Safety
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Enforcement Report for September 7, 2011
September 7, 2011 11-36
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
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PRODUCT
The products a frozen gyoza containing seafood that was mistakenly packaged in bags labeled as vegetable gyoza. Each bag contains a tray of 12 dumplings and each case contains 20 bags. The label reads in part: "AJINOMOTO FROZEN FOODS Vegetable Gyoza Dumplings***Net wt. 8.47 oz (240g)/ 12 pcs. Ingredients: Cabbage, Wheat Flour***Textured Soy Protein***Egg Whites**". Each bag/tray has a UPC of: 0-71757-05548-3. Each case has a UPC of: 1-00-71757-05549-7. Recall # F-1664-2011
CODE
Each bag has an ink-jet code of: 231751. Each case has a lot code of: 231751. Code Breakdown: 23=Japan Emperor Year; 175=Julian Date (6/24/2011); 1=batch number.
RECALLING FIRM/MANUFACTURER
Ajinomoto Frozen Foods U.S.A., Inc., Portland, OR, by e-mail, telephone, letter and press release on August 19, 2011. Firm initiated recall is ongoing.
REASON
Product mislabeled, contains undeclared allergens.
VOLUME OF PRODUCT IN COMMERCE
1206 cases each containing 20 8.47oz bag/trays (24120 bags/trays.)
DISTRIBUTION
Nationwide
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PRODUCT
Nonfat New York Cheesecake Frozen Yogurt Mix is a soft serve frozen yogurt mix with a New York Cheesecake flavor. It is being used in food service or yogurt manufacturers. It is packaged in a half gallon paperboard carton, 6 cartons/case. Net Wt. 4.55 lb/carton. This product has an Item Number 92147. The UPC is 81995 92147. The product is labeled in parts: "***YOCREAM***Non Fat Frozen Yogurt***Soft Serve Mix***Half Gallon***New York Cheese Cake Ingredients: Pasteurized and Cultured Skim Milk, Sucrose, Corn Sweetener, Cheesecake Base (Water, Corn Syrup, High Fructose Corn Syrup, Sugar, Modified Food Starch, Non Fat Dry Milk, Milk, Skim Milk, Cheese (Pasteurized Non Fat Milk & Enzyme), Maltodextrin, Citric Acid, Natural & Artificial Flavor, Partially Hydrogenated Vegetable Oil, Whey, Lactic Acid, Non Fat Milk, Titanium Dioxide (Color), Tragacanth Gum, Turmeric and Yellow #6 (Color), Sucrose, Corn Sweetener, Whey, Non Fat Dry Milk, Milk Protein Isolate, Cellulose Gum, Guar Gum, Carrageenan, Mono & Diglycerides. Allergen Info: Contain Milk***". Recall # F-1665-2011
CODE
Lot codes: 0391, 0461, 0591, 0731, 0871, 0961, 1131, 1171, 1231, 1291, 1541, 1661, 1811, 1921, 2061, 2131, 2990, 3200, 3470, and 3520. Expiration dates: April 26, 2013; May 16, 2013; June 13, 2013; June 18, 2013; August 8, 2013; August 15, 2013; August 28, 2013; September 14, 2013; September 28, 2013; October 6, 2013; October 23, 2013; October 27, 2013; November 3, 2013; November 9, 2013; December 3, 2013; December 15, 2013; December 30, 2013; January 11, 2014; January 25, 2014; February 1, 2014; and February 19, 2014. -Code description: 4-digit lot code is an ordinal date followed by the last digit of the current year. Date corresponds to the date of manufacture. -Expiration dates: Expiration date is 30 months from the date of manufacture when kept frozen; 21 days from the point the product begins to be thawed for use.
RECALLING FIRM/MANUFACTURER
YoCream International, Inc., Portland, OR, by letters beginning on August 20, 2011 and by press release on August 23, 2011. Firm initiated recall is ongoing.
REASON
Undeclared allergen: Product contains egg but the ingredient statement does not declare egg.
VOLUME OF PRODUCT IN COMMERCE
69,538 cases (6 cartons per case)
DISTRIBUTION
Nationwide and Canada
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PRODUCT
The papayas are individually labeled - 1) Blondie 4395 Mexico, 2) Yaya Premium Papayas 4395 Mexico, 3) Mexico Maanita 4395, 4) 4395 Tastylicious MEXICO, The papaya cases are labeled - 5) Tropical Fruits, 6) Tropical MAYA, packed a generic, plain brown cardboard box. Recall # F-1666-2011
CODE
All product on the market.
RECALLING FIRM/MANUFACTURER
Agromod Produce, Inc., McAllen, TX, by press release on July 23, 2011. FDA initiated recall is ongoing.
REASON
The papayas have the potential to be contaminated with Salmonella Agona.
VOLUME OF PRODUCT IN COMMERCE
488,303 cases
DISTRIBUTION
Nationwide and Canada
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PRODUCT
Fresh packed strawberries stored in 1-pint cardboard containers with twelve 1-pint cardboard containers per cardboard case. There is no grower information provided on labels. Recall # F-1667-2011
CODE
No codes available. All berries were picked between 6/10/2011 and 7/29/2011 and were distributed within 24-hours of being picked.
RECALLING FIRM/MANUFACTURER
Jaquith Strawberry Farm, Newberg, OR, by telephone and press release on August 8, 2011, and by press release on August 11, 2011. Oregon initiated recall is ongoing.
REASON
Potential contamination with E.coli 0157:H7.
VOLUME OF PRODUCT IN COMMERCE
25,526.5 crates of strawberries and 4000 lbs. picked by local farmers
DISTRIBUTION
OR, WA
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PRODUCT
Miss Bonnie's Gourmet Classic Cheddar Cheese Spread, packaged in 8 oz, glass jars, 12 (10 - 8 oz. jars and 2 - 8 oz. sample tubs)/case. Recall # F-1668-2011
CODE
Lot # 0116206G113 Best By DEC 23 2011
RECALLING FIRM/MANUFACTURER
Miss Bonnie's Gourmet, LLC, Winchester, VA, by e-mail and press release on August 11, 2011. Virginia initiated recall is complete.
REASON
Cheese spread is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
75 cases
DISTRIBUTION
IN
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PRODUCT
Monterey Bay Spice Company Sage, c/s Organic; Salvia oifficinalis; Packaged in 1 lb (454 grams) and 0.25 lb sealed plastic bags. Recall # F-1669-2011
CODE
Lot # 10L347-1002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Monterey Bay Spice CO., Santa Cruz, CA, by telephone on August 18, 2011, and by a letter sent by e-mail, fax or mailed on August 22, 2011.
Manufacturer: American Natural & Organic Spices, Inc., Fremont, CA. Firm initiated recall is ongoing.
REASON
Organic Sage supplied by American Natural & Organic Spices is under recall for Salmonella.
VOLUME OF PRODUCT IN COMMERCE
564.85 lbs
DISTRIBUTION
CA, PA, NJ, MA, GA, IL, LA, NV, OR, OH, FL, SC, CO, WA, IA, MI, MD, VA, AZ and Hong Kong
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PRODUCT
1) Paleteria La Super NUT is a flavored ice cream bar on a wooden stick. This product contains walnuts. It is packaged in a clear plastic wrapper, and a net weight is 3.5 oz. There is no UPC code on package. The product is labeled in parts: "***Paleteria La Super***NUT***Net wt 3.5 oz (103 mls)***Ingredients: Water, Milk cream sugar, corn syrup, solids, non fat dry milk, whey, guar gum, carob bean gum, lecithin, dextrose, carrageenan, sugar, shredded nut, and artificial flavor". Recall # F-1670-2011;
2) Paleteria La Super Esquimal is a flavored ice cream bar on a wooden stick. It is packaged in a clear plastic wrapper, and a net weight is 3.5 oz. The product is labeled in parts: "Paleteria La Super***Esquimal***Net wt 3.5 oz (103 mls), Ingredients: Vanilla, chocolate, coconut, peanuts, water, sugar, ice cream mix, artificial flavors and color". Recall # F-1671-2011
CODE
No codes
RECALLING FIRM/MANUFACTURER
Paleteria La Super, Yakima, WA, by visit on August 16, 2011 and by press release on August 18, 2011, FDA initiated recall is ongoing.
REASON
Products contains undeclared allergens.
