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U.S. Department of Health and Human Services

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Enforcement Report for December 20, 2006

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.

 

December 20, 2006
06-51

RECALLS AND FIELD CORRECTIONS: FOOD and COSMETICS - CLASS III

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PRODUCT
Family Pantry Buttermilk Pancake and Waffle Mix, packaged in 32-oz. boxes, 12 boxes/case, Recall # F-077-7
CODE
JUL192007AL1, JUL192007AL2, JUL202007AL1, JUL202007AL2, JUL212007AL1, JUL212007AL2
RECALLING FIRM/MANUFACTURER
Recalling Firm: ADM Milling Co., Overland Park, KN., by telephone on September 29, 2006, and e-mail dated October 5, 2006.
Manufacturer: A D M Milling Co., Lincoln, NB. Firm initiated recall is ongoing.
REASON
Product is infested with red flour beetles.
VOLUME OF PRODUCT IN COMMERCE
5,880/12-box cases
DISTRIBUTION
TX, AR, VA, IA, and FL.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

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PRODUCT
FERO-FOLIC -500 Filmtab Tablets (Controlled Release Iron with Vitamin C and Folic Acid ), 30 Filmtab Tablets, Rx only, NDC 0074-7079-30
Recall # D-412-7
CODE
Lots # 08-173-AA-2 Exp Date; Oct 1, 2006 // 1, 08-173-AA-22 Exp Date; Oct 1, 2006 and 15-829-AA-21 Exp Date; May 1, 2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories MPG, Abbott Park, IL, by letter on August 23, 2006.
Manufacturer: Abbott Pharmaceuticals PR Ltd., Barceloneta, PR. Firm initiated recall is ongoing.
REASON
Current Good Manufacturing Practices (cGMP) Deviations.
VOLUME OF PRODUCT IN COMMERCE
150,986 cartons
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

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PRODUCT
Antacid Liquid Antacid/Antigas (in each 5 ml teaspoon) Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg), Cooling Mint and Mint Creme, packaged in 12 and 26 fl oz bottles under the following brand labels: CVS Pharmacy, Dist by CVS Pharmacy, Inc, NDC 59779-851-35; Good Neighbor Pharmacy, Dist by AmerisourceBergen, NDC 24385-358-40; Longs Wellness, Dist by Longs Drugs, NDC 12333-9093-1; Kroger, Dist by NDC 30142-851-40; TopCare, Dist by Topco Associates LLC., NDC 36800-851-40; Equate, Dist by Wal-Mart Stores, Inc., NDC 49035-851-35; HyVee, Dist by Hy-Vee, Inc., NDC 42507-851-40; Shop Rite, Dist by Wakefern Food Corp, Elizabeth, NJ; Leader, Dist by Cardinal Health, NDC 37205-314-40; equaline, Dist by Albertsons Inc., NDC 41163-851-40; Food Lion, Dist by Food Lion, NDC 55316-851-40; Sunmark, Dist by McKesson, NDC 49348-019-39; Good Sense, Dist by Perrigo Company, NDC 0113-0851-40, Recall # D-413-7
CODE
Lots 6AK0052, exp. 11/2007; 6AK0212, exp. 11/2007; 6AK0135, exp. 11/2007; 6BK0131, exp. 11/2007; 6EK0026, exp. 03/2008; 6FK0038, exp. 03/2008; 6EK0321, exp. 03/2008; 6FK0089, exp. 03/2008; 6EK0164, exp. 03/2008; 6FK0155, exp. 03/2008; 6EK0269, exp. 03/2008.
letter mailed on 11/6/06
RECALLING FIRM/MANUFACTURER
Perrigo Company, Allegan MI, by letter mailed on November 6, 2006. Firm initiated recall is ongoing.
REASON
Subpotent, simethicone.
VOLUME OF PRODUCT IN COMMERCE
123,702 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

