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U.S. Department of Health and Human Services

Safety

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Enforcement Report for January 11, 2012

 

January 11, 2012                                                                                               12-02
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
Crab Rangoon, The product does not have any brand names. 200, 1 oz. pieces make one unit of product. The product is packaged in brown cardboard boxes with 4 plastic trays that fit 50 pieces of product and are placed on top of each other in the box. The boxes are labeled with a white label with black writing and is labeled in part: ***CRAB RANGOON***Ingredient: crab meat, cream cheese, garlic powder, chili sauce, salt, white pepper***Pack: 200 x case KEEP FROZEN. The product has a shelf life of 6 months but is not listed on labeling. Recall # F-0570-2012
CODE
Product does not contain Lot Codes. All products manufactured before 12/14/2011.
RECALLING FIRM/MANUFACTURER
Asia Food Inc., Monterey Park, CA, by letter on December 19, 2011. Firm initiated recall is ongoing.
REASON
Asia Food has confirmed that the Crab Rangoon Wonton Dumpling may contain undeclared soy, fish, and wheat.
VOLUME OF PRODUCT IN COMMERCE
30-35 boxes
DISTRIBUTION
CA
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PRODUCT
The product is the same, but privately labeled under two different brands. --- Label 1: BakeMark Chocolate Butter crème Icing Artificially Flavored H&H #503180 --- Net Wt - 30 lb (13.61 kg) --- UPC 0 18609 11901 6 --- Label 2: HENRY & HENRY 345202 --- Imperial Chocolate Crème Icing --- Net Wt 30 lb (13.61 kg). Recall # F-0571-2012
CODE
1) Lot codes: 1130700023, 1129000055; 2) Lot codes: 1129000043, 1130400209
RECALLING FIRM/MANUFACTURER
CSM Bakery Products NA, Lancaster, NY, by telephone and letters on December 9, 2011. Firm initiated recall is ongoing.  
REASON
Recall due to undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
459 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Baraka Apricot Candies, Ingredients: Apricots, Corn Syrup, and Olive Oil. Net Wt: 14:08 oz (400 g) Expiry: 5/2013. Recall # F-0574-2012
CODE
Expiry: 5/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.B.C Food Distributors, Inc., Dearborn, MI, by telephone and letter beginning December 27, 2011, and by press release on December 27, 2011.
Manufacturer: Baraka Co., Alrafid, Lebanon. New York initiated recall is ongoing.
REASON
The product contains undeclared sulfites based on the New York State Department of Agriculture and Markets' analysis.
VOLUME OF PRODUCT IN COMMERCE
492 cases
DISTRIBUTION
Nationwide
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PRODUCT
FTD Gift Towers (baskets): Elegant Gourmet Tower, Holiday Harvest Tower, Let It Snow Tower, Starbucks Reindeer Tower, Happy Birthday Tower, Birthday Celebration Cupcake, Starbucks Skater Tower, and Starbucks Sampler Tower. Recall # F-0575-2012
CODE
SKU: F11589, F11590 ,F11591 ,F11592,F11593 ,F11594, F11595, F11596, F11597, F11674 , F11673, F11672, F11604, F11602
RECALLING FIRM/MANUFACTURER
Giftcorp, Inc., East Hartford, CT, by letters on December 14, 2011 and December 16, 2011. Firm initiated recall is ongoing.
REASON
Omitted ingredient statement that identifies allergens- milk, egg, peanuts, tree nuts or wheat in packaged gift towers.
VOLUME OF PRODUCT IN COMMERCE
1,787 Gift Towers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Celery Seed Whole Organic. Product sold in bulk – 1) 25 lbs and 55 lbs; and 2) 1 lb, UPC 7 67963 07864-3; 3) 2 oz, UPC 7 67963 10619-3. Mylar packages with Starwest Botanicals label. Recall # F-0576-2012
CODE
1) Lot # 72281-00; 2) lot # 40302; 3) lot # F7073
RECALLING FIRM/MANUFACTURER
Recalling Firm: Starwest Botanicals, Inc., Rancho Cordova, CA, by letters on December 14, 2011, and by press release on December 20, 2011. 
Manufacturer: Egy Herbal Co., El Fayom, Egypt. Firm initiated recall is ongoing.  
REASON
Organic Celery Seed is potentially contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
4,159 pounds
DISTRIBUTION
Nationwide and Canada
 
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
___________________________________
PRODUCT
1) OLD LABEL: Alfajor Gelato is labeled in part: "***KDM***ALFAJOR *** (GELATO)***" NEW LABEL: "***ALFAJOR - (GELATO)***INGREDIENTS: water, sugar, cream, skim milk, dextrose, chocolate (cocoa mass), cocoa powder, dulce de leche (milk, sugar, dextrose, acidity regulator: sodium carbonate), orange and lemon peel, vanilla and almond flavor, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***Net Weight 6.6 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Weight 6.6 lbs. Recall # F-0506-2012;
 
2) OLD LABEL: Almond Cream (Gelato) is labeled in part: "***KDM***ALMOND CREAM***(GELATO)***" NEW LABEL: Almond Cream Gelato is labeled in part: "***ALMOND- (GELATO)***Net Weight***Ingredients: water, cream, sugar, skim milk, dextrose, almond flavor, almond paste (almond butter, sugar, palm oil, natural and artificial flavors, lecithin. CONTAINS TREE NUTS), almonds, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers).***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Weight 7.7 lbs BALDE - Net Weight 12.1 lbs. Recall # F-0507-2012;
 
3) OLD LABEL: Amarena (Gelato) is labeled in part: "***KDM***AMARENA***(GELATO)***" NEW LABEL: AMARENA (Gelato) is labeled in part: "***AMARENA - (GELATO)***Ingredients: water, cream, sugar, skim milk, dextrose, natural vanilla flavor, wild cherry topping (sugar, wild cherries, glucose syrup, water, citric acid, stabilizer E406 (agar), E440 (pectin), color anthocyanins (vegetable juice color), flavoring preservatives E202 (potassium sorbate), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locustbeangum (stabilizers)***Net Weight 7.7 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Weight 7.7 lbs. Recall # F-0508-2012;
 
4) OLD LABEL: NEW LABEL: ARABIAN CREAM (Gelato) is labeled in part: "***ARABIAN CREAM - (GELATO)***INGREDIENTS: water, cream, sugar, skim milk, dextrose, yellow 5 and 6 (artificial color), natural vanilla flavor and vanilla bean paste, figs, rum flavor, walnuts, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight 7.7 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Weight 7.7 lbs. Recall # F-0509-2012;
 
5) OLD LABEL: Banana (Gelato) is labeled in part: "***KDM***BANANA (GELATO)***" NEW LABEL: Banana (Gelato) is labeled in part: "***BANANA - (GELATO) Net Weight 6.6 lbs***Ingredients: water, cream, sugar, skim milk, dextrose, banana, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locustbeangum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Weight 6.6 lbs. Recall # F-0510-2012;
 
6) OLD LABEL: Banana Split (Gelato) is labeled in part: "***KDM***BANANA SPLIT (GELATO)***" NEW LABEL: BANANA SPLIT (GELATO) is labeled in part: "***BANANA SPLIT - (GELATO) Net Weight***Ingredients: water, cream, sugar, skim milk, dextrose, banana, dulce de leche (milk, sugar, dextrose, acidity regulator: sodium carbonate), chocolate (cocoa mass), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Weight 6.6 lbs. BACHA DOBLE - Net Weight 9.9 lbs. BALDE - 12.1 lbs. Recall # F-0511-2012;
 
7) OLD LABEL: Capuccino (Gelato) is labeled in part: "***KDM***CAPUCCINO (GELATO)***" NEW LABEL: Capuccino (Gelato) is labeled in part: "***CAPUCCINO - (GELATO) Net Weight***Ingredients: water, cream, sugar, skim milk, dextrose, coffee powder, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***" NEW LABEL: Capuccino (Gelato) is labeled in part: "***CAPUCCINO MIX - (GELATO) Net Weight 12.1 lbs***Ingredients: water, cream, sugar, skim milk, dextrose, coffee powder, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BALDE - 12.1 lbs. Recall # F-0512-2012;
 
8) OLD LABEL: Chantilly (Gelato) is labeled in part: "***KDM***CHANTILLY (GELATO)***" NEW LABEL: Chantilly (Gelato) is labeled in part: "***CHANTILLY - (GELATO) Net Weight 12.1 lbs***Ingredients: water, cream, sugar, skim milk, dextrose, natural vanilla flavor, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locustbeangum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BALDE - 12.1 lbs. Recall # F-0513-2012;
 
9) OLD LABEL: Chocolate (Gelato) is labeled in part: "***KDM***CHOCOLATE(GELATO)***" NEW LABEL: Chocolate (Gelato) is labeled in part: "***CHOCOLATE - (GELATO)***INGREDIENTS: water, sugar, cream, skim milk, dextrose, chocolate (cocoa mass), cocoa powder, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. BACHA DOBLE - Net Wt. 9.9 lbs. BALDE - 12.1 lbs. Recall # F-0514-2012;
 
10) OLD LABEL: Chocolate w/Almond (Gelato) is labeled in part: "***KDM***CHOCOLATE W/ALMOND(GELATO)***" NEW LABEL: Chocolate w/Almond (Gelato) is labeled in part: “***CHOCOLATE W/ ALMONDS- (GELATO)***INGREDIENTS: water, sugar, cream, skim milk, dextrose, chocolate (cocoa mass), cocoa powder, almonds, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)*** Net Weight 9.9 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA DOBLE - Net Wt. 9.9 lbs. Recall # F-0515-2012;
 
11) OLD LABEL: Chocolate w/Orange (Gelato) is labeled in part: "***KDM***CHOCOLATE W/ORANGE (GELATO)***" NEW LABEL: Chocolate w/Orange (Gelato) is labeled in part: "***CHOCOLATE W/ ORANGE - (GELATO)***INGREDIENTS: water, sugar, cream, skim milk, dextrose, chocolate (cocoa mass), cocoa powder, orange flavoring, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight 9.9 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA DOBLE - Net Wt. 9.9 lbs. Recall # F-0516-2012;
 
12) OLD LABEL: Chocolate w/Pepper (Gelato) is labeled in part: "***KDM***CHOCOLATE W/PEPPER (GELATO)***" NEW LABEL: Chocolate w/Pepper (Gelato) is labeled in part: "***CHOCOLATE W/ PEPPER - (GELATO)***INGREDIENTS: water, sugar, cream, skim milk, dextrose, chocolate (cocoa mass), cocoa powder, espelette pepper flakes, red bell pepper, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight 9.9 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA DOBLE - Net Wt. 9.9 lbs. Recall # F-0517-2012;
 
13) OLD LABEL: Chocolate Chips (Gelato) is labeled in part: "***KDM***CHOCOLATE CHIPS (GELATO)***" NEW LABEL: Chocolate Chips(Gelato) is labeled in part: "***CHOCOLATE CHIPS - (GELATO)***Ingredients: water, cream, sugar, skim milk, dextrose, natural vanilla flavor, chocolate (cocoa mass), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locustbeangum (stabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BLADE - Net Wt. 12.1 lbs. Recall # F-0518-2012;
 
14) OLD LABEL: Italian Chocolate (Gelato) is labeled in part: "***KDM***ITALIAN CHOCOLATE (GELATO)***" NEW LABEL: Italian Chocolate (Gelato) is labeled in part: "***ITALIAN CHOCOLATE - (GELATO)***INGREDIENTS: water, sugar, cream, skim milk, dextrose, chocolate (cocoa mass), cocoa powder, golden raisins, rum flavor, walnuts, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight 9.9 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA DOBLE - Net Wt. 9.9 lbs. Recall # F-0519-2012;
 
15) OLD LABEL: Chocolate Mousse (Gelato) is labeled in part: "***KDM***CHOCOLATE MOUSSE (GELATO)***" NEW LABEL: Chocolate MOUSSE (Gelato) is labeled in part: "***CHOCOLATE MOUSSE- (GELATO)***INGREDIENTS: water, sugar, cream, skim milk, dextrose, chocolate (cocoa mass), cocoa powder, pan wips (hydrogenated vegetable fat, whey milk powder, lactose, sugar, milk protein, stabilizers E401 {sodium alginate}, E407 {carrageenan}, emulsifiers E472a {acetic acid esters of mono-and diglycerides of fatty acids}, flavoring) mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight 9.9 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA DOBLE - Net Wt. 9.9 lbs. Recall # F-0520-2012;
 
16) OLD LABEL: Chocolate Rocher (Gelato) is labeled in part: "***KDM***CHOCOLATE ROCHER (GELATO)***" NEW LABEL: Chocolate Rocher (Gelato) is labeled in part: "***CHOCOLATE ROCHER - (GELATO)***Net Weight***Ingredients: water, cream, sugar, skim milk, dextrose, gianduia paste (Hazelnuts, cocoa, sugar, vegetable fat (peanuts), emulsifier: E 471 mono- and diglycerides of fatty acids, E322 soy lecithin, antioxidant: E307 alpha-tocopherol), Arabeschi Donatella Rock Topping (hazelnut, sugar, peanut oil, wafers{wheat flour, starch, sugar, skimed milk powder, vegetable fat, baking powder: E500ii, sodium hydrogen carbonate, E503ii ammonium hydrogen carbonate, salt, flavors}, cocoa, skimmed milk powder, flours, emulsifiers: E322 soya lecithin, antioxidant: E307 alpha-tocopherol), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locustbeangum (stabilizers).***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA DOBLE - Net Wt. 9.9 lbs. BACHA PLANA - Net Wt. 6.6 lbs. Recall # F-0521-2012;
 
17) OLD LABEL: Coconut (Gelato) is labeled in part: "***KDM***COCONUT (GELATO)***" NEW LABEL: Coconut (Gelato) is labeled in part: "***COCONUT - (GELATO) Net Weight***Ingredients: water, cream, sugar, skim milk, dextrose, coconut emulsion (water, natural and artificial flavoring compounds, propylene glycol, xanthan gum, sodium benzoate), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locustbeangum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. BACHA DOBLE - Net Wt. 9.9 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0522-2012;
 
18) OLD LABEL: Coffee (Gelato) is labeled in part: "***KDM***COFFEE (GELATO)***" NEW LABEL: Coffee (Gelato) is labeled in part: "***COFFEE - (GELATO)***Net Weight 7.7 lbs***Ingredients: water, cream, sugar, skim milk, dextrose, coffee powder, Mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0523-2012;
 
19) OLD LABEL: Coffee Mocha (Gelato) is labeled in part: "***KDM***COFFEE MOCHA (GELATO)***" NEW LABEL: Coffee Mocha (Gelato) is labeled in part: "***COFFEE MOCHA - (GELATO)***Net Weight 7.7 lbs***Ingredients: water, cream, sugar, skim milk, dextrose, coffee powder, chocolate (cocoa mass) mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. Recall # F-0524-2012;
 
20) OLD LABEL: Dark Chocolate (Gelato) is labeled in part: "***KDM***DARK CHOCOLATE (GELATO)***" NEW LABEL: Dark Chocolate (Gelato) is labeled in part: "***DARK CHOCOLATE - (GELATO)***INGREDIENTS: water, sugar, cream, skim milk, dextrose, chocolate (cocoa mass), cocoa powder, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BACHA ALTA - Net Wt. 7.7 lbs. BACHA DOBLE - Net Wt. 9.9 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0525-2012;
 
21) OL D LABEL: Dark Chocolate Chips (Gelato) is labeled in part: "***KDM***DARK CHOCOLATE CHIPS (GELATO)***" NEW LABEL: Dark Chocolate Chips (Gelato) is labeled in part: "***DARK CHOCOLATE CHIPS - (GELATO)***INGREDIENTS: water, sugar, cream, skim milk, dextrose, chocolate (cocoa mass), cocoa powder, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight 12.1 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BALDE - Net Wt. 12.1 lbs. Recall # F-0526-2012;
 
22) OLD LABEL: Diet Chocolate (Gelato) is labeled in part: "***KDM***DIET CHOCOLATE (GELATO)***" NEW LABEL: Diet Chocolate (Gelato) is labeled in part: "***DIET CHOCOLATE - (GELATO)***INGREDIENTS: water, skim milk powder, cocoa powder, fructose, atarch, stabilizers:E412 guar gum, E410 locust bean gum, emulsifiers, E471 mono and diglycerides of fatty acids, E472b lactic acid esters of mono and diglycerides of fatty acids, E477 propane-1.2- diol esters of fatty acids***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BACHA DOBLE - Net Wt. 9.9 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0527-2012;
 
23) OLD LABEL: Diet French Vanilla (Gelato) is labeled in part: "***KDM***DIET FRENCH VANILLA (GELATO)***" NEW LABEL: Diet Vanilla (Gelato) is labeled in part: "***DIET VANILLA - (GELATO)***INGREDIENTS: water, skim milk powder, yellow 5 and 6 (artificial color), natural vanilla flavor, fructose, starch, stabilizers:E412 guar gum, E410 locust bean gum, emulsifiers, E471 mono and diglycerides of fatty acids, E472b lactic acid esters of mono and diglycerides of fatty acids, E477 propane-1.2- diol esters of fatty acids***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0528-2012;
 
24) OLD LABEL: Dulce De Leche Brownie (Gelato) is labeled in part: "***KDM***DULCE DE LECHE (GELATO)***" NEW LABEL: "***DULCE DE LECHE - (GELATO)***INGREDIENTS: water, dulce de leche (milk, sugar, dextrose, acidity regulator: sodium carbonate), cream,, dextrose, skim milk, sugar, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BACHA DOBLE - Net Wt. 9.9 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0529-2012;
 
