Enforcement Report for January 11, 2012

1. Lot codes: 1130700023, 1129000055;
2. Lot codes: 1129000043, 1130400209

1. Lot # 72281-00;
2. lot # 40302;
3. lot # F7073

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

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.

1. Lot 10068948, Exp 03/12.
2. Lot 10084053, Exp 12/12.

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.

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.

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

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

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

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

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

1. Lot # Y04033, Exp 12/12;
2. Lot # Y05037, Exp 05/13

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

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

1. Unit: W141607086940;
2. Unit: W141607134612;
3. Unit: W141607132693;
4. Units: W141607982838; W141607083042

1. Cryoprecipitated AHF. Recall # B-0352-12;
2. Red Blood Cells Leukocytes Reduced. Recall # B-0353-12

1. Red Blood Cells Leukocytes Reduced. Recall # B-0356-12;
2. Plasma Frozen. Recall # B-0357-12

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

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

1. Cryoprecipitated AHF. Recall # B-0387-12;
2. Recovered Plasma. Recall # B-0388-12

1. Units: 8324252, 8322169, 8326106;
2. Units: 8326106, 8324252, 8322169, 6399450, 6396748

1. Flow PRA Class I Positive Control Serum. Recall # B-0487-12;
2. Flow PRA Class II Positive Control Serum. Recall # B-0488-12

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

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

1. Lot 887628-5;
2. Lot 848478

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

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

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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

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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. 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. 1. Lot #: 074349P;
   2. Lot #: 073995PA, 077870PB;
   3. 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

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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

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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

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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

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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

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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
1. Lot # 1364, 1731, 1862;
2. 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

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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

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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

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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

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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

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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

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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

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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 20110531201012292011061520110809 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

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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

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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

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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

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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

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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

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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

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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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