VOLUME OF PRODUCT IN COMMERCE
1) 352 units; 2) 200 units
DISTRIBUTION
WA
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS II
1) Assorted Creme Pies (Sugar Free/No Added Sugar), 9", KEEP FROZEN UNTIL USED, Avg Net Wt: Varies, 4, 6, or 8 units/case; Item 7065880. Recall # F-0806-2011;
2) Banquet Carmel Apple Pecan Pie, Baked, 10", KEEP FROZEN UNTIL USED, Avg. Net Wt: 47 oz., 4, 6, or 8 units/case; Item 7065700. Recall # F-0807-2011;
3) Blueberry Pie, No Added Sugar, Baked, 10", KEEP FROZEN UNTIL USED, Avg. Net Wt: 45 oz., 4, 6, or 8 units/each; Item 7100620. Recall # F-0808-2011;
4) Chocolate Creme Banquet Pie, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 32 oz., 4, 6, or 8 units/each. Item 7150460. Recall # F-0809-2011;
5) Coconut Creme Banquet Pie, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 33 oz., 4, 6, or 8 units/each; Item 7150420. Recall # F-0810-2011;
6) Dutch Apple Pie, 10", Preheat oven to 350 degrees, top frozen pie with milk and dust with sugar. Bake on baking sheet for 90 minutes, cool and serve. Note baking time may vary. Avg. Net Wt: 47 oz. Item 7066230. Recall # F-0811-2011;
7) Pecan Pie, Banquet, 10", KEEP FROZEN UNTIL USED, Avg. Net Wt: 45 oz. Item 7064870. Recall # F-0812-2011;
8) Lemon Meringue Banquet Pie, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 33 oz., 4, 6, or 8 units/case. Item 7150480, Recall # F-0813-2011;
9) Rhubarb Pie, 10", Unbaked, Preheat oven to 350 degrees, top frozen pie with milk and dust with sugar. Bake on baking sheet for 90 minutes, cool and serve. Note baking time may vary. Avg. Net Wt: 46 oz. Item 7066440. Recall # F-0814-2011;
10) Strawberry Rhubarb Pie, Unbaked, 10", Preheat oven to 350 degrees, top frozen pie with milk and dust with sugar. Bake on baking sheet for 90 minutes, cool and serve. Note baking time may vary. Avg. Net Wt: 46 oz. Item 7110100. Recall # F-0815-2011;
11) Cherry Almond Bread, KEEP FROZEN UNTIL USED, Avg. Net Wt. 5 lbs. 4, 6, or 8 units/case,Item 7155080. Recall # F-0816-2011;
12) Lemon Bread, KEEP FROZEN UNTIL USED, Avg. Net Wt. 5 lbs. 4, 6, or 8 units/case’ Item 7155060. Recall # F-0817-2011;
13) Pound Bread, KEEP FROZEN UNTIL USED, Avg. Net Wt. 5 lbs. 4, 6, or 8 units/case, Item 7155220. Recall # F-0818-2011;
14) Apple Cinnamon Scone, 12-4 oz pies, unbaked, Avg. Net Wt: 48 oz., BAKING INSTRUCTIONS: Conventional Oven: Bake from frozen state at 385 degrees for 20-25 minutes. Check after 15 minutes for even browning. Convection Oven: Bake from a frozen state at 325 degrees for 30-35 minutes. Check after 20 minutes for even browning. Brush top with egg wash & coarse sugar for effect prior to baking, Item 7064290. Recall # F-0819-2011;
15) Blueberry Scone, 12-4 oz pies, unbaked, BAKING INSTRUCTIONS: Conventional Oven: Bake from a frozen state at 385 degrees for 20-25 minutes. Check after 14 minutes for even browning. Convection Oven: Bake from a frozen state at 325 degrees for 30-35 minutes. Check after 20 minutes for even browning. Brush top with egg wash and coarse sugar for effect prior to baking, Avg. Net Wt: 48 oz. Item 7064260. Recall # F-0820-2011;
16) Butterscotch Pecan Scone, 12-4 oz pies, unbaked, BAKING INSTRUCTIONS: Conventional Oven: Bake from a frozen state at 385 degrees for 20-25 minutes. Check after 15 minutes for even browning. Convection Oven: Bake from a frozen state at 325 degrees for 30-35 minutes. Check after 20 minutes for even browning. Brush top with egg wash & coarse sugar for effect prior to baking. Avg. Net Wt: 48 oz. Item 7064280. Recall # F-0821-2011;
17) Cranberry Citrus Scone, 12-4 oz pies, unbaked, BAKING INSTRUCTIONS: Conventional Oven: Bake from a frozen state at 385 degrees for 20-25 minutes. Check after 15 minutes for even browning. Convection Oven: Bake from a frozen state at 325 degrees for 30-35 minutes. Check after 20 minutes for even browning. Brush top with egg wash & coarse sugar for effect prior to baking. Avg. Net Wt: 48 oz. Item 7064310. Recall # F-0822-2011;
18) Maple Rum Raisin Scone, 12-4 oz pies, unbaked, BAKING INSTRUCTIONS: Conventional Oven: Bake from a frozen state at 385 degrees for 20-25 minutes. Check after 15 minutes for even browning. Convection Oven: Bake from a frozen state at 325 degrees for 30-35 minutes. Check after 20 minutes for even browning. Brush top with egg wash & coarse sugar for effect prior to baking. Avg. Net Wt: 48 oz. Item 7064200. Recall # F-0823-2011;
19) Cherry Almond Cobbler, No Added Sugar, BAKING INSTRUCTIONS: Conventional Oven: 400 degrees, Bake for 20 to 25 minutes from frozen state, Item 7066120. Recall # F-0824-2011;
20) Butterscotch Cookie, Sugar Free, Unbaked, 192 CT-1.5 oz. each. Cookies should be baked from a frozen state; do not thaw. Conventional oven: 385 degrees. Total baking time 5-7 minutes. Check for doneness after 5 minutes. Convection oven: 325 degrees. Total baking time 10-12 minutes. Check for doneness after 7 minutes. Avg. Net Wt: 18 lbs. Item 7077340. Recall # F-0825-2011;
21) Chocolate Chunk Cookie, Sugar Free, Unbaked, 192 CT- 1.5 oz. each, Cookies should be baked from a frozen state: do not thaw. Conventional oven: 385 degrees. Total baking time 5-7 minutes. Check for doneness after 5 minutes. Convection oven: 325 degrees. Total baking time 10-12 minutes. Check for doneness after 7 minutes. Avg. Net Wt: 18 lbs. Item 7077300. Recall # F-0826-2011;
22) Coconut White Chocolate Macademia Cookie Sugar Free, Unbaked, 192 CT - 1.5 oz. Each, ALL COOKIES SHOULD BE BAKED FROM A FROZEN STATE AND NOT ALLOWED TO THAW. THE FOLLOWING ARE RECOMMENDED BAKING TIMES AND TEMPERATURES. CONVENTIONAL: 385 DEGREES FOR 5-7 MINUTES. CONVECTION: 325 DEGREES FOR 10-12 MINUTES, Avg. Net Wt: 18 lbs. Item 7077420. Recall # F-0827-2011;
23) Cookie Bar- Cookies 'n Cream, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 6 lbs. Item 7110220. Recall # F-0828-2011;
24) Cookie Bar- Lemon Delight, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 6 lbs. Item 7110320. Recall # F-0829-2011;
25) Cookie Bar- M & M's, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 6 lbs. Recall # F-0830-2011;
26) Cookie Bar- Peanut Butter Cup, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 6 lbs. Item 7110200. Recall # F-0831-2011;
27) Cookie Bar- Raspberry, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 6 lbs. Item 7110300. Recall # F-0832-2011;
28) Cookie Bar- Snickers Pieces, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 6 lbs. Item 7110280. Recall # F-0833-2011;
29) Cookie Bar- Toffee Pieces, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 6 lbs. Item 7110260. Recall # F-0834-2011;
30) Maple Pecan Cookies, Sugar Free, Unbaked, 192 CT - 1.5 oz. each, Cookies should be baked from a frozen state; do not thaw. Conventional oven: 385 degrees. Total baking time 5-7 minutes. Check for doneness after 5 minutes. Convection oven: 325 degrees. Total baking time 10-12 minutes. Check for doneness after 7 minutes. Avg. Net Wt: 18 lbs. Item 7077260. Recall # F-0835-2011;
31) Oatmeal Walnut Cookie, Sugar Free, Unbaked, 192 CT - 1.5 oz. each, Cookies should be baked from a frozen state; do not thaw. Conventional oven: 385 degrees. Total baking time 5-7 minutes. Check for doneness after 5 minutes. Convection oven: 325 degrees. Total baking time 10-12 minutes. Check for doneness after 7 minutes. Avg. Net Wt: 18 lbs. Item 7077220. Recall # F-0836-2011;
32) Peanut Butter Cookie, Sugar Free, Unbaked, 192ct - 1 oz. each, Cookies should be baked from a frozen state; do not thaw. Conventional oven: 385 degrees. Total baking time 5-7 minutes. Check for doneness after 5 minutes. Convection oven: 325 degrees. Total baking time 10-12 minutes. Check for doneness after 7 minutes. Avg. Net Wt: 18 lbs. Item 7077380. Recall # F-0837-2011;
33) Pumpkin Roulade Roll, KEEP FROZEN UNTIL USED, Avg. Net Wt: 39 oz., 4, 6, or 8 units/case. Item 7069240. Recall # F-0838-2011;
34) Amaretto White Chocolate Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 61 oz, 4, 6, or 8 units/case; Item 7060750. Recall # F-0839-2011;
35) Individual Strawberry Shortcake 3", KEEP FROZEN UNTIL READY TO USE, Avg. Net Wt: 5 oz., 9 CAKES PER BOX 36 CAKES PER CASE. Item 7156000. Recall # F-0840-2011;
36) Karmel Apple Tart No Added Sugar, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 33 oz, 4, 6, or 8 units/case. Item 7065840. Recall # F-0841-2011;
37) Banana Fudge Cake 10", 3 Layer Uncut, Avg. Net Wt: 76 oz, 8, 10, 12, 14, 16, or 20 cuts. Item 7152260. Recall # F-0842-2011;