25) OLD LABEL: Dulce De Leche Chips (Gelato) is labeled in part: "***KDM***DULCE DE LECHE CHIPS (GELATO)***" NEW LABEL: Dulce De Leche Chips (Gelato) is labeled in part: "***DULCE DE LECHE CHIPS- (GELATO)***INGREDIENTS: water, dulce de leche (milk, sugar, dextrose, acidity regulator: sodium carbonate), cream, chocolate (cocoa mass), dextrose, skim milk, sugar, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BACHA DOBLE - Net Wt. 9.9 lbs. Recall # F-0530-2012;
 
26) OLD LABEL: Green Tea (Gelato) is labeled in part: "***KDM***GREEN TEA (GELATO)***" NEW LABEL: Green Tea (Gelato) is labeled in part: "***GREEN TEA - (GELATO) Net Weight 6.6 lbs***Ingredients: water, cream, sugar, skim milk, dextrose, matcha kakko-yo #5, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. Recall # F-0531-2012;
 
27) OLD LABEL: Mint Chips (Gelato) is labeled in part: "***KDM***MINT CHIPS (GELATO)***" NEW LABEL: Mint Chips (Gelato) is labeled in part: "***MINT CHIPS - (GELATO) Net Weight***Ingredients: water, cream, sugar, skim milk, dextrose, peppermint flavor, chocolate (cocoa mass), green color (water, yellow #5, propylene glycol, blue #1, sodium carboxymethylcellulose, citric acid, sodium benzoate), blue color (water, FD&C blue #1, propylene glycol, sodium carboxymethylcellulose, citric acid, sodium benzoate), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0532-2012;
 
28) OLD LABEL: Nocciola (Gelato) is labeled in part: "***KDM***NOCCIOLA (GELATO)***" NEW LABEL: Nocciola (Gelato) is labeled in part: "***NOCCIOLA - (GELATO) Net Weight***Ingredients: water, cream, sugar, skim milk, dextrose, hazelnut paste (hazelnut butter, CONTAINS TREE NUTS), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)****" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA Net Wt. 7.7 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0533-2012;
 
29) OLD LABEL: Oreo Cookie (Gelato) is labeled in part: "***KDM***OREO COOKIE (GELATO)***" NEW LABEL: Oreo Cookie (Gelato) is labeled in part: "***OREO COOKIE - (GELATO) Net Weight***Ingredients: water, cream, sugar, skim milk, dextrose, chocolate cookies [enriched wheat flour (niacin, iron, thiamine, riboflavin, folic acid), sugar, dulce de leche(milk, sugar, dextrose, acidity regulator: sodium carbonate) vegetable, cocoa, shortening (partially hydrogenated soybeanand/or cottonseed oil, citric acid), high fructose corn syrup, salt, corn starch, baking soda, soy lecithin, chocolate liquor, natural flavor], mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locustbeangum (estabilizers***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs BACHA DOBLE - Net Wt. 9.9 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0534-2012;
 
30) OLD LABEL: Peanut Butter(Gelato) is labeled in part: "***KDM***PEANUT BUTTER (GELATO)***" NEW LABEL: Peanut Butter (Gelato) is labeled in part: "***PEANUT BUTTER - (GELATO) Net Weight***Ingredients: water, cream, sugar, skim milk, dextrose, creamy peanut butter (roasted peanut, sugar, hydrogenated vegetable oils (rapeseed, cottonseed and soy bean), salt, molasses), peanut topping (sugar, vegetable oil, cocoa powder, peanut, skimmed milk, emulsifiers INS322, salt, vanilla flavor,) mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. Recall # F-0535-2012;
 
31) OLD LABEL: Pistaccio (Gelato) is labeled in part: "***KDM***PISTACCIO (GELATO)***" NEW LABEL: Pistaccio (Gelato) is labeled in part: "***PISTACCHIO - (GELATO) Net Weight***Ingredients: water, cream, sugar, skim milk, dextrose, pistachios paste (sugar, soy protein, vegetable fat, hazelnuts, almonds, pistachios, skimmed milk powder, cashews, flavors, emulsifier: mono and diglycerides, certified color: tartrazine and indigo carmine, antioxidant: alpha-tocopherol), dextrose, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers), artificial flavor***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0536-2012;
 
32) OLD LABEL: Rum Raisin (Gelato) is labeled in part: "***KDM***RUM RAISIN (GELATO)***" NEW LABEL: Rum Raisin (Gelato) is labeled in part: "***RUM RAISINS - (GELATO)***INGREDIENTS: water, cream, sugar, skim milk, dextrose, yellow 5 and 6 (artificial color), rum flavor, golden raisins, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. Recall # F-0537-2012;
 
33) OLD LABEL: Sky Cream (Gelato) is labeled in part: "***KDM***SKY CREAM (GELATO)***" NEW LABEL: Sky Cream (Gelato) is labeled in part: "***SKY CREAM - (GELATO)***INGREDIENTS: water, cream, sugar, skim milk, dextrose, blue 1 (artificial color), natural vanilla flavor, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. BACHA DOBLE - Net Wt. 9.9 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0538-2012;
 
34) OLD LABEL: Strawberry Chips (Gelato) is labeled in part: "***KDM***STRAWBERRY CHIPS (GELATO)***" NEW LABEL: Strawberry Chips (Gelato) is labeled in part: "***STRAWBERRY CHIPS- (GELATO)***INGREDIENTS: water, skim milk, heavy cream, strawberries, sugar, dextrose, strawberry paste (sugar, strawberries, corn syrup solids, water, natural and artificial flavors, citric acid, carrageenan, FD&C Red #40), chocolate (cocoa mass), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0539-2012;
 
35) OLD LABEL: Strawberry (Gelato) is labeled in part: "***KDM***STRAWBERRY (GELATO)***" NEW LABEL: Strawberry (Gelato) is labeled in part: "***STRAWBERRY- (GELATO)***INGREDIENTS: water, skim milk, heavy cream, strawberries, sugar, dextrose, strawberry paste (sugar, strawberries, corn syrup solids, water, natural and artificial flavors, citric acid, carrageenan, FD&C Red #40), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight 12.1 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BALDE - Net Wt. 12.1 lbs. Recall # F-0540-2012;
 
36) OLD LABEL: Super Sambayon (Gelato) is labeled in part: "***KDM***SUPER SAMBAYON (GELATO)***" NEW LABEL: Super Sambayon (Gelato) is labeled in part: "***SUPER SAMBAYON - (GELATO)***Ingredients: water, cream, sugar, skim milk, marsala wine, egg yolk, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locustbeangum (stabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - 6.6 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0541-2012;
 
37) OLD LABEL: Super Sambayon Chips (Gelato) is labeled in part: "***KDM***SUPER SAMBAYON CHIPS (GELATO)***" NEW LABEL: Super Sambayon Chips (Gelato) is labeled in part: "***SUPER SAMBAYON CHIP- (GELATO)***Ingredients: water, cream, sugar, skim milk, marsala wine, egg yolk, chocolate (cocoa mass) mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locustbeangum (stabilizers)***Net Weight 6.6 lbs***Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. Recall # F-0542-2012;
 
38) OLD LABEL: Swiss Chocolate (Gelato) is labeled in part: "***KDM***SWISS CHOCOLATE (GELATO)***" NEW LABEL: Swiss Chocolate (Gelato) is labeled in part: "***SWISS CHOCOLATE - (GELATO)***INGREDIENTS: water, sugar, cream, skim milk, dextrose, chocolate (cocoa mass), cocoa powder, dulce de leche (milk, sugar, dextrose, acidity regulator: sodium carbonate) , mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Weight 6.6 lbs. BACHA PLANA - Net Wt. 9.9 lbs. Recall # F-0543-2012;
 
39) OLD LABEL: Tiramisu (Gelato) is labeled in part: "***KDM**TIRAMISU (GELATO)***" NEW LABEL: Tiramisu (Gelato) is labeled in part: "***TIRAMISU - (GELATO)*** Net Weight 7.7 lbs***Ingredients: water, cream, sugar, skim milk, dextrose, tiramisu paste(wine, sugar, eggs, glucose syrup, flavors {with caffeine}, vegetable oil {peanuts}, hazelnut, sweetmeat, soya proteins), cocoa powder, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locustbeangum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. Recall # F-0544-2012;
 
40) OLD LABEL: Vanilla Beans (Gelato) is labeled in part: "***KDM**Vanilla Beans (GELATO)***" NEW LABEL: Vanilla Beans (Gelato) is labeled in part: "***VANILLA BEANS - (GELATO)***INGREDIENTS: water, cream, sugar, skim milk, dextrose, yellow 5 and 6 (artificial color), natural vanilla flavor and vanilla bean paste, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. BACHE DOBLE - Net Wt. 9.9 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0545-2012;
 
41) OLD LABEL: White Chocolate(Gelato) is labeled in part: "***KDM**White Chocolate (GELATO)***" NEW LABEL: White Chocolate (Gelato) is labeled in part: "***WHITE CHOCOLATE - (GELATO)***Ingredients: water, cream, sugar, skim milk, dextrose, white chocolate (sugar, cocoa butter, whole milk powder, soy lecithin (an emulsifier), natural vanilla), white chocolate paste (vegetable fat {peanuts}, sugar, skimmed milk powder, cocoa butter, flavors, emulsifier: E471 mono and diglycerides of fatty acids, E322 soya lecithin, antioxidant,: E307 alpha-tocopherol) mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BACHE DOBLE - Net Wt. 9.9 lbs. Recall # F-0546-2012;
 
42) OLD LABEL: Yogurt (Gelato) is labeled in part: "***KDM**YOGURT (GELATO)***" NEW LABEL: Yogurt (Gelato) is labeled in part: "***YOGURT - (GELATO) Net Weight 7.7 lbs***Ingredients: water, cream, sugar, skim milk, dextrose, yogi powder (non fat dry milk, non fat yogurt powder{skimmed milk culture}, natural flavors, citric acid) , mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0547-2012;
 
43) OLD LABEL: Tartufo Chantilly (Gelato) is labeled in part: "***KDM**TARTUFO CHANTILLY (GELATO)***" NEW LABEL: Tartufo Chantilly (Gelato) is labeled in part: "***CHANTILLY - (GELATO TARTUFO)***Ingredients: water, cream, sugar, skim milk, dextrose, natural vanilla flavor, chocolate (cocoa mass), dulce de leche (milk, sugar, dextrose, acidity regulator: sodium carbonate), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locustbeangum (stabilizers)***Net Weight 6 X 0.25 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sixe is 6 X 0.25 lbs. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 6 X 0.25 lbs. Recall # F-0548-2012;
 
44) OLD LABEL: Tartufo D. D. Leche (Gelato) is labeled in part: "***KDM**TARTUFO D. D. LECHE (GELATO)***" NEW LABEL: Tartufo D. D. Leche (Gelato) is labeled in part: "***DULCE DE LECHE(GELATO TARTUFO)***INGREDIENTS: water, dulce de leche (milk, sugar, dextrose, acidity regulator: sodium carbonate), cream,, dextrose, skim milk, sugar, chocolate (cocoa mass), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***" Gelato products are distributed frozen in disposable plastic containers. Unit size is 6 X 0.25 lbs. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt 6 X 0.25 lbs. Recall # F-0549-2012;
 
45) OLD LABEL: Tartufo Chocolate (Gelato) is labeled in part: "***KDM**TARTUFO CHOCOLATE (GELATO)***" NEW LABEL: Tartufo Chocolate (Gelato) is labeled in part: "***CHOCOLATE (GELATO TARTUFO)***INGREDIENTS: water, sugar, cream, skim milk, dextrose, chocolate (cocoa mass), cocoa powder, dulce de leche (milk, sugar, dextrose, acidity regulator: sodium carbonate , mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight 6 X 0.25 lbs***" Tartufo Gelato products are distributed frozen in disposable plastic containers. Unit size is 6 X 0.25 lbs. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 6 X 0.25 lbs. Recall # F-0550-2012;
 
46) OLD LABEL: Tartufo Pistaccio (Gelato) is labeled in part: "***KDM**TARTUFO PISTACHIO (GELATO)***" NEW LABEL: Tartufo Pistachio (Gelato) is labeled in part: "***PISTACHIO (GELATO TARTUFO)***INGREDIENTS: water, cream, sugar, skim milk, dextrose, pistachios paste (sugar, soy protein, vegetable fat, hazelnuts, almonds, pistachios, skimmed milk powder, cashews, flavors, emulsifier: mono and diglycerides, certified color: tartrazine and indigo carmine, antioxidant: alpha-tocopherol), dextrose, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers), artificial flavor, chocolate (cocoa mass)***Net Weight 6 X 0.25 lbs***" Tartufo Gelato products are distributed frozen in disposable plastic containers. Unit size is 6 X 0.25 lbs. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 6 X 0.25 lbs. Recall # F-0551-2012;
 
47) OLD LABEL: Blackberry (Sorbette) is labeled in part: "***KDM***BLACKBERRY (SORBETTE)***" NEW LABEL: Blackberry (Sorbette) is labeled in part: "***BLACKBERRY- (SORBETTE)***INGREDIENTS: water, blackberries, sugar, dextrose,, acidulant: citric acid, blackberry paste (sugar, blackberries, corn syrup solids, citric acid, natural flavors, carrageenan), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***Net Weight 12.1 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BALDE - Net Wt. 12.1 lbs. Recall # F-0552-2012;
 
48) OLD LABEL: Mango (Sorbette) is labeled in part: "***KDM***MANGO (SORBETTE)***" NEW LABEL: Mango (Sorbette) is labeled in part: "***MANGO- (SORBETTE) INGREDIENTS: water, mangoes, sugar, dextrose, acidulant: citric acid, mango paste (glucose syrup, mango pulp, sugar, acidifier{E330 citric acid}, stabilizer {E440i pectin},flavors, certified color {E 160a beta-carotene}, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0553-2012;
 
49) OLD LABEL: Kiwi(Sorbette) is labeled in part: "***KDM***KIWI (SORBETTE)***" NEW LABEL: Kiwi (Sorbette) is labeled in part: "***KIWI- (SORBETTE) INGREDIENTS: water, kiwis, sugar, dextrose, kiwi paste (sugar, kiwis, corn syrup solids, natural and artificial flavors, citric acid, carrageenan, FD&C yellow #5 and FD&C blue #1), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***Net Weight 12.1 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BALDE - Net Wt. 12.1 lbs. Recall # F-0554-2012;
 
50) OLD LABEL: Lemon (Sorbette) is labeled in part: "***KDM***LEMON (SORBETTE)***" NEW LABEL: Lemon (Sorbette) is labeled in part: "***LEMON- (SORBETTE) INGREDIENTS: water, sugar, dextrose, skim milk, lemon paste (dextrose, citric acid, lemon juice, mono and diglycerides of fatty acids, guar gum, modified vegetable gum, natural and artificial flavors, dehydrated glucose syrup, soy protein), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0555-2012;
 
51) OLD LABEL: Passion Fruit (Sorbette) is labeled in part: "***KDM***PASSION FRUIT (SORBETTE)***" NEW LABEL: Passion Fruit (Sorbette) is labeled in part: "***PASSION FRUIT- (SORBETTE)***INGREDIENTS: water, passion fruits, sugar, dextrose, passion fruit paste (sugar, passion fruit juice, natural flavors, citric acid, stabilizer pectin, colour E160a{Beta-carotene}), yellow coloring (water, FD&C Yellow #5, propylene glycol FD&C Yellow #6, sodium carboxymethylcellulose, FD&C Red #40, citric acid and sodium benzoate), red coloring (Water, FD&C Red #40, propylene glycol, FD&C Red #3, citric acid and propyl paraben), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)*** Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0556-2012;
 
52) OLD LABEL: Pear (Sorbette) is labeled in part: "***KDM***PEAR (SORBETTE)***" NEW LABEL: Pear (Sorbette) is labeled in part: "***PEAR- (SORBETTE) INGREDIENTS: water, pears, sugar, dextrose, acidulant: citric acid, pear paste (sugar, pears, corn syrup solids, natural and artificial flavors, citric acid, water, carrageenan), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***Net Weight 6.6 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. Recall # F-0557-2012;
 
53) OLD LABEL: Pineapple (Sorbette) is labeled in part: "***KDM***PINEAPPLE (SORBETTE)***" NEW LABEL: Pineapple (Sorbette) is labeled in part: "***PINEAPPLE- (SORBETTE)***INGREDIENTS: water, pineapples, sugar, dextrose,, acidulant: citric acid, pineapple paste (sugar, pineapples, corn syrup solids, natural flavors, citric acid, carrageenan, fd&c yellow #5), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0558-2012;
 
54) OLD LABEL: Raspberry (Sorbette) is labeled in part: "***KDM***RASPBERRY (SORBETTE)***" NEW LABEL: Raspberry (Sorbette) is labeled in part: "***RASPBERRY- (SORBETTE) ***INGREDIENTS: water, raspberries, sugar, dextrose, , acidulant: citric acid, raspberry paste (sugar, raspberries, corn syrup solids, natural and artificial flavors, water, citric acid, carrageenan, FD&C red #40 and FD&C blue #1), mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0559-2012;
 
55) OLD LABEL: Nocciola w/Chocolate is labeled in part: "***NOCCIOLA C/ CHOCOLATE (GELATO)***" NEW LABEL: Nocciola w/Chocolate is labeled in part: "***NOCCIOLA W/ CHOCOLATE- (GELATO)***Net Weight 7.7 lbs***Ingredients: water, cream, sugar, skim milk, dextrose, hazelnut paste (hazelnut butter, CONTAINS TREE NUTS), mono and diglycerides (emulsifier), chocolate (cocoa mass), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers).***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA ALTA - Net Wt. 7.7 lbs. Recall # F-0560-2012;
 
