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U.S. Department of Health and Human Services

Safety

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Enforcement Report for September 9, 2009

September 9, 2009
09-36

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
1) Victorian Inn Cream of Mushroom Instant Soup Mix; Net Wt. 300 g (.66 lb) foil lined fiberboard pull-tab can with resealable plastic lid, 6 cans per case; a) item 16300, UPC 0 94265 16300 6 The soup was also packaged in 1.5 lb plastic pouches labeled Perfect Servings Powdered Products Cream of Mushroom Soup; 6 pouches per case; UPC 0 94265 99300 9, b) item 99300, Recall # F-991-9;

2) Victorian Inn Baked Potato with Bacon Instant Soup Mix; Net Wt. 300 g (.66 lb) foil lined fiberboard pull-tab can with resealable plastic lid, 6 cans per case, and 21 grams single serve packets, 10 packets per box, 10 boxes per case; UPC 0 94265 16302 0 (300 g) and 0 94265 45163 9 (21 g) The soup was also packaged in 1.5 lb plastic pouches labeled Perfect Servings Powdered Products Baked Potato with Bacon Soup; 6 pouches per case; UPC 0 94265 99302 9; a) item 16302, b) item 45163, c) item 99302, Recall # F-992-9;

3) Victorian Inn Cream of Chicken Instant Soup Mix; Net Wt. 300 g (.66 lb) foil lined fiberboard pull-tab can with resealable plastic lid, 6 cans per case, and 21 grams single serve packets, 10 packets per box, 10 boxes per case; UPC 0 94265 16303 7 (300 g) and 0 94265 45160 8 (21 g) The soup was also packaged in 1.5 lb plastic pouches labeled Perfect Servings Powdered Products Cream of Chicken Soup; 6 pouches per case; UPC 0 94265 99303 0; a) item 16303, b) item 45160, c)  item 99303, Recall # F-993-9; 

4) Victorian Inn Cream of Broccoli Instant Soup Mix; Net Wt. 250 g (.55 lb) foil lined fiberboard pull-tab can with resealable plastic lid, 6 cans per case, and 21 grams single serve packets, 10 packets per box, 10 boxes per case; UPC 0 94265 16304 4 (250 g) and 0 94265 45162 2 (21 g) The soup was also packaged in 1.5 lb plastic pouches labeled Perfect Servings Powdered Products Cream of Broccoli Soup; 6 pouches per case; UPC 0 94265 99304 7; a) item 16304; b) item 45162; item 99304, Recall # F-994-9;

5) Perfect Servings Powdered Products Hot Dutch Chocolate with Marshmallows; packaged in 1.5 lb plastic pouches/6 pouches per case; UPC 0 94265 99207 1; item 99207, Recall # F-995-9;

6) Perfect Servings Powdered Products French Vanilla Cappuccino; packaged in 1.5 lb plastic pouches/6 pouches per case; UPC 0 94265 99200 2; item 99200, Recall # F-996-9;

7) Victorian Inn Cappuccino Topping; Net Wt. 17.6 oz (1.1 lb) (500 g) plastic pouches/20 pouches per case; UPC 0 94265 26001 9; item 26001, Recall # F-997-9;

8) Cappuccino Frothing Milk, packaged in 1.5 lb plastic pouches/5 pouches per case; UPC 0 94265 26004 0; item 26004, Recall # F-998-9;

9) Henrico Horchata Instant Mix; a sweet rice milk drink with a hint of cinnamon and vanilla; packaged in 1.25 LB plastic film pouches/10 pouches per case, a) item 60125 and 25 lbs white plastic pails, b) item 60127; UPC 0 94265 60125 6 (1.25 lb), Recall # F-999-9
CODE
1) a) Lot numbers: 0170208 and 0880107, b) lot number could not be determined;

2) a) Lot numbers: 0300209, 0870908, 0920407 and 1450307; b) lot numbers could not be determined, c) lot numbers: 0300209, 0870908 and 1450307;

3) a) Lot number: 289107,  b) lot numbers could not be determined, c) lot numbers: 0930807, 2890107, 2890207, 1410507, 2200208, 2890107, 2890207 and 3230608;

4) a) Lot numbers: 1390208 and 3520806; b) lot numbers could not be determined; c) lot numbers: 1400508 and 1410707;

5) Lot numbers: 0300608, 0300708, 0590208, 0590308, 0640209, 0920107, 0920207, 1940707, 0920107, 1280309, 1820208, 1940707, 2120608, 2320108, 2330208, 2550707, 2990707, 3150608, 3441007, 3510508 and 3510708;

6) Lot numbers: 0190507, 0390108, 0470109, 1690307, 1920708, 2810508 and 3380507;

7) Lot numbers: 1370107, 2590708, 3190108, 3480907, 2710507, 3480907 and 2560208;

8) Lot numbers: 125, 160C2, 334J2, 334JA, 397K2 and 403B2;

9) a) Lot numbers: 290408, 1140208, 1230408, 1350407, 1440208, 1440408, 1610408, 1900108, 1900208, 2110207, 2420107, 2540708, 2620107, 2680108, 2890307, 2910408, 3120307, 3160408, 3170907, 3230708, 3500408, 0400509, 0560409, 0650109, 1400109, 1350407, 1420107, 2680108, 2910408, 1440408, 1610408, 2910408 and 3170807; b) lot numbers: 0290408, 0400509, 0570107, 0650109, 0770808, 1400408, 1420107, 1640407, 2110608, 2680108, 3120307, 3160408 and 3390607
RECALLING FIRM/MANUFACTURER
United Food Group, Inc. Elgin, IL, by letters dated June 30, 2009 and by press release on July 30, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
11,042 cases, 783 pails
DISTRIBUTION
Nation wide and Canada
___________________________________
PRODUCT 
1) San Myo Juiced Mass Gainer Rich Chocolate Delight, Recall # F-1000-9;
2) San Myo Juiced Mass Gainer Vanilla Malt, Recall # F-1001-9
CODE
1) Lots: 25420 and 25306;
2) Lots: 25239 and 25305
RECALLING FIRM/MANUFACTURER
Recalling Firm: S.A.N. Corporation, Oxnard, CA, by e-mails on July 2, 2009 and a follow-up letter on July 20, 2009. Firm initiated recall is ongoing.
REASON
Products were manufactured using an ingredient recalled by Milk Specialties Global because it was processed at Plainview Milk Products Cooperative and has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,871
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Instant Non-Fat Dry Milk, Recall # F-1002-9;
2) Instant Extra Grade Vit A Palmitate Vit D – 3, Recall # F-1003-9;
3) Instant High Heat Non-Fat Dry Milk, Recall # F-1004-9;
4) Instant Non-Fat Dry Milk Organic, Recall # F-1005-9;
5) Instant 80% Whey Protein Concentrate, Recall # F-1006-9
CODE
Lot numbers 255 thru 465 and/or production dates from June 4, 2007 through December 31, 2007; Lot numbers 101 through 465 and/or production dated from January 1, 2008 through December 31, 2008; and lot numbers 101 through 255 and/or production dates January 1, 2009 through June 4, 2009
RECALLING FIRM/MANUFACTURER
Plainview Milk Products Cooperative, Plainview, MN, by telephone beginning June 20, and letters on June 23 and June 24. Firm initiated recall is ongoing.
REASON
Plainview Milk Products Cooperative voluntary recalled agglomerated ("instant") products because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
7,027,844 lbs
DISTRIBUTION
AR, CA, IA, IL, MI, MN, MO, MT, NH, NJ, NY, OH, PA, TN, WI
___________________________________
PRODUCT 
1) VPX Stealth 5lb Vanilla, VPX Item #0357, UPC #6 1076482484 4, a total of four 5lb plastic bottles per case. Labeled VPX, New Innovation, Stealth, Muscle Amplification Lean Mass Gainer, Vanilla Blast, Dietary Supplement, Net Wt. 5lbs. (2.25 Kg). 2) VPX Stealth Vanilla 75 gram sample pouches, VPX Item #1011, UPC #6 1076482496 7, a total of twenty 75g foil pouches per case. Labeled VPX, New Innovation, Stealth, Muscle Amplification Lean Mass Gainer, Vanilla Blast, Dietary Supplement, 75 Grams (half serving) Not for Resale, Recall # F-1007-9;

2) a) VPX Stealth 5lb Chocolate, VPX Item #0356, UPC #6 1076482486 8, a total of four 5lb plastic bottles per case. Labeled VPX, New Innovation, Stealth, Muscle Amplification Lean Mass Gainer, Chocolate Rush, Dietary Supplement, Net Wt. 5lbs. (2.25 Kg). b) VPX Stealth Chocolate 75 gram sample pouches, VPX Item #1010, UPC #6 1076482498 1, a total of twenty 75g foil pouches per case. Labeled VPX, New Innovation, Stealth, Muscle Amplification Lean Mass Gainer, Chocolate Rush, Dietary Supplement, 75 Grams (half serving) Not for Resale, Recall # F-1008-9
CODE
1) a) Lot numbers: SP9118A2, SP9119B2, SP9120A2, SP9120B2, SP9121A2, SP9121B2, SP9131A2, SP9140A2; b) Lot number: SP9125A3;