38) Banana Split Cake, 10", 2 Layer, 14 cut, KEEP FROZEN UNTIL USED, SERVING CUTS: 14, 4, 6, or 8 units/case. Item 7152400. Recall # F-0843-2011;
39) Blueberry Crumbcake, KEEP FROZEN UNTIL USED, Avg. wt. 5 lbs, Item: 7157060. Recall # F-0844-2011;
40) Butterscotch Fudge Cake, 10", 2 Layer, 14 SERVING CUTS, KEEP FROZEN UNTIL USED, Avg. Net Wt: 66 oz, 4, 6, or 8 units/case; Item 7152160. Recall # F-0845-2011;
41) Carmel Banana Cake, 10", 2 Layer, 14 Cut, KEEP FROZEN UNTIL USED, Avg. Net Wt: 44 oz, 4, 6, or 8 units/case; Item 7152440. Recall # F-0846-2011:
42) Carmel Banana Cake, 10", 2 Layer, Uncut, KEEP FROZEN UNTIL USED, Avg. Net Wt: 44 oz, 4, 6, or 8 units/case; Item 7154400. Recall # F-0847-2011;
43) Carmel Pecan Cake 10", 3 Layer, Uncut, Avg. Net Wt: 65 oz, 8, 10, 12, 14, 16, or 18 Cuts. Item 7151120. Recall # F-0848-2011;
44) Chocolate Cake with Chocolate Icing, Sugar Free, 1/2 Sheet, Avg. Net Wt: 5.5 lbs., 8, 10, 12, 14, 16, 20 Cut. Item 7150340. Recall # F-0849-2011;
45) Chocolate Decadence Cake, 10", 5 Layer, KEEP FROZEN UNTIL USED, Avg. Net Wt: 92 oz, 4, 6, or 8 units/case. Item 7151040. Recall # F-0850-2011;
46) Chocolate Mousse with Peanuts Cake, 10", 3 Layer, Uncut, KEEP FROZEN UNTIL USED, Avg. Net Wt: 56 oz, 4, 6, or, 8 units/case. Item 7151140. Recall # F-0851-2011;
47) Chocolate Mint Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 63 oz., 4, 6, or 8 units/case. Item 7060830. Recall # F-0852-2011;
48) Chocolate Rasberry Cake, 10", 2 Layer, SERVING CUTS: 14, KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz, 4, 6, or 8 units/case. Item 7152200. Recall # F-0853-2011;
49) Chocolate Raspberry Cake, 10", 2 Layer, Uncut, KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz, 4, 6, or 8 units/case. Item 7154440. Recall# F-0854-2011;
50) Cookies N Cream Cake 10", 3 Layer, Uncut, KEEP FROZEN UNTIL USED, Avg. Net Wt: 67 oz., 4, 6, or 8 units/case. Item 7065600. Recall # F-0855-2011;
51) Double Berry, 10" 2 Layer, Uncut, KEEP FROZEN UNTIL USED, Avg. Net Wt: 83 oz, 4, 6, or 8 units/case. Item 7152460. Recall # F-0856-2011;
52) Double Dutch Chocolate Cake, 10", 2 Layer, 14 Cut, KEEP FROZEN UNTIL USED, Avg. Net Wt: 55 oz, 4, 6, 8 units/case. Item 7152320. Recall # F-0857-2011;
53) German Butter Crumbcake, KEEP FROZEN UNTIL USED, Avg. wt. 5 lbs. Item 7157100. Recall # F-0858-2011;
54) German Chocolate , 10" 2 Layer, 14 Cut, KEEP FROZEN UNTIL USED, 4, 6, or, 8 units/case. Item 7152360. Recall # F-0859-2011;
55) German Chocolate Cake, 10", 5 Layer, Avg. Net Wt: 117 oz, 8, 10, 12, 14, 16, 20 Cuts. Item 7151020. Recall # F-0860-2011;
56) Individual Apple Spice Cakes 3", KEEP FROZEN UNTIL READY TO USE, Avg. Net Wt: 7 oz., 9 CAKES PER BOX 36 CAKES PER CASE. Item 7156020. Recall # F-0861-2011;
57) Individual Carrot Cakes 3", KEEP FROZEN UNTIL READY TO USE, Avg. Net Wt: 5 oz., 9 CAKES PER BOX 36 CAKES PER CASE. Item 7156040. Recall # F-0862-2011;
58) Individual Red Velvet Cakes 3", KEEP FROZEN UNTIL READY TO USE, Avg. Net Wt: 4 oz., 9 CAKES PER BOX 36 CAKES PER CASE, Item 7156080. Recall # F-0863-2011;
59) Key Lime Cake, 10", 3 Layers, Uncut KEY LIME CAKE, 10", Avg. Net Wt: 60 oz, 8, 10, 12, 14, 16, or 20 Cuts, Item 7152280. Recall # F-0864-2011;
60) Lemon Sunrise Cake, 10”, 2 Layer, 14 cut, avg. net Wt: 37 oz. KEEP FROZEN UNTIL USED, 4, 6 or 8 units/case. Recall # F-0865-2011;
61) Lemon Sunrise Cake, 10", 2 Layer, Uncut, 14 CUT, KEEP FROZEN UNTIL USED, Avg. Net Wt: 83 oz, 4, 6, or 8 units/case, Item 7154420. Recall # F-0866-2011;
62) Marble Crumbcake, KEEP FROZEN UNTIL USED, Avg. wt. 5 lbs, Item 7157080. Recall # F-0867-2011;
63) Marble Dutch Chocolate Cake, 10", 2 Layer, 14 Cut, KEEP FROZEN UNTIL USED, Avg. Net Wt: 60 oz, 4, 6, or 8 units/case, Item 7152340. Recall # F-0868-2011;
64) Original Crumbcake, KEEP FROZEN UNTIL USED, Avg. wt. 5 lbs, Item 7157000. Recall # F-0869-2011;
65) Rasberry Crumbcake, KEEP FROZEN UNTIL USED, Avg. wt. 5 lbs, Item 7157040. Recall # F-0870-2011;
66) Red Velvet Cake 10", 2 Layer 14 CUT, KEEP FROZEN UNTIL USED, Avg. Net Wt: 59 oz, 4, 6, or 8 units/case, Item 7152300. Recall # F-0871-2011;
67) Red & White Lace Cake 10", 2 Layer, KEEP FROZEN UNTIL USED, Avg. Net Wt: 55 oz, 4, 6, or 8 units/case, Item 7152420, Recall # F-0872-2011;
68) Sacher Torte Cake, 10", 2 Layer, 14 Cut, KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz, 4, 6, or 8 units/case, Item 7152220. Recall # F-0873-2011;
69) Snickers Cake, 1/2 Sheet, Avg. Net Wt: 4 lbs., 8, 10, 12, 14, 16, or 20 Cuts, Item 7067800. Recall # F-0874-2011;
70) White Cake with White Icing 1/2 Sheet, Avg. Net Wt: 5 lbs., 8, 10, 12, 14, 16, or 20 Cuts, Item 7067820. Recall # F-0875-2011;
71) White Cake with White Icing, Sugar Free, 1/2 Sheet, Avg. Net Wt: 5.5 lbs., 8, 10, 12, 14, 16, or 20 Cuts, Item 7150360. Recall # F-0876-2011;
72) Apple Muffins, 18 CT, Avg. wt. 5 oz., KEEP FROZEN UNTIL USED, Item 7157200. Recall # F-0877-2011;
73) White/ Chocolate Mousse Cake 9", CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to cut product into pieces. Clean knife frequently. Item 7151180. Recall # F-0878-2011;
74) Assorted Muffins, 18 CT, blueberry, cinnamon swirl, apple, KEEP FROZEN UNTIL USED, Avg. wt. 5 oz. Item 7157400. Recall # F-0879-2011;
75) Banana Chip Muffins, 18 ct, KEEP FROZEN UNTIL USED, Avg. wt. 5 oz. Item 7157220. Recall # F-0880-2011;
76) Blueberry Muffins, 18 CT BLUEBERRY MUFFINS, 18 CT, KEEP FROZEN UNTIL USED, Avg. wt. 5 oz, Item 7157240. Recall # F-0881-2011;
77) Carrot Muffins, 18 CT, KEEP FROZEN UNTIL USED, Avg. wt. 5 oz. Item 7157300. Recall # F-0882-2011;
78) Cinnamon Muffins, 18 CT, KEEP FROZEN UNTIL USED, Avg. wt. 5 oz. Item 7157620. Recall # F-0883-2011;
79) Double Chocolate Muffins, 18 CT, KEEP FROZEN UNTIL USED, Avg. Net Wt: 5 oz. Item 7157280. Recall # F-0884-2011;
80) Assorted Mini Cheesecakes, 96 CT, Avg. Net Wt: 50 oz., 8, 10, 12, 14, 16, or 20 cut. Item 7150520. Recall # F-0885-2011;
81) Banana Pudding Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 60 oz., 4, 6, or 8 units/case, Item 7061040. Recall # F-0886-2011;
82) Blueberry Topped Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 63 oz., 4, 6, or 8 units/case. Item 7060794. Recall # F-0887-2011.
83) Apple Topped Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 63 oz., 4, 6, or 8 units/case. Item 7060775. Recall # F-0888-2011;
84) Bourbon Pecan Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 60 oz., 4, 6, or 8 units/case. Item 7061020. Recall # F-0889-2011;
85) Cappuccino French Vanilla Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 59 oz., 4, 6 ,or 8 units/case. Item 7062040. Recall # F-0890-2011;
86) Cappuccino Hazelnut Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 56 oz., 4, 6, or 8 units/case. Item 7062080. Recall # F-0891-2011;
87) Cappuccino White Chocolate Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 59 oz., 4, 6, or 8 units/case. Item 7062020. Recall # F-0892-2011;
88) Caramel Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz., 4, 6, or 8 units/case. Item 7060815. Recall # F-0893-2011;
89) Carmel Apple Cheesecake Bars, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 8.4 lbs. Item 7154140. Recall # F-0894-2011;
90) Cherry Swirl Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 60 oz., 4, 6, or 8 units/case. Item 7060798. Recall # F-0895-2011;
91) Cherry Topped Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 63 oz., 4, 6, or 8 units/case. Item 7060796. Recall # F-0896-2011;
92) Chocolate Chocolate Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 59 oz., 4, 6, or 8 units/case. Item 7060824. Recall # F-0897-2011;
93) Christmas Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz., 4, 6, or 8 units/case. Item 7060828. Recall # F-0898-2011;
94) Coconut Almond Delight Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz., 4, 6, or 8 units/case. Item 7060820. Recall # F-0899-2011;
95) Cranberry Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 63 oz., 4, 6, or 8 units/case. Item 7060834. Recall # F-0900-2011;
96) Crazy Coconut Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz., 4, 6, or 8 units/case. Item 7060832. Recall # F-0901-2011;
97) Crème Brule Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz., 4, 6, or 8 units/case. Item 7060826. Recall # F-0902-2011;
98) Grand Marnier Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz., 4, 6, or 8 units/case. Item 7060838. Recall # F-0903-2011.