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PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0214-7
CODE
Unit 269722020
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by fax on May 5, 2006. Firm initiated recall is complete.
REASON
Red Cells, collected from donors with unacceptable hematocrits, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1unit
DISTRIBUTION
TX
______________________________
PRODUCT
Platelets Pheresis Leukocyte Reduced Irradiated, Recall # B-0268-7
CODE
Unit: 2066349
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by telephone on September 8, 2005 and by fax on September 12, 2005.
Firm initiated recall is complete
REASON
Blood product, labeled as leukoreduced, but which did not meet the requirements for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0335-7
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0336-7
c) Platelets, Recall # B-0337-07
d) Fresh Frozen Plasma, Recall # B-0338-7
e) Recovered Plasma, Recall # B-0339-7
CODE
a) Units 20281734 and 204007629
b) Unit 207265268
c) Units 20281734 and 204007629
d) Unit 202817535
e) Units 204007629 and 207265268
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Lafayette, LA, by e-mail and letter on September 27, 2005. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to a history of jaundice, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
LA, VA, TX and Switzerland
______________________________
PRODUCT
a) Red Blood Cells, Recall # B-0352-7;
b) Red Blood Cells, Leukocytes Reduced, Recall # B-0353-7;
c) Platelets, Leukocytes Reduced, Recall # B-0354-7;
d) Fresh Frozen Plasma, Recall # B-0355-7
CODE
a) Units 22GH27742, 22GH27756
b) Units 22LP14611, 22FX27910, 22FZ25495, 22FZ25493, 22FZ25484, 22FZ25491, 22FZ25488, 22FQ37529, 22FQ37175, 22FQ37531, 22FQ37511, 22FQ37186, 22GG02764, 22GG02765, 22GG02759, 22GG02758, 22GH28058, 22GH28057, 22GH27100, 22GH28069, 22GH28072, 22GH28062, 22GQ14442, 22GS22279, 22GS22298, 22KN68386, 22KN69321, 22KT81095, 22KT81098, 22KT81091, 22KT81067, 22KT81064, 22KT81063, 22KT81061, 22KT81069
c) Units 22FQ37175, 22FQ37186, 22FQ37513, 22FQ37511, 22FZ25488, 22FZ25491, 22FZ25493, 22FZ25495, 22GG02758, 22KT81061, 22KT81064, 2KT81069, 22KT81095, 22KN68386, 22LP14611;
d) Units 22KN68386, 22KT81063, 22KT81069, 22KT81091, 22GG02758, 22FZ25493, 22FZ25495, 22FQ37513, 22KT81067, 22FQ37175, 22FQ37186, 22FX27963
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn-Jersey Region, Philadelphia, PA, by telephone on May 26 and 31, 2006 and June 6, 2006 and by letter on May 26, 2006. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of sterility due to an inadequate arm rub were distributed.
VOLUME OF PRODUCT IN COMMERCE
65 units
DISTRIBUTION
MD, PA, NJ and PR
______________________________
PRODUCT
Red Blood Cells (Apheresis), Recall # B-0356-7
CODE
Units 8950501 (A&B)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, Inc., New York, NY, by telephone on October 24, 2000 and by letters on October 24, 2000
Manufacturer: New York Blood Center, Inc., Westbury, New York. Firm initiated recall is complete.
REASON
Red Cells, that did not meet product specifications, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-0380-7
CODE
Units 0265082, 0273029, 0246062, and 0270566
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone and letter on July 12, 2005. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly labeled as having been irradiated,
were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
LA
______________________________
PRODUCT
Source Plasma, Recall # B-0402-7
CODE
Units: 05YARD7596, 05YARD6714, 05YARD6337, 05YARD5797, 05YARD5454, 05YARD4525, 05YARD3946, 05YARD3616, 05YARD3092, 05YARD2762, 05YARD2222, 05YARD1921, 05YARD1383, 05YARD1041, 05YARD0469, 05YARD0152, 05YARC9586, 05YARC9286, 05YARC8149, 05YARC7595, 05YARC7259, 05YARC6686, 05YARC6304, 05YARC5700, 05YARC4661, 05YARC4360, 05YARC2648, 05YARC2024, 05YARC1666, 05YARC0864, 05YARC0249, 05YARB9972, 05YARB8503, 05YARB8186, 05YARB7699, 05YARB7354, 05YARB6851, 05YARB6514, 05YARB6037, 05YARB5732, 05YARB5250, 05YARB4931, 05YARB4375, 05YARB4042, 05YARB3510, 05YARB3176, 05YARB2633, 05YARB2270, 05YARB1748, 05YARB1419, 05YARB0846, 05YARB0504, 05YARA9997, 05YARA9683, 05YARA9226, 05YARA8961, 05YARA8465, 05YARA8122, 05YARA7581, 05YARA7260, 05YARA6755, 05YARA6443, 05YARA5983, 05YARA5652, 05YARA5165, 05YARA4856, 05YARA3570, 05YARA3270, 05YARA2749, 05YARA2189, 05YARA1923, 05YARA1397, 05YARA1118, 05YARA0625, 05YARA0359, 04YARD6410, 04YARD6001, 04YARD5753, 04YARC6289, 04YARC6013, 04YARC3786, 04YARB8591, 04YARB8147, 04YARB7895, 04YARB7453, 04YARB7193, 04YARB6640, 04YARB6057, 04YARB5812, 04YARB5359, 04YARB5107, 04YARB4695, 04YARB4410, 04YARB3806, 04YARB3364, 04YARB3148, 04YARB2763, 04YARB2530, 04YARB2152, 04YARB1733, 04YARB1285, 04YARB0995, 04YARB0532, 04YARB0219, 04YARA9752, 04YARA9224, 04YARA8973, 04YARA8561, 04YARA8297, 04YARA7839, 04YARA7558, 04YARA7114, 04YARA6775, 04YARA6582, 04YARA6205, 04YARA5773, 04YARA5505, 04YARA5074, 04YARA4803, 04YARA4460, 04YARA4122, 04YARA3772, 04YARA2800, 04YARA2503, 04YARA2163, 04YARA1203, 04YARA1085, 04YARA0595, 04YARA0327, 03YARD1159, 03YARD0878, 03YARD0655, 03YARD0326, 03YARD0095, 03YARC9788, 03YARC9575, 03YARC9191, 03YARC9031, 03YARC8542, 03YARC8236, 03YARC7907, 03YARC7580, 03YARC7348, 03YARC6762, 03YARC6433
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fayetteville, AR, by facsimile dated December 21, 2005. Firm initiated recall is complete.
REASON
Source Plasma, collected from a donor who was at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was
distributed.
VOLUME OF PRODUCT IN COMMERCE
145 units
DISTRIBUTION
NC
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0429-7
CODE
Unit number 5876975
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute, Oklahoma City, OK, by fax on March 27, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who did not have a documented hematocrit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced, Recall # B-0430-7
CODE
Units 8716580 (split unit)
RECALLING FIRM/MANUFACTURE
Florida’s Blood Centers, Inc., Lake Park, FL, by fax on November 10, 2004. Firm initiated recall is complete.
REASON
Platelets, which were possibly contaminated with bacteria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
______________________________
PRODUCT
Platelet Pheresis Leukocytes Reduced, Recall # B-0431-7
CODE
Unit number 8507956
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers Inc., Orlando, FL, by telephone on May 7, 2002 and by letter on May 21, 2002. Firm initiated recall is complete.
REASON
Blood product, with platelet yield below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
______________________________
PRODUCT
Red Blood Cells Irradiated, Recall # B-0436-7
CODE
Units: 71N566440, 71N566688
RECALLING FIRM/MANUFACTURER
Life South Community Blood Center, Birmingham, AL, by fax on January 13, 2005
REASON
Blood products, incorrectly labeled as irradiated, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
______________________________
PRODUCT
Fresh Frozen Plasma, Recall # B-0437-7
CODE
Units: 2233889, 2708213
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by telephone August 8, 2005 and by fax on August 30, 2005. Firm initiated recall is complete.
REASON
Blood products, associated with red cell components which contained clots, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