56) OLD LABEL: Super Dulce de Leche is labeled in part: "***KDM***SUPER DULCE DE LECHE***(GELATO)***" NEW LABEL: Super Dulce de Leche is labeled in part: "***SUPER DULCE DE LECHE - (GELATO)***INGREDIENTS: water, SUPER DULCE DE LECHE (milk, sugar, dextrose, acidity regulator: sodium carbonate), cream,, dextrose, skim milk, sugar, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight 6.6 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA PLANA - Net Wt. 6.6 lbs. Recall # F-0561-2012;
 
57) OLD LABEL: Strawberry Sorbette is labeled in part: "***KDM STRAWBERRY (SORBETTE)***". NEW LABEL: Strawberry Sorbette is labeled in part: "***STRAWBERRY- (SORBETTE)***INGREDIENTS: water, strawberries, sugar, dextrose, strawberry paste (sugar, strawberries, corn syrup solids, water, natural and artificial flavors, citric acid, carrageenan, FD&C Red #40), acidulant: citric acid, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***". Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BACHA - Net Wt. 6.6 lbs. BALDE - Net Wt. 12.1 lbs. Recall # F-0562-2012;
 
58) OLD LABEL: Orange Sorbette is labeled in part: "***KDM ORANGE (SORBETTE)***" NEW LABEL: Orange Sorbette is labeled in Part: "***ORANGE- (SORBETTE) INGREDIENTS: water, orange juice, orange extract, sugar, dextrose, acidulant: citric acid, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers)***Net Weight 12.1 lbs***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BALDE - Net Wt. 12.1 lbs. Recall # F-0563-2012;
 
59) OLD LABEL: Strawberry Gelato Mix is labeled in part: "***STRAWBERRY MIX***" NEW LABEL: Strawberry Gelato Mix is labeled in Part: "***STRAWBERRY MIX - (GELATO)***Net Weight 12.1 lbs***Ingredients: water, cream, skim milk, strawberry, fruit base (fructose, acidifier: E330, citric acid, starch, stabilizer: E412, guar gum, emulsifier,: E471 mono and diglycerides of fatty acids, E472b lactic acid, esters diglycerides of fatty acids, E477 propane 1,2 diolesters of fatty acids, lactose, sodium, caseinate.)***" Gelato products are distributed frozen in disposable plastic containers. Unit sizes are 7 lb pan liners and 2 gal buckets. Products were not labeled with any product codes or lot numbers. BALDE - Net Wt. 12.1 lbs. Recall # F-0564-2012;
 
60) OLD LABEL: Dulce de Leche Mix is labeled in part: "***KMD DULCE DE LECHE (MIX)***" NEW LABEL: Dulce de Leche Mix is labeled in part: "***DULCE DE LECHE - (MIX)***INGREDIENTS: water, dulce de leche (milk, sugar, dextrose, acidity regulator: sodium carbonate), cream,, dextrose, skim milk, sugar, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (estabilizers)***Net Weight 12.1 lbs***" Products were not labeled with any product codes or lot numbers. This is a 12.1 lb bucket of the Dulce de Leche Mix (Liquid). Recall # F-0565-2012;
 
61) OLD LABEL: Capaccuino Mix is labeled in part: "***KMD Capaccuino (MIX)***" NEW LABEL: Capaccuino Mix is labeled in part: "***CAPACCUINO MIX - (GELATO)***Net Weight 12.1 lbs***Ingredients: water, cream, sugar, skim milk, dextrose, coffee powder, mono and diglycerides (emulsifier), sodium carboxymethylcellulose, guar gum and locust bean gum (stabilizers) ***" Products were not labeled with any product codes or lot numbers. This is a 12.1 lb bucket of the Capaccuino Mix (Liquid). Recall # F-0566-2012
CODE
All unused products distributed August 1, 2011 through October 27 2011.
RECALLING FIRM/MANUFACTURER
TF Manufacturing Corp., North Miami Beach, FL, by letter dated November 1, 2011 and by telephone. FDA initiated recall is ongoing.
REASON
Inadequate labeling: No net weight, manufacturer information, or declaration of artificial colors or milk, soy, egg, and/or tree nut allergens were listed on the labeling. The Dolce Vita Gelato products include all varieties and flavors of gelato, tartufo gelato, and sorbettes.
VOLUME OF PRODUCT IN COMMERCE
6,477 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Lavender Sea Salt Caramels - 3 oz., in clear, acetate packaging, with a stick-on label. The labels have changed since the recall in 12/2010 as the ingredient statement has been corrected. The current label, similar to the old label, reads in part, "Lillie Belle Farms Ingredients: sugar, corn syrup, organic chocolate (organic cocoa mass, organic cocoa liquor, organic sugar, organic vanilla, organic soy lecithin) cream (milk) lavender flowers butter (milk), sea salt. Allergy Information. This product is made in a facility that uses nuts, dairy (milk) and soy products. Recall # F-0572-2012
CODE
Lot #: 50611
RECALLING FIRM/MANUFACTURER
JJBL LLC, Central Point, Or, by telephone on December 8, 2010. Oregon initiated recall is complete.
REASON
Milk was not declared as a sub-ingredient in the butter or cream on the labels for Lavender Sea Salt Caramels.
VOLUME OF PRODUCT IN COMMERCE
16 - 3 ounce units
DISTRIBUTION
WA
___________________________________
PRODUCT
Quaker Chewy Granola Bars, Chocolate Chip Flavor; 18 - 0.84 OZ (24 g) Bars per Net Wt 15.2 OZ (432 g) box, 12 boxes per case; UPC 0 30000 45017 8, Recall # F-0573-2012
CODE
Best Before MAR 24 12 BW 1 1255
RECALLING FIRM/MANUFACTURER
Recalling Firm: Quaker Foods and Snacks North America, Chicago, IL, by press release on November 11, 2011.
Manufacturer: Hearthside Food Solutions, LLC, Kentwood, MI. Firm initiated recall is ongoing.
REASON
Product mis-packed: The cartons actually contained properly labeled Peanut Butter Granola Bars, Oatmeal Raisin Granola Bars and Dark Chocolate Cherry Granola Bars, six of each of the three flavors.
VOLUME OF PRODUCT IN COMMERCE
18 cases
DISTRIBUTION
NH, MA
___________________________________
PRODUCT
Tejava, Premium Iced Tea Handpicked, Micro brewed; Unsweetened. 12 Fl oz. 355 ML. Sold in packages of 4 x 12 oz bottles. UPC code - label: 6 54871 00901 5; UPC code 4 pack: 6 54871 04901 1; UPC cod 6/4 pack tray: 1 06 54871 24901 2. Recall # F-0578-2012
CODE
Units: 1BT220; 1BT221, 1BT222, 1BT223, 1BT252, 1BT253, 1BT245, 1BT255, 1BT277, 1BT278, 1BT279, 1BT280 1BT313
RECALLING FIRM/MANUFACTURER
Recalling Firm: Crystal Geyser Water Co., San Francisco, CA, by telephone on December 8, 2011 and by press release on December 9, 2011.
Manufacturer: Crystal Geyser Water Co., Bakersfield, CA. Firm initiated recall is ongoing.
REASON
Crystal Geyser received complaints of glass fragments in their 12 oz. Tejava and is recalling production runs from August 9 to November 9, 2011.
VOLUME OF PRODUCT IN COMMERCE
62,182 cases
DISTRIBUTION
CO, AZ, CA, NV, TX, IA, OR, HI, IL, IN, WA, MI, PA
 
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
 
RECALLS PENDING CLASSIFICATION: DRUGS
____________________________________________________
PRODUCT
Fluoxetine Capsules USP, 20 mg, 100-count capsules per bottle, Rx only, Sandoz Inc., Princeton, NJ 08540, NDC 0781-2822-01.
CODE
Lot BU9661, Exp 06/14
RECALLING FIRM/MANUFACTURER
Recalling/Manufacturing Firm: Sandoz Incorporated, Broomfield, CO
REASON FOR RECALL
CGMP Deviations: The batch was not manufactured utilizing Good Manufacturing Processes.
___________________________________________________
PRODUCT
1.      Excedrin Extra Strength (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) caplets, 100-count caplets per bottle, Dist. by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-2000-91, UPC 3 0067-2000-91 0.
2.      Excedrin Migraine (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) caplets, 250-count caplets per bottle, Dist. by Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-2039-07, UPC 3 0067-2039-07 1.
CODE
1.      Lot 10068948, Exp 03/12.
2.      Lot 10084053, Exp 12/12.
RECALLING FIRM/MANUFACTURER
Recalling/Manufacturing Firm: Novartis Consumer Health, Lincoln, NE
REASON FOR RECALL
Adulterated Presence of Foreign Tablets: Foreign tablets contained in bottles.
______________________________________________________________
PRODUCT
1.      Excedrin Tension Headache Caplets packaged in 250-ct. btls (NDC 0067204507), 125-ct. btls (NDC 0067204584) and 100-ct. btls (NDC 0067204591), each caplet contains 500 mg. acetaminophen and 65 mg. caffeine. Dist. by: Novartis Consumer Health, Inc., Parsippany, NJ
2.      Excedrin Extra Strength Tablets, packaged in 100-ct. btls (NDC 0067203091), 250-ct. btls (NDC 0067203077), and 300-ct. btls (NDC 0067203033), AND Excedrin Extra Strength Caplets, packaged in 24-ct. btls (NDC 0067200024), each tablet or caplet contains 250 mg. acetaminophen, 250 mg. aspirin, and 65 mg. caffeine. Dist. by: Novartis Consumer Health, Inc., Parsippany, NJ.
3.      Excedrin, Extra Strength, Acetominophen, Aspirin (NSAID), and Caffeine, Pain Reliever/Pain Reliever Aid, Express Gels, 80 Gelcaps, NDC 0067627094, Dist. by: Novartis Consumer Health, Inc., Parsippany, NJ.
4.      Excedrin Migraine Caplets, packaged in 24-ct. btls (NDC 0067203924) and 250-ct. btls (NDC 0067203777), each caplet contains 250-mg. acetaminophen, 250-mg. aspirin, and 65-mg. caffeine. Dist. by Novartis Consumer Health, Inc., Parsippany, NJ.
CODE
1.      250-ct - Lot #10063947, Exp. 11/30/2011; 125-ct - Lot #10089902, Exp. 4/30/2013; 100-ct - Lot #10087530, Exp. 3/31/2013.
2.      24-ct caplets - Lot #10085080, Exp. 1/31/2013; 100-ct tablets - Lot #10091817, Exp. 5/31/2013; 250-ct tablets - Lot #10092843, Exp. 6/30/2013; and 300-ct tablets - Lot #10073080, Exp. 6/30/2012
3.      Lot #10089353, Exp. 04/30/12.
4.      24 ct. - Lot #10074660, Exp. 7/31/2012; #10066070, Exp. 1/31/2012; #10066069, Exp. 1/31/2012; #10101757, Exp. 10/31/2013; and #10102541, Exp. 11/30/2013; and 250-ct. - Lot #10092845, Exp. 6/30/2013 and #10086758, Exp. 2/28/2013.
RECALLING FIRM/MANUFACTURER
Recalling/Manufacturing Firm: Novartis Consumer Health, Lincoln, NE
REASON FOR RECALL
Adulterated Presence of Foreign Tablets: Foreign tablets contained in bottles.
_________________________________________________________
PRODUCT
Acetylcysteine Solution, USP 20%, 200mg/mL, 30mL vials, Rx, NDC 0054-3026-02
CODE
Lot 1877093, Item 0233-53-1877093, Exp 06/30/2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ben Venue Laboratories, Inc., Bedford, OH
Manufacturer: Ben Venue Laboratories, Bedford, OH
REASON FOR RECALL
Presence of Foreign Substance; glass particles identified during review of retain samples.
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
___________________________________
PRODUCT
1) Plak-Vac Oral Care System, Memorial Hospital q2 Oral Care Kit, containing 4 - 0.5 oz. Pack Mint Mouthwash (1.5% Hydrogen Peroxide), 6 - 0.5 oz. Pack Mint CPC Mouthwash (.05% Cetylpyridinium Chloride), 12 - 2 gm. Tube Mouth Moisturizer, 2 - 1 oz. Medicine Cup, 12 - Foam Applicator Swabs, 10 - Suction Swabs, 4 - Non-Sterile 18 Fr. Suction Catheters, 1 - Yankauer Suction Instrument, 1 - Plak-Vac Storage Holder, 1 - Tubing Clamp, 1 - "Y" Connector, and 1 - Vent Bundle Checklist, Order No. 2381. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. Recall # D-1159-2012;
 
2) Plak-Vac Oral Care System, St. John's Mercy Medical Center q2 Oral Care Kit, containing 6 - 0.34 oz. Pack Mint Mouthwash (1.5% Hydrogen Peroxide), 6 - 0.5 oz. Pack Mint CPC Mouthwash (.05% Cetylpyridinium Chloride), 12 - 2 gm. Tube Mouth Moisturizer, 1 - 0.6 oz. Tube Fluoride Mint Toothpaste, 12 - Foam Applicator Swabs, 22 - Suction Swabs, 1 - Yankauer Suction Instrument, 1 - Plak-Vac Storage Holder, and 1 - Plak-Vac Suction Toothbrush, Order No. 2330-A. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. Recall # D-1160-2012;
 
3) Plak-Vac Oral Care System, Swedish Covenant Hospital, Non-Trach/Vent Oral Care Kit, containing 2 - 0.34 oz. Pack Mint Mouthwash (1.5% Hydrogen Peroxide), 2 - 0.5 oz. Pack Mint CPC Mouthwash (.05% Cetylpyridinium Chloride), 4 - 2 gm. Tube Mouth Moisturizer, 1 - 0.6 oz. Tube Fluoride Mint Toothpaste, 8 - Foam Applicator Swabs, 4 - Suction Swabs, 1 - Plak-Vac Suction Toothbrush, 1 - Plak-Vac Storage Holder, and 1 - Yankauer Suction Instrument, Order No. 2358. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. Recall # D-1161-2012;
 
4) Plak-Vac Oral Care System, Swedish Covenant Hospital q4 Oral Care Kit, containing 4 Suction Swab, 12 Applicator Swab, 6 Mouth Moisturizer, 1 Yankauer Suction Instrument, 1 Plak-Vac Suction Toothbrush, 4 Mouthwash (H2O2), 2 Mouthwash (CPC), 1 Toothpaste, 2 Suction Catheter, and 1 Plak-Vac Storage Holder, Order No. 2329. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. Recall # D-1162-2012;
 
5) Plak-Vac Oral Care System, Des Peres Hospital q4 Oral Care Kit, containing 4 - 0.5 oz. Pack Mint Mouthwash (1.5% Hydrogen Peroxide), 2 - 0.5 oz. Pack Mint CPC Mouthwash (.05% Cetylpyridinium Chloride), 6 - 2 gm. Tube Mouth Moisturizer, 1 - 0.6 oz. Tube Fluoride Mint Toothpaste, 6 - Foam Applicator Swabs, 4 - Suction Swabs, 2 - Non-Sterile 18 Fr. Suction Catheters, 1 - Yankauer Suction Instrument, and 1 - Plak-Vac Storage Holder, Order No. 2336. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. Recall # D-1163-2012;
 
6) Plak-Vac Oral Care System, University of Tennessee Medical Center q4 Oral Care Kit, containing 3 - 0.34 oz. Pack Mint Mouthwash (1.5% Hydrogen Peroxide), 3 - 0.5 oz. Pack Mint CPC Mouthwash (0.5% Cetylpyridinium Chloride), 6 - 2 gm. Tube Mouth Moisturizer, 1 - 0.6 oz. Tube Fluoride Mint Toothpaste, 6 - Foam Applicator Swabs, 4 - Suction Swabs, 2 - Non-Sterile 18 Fr. Suction Catheters, 1 - Yankauer Suction Instrument, 1 - Plak-Vac Storage Holder, 1 - Sani-Stor Yankauer Storage Holder, and 1 - Plak-Vac Suction Toothbrush, Order No. 2460. The recalled component is a foil packet labeled as: Plak-Vac Oral Care System Mouthwash, Ingredients: Purified Water, Glycerin, Polysorbate 80, Polysorbate 20, Flavor, Cetyl Pyridinium Chloride, Sodium Saccharin, FD & C Blue #1, Fill 15 mL. Recall # D-1164-2012
CODE
1) Kit Lot #: 101011; Mouthwash Lot # 13068;
2) Kit Lot #: 082611, 090611, 091211, 091411, 091611, 092611, and 092911; Mouthwash Lot # 13068;
3) Kit Lot #: 092711, 0390016-090711, and 0390077-090811; Mouthwash Lot # 13068;
4) Kit Lot #: 0390016-090711 and 0390963-101111; Mouthwash Lot # 13068;
5) Kit Lot #: 389839; Mouthwash Lot # 13068;
6) Kit Lot #: 092211; Mouthwash Lot # 13068
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trademark Medical LLC, Ballwin, MO, by telephone or e-mail on October 25, 2011 and letters dated October 27, 2011.
Manufacturers: Care Line Inc., Greenbrier, TN;
Birchwood Laboratories, Inc., Eden Prairie, MN. Firm initiated recall is complete.
REASON
Microbial Contamination of Non-Sterile Products: The mouthwash component of the kit was found to be contaminated with Burkholderia cepacia.
VOLUME OF PRODUCT IN COMMERCE
2,200 kits
DISTRIBUTION
IL, MO, KY, and TN
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Ovcon 50 (Norethindrone and ethinyl estradiol ) Tablets, 1 mg/50 mcg, USP, NDC #0430-0585-45, (Trade) NDC #04300585-95 (Sample). Recall # D-1166-2012
CODE
Units: 02260F, 504705A, 504705B (Sample)
RECALLING FIRM/MANUFACTURER
Warner Chilcott Company LLC, Fajardo, PR, by letter dated December 30, 2011. FDA initiated recall is ongoing.
REASON
Subpotent (Multiple Ingredient Drug)
VOLUME OF PRODUCT IN COMMERCE
23,364 blisters
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
1) Maalox Advanced Maximum Strength Antacid & Anti-gas, each teaspoonful contains 400 mg aluminum hydroxide (equiv. to dried gel, USP), 400 mg magnesium hydroxide, and 40 mg simethicone, Cherry Flavored Liquid packaged in 12-fl. oz. bottles, NDC 0067-6280-12. Recall # D-1147-2012;
 
