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U.S. Department of Health and Human Services

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Enforcement Report for December 9, 2009

December 9, 2009
09-49

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT
1) Sundae Cones, vanilla ice cream in a sugar cone topped with chocolate and peanuts as follows: Best Choice Sundae Slugger, 6- 4.5 fl. oz. cones, 27 fl. oz., UPC 7003859635; Country Delight Sundae Cones, 6 - 4 fl oz, 24 fl oz, UPC 7287090629 and another UPC which is no longer known to the firm; DeConna Ice Cream Nutty Buddy, 4 fl. oz., UPC 1297124247; DeConna Ice Cream Everyday Sundae Cone, 4.5 fl. oz., UPC 1297124242; Jewel Sundae Nut Cones, Vanilla, 8 - 4.6 fl oz cones, 36.8 fl. oz., UPC 4128011853; Kemps Family Classics Sundae Cones, Vanilla, 6 - 4.5 fl oz. cones, 27 fl oz., UPC 4148302575; Kemps Sundae Cones, UPC 4148303439; Market Pantry Sundae Cones, 6 -4 fl oz cones, 24 fl oz, UPC 8523907614; Megaroons Sundae Cone, 6 - 2 1/2 fl oz., 15 fl oz., UPC 9943021739; Nestle Cone, Vanilla, 4 fl oz., UPC 5105217511; North Star Ice Cream Sundae Cone, 4 fl oz, UPC 7273066022; Nutty Buddy 6 Chocolate Nut Sundae Cones 4 fl oz., 24 fl oz., UPC 7077009016; North Star Olde Fashioned Sundae Cones, Vanilla, 6 - 4.5 fl oz., 27 fl oz., UPC 7273062045; North Star Nutty Royale, 4 fl oz., UPC 7273066000; North Star Ice Cream Sundae Cone, 4 fl oz., UPC 7273066022; North Star Nutty Royale, 6 - 4 oz., 24 fl oz., UPC 7273062013; Olde Fashioned Sunade Cones, Vanilla, 4.5 fl oz., UPC 7273066044; Our Family Ice Cream Sundae Cones, 6 - 2 1/2 oz, 15 fl oz., UPC 7025371205; Our Family Sundae Nut Cones, 6 - 4 oz. 24 fl oz., UPC 7025371205; Pierre's 6 Sundae Cones, 6 - 3.65 fl oz., 21.9 fl oz., UPC 4817810606; Pierre's Sundae Cone, 4.5 fl oz., UPC 4817810801; Piggly wiggly Sundae Nut Cones, Vanilla, 6 -4 fl oz., 24 fl oz., UPC 4129011220; Ruggles from Smith Dairy premium Vanilla Sundae Cone, 4.5 fl oz., UPC 7042409110; Ruggles from Smith Dairy premium Vanilla Sundae Cone, 6 - 4.5 fl oz., 27 fl oz., UPC 7024209002; Shamrock Farms Nutty Sundae Cone, 4.5 fl. oz., UPC 2830090170; Shurfine Sundae Cones, 6 - 4 fl oz., 24 fl. oz., UPC 1116145053; Supreme Indulgence Super Premium Ice Cream Cone, 5 fl oz, UPC 7273066072; Sundae Shoppe Sundae Nut Cones, 6 - 4 fl oz. cones, 24 fl oz., UPC 4149815643; Super A 6 Sundae Nut Cones, 6 - 4.0 fl oz cones, 24 fl oz, UPC 2362755065; Olde Mill Vanilla Sundae Cone, Velvet, 4.6 fl. oz., UPC 7068210820; Velvet Sundae Cones, 4 - 4 fl oz. cones, 16 fl oz., UPC 7068210824; Wegmans Sundae Nut Cones, 6 - 4.0 fl oz cones, 24 fl oz., UPC 7789032607 and White Rose Sundae Cones, 6 - 4 fl oz., 24 fl oz., UPC 1119680168; Flav-o-Rich Nutty Royale, 6pkc, UPC 7230070732; Hy-Top Sundae Cones, 6 pack, UPC 5070003490; Pierre's Vanilla Sundae Cones, 6 pack, UPC 4817810701; Ruggles Sundae Cones, 6pack, UPC 7042409105; Ruggles Sundae Cones, Bulk, UPC 7042409115; Southern Belle Sundae Cones, 6pack, UPC 7163200142; Piggly Wiggly Sundae Cones, 6 pack, UPC 1234567890. Recall # F-0198-2010;

2) Sundae Cones, vanilla ice cream with a caramel core in a sugar cone topped with chocolate and peanuts as follows: Kemps Family Classics Sundae Cones, Caramel, 6- 4.5 fl oz cones, 27 fl oz., UPC 4148303059; North Star Olde Fashioned Sundae Cones, Caramel, 6 - 4.5 fl oz., 27 fl oz., UPC 7273062050; Olde Fashioned Sundae Cones, Caramel, 4.5 fl. oz., UPC 7273066033 and Sundae Shoppe Sundae Nut Cones with Caramel Core, 6 -4 oz. cones, 24 fl oz., UPC 4149818629. Recall # F-0199-2010;

3) Sundae Cones, chocolate ice cream in a sugar cone topped with chocolate and peanuts as follows: Kemps Sundae Cones, Chocolate, 1 cone, UPC 4148303440; Olde Fashioned Sundae Cones, Chocolate, 4.5 fl oz., UPC 7273066045 and Ruggles from Smith Dairy premium Chocolate Sundae Cone, 4.5 fl. oz., UPC 7042409101. Recall # F-0200-2010;

4) Sundae Cones, vanilla ice cream with a fudge core in a sugar cone topped with chocolate and peanuts as follows: North Star Ice Cream Fudge Core Sundae Cones, 4 fl. oz., UPC 7273066067; Olde Fashioned Sundae Cones, Fudge Core, 4.5 fl oz., UPC 7273066066 and Sundae Shoppe Sundae Nut Cones with fudge core, 6 - 4 fl oz cones, 24 fl oz., UPC 4149818628. Recall # F-0201-2010;