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PRODUCT
a) Red Blood Cells, Leukocytes Reduced, Recall # B-0357-7
b) Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-0358-7
CODE
a) Units: 17735-5133, 17735-5701, 17735-7219, 17735-7220, 17735-7223, 17735-7225, 17735-7226,
17735-7903, 17735-8302, 17735-8313, 17735-8316, 17735-8317, 17735-8314, 17735-8315, 17735-8740, 17735-9629, 17735-9227, 17735-9230, 17735-9231, 17735-9232, 17735-8876, 17735-8878, 17735-8882, 17735-9628, 17735-9237, 17735-9630, 17735-8901, 17735-8894, 17735-8898, 17735-9229, 17735-8891, 17735-9710, 17735-9233, 17735-9236, 17735-8881, 17735-8760, 17735-8753, 17735-8752, 17735-9082, 17735-9034, 17735-9029, 17735-9054, 17735-9055, 17735-9041, 17735-9046, 17735-9050, 17735-9066, 17735-9086, 17735-9051, 17735-9049, 17735-9039, 17735-9052, 17735-9057, 17735-8937, 17735-9635, 17735-9638, 17735-9634, 17735-8966, 17735-9285, 17735-8967, 17735-8976, 17736-0215, 17735-8978, 17735-8981, 17735-9442, 17735-9444, 17735-9478, 17735-9450, 17735-9509, 17735-9485, 17735-9437, 17735-9448, 17735-9472, 17736-0291, 17735-9436, 17735-9441, 17735-9452, 17735-9434, 17735-9438, 17735-9652, 17735-9651, 17735-9657, 17735-9655, 17735-9656, 17736-0249, 17736-0251, 17735-9543, 17735-9570, 17736-0351, 17735-9844, 17735-9549, 17735-9565, 17735-9571, 17736-0350, 17735-9538, 17735-9563, 17735-9566, 17736-0265, 17735-9904, 17735-9895, 17735-9881, 17736-0358, 17735-9882, 17735-9880, 17735-9902, 17736-0368;
b) Units: 17735-8883, 17735-9225(1), 17735-9225(2), 17735-9228(1), 17735-9228(2), 17735-9235(1), 17735-9235(2), 17735-8877(1), 17735-8877(2), 17735-8880, 17735-8902, 17735-9627(1), 17735-9627(2), 17735-9226(1), 17735-9226(2), 17735-9239(1), 17735-9239(2), 17735-9242(1), 17735-9242(2), 17735-9244(1), 17735-9244(2), 17735-9247(1), 17735-9247(2), 17735-9249(1), 17735-9249(2), 17735-8879(1), 17735-8879(2), 17735-8886(1), 17735-8886(2), 17735-8736(1), 17735-8736(2), 17735-8900(1), 17735-8900(2), 17735-9251(1), 17735-9251(2), 17735-9255(1), 17735-9255(2), 17735-9257(1), 17735-9257(2), 17735-9259,
17735-9260(1), 17735-9260(2), 17735-8735(1), 17735-8735(2), 17735-8893(1), 17735-8893(2), 17735-8889(1), 17735-8889(2), 17735-8883(1), 17735-8883(2), 17735-8885(1), 17735-8885(2), 17735-9030(1), 17735-9030(2), 17735-9031(1), 17735-9031(2), 17735-9045(1), 17735-9045(2), 17735-9081(1), 17735-9081(2), 17735-9060(1), 17735-9060(2), 17735-9062(1), 17735-9062(2), 17735-9080(1), 17735-9080(2), 17735-9067(1), 17735-9067(2), 17735-9076(1), 17735-9076(2), 17735-9022(1), 17735-9022(2), 17735-9038(1), 17735-9038(2), 17735-9042(1), 17735-9042(2), 17735-9056(1), 17735-9056(2), 17735-9024(1), 17735-9024(2), 17735-9047(1), 17735-9047(2), 17735-9059(1), 17735-9059(2), 17735-9061(1),
17735-9061(2), 17735-9074(1), 17735-9074(2), 17735-9083(1), 17735-9083(2), 17735-9058, 17735-9048(1), 17735-9048(2), 17735-9070(1), 17735-9070(2), 17735-9043(1), 17735-9043(2), 17735-9044(1), 17735-9044(2), 17735-9037(1), 17735-9037(2), 17735-9033(1), 17735-9033(2), 17735-8946(1), 17735-8946(2), 17735-8948(1), 17735-8948(2), 17735-9639(1), 17735-9639(2), 17735-8783(1), 17735-8783(2), 17735-8962(1), 17735-8962(2), 17735-8965(1), 17735-8965(2), 17735-9287(1), 17735-9287(2), 17735-9282(1), 17735-9282(2), 17735-9295(1), 17735-9295(2), 17735-9296(1), 17735-9296(2), 17735-9474(1), 17735-9474(2), 17735-9486(1), 17735-9486(2), 17735-9432(1), 17735-9432(2), 17735-9439(1), 17735-9439(2), 17735-9466(1), 17735-9466(2), 17735-9449(1), 17735-9449(2), 17735-9445(1), 17735-9445(2), 17735-9456(1), 