2) Premium Liquid Maalox Nighttime, Antacid with Acid Reflux Barrier, Mint, each teaspoonful contains 300-mg calcium carbonate, 125-mg magnesium carbonate, and 275-mg sodium alginate, packaged in 350-mL bottles, --- NPN 02248635. Recall # D-1148-2012;
 
3) Extra Strength Stomak-Care Multi Action, Bismuth Subsalicylate Suspension, Peppermint, contains 35 mg/mL bismuth subsalicylate, packaged in 350-ml. bottles, --- DIN 02262363. Recall # D-1149-2012;
 
4) Buckley's Complete, each teaspoonful contains 325-mg acetaminophen and 20-mg menthol, packaged in 150- and 250-ml. bottles --- DIN 02279703. Recall # D-1150-2012
CODE
1) Lot 10105720, Exp. Feb 2013;
2) Lot 10113253, Exp. Apr 2013;
3) Lot 10106536, Exp. Mar 2013;
4) 150 ml - Lot 10112301, Exp. Apr 2013 and 10107573, Exp. Jan 2013; 250-ml - Lot 10106138, Exp. Apr 2013; 10105856, Exp. Jan 2013, and 10105855, Exp. Jan 2013
RECALLING FIRM/MANUFACTURER
Novartis Consumer Health, Lincoln, NB, by letters dated September 12, 2011 and September 13, 2011. Firm initiated recall is ongoing. 
REASON
Presence of Foreign Substance; a small amount of non-USP water leaked into the batches due to a seal breach on a pump.
VOLUME OF PRODUCT IN COMMERCE
40,620/350-mL bottles, 83,292/250-mL bottles, 91,656/150-mL bottles, and 200,508/12-fl. oz. bottles
DISTRIBUTION
Nationwide, and Canada
___________________________________
PRODUCT
1) Ondansetron Hydrochloride Tablets, 4 mg, 1 Card x 3 Tablets per carton, Rx only, NDC 0093-0233-33. Recall # D-1151-2012;
 
2) Ondansetron Hydrochloride Tablets, 8 mg, 1 Card x 3 Tablets per carton, Rx only, NDC 0093-7236-33. Recall # D-1152-2012
CODE
1) Lot # Y04033, Exp 12/12;
2) Lot # Y05037, Exp 05/13
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letteron October 28, 2011. 
Manufacturer: Teva Pharmaceutical Industries, Jerusalem, Israel. Firm initiated recall is ongoing.
REASON
Labeling: Incorrect or Missing Package Insert: Packages contain out-dated product inserts.
VOLUME OF PRODUCT IN COMMERCE
3,732 cartons
DISTRIBUTION
Nationwide 
___________________________________
PRODUCT
1) Hemorrhoidal Pads (witch hazel 50%), 100-count Pads per jar, labeled Best Choice Health Care, UPC 0-70038-5925. Recall # D-1153-2012;
 
2) Pre-Moistened Hemorrhoidal/Vaginal Pads (witch hazel 50%), 100-count Pads per jar, labeled BI-MART, UPC 0-71357-00724. Recall # D-1154-2012;
 
3) Hygenic cleansing Medicated Pads (witch hazel 50%), 100-count pads per jar, labeled Publix, UPC 0-41415-25573-9. Recall # D-1155-2012;
 
4) Hygienic Cleansing medicated pads, 100-count pads per jar, labeled Shopko, UPC 4-00031-80411-8. Recall # D-1156-2012;
 
5) Cleansing Pads (witch hazel 50%),100-count Pads per jar, labeled TopCare, UPC 0-36800-06868-1. Recall # D-1157-2012;
 
6) Medicated Pads (witch hazel 50%), 100-count Pre-Moistened Hemorrhoidal/Vaginal Pads per jar, labeled Western Family, UPC 0-15400-06166-7. Recall # D-1158-2012
CODE
1) Lot 030810017, Exp 12/13;
2) Lot 0308100017, Exp 12/13;
3) Lot 0308100005, Exp 03/13;
4) Lot 030810005, Exp 03/13; Lot 030810017, Exp 12/13;
5) Lot 030810003, Exp 03/13;
6) Lot 030810017, Exp 12/13
RECALLING FIRM/MANUFACTURER
G & W Laboratories Inc., South Plainfield, NJ, by letters dated August 22, 2011. Firm initiated recall is ongoing. 
REASON
Stability Data Does Not Support Exp: Three lots failed to meet specifications for alcohol content through the expiration date.
VOLUME OF PRODUCT IN COMMERCE
28,248 jars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Ciclopirox Gel, 0.77%, 45 gram tube, Rx Only, UPC 3 0574-2061-45 7, NDC # 0574-2061-45. Recall # D-1165-2012
CODE
Lot #: 2010433330, Exp. 10/12; 2011155328, Exp. 04/13
RECALLING FIRM/MANUFACTURER
Paddock Laboratories, Inc., Minneapolis, MN, by letter dated December 16, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Two lots did not conform to product specifications for an unspecified impurity at the 9 month stability test station.
VOLUME OF PRODUCT IN COMMERCE
24,664 Tubes
DISTRIBUTION
Nationwide and Puerto Rico
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
___________________________________
PRODUCT
Source Plasma. Recall # B-0216-12
CODE
Units: 07KINF3436, 07KINF5486, 07KINF6442, 07KINF6927, 07KINF7851, 08KINA1752, 08KINA3645, 08KINA4233, 08KINA4920, 08KINB0194, 08KINB0669, 08KINB2027, 08KINB2573, 08KINB3415, 08KINB3697, 09KINA6864, 09KINA7406, 09KINA8424, 09KINB0489, 09KINB1076, 09KINB1907, 09KINB2500, 09KINB3375, 09KINB4335, 09KINB5012, 09KINB5897, 09KINB6857, 09KINB7567, 09KINB5820, 09KINC3232, 09KINC3617, 09KINC5027, 09KINC6038, 09KINC7881, 09KINC8444, 09KINC9495, 07KIND5142, 07KIND6161, 07KIND6664, 07KINF8412, 07KING8746, 07KING9889, 08KINA9032, 08KINA9411, 08KINB4643, 08KINB5084, 08KINB5900, 08KINB6666, 08KINB7146, 08KINB7974, 08KINB9035, 08KINB9431, 08KINC0207, 08KINC1647, 08KINC3255, 08KINC3865, 08KINC4764, 08KINC5901, 08KINC6222, 08KINC7377, 08KINC8171, 08KINC8894, 08KINC9322, 08KIND1033, 08KIND1524, 08KIND2226, 08KIND2580, 08KIND3360, 08KIND3984, 08KIND4845, 08KIND5427, 08KIND6129, 08KIND6882, 08KIND8385, 08KIND8999, 08KINE0275, 08KINE0930, 08KINE2158, 08KINE2600, 08KINE3466, 08KINE3834, 08KINE4644, 08KINE6074, 08KINE6810, 08KINE7555, 08KINE8307, 08KINE8892, 08KINE9794, 08KINF0222, 08KINF1066, 08KINF1543, 08KINF2186, 08KINF2773, 08KINF8614, 08KINF9750, 08KING0123, 08KING1511, 08KING1696, 08KING3079, 08KING4351, 09KINA0934, 09KINA1632, 09KINA2281, 09KINA3014, 09KINA5513, 09KINA6020, 08KINA1333
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, by fax on April 8, 2010.
Manufacturer: BioLife Plasma Services L.P., Kokomo, IN. 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
107 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0218-12;
2) Red Blood Cells. Recall # B-0219-12;
3) Red Blood Cells Leukocytes Reduced. Recall # B-0220-12;
4) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0221-12
CODE
1) Unit: W141607086940;
2) Unit: W141607134612;
3) Unit: W141607132693;
4)Units: W141607982838; W141607083042
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center, Seattle, WA, by fax on August 29, 2007 and letter dated September 11, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to an area possibly endemic for malarial, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0222-12
CODE
Unit: 239659474
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems Inc., Scottsdale, AZ., by telephone on September 25, 2007.
Manufacturer: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MT
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0229-12
CODE
Units: 7086090 (1); 7086090 (2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: New York Blood Center, inc-cellular Therapy Laboratory, New York, NY, by fax on May 1, 2007.
Manufacturer: New York Blood Center, Inc., Westbury, NY. Firm initiated recall is complete.
REASON
Blood products, possibly contaminated with Bacillus sp., were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0352-12;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0353-12
CODE
1) and 2) Unit: 9324820
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by telephone and fax on November 1, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Azulfidine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0355-12
CODE
Unit:06LZ12731
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by e-mail and letter dated December 13, 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
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0356-12;
2) Plasma Frozen. Recall # B-0357-12
CODE
1) and 2) Unit: 06GN76586
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letter dated January 25, 2007. 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
1) Red Blood Cells Leukocytes Reduced. Recall # B-0372-12;
 
2) AS-3 Red Blood Cells Leukocytes Reduced Adenine-Saline Added. Recall # B-0373-12
CODE
1) Units: 032FT28488; 032GC74141; 032GC74437; 032GC74608; 032GJ05008; 032GJ05112; 032GN89985; 032GN90057; 032GN90078; 032GN90094; 032GN90187; 032GN90272; 032GN90295; 032GN90297; 032GN90301; 032GN90313; 032GN90638; 032GN90075; 032GN90729; 032GN90881;
 
2) Units: 032GH14473, 032GH14473
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Madison, WI, by fax on August 24, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from donors, whose suitability to donate were not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
WI, IL, TN, GA. SC, PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0374-12
CODE
Unit: 06GJ95801
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letter November 8, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0384-12
CODE
Units: 4600077917; 4600077652; 4600077230; 4600076138; 4600075737; 4600075018; 4600074069; 4600073360; 4600072669; 4600072269; 4600070307; 4600070047; 4600069629; 4600068193; 4600067940; 4600067520; 4600067284; 4600071417; 4600064724; 4600058109; 4600057841; 4600057445; 4600057165; 4600056686; 4600056424; 4600055979; 4600055686; 4600055166; 4600054910; 4600054353
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Salt Lake City, UT, by facsimile on September 3, 2010. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose scheduled physical examination was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
30 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0385-12
CODE
Unit: 06FS06803
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on January 24, 2007 and letter on April 6, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0387-12;
2) Recovered Plasma. Recall # B-0388-12
CODE
1) Units: 8324252, 8322169, 8326106;
2) Units: 8326106, 8324252, 8322169, 6399450, 6396748
RECALLING FIRM/MANUFACTURER
Recalling Firm: Northern California Community Blood Bank, Eureka, CA, by fax on November 21, 2005.
Manufacturer: Central California Blood Center, Fresno, CA. Firm initiated recall is complete.
REASON
Blood products, for which viral testing was performed using an invalid sample, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
CA, FL, Austria
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0395-12
CODE
Unit: W141608190893
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by fax on February 25, 2008. 
Manufacturer: Puget Sound Blood Center and Program, Silverdale, WA. 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
WA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0396-12
CODE
Unit: W141606001436
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center, Seattle, WA, by electronic mail March 21, 2008. 
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. 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
Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0397-12
CODE
Unit: W141608391566
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by fax on March 18, 2008. 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
WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0398-12
CODE
Unit: 2705404
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by fax on March 7, 2008. 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
AK
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0399-12
CODE
Unit: 20FE04714
RECALLING FIRM/MANUFACTURER
American National Red Cross, Lewis and Clark Region, Salt Lake City, UT, by fax February 19, 2008.   
Manufacturer: American National Red Cross, Missoula, MT. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who lived in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MT
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0400-12
CODE
Unit: V71842
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by electronic mail on March 17, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0401-12
CODE
Units: 40FP39865 - part 1, 40FP39865 - part 2, 40FP39875 - part 1, 40FP39875 - part 2, 40FP39879 - part 1, 40FP39879 - part 2, 40FP39879 - part 3, 40FP39884 - part 3, 40FP39889 - part 1, 40FP39889 - part 2, 40FP39889 - part 3, 40FP39893 - part 1, 40FP39893 - part 2, 40FP39893 - part 3
RECALLING FIRM/MANUFACTURER
American National Red Cross Heart of America Region, Peoria, IL, by fax on June 15 & 16, 2011. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
IL, MO
___________________________________
PRODUCT
Flow PRA Class I Positive Control Serum. Recall # B-0486-12
CODE
Lot Numbers: 7.1
RECALLING FIRM/MANUFACTURER
One Lambda Inc., Canoga Park, CA, by letters dated June 10, 2009. Firm initiated recall is complete.
REASON
Flow Class I and II Positive Control Serums, with incomplete or positive infectious disease testing, as required for human source components for use in vitro diagnostic products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8,147 Units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0313-12
CODE
Units: 20FM47523, 20FM47524, 20FM47525, 20FM47526, 20FM47527, 20FM47528, 20FM47529, 20FM47530, 20FM47531, 20FM47533, 20FM57534, 20FM47535, 20FM47536, 20FM47537, 20FM47538, 20FM47539, 20FM47540, 20FM47541, 20FM47542, 20FM47543, 20FM47544, 20FM47545, 20FM47546, 20FM47547, 20FM47548, 20FM47550, 20FM47551, 20FM47552, 20FM47553, 20FM47555, 20FM47556, 20LN91806, 20LN91807, 20LN91808, 20LN91809, 20LN91810, 20LN91811, 20LN91812, 20LN91813, 20LN91814, 20LN91815, 20LN91816, 20LN91818, 20LN91819, 20LN91820, 20LN91822, 20LN91823, 20LN91824, 20LN91825, 20LN91826, 20LN91827, 20LN91828, 20LN91829, 20LN91830, 20LN91831, 20LN91832, 20LN91833, 20LN91834, 20LN91835, 20LN91837, 20LN91838, 20LN91839, 20LN91840, 20LN91841, 20LN91843, 20LN91844, 20LN91846, 20LN91847, 20LN91848, 20LN91849, 20LN91850, 20LN91851, 20LN91853, 20LN91854, 20LN91855, 20LN91856, 20LN91858, 20LN91859, 20LN91860, 20LN91861, 20LN91862, 20LN91863, 20LN91864, 20LN91865, 20LN91866, 20LN91867, 20LN91869, 20LN91871, 20LN91872, 20LN91873, 20LN91874, 20LN91875, 20LN91876, 20LN91877
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by telephone beginning February 19, 2007 and by facsimile on March 20, 2007. Firm initiated recall is complete.
REASON
Blood products, manufactured from Whole Blood, which may have been exposed to unacceptable temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
94 units
DISTRIBUTION
CA, ID, MT, UT, WA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0325-12
CODE
Unit: 9964888
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by telephone and fax on October 29, 2007. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire amount of red cell preservative solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0342-12
CODE
Units: 3300037479, 3300037481, 3300037476, 3300037490, 3300037492, 3300037494, 3300037502, 3300037516, 3300037533, 3300037557, 3300037571, 3300037570, and 3300037574
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Saginaw, MI, by fax on March 26, 2009. Firm initiated recall is complete.
REASON
Blood products, exposed to unacceptable storage temperatures and not relabeled as Source Plasma, Salvaged, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0354-12
CODE
Unit:06LZ12731
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by e-mail and letter dated December 13, 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
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0371-12
CODE
Unit: FN24282
RECALLING FIRM/MANUFACTURER
Sacramento Medical Foundation, Sacramento, CA, by telephone on June 14, 2007. Firm initiated recall is complete.
REASON
Blood product, which may have been exposed to unacceptable storage temperature, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0375-12
CODE
Unit: 06GJ95801
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by letter November 8, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0376-12
CODE
Unit: 3620466
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by telephone on October 25, 2006. Firm initiated recall is complete.  
REASON
Blood product, manufactured without the entire quantity of additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0377-12
CODE
Unit: 9960479
RECALLING FIRM/MANUFACTURER
Northern California Community Blood Bank, Eureka, CA, by telephone call on September 7, 2006. Firm initiated recall is complete.
REASON
Blood product, for which the documented time period out of controlled storage did not meet specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0386-12
CODE
Unit: 06FS06803
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on January 24, 2007 and letter on April 6, 2007. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Flow PRA Class I Positive Control Serum. Recall # B-0487-12;
2) Flow PRA Class II Positive Control Serum. Recall # B-0488-12
CODE
1) Lot Numbers: 8.2 and 9.1;
2) Lot Numbers: 5.1 and 6.1
RECALLING FIRM/MANUFACTURER
One Lambda Inc., Canoga Park, CA, by letters dated June 10, 2009. Firm initiated recall is complete.
REASON
Flow Class I and II Positive Control Serums, with incomplete or positive infectious disease testing, as required for human source components for use in vitro diagnostic products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4,691 Units
DISTRIBUTION
Nationwide and Internationally
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS I
___________________________________
PRODUCT
1) St. Jude Medical Riata (8Fr), Models: 1560, 1561, 1562, 1570, 1571, 1572, 1580, 1581, 1582, 1590, 1591, 1592 Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart rate by providing pacing therapy and/or tachyarrhythmia therapy. Recall # Z-0457-2012;
 