99) Irish Cream Cheesecake 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 59 oz., 4, 6, or 8 units/case. Item 7060880. Recall # F-0904-2011;
100) Key Lime Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 59 oz., 4, 6, or 8 units/case. Item 7060900. Recall # F-0905-2011;
101) Key Lime "FDS" Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 88 oz., 4, 6, or 8 units/case. Item 7061860. Recall # F-0906-2011;
102) Lemon Rasberry Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 59 oz., 4, 6, or 8 units/case. Item 7060930. Recall # F-0907-2011;
103) Lemon Zest Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 59 oz., 4, 6, or 8 units/case. Item 7060935. Recall # F-0908-2011;
104) Mint Julep Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz., 4, 6, or 8 units/case. Item 7060950. Recall # F-0909-2011;
105) Peanut Butter Cup Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 60 oz., 4, 6, or 8 units/case. Item 7061140. Recall # F-0910-2011;
106) Pineapple Surprise Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz., 4, 6, or 8 units/case. Item 7061180. Recall # F-0911-2011;
107) Pistachio Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz., 4, 6, or 8 units/case. Item 7061160. Recall # F-0912-2011;
108) Praline Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz., 4, 6, or 8 units/case. Item 7061200. Recall # F-0913-2011
109) Pumpkin Cheesecake Bars, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 6.5 lbs. Item 7154200. Recall # F-0914-2011;
110) Rasberry Cheesecake Bars, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 7.6 lbs. Item 7154080. Recall # F-0915-2011;
111) Rasberry Top Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 60 oz., 4, 6, or 8 units/case, Item 7061400. Recall # F-0916-2011;
112) Rasberry White Chocolate Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 59 oz., 4, 6, or 8 units/case. Item 7061411. Recall # F-0917-2011;
113) Rasberry & White Chocolate "FDS" Cheesecake. 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 90 oz., 4, 6, or 8 units/case. Item 7061820. Recall # F-0918-2011;
114) Rocky Road Cheesecake, KEEP FROZEN UNTIL USED, Avg. Net Wt: 59 oz., 4, 6, or 8 units/case. Item 7061480. Recalling Firm: F-0919-2011;
115) Rocky Road Cheesecake Bars, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 8 lbs. Item 7154120. Recall # F-0920-2011;
116) Strawberry Dream Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 58 oz., 4, 6, or 8 units/case. Item 7061422. F-0921-2011;
117) Strawberry Top Cheesecake, 9", Item 7061424. Recall # F-0922-2011;
118) Triple Chip Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 60 oz., 4, 6, or 8 units/case. Item 7061430. Recall # F-0923-2011;
119) Triple Chocolate Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 60 oz., 4, 6, or 8 units/case. Item 7061434. Recall # F-0924-2011;
120)Triple Chocolate Cheesecake Bars, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of,box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 8 lbs. Item 7154100. Recall # F-0925-2011;
121) Triple Derby Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 60 oz., 4, 6, or 8 units/case. Item 7061432. Recall # F-0926-2011;
122) Triple Strawberry Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 63 oz., 4, 6, or 8 units/case. Item 7061426. Recall # F-0927-2011;
123) Turtle Cheesecake Bar, CUTTING INSTRUCTIONS: For best results, cut product in frozen state. Use hot, moistened knife to separate product from sides of box. Cut corners of box and bend sides down. Use hot, moistened knife to cut product into squares. Clean knife frequently. Avg. Net Wt: 7.75 lbs. Item 7154160. Recall # F-0928-2011;
124) Apple Crumb Cheesecake, 9", KEEP FROZEN UNTIL USED, Avg. Net Wt: 56 oz., 4, 6, or 8 units/case. Item 7060755. Recall #F-0930-2011;
125) Apple Crumbcake, KEEP FROZEN UNTIL USED, Avg. wt. 5 lbs. Item 7157020. Recall # F-0931-2011;
126) Blonde Brownie, 1/2 Sheet, Avg. Net Wt: 5 lbs. Item 7154020. Recall # F-0932-2011;
127) Brownie, Chocolate Topped, Sugar Free, 1/2 Sheet, Avg. Net Wt: 7 lbs. Item 7150080. Recall # F-0933-2011;
128) Iced Fudge Brownie, 1/2 Sheet, Avg. Net Wt: 7 lbs. Item 7158000. Recall # F-0934-2011;
129) Mini Assorted Confectionaries, 96ct, Avg. Net Wt: 64.5 oz., 8, 10, 12, 14, 16, or 20 Cuts. Item 7150500. Recall # F-0935-2011;
130) Apple Banquet Pie, Baked, 10", KEEP FROZEN UNTIL USED, Avg. Net Wt: 48 oz., 4, 6, or 8 units/case. Item 7065600. Recall # F-0936-2011;
131) Apple Pie, No Added Sugar, Baked, 10", KEEP FROZEN UNTIL USED, Avg. Net Wt: 45 oz., 4, 6, or 8 units/case, Item 7100580. Recall # F-0937-2011;
132) Turtle Brownie, 1/2 Sheet, Avg. Net Wt: 5 lbs. Item 7154000. Recall # F-0938-2011;
133) Coconut Crème Pie, 9" No Added Sugar, Contains: Wheat, Milk, Soy. Not a reduced calorie product. Contain: Wheat, Milk, Soy. Net Wt. 35 oz (992g). Ingredients: Sugar Free Non-dairy Whip Topping (water, hydrogenated starch hydrolysate, partially hydrogenated coconut oil, partially hydrogenated palm kernel oil, carbohydrate gum, polysorbate 60, polyglycerol esters of fatty acids, salt, sodium alginate, soy lecithin, artificial flavor, sodium citrate, natural flavor, colored with beta carotene), Milk, Pastry Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Vegetable Shortening (partially hydrogenated vegetable oil [soybean and cottonseed oils]), Corn Starch, Coconut, Maltitol Syrup, Maltodextrin, Nonfat Powdered Milk, Coconut Flavoring, Salt, Key Lime Juice, Sucralose. Item 7065900. Recall # F-0939-2011;
134) Cool Key Lime Pie, 9" Sugar Free, Contains: Wheat, Milk, Eggs, Soy. **Not a reduced calorie product. Net Wt. 30 oz (850g) Ingredients: Sugar Free Non-dairy Whip Topping (water, hydrogenated starch hydrolysate, partially hydrogenated coconut oil, partially hydrogenated palm kernel oil, carbohydrate gum, polysorbate 60, polyglycerol esters of fatty acids, salt, sodium alginate, soy lecithin, artificial flavor, sodium citrate, natural flavor, colored with beta carotene), Pastry Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Key Lime Juice, Vegetable Shortening (partially hydrogenated vegetable oil [soybean and cottonseed oils]), Isomalt, Eggs, Egg Yolks, Unsalted Butter (pasteurized cream and natural flavorings), Maltodextrin, Corn Starch, Clear Gelatin, Nonfat Powdered Milk, Salt, Sucralose. Item 7065780. Recall # F-0940-2011;
135) Peach & Blueberry Cobbler, No Added Sugar, INGREDIENTS: Peaches, Blueberries, Pastry Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Maltodextrin, Mira-thick, Vegetable Shortening (partially hydrogenated vegetable oil [soybean and cottonseed oils]), Peach Emulsion, Key Lime Juice, Polydextrose, Nonfat Powdered Milk, Salt, Sucralose, Cinnamon, Artificial Coloring; UPC: 8 15874 01106 5. Recall # F-0943-2011;
136) Carrot Cake, Uncut, Layers: 3, INGREDIENTS: Carrot Cake Mix (sugar, enriched wheat flour bleached, soybean oil, dextrose, carrots, food starch modified, dry egg yolk, leavening [baking soda, sodium acid pyrophosphate, sodium aluminum phosphate, aluminum sulfate], dry egg whites, natural and artificial flavor, salt, xanthum gum, guar gum, carmel color, corn starch, corn syrup, glycerin, polysorbated 60, propylene glycol, corn oil, wheat starch sulfites), Cream Cheese (pasteurized milk and cream, cheese culture, salt stabilizers [carob bean and/or xanthan and/or guar gum]), Powdered Sugar, White Cake Mix (egg whites, soybean oil, preservatives, leavening [baking soda, sodium acid phosphate, aluminum sulfate, monocalcium phosphate], dry egg yolks, food starch-modified dextrose, mono & diglycerides, sorbitan monostearate, nonfat milk solids, artificial flavor, soy lecithin, cellulose gum, polysorbate 60, xanthum gum, wheat starch, propylene glycol), Canola Oil, Carrots, Salted Butter, Cream Salt (contains milk), Walnuts, Pineapple, Brown Sugar, Vanilla Extract (Madagascar vanilla bean extractives, water, alcohol [35%]), Sugar, Cinnamon, Allspice Ground, Mace Ground, Nutmeg Cloves. UPC: 8 15874 01117 1. Recall # F-0945-2011;
137) Apple Spice Cake, No Added Sugar, Uncut, Layer: 2, Ingredients: Pastry Flour (wheat flour, malted barly flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Cci Apples, Diced Frozen (30lb), Eggs, Half & Half Milk, Canola Oil, Cream Cheese (pasteurized milk and cream, cheese culture, salt stabilizers [carob bean and/or xanthan and/or guar gum]), Maltodextrin, Walnuts, Maltitol, Salted Butter, Cream Salt (contains milk), Vanilla Extract (Madagascar Vanilla bean extractives, water, alcohol [35%]), Apple Flavoring, Baking Soda, Cinnamon, Salt, Baking Powder, Sucralose, Nutmeg. UPC: 8 15874 01012 9. Recall # F-0951-2011;
138) Key Lime Pie, Sugar Free, INGREDIENTS: Sugar Free Non-dairy Whip Topping (water, hydrogenated starch hydrolysate, partially hydrogenated coconut oil, partially hydrogenated palm kernel oil, carbohydrate gum, polysorbate 60, polyglycerol esters of fatty acids, salt, sodium alginate, soy lecithin, artificial flavor, sodium citrate, natural flavor, colored with beta carotene), Cci, Whipped Topping, Instant whip Sugar Free, Pastry Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Key Lime Juice, Vegetable Shortening (partially hydrogenated vegetable oil [soybean and cottonseed oils]), Isomalt, Eggs, Egg Yolks, Unsalted Butter (pasteurized cream and natural flavorings), Maltodextrin, Clear Gelatin, Corn Starch, Nonfat Powered Milk, Salt, Green Coloring, Sucralose.. UPC: 8 15874 01102 7. Recall # F-0952-2011;
139) Karmel Apple Tart, No Added Sugar, INGREDIENTS: Cci Apples, Diced Frozen (30lb), Pastry Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Unsalted Butter (pasteurized cream and natural flavorings), Maltodextrin, Almond Flour, Pecans, Dextrose, Maltitol Syrup, Sugar Free Non-dairy Whip topping (water, hydrogenated starch hydrolysate, partially hydrogenated coconut oil, partially hydrogenated palm kernel oil, carbohydrate gum, polysorbate 60, polyglycerol esters of fatty acids, salt, sodium alginate, soy lecithin, artificial flavor, colored with beta carotene), Maltitol, Eggs, Apple Flavoring, Modified Corn Starch, Margarine (vegetable oil blend [partially hydrogenated soybean and palm oils], water, non-fat dry milk, soy lecithin), Egg Yolks, Polydextrose, Cinnamon, Maple Emulsion, Sucralose, Nutmeg, Rum Emulsion, Vanilla Extract (Madagascar Vanilla bean extractives, water, alcohol [35%]), Carmel Oil, Cci Kosher Salt (10lbs), Unbleached Lecithin, Powdered Egg Whites, Butter Oil, Carmel Coloring. UPC: 8 15874 01232 1. Recall # F-0954-2011;
140) Banana Cream Pie (Sugar Free), 9", Contains: Wheat, Milk, Soy, Net Wt: 35 oz. (992g), **Not a reduced calorie product, INGREDIENTS: Sugar Free Non-dairy Whip Topping (water, hydrogenated starch hydrolysate, partially hydrogenated coconut oil, partially hydrogenated palm kernel oil, carbohydrate gum, polysorbate 60, polyglycerol esters of fatty acids, salt, sodium alginate, soy lecithin, artificial flavor, sodium citrate, natural flavor, colored with beta carotene), Pastry Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Banana Puree, Vegetable Shortening (partially hydrogenated vegetable oil [soybean and cottonseed oils]), Milk, Corn Starch, Banana Flavoring, Nonfat Powdered Milk, Salt, Polydextrose, Artificial Coloring. Item 7065740. Recall # F-0955-2011
CODE
All lots, All Dates and Exp. Dates
RECALLING FIRM/MANUFACTURER
Logan's Luscious Lines, Indianapolis, IN, by letter on March 8, 2011. Firm initiated recall is ongoing.
REASON
Product label does not contain an ingredient list or nutrition facts panel as required by 21 CFR 101.4 and 21 CFR 101.9 respectively. As a result, consumers are unable to assess potential threats of allergens or dietary restrictions.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
IN
___________________________________
PRODUCT
Western Family Ice Cream - Rainbow Sherbet (Orange, Lime, and Raspberry Flavored Sherbets), Net Wt. 5 Quarts (4.73 L), Item #29533, UPC 015400224819. Recall # F-1639-2011
CODE
Best By: 02/28/2012, 05/01/2012, 05/20/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dean Foods, Inc., Dallas, TX, by telephone on August 12, 2011.
Manufacturer: Dean Foods, Inc. dba Meadow Gold Dairies, Orem, UT. Firm initiated recall is ongoing.