2) 2) a) Lot numbers: SP9118B2, SP9119A2, SP9121C2, SP9124A2, SP9124B2, SP9127A2, SP9127B2; b) Lot number: SP9126A3
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vital Pharmaceuticals, Inc., dba VPX Sports, Davie, FL, by e-mail on July 2, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
5,048-5lb VPX Stealth Chocolate; 14,208 of 5lb VPX Stealth Vanilla; 14,598-75g pouches VPX Stealth Vanilla; 14,700 -75g pouches VPX Stealth C
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Camp Masters Gourmet Popcorn, 88 oz, Chocolately Treasures Tin, UPC 7520100820. The tin contains 5 different products, but only the following product within the tin is subject to the recall: Chocolate Peanut Clusters, net wt. 12 oz, Recall # F-1009-9
CODE
Best by May 24, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ramsey Popcorn Co., Inc., Ramsey, IN, by letter on February 20, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
117 tins
DISTRIBUTION
MD, MS, and TX
___________________________________
PRODUCT 
1) Michaelene's Fat Chance, Honey Granola, net wt. 2 oz, no UPC; net wt. 12 oz., UPC 9696500110; net wt. 16 oz., UPC 9696500110; case wt. 22 pounds, no UPC, Recall # F-1010-9; 

2) Michaelene’s Heavenly Organic Granola, net wt. 2 oz, no UPC; net wt. 12 oz., UPC 9696500129; net wt. 16 oz., UPC 9696500129; case wt. 22 pounds, no UPC, Recall # F-1011-9
CODE
All lots beginning with 70 or 80 plus lots 905010 through 909210
RECALLING FIRM/MANUFACTURER
Michaelenes, Inc., Clarkston, MI, by press release on March 6, 2009 and by telephone, fax and/or by letter dated March 9, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Not available
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) Nestl TOLL HOUSE Chocolate Chip cookie dough, packaged in 16 oz, 16.5 oz, 32 oz, 40 oz and 80 oz bars, tubs and tubes; UPC codes: 0 50000 62231 3, 0 50000 11308 8, 0 50000 62235 1, 0 50000 62237 5, 0 50000 62242 9, 0 5000012188 5, 0 50000 62246 7, 0 50000 00934 3, 0 50000 62239 9, 0 50000 00400 3, 0 50000 00926 8, Recall # F-1012-9;

2) Nestl TOLL HOUSE Sugar Cookie dough, packaged in 16.5 oz bars and 40 oz tubs;   UPC codes: 0 50000 62244 3, 0 50000 12178 6, 0 50000 62253 5, Recall # F-1013-9;

3) Nestl TOLL HOUSE Ultimates Chocolate Chip Lovers cookie dough bar, 16 oz packages, UPC: 0 50000 00926 8, Recall # F-1014-9;

4) Nestl TOLL HOUSE Valentine Hearts Sugar Cookie Shapes dough, in 15.5 oz packages, UPC: 0 50000 12009 3, Recall # F-1015-9;

5) Nestl TOLL HOUSE Easter Eggs Sugar Cookie Shapes dough, in 15.5 oz packages, UPC: 0 50000 52009 1, Recall # F-1016-9;

6) Nestl TOLL HOUSE Halloween Pumpkin Pals Sugar Cookie dough, in 13.5 oz packages, UPC: 0 50000 06217 1, Recall # F-1017-9;

7) Nestl TOLL HOUSE Christmas Shapes Sugar Cookie dough, in 15.5 oz packages, UPC: 0 50000 00505 5, Recall # F-1018-9;

8) Nestl TOLL HOUSE Valentine Hearts Sugar Cookie dough, in 13.5 oz packages, UPC: 0 50000 44056 6, Recall # F-1019-9;

9) Nestl TOLL HOUSE Easter Bunnies Sugar Cookie dough, in 13.5 oz packages, UPC: 0 50000 44058 0, Recall # F-1020-9;

10) Nestl TOLL HOUSE Halloween Sugar Shapes cookie dough, in 15.5 oz packages, UPC: 0 50000 00829 2, Recall # F-1021-9;

11) Nestl TOLL HOUSE Christmas Sugar Cookie dough, packaged in 16 oz tubes, UPC: 0 50000 00448 5, Recall # F-1022-9; 

12) Nestl TOLL HOUSE Ultimates Chocolate Chip with Caramel Filling Cookie dough, in 16 oz packages, UPC: 0 50000 44066 5, Recall # F-1023-9;

13) Nestl TOLL HOUSE Ultimates Chocolate Chip with Chocolate Filling Cookie dough, in 16 oz packages, UPC: 0 50000 44069 6, Recall # F-1024-9;

14) Nestl TOLL HOUSE Fudgy Brownies With Raspberry Filling Cookie dough, in 19 oz packages, UPC: 0 50000 20090 0, Recall # F-1025-9;

15) Nestl TOLL HOUSE Limited Edition Mint Swirled Chocolate Chip Cookie dough, in 16 oz packages, UPC: 0 50000 00827 8, Recall # F-1026-9;

16) Nestl TOLL HOUSE Ultimates Chocolate Chip & Chunks with Pecans Cookie dough, in 16 oz packages, UPC: 0 50000 00925 1, Recall # F-1027-9;

17) Nestl TOLL HOUSE Ultimates White Chip Macadamia Nut Cookie dough, in 16 oz packages, UPC: 0 50000 00923 7, Recall # F-1028-9;

18) Nestl TOLL HOUSE Walnut Chocolate Chip Cookie dough, in 16.5 oz packages, UPC: 0 50000 62233 7, Recall # F-1029-9;

19) Nestl TOLL HOUSE Ultimates Turtles Cookie dough, in packages, UPC: 0 50000 00928 2, Recall # F-1030-9;

20) Nestl TOLL HOUSE Fudgy Brownie With Peanut Butter Filling Cookie dough, in 19 oz packages, UPC: 0 50000 00820 9, Recall # F-1031-9;

21) Nestlé® TOLL HOUSE® Peanut Butter Cookie dough, packaged in 40 oz plastic tubs, UPC: 0 50000 44062 7, Recall # F-1032-9;

22) Nestl TOLL HOUSE Ultimates Peanut Butter Cups, Chips & Chocolate Chunks Cookie dough, in 16 oz packages, UPC: 0 50000 00922 0, Recall # F-1033-9;

23) Nestl TOLL HOUSE Ultimates Peanut Butter Lovers Cookie dough, in 16 oz packages, UPC: 0 50000 00507 9, Recall # F-1034-9;

24) Nestl TOLL HOUSE Gingerbread Cookie dough, packaged in 40 oz tubs, UPC: 0 50000 44060 3, Recall # F-1035-9;

25) Nestl TOLL HOUSE Oatmeal Cranberry Cookie dough, packaged in 48 oz. tub, UPC: 0 50000 62229 0, Recall # F-1036-9;

26) Nestl TOLL HOUSE Oatmeal Raisin Cookie dough, in 16.5 oz packages, labeled in part, UPC: 0 50000 06219 5, Recall # F-1037-9;

27) Nestl TOLL HOUSE Mini Brownie Bites dough, in 16 oz packages, labeled in part, UPC: 0 50000 62227 6, Recall # F-1038-9;

28) Nestl TOLL HOUSE Easter Swirled Mini Brownie Bites dough, in 18 oz packages, UPC: 0 50000 20093 1, Recall # F-1039-9;

29) Nestl TOLL HOUSE Halloween Swirled Fudgy Brownies dough, in 18 oz packages,  
UPC: 0 50000 00088 3, Recall # F-1040-9;

30) Nestl TOLL HOUSE Christmas Swirled Fudgy Brownies dough, in 18 oz packages,  
UPC: 0 50000 00089 0, Recall # F-1041-9;

31) Nestl TOLL HOUSE Easter Brownie Bar dough, in 18 oz packages, UPC: 0 50000 00518 5, Recall # F-1042-9;

32) Nestl TOLL HOUSE Valentine Swirled Chocolate Chip dough, in 16 oz packages,  
UPC: 0 50000 00931 2, Recall # F-1043-9;

33) Nestl TOLL HOUSE Easter Swirled Chocolate Chip dough, in 16 oz packages,  
UPC: 0 50000 00932 9, Recall # F-1044-9;

34) Nestl TOLL HOUSE Red, White & Blue Swirled Choc Chip dough, in 16 oz packages, UPC: 0 50000 00937 4, Recall # F-1045-9;

35) Nestl TOLL HOUSE Halloween Swirled Chocolate Chip dough, in 16 oz packages, UPC: 0 50000 00929 9, Recall # F-1046-9;

36) Nestl TOLL HOUSE Christmas Swirled Chocolate Chip dough, in 16 oz packages, UPC: 0 50000 00930 5, Recall # F-1047-9
CODE
All date codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nestle USA, Glendale, CA, by press release on June 19, 2009 and June 29, 2009 and by letter, e-mail and visit on June 19, 2009. Firm initiated recall is ongoing.
REASON
Products may be contaminated with E. coli 0157:H7.
VOLUME OF PRODUCT IN COMMERCE
2,649,630 cases
DISTRIBUTION
Nationwide, Bermuda, Bahrain, Kuwait, Qatar, Saudi Arabia and the United Arab Emirates
___________________________________
PRODUCT 
1) Caf Delight" White Chocolate Caramel Cappuccino, 12-ounce foil pouch, Recall # F-1048-9;

2) Chefs Blend White Chocolate Caramel Blend Cappuccino, 12-ounce foil pouch,
Recall # F-1049-9;

3) Chefs Supreme English Toffee Cappuccino, 12-ounce foil pouch, Recall # F-1050-9;

4) Chefs Supreme Hot Cocoa Mix, 12-ounce foil pouch, Recall # F-1051-9;

5) Diamond Crystal Cappuccino Mix, 12-ounce foil pouch, Recall # F-1052-9;

6) Diamond Crystal English Toffee Cappuccino, 12-ounce foil pouch, Recall # F-1053-9;

7) Diamond Crystal Malted Milk Powder, 12-ounce foil pouch. Recall # F-1054-9;

8) Diamond Crystal Nonfat Dry Milk, 5-pound foil pouch, Recall # F-1055-9;