17735-9456(2), 17735-9469(1), 17735-9469(2), 17735-9433(1), 17735-9433(2), 17735-9470(1), 17735-9470(2), 17735-9479(1), 17735-9479(2), 17735-9481(1), 17735-9481(2), 17735-9487(1), 17735-9487(2), 17735-9489(1), 17735-9489(2), 17735-9493(1), 17735-9493(2), 17735-9491(1), 17375-9491(2), 17735-9519(1), 17735-9519(2), 17735-9508(1), 17735-9508(2), 17735-9430(1), 17735-9430(2), 17735-9457(1), 17735-9457(2), 17735-9464(1), 17735-9464(2), 17735-9443(1), 17735-9443(2), 17735-9453, 17735-9468(1), 17735-9468(2), 17735-9496, 17735-9495, 17735-9501(1), 17375-9501(2), 17735-9496(1), 17735-9496(2), 17735-9516(1), 17735-9516(2), 17735-9463(1), 17735-9463(2), 17735-9482(1), 17735-9482(2), 17735-9514(1), 17735-9514(2), 17735-9454(1), 17735-9454(2), 17735-9480(1), 17735-9480(2), 17735-9446(1), 17735-9446(2), 17735-9467(1), 17735-9467(2), 17735-9490(1), 17735-9490(2), 17735-9502(1), 17735-9502(2), 17735-9505(1), 17735-9505(2), 17735-9547(1), 17735-9547(2), 17735-9593(1), 17735-9593(2), 17735-9586(1), 17735-9586(2), 17735-9856(1), 17735-9856(2), 17735-9541(1), 17735-9541(2), 17735-9551(1), 17735-9551(2), 17735-9555(1), 17735-9555(2), 17735-9552(1), 17735-9552(2), 17735-9554(1), 17735-9554(2), 17735-9561(1), 17735-9561(2), 17735-9588(1), 17735-9588(2), 17735-9852(1), 17735-9852(2), 17735-9853(1), 17735-9853(2), 17735-9546(1), 17735-9546(2), 17735-9583(1), 17735-9583(2), 17735-9599(1), 17735-9599(2), 17735-9548(1), 17735-9548(2), 17735-9897(1), 17735-98979(2), 17735-9899(1), 17735-9899(2), 17735-9898(1), 17735-9898(2), 17735-9900
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., McAllen, TX, by telephone and fax on May 6, 2005. Firm initiated recall is complete.
REASON
Red Cells, held at an incorrect temperature during component
preparation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
347 units
DISTRIBUTION
TX
______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced, Recall # B-0371- 7
CODE
Units:26836-3733(1), 26836-3733(2), 26836-3736(1), 26836-3736(2), 26836-4568(1), 26836-4568(2), 26836-4578(1), 26836-4578(2), 26836-5395(1), 26836-5395(2), 26836-5424(1), 26836-5424(2), 26836-5425(2), 26836-5429(1), 26826-5432(1), 26826-5432(2), 26836-5433(1), 26836-5433(2), 26836-5435(2), 26836-5444(1), 26836-5556(1), 26836-5556(2), 26836-5558(1), 26836-5558(2), 26837-0802(1), 26837-0802(2), 26971-2538(1), 26971-2538(2), 26971-2543(1), 26971-2543(2), 26971-2593(1), 26971-2593(2), 26971-2594(1), 26971-2594(2), 26971-2595(1), 26971-2595(2), 26971-2609(1), 26971-2609(2), 26971-2615(1), 26971-2615(2), 26971-2616(1), 26971-2616(2), 26971-3490(1), 26971-3490(2), 26971-3492(1), 26971-3492(2), 26971-3494(1), 26971-3494(2), 26971-3495(1), 26971-3495(2), 26971-3499(1), 26971-3499(2), 26836-3735, 36836-3738, 26836-3741, 26836-3742, 26836-4570, 26836-4573, 26836-5196, 26836-5197, 26836-5393, 26836-5394, 26836-5396, 26836-5397, 26836-5423, 26836-5446, 26836-5553, 26836-5563, 26837-0821, 26971-2589, 26971-2590, 26971-2591, 26971-2610, 26971-2612, 26971-2614, 26971-3488, 26971-3489, 26971-3491
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Fort Smith, AR, by fax on January 26, 2006. Firm initiated recall is complete.
REASON
Red Cells, collected from donors who were not properly qualified for donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
78 units
DISTRIBUTION
AR, OK and TX
______________________________
PRODUCT
Red Blood Cells, Recall # B-0381-7
CODE
Unit 0334827
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on February 23, 2006. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