5) Sundae Cones, vanilla ice cream in a sugar cone topped with chocolate and peanuts, no sugar added and reduced fat as follows: Nestle Good for you Reduced Fat, No sugar added Sundae Cones, Splenda, 4 - 4 fl oz., 16 fl. oz., UPC 5105252586;  North Star Sweet Wise no sugar added and reduced fat Vanilla Sundae Cone, Splenda, 4.5 fl oz., UPC 7273066057 and North Star Sweet Wise no sugar added and reduced fat Vanilla Sundae Cone, Splenda, 6 - 4.5 fl oz., 27 fl oz., UPC 7273062055. Recall # F-0202-2010;

6) Sundae Cones, vanilla flavored no sugar added reduced fat ice cream in a sugar cone with chocolate flavored no sugar added fudge and roasted peanuts as follows: Pierre's Slender Reduced Fat Sundae Cones, Splenda, 4-4 fl oz. cones, 16 fl oz., UPC 4817894601. Recall # F-0203-2010;

7) Vanilla ice cream bar dipped in a chocolate flavored coating and roasted peanuts, on a stick as follows: Nestle Crocanti, 2.5 fl oz., UPC 5105257211 and Nestle Crocanti, 6 - 2.5 fl oz bars, 15 fl oz., UPC 5105255247. Recall # F-0204-2010;

8) Sundae Cones, vanilla ice cream cones and chocolate ice cream cones in a sugar cone topped with chocolate and peanuts packaged as a combination with both ice cream flavors, as follows: Kemps Family Classics Sundae Cones Chocolate and Vanilla Combo Pack, 6-4.5 fl oz cones, 27 fl oz., UPC 4148302576; North Star Olde Fashioned Sundae Cones, Combo, 6 - 4.5 oz cones, 27 fl oz., UPC 7273062046 and Ruggles from Smith Dairy premium Vanilla & Chocolate Sundae Cones, 6 - 4.5 oz. cones, 27 fl oz., UPC 7042409003. Recall # F-0205-2010;

9) Sundae Cones, vanilla ice cream cones, vanilla ice cream with cones with a fudge core and vanilla ice cream cones with a caramel core in a sugar cone topped with chocolate and peanuts packaged as a combination with all three ice cream flavors, as follows: North Star Sundae Cones, Vanilla, Fudge, Caramel, 24 count 4.0 fl oz cones, 96 fl oz., UPC 7273069054. Recall # F-0206-2010;

10) Combination ice cream pack with vanilla ice cream sandwiches, ice cream bars, and sundae cones (vanilla ice cream in a sugar cone topped with chocolate and peanuts) as follows: Supreme Indulgence, 36 count variety pack individually wrapped for retail sale, 8 - 5.0 fl oz sandwiches, 10 -3.0 fl oz. bars, 18 - 5.0 fl oz. cones, 160 fl oz., UPC 7273069150. Recall # F-0207-2010;

11) Combination ice cream pack with vanilla and neapolitan ice cream sandwiches; vanilla ice cream bars; vanilla and vanilla ice cream with fudge core sundae cones in a sugar cone topped with chocolate and peanuts) as follows: North Star 40 Ice Cream Treats Variety Pack, 12 ice cream bars, 4 fudge core cones, 4 vanilla cones, 10 neapolitan ice cream sandwiches and 10 vanilla ice cream sandwiches, 132 fl oz., UPC 7273069064 and Artic Star 50 Ice Cream Treats variety pack, 14 ice cream bars, 12 vanilla ice cream sandwiches, 12 Neapolitan ice cream sandwiches, 6 vanilla cones, 6 fudge core cones, 167 fl oz., individually labeled for resale, UPC 7273069059. Recall # F-0208-2010;

 12) Bulk DeConna Incredible Crunch Bars, UPC 1297124225. Recall # F-0209-2010
CODE
1) UPC 7003859635-Lots 0017 through 2138; UPC 9943021739-Lots 0017 through 0317; UPC 5070003490- Lots 0017 through 1517; UPC 4817810701-Lots 0017 through 3557;;;; UPC 7287090629; UPC 1297124247; UPC 1297124242; UPC 4128011853; UPC 4148302575; UPC 4148303439; UPC 7273066022; UPC 7077009016; UPC 7273062045; UPC 7273066000; UPC 7273062013; UPC 7273066044; UPC 7025371205; UPC 4817810801; UPC 4129011220; UPC 7042409110; UPC 7024209002; UPC 2830090170; UPC 1116145053; UPC 7273066072; UPC 2362755065; UPC 7068210820; UPC 7068210824; UPC 1119680168; UPC 7230070732; UPC 7042409105; UPC 7042409115; UPC 7163200142; UPC 1234567890;--Lots 0017 through 0149;;;UPC 8523907614--Best by July 1, 2008 through July 12, 2010; UPC 5105217511--Best by: January 1, 2008 through January 14, 2010; UPC 4149815643--Best by January 1- July 31, 2008; UPC 7789032607- Best by October 1, 2007 through October 14, 2009;

2) Lots 0017 through 0149; Best by January 1-December 21, 2008;

3) Lots 0017 through 0149;

4) Lots 0017 through 0149; Best by January 1 through September 31, 2008;

5) Best by January 1, 2008 through January 14, 2010; Lots 0017 through 0149;

6) Lots 0017 through 0149;

7) January 1, 2008 through January 14, 2010;

8) Lots 0017 through 0149;

9) Lots 0017 through 0149;

10) Lots 0017 through 2448;

11) Lots 0017 through 0149;