9) Diamond Crystal Oatmeal Variety Pack, 55.6-ounce pouch, Recall # F-1056-9;

10) Diamond Crystal Raspberry Vanilla Cappuccino, 12-ounce foil pouch, Recall # F-1057-9;

11) First Cafe Original Cappuccino, 12-ounce foil pouch, Recall # F-1058-9;

12) First Cafe White Chocolate Caramel Cappuccino Mix, 12-ounce foil pouch, Recall # F-1059-9;

13) Grindstone Cafe" White Chocolate Caramel Cappuccino, 12-ounce foil pouch, Recall # F-1060-9;

14) Hormel Solutions Vanilla Instant Breakfast Drink, Reduced Calorie, 5.4-ounce pouch, 8 pouches per case; item #36479, Recall # F-1061-9;

15) Monarch Nonfat Milk Powder, 5-pound foil pouch, Recall # F-1062-9;

16) Rituals English Toffee Cappuccino, 12-ounce foil pouch, Recall # F-1063-9;

17) Rituals Original Cappuccino, 12-ounce foil pouch, Recall # F-1064-9
CODE
1) Lot numbers: 041KCB, 041KCB0203, 312JCA0203, 325JCB0203, 326JCA0203 and 326JCB0203;

2) Lot numbers: 053HCA0236, 126JCB0236, 126KCB, 127KCC, 128JCB0236, 129JCC0236, 186HCB0236, 259JCB0236, 282HCA0236, 326JCB0236, 328JCB0236 and 365HCA0236;

3) Lot numbers: 051JCA and 051JCA0225;

4) Lot numbers: 005KCA0266, 009JCA0266, 013KCA0266, 013KCB, 013KCB0266, 015JCB0266, 015JCB0566, 015JCB0566, 015JCB0566, 016JCC0266, 030KCB, 030KCB0266, 032JCA0266, 078JCA0266, 160KCA, 266JCA0266, 276HCB0266 and 357JCA0266;

5)  Lot numbers: B028J50206, D028J50206 and 028JCB0206;
 
6) Lot numbers: B015J50218, B045J50218, 015JCA0218, 045JCA01 and 045JCA0218;

7) Lot numbers: 003JBA0521, 092JCA, 092JCA0521, 092JCB0521, 127KC, 127KCB, 192JCA0521, 192JLA0521, 247JCA0521, 274JCA, 274JCA0521, 276JCA0521, 341HCA0521, 346HCA0321 and 346HCA0521;

8) Lot numbers: 009JDB8262, 010JDA8262, 022JDA8262, 022JDB8262, 026KDB8262, 027KDA, 027KDA8262, 027KDB8262, 047KDB8262, 048KDA8262, 048KDC8262, 063JDA8262, 063JDB8262, 063KDB, 063KDB8262, 064JDA8262, 064KCC8262, 064KDA8262, 064KDC8262, 077KDA8262, 077KDB8262, 085JDB8262, 086JDA8262, 086JDB8262, 096KDA, 096KDA8262, 096KDB, 096KDB8262, 097KDC, 097KDC8262, 105JBA8262, 105JBA8262, 105JDA8262, 111KDB, 111KDB8262, 129JAB8262, 131KD, 131KDB, 132KD, 132KDA, 136JDA, 136JDA8262, 136JDB8262, 136JSA8262, 140KD, 140KDA, 140KDB, 141KD, 144JDB3043, 158JDA8262, 158JDB8262, 161JDA8262, 167KDA, 167KDB, 169JDB, 169JDB0262, 169JDB8262, 169JFB8262, 169JFB8262, 170JDA0862, 170JDB8262, 192JDA8262, 225JDA8262, 227JDA8262, 227JDB8262, 262HDB8262, 263HDA3862, 263HDA8262, 263HDB8262, 269JDB8262, 274JDB8262, 276JDA8262, 281HDB8262, 282HAA8262, 282HDA8262, 288JDB8262, 292HDA8262, 292HDB8262, 292HDC8262, 305HDA8262, 305HDB8262, 315JDB8262, 316JDA8262, 316JDA9262, 318HDB8262, 332JDB8262, 336JDB8262, 337JDB8262, 339JDC8262, 341HDA8262, 341HDB8262, 345HDA8262, 354HDA8262, 354HDB8262, 358JDA8262, 358JDC8262 and 359HDA8262;

9) Lot numbers: JUN2610I83, JUN2610I8A, JUN2610I8B, MAR10I8A, MAR1810, MAR1810I, 18MAR10, BBMAR1810, MAR1810I2A, MAR1810I8, MAR1810I8A, MAR1810I8B, MAR1810I8M, MAY1810, MAR1910I8A, MAY2810, 052810, MAY281018B, BBMAY2810, MAY2810I, MAY2810I8A, MAY2810I8B, MAY2810I8E, MAY2810I9P, MAY282010, OCT09I8B, CT2309, BBOCT2309, OCT2309I, OCT2309I2B, OCT2309I8A, OCT2309I8B, OCT2309I8C, OCT2309IB, OCT2309KA, OCT23I8B, OCT2709I8B, 107029, OCT2309, OCT2509, SEP009SA2, SEP0309KA2, SEP0809K, SEP0809K2A and SEP0890KA2;

10) Lot numbers: 049KCB0235, 049KCC0235, 049KCC0255, 060JCB0235, 155KCA, 208HCA0235, 231HCB0235, 260JCA0235, 282HCA0235, 311HCB0235, 326JCA0235, 326JCA0255 and 331HCB0235;

11) Lot numbers: B015J29364, B015J50204, B028J50204, 015JCB0204 and 028JCB0204;

12) Lot numbers: B015J50291, B020K50291, B027K50291, B031J50291, B071J50291, B316H50291, B341H50291, B365H50291, D015J50291, V134K50291, 015JCA0291, 020KCA, 020KCA0291, 027KCA, 027KCA0291, 031JCA0291, 222HCA0291, 228HCB0291, 267JCA0291, 316HCB0291, 341HCA0291, 365HCA0291 and 391HCA0291;

13) Lot numbers: B004J50313, B015J50310, B015J50313, B021K50313, B034K50313, B129J50313, B152J50313, B219J50313, B232J50313, B287J50313, B295J50313, B299J50313, B299K50313, B303J50313, B326J50313, B365H50313, D015J50313, D129J50313, D299H50313, D326J50313, M179J50313, V021K50313, V287J50313, 004JCB0313, 015JCA0313, 015JCB0204, 021JCA0313, 021KCA, 021KCA0313, 037KEB0913, 120KCA, 129JCC0313, 287JCA0313, 295JCA0313 and 326JCB0313;

14) Lot numbers: V03129, V03129-2, V031292, V03208, V03208-1, V032081, V06117-1, V061171, V08018, V08018-2, V080182, V08317-2, V083172, V103081, V10318, V10318-1, V103181, V12117-1, V121171, V121171-1, V127B and V132117-1;

15) Lot numbers: 009JDB8265, 010JDA8265, 011JDA8265, 011JDB8265, 027KDA8262, 027KDA8265, 027KDB8265, 033JDA8265, 048KDA8265, 048KDB8265, 060JDA8265, 063JDB8265, 063KDA8265, 063KDB, 063KDB8265, 079KDC, 079KDC8265, 082KDC8265, 085JDA8265, 085JDB8265, 097KDA, 097KDA8265, 097KDC, 097KDC8265, 111KDB, 111KDB8265, 112KDC, 112KDC8265, 120JDA8265, 122JDA8265, 122JDB8265, 123JDA8265, 131KDA, 131KDB, 135JDB8265, 136JDA8255, 136JDA8265, 136JDC, 136JDC8265, 141KD, 141KDA, 143JDA8265, 167KD, 169JDA8265, 169JDB8265, 193JDB8265, 202JDB8265, 226JDB6265, 226JDB8265, 227JDA8265, 228JDB8265, 240HDA8265, 250HDA8265, 263HDB3265, 263HDB8265, 263HFB8265, 264HDA8265, 272HDB8265, 276JDA8265, 288JDA8265, 289JDA8265, 292HDB8265, 306HDB8265, 315JDA8265, 315JDB, 315JDB8265, 318JDB8265, 337HDA8265, 337HDB8265, 354HDB8265, 358JDA8265, 358JDB8265, 360HDA8265 and 364HDB8265;

16) Lot numbers: 060JCA0273 and 560JCA0273;

17) Lot numbers: 030JCB0275 and 030JGB0275
RECALLING FIRM/MANUFACTURER
Recalling Firm: Diamond Crystal Brands, Inc., Savannah, GA, by letter on/about July 6, 2009 and press release on July 10, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it had the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
55,917 cartons (total 1,273,074 lbs)
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
BVA-100 Reference Standard, 1.0mL, Total Radioactivity at TOC: 0.025 uCi, IODINATED I-131, Dil. Factor: 1:999, Recall # D-1949-2009
CODE
Lot numbers ending in: 347, 348, 350, 352, and 353
RECALLING FIRM/MANUFACTURER
Daxor Corporation, Oak Ridge, TN, by telephone beginning on April 6, 2009 and by letter beginning April 21, 2009. Firm initiated recall is ongoing.
REASON
Superpotent reference standard
VOLUME OF PRODUCT IN COMMERCE
20 sets
DISTRIBUTION
NY, CA, OK, DE, NJ, VA, OR, SC, PA, and NE

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Source Plasma, Recall # B-1525-09
CODE
Units: 0460052970, 0460050756, 0460050514
RECALLING FIRM/MANUFACTURER
Pyramid Biological Corporation DBA Life Sera, Inc., San Diego, CA, by e-mail on March 20, 2009. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined following discovery that the donor may have received a tattoo within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria
___________________________________
PRODUCT 
1) Platelets Pheresis Leukocytes Reduced Irradiated, Recall # B-1526-09;