____________________________
PRODUCT
One Touch Ultra test strips, LifeScan, a Johnson & Johnson Co., 50 test strips, 2 vials of 25 test strips, Recall # Z-0206-2007
CODE
Lot No. 2691191, exp 2008-02
RECALLING FIRM/MANUFACTURER
Discount Diabetic Supply, Oxford MS, by telephone on October 19, 2006 and by letter on October 30, 3006. Firm initiated recall is ongoing.
REASON
Counterfeit-Blood glucose test strips were reported to be counterfeit.
VOLUME OF PRODUCT IN COMMERCE
240 units
DISTRIBUTION
Nationwide
______________________________
PRODUCT
OneTouch®/Basic®/Profile® Blood Glucose Test Strips, 50 Test Strips per box. Part Number 020-848, LIFESCAN, a Johnson & Johnson company. (The product is labeled in English, Greek and Portuguese), Recall # Z-0207-2007
CODE
Lots 2606340, 2619932, 272894A; Part # 020-848.
RECALLING FIRM/MANUFACTURER
Medishop, Inc., Brooklyn, NY, by letters dated October 17, 2006. Firm initiated recall is ongoing.
REASON
Counterfeit-The product is reported to be counterfeit
VOLUME OF PRODUCT IN COMMERCE
7,727 boxes (50 strips per box)
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