REASON
Certified color, Yellow #5, is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
7,310 pails
DISTRIBUTION
MT, UT, WY
___________________________________
PRODUCT
Sweet Bread Ingredients: Flour: Bleached Wheat Flour Enriched (NIACIN, Reduced Iron, Thiamine Monotrate, Riboflavin, FL OIC Acid), Malted Barley Flour, Potassium Bromate, Sugar, Water, 1 or more of the Following Partially Hydrogenated Oils: Soybean, Palm, Cottonseed, Eggs, Compressed Yeast, Salt, Cinnamon, FD&C Yellow # 5, Yellow # 6, Citric Acid, 1% Sodium Benzoate (a Preservative). Vanilla Extract: Artificial Vanilla being used. Ingredients: Water, Proplyene Glycol, Caramel Color, Ethyl Vanilla and Artificial Flavoring. Recall # F-1651-2011
CODE
Sell By date Jul 22, 11
RECALLING FIRM/MANUFACTURER
El Palenque Inc, Fort Worth, TX, by letter on July 19, 2011. FDA initiated recall is ongoing.
REASON
The product contains undeclared pecans.
VOLUME OF PRODUCT IN COMMERCE
25 muffins per day with a shelf life of approximately 4 days
DISTRIBUTION
TX
___________________________________
PRODUCT
Paleteria La Super Pina Colada is a flavored ice cream bar on a wooden stick. It is packaged in a clear plastic wrapper, and a net weight is 3 oz. There is no UPC on the package. The product is labeled in parts: Paleteria La Super***Pina Colada***Net wt 3.5 oz (103 mls)***Ingredients: Water, milk cream, sugar, crushed pineapple, guar gum, carrageenan, citric acid, artificial flavor and color FD&C yellow #5. Recall # F-1672-2011
CODE
No codes
RECALLING FIRM/MANUFACTURER
Paleteria La Super, Yakima, WA, by visit on August 16, 2011 and by press release on August 18, 2011, FDA initiated recall is ongoing.
REASON
Products contains undeclared allergens.
VOLUME OF PRODUCT IN COMMERCE
400 units
DISTRIBUTION
WA
__________________________________
PRODUCT
Crunch time red licorice bites, Net Wt. 14.25 oz. (403 g), UPC 6 18645 24138 4. The product is packaged in a clear, hard plastic tub. Recall # F-1673-2011
CODE
"Best By" dates: September 28, 2012, October 28, 2012
RECALLING FIRM/MANUFACTURER
Nassau Candy, Hicksville, NY, by letter on August 26, 2011. Firm initiated recall is ongoing.
REASON
The licorice candy contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
8,416 tubs
DISTRIBUTION
Nationwide
RECALLS AND FIELD CORRECTIONS: FOODS - CLASS III
___________________________________
PRODUCT
1) Strawberry Rhubarb, No Added Sugar Baked, 10", INGREDIENTS: Rhubarb, (Frozen), Strawberries (Frozen), Flour (unbleached, unbromatted), Vegetable Shortening, Corn Starch, Maltodextrin, Sucralose, Vanilla, Lime Juice, Strawberry Flavoring. Contains: Wheat, Soy, Avg. Net Wt: 46 oz. (1.3 kg); Item 8800240. Recall # F-0941-2011
2) Banquet Peach Pie, No Added Sugar, INGREDIENTS: Blueberries, Pastry Flour (wheat flour, malted barly flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Vegetable Shortening (partially hydrogenated vegetable oil [soybean and cottonseed oils]), Modified Corn Starch, Maltodextrin, Strawberry Emulsion, Key Lime Juice, Nonfat Powdered Milk, Salt, Sucralose, Vanilla Extract (Madagascar Vanilla bean extractives, water, alcohol [35%]), Cinnamon; UPC: 108158740114. Recall # F-0942-2011;
3) Candy Cane Cheesecake, 16 Cut, Serving Instructions: Serve refrigerated, Keep remaining portions frozen, Cheesecake will keep 7-10 days when refrigerated, No artificial colors or preservatives added, INGREDIENTS: Cream Cheese (pasteurized milk and cream, cheese culture, salt stabilizers [carob bean and/or xanthan and/or guar gum]), Sugar, Eggs, Milk, Pastry Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Cci, Whipped Topping Instant whip, (12 Qts), Margarine (vegetable oil blend [partially hydrogenated soybean and palm oils], water, non-fat dry milk, soy lecithin), Salted Butter, Cream Salt (contains mild), Peppermint Candy, Peppermint Extract, Vanilla Extract (Madagascar Vanilla bean extractives, water, alcohol [35%]), Red Coloring, Salt, Cinnamon; UPC: 8 15874 01202 4. Recall # F-0944-2011;
4) Candy Cane Cheesecake, Uncut, Serving Instructions: Serve refrigerated, Keep remaining portions frozen, Cheesecake will keep 7-10 days when refrigerated, No artificial colors or preservatives added, INGREDIENTS: Cream Cheese (pasteurized milk and cream, cheese culture, salt stabilizers [carob bean and/or xanthan and/or guar gum]), Sugar, Eggs, Milk, Pastry Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Cci, Whipped Topping Instant whip, (12 Qts), Margarine (vegetable oil blend [partially hydrogenated soybean and palm oils], water, non-fat dry milk, soy lecithin), Salted Butter, Cream Salt (contains mild), Peppermint Candy, Peppermint Extract, Vanilla Extract (Madagascar Vanilla bean extractives, water, alcohol [35%]), Red Coloring, Salt, Cinnamon. UPC: 8 15874 01223 1. Recall # F-0946-2011;
5) Strawberry Swirl Cake Uncut, 3 Layer, INGREDIENTS: Cci, Cake Mix, Yellow Multifoods (50lbs), Whipped Topping Instant whip (12 Qts), Eggs, Cci, Strawberry Marmalade, Hero (27lb-9oz), Canola Oil, Strawberry Compound, White Chocolate, Strawberry Paste, Red Coloring. UPC: 8 15874 01121 8. Recall # F-0947-2011;
6) Raspberry White Chocolate Cheesecake, Uncut, Serving Instructions: Serve refrigerated, Keep remaining portions frozen, Cheesecake will keep 7-10 days when refrigerated, No artificial colors or preservatives added, INGREDIENTS: Cream Cheese (pasteurized milk and cream, cheese culture, salt stabilizers [carob bean and/or xanthan and/or guar gum]), Sugar, Eggs, White Chocolate, Milk, Pastry Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Raspberry Puree, Margarine (vegetable oil blend [partially hydrogenated soybean and palm oils], water, non-fat dry milk, soy lecithin), Salted Butter, Cream Salt (contains mild), Strawberry Curls, Vanilla Extract (Madagascar Vanilla bean extractives, water, alcohol [35%]), Red Coloring, Salt, Cinnamon, ---, ----filling ----. UPC: 8 15874 01246 8. Recall # F-0948-2011;
7) Raspberry White Chocolate Cheesecake, 16 Cut, Serving Instructions: Serve refrigerated, Keep remaining portions frozen, Cheesecake will keep 7-10 days when refrigerated, No artificial colors or preservatives added, INGREDIENTS: Cream Cheese (pasteurized milk and cream, cheese culture, salt stabilizers [carob bean and/or xanthan and/or guar gum]), Sugar, Eggs, White Chocolate, Milk, Pastry Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Raspberry Puree, Margarine (vegetable oil blend [partially hydrogenated soybean and palm oils], water, non-fat dry milk, soy lecithin), Salted Butter, Cream Salt (contains mild), Strawberry Curls, Vanilla Extract (Madagascar Vanilla bean extractives, water, alcohol [35%]), Red Coloring, Salt, Cinnamon, filling--------UPC: 8 15874 01002 0.F-0949-2011;
8) Neapolitan Cheesecake, 16 Cut, Serving Instructions: Serve refrigerated, Keep remaining portions frozen, Cheesecake will keep 7-10 days when refrigerated, No artificial colors or preservatives added, INGREDIENTS: Cream Cheese (pasteurized milk and cream, cheese culture, salt stabilizers [carob bean and/or xanthan and/or guar gum]), Sugar, Eggs, White Chocolate, Milk, Pastry Flour (wheat flour, malted barley flour, niacin, reduced iron, thiamine mononitrate, riboflavin, folic acid), Cci, Choc. Semi-Sweet, Morsels 1000 ct.(30lb), Salted Butter, Cream Salt (contains milk), Margarine (vegetable oil blend [partially hydrogenated soybean and palm oils], water, non-fat dry milk, soy lecithin), Cocoa, Strawberry Paste, Vanilla Extract (Madagascar Vanilla bean extractives, water, alcohol [35%]), Red Coloring, Salt, Cinnamon. UPC: 8 15874 01169 0. Recall # F-0950-2011;
9) Red Velvet Cake, 10", 5 Layer, Uncut, INGREDIENTS: Cream Cheese (pasteurized mild and cream, cheese culture, salt, stabilizers [carob bean and/or xanthum and/or guar gum]), Cci, Cake Mix Red Velvet Dawn (25lb), Powdered Sugar, Salted Butter, Cream Salt (contains milk), Canola Oil, Vanilla Extract (Madagascar vanilla bean extractives, water, alcohol [35%]). UPC: 8 15874 01125 6. Recall # F-0953-2011
CODE
All lots, All Dates and Exp. Dates
RECALLING FIRM/MANUFACTURER
Logan's Luscious Lines, Indianapolis, IN, by letter on March 8, 2011. Firm initiated recall is ongoing.
REASON
Product label does not contain an ingredient list or nutrition facts panel as required by 21 CFR 101.4 and 21 CFR 101.9 respectively. As a result, consumers are unable to assess potential threats of allergens or dietary restrictions.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
IN
________________________________________
PRODUCT
Navy Beans, packaged under the following brands: Albertsons, Flavorite, HY-TOP, Peak, Classic Sysco; Small White Beans, packaged under Peak and Classic Sysco. Sysco Classic, a) Small White Beans, 20#, SUPC 4183976; b) Sysco Classic, Navy Beans, 20#, SUPC 4099099; c) Peak, Small White Beans, 25#, UPC 007118722156; d) Peak, Navy Beans, 25#, UPC 007118720019; e) HY-TOP, Navy Beans, 12/2#, UPC 005070024173; f) Albertsons, Navy Beans, 12/1#, UPC 004116348454; g) Flavorite, Navy Beans, 2#, UPC 004113016061. Recall # F-1674-2011
CODE
a) Date Code 07JUL12Z, 11JUL12Z, 18JUL12Z; b) Date Code 11JUL12Z, 18JUL12Z; c) Date Code 18JUL12Z; Peak, d) Date Code 11JUL12Z; e) Date Code 08JUL12Z, Date Code 08JUL12Z; f) Date Code 12JUL12Z; g) Date Code 08JUL12Z. Recall # F-1674-2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trinidad Benham Corp., Denver, CO, by e-mail on August 2, 2011.
Manufacture: Treasure Valley Seed Co., LLC, Wilder, ID. Firm initiated recall is ongoing.
REASON
Beans possibly contaminated with fungicide.