2)  Platelets Pheresis Leukocytes Reduced, Recall # B-1527-09
CODE
1) 40GP09707, 40GP09708, 40KP05080;

2) Units: 40GP09707, 40GP09708, 40GP09712 (2 units), 40GP09716, 40KP05080, 40KP05082 (3 units), 40KP05085, 40KP05096, 40KP05100 (2 units)
RECALLING FIRM/MANUFACTURER
American National Red Cross Heart of America Region, Peoria, IL, by telephone on March 24, 2009. Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
IL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1530-09
CODE
Unit: W038309026724
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, IA, by telephone and facsimile on March 19, 2009. Firm initiated recall is complete.
REASON
Blood product, for which quality control testing was not performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1532-09
CODE
Units: 1681022 (3 units)
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ by telephone and facsimile on March 10, 2009.  Firm initiated recall is complete.
REASON
Blood products, which were labeled leukoreduced, but exceeded the acceptable limit for white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1533-09
CODE
Unit: W14160900519
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by telephone on March 3, 2009.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1534-09;
2) Plasma Frozen Within 24 hours (FP24), Recall # B-1535-09
CODE
1) and 2) Unit: 033FL08376
RECALLING FIRM/MANUFACTURER
ARC Blood Services, New England Region, Dedham, MA, by facsimile on February 24, 2009 and by letters dated February 24, 2009 and April 6, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY, CT
___________________________________
PRODUCT 
1) Recovered Plasma, Recall # B-1551-09;
2) Red Blood Cells Leukocytes Reduced, Recall # B-1552-09
CODE
1) and 2) Unit: W115909241001
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by fax and e-mail on April 1, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, CA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Source Plasma, Recall # B1419-09
CODE
Unit: AQ030680
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Asheville, NC, by facsimile on September 28, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1528-09
CODE
Unit: 08MOHB2215
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Lima, OH, by facsimile on December 11, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Platelets Pooled, Recall # B-1531-09
CODE
Unit: W141609041955
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by telephone on March 12, 2009.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1548-09;
2) Fresh Frozen Plasma, Recall # B-1549-09
CODE
1 and 2) Unit: F59046
RECALLING FIRM/MANUFACTURER
Community Blood Center of Carolinas, Charlotte, NC, by fax on March 29, 2009, and e-mail on April 6, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose arm inspection was documented as unsatisfactory, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1550-09
CODE
Unit: 3719900 (split product)
RECALLING FIRM/MANUFACTURER
Lifesource, Glenview, IL, by telephone and fax on April 16, 2009. Firm initiated recall is complete.
REASON
Blood products, collected in an expired collection kit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL
___________________________________
PRODUCT 
Source Plasma, Recall # B-1553-09
CODE
Unit: AQ030660
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Asheville, NC, by fax on October 2, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1554-09
CODE
Unit: AQ030669
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Asheville, NC, by fax on October 2, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

___________________________________
PRODUCT 
Gel Filled Teethers, various shapes and sizes, marketed under the names: Nuby, Cottontails, and Playskool. This product is intended for use by infants for medical purposes to soothe gums during the teething process. UPC codes: 48526-00451 Nuby 48526-00452 Nuby 48526-00453 Nuby 48526-00454 Nuby 48526-00455 Nuby 48526-00459 Nuby 48526-00467 Nuby 48526-00472 Nuby 48526-00473 Nuby 48526-00482 Nuby 48526-00483 Nuby 48526-00487 Nuby 48526-00490 Nuby 48526-00519 Nuby 48526-00521 Nuby 48526-87115 Cottontails 48526-91511 Playskool 48526-91660 Cottontails, Recall # Z-1878-2009
CODE
UPC Codes only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Luv N' Care Ltd, Monroe LA, by telephone and email, and followed with letters and Press Release on July 17, 2009.  
Manufacturing Firm 1: Elung Industrial Co. Ltd, Hong K, China.
Manufacturer Firm 2: Technic Star Products Factory, Buji Shenzhen, China. Firm initiated recall is ongoing.
REASON
Gel filled teethers were found to contain Bacillus circulans and Bacillus subtilis.
VOLUME OF PRODUCT IN COMMERCE
546,320 units
DISTRIBUTION
Nationwide, Canada, Haiti, West Indies, Surinam, Antilles, Uruguay, Mexico, Bermuda, Canada, Dominican Republic, Dutch West Indies, Bahamas, North Antilles and Paraguay
___________________________________
PRODUCT 
Stabilet Infant Warming System, model numbers 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200, Recall # Z-1955-2009
CODE
All units
RECALLING FIRM/MANUFACTURER
Recalling Firm: Draeger Medical Systems, Inc, Telford, PA, by press release and letter on July 20, 2009.
Manufacturer: Hill-Rom, Inc, Batesville, IN. Firm initiated recall is ongoing.
REASON
Hot particles fell into the infant bassinet beneath a Radiant Infant Warmer. The resulting fire injured an infant. These devices are obsolete.
VOLUME OF PRODUCT IN COMMERCE
6489 units
DISTRIBUTION
Nationwide and Brazil, Canada, China, Dominican Republic, France, Korea, Lebanon, Mexico, Nigeria, Panama, Poland, Saudi Arabia, Taiwan, Turkey, United Kingdom, Uruguay, and Venezuela

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
Heater Elements for Resuscitaire Infant Radiant Warmers model numbers RW82, RW82 VHA, WBR82, and WMRW82, 120 volt configuration only, Recall # Z-1693-2009
CODE
Date codes ending in 07
RECALLING FIRM/MANUFACTURER
Draeger Medical Systems, Inc., Telford, PA, by letter on August 7, 2009. Firm initiated recall is ongoing.
REASON
Spark, flame and smoke: A mis-positioned crimp on heater element lead wire resulted in flame and smoke aerating from the top of the warmer assembly.
VOLUME OF PRODUCT IN COMMERCE
2915 elements
DISTRIBUTION
Nationwide, Canada, Saudi Arabia, Bermuda, Virgin Islands, Mexico, Panama, Colombia, and Costa Rica
___________________________________
PRODUCT 
Amvex Integrated Flowmeter; a nonback-pressure compensated Bourdon gauge flowmeter; Amvex Corporation, 25B East Pearce St, Richmond Hill, Ontario L4B 2M9, Canada; Model No. FI. The Integrated Flowmeter has two parts, the Outlet port and the Flowmeter port. The Outlet port is intended to be used as a standard wall Outlet, delivering a high flow of gas to secondary equipment. The Flowmeter port is intended to deliver a fixed flow of gas to patient or equipment, Recall # Z-1724-2009
CODE