12) Lots 0017 through 2128
RECALLING FIRM/MANUFACTURER
Ice Cream Specialties, Inc., Lafayette, IN, by press release, telephone and letter on January 30, 2009. Firm initiated recall is complete.
REASON
The products 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
Approx. 1,600,000 cases of all products
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Toasty crackers with peanut butter sold under the Keebler, Austin, Little Debbie Snacks, Weis, and Shoprite brand names as follows: Keebler Toast & Peanut Butter Sandwich Crackers, 8ct-1.38oz/11.04oz, Case UPC 3010047357, Individual UPC 3010054552; Keebler Toast & Peanut Butter Sandwich Crackers Snack Pack, 12ct-1.8oz/21.6oz, Case UPC, 3010021167, Individual UPC 3010012518; Austin Quality Foods Toasty Crackers with Peanut Butter, 120ct-1.38oz/165.6oz, UPC 7978340620; Austin Quality Foods Toasty Crackers with Peanut Butter, 45ct-1.38oz/62.1oz, Case UPC 7978325883; Individual UPC 7978325884; Austin Quality Foods Toasty Crackers with Peanut Butter, 8 packs of 4-0.93oz/7.44oz, Case UPC 7978340925; Individual UPC 7978340922; Austin Quality Foods Toasty Crackers with Peanut Butter (bilingual package), 24ct-1.38oz/31.2oz, UPC 7978348902; Austin Quality Foods Toasty Crackers with Peanut Butter, 16ct-0.93oz/14.88oz, UPC 7978335968; Austin Quality Foods Toasty Crackers with Peanut Butter, 8 packs of 4-0.93oz/7.44oz, Case UPC 7978348665; Individual UPC 7978340922; Austin Quality Foods Toasty Crackers with Peanut Butter, 12ct-1.38oz/16.56oz, UPC 7978340420; Austin Quality Foods Toasty Crackers with Peanut Butter, 24ct-1.38oz/33.1oz, UPC 7978340820; Austin Quality Foods Toasty Crackers with Peanut Butter, 8ct-1.38oz/11oz, UPC 7978348802; Little Debbie Snacks Peanut Butter Toast Sandwich Crackers, 12ct-1.38oz/16.56oz, UPC 2430083152; Little Debbie Snacks Peanut Butter Toast Sandwich Crackers, 12ct-1.38oz/16.56oz, UPC 2430045557; Little Debbie Snacks Peanut Butter Toast Sandwich Crackers, 1.38oz, Little Debbie Snacks Peanut Butter Toasty Sandwich Crackers, 8ct of 4-0.93oz/7.44oz, UPC 2430004163; Weis Quality Toasty Peanut Butter Snack Crackers, 12ct of 8 packages- 1.38oz/11oz, Case UPC 4149756443, Individual UPC 4149756447; Shoprite Peanut Butter on Toasty Crackers, 8ct-1.38oz/11oz, Case UPC 4119003540, Individual UPC 4119003886. Recall # F-0214-2010;

2) Peanut Butter and Cheese Sandwich Cracker sold under the Keebler, Austin, Little Debbie Snacks, Weis, Shoprite, and Cambridge brand names as follows: Keebler Cheese & Peanut Butter Sandwich Crackers Snack Pack, 12ct-1.8oz/21.6oz, Case UPC 3010021164, Individual UPC 3010021165; Keebler Cheese & Peanut Butter Sandwich Crackers, 8ct-1.38oz/11oz, UPC 3010047324; Austin Quality Foods Cheese Crackers with Peanut Butter Super Snack Pack, 8 packs of 4-0.93oz/7.44oz, UPC 7978340921; Austin Quality Foods Cheese Crackers with Peanut Butter, 24ct-1.38oz/33.1oz, UPC 7978340812; Austin Quality Foods Cheese Crackers with Peanut Butter, 45ct-1.38oz/62.1oz, Case UPC 7978325873, Individual UPC 7978325875; Austin Quality Foods Cheese Crackers with Peanut Butter, 8ct of 4-0.93oz/7.44oz, Case UPC 7978323712, Individual UPC 7978340921; Austin Quality Foods Cheese Crackers with Peanut Butter (Bilingual packaging), 24ct-1.38oz/33.12oz, UPC 7978348795; Austin Quality Foods Cheese Crackers with Peanut Butter, 8ct- 1.38oz/11oz, UPC 7978348801; Austin Quality Foods Cheese Crackers with Peanut Butter Super Singles, 120 ct-0.93oz/111.6oz, UPC 7978340725; Austin Quality Foods Cheese Crackers with Peanut Butter Super Snack Pack, 8 ct- 0.93oz/7.44oz, UPC 7978340924; Austin Quality Foods Cheese Crackers with Peanut Butter, 8ct- 0.93oz/7.44oz, Case UPC 7978348664, Individual UPC 7978340921; Austin Quality Foods Cheese Crackers with Peanut Butter, 120ct- 1.38oz/165.6oz, UPC 7978340612; Austin Quality Foods Cheese Crackers with Peanut Butter, 12ct- 1.38oz/16.56oz, UPC 7978340412; Austin Quality Foods Cheese Crackers with Peanut Butter, 16ct- 0.93oz/14.88oz, Case UPC 7978335970, Individual UPC 7978335971; Little Debbie Snacks Peanut Butter Cheese Sandwich Crackers Super Snack Pack, 8ct-0.93/7.44oz, UPC 2430004115; Little Debbie Snacks Peanut Butter Cheese Crackers, 12ct-1.38oz/16.56oz, UPC 2430083150; Little Debbie Snacks Peanut Butter Cheese Crackers, 12ct- 1.38oz/16.56oz, UPC 2430045555; Little Debbie Snacks Peanut Butter Cheese Crackers, 1.38oz, Weis Quality Cheese Peanut Butter Snack Crackers, 8ct- 1.38oz/11oz, Case UPC 4149756442, Individual UPC 4149756446; Shoprite Peanut Butter & Cheese Cracker Snacks, 8ct- 1.38/11oz, Case UPC 4119003542, Individual UPC 4119003539; Cambridge Peanut Butter on Cheese crackers, 8ct of 4- 0.93oz/7.44oz, UPC 4149818660. Recall # F-0215-2010;