2) St. Jude Medical Riata ST Silicone Endocardial Defibrillation Leads Riata (7Fr), Models: 7000, 7001, 7002, 7010, 7011, 7040, 7041, 7042 Product Usage: These Silicone transvenous high voltage (HV) leads connect an implantable cardioverter-defibrillator (lCD or CRT-D) to cardiac tissue to monitor and regulate a patients heart rate by providing pacing therapy and/or tachyarrhythmia therapy. Recall # Z-0458-2012
CODE
None
RECALLING FIRM/MANUFACTURER
St Jude Medical CRMD, Sylmar, CA, letters dated November 28, 2011, November 29, 2011, and December 15, 2010. Firm initiated recall is ongoing.
REASON
The recall was initiated because St. Jude Medical has confirmed the failures associated with all cause insulation failure on the St. Jude Medical Riata and Riata ST Silicone Endocardial Defibrillation Leads with specific emphasis on externalized conductors.
VOLUME OF PRODUCT IN COMMERCE
128,000 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. Prescription Use: Federal law restricts the sale of this device except by or on order of a physician. Each of the affected devices is individually serialized. Recall # Z-0510-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Carefusion 211 Inc., Yorba Linda, CA, by letter dated September 25, 2011.   
Manufacturer:Carefusion 207, Inc., Palm Springs, CA. Firm initiated recall is ongoing.
REASON
The recall was initiated because Carefusion has identified a potential risk associated with certain AVEA ventilators and affected replacement parts manufactured between March 1, 2009 and June 30, 2011. Carefusion is voluntarily initiating a field correction of the affected devices to preclude the possibility of this risk.
VOLUME OF PRODUCT IN COMMERCE
6797 (1891 in the US)
DISTRIBUTION
Nationwide and Internationally.
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS II
___________________________________
PRODUCT
1) "***BIOMET 3i***REF AC4425***Conical 25 ANGLED ABUTMENT***4.1mm (D) X 4mm (H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1' ***". Attach an implant to an implant restoration. Recall # Z-0158-2012;
 
2) "***BIOMET 3i***REF SWCA62***Conical Abutment Gold Standard ZR***6mm(D) X 2mm(H)***Abutment; Pilier: Abutment; Abutment; Pilastro; Pilar***RX Only***Sterile***BIOMET 3i Dental Iberica S.L. WTC Almeda Park. Ed. 1. Planta 1'***". Attach an implant to an implant restoration. Recall # Z-0159-2012
CODE
1) Lot 887628-5;
2) Lot 848478
RECALLING FIRM/MANUFACTURER
Biomet 3i, LLC, Palm Beach Gardens, FL, by letter dated September 28, 2011. Firm initiated recall is ongoing.
REASON
The packaging for the referenced products may not have been completely sealed prior to shipment.
VOLUME OF PRODUCT IN COMMERCE
122 Conical Angled... and 8 Standard Conical
DISTRIBUTION
Nationwide and Chile, Italy, Japan, Korea, Spain, and Sweden
___________________________________
PRODUCT
Synthes Spine T-PAL Spacer System. Transforaminal posterior atraumatic lumbar spacer system. Transforaminal posterior atraumatic lumbar spacer system. Synthes T-PAL Spacer is indicated for use in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1 whose condition requires the use of interbody fusion combined with supplemental fixation. The interior of the T-PAL Spacer should be packed with autogeneous bone graft (i.e. autograft). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment.
Part number 01.812.001 - T-PAL Instrument and Implant Set. Recall # Z-0161-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester, PA, by letter dated September 23, 2011. Firm initiated recall is ongoing.
REASON
LABELING CORRECTION for Medical Device - previous labeling and promotional materials associated with the T-PAL Spacer system reference the use of T-PAL spacer with allograft material. T-PAL Spacer is currently indicated for use with autograft material. All accounts with record of receiving T-PAL Implant will receive notification of the labeling correction and a copy of the updated brochure. All Synthes Spine Sales Consultants will receive notification of the labeling correction and a copy of the updated brochure.
VOLUME OF PRODUCT IN COMMERCE
N/A - Labeling Correction
DISTRIBUTION
Nationwide, Canada and Japan
___________________________________
PRODUCT
Extended Brilliance Workstation-NM (EBW-NM) with software version 1.0P, 1.1.1A, 1.5H, 1.5.1A and 2.0Q -Field Test Period A nuclear medicine image display and processing application suite that provided software applications used to process analyze and display medical images/data. Model Number 882488: EBW NM Special Model Number 882489: Extended Brilliance Workspace NM Model number 728260: Extended Brilliance Workspace. Recall # Z-0182-2012
CODE
Serial numbers: 66762, 66790 66146 66001, 66002 66235, 66812, 66820 67160 12344, 66393, 66398, 66418, 66422 12502, 66351 66193, 66223, 66921 66208, 66213, 66217 66952, 66959, 67056 66016 66564 66590, 66591, 66595 66065 66895 66685, 66733, 66735, 66736 66098 66553 66673 66257, 66260 66660, 67126 C66319 67319 66362, 66370 66558 12510 67123 66683 12718 14312 66800 66481 66042, 66194, 66727 66953 66662 12540 66579 66107, 66168 66551 67009, 67014 66077 66641, 66643 66212 C66326 66295 66140, 66379 66088 66097 66367 67274 66674 66723 66778 66599 66196, 66863, 66899 66114 66020, 66021, 66170 C66507 67004 66661 66716 66406 66821 66040 66242, 66244 67065 66687, 66701 67064 66070 66402 67140 66222, 66354 67308 66729, 66741, 66751, 66913 67204, 67208 66104 66782, 66788 66882 67122, 66818A, 66819A 66421 66721 66835 67206 66456 66695, 66699 67285 66209, 66504 66932 66652 67191 66602, 66658 C66331 67217 66901 66468 66697, 66700, 67180 66363, 66369 66382, 66384, 66464, 666112 66717 66575 67280, 67315 66409 66286 67055 66237 66902 66448 66872 12334 66839 66709 66905 67125 66671, 66711, 66726 66621 C66513 67046 66412 66019 66436, 66615, 66710 67057, 67172 66843 67109 66912 66025 66136, 66137, 66252, 66259, 66263, 66306, 66307, 66310, 66311 66400 C66502 66167 66440, 66659 67213, 67214 66452 66636, 66663, 67184, 67187, C66327, C66341 66268, 66555, 67157, 67162, 67167 66761 12624, 12639 66582 66483 67216, 67237 12606 67003, 67059 66004, 66006 67005, 67013, 67170 67255 66649 66570 66844 66926, 66928, 66936 66890 66132, 66728 66494, 66946 66078, 66081 66879 66381 66497 66737 67006 66229 66285 66598, 66600, 66601 67271 66688 66298, 66350, 66360 66038, 66051, 66052 66227 66067 66383 66055, 67212 66186 66753, 66008, 66012 66607 67230, 67234 66180 66568 66813, 66837 66900 66493, 66498 66487, 66489, 67158 66931 66183 66732 67176, 67269 66619 12266, 12269 66686 C66320 C66509, C66510 66754, C66500 66757, 66763, 66764 66552 66707 66438 66884 66950, 66954 66130, 66131, 66133, 66945 66560 66787 66791, 66795, C66342, C66344 66368 67151, 67231 66182 66608, 66609 66634 66109, 66152 67288, 67294 66403, 66405, 66466 66410, 66496 12131 66894, 66935 66429, 66476 66876, 67021, 67022, 67030 66625 66958, 66960 66148, 66154, 67070 C66339 66450, 67233 66829 66749 67264 66846 66877 66783 12355 66197 66583 12334, 12335, 12340, 66393, 66395, 66404, 66414, 66425, 66427, 66435, 66444, 66445, 66449, 66453, 6645566462, 66462 66809 66123, 66127 66224, 66718 13174, 13176, 66144, 66394, 66480 66240, 66613 66887, 66889 66574, 66585 66740, 66744 66893, 66896, 66907,67185, 67198, 66106, 66230 66645 66115 67020, 67023, 67024, 67028 66680 C66349 66747, 66748 66108, 66850 67053 66647, 66691 66376, 66387 12825 67111, 67113, 67134, 67169 66799, C66345, C66346 66245, 66784 66102, 66105 66702 66039 66218 66927, 66933 66916, 66918, 66957 66703, 66705 66071, 66074, 66075 67232 12517, 12519, 66177, 66202 66266, 66282, 66807 66554 66411, 66415, 66469 C66512 66041, 66054 12437, 66014, 66015, 66018, 66022, 66031, 66035, 66420, 66441, 66575, 66593, 66603, 67044 67000, 67017, 67054, 67142 66848, 66851, 67084, 67092 66231, 66233, 66249, 66267, 66271, 66355 66299 66397, 67026, 67040 66808 67007, 67011 66169, 66175, 66767, 66768, 66769, 66770 66565, 66586, 66589 66471, 66477 66875, 66898, 66947, 66948 66801, 66802 66597, 66604, 66606 66232, 66234, 66955, 66962 66189, 66377 67175 66236, 66246, 66269, 66275 66084, 66089, 66092 67268, 67257 66796, C66511 66883 66903, 66914 12516, 66017, 66024, 66592 66592 66437, 66439 66353, 66380 66648, 66656, 66666, 66096 66296, 66357 66143, 66184, 66199, 66283, 66287, 66364 66047, 66053, 66057, 66068, 66069, 66099, 66100, 66118, 66121, 66125, 66126, 66149, 66156 67190, 67192 66103, 66159, 66191, 66192, 66198 66644, 66670, 66672, 66681, 67226 66712, 66713, 66888, 66904, 66956 67200, 67201 67077, 67002 9300 66805, 66823, 66832, 66833, 66840, 66841, 66842 66029, 66033, 66044 66704 66443 66792, 66734, 66906 11728, 11774, 66000 66793 66689, 66690 66794, 66798, 66836 66365 66049, 66190 67183 11875, 11876 66490, 66492 8689 66073 66056, 66059, 66451 66569 66550, 67182, 67292, 67286 67174, 67177 66488 67220 67272, 67276 67293 12635, 12642, 66467 C66314, C66315 66881, 66944 67195 12736, 12737, 12738 C66300 12433, 66220 12368, 12371 12728, 12729 11799, 66200 66797 66584 66007, 66096, 66101, 66484 66618, 66730 66082 66390 66389, 66482 66239 66358, 66485, 66614, 66633 66627, 666113 66214 66622 66961, 67088 12404 66164, 66165 66171, 66204 66682, 66815 66824 13442, 13554, 13555 12715, 67146, 66284 66675 67079 66566 66562, 66572, 66573 66720 67278, 67282 66580 66859 67082 66086, 66909, 66911, 66930 66495 67145, 67165 66826 67062 67043 66715 67090 67263 67001, 67012 66201 66172, 66251 66878 66273, 66290 67211 12357, 66816, 66830, 66834 66392 66979, 66980 66966 66773, 66810 66662 66852, 66855, 67076 67093 67080 66215 67015 66247 67246 66776 66288 66920, 66925 66083 66746 66861 67130 66775 66974, 66975, 66977 66588 66873, 66922, 67283 66581 13193, 66243, 66698 66692, 66719 66766, 66770 66027, 66036, 66043, 66045 67039 66312 12607 66258 66653, 66678, 67018 12613, 12615, 66076 67210 66860 66113 66915 66473 66502 66630 66623 66009, 66011 66058, 66060 66866, 66870 67254 66973 66620 C66323 66640, 66642, 67029, 67221, 67225, 67227 66771 66187, 66248 66868 66090 67085 66428 67238 13040, 66371, 66374 66201, 66228 66085, 66093, 66094 66447, 66454 67036 66155, 66160 67189, 67338 66458 66417, 66419 66651, 66667 66270, 66276 66226, 66274 66862 67164 66122, 66162 13126, 13144 67188 66386, 66388 C66328 66929 67281 66869, 67236, C66324 66777 C66334 C66317 66759, 66867 C66325 66446 66871 66738 66091, 66128, 66129 67194, 67229, 67265, 67277, 67279, 67168F 66655 67025, 67049, 67066 66509 66460 67193 66561 66279, 66472, 66677 66976, 66978 67139 C66342 C66340, C66503 C13070 66173 66206 C66329 C66322 67222 66141, 66145 12975, 12977 67069, 67166, 67173 66768, 66769, 66785, 67179 66938 66724 66157, 66161, 66293 67124 66506 66571 C66348, C66508 67041 66254 66664 66845, 66847, 66849, 66856, 12964, 12978 66116 12644 66124, 66163 67197 66828 66941 C66301 66087, 66111, 66923 66188 66650 66743 66305 66668 66475 12721 66062, 66063 66818, 66819, 67008, 67016 67186 66461 12779, 12785 12375 66706, 66745 66864 66238, 66142 C66313 66361 67108 66147, 66158 66665 66080, 66117 66211 66765 67034, 67118 66563 66166, 66838, 66806A 66611, 66612 66865 66265, 66277 13346, 13347, 13354 66297 C66504 66066, 66151 66178 66289 67052, 67178 66886 66216 66857 67154 66858 66262 67137 12878 66825 66512 66399 13263 66241 66372, 66375 13364 12877, 66510 13264 66939, 66940 13175 66880, 66892 67273 66359 67031, 67050, 67058 12982, 12993 66731 66817, 66822, 66908, 66910, 67027 66626 66594 67270, 66352 66714 12372 66617 66610 12575 12566, 12572, 12576, 12577 67063 66205, 66219, 66416, 66423, 66432, 66654, 66679, 66676 66046 67252 66272, 66278 66030, 66032 66684 66657 67138 66378 67037 66261 67148 66853 66804, 66814, 66827 66153 66972 C66316 12532 12362 66005 C66304, C66309 C66321 66174, 66179 C66333 66023 C66501 13216 67019 66037, 66291, 66292 66739 66253, 66255, 66628, 66629, 66631, 66635, 66638, 67083 66806, 66811, 67087, 67094 66280 66176 66181 66003, 66072, 66366 12387 66391 66491 66119 66470 66185 66772, 66774 C66303 12910 66616 67074 66708 66587 67239 66781 66478, 66576 66250, 66256 66897, 67091 66207, 66373 66578, 66596 11331 C66332, C66335 66624, 66632, 66654 67181 66885 66110, 66112, 66221, 66225, 66457, 66459, 66474 66356, C66505 66750 12508, 66026 66203 66891 67033, 67042, 67117, 67127 66064 66079 C66337 66722 12378, 12384, 12395 66637 66969
RECALLING FIRM/MANUFACTURER
Recalling Firm:  Philips Medical Systems, San Jose, CA, by letter on September 27, 2011. 
Manufacturer: Philips Medical Systems (Cleveland) Inc., Cleveland, OH. Firm initiated recall is ongoing.
REASON
A problem related to a software error has been detected. A false negative interpretation due to a falsely elevated ejection fraction or a false positive interpretation due to a false low ejection fraction could occur.
VOLUME OF PRODUCT IN COMMERCE
1,181 systems
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
PDI Alcohol Prep Pads packaged in the INRatio kit. PDI Alcohol Prep Pads, 100/box. Alcohol Prep Pads, packaged in the Alere INRatio 2 PT/INR Home Monitoring Kit; or Hemosense INRatio 2 Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the Hemosense INRatio Prothrombin Time/INR Testing Kit, Self-Test System; Alcohol Prep Pads, packaged in the INRatio Starter Kit Product Model Number: 0200086, 0200432, 0100007, 0100072 The Alere INRatio2 PT/INR Home Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The Alere INRatio2 PT/INR Home Monitoring System is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The Alere INRatio2 PT/ INR Home Monitoring System is not intended to be used for screening purposes. The Alere INRatio2 PT/INR Home Monitoring System should only be used with a prescription from your physician. The INRatio2 PT Monitoring system is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. The INRatio2 PT Monitoring system is intended for use outside the body (in vitro diagnostic use) by people taking warfarin and other oral anticoagulant (blood thinning) therapy who need to monitor the clotting time of their blood. The INRatio2 PT Monitoring System is not intended to be used for screening purposes. The INRatio2 PT Monitoring system should only be used with a prescription from your physician. The INRatio system performs Prothrombin Time (PT) testing on fresh, capillary whole blood. The PT test is the principle assay used to monitor warfarin therapy. Patients taking warfarin and other oral anticoagulants should consult with their healthcare provider before adjusting their dosage. The thromboplastins used in performing PT tests can vary substantially causing differences in results between methods. The International Normalized Ratio (INR) is a mathematical correction of the PT result that adjusts for differences in thromboplastins. Consult your physician for the appropriate therapeutic range for you. Recall # Z-0188-2012
CODE
Lot/Unit Codes: 245765R, 245763R, 245766R, 245768, 245769, 252549, 245770, 252020, 252021, 252530, 252532, 252533, 256080, 256081, 256082, 256083, 256084, 256085, 260082, 256086, 256087, 256088, 256089, 256090, 256091, 256092, 261879, 261880
RECALLING FIRM/MANUFACTURER
Alere San Diego, San Diego, CA, letter dated October 6, 2011. Firm initiated recall is ongoing.
REASON
Alere has initiated a recall due to the potential presence of low levels of the microorganism Bacillus cereus.
VOLUME OF PRODUCT IN COMMERCE
14,248 total units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# 2607EXP.2-EHEC Detection Antibody 10.0ml Lot# 8603EXP.3-EHEC-Enzyme Conjugate 10.0ml Lot# 8604EXP.4-Substrate II 12.5ml Lot# 1601EXP.5-Stop-Solution II 10.0 ml Lot# 1601EXP.6-EHEC Positive Control 3.4 ml Lot# 8601EXP.7-EHEC Negative Control 3.4 ml Lot# 1603EXP.8-96 transfer pipettes-1 Microwell holder-3 Microwell strip sealers The Premier EHEC test kit is a rapid in vitro microwell EIA for the detection of Shiga Toxins I and II (verotoxins) in stool specimens, broth cultures, from individual colonies or colony sweeps of agar plates. The Premier EHEC test is intended for use as an aid in the diagnosis of enterohemorrhagic E. Coli (EHEC) infections. Recall # Z-0203-2012
CODE
Lot # 608096, Lot# 8602 EXP.1, Lot # 2607 EXP.2, Lot # 8603 EXP.3, Lot # 8604 EXP.4, Lot # 1601 EXP.5, Lot # 1601 EXP.6, Lot # 8601 EXP.7, Lot # 1603 EXP.8
RECALLING FIRM/MANUFACTURER
Meridian Bioscience Inc., Cincinnati, OH, by letter dated October 11, 2011. Firm initiated recall is ongoing.
REASON
Internal testing has shown that the indicated kits produce false negative results when tested with some direct stool specimens. These false negative reactions are not observed for all devices tested, however, the rate of occurrence will likely impact clinical sensitivity as defined by product registration and associated instructions for use.
VOLUME OF PRODUCT IN COMMERCE
3,236 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
VNS Therapy Aspire HC Generator and VNS, Model 105 For implantation in humans to treat Epilepsy and Depression. Recall # Z-0210-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Cyberonics, Inc., Houston, TX, by letter on August 15, 2011, and on September 19, 201l. Firm initiated recall is ongoing.
REASON
The devices are being recalled because the output current delivered to the vagus nerve is less than the design intent and there is a potential charge imbalance at the lead cathode and generator-can during stimulation.
VOLUME OF PRODUCT IN COMMERCE
346 units
DISTRIBUTION
Nationwide and Norway
___________________________________
PRODUCT
IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2. Recall # Z-0211-2012
CODE
Software Versions: RM2.04.37.04 to RM 7.8 SU2 (RM 2.04.37.04 is a version prior to CV 7.2 release).
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA Corp., Greenville, SC, by letter dated May 27, 2011.
Manufacturer: AGFA HealthCare Corp., Westerly, RI. Firm initiated recall is ongoing.
REASON
Improper merging of IMPAX Cardiovascular Results Management (RM) reports causes the signed report to become unavailable.
VOLUME OF PRODUCT IN COMMERCE
323 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
PDI Electrode Prep Pads, Skin Prep B339 are non-sterile alcohol prep pads. They are included in the Spacelabs Healthcare Hook-Up kits. Each kit contains 2-4 pieces of PDI Electrode Prep Pads. Hook-up kits that contain the affected alcohol prep pads are as follows: Aria, Kit Part number 23189-010, Kit, Basic hookup, AA; CardioCall, Kit Part number 23189-020, Kit, Hookup, CardioCall; Aria, Kit Part number 23189-106, Kit, Aria Hookup; Aria, Kit Part number 23189-110, Kit, Aria Hookup; Flashcorder, Kit Part number 23189-111, Kit, Flashcorder Hookup; Aria, Kit Part number 23189-113, Holter Hookup Kit 7 electrode; LifeCard 12, Kit Part number 23189-114, Kit, Hookup, LC12, Multilingual; Aria, Kit Part number 23189-115, Kit, Basic Hookup, AAA; LifeCard, Kit Part number 23189-116, Kit, Holter Hookup, LifeCard; 483, Kit Part number 23189-117, Kit, Holter Hookup 483; Aria, Kit Part number 23189-153, Holter Hookup Kit, 7 electrode; Aria VLC, Kit Part number 23189-207, Kit, Aria Hookup, VLC; EVO, Kit Part number 50-0048, 4 electrode hookup kit without pouch; EVO, Kit Part number 50-0049, 4 electrode hookup kit with pouch; EVO, Kit Part number SK10456, Sample Kit, Disposables. A surgical skin degreaser or an adhesive tape solvent is a device that consists of a liquid such as 1,1,2-trichloro-1,2,2-trifluoroethane; 1,1,1-trichloroethane; and 1,1,1-trichloroethane with mineral spirits intended to be used to dissolve surface skin oil or adhesive tape. Recall # Z-0262-2012
CODE
No lot #’s
RECALLING FIRM/MANUFACTURER
Del Mar Reynolds Medical, Ltd., Hertford, United Kingdom, by letter dated October 21, 2011. Firm initiated recall is ongoing.
REASON
The non-sterile alcohol prep pads (B339) are included in Spacelabs Healthcare hook-up kits may have the presence of a bacterium, Bacillus cereus. These alcohol prep pads were manufactured and recalled by Professional Disposables International (PDI).
VOLUME OF PRODUCT IN COMMERCE
25,000 pieces of PDI alcohol pads-total 15 different Spacelabs Hook up kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Brilliance Big Bore Computed Tomography X-Ray System, 510(k) #K033357, Model Number: 728243. The recalled device systems are equipped with Version 3.5 Beta 1 software. Recall # Z-0334-2012;
 