All serial numbers shipped between 4/12/07 and 8/31/07. Serial numbers: FIA05076LF, FIA05078LF, FIA05086LF, FIA05089LF, FIA05090LF, FIA05091LF, FIA05173LF, FIA05174LF, FIA05175LF, FIA05176LF, FIA05177LF, FIA05178LF, FIA05179LF, FIA05180LF, FIA05181LF, FIA05182LF, FIA05183LF, FIA05184LF, FIA05186LF, FIA05187LF, FIA05188LF, FIA05189LF, FIA05190LF, FIA05191LF, FIA05192LF, FIA05193LF, FIA05194LF, FIA05195LF, FIA05196LF, FIA05197LF, FIA05198LF, FIA05200LF, FIA05201LF, FIA05202LF, FIA05203LF, FIA05204LF, FIA05205LF, FIA05206LF, FIA05207LF, FIA05208CF, FIA05208LF, IA05209LF, FIA05210LF, FIA05211LF, FIA05212LF, FIA05213LF, FIA05214LF, FIA05215LF, FIA05216LF, FIA05217LF, FIA05218LF, FIA05219LF, FIA05220LF, FIA05221LF, FIA05222LF, FIA05223LF, FIA05224LF, FIA05226LF, FIA05229LF, FIA05230LF, FIA05231LF, FIA05233LF, FIA05234LF, FIA05236LF, FIA05237LF, FIA05238LF, FIA05239LF, FIA05240LF, FIA05241LF, FIA05242LF, FIA05243LF, FIA05244LF, FIA05245LF, FIA05246LF, FIA05247LF, FIA05248LF, FIA05249LF, FIA05250LF, FIA05251LF, FIA05252LF, FIA05253LF, FIA05254LF, FIA05255LF, FIA05256LF, FIA05257LF, FIA05258LF, FIA05259LF, FIA05261LF, FIA05262LF, FIA05263LF, FIA05265LF, FIA05266LF, FIA05267LF, FIA05268LF, FIA05269LF, FIA05270LF, FIA05271LF, FIA05272LF, FIA05273LF, FIA05274LF, FIA05276LF, FIA05277LF, FIA05278LF, FIA05280LF, FIA05281LF, FIA05283LF, FIA05284LF, FIA05286LF, FIA05287LF, FIA05288LF, FIA05289LF, FIA05290LF, FIA05291LF, FIA05293LF, FIA05294LF, FIA05295LF, FIA05296LF, FIA05297LF, FIA05298LF, FIA05299LF, FIA05300LF, FIA05301LF, FIA05302LF, FIA05304LF, FIA05305LF, FIA05306LF, FIA05307LF, FIA05308LF, FIA05309LF, FIA05310LF, FIA05313LF, FIA05314LF, FIA05315LF, FIA05316LF, FIA05317LF, FIA05318LF, FIA05319LF, FIA05320LF, FIA05321LF, FIA05322LF, FIA05323LF, FIA05324LF, FIA05325LF, FIA05326LF, FIA05327LF, FIA05328LF, FIA05331LF, FIA05332LF, FIA05334LF, FIA05335LF, FIA05336LF, FIA05337LF, FIA05338LF, FIA05339LF, FIA05340LF, FIA05341LF, FIA05342LF, FIA05343LF, FIA05344LF, FIA05345LF, FIA05346LF, FIA05347LF, FIA05348LF, FIA05349LF, FIA05352LF, FIA05353LF, FIA05354LF, FIA05354LF, FIA05355LF, FIA05356LF, FIA05358LF, FIA05361LF, FIA05362LF, FIA05363LF, FIA05364LF, FIA05365LF, FIA05366LF, FIA05367LF, FIA05368LF, FIA05370LF, FIA05371LF, FIA05372LF, FIA05373LF, FIA05374LF, FIA05375LF, FIA05376LF, FIA05378LF, FIA05380LF, FIA05381LF, FIA05382LF, FIA05383LF, FIA05384LF, FIA05386LF, FIA05387LF, FIA05388LF, FIA05389LF, FIA05390LF, FIA05392LF, FIA05392LF, FIA05396LF, FIA05397LF, FIA05398LF, FIA05399LF, FIA05400LF, FIA05401LF, FIA05403LF, FIA05404LF, FIA05405LF, FIA05406LF, FIA05407LF, FIA05408LF, FIA05409LF, FIA05411LF, FIA05412LF, FIA05413LF, FIA05414LF, FIA05415LF, FIA05416LF, FIA05417LF, FIA05418LF, FIA05419LF, FIA05420LF, FIA05421LF, FIA05422LF, FIA05423LF, FIA05424LF, FIA05425LF, FIA05427LF, FIA05428LF, FIA05429LF, FIA05431LF, FIA05432LF, FIA05433LF, FIA05434LF, FIA05435LF, FIA05439LF, FIA05440LF, FIA05443LF, FIA05444LF, FIA05445LF, FIA05446LF, FIA05447LF, FIA05448LF, FIA05449LF, FIA05450LF, FIA05451LF, FIA05452LF, FIA05453LF, FIA05454LF, FIA05455LF, FIA05457LF, FIA05458LF, FIA05460LF, FIA05462LF, FIA05463LF, FIA05464LF, FIA05465LF, FIA05466LF, FIA05467LF, FIA05468LF, FIA05469LF, FIA05470LF, FIA05471LF, FIA05472LF, FIA05473LF, FIA05473LF, FIA05475LF, FIA05476LF, FIA05477LF, FIA05478LF, FIA05479LF, FIA05480LF, FIA05481LF, FIA05482LF, FIA05486LF, FIA05487LF, FIA05488LF, FIA05489LF, FIA05490LF, FIA05491LF, FIA05493LF, FIA05494LF, FIA05495LF, FIA05496LF, FIA05497LF, FIA05498LF, FIA05499LF, FIA05500LF, FIA05501LF, FIA05502LF, FIA05503LF, FIA05504LF, FIA05505LF, FIA05507LF, FIA05508LF, FIA05509LF, FIA05510LF, FIA05511LF, FIA05512LF, FIA05513LF, FIA05514LF, FIA05515LF, FIA05516LF, FIA05517LF, FIA05518LF, FIA05519LF, FIA05520LF, FIA05521LF, FIA05522LF, FIA05523LF, FIA05524LF, FIA05525LF, FIA05526LF, FIA05527LF, FIA05528LF, FIA05529LF, FIA05530LF, FIA05532LF, FIA05533LF, FIA05534LF, FIA05538LF, FIA05539LF, FIA05539LF, FIA05540LF, FIA05541LF, FIA05543LF, FIA05543LF, FIA05544LF, FIA05546LF, FIA05547LF, FIA05548LF, FIA05549LF, FIA05550LF, FIA05551LF, FIA05553LF, FIA05554LF, FIA05555LF, FIA05556LF, FIA05557LF, FIA05558LF, FIA05560LF, FIA05561LF, FIA05562LF, FIA05566LF, FIA05567LF, FIA05568LF, FIA05569LF, FIA05571LF, FIA05572LF, FIA05574LF, FIA05575LF, FIA05577LF, FIA05578LF, FIA05579LF, FIA05580LF, FIA05581LF, FIA05581LF, FIA05582LF, FIA05583LF, FIA05584LF, FIA05585LF, FIA05587LF, FIA05588LF, FIA05590LF, FIA05592LF, FIA05593LF, FIA05594LF, FIA05595LF, FIA05596LF, FIA05597LF, FIA05598LF, FIA05599LF, FIA05600LF, FIA05601LF, FIA05603LF, FIA05605LF, FIA05606LF, FIA05607LF, FIA05608LF, FIA05609LF, FIA05611LF, FIA05612LF, FIA05614LF, FIA05618LF, FIA05619LF, FIA05621LF, FIA05622LF, FIA05624LF, FIA05625LF, FIA05626LF, FIA05628LF, FIA05629LF, FIA05630LF, FIA05631LF, FIA05634LF, FIA05635LF, FIA05635LF, FIA05636LF, FIA05637LF, FIA05638LF, FIA05641LF, FIA05642LF, FIA05643LF, FIA05646LF, FIA05647LF, FIA05649LF, FIA05650LF, FIA05651LF, FIA05652LF, FIA05654LF, FIA05655LF, FIA05656LF, FIA05657LF, FIA05659LF, FIA05660LF, FIA05661LF, FIA05662LF, FIA05663LF, FIA05664LF, FIA05665LF, FIA05666LF, FIA05666LF, FIA05667LF, FIA05668LF, FIA05669LF, FIA05670LF, FIA05671LF, FIA05672LF, FIA05673LF, FIA05674LF, FIA05675LF, FIA05676LF, FIA05677LF, FIA05678LF, FIA05679LF, FIA05680LF, FIA05683LF, FIA05684LF, FIA05685LF, FIA05686LF, FIA05687LF, FIA05688LF, FIA05689LF, FIA05690LF, FIA05691LF, FIA05692LF, FIA05693LF, FIA05694LF, FIA05695LF, FIA05696LF, FIA05697LF, FIA05698LF, FIA05699LF, FIA05700LF, FIA05701LF, FIA05702LF, FIA05703LF, FIA05704LF, FIA05705LF, FIA05707LF, FIA05708LF, FIA05709LF, FIA05710LF, FIA05711LF, FIA05714LF, FIA05715LF, FIA05716LF, FIA05717LF, FIA05719LF, FIA05720LF, FIA05721LF, FIA05723LF, FIA05724LF, FIA05725LF, FIA05727LF, FIA05729LF, FIA05731LF, FIA05732LF, FIA05733LF, FIA05735LF, FIA05736LF, FIA05737LF, FIA05738LF, FIA05739LF, FIA05740LF, FIA05741LF, FIA05742LF, FIA05743LF, FIA05744LF, FIA05745LF, FIA05746LF, FIA05747LF, FIA05748LF, FIA05749LF, FIA05750LF, FIA05751LF, FIA05752LF, FIA05753LF, FIA05754LF, FIA05755LF, FIA05756LF, FIA05757LF, FIA05759LF, FIA05760LF, FIA05761LF, FIA05762LF, FIA05763LF, FIA05764LF, FIA05765LF, FIA05766LF, FIA05768LF, FIA05769LF, FIA05770LF, FIA05771LF, FIA05772LF, FIA05773LF, FIA05774LF, FIA05775LF, FIA05776LF, FIA05777LF, FIA05778LF, FIA05779LF, FIA05781LF, FIA05782LF, FIA05783LF, FIA05785LF, FIA05786LF, FIA05787LF, FIA05788LF, FIA05789LF, FIA05790LF, FIA05791LF, FIA05792LF, FIA05793LF, FIA05794LF, FIA05795LF, FIA05796LF, FIA05797LF, FIA05798LF, FIA05799LF, FIA05800LF, FIA05801LF, FIA05802LF, FIA05803LF, FIA05804LF, FIA05805LF, FIA05806LF, FIA05807LF, FIA05808LF, FIA05809LF, FIA05810LF, FIA05811LF, FIA05812LF, FIA05813LF, FIA05814LF, FIA05815LF, FIA05816LF, FIA05817LF, FIA05818LF, FIA05819LF, FIA05820LF, FIA05821LF, FIA05822LF, FIA05823LF, FIA05824LF, FIA05825LF, FIA05826LF, FIA05827LF, FIA05828LF, FIA05829LF, FIA05832LF, FIA05833LF, FIA05835LF, FIA05836LF, FIA05837LF, FIA05838LF, FIA05839LF, FIA05841LF, FIA05842LF, FIA05843LF, FIA05844LF, FIA05846LF, FIA05847LF, FIA05849LF, FIA05851LF, FIA05852LF, FIA05855LF, FIA05857LF, FIA05858LF, FIA05879LF, FIA05905LF, FIA05907LF, FIA05908LF, FIA05909LF, FIA05910LF, FIA05916LF, FIA05920LF, FIA05921LF, FIA05923LF, FIA05924LF, FIA05925LF, FIA05928LF, FIA05930LF, FIA05931LF, FIA05932LF, FIA05933LF, FIA05934LF, FIA05935LF, FIA05936LF, FIA05937LF, FIA05938LF, FIA05939LF, FIA05940LF, FIA05941LF, FIA05942LF, FIA05943LF, FIA05944LF, FIA05945LF, FIA05946LF, FIA05947LF, FIA05948LF, FIA05949LF, FIA05950LF, FIA05951LF, FIA05952LF, FIA05953LF, FIA05955LF, FIA05956LF, FIA05957LF, FIA05959LF, FIA05960LF, FIA05962LF, FIA05963LF, FIA05964LF, FIA05965LF, FIA05966LF, FIA05967LF, FIA05968LF, FIA05969LF, FIA05971LF, FIA05972LF, FIA05973LF, FIA05974LF, FIA05975LF, FIA05976LF, FIA05977LF, FIA05978LF, FIA05979LF, FIA05980LF, FIA05981LF, FIA05982LF, FIA05983LF, FIA05984LF, FIA05985LF, FIA05986LF, FIA05987LF, FIA05988LF, FIA05989LF, FIA05990LF, FIA05991LF, FIA05992LF, FIA05993LF, FIA05994LF, FIA05995LF, FIA05996LF, FIA05997LF, FIA05998LF, FIA05999LF, FIA06000LF, FIA06001LF, FIA06002LF, FIA06003LF, FIA06004LF, FIA06005LF, FIA06006LF, FIA06007LF, FIA06008LF, FIA06009LF, FIA06010LF, FIA06011LF, FIA06012LF, FIA06013LF, FIA06014LF, FIA06015LF, FIA06016LF, FIA06017LF, FIA06018LF, FIA06019LF, FIA06020LF, FIA06021LF, FIA06022LF, FIA06023LF, FIA06024LF, FIA06025LF, FIA06027LF, FIA06028LF, FIA06029LF, FIA06030LF, FIA06031LF, FIA06032LF, FIA06033LF, FIA06034LF, FIA06035LF, FIA06036LF, FIA06037LF, FIA06038LF, FIA06040LF, FIA06041LF, FIA06042LF, FIA06043LF, FIA06044LF, FIA06045LF, FIA06046LF, FIA06047LF, FIA06048LF, FIA06049LF, FIA05658LF, FIA05050CG, FIA05051CG, FIA05052CG, FIA05053CG, FIA05054CG, FIA05055CG, FIA05056CG, FIA05058CG, FIA05059CG, FIA05060CG, FIA05061CG, FIA05062CG, FIA05063CG, FIA05064CG, FIA05065CG, FIA05067CG, FIA05068CG, FIA05069CG, FIA05070CG, FIA05071CG, FIA05072CG, FIA05073CG, FIA05074CG, FIA05075CG, FIA05076CG, FIA05077CG, FIA05078CG, FIA05079CG, FIA05080CG, FIA05081CG, FIA05082CG, FIA05083CG, FIA05084CG, FIA05085CG, FIA05086CG, FIA05087CG, FIA05088CG, FIA05090CG, FIA05091CG, FIA05092CG, FIA05093CG, FIA05094CG, FIA05095CG, FIA05096CG, FIA05097CG, FIA05098CG, FIA05099CG, FIA05100CG, FIA05101CG, FIA05102CG, FIA05103CG, FIA05104CG, FIA05105CG, FIA05106CG, FIA05107CG, FIA05108CG, FIA05109CG, FIA05110CG, FIA05111CG, FIA05112CG, FIA05114CG, FIA05115CG, FIA05116CG, FIA05117CG, FIA05118CG, FIA05119CG, FIA05120CG, FIA05121CG, FIA05122CG, FIA05123CG, FIA05124CG, FIA05125CG, FIA05125CG, FIA05126CG, FIA05127CG, FIA05128CG, FIA05129CG, FIA05130CG, FIA05131CG, FIA05132CG, FIA05133CG, FIA05134CG, FIA05135CG, FIA05136CG, FIA05137CG, FIA05138CG, FIA05139CG, FIA05140CG, FIA05141CG, FIA05142CG, FIA05143CG, FIA05144CG, FIA05146CG, FIA05147CG, FIA05148CG, FIA05149CG, FIA05150CG, FIA05151CG, FIA05152CG, FIA05153CG, FIA05154CG, FIA05155CG, FIA05156CG, FIA05157CG, FIA05158CG, FIA05159CG, FIA05160CG, FIA05161CG, FIA05162CG, FIA05163CG, FIA05165CG, FIA05166CG, FIA05167CG, FIA05168CG, FIA05169CG, FIA05170CG, FIA05171CG, FIA05172CG, FIA05173CG, FIA05174CG, FIA05175CG, FIA05176CG, FIA05177CG, FIA05178CG, FIA05179CG, FIA05180CG, FIA05181CG, FIA05182CG, FIA05183CG, FIA05184CG, FIA05185CG, FIA05185CG, FIA05186CG, FIA05187CG, FIA05188CG, FIA05189CG, FIA05190CG, FIA05191CG, FIA05192CG, FIA05193CG, FIA05194CG, FIA05195CG, FIA05196CG, FIA05197CG, FIA05199CG, FIA05201CG, FIA05202CG, FIA05203CG, FIA05204CG, FIA05205CG, FIA05207CG, FIA05209CG, FIA05210CG, FIA05211CG, FIA05212CG, FIA05213CG, FIA05213CG, FIA05214CG, FIA05215CG, FIA05216CG, FIA05217CG, FIA05218CG, FIA05219CG, FIA05220CG, FIA05221CG, FIA05222CG, FIA05223CG, FIA05224CG, FIA05225CG, FIA05226CG, FIA05227CG, FIA05228CG, FIA05229CG, FIA05230CG, FIA05231CG, FIA05232CG, FIA05233CG, FIA05234CG, FIA05235CG, FIA05236CG, FIA05237CG, FIA05238CG, FIA05239CG, FIA05240CG, FIA05241CG, FIA05242CG, FIA05243CG, FIA05244CG, FIA05245CG, FIA05246CG, FIA05247CG, FIA05250CG, FIA05251CG, FIA05252CG, FIA05253CG, FIA05254CG, FIA05255CG, FIA05256CG, FIA05257CG, FIA05258CG, FIA05259CG, FIA05261CG, FIA05262CG, FIA05263CG, FIA05264CG, FIA05266CG, FIA05267CG, FIA05268CG, FIA05269CG, FIA05270CG, FIA05271CG, FIA05272CG, FIA05273CG, FIA05274CG, FIA05275CG, FIA05276CG, FIA05278CG, FIA05279CG, FIA05280CG, FIA05281CG, FIA05282CG, FIA05283CG, FIA05284CG, FIA05285CG, FIA05286CG, FIA05287CG, FIA05288CG, FIA05290CG, FIA05291CG, FIA05292CG, FIA05293CG, FIA05294CG, FIA05295CG, FIA05296CG, FIA05297CG, FIA05298CG, FIA05299CG, FIA05300CG, FIA05301CG, FIA05302CG, FIA05303CG, FIA05304CG, FIA05305CG, FIA05306CG, FIA05307CG, FIA05308CG, FIA05309CG, FIA05310CG, FIA05311CG, FIA05312CG, FIA05313CG, FIA05314CG, FIA05315CG, FIA05316CG, FIA05317CG, FIA05318CG, FIA05319CG, FIA05320CG, FIA05321CG, FIA05322CG, FIA05323CG, FIA05324CG, FIA05325CG, FIA05326CG, FIA05328CG, FIA05330CG, FIA05331CG, FIA05332CG, FIA05333CG, FIA05334CG, FIA05335CG, FIA05336CG, FIA05337CG, FIA05338CG, FIA05341CG, FIA05342CG, FIA05343CG, FIA05344CG, FIA05345CG, FIA05346CG, FIA05347CG, FIA05348CG, FIA05349CG, FIA05350CG, FIA05351CG, FIA05352CG, FIA05353CG, FIA05354CG, FIA05355CG, FIA05356CG, FIA05357CG, FIA05358CG, FIA05359CG, FIA05360CG, FIA05361CG, FIA05362CG, FIA05363CG, FIA05364CG, FIA05365CG, FIA05366CG, FIA05367CG, FIA05368CG, FIA05369CG, FIA05370CG, FIA05371CG, FIA05372CG, FIA05373CG, FIA05374CG, FIA05375CG, FIA05376CG, FIA05377CG, FIA05378CG, FIA05379CG, FIA05380CG, FIA05381CG, FIA05383CG, FIA05385CG, FIA05386CG, FIA05387CG, FIA05388CG, FIA05389CG, FIA05390CG, FIA05391CG, FIA05391CG, FIA05392CG, FIA05393CG, FIA05394CG, FIA05395CG, FIA05396CG, FIA05397CG, FIA05398CG, FIA05399CG, FIA05400CG, FIA05401CG, FIA05402CG, FIA05403CG, FIA05404CG, FIA05405CG, FIA05406CG, FIA05407CG, FIA05408CG, FIA05409CG, FIA05411CG, FIA05412CG, FIA05413CG, FIA05414CG, FIA05415CG, FIA05416CG, FIA05418CG, FIA05419CG, FIA05420CG, FIA05421CG, FIA05422CG, FIA05423CG, FIA05424CG, FIA05426CG, FIA05427CG, FIA05428CG, FIA05429CG, FIA05430CG, FIA05431CG, FIA05432CG, FIA05433CG, FIA05434CG, FIA05435CG, FIA05436CG, FIA05437CG, FIA05439CG, FIA05440CG, FIA05442CG, FIA05443CG, FIA05444CG, FIA05445CG, FIA05446CG, FIA05447CG, FIA05448CG, FIA05449CG, FIA05450CG, FIA05451CG, FIA05452CG, FIA05453CG, FIA05455CG, FIA05456CG, FIA05457CG, FIA05458CG, FIA05459CG, FIA05460CG, FIA05461CG, FIA05462CG, FIA05463CG, FIA05464CG, FIA05465CG, FIA05466CG, FIA05467CG, FIA05468CG, FIA05469CG, FIA05470CG, FIA05471CG, FIA05472CG, FIA05473CG, FIA05474CG, FIA05476CG, FIA05477CG, FIA05478CG, FIA05479CG, FIA05480CG, FIA05481CG, FIA05482CG, FIA05483CG, FIA05484CG, FIA05485CG, FIA05486CG, FIA05487CG, FIA05488CG, FIA05489CG, FIA05490CG, FIA05491CG, FIA05492CG, FIA05493CG, FIA05494CG, FIA05495CG, FIA05496CG, FIA05497CG, FIA05498CG, FIA05499CG, FIA05500CG, FIA05502CG, FIA05503CG, FIA05504CG, FIA05505CG, FIA05506CG,,FIA05507CG, FIA05508CG, FIA05509CG, FIA05510CG, FIA05511CG, FIA05512CG, FIA05514CG, FIA05515CG, FIA05516CG, FIA05517CG, FIA05518CG, FIA05519CG, FIA05520CG, FIA05521CG, FIA05522CG, FIA05523CG, FIA05524CG, FIA05525CG, FIA05526CG, FIA05527CG, FIA05528CG, FIA05529CG, FIA05530CG, FIA05532CG, FIA05533CG, FIA05534CG, FIA05535CG, FIA05537CG, FIA05538CG, FIA05539CG, FIA05540CG, FIA05541CG, FIA05542CG, FIA05543CG, FIA05545CG, FIA05546CG, FIA05547CG, FIA05548CG, FIA05549CG, FIA05550CG, FIA05551CG, FIA05552CG, FIA05553CG, FIA05554CG, FIA05555CG, FIA05556CG, FIA05557CG, FIA05559CG, FIA05560CG, FIA05562CG, FIA05563CG, FIA05564CG, FIA05565CG, FIA05566CG, FIA05567CG, FIA05568CG, FIA05569CG, FIA05570CG, FIA05571CG, FIA05572CG, FIA05573CG, FIA05574CG, FIA05575CG, FIA05576CG, FIA05577CG, FIA05578CG, FIA05579CG, FIA05580CG, FIA05581CG, FIA05582CG, FIA05583CG, FIA05584CG, FIA05585CG, FIA05586CG, FIA05587CG, FIA05588CG, FIA05589CG, FIA05590CG, FIA05591CG, FIA05592CG, FIA05593CG, FIA05594CG, FIA05595CG, FIA05596CG, FIA05597CG, FIA05598CG, FIA05599CG, FIA05600CG, FIA05601CG, FIA05602CG, FIA05604CG, FIA05605CG, FIA05606CG, FIA05607CG, FIA05608CG, FIA05609CG, FIA05610CG, FIA05611CG, FIA05612CG, FIA05613CG, FIA05614CG, FIA05615CG, FIA05616CG, FIA05617CG, FIA05618CG, FIA05619CG, FIA05620CG, FIA05621CG, FIA05622CG, FIA05623CG, FIA05626CG, FIA05628CG, FIA05629CG, FIA05631CG, FIA05633CG, FIA05634CG, FIA05635CG, FIA05636CG, FIA05637CG, FIA05638CG, FIA05639CG, FIA05640CG, FIA05641CG, FIA05642CG, FIA05643CG, FIA05644CG, FIA05645CG, FIA05646CG, FIA05647CG, FIA05649CG, FIA05650CG, FIA05651CG, FIA05652CG, FIA05653CG, FIA05654CG, FIA05655CG, FIA05656CG, FIA05657CG, FIA05659CG, FIA05660CG, FIA05661CG, FIA05662CG, FIA05663CG, FIA05664CG, FIA05665CG, FIA05666CG, FIA05667CG, FIA05669CG, FIA05670CG, FIA05671CG, FIA05672CG, FIA05673CG, FIA05674CG, FIA05675CG, FIA05678CG, FIA05679CG, FIA05680CG, FIA05681CG, FIA05686CG, FIA05687CG, FIA05690CG, FIA05694CG, FIA05695CG, FIA05698CG, FIA05699CG, FIA05700CG, FIA05701CG, FIA05702CG, FIA05703CG, FIA05704CG, FIA05705CG, FIA05706CG, FIA05708CG, FIA05712CG, FIA05713CG, FIA05714CG, FIA05715CG, FIA05717CG, FIA05718CG, FIA05719CG, FIA05720CG, FIA05721CG, FIA05722CG, FIA05723CG, FIA05725CG, FIA05726CG, FIA05728CG, FIA05731CG, FIA05732CG, FIA05733CG, FIA05734CG, FIA05736CG, FIA05744CG, FIA05745CG, FIA05746CG, FIA05747CG, FIA05749CG, FIA05751CG, FIA05752CG, FIA05755CG, FIA05759CG, FIA05760CG, FIA05765CG, FIA05767CG, FIA05771CG, FIA05774CG, FIA05775CG, FIA05776CG, FIA05779CG, FIA05781CG, FIA05783CG, FIA05784CG, FIA05785CG, FIA05786CG, FIA05789CG, FIA05790CG, FIA05792CG, FIA05806CG, FIA05807CG, FIA05808CG, FIA05810CG, FIA05811CG, FIA05812CG, FIA05814CG, FIA05815CG, FIA05816CG, FIA05817CG, FIA05820CG, FIA05821CG, FIA05822CG, FIA05823CG, FIA05826CG, FIA05832CG, FIA05833CG, FIA05834CG, FIA05836CG, FIA05837CG, FIA05838CG, FIA05839CG, FIA05840CG, FIA05841CG, FIA05842CG, FIA05844CG, FIA05845CG, FIA05846CG, FIA05847CG, FIA05848CG, FIA05849CG, FIA05850CG, FIA05851CG, FIA05853CG, FIA05854CG, FIA05855CG, FIA05856CG, FIA05861CG, FIA05862CG, FIA05863CG, FIA05864CG, FIA05865CG, FIA05866CG, FIA05868CG, FIA05869CG, FIA05870CG, FIA05875CG, FIA05876CG, FIA05878CG, FIA05882CG, FIA05883CG, FIA05884CG, FIA05885CG, FIA05950CG, FIA05984CG, FIA05988CG, FIA05991CG, FIA06039CG and FIA05058HG
RECALLING FIRM/MANUFACTURER
Amevex Corporation, Richmond Hill, Canada, by letter dated May 29, 2009. Firm initiated recall is ongoing.
REASON
The affected flowmeters may have a damaged o-ring which may cause the flowmeter to deliver higher amounts of gas and or not be able to shut off fully.
VOLUME OF PRODUCT IN COMMERCE
1,424 units
DISTRIBUTION
Nationwide, Canada, Iran, Peru, Taiwan and Thailand