3) Reduced fat sandwich crackers variety pack (cheese crackers with PB and toasty crackers with PB) sold under the Austin brand name as follows: Austin Quality Foods Cheese Crackers with Peanut Butter Reduced Fat (part of variety pack), 10ct- 1.3oz/13oz, Case UPC 7878348669, Individual UPC 7978340671; Austin Quality Foods Toasty Crackers with Peanut Butter Reduced Fat (part of variety pack), 10ct- 1.3oz/13oz, Case UPC 7878348669, Individual UPC 7978340672. Recall # F-0216-2010

4) Mega stuffed cheese crackers with peanut butter sold under the Austin brand name as follows: Austin Quality Foods, 8ct- 1.68oz/13.44oz, UPC 7978319354; Austin Quality Foods, 100ct- 1.68oz/168oz, UPC 7978340613; Austin Quality Foods, 120ct- 0.93oz/111.6oz, UPC 7978340726. Recall # F-0217-2010;

5) Sandwich Crackers sold under the Keebler and Austin Quality Foods names: Keebler Sandwich Crackers, 60ct- 10.4oz/624oz, UPC 3010026127; Keebler Sandwich Crackers, 48-12ct 11oz, Keebler Sandwich Crackers, 48ct- 11oz, UPC 3010044372, UPC 3010044372. Recall # F-0218-2010;

6) Toast and PB and Jelly Sandwich Crackers sold under the Keebler and Austin Quality Foods brand names: Snack Pack Kebbler Toast & PB 'nJ sandwich crackers made with real peanut butter, Keebler, 12ct- 1.8oz/21.6 oz, Case UPC: 3010021149, Individual UPC: 3010021151; Austin Quality Foods PB & J Cracker Sandwiches, 8 packs of 4- 0 .93 oz/7.44 oz, Case UPC 7978322897, Individual UPC 7978322898; Austin Quality Foods PB & J Cracker Sandwiches, 8ct-1.38 oz/11oz, UPC 7978319531; Austin Quality Foods PB & J Sandwich Crackers 12ct-1.38 oz/16.56 oz, Case UPC 7978318980, Individual UPC 7978308980; Austin Quality Foods PB & J Cracker Sandwiches, 120ct-1.38 oz/165.6 oz, Case UPC 7978320545, Individual UPC 7978308980. Recall $ F-0219-2010;

7) Chocolatey Peanut Butter Cracker Sandwiches sold under the Austin brand name as follows: Austin Quality Foods, 12ct- 1.38oz./16.5 oz, Case UPC 797833329, Individual UPC 7978333330. Recall # F-0220-2010;

8) Variety Pack of Cookies and Crackers individually wrapped packages of (choco cremes, vanilla cremes, lemon ohs!, peanut butter and cheese crackers, peanut butter with toasty crackers, cheddar cheese and cheese crackers, and cheddar cheese with wheat crackers) sold under the Austin brand name as follows: Austin Quality Foods, 45 ct-1.38oz/62.1oz, Case UPC 7978325876, Individual UPC 7978325877. Recall # F-0221-2010 ;

9) Variety Pack of Crackers with (4 types: Cheese Crackers w/PB, Toasty Crackers w/PB, Cheese Crackers with Cheddar Cheese, and Wheat Crackers with Cheddar Cheese) sold under the Austin brand name as follows: Austin Quality Foods Variety Pack Crackers 10ct-1.38.oz/13.8oz, UPC 7978330364; Austin Quality Foods Variety Pack Crackers 10ct-1.38.oz/13.8oz, UPC 7978348635.  Recall # F-0222-2010;

10) Variety Pack of Crackers with (3 types: Cheese Crackers w/PB, Toasty Crackers w/PB, Cheese Crackers with Cheddar Cheese) sold under the Austin brand name as follows: Austin Quality Foods Variety Pack Crackers 10ct-1.38.oz/13.8oz, Case UPC 7978338440, Individual UPC 7978338441.  Recall # F-0223-2010;

11) Soft Batch Homestyle Peanut Butter Cookies sold under the Keebler brand name as follows: Keebler, 12ct-2.5oz/30oz individual packages, Case UPC 3010035406, Individual UPC 3010035407. Recall # F-0224-2010;

12) Famous Amos Peanut Butter Cookies Snack Size, 1ct-16oz carton, UPC 7667725733; Famous Amos Peanut Butter Cookies Bite Size Cookies Grab n' Go 6ct- 3oz/18oz, Case UPC 7667726471, Individual UPC(s) 7667726472, 7667726473; Famous Amos Peanut Butter Cookies Bite Size Cookies, 60ct- 2oz, UPC 766718165. Recall # F-0225-2010;

 13) Famous Amos Premium Choice Batter (frozen cookie dough) sold in bulk. NOTE: This product is not sold in the United States. Recall # F-0226-2010
CODE
1) – 12) All manufacturing codes prior to September 16, 2009 (09 16 9);
13) All product manufactured since 7/1/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kellogg USA, Inc., Battlecreek, MI, by press release on January 14, 2009, January 16, 2009, and February 2, 2009, and by letter on January 17, 2009.
Manufacturer: Kellogg’s Snacks, Cary, NC. Firm initiated recall is complete.
REASON
The products was manufactured using peanut paste recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
7 million cases of crackers and 33 million cases of cookies
DISTRIBUTION
Nationwide, Virgin Islands, Australia, Bahamas, Japan, Malaysia and Singapore
___________________________________
PRODUCT 
Fruit and Nut Blend Trail Mix, Caribou Coffee, An All Natural Blend of Cranberries, Raisins, and Nuts, 3-oz in clear plastic bag, with manufacturing dates of NOV 03 2008 and DEC 30 2008. (SKU#007845. 12 individual bags per case. Recall # F-0256-2010
CODE
Sell by dates of MAR 03 2009 and JUN 30 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Caribou Coffee Co., Inc., Brooklyn Center, MN, by press release on January 30, 2009.
Manufacturer: Marra Bros Distributing Co., Morgan Hill, CA. Firm initiated recall is complete.
REASON
The product was manufactured using peanut paste recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1230 cases or 14760 3 oz packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Hippie Cookie - Product is unlabeled, with no UPC or code information; sold in 6-pack or single. 6-pack is shrink-wrapped and packed into unlabeled brown cardboard box; net weight 20.25 oz. Single packed into unlabeled brown cardboard box and shrink wrapped or loose in a variety box with other pastries; net weight 3.37 oz. Recall # F-0296-2010

