a) UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26004
Femoral Component Size 4, 26006 Femoral Component Size 6,
26008 Femoral Component Size 8 and 26010 Femoral Component Size 10,
Recall # Z-0191-2007;
b) UC-PLUS Solution Unicondylar Knee System, Model Numbers: 26014
Femoral Component Size 4, 26016 Femoral Component Size 6, 26018
Femoral Component Size 8 and 26020 Femoral Component Size 10,
Recall # Z-0192-2007
CODE
a) All lots considered affected Serial Number: None;
b) Lot number 0305.13.2814, 26016: Lot number 0305.13.2815, 26018:
Lot number 0305.13.2816, 26020: Lot number 0305.13.2817
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plus Orthopedics USA, San Diego,CA., by letter on July 30, 2003.
Manufacturer: Plus Orthopedics AG, Rotkreuz, Switzerland. Firm initiated recall is complete.
REASON
There exists the possibility that incomplete bony support or insufficient cementing of the implanted device can result in fatigue fracture of the UC-PLUS Solution Femoral Component.
VOLUME OF PRODUCT IN COMMERCE
80 units
DISTRIBUTION
CA

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PRODUCT
Optetrak, B-series cemented finned tibial tray, size 2f/2t. Catalog # 220-04-02, Recall # Z-0196-2007
CODE
Serial numbers: 0886395-0886424
RECALLING FIRM/MANUFACTURER
Exactech, Inc., GainesvilleFL., by fax, e-mail and telephone on August 31, 2006. Firm initiated recall is ongoing.
REASON
Improperly machined parts: The Cemented Finned Tibial Trays could not seat the size 2 mating trial or polyethylene insert.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Internationally

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PRODUCT
Cytomics FC 500 Flow Cytometry System with CXP Software Versions 2.0 & 2.1, Recall # Z-0197-2007
CODE
Part Numbers: 722645 Software Kit; CXP version 2.1 New User; 723113 Software Kit;
CXP version 2.1 Upgrade; 629637 Software Kit;
CXP version 2.0 New User; 629636 Software Kit;
CXP version 2.0 Upgrade; 626553 TN;
FC500 WITH UPS; 6605627 TN;
5 CLR, FC500 (IOOV); 6605628 TN;
5 CLR, FC500 (120V); 6605629 TN;
5 CLR, FC500 (220V); 6605630 TN;5 CLR, FC500 (240V)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea,CA., by letters the week of July 24, 2006.
Manufacturer: Applied Cytometry, Sheffield, UK. Firm initiated recall is ongoing.
REASON
Mis-identification-If a panel or protocol is added to an existing worklist but the tube location is not specified, the CXP Acquisition software will run the last specified tube through the remaining protocols and will generate results and printouts of these runs leading to a Mis-Identification condition.
VOLUME OF PRODUCT IN COMMERCE
476 units
DISTRIBUTION
Nationwide and Canada

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PRODUCT
StatSpin Express 3 Centrifuge with RTX8 Rotor Model: M502, Recall # Z-0198-2007
CODE
Serial numbers: B1562 to B1738
RECALLING FIRM/MANUFACTURER
Iris Sample Processing, Westwood, MA, telephoned on September 29, 2006 . Firm initiated recall is ongoing.
REASON
Rotor may crack and separate causing device to fail. A failed rotor not successfully contained may seriously injure the laboratory worker.
VOLUME OF PRODUCT IN COMMERCE
94 units
DISTRIBUTION
Nationwide