VOLUME OF PRODUCT IN COMMERCE
17,819 pounds
DISTRIBUTION
Nationwide
The FDA begins a pilot program seeking to expedite notifications of human drug product recalls to the public. The agency will modify the drug product section of the Enforcement Report17, published every Wednesday, to include actions that have been determined to be recalls, but that remain in the process of being classified as a Class I, II, or III action. Such recalls will be listed under the heading, “Recalls Pending Classification: DRUGS.” They will be reposted with their classification once that determination has been made. Send comments or suggestions to CDERRecallPilot@fda.hhs.gov.
RECALLS PENDING CLASSIFICATION: DRUGS
___________________________________________________
PRODUCT
Vimovo (naproxen/esomeprazole magnesium) 500/20 mg Delayed Release Tablets, 60 count bottles NDC 0186-0520-60, Unit dose blister packs NDC 0186-0520-39, and
6 count bottles NDC 0186-0520-06
CODE
60 cnt/WH0099, 2/23/2012; WL0144, 2/24/2012; Unit dose blister package of 100/WH0061, 2/29/2012; 6cnt/WJ5003, 2/23/2012; WK5000, 2/23/2012, WJ5006, 3/26/2012 AND WM5011,
4/26/2012
RECALLING FIRM/MANUFACTURER
Recalling firm: Astera Zeneca Lp, Wilmington DE
Manufacturer: Patheon Pharmaceuticals, Cincinnati, OH
REASON FOR RECALL
Failed Dissolution Specification; naproxen
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS I
________________________________________
PRODUCT
Endocet (oxycodone and acetaminophen tablets, USP), 10/325 mg, C-II, 100-count bottles, Rx Only, NDC 60951-712-70. Recall # D-908-2011
CODE
Lot #: 402426NV and 402415NV, Exp 01/14
RECALLING FIRM/MANUFACTURER
Recalling Firm: Endo Pharmaceuticals, Inc., Chadds Ford, PA, by letters and press release on June 24, 2011 and by letters dated June 29, 2011.
Manufacturer: Novartis Consumer Health, Lincoln, NB. FDA initiated recall is ongoing.
REASON
Adulterated presence of foreign tablets: Bottles of Endocet 10/325-mg tablets, (100-count bottles) may contain some Endocet 10/650-mg tablets.
VOLUME OF PRODUCT IN COMMERCE
44,462 bottles
DISTRIBUTION
Nationwide and PR
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II
___________________________________
PRODUCT
Adagen (pegademase bovine) injection, 250 units/mL, 1.5 mL single-dose vials, 4-count 1.5 mL single-dose vials per carton, Rx Only, NDC 57665-001-01. Recall # D-877-2011
CODE
Lot # 1004A, Exp 12/02/11
RECALLING FIRM/MANUFACTURER
Sigma-Tau Pharmasource, Inc., Indianapolis, IN, by letter on August 24, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Firm recently observed an elevated result during routine stability testing, indicating the level of Impurity C (in vitro) for one lot of ADAGEN has exceeded the specification.
VOLUME OF PRODUCT IN COMMERCE
235 cartons
DISTRIBUTION
France, South Australia, and Japan
___________________________________
PRODUCT
Prednisolone Sodium Phosphate Oral Solution, 15 mg (base)/5 mL, Rx Only, 8 fl oz (237 mL) bottle, NDC 0603-9388-56. Recall # D-878-2011
CODE
Lot #: L018F10C, L019F10A, L020F10A, Exp. 12/2011, L078F10A, Exp. 2/2012; L071J10A, Exp. 4/2012
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by letters on August 23, 2011. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Out of specification for related compounds at the 12-month room temperature stability time point.
VOLUME OF PRODUCT IN COMMERCE
24,980 bottles
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Nimbex (cisatracurium besylate) Injection, 20 mg/10 mL (2 mg/mL), 10 mL Multiple-dose vial, Rx only; NDC 0074-4380-10. Recall # D-881-2011
CODE
Lot #: 04220DD, Exp 10/01/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letters dated August 24, 2011.
Manufacturer: Hospira Inc., Mcpherson, KS. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Abbott is recalling the lot of Nimbex as a precaution due to the presence of one foreign Lyo-stopper on one single vial of Nimbex discovered during the visual inspection of a subsequently manufactured and undistributed lot. Since formal data supporting the use of the foreign stopper with Nimbex is not readily available, there are potential risks for a patient which could include allergic reaction due to the natural rubber formulation of the foreign stopper.
VOLUME OF PRODUCT IN COMMERCE
84,910 vials
DISTRIBUTION
Nationwide
________________________________________
PRODUCT
1) Blood Specimen Collection Kit, Reorder No. BSC50 and BSC50CS-Case of 25, For Alcohol, Drug and Other Determinations. Recall # D-882-2011;
2) Blood/Urine Collection Kit, Reorder No. BUK200 and BUK200CS-Case of 10. Recall # D-883-2011;
3) Blood Alcohol Kit, Reorder No. BSC100, BSK100, and BSK100CS-Case of 25. Recall # D-884-2011;
4) Blood Alcohol/Urine Specimen Kit, Reorder No. BUK100. Recall # D-885-2011;
5) Montana Blood Kit (custom), Reorder No. MBK100. Recall # D-886-2011;
6) Alaska Blood Alcohol Kit (custom), Reorder No. AKBA100. Recall # D-887-2011;
7) Las Vegas Blood Alcohol Kit (custom), Reorder No. LVBA100. Recall # D-888-2011;
8) Alabama DUI Kit (custom), Reorder No. ALDW1200. Recall # D-889-2011;
9) West Virginia Blood Kit (custom), Reorder No. WVBSC300. Recall # D-890-2011
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sirchie Finger Print Labs Inc., Youngsville, NC, by letter on/about April 1, 2011.
Manufacturer: Sirchie Finger Print Labs Inc., Youngsville, NC;
H & P Industries, Inc., Hartland, WI.
FDA initiated recall is ongoing.
REASON
Microbial Contamination of Non-Sterile Products: This is a sub-recall of H&P, Povidine Iodine Prep Pads; The Kits under recall contain Povidine Prep Pads recalled by H&P Industries due to the potential contamination with an objectionable organism, Elizabethkingia meningoseptica.
VOLUME OF PRODUCT IN COMMERCE
13,535 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ADD-Vantage Unit 0.9% SODIUM CHLORIDE Injection, USP 50 mL bag, NDC 0409-7101-66. Recall # D-891-2011
CODE
Lot: 88-068-JT
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter on May 6, 2011.
Manufacturer: Hospira, Inc., Austin, TX. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility: The product is being recalled due to defective containers. The bags containing the 0.9% Sodium Chloride Injection, USP solution have the potential to leak. Leaking bags have the potential to result in contamination.
VOLUME OF PRODUCT IN COMMERCE
230,300
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
1) Coumadin (warfarin sodium), 5 mg tablets, 1000 count bottle, Rx only, NDC 0056-0172-90. Recall # D-892-2011;
2) Coumadin (warfarin sodium), 2.5 mg tablets, a) 100 count bottles (NDC 0056-0176-70), b) 1000 count bottles (NDC 0056-0176-90), Rx only. Recall # D-893-2011;
3) Coumadin (warfarin sodium), 4 mg tablets, a) 100 count bottles (NDC 0056-0168-70), b) 1000 count bottles (NDC 0056-0168-90), c) 100 count blister packages, unit dose blister packages of 10 blister cards containing 10 tablets each (NDC 0056-0168-75), Rx only. Recall # D-894-2011;
4) Coumadin (warfarin sodium), 7.5 mg tablets, a) 100 count bottle (NDC 0056-0173-70), b) 100 count blister packages, unit dose blister packages of 10 blister cards with 10 tablets each (NDC 0056-0173-75), Rx only. Recall # D-895-2011;
5) Coumadin (warfarin sodium), 10 mg tablets, a) 100 count bottle (NDC 0056-0174-70), b) 100 count blister packages, unit dose blister packages of 10 blister cards containing 10 tablets each (NDC 0056-0174-75), Rx only. Recall # D-896-2011
CODE
1) Lot # 9H49374A, Exp 09/12;
2) Lot #s: a) J951681C, Exp 10/12; 9J51684B, Exp 10/12; 9K52102A, Exp 10/12; b) 9J51678A, Exp 10/12; 9J51686D, Exp 10/12 ;
3) Lot #s: a) 9J54843A, Exp 10/12; b) 9J54837B, Exp 10/12; 9J54846A, Exp 10/12; c) 9J54837C, Exp 10/12;
4) Lot #s: a) 9J49837A, Exp 08/12; 9J49839B, Exp 08/12; b) 9J49837B, Exp09/12; 9J49839C, Exp09/12;
5) Lot #s: a) 9J53293C, Exp 10/12; 9J53293F, Exp 10/12; 9K50111A, Exp 10/12; b) 9J53293D, Exp 10/12
RECALLING FIRM/MANUFACTURER
Bristol-Myers Squibb Holdings Pharma LLC, Manati, PR, by press release and letter on May 2, 2011, and by letter on May 27, 2011.
REASON
Failed USP Content Uniformity Requirements: There is a possibility that some tablets from this lot may not meet potency specifications.
VOLUME OF PRODUCT IN COMMERCE
207,918 units (1000 count bottles: 10,614; 100 count bottles: 162,704; Blister Packages of 100 tablets: 34,600)
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Fluconazole Tablets, 100 mg, 30-count bottle, NDC 0172-5411-46, Rx only. Recall # D-898-2011
CODE
Lot # Y02582, exp 9/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter on June 3, 2011.
Manufacturer: Cipla, Ltd., Maharashtra, India. Firm initiated recall is ongoing.
REASON
Adulterated Presence of Foreign Tablets; There is the potential for the presence of 200 mg tablets comingled in bottles of product labeled 100 mg.
VOLUME OF PRODUCT IN COMMERCE
31,032 units
DISTRIBUTION
Nationwide and PR
__________________________________
PRODUCT
1) Mag-Al Plus XS, 30 ml, NDC 0121-1761-30. Recall # D-899-2011;
2) Mag-Al Liquid, 30 mL, NDC 0121-1760-30. Recall # D-900-2011;
3) Mag-AL Plus XS, 30 mL, NDC 0121-1762-30. Recall # D-901-2011;
4) Mag-Al Ultimate Strength, Antacid, 20 mL, NDC 0121-4800-20. Recall # D-902-2011;
5) Quality Value, Aluminum Hydroxide Gel USP, 320 mg/5 mL, Antacid, , 16 fl oz (473 mL), NDC 0121-0733-16. Recall # D-903-2011;
6) Quality Value, Aluminum Hydroxide Gel USP, 320 mg/5 mL, Antacid, 12 fl oz (355 mL), NDC 0121-0733-12. Recall # D-904-2011;
7) Aluminum Hydroxide Gel USP, 320 mg/5 mL, Antacid, NDC 0121-0733-30. Recall # D-905-2011
CODE
1) Lot 0A19, 0A59, Exp. 07/11; 0B66, Exp. 08/11; 0C22, 0C46, Exp. 09/11; 0D79, Exp. 10/11.-30;
2) Lot 0A06, Exp. 07/11, 0B45, Exp. 08/11, 0E01, Exp.11/11;
3) Lot 0A06, Exp. 07/11; 0B45, Exp. 08/11, 0E01, Exp.11/11;
4) Lot 0A41, Exp. 07/11;
5) Lot 0B44, Exp. 08/11; 0E50, Exp. 11/11; 0J65, Exp. 03/12; 0L64, Exp. 03/12;
6) Lot 0B43, Exp. 08/11; 0E49, Exp. 11/11; 0J64, Exp. 03/12; 0L63, Exp. 03/12;
7) Lot 9L47, Exp. 06/11; 0D52, Exp. 10/11; 0F65, Exp. 12/11; 0J63, Exp.03/12
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pharmaceutical Associates Inc., Greenville, SC, by letter beginning June 20, 2011.