2) Peanut butter Bar - Product is unlabeled, with no UPC or code information. Sold in 12-pack shrink-wrap and packed into unlabeled brown cardboard box, net weight 36 oz. Recall # F-0297-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Neighborhood Baking Co., Portland, OR, by telephone on February 27, 2009, by visit beginning March 4, 2009 and by letter on March 5, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
23,753 pieces
DISTRIBUTION
OR
___________________________________
PRODUCT 
Dove Caramel Pecan Perfection Ice Cream sold in 15.10 fl. oz container, UPC Code 47677-13943. Recall # F-0774-2010
CODE
Lot # 931AB5YN07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mars Snackfood US LLC, Hackettstown, NJ, by telephone and e-mail on October 24, 2009.
Manufacturer: Yarnell Ice Cream Co, Inc., Searcy, AR. Firm initiated recall is complete.   
REASON
Product has the potential to contain undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
7,024 cases
DISTRIBUTION
AL, CO, FL, GA, IA, IL, IN, KS, KY, LA, MI, MN, NC, OH, OR, TX, UT, WA and WI
___________________________________
PRODUCT
Pop's Bakery Home Style Flour Tortillas, packed in a clear plastic bag with color labeling inside in the following sizes: 11 count, Net Wt. 16 oz (1 lb) 453gr; 11 count, Net Wt. 21 oz (1 lb - 5 oz) 595 gr; 12 count, Net Wt. 14 oz. 396 gr.; and 6 count Net Wt. 15 oz. 426 gr; 325/655-1170. Pop's Bakery Especial Flour Tortillas, packed in a clear plastic bag with color labeling inside, 11 count, Net Wt. 21 oz (1 lb - 5 oz) 595 gr. Recall # F-0775-2010
CODE
Codes: 110609, 110509, 110409, 110309, 110209, 110109, 103109, 103009, 102909, 102809, 102709, 102609, 102509, 102409, 102309, 102209, 102109, 102009, 101909, 101809, 101709, 101609, 101509, 101409, 101309, 101209, 101109, 101009, 100909, 100809, and 100709; manufactured between the dates of 10/7/09 and 11/06/09
RECALLING FIRM/MANUFACTURER
Pops Bakery, San Angelo, TX, by press release on October 2, 2009 and letter and visit on October 30, 2009. Firm initiated recall is complete.
REASON
Product may contain undeclared whey (milk).
VOLUME OF PRODUCT IN COMMERCE
2,616 packages of tortillas
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT
Propofol Injectable Emulsion 1%, 200 mg/20 mL, (10 mg/mL), 20 ml vials, NDC on vials is 0703-2856-01, shipped in packages containing 25 vials, NDC on package is 0703-2856-04. Recall # D-132-2010
CODE
Lot numbers: 31308134B exp 8/2011, 31308278B exp 8/2011, 31308279B 8/2011, 31308350B exp 9/2011, 31308659B exp 9/2011, 31308784B exp 9/2011, 31308785B exp 9/2011, and 31309201B exp 9/2011
RECALLING FIRM/MANUFACTURER
Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letters on October 27, 2009 and October 28, 2009.
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Lack of Sterility Assurance: The product was manufactured on equipment found to be contaminated with microbiological organisms.
VOLUME OF PRODUCT IN COMMERCE
1,138,800 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0279-10
CODE
Unit: 1695326
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter on April 26, 2007.  Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT 
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0280-10;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-0281-10
CODE
1) and 2) Unit: 2875266
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by telephone on March 22, 2009 and by follow up letter on March 23, 2009. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0282-10;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0283-10
CODE
1) and 2) Unit: 36LC40766
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Columbia, SC, by telephone and letter on March 20, 2009. 
Manufacturer: American Red Cross Blood Services, Myrtle Beach, SC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PR, SC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0284-10
CODE
Unit: 041FL11595
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone and email on March 4, 2009 and fax on March 9, 2009. 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
AL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0287-10
CODE
Unit: 22GJ08430
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter and fax on July 15, 2009. 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
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0289-10
CODE
Unit: 009GT32529
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Omaha, NB, by letter and email on November 18, 2008.
Manufacturer: American Red Cross Blood Services, North Platte, NB. 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
MA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0291-10
CODE
Unit: W127809201514 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone on July 20, 2009 and letter on July 21 and 29, 2009. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced without the assurance that they met the criteria for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA, MD
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0292-10;
2) Fresh Frozen Plasma. Recall # B-0293-10
CODE
1) and 2) Unit: 36GC12646
RECALLING FIRM/MANUFACTURER
American National Red Cross, Columbia, SC, by fax on January 19, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
SC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0294-10;
CODE
Unit: 36GJ27096
RECALLING FIRM/MANUFACTURER
American National Red Cross, Columbia, SC, by letter and email on May 23, 2009. 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
SC
___________________________________
PRODUCT 
Source Plasma. Recall # B-0296-10
CODE
Units: TQ018958, TQ017126, TQ014267, TQ010782, TQ010441, TQ009314, TQ008757, TQ008597, TQ008446, TQ008204, TQ007907, TQ007669, TQ007431, TQ029592, TQ027200, TQ009104, TQ008978
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp, Knoxville, TN, by fax on July 13, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
NC
___________________________________
PRODUCT
1) Recovered Plasma. Recall # B-0297-10
2) Red Blood Cells Leukocytes Reduced. Recall # B-0298-10
CODE
1) and 2) Unit: GK09556
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc., Milwaukee, WI, by fax on May 29, 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
Switzerland, WI
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0325-10
CODE
Unit: W072109001951
RECALLING FIRM/MANUFACTURER
Southern California Permanente Medical Group, San Diego, CA, by telephone and fax on July 13, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0326-10;
2) Red Blood Cells. Recall # B-0327-10
CODE
1) Unit: 017GJ50606;
2) Unit: 017KV73076
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax and email on August 1, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0329-10
CODE
Unit: 6328687
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter on May 26, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Source Plasma. Recall # B-0330-10
CODE
Unit: 08CIAK1053
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Cedar Rapids, IA, by fax on August 6, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose scheduled physical exam was not completed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0331-10;
2) Platelets. Recall # B-0332-10;
3) Recovered Plasma. Recall # B-0333-10
CODE
1), 2), and 3) Unit: 7037946
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by letter on May 21, 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
3 units
DISTRIBUTION
MO, AR
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0334-10;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0335-10;
CODE
1) Units: 038C64071, 038C66600;
2) Unit: 038C61692
RECALLING FIRM/MANUFACTURER
American National Red Cross Indiana-Ohio Region, Fort Wayne, IN, by fax on July 6, 2009 and by letter on September 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
IN
___________________________________
PRODUCT 
Platelets Pooled Leukocytes Reduced. Recall # B-0336-10
CODE
Unit: 1014821
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by letter on July 6, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0337-10;
2) Platelets Pooled Leukocytes Reduced. Recall # B-0338-10
CODE
1) Unit: W120609114544;
2) Unit: W120609182528
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by fax on July 22, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-0340-10;
2) Cryoprecipitated AHF. Recall # B-0341-10
CODE
1) and 2) Unit: 011GR97685
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by telephone and fax on May 21, 2009 and by letter on July 7, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX, OK