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PRODUCT
Eridan Automated Slide Stainer and Support Cart, REF E300 and E300SC1, (Catalog No. (ER 00130, 00331, 00230, 00431), Recall # Z-0199-2007
CODE
Serial numbers: ER103, ER105, ER106, ER107, ER108, ER110, ER111, ER113, ER115, ER117, ER118
RECALLING FIRM/MANUFACTURER
Dako Colorado, Inc., Fort Collins, CO, by telephone on October 2, 2006 and by letter on October 20, 2006. Firm initiated recall is ongoing.
REASON
Automated slide staining device may not stain speciman slides correctly, and therefore slides cannot be used for patient diagnosis.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Gambro Phoenix Hemodialysis Machine, Model numbers: 6022933700, 6023006700, 6022966700, Recall # Z-0200-2007
CODE
Serial numbers: 11637 thru 12321.
RECALLING FIRM/MANUFACTURER
Gambro Renal Products, Inc., LakewoodCO, by fax on May 12, 2006 and by letter on May 16, 2006.
Manufacturer: Gambro Dasco S.p.A. Monitor Division, Medolla, Italy. Firm initiated recall is complete.
REASON
Defective Heat Exchanger/membrane; this may result in perforation of the membrane thus allowing the presence of infectious organisms and/or pathogens to pass from patient to patient.
VOLUME OF PRODUCT IN COMMERCE
783 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Datex-Ohmeda Tec 6 Plus Desflurane Vaporizer. It is an electronic vaporizer which delivers the anesthetic agent desflurane, Recall # Z-0201-2007
CODE
Serial numbers: AETK25021 thru AETK25023, AETK25024, AETK25025, AETK25027 thru AETK25030, AETK27001, AETK27002, AETK27004, AETK27006, AETK27007, AETK27010 thru AETK27015, AETK27017, AETK27019, AETK27020, AETK27024, AETK27025, AETK27027, AETK27031 thru AETK27034, AETK27039, AETK27040, AETK28001 thru AETK28003, AETK28005, AETK28006, AETK28008, AETK28010, AETK28011, AETK28013 thru AETK28017, AETK28019, AETK28021, AETK28023 thru AETK28025, AETK28029, AETK28031thru AETK28038, AETK28040 thru AETK28046, AETK28048, AETK28050 thru AETK28052, AETK28056, AETK28057, AETK28059, AETK28063, AETK28065, AETK28067, AETK28070 thru AETK28072, AETK28074 thru AETK28076, AETK29004, AETK29006, AETK29035, AETK29037, AETK29039, AETK29043, AETK29045, AETK29061, AETK29068, AETK29073, AEWK30001
RECALLING FIRM/MANUFACTURER
Datex - Ohmeda, Inc., Madison,WI, by letter dated September 15, 2006. Firm initiated recall is ongoing.
REASON
There is a possibility of a vaporizer power failure, with audible and visual alarms, when using the Tec 6 Plus Desflurane Vaporizer.
VOLUME OF PRODUCT IN COMMERCE
93 units
DISTRIBUTION
Nationwide and Canada

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PRODUCT
a) Access Point Medical Canes, Cane, Off-Set Crook w/Strap-Black,
Product Code CN10051, packaged 20/case, Recall # Z-0202-2007;
b) Access Point Medical Canes, Quad Cane, Medium Base (Gold, Chrome),
Product Code CN11050, packaged 10/case., Z-0203-2007
c) Access Point Medical Canes, Quad Cane, Small Base - Gold,
Product Code CN11050B, and Small Base - Chrome,
Product Code CN11050C, both packaged 6/case, Recall # Z-0204-2007;
d) Access Point Medical Canes, Quad Cane, Large Base - Gold,
Product Code CN11070B, and Large Base - Chrome,
Product Code CN11070C, both packaged 6/case, Recall # Z-0205-2007
CODE
All canes bearing the model number.
RECALLING FIRM/MANUFACTURER
Access Point Medical LLC, St. Louis, MO, by telephone and letters dated March 9, 2006. Firm initiated recall is ongoing.
REASON
The canes were made of unacceptable materials and could break.
VOLUME OF PRODUCT IN COMMERCE
3,188 canes
DISTRIBUTION
Nationwide

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PRODUCT
Pioneer Catheter (Crosspoint TransAccess Catheter); Model TA-XP-001, Recall # Z-0208-2007
CODE
All codes
RECALLING FIRM/MANUFACTURER
Medtronic Vascular, Santa Rosa, CA, by letters on November 1, and November 3, 2006, and by telephone and email week of October 30, 2006. Firm initiated recall is ongoing.
REASON
Sterility may be compromised as evidenced by a loss of package integrity.
VOLUME OF PRODUCT IN COMMERCE
502 units
DISTRIBUTION
Nationwide and Internationally