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PRODUCT
AMO Tecnis Acrylic Model ZA9003 Intraocular Lenses, Recall # Z-0148-2007
CODE
Serial numbers: 531644065, 5316450605, 5316460605, 5316470605, 5316490605, 5316500605, and 5316510605
RECALLING FIRM/MANUFACTURER:
Recalling Firm: Advanced Medical Optics, Inc., Santa Ana CA, by letter and telephone on November 13, 2006.
Manufacturer: A.M.O. Puerto Rico Manufacturing, Inc., Anasco, PR. Firm initiated recall is ongoing.
REASON
The lenses are incorrectly labeled as 11 diopter lenses; these lenses are actually 22.5 diopters.
VOLUME OF PRODUCT IN COMMERCE
10 devices
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
a) Terumo Perfusion System 9000, 100v, with color screen; Model 9000; Catalog No. 164280, Recall # Z-0233-2007;
b) Terumo Perfusion System 9000, 220/240v, with color screen; Model 9000; Catalog No. 164290, Recall # Z-0234-2007;
c) Terumo Perfusion System 9000, 115v, with color screen; Model 9000; Catalog No. 164300, Recall # Z-0235-2007;
d) Terumo Perfusion System 8000 Base, 4 pump, 115v; Model 8000; Catalog No. 16400, Recall # Z-0236-2007;
e) Terumo Perfusion System 8000 Base, 5 pump, 115v; Model 8000; Catalog No. 16401, Recall # Z-0237-2007;.
f) Terumo Perfusion System 8000 Base, 4 pump, 220/240v; Model 8000; Catalog No. 16405, Recall # Z-0238-2007;
g) Terumo Perfusion System 8000 Base, 5 pump, 220240v; Model 8000; Catalog No. 16406, Recall # Z-0239-2007;
h) Terumo Perfusion System 8000 Base, 4 pump, 100v, Model 8000; Catalog No. 16409, Recall Z-0240-2007;
i) Terumo Perfusion System 8000 Base, 5 pump, 100v, Model 8000; Catalog No. 16410., Recall # Z-0241-2007;
j) Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268, Recall # Z-0242-2007
CODE
a) Serial numbers 5305, 5377 and 5379;
b) Serial numbers 5304, 5306 through 5329, 5335, 5336, 5338, 5345, 5348, 5349, 5351, 5352, 5353, 5354, 5355, 5357 through 5361, 5363 through 5367, 5371 through 5376, 5380, 5385 through 5388, 5390 through 5395, 5399, 5401 through 5408, 5410, 5414, 5417, 5422, 5428, 5429, 5431, 5432, 5435, 5438, 5440, 5443, 5447, 5448, 5449, 5450, 5452, 5453 and 5463;
c) Serial numbers 5331, 5332, 5333, 5334, 5337, 5339, 5340, 5341, 5342, 5343, 5344, 5346, 5347, 5350, 5356, 5362, 5368, 5369, 5370, 5378, 5383, 5384, 5389, 5396, 5397, 5398, 5400, 5409, 5411, 5412, 5413, 5415, 5416, 5418, 5419, 5420, 5421, 5423, 5424, 5425, 5430, 5433, 5434, 5436, 5437, 5439, 5441, 5442, 5444, 5445, 5446, 5451, 5454, 5455, 5456, 5457, 5458, 5459, 5460, 5461 and 5462;
d) Serial numbers 1120, 1121, 1122, 1123, 1124, 1125, 1126, 1127, 1128, 1129, 1130, 1131, 1132, 1133, 1134, 1135, 1136, 1137, 1138, 1139, 1140 1141, 1143 through 1194 and 1196 through 1245;
e) Serial numbers 1396 through 1501, 1570 through 1647, 1650 through 1679, 1681 through 1778, 1781 through 1821, 1824 through 1837 and 1839 through 1986;
f) Serial numbers 1126 through 1305;
g) Serial numbers 1081 through 1177 and 1179 through 1213;
h) Serial numbers 1020, 1021, 1022, 1023, 1024, 1025 and 1026;
i) Serial numbers 1051, 1052, 1053, 1054, 1055, 1056, 1057, 1058, 1059, 1060, 1061
and 1602 through 1621;
j) Serial numbers 1997 through 2005, 2011 through 2068, 2070 through 2077, 2079 through 2137, 2141 through 2154, 2156 through 2241, 2243 through 2257, 2259, 2260, 2262, 2263, 2265 through 2274, 2276 through 2278, 2280, 2282 through 2310, 2312 through 2350, 2353 through 2365, 2367 through 2460,
2462 through 2475, 2477 through 2485, 2488 through 2523, 2526 through 2555, 2558 through 2583, 2585 through 2600, 2602, 2606 through 2621, 2624 through 2628, 2630 through 2636, 2638, 2639, 2641 through 1645, 2647, 2650, 2652 through 2657 and 2661 through 2668
RECALLING FIRM/MANUFACTURER
Terumo Cardiovascular Systems, Corp., Ann Arbor, MI, by letter dated September 14, 2006 and September 17, 2006. Firm initiated recall is ongoing.
REASON
The hand crank handle may separate and detach from the unit during use.
VOLUME OF PRODUCT IN COMMERCE
1,836 devices
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
a) Level 1® Normothermic I.V. Fluid Administration Set REF D-60HL,
Recall # Z-0250-2007;
b) Level 1® Normothermic I.V. Fluid Administration Set REF DI-60HL
(Foreign Distribution Only), Recall # Z-0251-2007
CODE
a) Lot numbers: 1009446, 1035977, 1043174, 1046075, 1048466, 1060983;
b) Lot number: 725769, 1011870, 1019492, 1011871, 1027190, 1028662, 1037117,
1037809, 1049619, 1058925, 1060998, 1064376, 1067796, 1067797, 1074088, 1074089
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Rockland, MA, by letter on or about November 6, 2006. Firm initiated recall is ongoing.
REASON