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1052-09; 
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1053-09;
3) Fresh Frozen Plasma. Recall # B-1054-09;
4) Platelets Pheresis Leukocytes Reduced. Recall # B-1055-09;
5) Blood and Blood Products for Reprocessing. Recall # B-1056-09; 
6) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # Recall # B-1057-09
CODE
1) Units: W071208006142, W071208006143, W071208006144, W071208006145, W071208006146, W071208006147, W071208006148, W071208006149, W071208006150, W071208006153, W071208007217, W071208007218, W071208007220, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007231, W071208007232, W071208007233, W071208007234, W071208007235, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008724, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;

2) Units: W071208008713, W071208008713;

3) Units: W071208006144, W071208006148, W071208006150, W071208007217, W071208007218, W071208007220;

4) Units: W071208008715, W071208008721;

5) Units: W071208006142, W071208006143, W071208006145, W071208006146, W071208006147, W071208006149, W071208006153, W071208007222, W071208007223, W071208007224, W071208007225, W071208007226, W071208007227, W071208007228, W071208007229, W071208007230, W071208007232, W071208007233, W071208007234, W071208007235, W071208007236, W071208007237, W071208007238, W071208007239, W071208007240, W071208007241, W071208008168, W071208008169, W071208008171, W071208008174, W071208008175, W071208008714, W071208008716, W071208008717, W071208008720, W071208008722, W071208008723, W071208008725, W071208008726, W071208008727, W071208008728, W071208008729, W071208008730;

6) Units: W071208008170, W071208008170, W071208008173, W071208008173, W071208008718, W071208008719, W071208008719
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone, fax and letter beginning July 31, 2008. Firm initiated recall is complete.
REASON
Blood products that lacked complete documentation of testing for HIV-1/2 by EIA, were distributed.
VOLUME OF PRODUCT IN COMMERCE
110 units
DISTRIBUTION
TN, NY
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1142-09
CODE
Unit: W287608002663
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on October 20, 2008.
Manufacturer: LifeSource Lincoln Park, Chicago, IL. Firm initiated recall is complete.
REASON
Blood product, with an unacceptable total hemoglobin level, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Washed. Recall # B-1547-09
CODE
Units: 24FC65052; 24FC65379; 24GY40848; 24KZ61173
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Louisville, KY, by fax and letter on February 12, 2009. Firm initiated recall is complete.
REASON
Blood products, with unacceptably low red cell recoveries after washing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0285-10
CODE
Unit: 041FL11595
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Birmingham, AL, by telephone and email on March 4, 2009 and fax on March 9, 2009. 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
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0286-10
CODE
Unit: 22GJ08430
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by letter and fax on July 15, 2009. 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
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0290-10
CODE
Unit: 009GT32529
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Omaha, NB, by letter and email on November 18, 2008.
Manufacturer: American Red Cross Blood Services, North Platte, NB. 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
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0295-10
CODE
Unit: 36GJ27096
RECALLING FIRM/MANUFACTURER
American National Red Cross, Columbia, SC, by letter and email on May 23, 2009. 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
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0328-10
CODE
Units: 017GJ50606, 017KV73076
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax and email on August 1, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0342-10
CODE
Unit: 011GR97685
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by telephone and fax on May 21, 2009 and by letter on July 7, 2009. 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
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT
Cyberonics VNS Therapy Demipulse Generator Model 250 Programming System, version 4.6, 6.1, 7.0, and 7.1 labeling, for vagus nerve stimulation. Recall # Z-0264-2010
CODE
Version 4.6, 6.1, 7.0 or 7.1 labeling
RECALLING FIRM/MANUFACTURER
Cyberonics, Inc., Houston, TX, by letter on July 24, 2009. Firm initiated recall is ongoing.
REASON
Failure to deliver therapy. Some VNS Therapy System replacement Demipulse generators reporting low lead impedance readings. In rare instances, a system diagnostic test using Model 250 Programming Software (versions 7.1 and earlier) may report "Lead Impedance: OK" when a short-circuit condition exists that prevents the lead from delivering therapy to the vagus nerve.
VOLUME OF PRODUCT IN COMMERCE
9,500 programming devices
DISTRIBUTION
Nationwide, Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Iran, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Luxembourg, Malaysia, Mexico, Morocco, Netherlands, Norway, Poland, Portugal, Puerto Rico (US Territory), Russia, San Marino, Saudi Arabia, Singapore, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Arab Emirates, United Kingdom, and Venezuela
___________________________________
PRODUCT
1) Respiratory Gating System, Catalog #NPTA540, Model #4535 674 26701, which includes: Pulmonary digital assembly kit and Pulmonary toolkit oncology Pro available on the following GEMINI PET/CT systems: GEMINI GXL 16 slice configuration, Model Number: 4535 679 75691. Recall # Z-0286-2010;