___________________________________
PRODUCT 
Hemochron Jr. ACT- LR Assay (JACT- LR); ITC Catalogue/Code Number: JACTLR 45 Cuvettes; For Performance on the HEMOCHROM Whole Blood Microagulation Systems;  The HEMOCHRON Jr. ACT-LR is a quantitative assay for monitoring heparin anticoagulation during various medical procedures. The ACT-LR demonstrated linear correlation to the anticoagulation effects of heparin up to 2.5 unit/ml of blood. It is intended for use in monitoring low to moderate heparin doses frequently associated with procedures such as cardiac catheterization, Extracorporeal Membrane Oxygenation (ECMO) Hemodialysis, and Percutaneous Transluminal Coronary Angioplasty, Recall # Z-1732-2009
CODE
Lot number K8JLR118
RECALLING FIRM/MANUFACTURER
International Technidyne Corp., Edison, NJ, by letter dated May 4, 2009. Firm initiated recall is ongoing.  
REASON
One lot of ACT-LR was released when one finished good testing criteria acceptance limit did not meet acceptance criteria.
VOLUME OF PRODUCT IN COMMERCE
173 boxes of 45 cuvettes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) LEGION Pressfit Stem, Straight, 10 MM X 160 MM, REF 71424043, Sterile. The device is used for Orthopedic Knee Implants, Recall # Z-1819-2009;