2) Brilliance 64 Computed Tomography X-Ray System, 510(k) #K033326, Model Number: 728231. The recalled device systems are equipped with Version 3.5 Beta 1 software. Recall # Z-0335-2012
CODE
1) Serial Numbers: 7298, and 7060;
2) Serial Numbers: 9745, 90169, and 95414
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by a 'Field Change Order' (FCO #72800531) on September 12, 2011 and a letter dated October 17, 2011. Firm initiated recall is ongoing.
REASON
Software errors. A number of non-conformances were found for the Brilliance Big Bore and Brilliance 64 Computed Tomography X-ray Systems equipped with software version; 3.5 Beta1. The non-conformances stem from software errors identified in the operating software.
VOLUME OF PRODUCT IN COMMERCE
 five 5) system units
DISTRIBUTION
Nationwide, Italy, India and China
___________________________________
PRODUCT
Odyssey A radiation treatment planning system. Recall # Z-0345-2012
CODE
Versions 4.4 through 4.7
RECALLING FIRM/MANUFACTURER
PerMedics, Inc., San Bernardino, CA, by letter dated November 4, 2010. Firm initiated recall is ongoing.
REASON
Anomaly 1 - Invalid Export of Beam Table and or Collimator Angle for DICOM RT Ion, DICOM Image and RTP Link export files: During PerMedics' internal code reviews for lEC 61217 compliance verification, an issue was identified by PerMedics engineers in three export files: D1COM RT Ion Plan, D1COM RT Image and RTP Link. In some cases, this issue can result in table and/or collimator angle values to be exported that are not in compliance with either the lEC 61217 standard or the PerMedics D1COM Conformance Statement. Within Odyssey, the table angle increases counterclockwise (when viewed from Odyssey's "Beam's Eye View" feature) in compliance with the IEC 61217 Patient Support coordinate system. Likewise, within Odyssey, the collimator angle increases counterclockwise (when viewed from Odyssey's "Beam's Eye View" feature) in compliance with the IEC 61217 Beam Limiting Device coordinate system. Through its internal investigation, PerMedics discovered that Odyssey does not export the correct table and/or collimator angles to DICOM RT Ion Plan, DICOM RT Image and RTP Link when the treatment machine's table angle and/or collimator angle increase in the clockwise direction--opposite of the IEC 61217 and Odyssey's internal angle systems. In these cases, Odyssey converts the table and collimator angles to the treatment machine's angle system, which does not match IEC 61217. This conversion should never be performed for these files. Because Odyssey's DICOM and RTP Link exports are supposed to express angles in IEC 61217 coordinates, this conversion results in incorrect table and collimator angle values when the table and collimator angle systems of the beam's machine do not match Odyssey's internal angle systems. Note: If the actual treatment machine's table angle and collimator angle increases in the same direction as Odyssey's internal table angle and collimator angle system, then the conversion is not performed, and these files contain the correct table and collimator angle values. The following conditions must all be present in order for an invalid table angle to be exported for a beam: “The internal table angle of the beam displayed in Odyssey is not equal to zero. " The table angle system for the beam's machine is defined in Odyssey's MakeLib to increase in the clockwise direction when viewed in "Beam's Eye View". "The beam is exported to a DICOMRT Ion Plan, DICOMRT Image, or RTP Linkfile. If anyone of these conditions is not met, then the anomaly does not occur for table angles exported for a beam. The following conditions must all be present in order for an invalid collimator angle to be exported for a beam: “The internal collimator angle of the beam displayed in Odyssey is not equal to zero.” The collimator angle system for the beam's machine is defined in Odyssey's MakeLib to increase in the clockwise direction when viewed in "Beam's Eye View". “The beam is exported to a DICOMRT Ion Plan or RTP Linkfile. If anyone of these conditions is not met, then the anomaly does not occur for collimator angles exported for a beam. Anomaly 2 - Incorrect Monitor Unit Values when Changing Treatment Start Date: If the treatment start date is changed for a patient's fully computed IMRT plan, IMAT plan or a plan containing a "Region DVH" prescription, then Odyssey automatically re-computes the treatment schedule. However, this automatic re-computation also changes the monitor unit values in the schedule so they are no longer correct. In these cases it is necessary to manually perform a full re-computation of the plan to calculate the correct monitor unit values for the treatment schedule; however, Odyssey does not provide indication to the user of this anomaly, and allows export of the plan with these incorrect monitor unit values.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
Nationwide, Hungary, Brazil, China, India, Italy, and Mexico
___________________________________
PRODUCT
1) Product is labeled in part - Pouch label: "***ORTHOFIX***Description: Origen***DBM Paste***Size***REF:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only***" Product is labeled in part - Carton label: "***Origen DBM with Bioactive Glass***REF***ID*** Expiration*** Rx Only***ONE EACH***" Origen DBM with Bioactive Glass Catalog #: a) 22-2002 (2cc size); b) 22-2005 (5cc size); c) 22-2010 (10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis). Recall # Z-0346-2012;
 
2) Product is labeled in part - Pouch label: "***NanoFUSE***DBM*** Description: NanoFUSE DBM***Size***Order No.:***ID***Expiration***STERILE R***Donated Human Tissue Allograft***SINGLE PATIENT USE ONLY***Rx Only*** nanotherapeutics***" Product is labeled in part - Carton label: "***NanoFUSE DBM***Order No:***ID***Expiration***nanotherapeutics***Rx Only***ONE EACH***" NanoFUSE DBM Catalog #:a) NAN109-02 (2cc size); b) NAN109-05 (5cc size); c) NAN109-10(10cc size) "Bone void filler comprised of a gelatin carrier, bioactive glass (45s5), and human demineralized bone matrix (DBM) intended for transplantation." Indicated to be gently placed into bony voids or gaps of the skeletal system that is not intrinsic to the stability of the bony structure (e.g. the extremities and pelvis). Recall # Z-0347-2012
CODE
1) a) Lot #: 070281P, 070591P, 073221P, 073434P, 073504P, 073577PA, 073761PA, 073761PB, 074349P, 075075PA, 075128P, 075245PA, 075255P, 075259P, 077870PA, 078093PB, 078268PB; b)Lot #: 067559PA, 067559PB, 0700869, 070281P, 070546PA, 070546PB, 070552P, 070591P, 070743P, 070884PA, 070884PB, 073221P, 073222P, 073346PB, 073434P, 073496P, 073504P, 074032P, 075075PB, 075259P, 075481P, 075637PA, 075637PB, 075660P, 077642PA, 077870PB, 078048P, 078268PB, 078309PA, 079002PA; c) Lot #: 060095P, 067484P, 070203P, 070281P, 070512P, 070521P, 070603PA, 070607P, 070629P, 070703P, 070704P, 070755P, 070831P, 070916P, 071043PB, 071045PA, 071053PA, 071053PB, 073221P, 073319PB, 073346PA, 073346PB, 073411PB, 073434P, 073494PA, 073494PB, 073502P, 073590P, 073695P, 073751P, 073828P, 073879P, 075050PA, 075058P, 075167PB, 075230PA, 075230PB, 075245PB, 075338PA, 075338PB, 075492PA, 075629P, 077390P, 077715PA, 077715PB, 077863PA, 078093PA, 078268PA, 078268PB, 078344PB;
 
2) a) Lot #: 074349P; b) Lot #: 073995PA, 077870PB; c) Lot #: 071045PB, 071043PA, 070916P
RECALLING FIRM/MANUFACTURER
Nanotherapeutics, Inc., Alachua, FL, by letter dated April 12, 2011. Firm initiated recall is ongoing.
REASON
The products were manufactured without an approved 510k. Direct accounts were notified of the recall on 04/08/2011.
VOLUME OF PRODUCT IN COMMERCE
6,407 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Synthes Oscillating Saw Attachment/Large w/Key for Small Battery Drive. This surgical instrument motor and accessories are AC-powered, battery-powered or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver and saw blade. Catalog number: 532.026. Recall # Z-0348-2012
CODE
All lots
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester, PA, by letter dated October 17, 2011. Firm initiated recall is ongoing. 
REASON
The potential exists for the Large Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece, there is a potential for injury to the patient and/or user.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
P/N 801-01-013 Foundation Tibial Broach to be used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected Tibial plateau for acceptance of a keeled Tibial Baseplate stem. Recall # Z-0349-2012
CODE
Lot #'s: 35149L02, 36204L06, 37990L06, 38272L13, and 50479L12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Encore Medical, LP, Austin, TX, by letter dated October 26, 2011.
Manufacturer: Encore Medical, LP, Austin, TX. Firm initiated recall is ongoing.
REASON
The strike plate may dislodge from the broach stem handle during impaction of the device.
VOLUME OF PRODUCT IN COMMERCE
30 Units
DISTRIBUTION
Nationwide, UK and Italy
___________________________________
PRODUCT
SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7. SoftReports is a web-based report launching tool to be used in a hospital or laboratory environment by knowledgeable, trained, and experienced personnel. SoftReports enables the user to schedule and generate reports for the purpose of viewing and printing data stored in SCC product databases. Recall # Z-0362-2012
CODE
SoftReports version 1.1.8.2.4 with Hot Fixes 1.7199.7 or 1.7200.7.
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter dated October 25, 2011. Firm initiated recall is ongoing.    
REASON
When SoftReports Designer opened a layout, the system did not load the layout with the previously saved value in the NewPage property. This caused multiple patient records to be printed on the same page.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Kit 45CM Internal Sheath, Catalog No./REF 11402001, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0400-2012;
 
2) VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Kit 65CM Internal Sheath, Catalog No./REF 11402002, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0401-2012;
 
3) VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch 45cm Kit w/Gripper and RFID T, Catalog No./REF 11403001, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0402-2012;
 
4) VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch 65cm Kit w/Gripper and RFID T, Catalog No./REF 11403002, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0403-2012;
 
5) VenaCure EVLT NeverTouch - FRS .018" System PROCEDURE KIT Featuring Gold-Tipped Fiber, 25 cm, VC EVLT NeverTouch-FRS 0.18 25 cm Kit, Catalog No./REF 11403003, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0404-2012;
 
6) VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 90 cm, VC EVLT NeverTouch-FRS 90cm Kit, Catalog No./REF 11403004, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0405-2012;
 
7) VenaCure EVLT NeverTouch - FRS w/19Ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NT FRS 45cm Kit w/19Ga Needle, Catalog No./REF 11403005, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0406-2012;
 
8) VenaCure EVLT NeverTouch - FRS w/19Ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NT FRS 65cm Kit w/19Ga Needle, Catalog No./REF 11403006, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0407-2012;
 
9) VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, 45cm NeverTouch FRS .018 Procedure Kit, Catalog No/REF 11403012, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0408-2012;
 
10) VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, 65cm NeverTouch FRS .018 Procedure Kit, Catalog No./REF 11403013, STERILE. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0409-2012;
 
11) VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Procedure Kit 45cm, Catalog No./REF 51402007, STERILE. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0410-2012;
 
12) VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Procedure Kit 65cm, Catalog No./REF 51402008, STERILE. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0411-2012;
 
13) VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, VenaCure NeverTouch FRS 45cm Clear Needle, Catalog No./REF 51403001, STERILE. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0412-2012;
 
14) VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure NeverTouch FRS 65cm Clear Needle, Catalog No./REF 51403002, STERILE. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0413-2012;
 
15) VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VC NT FRS 65cm Clear Non-Echo Needle, Catalog No./REF 51403005, STERILE. This is a Special Order. Product Usage: The AngioDynamics, Inc. VenaCure Procedure Kit is indicated for endovascular coagulation of the Great Saphenous Vein (GSV) in patients with superficial vein reflux, for the treatment of varicose veins and varicosities associated with superficial reflux of the Great Saphenous Vein (GSV), and for the treatment of incompetence and reflux of superficial veins of the lower extremity. Recall # Z-0414-2012
CODE
1) Batch/Lot Numbers: 549594, 549802;
 
2) Batch/Lot Numbers: 549019, 549040, 549041, 549599, 549600, 549601, 549602, 549603, 549803, 549804, 549805, 551095, 551096, 551097;
 