Manufacturer: SPI Pharma, Inc., Lewes, DE. FDA initiated recall is ongoing.
REASON
Presence of Foreign Substance: Blue plastic particles were detected in unscreened lots of the affected products.
VOLUME OF PRODUCT IN COMMERCE
2,511,584 units
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Femhrt (norethindrone acetate/ethinyl estradiol) tablets, 0.5 mg/2.5 mcg, each pouch contains a 28-count tablet blister card, packaged in 5 pouches per box; NDC 0430-0145-14; UPC 3 0430-0145-14 1. Recall # D-906-2011
CODE
Lot 505758A, Exp 04/13
RECALLING FIRM/MANUFACTURER
Warner Chilcott Company LLC, Fajardo, PR, by letter on July 28, 2011. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: Product failed to meet dissolution specification for norethidnrone acetate at release testing and was shipped prior to being released from quarantine.
VOLUME OF PRODUCT IN COMMERCE
432 boxes
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Caffeine and Sodium Benzoate Injection, USP, 250 mg/mL (125 mg/mL Caffeine), 2 mL Single Dose Vial, NDC 0517-2502-10 --- 2 mL Single Dose Vials packed in boxes of 10 --- For IM or Slow IV use. Recall # D-907-2011
CODE
Lot 0084, exp. 2/2012
RECALLING FIRM/MANUFACTURER
Luitpold Pharmaceuticals, Inc., Shirley, NY, by e-mail, facsimile and/or letters dated May 5, 2011. Firm initiated recall is ongoing.
REASON
Presence of Particulate Matter: Visual particulate matter was observed in some retain vials and stability samples.
VOLUME OF PRODUCT IN COMMERCE
40,750 units
DISTRIBUTION
Nationwide and PR
RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III
___________________________________
PRODUCT
1) Bupropion HCL, Extended-release Tablets(XL), 150 mg, Once Daily, RX only, 500 tablets. NDC No. 0115-6811-02. Recall # D-852-2011;
2) Buproprion HCl, Extended Release Tablets(XL), 300 mg(Once Daily), RX only, 500 tablets, NDC No. 0093-5351-05. Recall # D-853-2011
CODE
1) Lot 8120242, Exp.11/10; 9020071, Exp.01/11; 9030081, Exp.02/11; 9040931, Exp.03/11; H0041752, H0041753, H0041761, H0041762, H0041801, H0041802, Exp.04/12; H9061521, Exp. 06/11;
2) Lot 8121591, 8121601, 8121611, 8121621, 8121631, 8121641, 9010731, 9010741, 9010751, 9010761, Exp.12/10; 9010771, 9010781, 9010791, 9010801, 9010811, 9010821, 9010831, 9010841, 9010851, 9010861, 9010871, 9011011, 9011021, 9011031, 9011041, 9011051, 9011061, 9011071, 9011081, 9011091, 9011101, 9011121, 9011131, 9011141, 9011151, 9011161, 9011171, Exp.01/11; 9020851, 9020861, 9020871, 9020881, 9020891, 9020901, 9020911, 9020921, 9020931, 9020941, 9020951, 9020961, 9020971, 9020981, 9020991, 9021001, 9021081, 9021091, Exp.02/11; 9021121, Exp.03/11; H0040361, H0040372, Exp.03/12;H0070781, H0070791, Exp.07/12; H0100391, Exp.09/12; H0110571, Exp.10/12
RECALLING FIRM/MANUFACTURER
Impax Laboratories, Inc., Hayward, CA, by letters on January 20, 2010. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: total impurity level exceeded. Out of specification results for the impurity M-chlorobenzoic acid (m-Cl) in two lots of Bupropion HCL.
VOLUME OF PRODUCT IN COMMERCE
12424 bottles 150 mg, 70756 bottles of 300 mg
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Azithromycin Tablets, USP 250 mg, A full course of antibiotic therapy in just 5 doses, Rx only, Unit of Use - 6 Tablets x 250 mg, NDC Number: 0781-1496-68. Recall # D-876-2011
CODE
Lot/Unit Number: BL6236
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sandoz, Inc., Princeton, NJ, by letter on August 3, 2011.
Manufacturer: Sandoz Inc., Broomfield, CO. Firm initiated recall is ongoing.
REASON
Labeling: Missing Label; Product packaging is missing information on the unit dose package.
VOLUME OF PRODUCT IN COMMERCE
129,088 cartons containing three (3) 6-count blister packs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Vicks Children's NyQuil Cold & Flu Nighttime Relief also labeled as Children's Nyquil Cold & Cough (Chlorpheniramine maleate 2 mg and Dextromethorphan HBr 15 mg, 6 FL OZ (177 mL) bottles, Cherry Flavor, NDC 37000-556-06. Recall # D-879-2011
CODE
Batch # 0013171931, Exp. Date 12/2011; Batch # 0039171931, Exp. Date 1/2012; Batch # 0104171931, Exp. Date 3/2012; Batch # 0127171931, Exp. Date 4/2012; Batch # 0132171931, Exp. Date 4/2012; Batch # 0137171931, Exp. Date 4/2012; Batch # 0215171932, Exp. Date 7/2012; Batch # 0221171931, Exp. Date 7/2012; Batch # 0235171931, Exp. Date 7/2012; Batch # 0252171931, Exp. Date 8/2012; Batch # 0279171931, Exp. Date 9/2012; Batch # 0285171932, Exp. Date 9/2012; Batch # 0312171931, Exp. Date 10/2012; Batch # 0322171931, Exp. Date 10/2012; Batch # 0342171932, Exp. Date 11/2012; Batch # 1012171932, Exp. Date 12/2012; Batch # 1027171931, Exp. Date 12/2012; Batch # 1031171931, Exp. Date 12/2012; Batch # 1032171931, Exp. Date 1/2013; Batch # 1053171931, Exp. Date 1/2013; Batch # 1053171932, Exp. Date 1/2013; Batch # 1054171931, Exp. Date 1/2013; Batch # 1054171932, Exp. Date 1/2013; Batch # 1055171931, Exp. Date 1/2013; Batch # 1059171931, Exp. Date 1/2013; Batch # 1059171932, Exp. Date 1/2013; Batch # 1060171931, Exp. Date 2/2013; Batch #, 9187171931, Exp. Date, 6/2011; Batch #, 9211171932, Exp. Date, 6/2011; Batch # 9247171932, Exp. Date 8/2011; Batch # 9248171931, Exp. Date 8/2011; Batch # 9282171931, Exp. Date 9/2011; Batch # 9306171932, Exp. Date 10/2011; Batch # 9320171931, Exp. Date 10/2011; Batch # 9342171931, Exp. Date 11/2011 & Batch # 9350171932, Exp. Date, 11/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Procter & Gamble Co., Mason, OH, letters on April 28, 2011.
Manufacturer: Procter & Gamble Manufacturing Co., Greensboro, NC. Firm initiated recall is ongoing.
REASON
Not in Accordance with Federal Register Requirements; label does not contain required statement regarding potassium content.
VOLUME OF PRODUCT IN COMMERCE
2.4 million/6 oz bottles
DISTRIBUTION
Nationwide
__________________________________
PRODUCT
Covera-HS (verapamil hydrochloride) Extended Release Tablets, NDC:0025-2021-31, 240 mg, 100 count bottle, Rx only. Recall # D-880-2011
CODE
Lot C091375
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Us Pharmaceutical Group, New York, NY, by letter on July 13, 2011.
Manufacturer: Pfizer Pharmaceuticals LLC, Caguas, PR. Firm initiated recall is ongoing.
REASON
Failed USP Dissolution Test Requirements: Product does not conform to dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE
7, 202 units
DISTRIBUTION
Nationwide and PR
___________________________________
PRODUCT
Australian Gold, spf 60, Sun Screen Stick, Ultimate Fade Protection, Tattoo Stick, Net wt. 14g. Recall # D-897-2011
CODE
Lot N79859, Exp. 05/14
RECALLING FIRM/MANUFACTURER
OraLabs, Incorporated, Parker, CO, by letter on Aug 15, 2011. Firm initiated recall is ongoing.
REASON
Superpotent (Multiple Ingredient) Drug: Sun screen active ingredient Octocrylene exceeds specifications.
VOLUME OF PRODUCT IN COMMERCE
12,319 sticks
DISTRIBUTION
IN
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II
______________________________________
PRODUCT
Source Plasma. Recall # B-1857-11
CODE
Unit: 2010314571
RECALLING FIRM/MANUFACTURER
PlasmaCare, Inc., Indianapolis, IN, by electronic mail on June 20, 2011. Firm initiated recall is complete.
REASON
Blood product, in which donor testing was not performed or incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis, Divided, Leukocytes Reduced, Irradiated, Washed. Recall # B-1949-11
CODE
Unit: W051511840058
RECALLING FIRM/MANUFACTURER
Memorial Blood Centers, Saint Paul, MN, by telephone on June 10, 2011. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1950-11
CODE
Unit: W036811192088
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Lake Worth, FL, by telephone on June 24, 2011 and by letter dated June 24, 2011. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but exceeded the White Blood Cell count limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1951-11
CODE
Unit: W044209528396
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by letter dated July 22, 2011. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as negative for the Jk(a) red cell antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1952-11
CODE
Units: 11631110627500 (2 units), 11631110627100 (2 units)
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., Pensacola, FL, by telephone and facsimile on July 11, 2011. Firm initiated recall is complete.