2) LEGION Pressfit Stem, Straight, 20 MM X 160 MM, REF 71424053, Sterile. The device is used for Orthopedic Knee Implants, Recall # Z-1820-2009
CODE
1) Lot Number: 06DAB0023;
2) Lot Number: 06DM08612
RECALLING FIRM/MANUFACTURER
Smith & Nephew Inc., Memphis, TN, by letter on January 22, 2009. Firm initiated recall is ongoing.
REASON
Products were mispackaged.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
Nationwide, Canada, Australia, Germany, GB, Italy, Switzerland, Spain, and France
___________________________________
PRODUCT 
1) Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, a) Models N118 and b) N119. Sterilized using ethylene oxide. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing, Recall # Z-1932-2009;

2) Boston Scientific TELIGEN, Implantable Cardiac Defibrillator, a) Models E102 and b) E110. Sterilized using ethylene oxide. The product is indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. COGNIS devices also provide bi-ventricular pacing, Recall # Z-1933-2009
CODE
1) a) Serial numbers: 559134, 559655, 560551, 561872, 561997, 562290, 562354, 562357, 563022, 563129, 564231, 564257, 564276 and 564489; and b) Serial numbers: 002009, 005588, 005947, 006015, 008336, 008383, 011748, 016012, 016410, 018621, 019026, 019284, 024632, 024670, 024705, 025094, 025446, 026128, 026211, 026713, 026935, 028047, 032967, 033881, 035717, 035791, 035824, 037277, 044056, 046565 and 046574;