3) Batch/Lot Numbers: 549604, 549605, 549607, 549806, 549991, 550848, 551098, 551099, 551100, 551101, 551102, 551503, 551970, 551971, 551972, 551973, 551974, 552939, 552960, 553299, 553300, 553301, 553302, 553583, 553605, 553937, 553938, 553939, 554040, 554041, 554267, 554268, 554269, 554270, 554624;
 
4) Batch/Lot Numbers: 549045, 549046, 549047, 549609, 549610, 549611, 549612, 549613, 549614, 549807, 549808, 549809, 549810, 551103, 551104, 551105, 551504, 551505, 551506, 551975, 551976, 551977, 551978, 551979, 552961, 552962, 552963, 553303, 553304, 553305, 553306, 553584, 553585, 553586, 554271, 554272, 554273, 554274, 554275, 554276, 554630, 554631, 554632, 554636;
 
5) Batch/Lot Numbers: 549811, 550576, 552000, 552964, 552965, 554277, 554278;
 
6) Batch/Lot Numbers: 549745, 549746;
 
7) Batch/Lot Numbers: 552001, 553679;
 
8) Batch/Lot Numbers: 549759, 549780, 549781, 549782, 549783, 550822, 551106, 551107, 552967, 553307;
 
9) Batch/Lot Numbers: 549616, 550415, 552004, 553309, 553589, 554285;
 
10) Batch/Lot Numbers: 549595, 549617, 550212, 551109, 552005, 552052, 552968, 553310, 554282, 554283, 554642;

11) Batch/Lot Number: 553311;
 
12) Batch/Lot Numbers: 551252, 551840, 556175;
 
13) Batch/Lot Number: 554047;
 
14) Batch/Lot Numbers: 551253, 553312, 554789;
 
15) Batch/Lot Numbers: 550483, 552969, 554284
RECALLING FIRM/MANUFACTURER
Recalling Firm: Angiodynamics Worldwide Headquarters, Latham, NY, by letters dated November 10, 2011.
Manufacturer: Angiodynamics, Inc., Queensbury, NY. Firm initiated recall is ongoing.
REASON
During an in-process inspection the hemostasis sidearm assemblies were identified to have the potential for flash to exist on the housing at the base of the threads. This flash has the potential to break off and relocate within the fluid path.
VOLUME OF PRODUCT IN COMMERCE
Nationwide: 11,036 units; Internationally: 1230 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY. Product Usage: Variable Angle technology in MTP, TMT, MFT, MXL, DFX, and EDL plates are indicated for fractures, fusions and osteotomies for small bones in the hand, wrist, foot and ankle in both pediatric and adult patients. Variable Angle Technology in MXL and CLA plates are indicated for the fractures, fusions, and osteotomies of the clavicle and small bones in the hand, wrist, foot and ankle. a) Model # VAR-031-35-10, Model # VAR-031-35-12, Model # VAR-031-35-14, Model # VAR-031-35-16, Model # VAR-031-35-18, Model # VAR-031-35-20, Model # VAR-031-35-22, Model # VAR-031-35-24, Model #, VAR-031-35-26, Model # VAR-031-35-28, Model # VAR-031-35-30 &, b) Model #, MXL-032-35 and Model # VAR-032-35. Recall # Z-0421-2012
CODE
a) Lot # 1364, 1731, 1862; b) Lot # 1365011, 1365012
RECALLING FIRM/MANUFACTURER
Orthohelix Surgical Designs Inc., Medina, OH, by letter dated August 22, 2011. Firm initiated recall is ongoing.
REASON
The firm discovered a testing protocol error, in both dynamic and static cantilever comparative testing, during the initial comparative testing.
VOLUME OF PRODUCT IN COMMERCE
2,722 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) HOTLlNE Disposable Administration Sets, Product Codes L-70 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr. Recall # Z-0422-2012;
 
2) HOTLlNE Disposable Administration Sets, Product Codes L-70NI Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr. Recall # Z-0423-2012;
 
3) HOTLlNE Disposable Administration Sets, Product Code L-270 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr. Recall # Z-0424-2012;
 
4) HOTLlNE Disposable Administration Sets, Product Code L-370 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr. Recall # Z-0425-2012;
 
5) HOTLlNE Disposable Administration Sets, Product Code L-80 Product Usage: Single patient use Sets designed for use by trained medical professionals, in conjunction with HOTLlNE Routine Flow Blood and Fluid Warmers (HL-90 and HL-290), for the warming and delivery of blood and I.V. solutions, at normothermic flow rates of 50 - 5,000 ml/hr. Recall # Z-0426-2012;
 
6) Level 1 Normothermic I.V. Fluid Administration Sets, Product Code D-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1® Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the warming and delivery of blood and I.V. solutions, at flow rates of 75ml/min - 530 ml/min. Recall #Z-0427-2012;
 
7) Level 1 Normothermic I.V. Fluid Administration Sets, Product Code DI-60HL , Product Usage: Single patient use sets designed for use by trained medical professionals, in conjunction with Level 1® Fast Flow Fluid Warmers (H1000, H-1025, H-1028, and H-1200), for the warming and delivery of blood and I.V. solutions, at flow rates of 75ml/min - 530 ml/min. Recall # Z-0428-2012
CODE
1) Lot Numbers: 1961565 1967233 1967234 1967235 1967236 1967237 1967238 1967239 1967240 1973118 1973119 1982938 1982939 1983243 1983244 1983246 1989241 1989242 1989243 1989244 1989245 1995431 1995554 1995555 1995556 1995698 1995699 1995700 1995701 1995702 2007275 2007276 2007277 2007278 2019640 2019641 2019642 2019643 2019644 2025123 2025125 2025126 2025127 2025128 2025129 2025130 2025131 2025133 2025134 2025135 2033081 2033082 2033083 2033084 2033085 2033086 2042613 2042614 2042615 2042617 2042618 2049316 2049317 2049318 2049437 2049438 2055173 2055174 2055175 2055176 2059473 2059474 2059475 2064014 2064015 2064017 2064018 2068138 2068139 2068140 2068141 2068142 2077203 2077204 2077205 2077206 2077207 2083507 2083508 2084305 2090782 2090783 2093663 2093664 2095298 2095300 2101204 2101205 2101206 2101207 2101208;
 
2) Lot Numbers: 1967243 1967244 1973126 1979964 1979965 1979966 1981255 1981256 1981257 1981258 1981259 1995557 2007279 2007280 2007281 2007282 2019645 2019646 2025136 2025137 2025138 2025140 2025143 2025144 2025145 2042619 2042620 2042621 2042622 2042623 2042624 2042625 2049440 2049441 2049442 2059476 2059477 2059478 2059479 2064019 2064020 2064021 2068143 2068144 2068145 2068146 2077341 2077342 2083509 2087640 2090784 2090785 2090786 2095293 2095294 2099545 2099546 2105392;
 
3) Lot Numbers: 1947531 1952652 1957058 1957059 1967245 1967246 1979007 1995553 1995693 1998983 1998984 2019637 2019638 2019639 2025120 2025121 2038143 2038144 2038146 2038147 2049439 2059469 2059470 2064010 2068137 2077198 2077199 2077200 2090779;
 
4) Lot Numbers: 1995695 1995696 2038150 2038151 2038152 2047423 2061923 2061924 2061929 2061930 2061931 2061932 2061933 2077201 2077202 2090780 2090781 2095295 2095302 2095306;
 
5) Lot Numbers: 1974580 2007256 2064012 2089416 2093985;
 
6) Lot Numbers: 1974580 2007256 2064012 2089416 2093985;
 
7) Lot Numbers: 2033447 2039136 2046398 2046400 2047961 2047963 2064528 2064529 2064530 2077404 2077405 2077406 2077407 2087667 2099050 2099766 2102361
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Rockland, MA, by letter dated November 28, 2011. Firm initiated recall is ongoing.
REASON
Disconnected/ loose Luer connectors at the patient end of the triple lumen tubing of the HOTLlNE Disposable Administration Sets and Level 1 D/DI-60HL Normothermic IV Administration Sets.
VOLUME OF PRODUCT IN COMMERCE
805,506 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
UniCel DxC and Synchron LX Clinical Systems 100 L Sample Syringe, 100UL-PKGD, Part Number 474171 Product Usage: The UniCel DxC and LX Synchron Clinical Systems are fully automated, computer-controlled clinical chemistry analyzers designed for the in vitro determination of a variety of general chemistries, therapeutic drugs, and other chemistries. Analysis can be performed on serum, plasma, urine, or cerebrospinal fluid (CSF) and whole blood (sample type is chemistry dependent). Recall # Z-0452-2012
CODE
Lot/Serial Numbers: All
RECALLING FIRM/MANUFACTURER
Beckman Coulter Inc., Brea, CA, by letter beginning September 2, 2010.  Firm Initiated recall is ongoing.
REASON
The Modular Chemistry (MC) and Cartridge Chemistry (CC) 100 uL sample syringes may experience premature wear as indicated by brown discoloration on the plunger and/or inside the glass syringe barrel. Excessive wear of the 100 uL sample syringe barrel and plunger could lead to leaking and may affect results.
VOLUME OF PRODUCT IN COMMERCE
3278 total (3083 Nationwide, 195 in Canada)
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Artiste Maverick Tint, Part Number: N36TB, Product Description and Intended Use: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Product Usage: The intended use of this device is for internal color characterization and includes 3 opaques for blocking out deep staining or metal substrates. Recall # Z-0455-2012
CODE
Lot/Serial Numbers: 3416180
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kerr Corp., Orange, CA, by letter on March 3, 2011.
Manufacturer: Pentron Clinical Dental Material, Villa Park, CA. Firm initiated recall is complete.
REASON
The resin material separates when the product is extruded from the syringe. Although there are no safety issues related with this situation, please refrain from using the affected product.
VOLUME OF PRODUCT IN COMMERCE
One hundred (100) units
DISTRIBUTION
Nationwide and Armenia, Russia and Ukraine
___________________________________
PRODUCT
SPOT-Light" HER2 CISH Kit, catalog #84-0150, 20 tests/kit, labeled in part ***Product Usage: The SPOT-Light HER2 CISH Kit is intended to quantitatively determine HER2 gene amplification in formalin-fixed, paraffin-embedded (FFPE) breast carcinoma tissue sections and is indicated as an aid in the assessment of patients for whom Herceptin (trastuzumab) treatment is being considered. Recall # Z-0461-2012
CODE
Lot 1029335, Exp. August 31, 2012
RECALLING FIRM/MANUFACTURER
Life Technologies Corp., Frederick, MD, by letter dated November 14, 2011. Firm initiated recall is ongoing.
REASON
In vitro diagnostic reagent may be contaminated with a fungal contaminant.
VOLUME OF PRODUCT IN COMMERCE
29 kits
DISTRIBUTION
Nationwide, Canada, Venezuela, and the UK
___________________________________
PRODUCT
SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8. Product Usage: SoftLab is a laboratory information system to be used in a medical research or clinical laboratory by knowledgeable, trained, and experienced personnel. SoftLab enables the user to handle data-processing and laboratory activities, for the purpose of storing, managing, querying, and reporting laboratory data. Recall # Z-0488-2012
CODE
SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4.0.1.16; 4.0.2.0-4.0.2.10; 4.0.3.0-4.0.3.16; 4.0.4.0-4.0.4.6; and 4.5.0.0-4.5.0.8
RECALLING FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter on May 3, 2011. FDA initiated recall is ongoing.
REASON
A client reported that results were not flagged correctly. This can occur when a test is ordered in Order Entry, then collected, received, and resulted from the Order Entry results tab in the same session in Order Entry, within a very short time frame. The patient results are accurate, but if the result interpretation flags are missing, an abnormal test result could be overlooked by a physician when reviewing the patient report. Also, if the abnormal flags are missing, the results will not qualify to the Call list.
VOLUME OF PRODUCT IN COMMERCE
220 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Lifescreen Apnea is Lifescreen ECG Screening System, Version 3.31. Lifescreen Apnea is indicated for screening adults for the probability that they suffer from obstructive sleep apnea, mixed apnea or hypopnea, in order to evaluate the necessity for a polysomonographic examination. The ECG recording may be obtained at any location specified by a physician including home, hospital or clinic. Subjects screened for sleep apnea should have periods of sleep of at least 4 hours duration during which the ECG is predominantly sinus rhythm in nature. Recall # Z-0520-2012
CODE
There is no Serial Numbers for 169 Kits. Serial Numbers for 519 units: 12038, 32288, 32300, 32302, 32327, 32329, 32330, 32389, 32410, 32411, 32415, 32417, 32418, 32470, 32471, 32472, 32473, 32474, 32475, 32476, 32478, 32479, 32480, 32481, 32482, 32483, 32484, 32485, 32486, 32487, 32488, 32532, 32546, 32547, 32548, 32549, 32550, 32551, 32552, 32553, 32554, 32557, 32558, 32561, 32567, 32568, 32569, 32570, 32648, 32649, 32650, 32651, 32652, 32653, 32655, 32656, 32657, 32658, 32659, 32676, 32677, 32678, 32679, 32680, 32681, 32682, 32683, 32684, 32686, 32687, 32712, 32713, 32714, 32715, 32716, 32717, 32718, 32719, 32720, 32721, 32722, 32723, 32726, 32742, 32759, 32790, 32791, 32797, 32798, 32799, 32800, 32801, 32802, 32803, 32804, 32805, 32806, 32814, 32821, 32822, 32823, 32824, 32860, 32861, 32862, 32863, 32864, 32865, 32866, 32867, 32868, 32869, 32870, 32871, 32872, 32873, 32877, 32878, 32880, 32881, 32944, 32945, 32946, 32947, 32948, 32949, 32950, 32951, 32952, 32954, 32955, 32956, 32957, 32958, 32959, 32960, 32961, 32963, 32977, 32979, 32980, 32982, 32983, 32984, 32986, 32987, 32989, 32990, 32991, 32992, 32993, 32994, 32995, 33015, 33017, 33058, 33095, 33096, 33097, 33098, 33099, 33100, 33101, 33102, 33103, 33104, 33105, 33106, 33107, 33108, 33113, 33114, 33115, 33116, 33117, 33118, 33119, 33120, 33121, 33122, 33123, 33124, 33132, 33135, 33158, 33159, 33160, 33161, 33162, 33164, 33165, 33166, 33167, 33184, 33185, 33186, 33188, 33189, 33190, 33200, 33201, 33213, 33219, 33221, 33240, 33241, 33242, 33243, 33244, 33245, 33254, 33255, 33257, 33258, 33259, 33260, 33261, 33262, 33263, 33264, 33265, 33267, 33268, 33269, 33270, 33322, 33323, 33324, 33326, 33327, 33328, 33329, 33330, 33336, 33337, 33338, 33339, 33343, 33347, 33348, 33352, 33355, 33386, 33387, 33388, 33391, 33392, 33393, 33394, 33396, 9310, 9520, 9885, 9933, 9934, IMP-002054, IMP-005010, IMP-005011, IMP-005013, IMP-005025, IMP-005027, IMP-005028, IMP-005029, IMP-005030, IMP-005031, IMP-005035, IMP-005036, IMP-005038, IMP-005039, IMP-005042, IMP-005043, IMP-005045, IMP-005046, IMP-005048, IMP-005049, IMP-005050, IMP-005062, IMP-005063, IMP-005065, IMP-005066, IMP-005068, IMP-005073, IMP-005077, IMP-005078, IMP-005087, IMP-005090, IMP-005091, IMP-005092, IMP-005094, IMP-005102, IMP-005108, IMP-005110, IMP-005111, IMP-005115, IMP-005141, IMP-005147, IMP-005151, IMP-005152, IMP-005160, IMP-005162, IMP-005165, IMP-005176, IMP-005218, IMP-005219, IMP-005237, IMP-005238, IMP-005253, IMP-005254, IMP-005258, LIFE-025878, LIFE-027365, LIFE-027527, LIFE-027528, LIFE-027866, LIFE-028314, LIFE-029149, LIFE-029150, LIFE-029718, LIFE-029719, LIFE-032784, LIFE-033181, LIFE-033791, PATH-000100, PATH-000101, PATH-000102, PATH-000103, PATH-000104, PATH-000105, PATH-000106, PATH-000107, PATH-006004, PATH-006005, PATH-006006, PATH-006007, PATH-006018, PATH-006019, PATH-006020, PATH-006039, PATH-006040, PATH-006041, PATH-006042, PATH-006043, PATH-006044, PATH-006045, PATH-006068, PATH-006069, PATH-006070, PATH-006071, PATH-006072, PATH-006073, PATH-006074, PATH-006075, PATH-006077, PATH-006099, PATH-006101, PATH-006102, PATH-006103, PATH-006104, PATH-006105, PATH-006106, PATH-006108, PATH-006109, PATH-006110, PATH-006112, PATH-006113, PATH-006114, PATH-006115, PATH-006120, PATH-006132, PATH-006158, PATH-006159, PATH-006160, PATH-006161, PATH-006162, PATH-006163, PATH-006164, PATH-006165, PATH-006166, PATH-006175, PATH-006182, PATH-006183, PATH-006184, PATH-006186, PATH-006188, PATH-006190, PATH-006237, PATH-006238, PATH-006239, PATH-006250, PATH-006251, PATH-006252, PATH-006253, PATH-006254, PATH-006255, PATH-006256, PATH-006258, PATH-006259, PATH-006299, PATH-006300, PATH-006301, PATH-006302, PATH-006306, PATH-006309, PATH-006314, PATH-006315, PATH-006316, PATH-006317, PATH-006318, PATH-006319, PATH-006320, PATH-006321, PATH-006322, PATH-006323, PATH-006324, PATH-006325, PATH-006326, PATH-006327, PATH-006328, PATH-006329, PATH-006332, PATH-006333, PATH-006344, PATH-006350, PATH-006351, PATH-006353, PATH-006382, PATH-006407, PATH-006409, PATH-006410, PATH-006447, PATH-006448, PATH-006451, PATH-006452, PATH-006471, PATH-006485, PATH-006486, PATH-006487, PATH-006488, PATH-006489, PATH-006490, PATH-006502, PATH-006505, PATH-006506, PATH-006522, PATH-006523, PATH-006524, PATH-006525, PATH-006526, PATH-006527, PATH-006528, PATH-006531, PATH-006533, PATH-006537, PATH-006538, PATH-006542, PATH-006543, PATH-006544, PATH-006545, PATH-006572, PATH-006573, PATH-006574, PATH-006602, PATH-006603, PATH-006604, PATH-006605, PATH-006606, PATH-006607, PATH-006608, PATH-006609, PATH-006610, PATH-006611, PATH-006612, PATH-006613, PATH-006614, PATH-006615, PATH-006630, PATH-006631, PATH-006632, PATH-006638, PATH-006650, PATH-006651, PATH-006652, PATH-006662, PATH-006663, PATH-006664, PATH-006665, PATH-006666, PATH-006667, PATH-006698, PATH-006712, PATH-006713, PATH-006714, PATH-006715, PATH-006716, PATH-006717, PATH-006735, PATH-006736, PATH-006738, PATH-006739, PATH-006740, PATH-006741, PATH-006742, PATH-006743, PATH-006744, PATH-006774, PATH-006830, PATH-006831, PATH-006853, PATH-006858, PATH-006859, PATH-006860, PATH-006861, PATH-006862, PATH-006872, PATH-006873, PATH-006874, PATH-006877, PATH-006878, PATH-006984
RECALLING FIRM/MANUFACTURER
Del Mar Reynolds Medical, Ltd., Hertford, UK, by letter dated November 11, 2011. Firm initiated recall is ongoing.
REASON
When Lifescreen is left open and a new recording is loaded from Sentinel Cardiology Information Management System, customers can get corruption in the data or a wrong ECG after the first 32 hours. Both recordings have to be longer than 32 hours for this to happen.
VOLUME OF PRODUCT IN COMMERCE
519 units and 16 9 kits (34 units and 7 kits Nationwide; 485 units and 162 kits Internationally)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Therakos Cellex Photopheresis System CellexUSA & Cellex. The photopheresis system is indicated for use in the ultraviolet-A (UVA) irradiation in the presence of the photoactive drug 8-methoxypsoralen (8-MOP) of extracorporeally circulating leukocyte-enriched blood in the palliative treatment of the skin manifestation of cutaneous T-cell lymphoma (CTCL) in person who have not been responsive to other forms of treatment. The Cellex procedural kits are designed to interface with the Cellex Photopheresis System to perform cell separation and photo activation in a single closed and sterile circuit. This is accomplished by use of an integrated centrifuge bowl and associated tubing for separation of whole blood into red blood cells, plasma, and buffy coat (leukocyte-enriched blood). All blood components are returned to the patient. The procedural kits are fully assembled as received by the customer and the customer is only required to place the components in the Cellex System to enable the system for use. Recall # Z-0595-2012
CODE
Lot Numbers and Expiration Dates CELLEXUSA 40115 20091201 CELLEXUSA 40117 20090707 CELLEXUSA 40122 120090713 CELLEXUSA 40129 120090618 CELLEXUSA 40130 20091103 40133 20091014 CELLEXUSA 40134 20091014 ICELLEXUSA 40136 20091019 ICELLEXUSA CELLEXUSA 40137 20091021 CELLEXUSA 40141 20091201 20091104 40142 ICELLEXUSA 40143 20091208 ICELLEXUSA CELLEXUSA 40151 20091215 - 40152 20100114 CELLEXUSA 40154 20100112 CELLEXUSA 40156 20100112 CELLEXUSA 40158 20100209 CELLEXUSA 40159 - 20100209 CELLEXUSA 40160 40161 20100128 CELLEXUSA 20100209 CELLEXUSA 40162 40163 20100128 CELLEXUSA 40165 20100322 CELLEXUSA 20100401 CELLEXUSA 40166 20101006 CELLEXUSA 40170 40171 20100623 CELLEXUSA 20101022 CELLEXUSA 40172 20100625 CELLEXUSA 40173 40174 20100625 CELLEXUSA 40175 20101029 CELLEXUSA 40176 20101026 CELLEXUSA 40177 20101029 CELLEXUSA 40178 20101130 CELLEXUSA 40179 20100625 CELLEXUSA 40180 20100927 CELLEXUSA 20101130 CELLEXUSA 40181 20101201 CELLEXUSA 40182 20101201 CELLEXUSA 140183 CELLEX 40111 20090327 CELLEX 40112 2009 1005 CELLEX 40113 20090327 CELLEX 40114 20090326 I CELLEX 40116 20090330 CELLEX 40118 20090522 CELLEX 40119 20090423 CELLEX 40120 20090522 CELLEX 40121 20090522 CELLEX 40124 200906 12 CELLEX 40125 20090603 CELLEX 40126 20090612 CELLEX 40127 20090604 CELLEX 40128 2009 1028 CELLEX 40131 20091002 CELLEX 40132 2009 10 15 CELLEX 40135 2009 10 15 CELLEX 40138 2009 11 10 CELLEX 40139 2009 1029 CELLEX 40140 2009 1026 CELLEX I 40144 2009 1029 CELLEX 40145 20091029 CELLEX 40147 2009 12 18 CELLEX 140148 2009 12 18 CELLEX 40149 2009 :12 18 CELLEX 40150 2009 12 18 CELLEX 40153 1201002 19 CELLEX 40155 201002 i9 CELLEX 40157 20100219 CELLEX 40164 20100323 CELLEX 40167 20100528 CELLEX 40184 20100920 CELLEX 40185 20100929 CELLEX 40186 2010 1021 CELLEX 40187 2010 10 26 CELLEX 40188 2010 1029 CELLEX 40190 20101223 CELLEX 40191 2010 1223 CELLEXUSA 40189 20100625 CELLEXUSA 40207 20110517 20110531 20101229 20110615 20110809 20110810 20110818 I CELLEXUSA 40208 CELLEXUSA 140209 ICELLEXUSA 40210 CELLEXUSA 40211 CELLEXUSA 40212 CELLEXUSA 40213 CELLEXUSA 40215 CELLEXUSA 40216 CELLEXUSA 40224
RECALLING FIRM/MANUFACTURER
Therakos, Inc., Raritan, NJ, by letter dated September 1, 2011. Firm initiated recall is ongoing.
REASON
There have been three confirmed reports of post reinfusion hemolysis or hemoglobinuria in patients treated on the Therakos Cellex Photopheresis System.
VOLUME OF PRODUCT IN COMMERCE
49 Nationwide, 65 Internationally
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Midmark M11 Ultra Steam Sterilizer. Sterilize reusable equipment that is heat and moisture stable. Model #'s: M11-001, M11D-001, M11-001R, M11D-002, M11-002, M11-002R, M11-003, M11-004, M-005, and M11-006. Recall # Z-0597-2012
CODE
None
RECALLING FIRM/MANUFACTURER
Midmark Corp., Versailles, OH, by letters the week of January 9, 2012. FDA Initiated recall is ongoing.
REASON
During and FDA inspection on 8/23/2011, it was discovered that the firm received numerous reports of the steam sterilizer malfunctioning.
VOLUME OF PRODUCT IN COMMERCE
30,255 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) OPUS Magnum 2 Plus Implant Product Number OM-1502 is a bone anchor Intended for rotator cuff repair in the shoulder. Recall # Z-0608-2012;
 