IV Fluid Administration Set may have a blockage of the recirculating warming fluid channel within the disposable administration set, causing an alarm condition of over-temperature during priming.
VOLUME OF PRODUCT IN COMMERCE
13,640 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD, Recall # Z-0253-2007
CODE
UPC (01)30382903649021 Catalog # 364902 Lot # 6138499 Exp. 4/09 Catalog # 364902 Lot # 6144043 Exp. 4/09 Catalog # 364902 Lot # 6144082 Exp. 4/09 Catalog # 364902 Lot # 6144090 Exp. 4/09 Catalog # 364902 Lot # 6144128 Exp. 4/09 Catalog # 364902 Lot # 6150373 Exp. 4/09 Catalog # 364902 Lot # 6150365 Exp. 5/09 Catalog # 364902 Lot # 6153085 Exp. 5/09 Catalog # 364902 Lot # 6154356 Exp. 5/09 Catalog # 364902 Lot # 6154358 Exp. 5/09 Catalog # 364902 Lot # 6173027 Exp. 5/09 Catalog # 364902 Lot # 6173028 Exp. 5/09 Catalog # 364902 Lot # 6178307 Exp. 5/09 Catalog # 364902 Lot # 6178357 Exp. 5/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin Lakes, NJ, by letters on September 8, 2006.
Manufacturer: Becton Dickinson Vacutainer Micrope, San Lorenzo, PR. Firm initiated recall is ongoing.
REASON
Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.
VOLUME OF PRODUCT IN COMMERCE
1,744,400 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Calstrux™ (Previously known as TCP Putty)- Absorbable Bone Void Filler, packaged in: Catalog Number: 400-05: quantity-5cc Catalog Number: 400-10: quantity 10cc Catalog Number: 400-15: quantity 15cc, Recall # Z-0254-2007
CODE
Lot Numbers: 5cc: TUAN003, TUAN007, TUBN012, TUBN013, TUCN018, TUEN023, TUEN024. 10cc: TUAN002, TUAN004, TUAN006, TUBN01. 15cc: TU06026, TUAN001, TUAN005, TUAN008, TUBN009, TUBN015, TUBN016, TUCN019, TUCN020, TUDN021, TUDN022, TUEN025
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Biotech, Hopkinton, MA, by letter on August 25, 2006.
Manufacturer: Howmedica International S de RL, Limerick, Ireland. Firm initiated recall is ongoing.
REASON
Lack of Labeling Precautions. Calstrux™ should not be used in combination with other products and the volume used should approximate the size of the defect. Adverse reactions have been reported with over filling the defect site or combination product usage, including localized induration, swelling, inflammation, wound drainage, infection and device migration.
VOLUME OF PRODUCT IN COMMERCE
3,304 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
AMO PhacoFlex Il Model SI40NB Intraocular Lenses, Recall # Z-0267-2007
CODE
Serial Numbers: 1114110408, 1119570408, 1142040205, 1143100207, 1147320306, 1147330306, 1157290307, 1159120306, 1200580409, 1200700409, 1215800307, 1245260307, 1251300402, 1269240205, 1312400308, 1320420307, 1322770202, 1339940208, 1346040309, 1376660402, 1403090305, 1519560303, 1519570303, 1537150408, 1544970308, 1545920407, 1552190306, 1644880406, 1649280409, 1701830307, 1718970304, 1736210308, 1771500312, 1793030407, 1794700312, 1812750311, 1850350301, 1852450310, 1868930404, 1869430308, 1891830306 & 1897480311.
All lenses are clearly identified with a 10 digit serial number. The format of the serial number is described below: Example of serial number format for lens: 1230010212. The first digit denotes the particular manufacturing plant within the AMO facility at Anasco, Puerto Rico, where the product was manufactured. The first digit codes are: - 1 or 2: Silicone Plant - 3: Silicone Rework Plant - 4 or 5: Acrylic Plant - 6: Acrylic Rework Plant Digits two through six denote the sequence of numbers assigned to the lenses. The seven and eighth digit denote the year of manufacture. The ninth and tenth digit denote the month of manufacture. In the serial number example above, the serial number represents the 23001 lens produced in the Silicone plant.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Advanced Medical Optics, Inc., Santa Ana, CA, by letter on October 31, 2006.
Manufacturer: A.M.O. Puerto Rico Manufacturing, Inc., Anasco PR. Firm initiated recall is ongoing.
REASON
These specific serial numbers of lenses are being recalled because AMO has received reports of post-implantation cloudiness related to some lenses contained in this grouping.
VOLUME OF PRODUCT IN COMMERCE
55 units
DISTRIBUTION
Nationwide
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PRODUCT
Medline Premium Wet Skin Prep Tray, Sterile, Latex Free; a single use surgical convenience tray, EO sterilized; Reorder DYND70660; 20 trays per case; Recall # Z-0268-2007
CODE
Lots: 06JC0016 and 06JC0017, Exp. 08-08
RECALLING FIRM/MANUFACTURER
Medline Industries, Inc, Mundelein, IL, by telephone on November 21, 2006. Firm initiated recall is ongoing.
REASON
The product, labeled as sterile, had not gone through the sterilization process at the time of shipment
VOLUME OF PRODUCT IN COMMERCE
47 cases
DISTRIBUTION
MN, IL, WI, and IN