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PRODUCT
Zimmer NexGen Complete Knee Solution Legacy Knee Tibial Component, 3 degree, fluted, size 4, stemmed option, for cemented use only, tivanium TI-6AL-4V alloy/UHMWPE, sterile; Catalog no. 05-5998-038-02, Recall # Z-0209-2007
CODE
Lot 60472442; exp. May 2011
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter dated October 12, 2006. Firm initiated recall is complete.
REASON
The polyethylene tibial articular surface may not lock into some of the tibial plates.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
Nationwide

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PRODUCT
Zimmer Trabecular metal shoulder instrumentation proximal provisional humeral stem, 48 degrees, 9/10 mm diameter, nonsterile; REF 4309-18-10, Catalog no. 00-4309-018-10, Recall # Z-0210-2007
CODE
Lots: 60457716 and 60492624
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter dated October 19, 2006. Firm initiated recall is ongoing.
REASON
The instrument may fracture at the threaded end during intramedullary trialing and leave the distal pilot trial in the humeral canal.
VOLUME OF PRODUCT IN COMMERCE
50 devices
DISTRIBUTION
Nationwide and Australia

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PRODUCT
CR NX Modality Workstation, Computed Radiography System (Software versions NX 1.0.2402 and NX 1.0.2405), Recall # Z-0219-2007
CODE
60+0026406, 60+00026407, 60+00026408, 60+00026857, 60+00026858, 60+00026410, ES885. Software versions: NX 1.0.2402 and NX 1.0.2405
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by service bulletin on September 1, 2006 and by telephone and email on October 13, 2006.
Manufacturer: AGFC Corp., Mortsel, Belgium. Firm initiated recall is ongoing.
REASON
Users may experience one or more of four (4) problems; 1. Image quality problem with full leg full spine exams. 2. Unable to print 2 or more images on 1 film. 3. Possible image loss when printing. 4. Study date and time not showing up on Imexius Web.
VOLUME OF PRODUCT IN COMMERCE
178 units
DISTRIBUTION
Nationwide

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PRODUCT
Konica Minolta PrintLink III Model - ID/IV, product code no. 0770, 0771 Medical Imaging Communication Device Model IV - product code 5000230 Model ID, product code 5000330, Recall # Z-0220-2007
CODE
Product code 0770, serial numbers: 0002, 0003, 0011, 0012, 0013, 0014, 0015, 0020, 0021, 0022, 0023, 0024, 0035, 0036, 0037, 0038, 0081, 0082, 0083, 0084, 0085, 0124, 0125, 0126, 0147, 0148, 0149, 0156, 0157, 0158, 0159, 0160; Product code 0771, serial numbers: 0001, 0003, 0004, 0012, 0013, 0014, 0015, 0016, 0017, 0018, 0019, 0020, 0021, 0026, 0027, 0028, 0029, 0030, 0034, 0035, 0044, 0045, 0046, 0047, 0048, 0049, 0050, 0051, 0065, 0066, 0067, 0068, 0069, 0125, 0126, 0127, 0128, 0129, 0155, 0156, 0157, 0159, 0160, 0161, 0162, 0163, 0167, 0168, 0169, 0170, 0234, 0235, 0236, 0241, 0242, 0243, 0244, 0245
RECALLING FIRM/MANUFACTURER
Recalling Firm: Konica Minolta Medical Imaging USA, Inc., Wayne, NJ, by letters, fax, email and telephone on October 10, 2006.
Manufacturer: Konica Medical and Graphic Cor, Shinjuku-Ku, Tokyo, Japan. Firm initiated recall is ongoing.
REASON
The power supply of a unit located in Japan overheated and caused a smoke condition and a small amount of flame coming off the unit.
VOLUME OF PRODUCT IN COMMERCE
91
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES -- CLASS III

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PRODUCT
Protex Continous Epidural anesthesia tray, Ref 4948-17, Recall # Z-0211-7
CODE
Lot number: 1063342
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Keene, NH, by letters on October 27, 2006. Firm initiated recall is ongoing
REASON
Misbranded: Tray label states 26G x 5/8 inch, needle is 25 G x 1 inch.
VOLUME OF PRODUCT IN COMMERCE
540 units
DISTRIBUTION
Nationwide and Panama

END OF ENFORCEMENT REPORT FOR November 29, 2006

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