2) OPUS Magnum 2 Plus Implant Product Number OM-9026 is one of two kits Intended for rotator cuff repair. Recall # Z-0609-2012;
 
3) OPUS Magnum 2 Plus Implant Product Number OM-9027 is one of two kits with product number OM-1502 Intended for rotator cuff repair.  Recall # Z-0610-2012;
 
4) OPUS SpeedStitch Product Number OM-8086 is a suture cartridge. For use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. Recall # Z-0611-2012;
 
5) OPUS SmartStitch Product Number OM-8178 is a suture cartridge; for use in approximation and/or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries. Recall # Z-0612-2012;
 
6) OPUS SmartStitch M-Connector Product Number OM-8007 is a suture passer. Recall # Z-0613-2012;
 
7) OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor intended to be used for fixation of soft tissue to bone. Recall # Z-0614-2012;
 
8) 3.0mm 45 Degree Beval with cable Product Number AC2430-01 is an ablation wand.
Recall # Z-0615-2012;
 
9) SideWinder Hip Wand Product Number AC2340-01 is an ablation wand intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0616-2012;
 
10) MultiVac Tristar 50 Product Number AS4630-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0617-2012;
 
11) CoVac 50 Product Number AS2530-01 is an ablation wand intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0618-2012;
 
12) CoVac 70 Product Number AS3730-01 is an ablation wand intended for resection, ablation, and coagulation of soft tissues and hemostasis of blood vessels in arthroscopic procedures. Recall # Z-0619-2012;
 
13) 3.0mm 45 Degree bevel Part Number A2430-01 is an ablation wand intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0620-2012;
 
14) 3.5mm 90 Degree Part Number A1335-01 is an ablation wand intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0621-2012
 
15) Saber 30 Part Number A4330-01 is an ablation wand Indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0622-2012;
 
16) Turbo Vac 90 with Cable Part Number ASC1335-01 is an ablation wand Indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall #Z-0623-2012;
 
17) Lancelot 90 Degree with Cable Part Number ASC4145-01 is an ablation wand. Recall # Z-0624-2012;
 
18) 90 Degree LoPro with Cable Part Number AC1336-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures. Recall # Z-0625-2012;
 
19) 3.0 60 Degree wand Part Number A2530-01 is an ablation wand Intended for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels. Recall # Z-0626-2012;
 
20) 5.0 mm Parafix Part Number 22-5011 is a suture anchor metal Intended for rotator cuff repair. Recall # Z-0627-2012;
 
21) OPUS Minimagnum Implant Part Number OM-2500 is a bone anchor Intended for rotator cuff repair. Recall # Z-0628-2012
CODE
1) Lot Numbers 120761, 120570, 120760, 120010, 1191150, and 120755;
2) Lot Number 114499;
3) Lot Number 114516;
4) Lot Numbers 1000044 and 1000162;
5) Lot Number 121748;
6) Lot Numbers 113086, 107304, 110511, and 112473;
7) Lot Number 1004579;
8) Lot Number Q833660-A;
9) Lot Number M305780-A;
10) Lot Numbers 5604941-2 and 5600411;
11) Lot Numbers 3018831-2 and 3014221;
12) Lot Number 3526250-A;
13) Lot Number 1324341-2;
14) Lot Numbers 0933831-2, 093534102, and 5L14150-A;
15) Lot Numbers 2711631, 2715201, and 2726711;
16) Lot Numbers 4C05970-A and 4C03160-C;
17) Lot Number N009660-A;
18) Lot Number Q732460-A;
19) Lot Number 1424970-A;
20) Lot Number 205091;
21) Lot Numbers 110730, 110874, 110400, 119256 and 117489
RECALLING FIRM/MANUFACTURER
Recalling Firm: Innovatech Medical Resources L.P., Midlothian, TX, by visit beginning August 8, 2011.
Manufacturer: ArthroCare Corp., Sunnyvale, CA. Firm initiated recall is ongoing.
REASON
Product is being removed from the field due to an over-label issue.
VOLUME OF PRODUCT IN COMMERCE
150 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Octopus 900. Product Usage: The OCTOPUS 900 Perimeter is designed for the examination, analysis and documentation of the field of sight, especially the light difference sensitivity and other functions of the human eye. Recall # Z-0638-2012
CODE
S/N's: 159, 231, 279, 313, 314, 315, 336, 338, 478, 479, 484, 485, 559, 560,561, 562, 563, 642, 644, 645, 646, 647, 648, 649, 650, 651, 772, 773, 774, 775, 776, 777, 797, 798, 804, 805, 806, 807, 808, 813, 814, 839, 840, 841, 842, 843, 844, 868, 869, 870, 871, 872, 873, 874, 903, 904, 905, 907, 908, 909, 910, 911, 956, 957, 958, 959, 975, 983, 984, 985, 986, 987, 1002, 1003, 1004, 1005, 1006, 1007, 1008, 1034, 1035, 1036, 1037, 1038, 1059, 1060, 1061, 1062, 1063, 1064, 1065, 1066, 1117, 1118, 1119, 1120, 1140, 1141, 1143, 1152, 1162, 1163, 1164, 1166, 1199, 1200, 1201, 1202, 1239, 1240, 1241, 1262, 1263, 1286, 1287, 1288, 1307, 1308, 1401, 1402, 1403, 1404, 1405, 1424, 1425, 1426, 1458, 1459, 1460, 1480, 1481, 1482, 1483, 1484, 1543, 1545, 1546, 1550, 1552, 1553, 1554, 1555, 1556, 1560, 1561, 1562, 1563, 1564, 1579, 1580, 1581, 1582, 1583, 1586, 1587, 1588, 1589 and 1591
RECALLING FIRM/MANUFACTURER
Recalling Firm: Haag-Streit USA Inc., Mason, OH, by letter dated November 11, 2011.
Manufacturer: Haag Streit Ag, Koeniz, Switzerland. Firm initiated recall is ongoing.
REASON
Currently there is a possibility, at the start of the perimetry examination, for the background illumination of the cupola not to turn on. If no illumination of cupola occurs, data obtained from the examination could provide the doctor with results that would appear to be better than actual.
VOLUME OF PRODUCT IN COMMERCE
158 units
DISTRIBUTION
Nationwide and Mexico
___________________________________
PRODUCT
1) Dimension(R) Vista(R) V-LYTE(R) Standard A (K820) Product Usage: V-LYTE(R) Standard A is for the calibration of NA, K, and CL on the Dimension Vista(R) system.
Recall # Z-0644-2012;
 
2) Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825) Product Usage: V-LYTE(R) Standard B/Salt Bridge is for the calibration and measurement of NA, K, and CL on the Dimension Vista(R) system. Recall # Z-0645-2012;
 
3) Dimension(R) Vista(R) V-LYTE(R) Diluent (K835) Product Usage: V-LYTE(R) Diluent is for the automatic dilution of samples processed in the V-LYTE(R) Integrated Multisensor on the Dimension Vista(R) system. Recall # Z-0646-2012
CODE
1) Lot number KA1G01, KA1H01, and KA1J01;
2) Lot number KB1G02, KB1J01, and KB1K01;
3) Lot number KE1H01, KE1J01, and KE1K01
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated October, 2011. Firm initiated recall is ongoing.
REASON
Firm has confirmed that specific lots of V-LYTE(R) Fluids may contribute to reduced V-LYTE(R) Integrated Multisensor on-board use life as demonstrated by increases in: Urine sodium QC results within 48 hours after installation of a new IMT sensor. The results can be elevated approximately 10-20% which may cause QC recovery being out of acceptable ranges. Patient Urine sodium results may also be significantly affected. Serum sodium QC may show an upward trend of up to 6 mmol/L for the serum QC.
VOLUME OF PRODUCT IN COMMERCE
19,524 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Synthes Drill Bit for 5.0mm Recon Screws with Large Quick Coupling. This orthopedic manual surgical instrument is a non powered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. Model number 03.010.228. Recall # Z-0676-2012
CODE
All lot numbers.
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester, PA, by letters on November 2, 2011. Firm initiated recall is ongoing.
REASON
Synthes is initiating a recall of the Drill Bit for 5.0mm Recon Screws with large Quick Coupling due to the potential for the drill stop to slip on the drill bit.
VOLUME OF PRODUCT IN COMMERCE
577 units
DISTRIBUTION
Nationwide
 
RECALLS AND FIELD CORRECTIONS: DEVICES – CLASS III
___________________________________
PRODUCT
Step 2, 3000-22000 GPD (Sodium Hydroxide 2.0N) cleaning solution. 4 oz plastic bottle. The Step 2, 3000-2000 GPD chemical is used in the cleaning procedures for the Isopure MD400 Series Reverse Osmosis System. Recall # Z-0190-2012
CODE
Lot # 11IC002, Serial #'s: 11IC00210 - 11IC002294
RECALLING FIRM/MANUFACTURER
Recalling Firm: Isopure Corp., Simpsonville, KY, by letter dated October 24, 2011.  
Manufacturer: Di-Chem Inc., Champlin, MN. Firm initiated recall is ongoing.  
REASON
The cleaning solution Step 2, 3000-22000 GPD labeled bottles (NaOH) were filled with Step 1, 3000-22000 GPD chemical (HCl).
VOLUME OF PRODUCT IN COMMERCE
91 cs/12/4 oz plastic bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
TUM-E-VAC Ethox International. Intended use: gastric lavage. Recall # Z-0271-2012
CODE
LOT 031123255
RECALLING FIRM/MANUFACTURER
Ethox International, Inc., Buffalo, NY, by letter dated March 25, 2011. Firm initiated recall is ongoing.
REASON
Ethox Tum-E-Vac Gastric Lavage Kit #2075 is labeled with expiration date symbol and date of 2010/10 on the unit product label. The carton is labeled with a manufacturing date symbol and date of 2010/10. The Ethox Tum-E-Vac Gastric Lavage Kit #2075 does not have an expiration date.
VOLUME OF PRODUCT IN COMMERCE
130 units
DISTRIBUTION
Nationwide
 
END OF ENFORCEMENT REPORT FOR JANUARY 11, 2012.
 
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