2)  Respiratory Gating System, Catalog Number: NPTA540, Model #4535 674 26701, for the following affected CT/PET scanning device systems : GEMINI TF CT/PET Systems 16 Slice, GEMINI TF CT/PET System 16 Slice Mobile; GEMINI TF CT/PET System 64 Slice Mobile; and GEMINI TF CT/PET System 64 Slice. Model Numbers: 16 slice: 4535 679 83931; 64 slice Mobile: 4535 674 47551; and 64 slice: 4535 679 94741. Recall # Z-0287-2010
CODE
1) Serial Numbers: 4004, 4039, 4045, 4068, 4080, 4104, 4112, 4115, 4117, 4118, 4121, 4127, 4132, 4139, 4146, 4152, 4156, 4158, and 4175;

2) Serial Numbers: Gemini TF 16 Slice: 7005, 7052, 7087, 7112, 7121, 7138, 7115, 7135, 7006, 7008, 7015, 7021, 7020, 7026, 7035, 7039, 7041, 7049, 7053, 7058, 7060, 7069, 7075, 7080, 7083, 7084, 7098, 7117, 7118, 7142; Gemini TF 16 Slice Mobile: 7059, 7104; Gemini TF 64 Slice Mobile: 7092; Gemini TF 64 Slice: 7012, 7013, 7032, 7071, 7082, 7091, 7126, 7132, 7088, 7103, 7136, 7027, 7109, 7105, 7028, 7167, 7078, and 7110
RECALLING FIRM/MANUFACTURER
The Philips Medical Systems (Cleveland), Cleveland, OH, by letter on November 24, 2009. Firm initiated recall is ongoing.
REASON
A leak between the Tube Interface and the Outlet Tube of the transducer for the Respiratory Gating System component may result in a failure of the device to produce respiratory correlated images.
VOLUME OF PRODUCT IN COMMERCE
71 units
DISTRIBUTION
Nationwide, Canada, Belgium, China, Denmark, Egypt, France, Germany, Hong Kong, India, Japan, Netherlands, Pakistan, Philippines, Poland, Saudi Arabia, Singapore, South Korea, Spain and Sweden
___________________________________
PRODUCT
PICIS, CareSuite Family- OR Manager (4235), Preop Manager (4250), Anesthesia Manager (4220), PACU Manager (4245) & Critical Care Manager (1110), patient information systems. Recall # Z-0365-2010
CODE
Software version 7.2.2
RECALLING FIRM/MANUFACTURER
Picis Inc., Wakefield, MA, by letter on April 8th 2009. Firm initiated recall is ongoing.
REASON
Demographic data, most notably allergy and precaution data, can be overwritten with incomplete data or blanks by the interface between non-Picis clinical systems (your "HIS" or "CIS") and certain Picis applications, if that interface is not configured properly.
VOLUME OF PRODUCT IN COMMERCE
325 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Denmark, Finland, France, Germany, Italy, Malaysia, Netherlands, Norway, Portugal, Singapore, Spain, Sweden, and United Kingdom
___________________________________
PRODUCT
1) Stryker Howmedica Osteonics, Skirted 5 40' Taper V40 Femoral Head (26 mm +8mm offset), hip prosthesis component. Catalog number 6260-5-326. Recall # Z-0390-2010;

2) Stryker Howmedica Osteonics, Skirtless 5 40' LFIT V40 Femoral Head (32 mm +0 mm offset); hip prosthesis component. Catalog number 6260-9-132. Recall # Z-0391-2010   
CODE
1) Lot code 29018201;
2) Lot Code 28759003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on September 4, 2009 and September 9, 2009.
Manufacturer: Stryker Ireland, Ltd., Orthopaedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON
Packaging mix up between the Taper V40 Femoral Head and the LFIT V40 Femoral Head.
VOLUME OF PRODUCT IN COMMERCE
6260-5-326 – 7 units; 6260-9-132 – 10 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Merit Medical Systems, Inc., Convenience Trays, custom packaged under the following Merit Medical labels: (1) Prentice PICC Kit, Catalog number K12T-03698; (2) Insertion Kit, catalog number K12T-03050C; and (3) Angio Procedure Pack, catalog number K09T-09530A. Recall # Z-0413-2010
CODE
Lots: V705949, Exp 2010-05 V698581, Exp 2010-04 V700586, Exp 2012-04 V707921, Exp 2012-04
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., Chester, VA, by telephone, fax or visit on May 19, 2009. Firm initiated recall is complete.
REASON
Surgical gloves in hospital convenience kits may be degraded and tear during use.
VOLUME OF PRODUCT IN COMMERCE
378 units
DISTRIBUTION
TX, CO
___________________________________
PRODUCT
The Natus Blue Light Phototherapy is also called the "neoBLUE LED Phototherapy System". The "neoBLUE mini LED Phototherapy System". Catalogue / Part Numbers: 010101 (110V, US, new); 010101R (110V, US, refurbish); 010102 (230V, UK, new); 010102R (230V, UK, refurbish); 010103 (230V, EUR, new); 010103R (230V, EUR, refurbish); 010104 (230V, EUR, new); 010104R (230V, EUR, refurbish). Recall # Z-0420-2010
CODE
Serial Numbers: 60011-60013, 60015, 60017, 60021-60029, 60031-60033, 60035, 60037, 60038, 60101-60120, 60124-60128, 60131-60324, 60327-60349, 60351-60403, 60405, 60407-60415, 60417-60507, 60509-60586, 60588-60606, 60608-60611, 60613-60845, 60847-61000, 61002-61293, 61295-61340, 61346-61574, 61577-61590, 62001-62026, 62028-62032, 62035-62145, 62147-62163, 62165-62245, 62247-62252, 62254-62309, 62311-62350, 62352-62433, 62435-62481, 62485-62634, 62636-62640, and 62642-62656
RECALLING FIRM/MANUFACTURER
Natus Medical Incorporated, Seattle, WA, by letter on October 1, 2009. Firm initiated recall is ongoing.
REASON
The clamp connecting the neoBLUE mini phototherapy light to the accessory pole stand can sustain stress fractures or break when excessive force is used when tightening the clamp. No injuries have been reported.
VOLUME OF PRODUCT IN COMMERCE
2127 units
DISTRIBUTION
Nationwide, Argentina, Australia, Austria, Belgium, Bermuda, Canada, Chile, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iraq, Israel, Italy, Japan, Kenya, Kuwait, Lithuania, Malaysia, Mexico, Morocco, Netherlands, Norway, Philippines, Poland, Portugal, PR, Qatar, Russia, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UAE, and UK
___________________________________
PRODUCT
1) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 22MM, spinal implant component. Catalog Number 48036022. Recall # Z-0423-2010;

2) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 25MM, spinal implant component. Catalog number 4803625. Recall # Z-0424-2010;

3) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 28MM, spinal implant component. Catalog number 48036028. Recall # Z-0425-2010;

4) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 31MM, spinal implant component. Catalog number 48036031. Recall # Z-0426-2010;

5) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 34MM, spinal implant component. Catalog number 48036034. Recall # Z-0427-2010;

6) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.0 x 37MM, spinal implant component. Catalog number 48036027. Recall # Z-0428-2010;

7) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 40MM, spinal implant component. Catalog number 48036040. Recall # Z-0429-2010;

8) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 43MM, spinal implant component. Catalog number 48036043. Recall # Z-0430-2010;

9) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 46MM, spinal implant component. Catalog number 48036046. Recall # Z-0431-2010;

10) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 49MM, spinal implant component. Catalog number 48036049. Recall # Z-0432-2010;

11) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 52MM, spinal implant component. Catalog number 48036052. Recall # Z-0433-2010;

12) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 55MM, spinal implant component. Catalog number 48036055. Recall # Z-0434-2010;

13) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 58MM, spinal implant component. Catalog number 48036058. Recall # Z-0435-2010;

14) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 61MM, spinal implant component. Catalog number 48036061. Recall # Z-0436-2010;  

15) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 64MM, spinal implant component. Catalog number 48036064. Recall # Z-0437-2010;

16) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.0 x 67MM, spinal implant component. Catalog number 48036067. Recall # Z-0438-2010;  

17) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 22MM, spinal implant component . Catalog number 48036522. Recall # Z-0439-2010;

18) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 25MM, spinal implant component. Catalog number 48036525. Recall # Z-0440-2010;

19) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 28MM, spinal implant component. Catalog number 48036528. Recall # Z-0441-2010;

20) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 31MM, spinal implant component. Catalog number 48036531. Recall # Z-0442-2010;

21) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 34MM, spinal implant component. Catalog number 48036534. Recall # Z-0443-2010;

22) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Screw 6.5 x 37MM, spinal implant component. Catalog number 48036537. Recall # Z-0444-2010;

23) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 40MM, spinal implant component. Catalog number 38036540. Recall # Z-0445-2010;

24) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 43MM, spinal implant component. Catalog number 48036543. Recall # Z-0446-2010;

25) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 46MM, spinal implant component. Catalog number 48036546. Recall # Z-0447-2010;

26) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 49MM, spinal implant component. Catalog number 48036549. Recall # Z-0448-2010;

27) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 52MM, spinal implant component. Catalog number 48036552. Recall # Z-0449-2010;

28) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 55MM, spinal implant component. Catalog number 48036555. Recall # Z-0450-2010;

29) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 58MM, spinal implant component. Catalog number 48036558. Z-0451-2010;

30) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 61MM, spinal implant component. Catalog number 48036561. Recall # Z-0452-2010;

31) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 64MM, spinal implant component. Catalog number 48036564. Recall # Z-0453-2010;

 32) Stryker Thor Anterior Plating System; Non Sterile Thor Standard Long Screw 6.5 x 67MM, spinal implant component. Catalog number 48036567. Recall # Z-0454-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by letters on October 19, 2009.
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.
REASON
Surgeons may apply an accidental axial torque to and/or over-angulate the All-In One Guide while implanting the screw. This may cause the screw not to seat properly in the locking ring and may cause the Thor screwdrivers to twist or break at the tip.
VOLUME OF PRODUCT IN COMMERCE
9550 screws
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Cargille Modified Kingsbury-Clark Albumin Standards For in vitro Diagnostics (Set of 8 Standards: 5, 10, 20, 30, 40, 50, 75, 100 mg/ml); Catalog number: 52064. Recall # Z-0479-2010
CODE
Lot number: Jan-12-05
RECALLING FIRM/MANUFACTURER
Cargille-Sacher Laboratories, Inc., Cedar Grove, NJ, by letters on July 7, 2006. Firm initiated recall is complete.
REASON
The 10 ml size standard of Cargille modified Kingsbury Clark Albumin Standards of lot Jan-12-05 appear shrunken or liquefied.
VOLUME OF PRODUCT IN COMMERCE
5 kits
DISTRIBUTION
OH, DC, PA, WI, VA
___________________________________
PRODUCT
ezManager Max Diabetes Management System version 2.0.9. Recall # Z-0481-2010
CODE
Version 2.0.9
RECALLING FIRM/MANUFACTURER
Animas Corp., West Chester, PA, by letter dated November 2, 2009. Firm initiated recall is ongoing.
REASON
Printed hard copy of results is not the same as the system screens-carbohydrate to insulin ratio incorrect.
VOLUME OF PRODUCT IN COMMERCE
20,648 units
DISTRIBUTION
Nationwide, Canada, Cayman Islands, and Denmark

END OF ENFORCEMENT REPORT FOR DECEMBER 9, 2009

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