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

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PRODUCT
Super Sensitive Link-Label IHC Detection System/Mega Volume, RTU Multi-Link-HRP, REF/Cat. No. QP300-XAK, Kit containing reagent vials, Recall # Z-0217-2007
CODE
Lot numbers QP3000905B, QP3000905C, QP3001205B, QP3001005, QP3001205, QP3000206, QP3001205C, QP3000506, QP3000506b, QP3000506C, QP3000606, QP3000706
RECALLING FIRM/MANUFACTURER
Biogenex Laboratories, San Ramon, CA, by letter on approximately October 3, 2006. Firm initiated recall is ongoing.
REASON
Mislabeling: The product's "contents section " labeling (outer box) is mislabeled incorrectly printed as ''1 x 100 mL Alk Phos Label'' which should read ''1 x 100 mL HRP Label''. A second, smaller label, incorrectly reads "RTU MultiLink HPR/AEC" which should be labeled as "RTU MultiLink HPR". The reagent vials in the box are correctly labeled.
VOLUME OF PRODUCT IN COMMERCE
158 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Custom 5.5 mm Bivona® Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S, Recall # Z-0260-2007
CODE
Lot CL47189.
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Gary, IN, by letter on November 17, 2006. Firm initiated recall is ongoing.
REASON
Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS: VETENINARY MEDICINE - CLASS II

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PRODUCT
Fort Dodge Nolvasan Otic Cleansing Solution, packaged in 4- and 16-fl. oz. bottles, 12 bottles/case, Recall # V-004-2007
CODE
Lot 022440, Exp. Nov08; 16-fl. oz. - Lot 022429, Exp. Nov07; 022430, Exp. Aug07; 022432, Exp. Dec07; 022434, Exp. Mar08; and 022438, Exp. Sep08
RECALLING FIRM/MANUFACTURER
Fort Dodge Laboratories, Inc., Fort Dodge. IA., by letters on July 7, 2006, October 6, 2006, October 18, 2006 and by e-mail on June 14, and October 9, 2006. Firm initiated recall is complete.
REASON
Product contains metal particles.
VOLUME OF PRODUCT IN COMMERCE
29,494/4-fl. oz. bottles and 39,529/16-fl. oz. bottles
DISTRIBUTION
Colombia, Japan, Malaysia, Singapore, and Turkey
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PRODUCT
Harina De Carne Y Hueso Porcina 58% Proteina (Pork Meat and Bone Meal 58% Protein), 50 kg bags, Recall # V-005-2007
CODE
No lot number. Shipment Purchase Order number: BH-06-1085.
RECALLING FIRM/MANUFACTURER:
Recalling Firm: Biofix Holding Inc, Denton, TX, by letter on October 16, 2006.
Manufacturer: Allied Premium Protein, Gaffney, SC. Firm initiated recall is ongoing.
REASON
Pork Meal with potential to be contaminated with prohibited material distributed without cautionary statement.
VOLUME OF PRODUCT IN COMMERCE
220,740 lbs
DISTRIBUTION
Honduras
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PRODUCT
a) Non-medicated horse feed - NUTRI-VET Hoof & Coat For Horses with Vitamins and Minerals Apple and Molasses Flavor Pellets 3.75 lbs, Recall # V-006-2007;
b) Non-medicated horse feed - State Line Track Hoof & Coat for Horses Apple and Molasses Flavor Pellets Net Wt. 3.0 lbs, Recall # V-007-2007;
c) Non-medicated goat feed: Nutri-Vet Hoof & Coat apple and molasses flavored pellets for goats 3.75 lbs, Recall # V-008-2007
CODE
a), b), and c) Lot # 44570
RECALLING FIRM/MANUFACTURER
Nutri Vet Nutritionals, Boise, ID, by telephone on November 7/8, 2006. Firm initiated recall is complete.
REASON
Product contains undeclared Monensin/Rumensin.
VOLUME OF PRODUCT IN COMMERCE
Nutri-Vet equine 174/3.75 lbs; Nutri-Vet caprine 52/3.75 lbs; State Line 336/3.0 lbs
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR December 20, 2006

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