2) a) Serial numbers: 002673, 003415, 004433, 004856, 005108, 005677, 006215, 006309, 006321, 006641, 006766, 006771, 006787, 006799, 006815, 006819, 006937, 006946, 006960, 006969, 006970, 006979, 006985, 007011, 007051, 007125, 007219, 007706, 007713, 007730, 008173, 008459, 008541, 008617, 008759, 008822, 008832, 008972, 008998, 009055, 009068, 009079, 009102, 009117, 009151, 009182, 009224, 009345, 009379, 009723, 010141, 010167 and 010186; and b) Serial numbers: 002872, 003458, 003681, 004229, 004300, 004979, 004989, 006517, 006935, 007106, 008280, 008356, 008591, 009837, 009865, 010026, 010341, 010365, 010393, 010413, 010508, 010510, 010533, 010555, 010581, 010596, 010694, 011538, 011578, 012363, 012373, 012571, 012712, 012785, 012809, 013015, 013024, 013759, 013885, 111500, 111570, 111584, 111599, 111610, 111661, 111664, 111700, 111703, 112637, 112716 and 113694
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific CRM Corp., Saint Paul, MN, by visit beginning July 17, 2009 and by letters dated July 17, 2009 and July 22, 2009.
Manufacturer: Guidant Ireland, Clomel, County Tipperary, Ireland. Firm initiated recall is complete.
REASON
Boston Scientific Cardiac Rhythm Management retrieved devices that could be subject to a potential for acute non-secure lead connections when implanted. Nonsecure lead connections can manifest as high impedance, or lead electrogram artifacts resulting in oversensing and/or inappropriate delivery of therapy.
VOLUME OF PRODUCT IN COMMERCE
149 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Medtronic Virtuoso DR, Model D154AWG, Dual Chamber implantable cardioverter defibrillator with atrial and ventricular therapies. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure. In addition, the device is indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias, Recall # Z-1953-2009;

2) Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure, Recall # Z-1954-2009
CODE
1) Serial number: PUL450634H;
2) Serial number: PUN421618H
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic, Inc., Cardiac Rhythm Management, Mounds View, MN, by visit on July 27, 2009.
Manufacturer: Medtronic Puerto Rico Operations Company, Juncos, PR. Firm initiated recall is complete.
REASON
Medtronic has detected a specific pattern of MOSFET IC malfunctions in its Concerto, Virtuoso and EnRhythm family of devices. The probability of occurrence decreases with time and, to date over 90% of the malfunctions related to the pattern have occurred within the first twelve months after implant.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

___________________________________
PRODUCT 
AmTech Group Inc. Gentamicin Sulfate Pig Pump Oral Solution, packaged in a 4-fl. oz. bottle, each ml contains gentamicin sulfate equivalent to 5 mg gentamicin, RX, ANADA 200-174, NDC 59130-663-07. Recall # V-259-2009
CODE
Lot #8080589, Exp. 11-2010
RECALLING FIRM/MANUFACTURER
TEVA Animal Health Inc., Saint Joseph, MO, by letters dated May 14, 2009. Firm initiated recall is ongoing.
REASON
Stability failure - The product did not meet assay or preservative specifications.
VOLUME OF PRODUCT IN COMMERCE
3,812/4-fl. oz. bottles
DISTRIBUTION
MO, CO, and NC
___________________________________
PRODUCT 
1) Levothyroxine Sodium Tablets 0.2 mg, packaged in 180-, and 1,000-tablet bottles, RX, under the following labels: (1) AmTech Group Inc. Levothyroxine Sodium Tablets 0.2 mg. and (2) Phoenix Pharmaceutical, Inc. Thyrozine 0.2 mg, Recall # V-260-2009;

2) Levothyroxine Sodium Tablets 0.5 mg, packaged in 180-, and 1,000-tablet bottles, RX, under the following labels: (1) AmTech Group Inc. Levothyroxine Sodium Tablets 0.5 mg. and (2) Phoenix Pharmaceutical, Inc. Thyrozine 0.5 mg, Recall # V-261-2009;

3) Levothyroxine Sodium Tablets 0.8 mg, packaged in 180-, and 1,000-tablet bottles, RX, under the following labels: (1) AmTech Group Inc. Levothyroxine Sodium Tablets 0.8 mg. and (2) Phoenix Pharmaceutical, Inc. Thyrozine 0.8 mg, Recall # V-262-2009;

4) Phenylbutazone Tablets, 1 g., packaged in 100-tablet bottles, RX, under the following labels: (1) A & G Pharmaceuticals Phenylbutazone Tablets, USP; (2) Pro Labs Pro-Bute Tablets; (3) Butler ButaTabs E; (4) AmTech Group Inc. Phenylbutazone Tablets, USP; (5) Phoenix Pharmaceutical Inc. Phenylbute Tablets; (6) VetTek Phenylbutazone Tablets; (7) VEDCO Bute Tabs; and (8) RXV Phenylbutazone Tablets, USP, Recall # V-263-2009;

5) Phenylbutazone Tablets, 100 mg, packaged in 1,000-tab. bottles, RX, under the following labels: (1) Butler ButaTabs D; and (2) AmTech Group, Inc. Phenylbutazone Tablets, USP, Recall # V-264-2009;

6) Praziquantel Tablets, 34 mg, RX, packaged under the following labels: (1) Trade Winds Tape Worm Tabs, packaged in 5-tab. bottles; (2) Farnam D-Worm Praziquantel Tablets, packaged in 5- and 10-tab. bottles; (3) Phoenix Pharmaceutical Inc. CestaTabs, packaged in 50- and 150-tab. bottles; (4) VEDCO Cestoved Tablets, packaged in 50- and 150-tab. bottles; (5) Butler Prazitabs D, packaged in 50- and 150-tab. bottles; and (6) AmTech Group Inc. Praziquantel Tablets, packaged in 50- and 150-tab. bottles, Recall # V-265-2009;

7) Clindamycin Hydrochloride Capsules, 25 mg, packaged in 600-cap. bottles, RX, under the following labels: (1) Butler Clincaps 25; (2) VEDCO ClindaCure; (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules; and (4) AmTech Group, Inc. Clindamycin Hydrochloride Capsules, Recall # V-266-2009;

8) Clindamycin Hydrochloride Capsules, 75 mg, packaged in 200-cap. bottles, RX, under the following labels: (1) Butler Clincaps 75; (2) VEDCO ClindaCure; (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules; and (4) AmTech Group, Inc. Clindamycin Hydrochloride Capsules, Recall # V-267-2009;

9) Clindamycin Hydrochloride Capsules, 150 mg, packaged in 100-cap. bo9ttles, RX, under the following labels: (1) Butler Clincaps 150; (2) VEDCO ClindaCure; (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules; and (4) AmTech Group, Inc. Clindamycin Hydrochloride Capsules, Recall # V-268-2009;

10) Clindamycin Hydrochloride Capsules, 300 mg, packaged in 100-cap. bottles, RX, under the following labels: (1) Butler Clincaps 300; (2) VEDCO ClindaCure; and (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules, Recall # V-269-2009
CODE
1) 180 ct. – Lot numbers: 8020127 and 8050365; 1,000-ct. - Lots 7071016, 7071017, 7101394, 7101395, 8010055, 8020128, 8030254, 8070482, 8070483, 8080551, and 8080552;

2) 180-ct. – Lot numbers: 8050366 and7081165; 1,000-ct. - Lots 7101396, 7101397, 7111484, 7111485, 8020129, 8020130, 8030211, 8030212, 8070484, and 8070485;

3) 180-ct. – Lot numbers: 7050762, 7111488, 8040300, and 8080553; 1,000-ct. - Lots 7040661, 7040662, 7040663, 7101398, 7101399, 7101400, 7101401, 7111486, 7111487, 8010042, 8010043, 8020131, 8020132, 8020133, 8030221, 8030222, 8030223, 8040300, 8040301, 8040302, 8040303, 8070486, and 8070487;

4) Lot numbers: 7081167, 7081168, 7101409, 7101410, 7101446, 7111480, 7111481, 7111482, 7121563, 7121564, 8020166, 8030225, 8030272, 8030273, 8040304, 8040305, 8050367, 8070477, 8070478, 8080554, 8080555, 8090611, 8090612, 8090613, 8100686, 8100687, 8110786, and 9010019;

5) Lot numbers: 7060905, 7111483, 8060462, and 8100756;

6) Lot numbers: 7050776 (150-ct.), 7050781 (10- and 150-ct.), 7060920 (5- and 10-ct.), 7081161 (50-ct.), 7101411 (5- and 10-ct.), 7101441 (150-ct.), 7111498 (5-ct.), 7121598 (50-ct.), 7121599 (150-ct.), 8020155 (5- and 10-ct.), 8020156 (5- and 10-ct.), 8030224 (150-ct.), 8060414 (10-ct.), 8060415 (5- and 10-ct.), 8060445 (5-ct.), 8060446 (50-ct.), 8080550 (5- and 10-ct.), 8090609 (50-ct.), 8090610 (150-ct.), 8100685 (10- and 150-ct.), 8110785 (5- and 10-ct.), 9010018 (50-ct.), and 9020094 (150-ct.);

7) Lot numbers: 7050763, 7050764, 7071012, 7081157, 7101389, 7111489, 8010001, 8010002, 8020165, 8030219, 8040338, 8070479, 8070480, 8080556, 8080557, 9010020, and 9010068;

8) Lot numbers: 7050761, 7071013, 7081160, 8010044, 8030220, 8040306, 8070481, 8120869, 9010021, and 9010022;

9) Lot numbers: 7101390, 7101440, and 8090614;

10) Lot numbers: 7071014 and 8080558
RECALLING FIRM/MANUFACTURER
TEVA Animal Health Inc., Saint Joseph, MO, by letters between May 1, 2009-May 7, 2009. Firm initiated recall is ongoing.
REASON
Some of the tablets have physical characteristic defects.
VOLUME OF PRODUCT IN COMMERCE
216,690/5-ct, 125,430/10-ct, 18,498/50-ct, 105,137/100-ct, 10,617/150-ct., 22,145/180-ct, 35,417/200-ct., 18,250/600-ct, and 25,527/1,000-ct
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR SEPTEMBER 9, 2009

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