REASON
Blood products, which were labeled as leukoreduced, but were not tested to verify white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets: Recall: B-1953-11
CODE
Unit: W067111011235
RECALLING FIRM/MANUFACTURER
The Blood Center, New Orleans, LA, by telephone on May 19, 2011 and by letter dated May 27, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was deferred for testing positive for the human immunodeficiency virus (HIV), was distributed. VOLUME OF PRODUCT IN COMMERCE
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1970-11
CODE
Unit: W038110355343
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on June 17, 2011 and by letter dated June 17, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1971-11
CODE
Unit: W037710096687
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated June 1, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1972-11
CODE
Unit: W043211024842
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by facsimile on July 5, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Plasma. Recall # B-1973-11
CODE
Units: W092911100045
RECALLING FIRM/MANUFACTURER
Poudre Valley Health Care, Inc. Blood Bank, Fort Collins, CO, by facsimile on July 16, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1974-11;
2) Cryoprecipitated AHF. Recall # B-1975-11
CODE
1) and 2) Unit: 2009979
RECALLING FIRM/MANUFACTURER
Community Blood Centers of South Florida, Inc., Miami, FL, by telephone on June 30, 2011 and by letter dated June 30, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma. Recall # B-1976-11
CODE
Unit: 11AIAB4456
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services LP, Ames, IA, by electronic notification on July 6, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-1977-11
CODE
Unit: W088411511405
RECALLING FIRM/MANUFACTURER
Blood Bank Of Hawaii, Honolulu, HI, by letter dated July 7, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Hawaii
___________________________________
PRODUCT
Cryoprecipitated AHF. Recall # B-1979-11
CODE
Unit: 011GY63530
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by facsimile and telephone on May 26, 2011 and by letter dated May 26, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, TN
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-1981-11;
2) Recovered Plasma. Recall # B-1982-11;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1983-11
CODE
1) Units: W115910087461; W11591022240; W115909222690; W115908252023;
2) Unit: 2023935;
3) Units: W115911081496; W115911080091; W115910087461; W115910233382; W115910222240; W115909222690; W115908252023; 2023935
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by facsimile on June 13, 2011 and email on June 21, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
NY, CA, Austria
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-1987-11;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1988-11;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1989-11;
4) Cryoprecipitated AHF. Recall # B-1990-11;
5) Plasma Cryoprecipitate Reduced. Recall # B-1991-11;
6) Red Blood Cells (Apheresis) Leukocytes Reduced. B-1992-11;
7) Fresh Frozen Plasma (Apheresis). Recall # B-1993-11;
8) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1994-11;
9) Platelets Pheresis Leukocytes Reduced. Recall # B-1995-11;
10) Recovered Plasma. Recall # B-1996-11
CODE
1) Units: 2071568, 6932772, 6932780, 9167668, 9167669, 9167673, 9167674, 9167676, 9167679, 9167683, 9167686, 9167687, 9167693, 9167696, 9167701, 9167702, 9207200, 9207202, 9207204, 9207205, 9207207, 9207208, 9207213, 9207215, 9207216, 9207217, 9307721, 9307724, 9307725, 9307729, 9307732, 9307734, 9307736, 9307740, 9307745, 9307747, 9307750, 9307751, 9307753, 9408754, 9408755, 9408757, 9408760, 9408764, 9408766, 9408767, 9408768, 9408772, 9408773, 9408778, 9408779, 9408781, 9610233, 9610235, 9610238, 9610239, 9610242, 9610244, 9610247, 9610249, 9610252, 9610254;
2) Units: 2071566, 2071567, 2071569, 2071571, 2071572, 2071574, 2071575, 2071576, 2071577, 2071578, 2071580, 2071581, 2071582, 2071583, 2071584, 2071585, 2071586, 2071588, 2071589, 2071590, 2071591, 2071592, 2071593, 2071594, 6932773, 6932774, 6932775, 6932776, 6932777, 6932778, 6932779, 6932781, 6932782, 6932783, 6932784, 6932785, 6984070, 6984071, 6984073, 6984074, 6984075, 6984078, 9167670, 9167672, 9167681, 9167682, 9167684, 9167689, 9167691, 9167694, 9167697, 9207197, 9207198, 9207199, 9207203, 9207206, 9207209, 9207211, 9207212, 9207214, 9307722, 9307726, 9307728, 9307733, 9307735, 9307737, 9307741, 9307746, 9307748, 9307754, 9408756, 9408758, 9408759, 9408762, 9408763, 9408765, 9408769, 9408770, 9408771, 9408776, 9408780, 9408782, 9610234, 9610245, 9610253;
3) Unit: 2071579, 2071587, 9167677;
4) Units: 9167684, 9167687, 9167689, 9167691, 9167693, 9167694, 9167701, 9167702, 9307721, 9307722, 9307724, 9307725, 9307729, 9307733, 9307734, 9307735, 9307741, 9307746, 9397747, 9307748, 9307751, 9610233, 9610234, 9310235, 9610238, 9610239, 9610244, 9610249, 9610250, 9610252, 9610254;
5) Unit: 9610250;
6) Units: 2071554, 6984076 (2 units), 6984077 (2 units), 9307703, 9307743, 9408753;
7) Units: 6742048 (Parts A, B, C, & D), 6742049 (Parts A, B, C, & D), 6702050 (Parts A, B, C, & D), 6742051 (Parts A & B), 6742052 (Parts A, B, C, & D), 9167678, 9167680, 9167688, 9167692 (Parts A & B), 9167695, 9167699 (Parts A & B), 9307710, 9307714, 9307730 (Parts A & B), 9307731, 9307739 (Parts A & B), 9307743, 9408775 (Parts A & B), 9610229, 9610232 (Parts A & B), 9610241 (Parts A & B), 9610248 (Parts A & B);
8) Units: 2071549, 2071565, 9167678, 9167680, 9167690 (2 units), 9167692, 9167695 (2 units), 9167698, 9307703, 9307712, 9307727, 9307730, 9307731 (2 units), 9307738, 9307739, 9307743, 9408775, 9610213, 9610219, 9610231 (2 units), 9610241, 9610243 (2 units);
9) Units: 2071549, 2071554, 9167671 (2 units), 9167678, 9167690, 9167692, 9167699 (2 units), 9307710, 9307712, 9307714 (2 units), 9408753 (2 units), 9610218 (2 units), 9610229, 9610232, 9610241, 9610248;
10) Units: 2071566, 2071567, 2071570, 2071571, 2071572, 2071573, 2071574, 2071575, 2071576, 2071578, 2071579, 2071580, 2071581, 2071582, 2071583, 2071584, 2071585, 2071586, 2071587, 2071588, 2071589, 2071590, 2071593, 2071594, 6932772, 6932773, 6932774, 6932775, 6932776, 6932777, 6932778, 6932779, 6932780, 6932781, 6932782, 6932783, 6932784, 6932785, 9167668, 9167669, 9167670, 9167672, 9167673, 9167674, 9167676, 9167677, 9167679, 9167681, 9167683, 9167684, 9167687, 9167691, 9167693, 9167694, 9167701, 9167702, 9207197, 9207199, 9207200, 9207202, 9207203, 9207204, 9207205, 9207206, 9207207, 9207208, 9207209, 9207212, 9207213, 9207214, 9207215, 9207216, 9207217, 9307721, 9307724, 9307725, 9307728, 9307734, 9307735, 9307736, 9307737, 9307741, 9307742, 9307747, 9307748, 9307750, 9307751, 9307753, 9307754, 9408754, 9408755, 9408756, 9408757, 9408758, 9408759, 9408762, 9408763, 9408766, 9408767, 9408769, 9408770, 9408771, 9408772, 9408773, 9408776, 9408779, 9408780, 9408781, 9408782, 9610233, 9610234, 9610235, 9610238, 9610239, 9610244, 9610249, 9610252, 9610254, 2071592
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by facsimile on September 21, 2006 or September 25, 2006. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for the antibody to hepatitis B core antigen (anti-HBc), were distributed.
VOLUME OF PRODUCT IN COMMERCE
400 units
DISTRIBUTION
AL, CA, CO, FL, IL, KY, MS, NJ, NM, NY, PA, TN, UT, Switzerland
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-1997-11
CODE
Unit: W137511100909
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by facsimile on June 8, 2011 and letter on June 9, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Republic Of (South) Korea, and TN
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-2004-11;
2) Recovered Plasma. Recall # B-2005-11;
3) Red Blood Cells. Recall # B-2006-11
CODE
1) Unit: W089810651879;
2) Unit: W089810702527
3) Units: W089810702527; W089810651879
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Inova Blood Donor Services, Sterling, VA, by fax on June, 15, 2011 and letter on July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NJ, VA, and D.C;
RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III
___________________________________
PRODUCT
Platelets Pheresis. Recall # B-1948-11
CODE
Unit: W0423110416765
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., dba United Blood Services, Scottsdale, AZ, by facsimile and telephone on July 5, 2011.
Manufacturer: Blood Systems, Inc., Billings, MT. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect volume, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AZ
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1978-11
CODE
Unit: 011GY63530
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by facsimile and telephone on May 26, 2011 and by letter dated May 26, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, TN
___________________________________
PRODUCT
Source Plasma. Recall # B-1984-11
CODE
Units: 5220048225, 5220044943, 5220044286, 5220043959, 5220043326, 5220043027, 5220042504, 5220039805, 5220045274, 5220075089, 5220070262, 5220063158, 5220062410, 5220061723, 5220052204, 5220048871, 5220075712
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Evansville, IN, by e-mail on July 1, 2011 and July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
Source Plasma. Recall # B-1985-11
CODE
Unit: 4600103438
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Salt Lake City UT, by e-mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-1986-11
CODE
Unit: 4290043736
RECALLING FIRM/MANUFACTURER
Ibr Plasmacenters, LLC, Garland, TX, by e-mail on July 5, 2011. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma, Recall # B-1998-11
CODE
Units: 4650158869; 4650156264; 4650155654
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., San Diego, CA, by electronic mail on July 1, 2011 and July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria, CA
___________________________________
PRODUCT
Source Plasma, Recall # B-1999-11
CODE
Units: 4650160258; 4650161032
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Inc., San Diego, CA, by electronic mail on July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-2000-11
CODE
Units: 4600106575; 4600106208; 4600105985
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Salt Lake City, UT, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-2001-11
CODE
Units: 4560063621; 4560063440; 4560063249
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Metairie, LA, by electronic mail on July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Source Plasma. Recall # B-2002-11
CODE
Units: 3880131628; 3880131380
RECALLING FIRM/MANUFACTURER
Octapharma Plasma Donation Center Aurora, Aurora, IL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-2003-11
CODE
Units: 5050145620; 5050144854; 5050144441; 5050143837; 5050142662; 5050142314; 5050141687; 5050141153; 5050140354; 5050140117; 5050139353; 5050138746; 5050138098
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Midfield, AL, by electronic mail on July 1, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-2007-11
CODE
Units: 4250033112; 4250032107; 4250031986; 4250031278
RECALLING FIRM/MANUFACTURER
Octapharma Plasma, Inc., Kalamazoo, MI, by electronic mail on July 1, 2011 and July 5, 2011. Firm initiated recall is complete.
REASON
Blood products, collected from a donor, for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, Austria
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
Medtronic SynchroMed II, Model 8637, (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories. Recall # 3043-2011
CODE
Serial numbers: NGP000370R thru NGP002152R, NGP000565N thru NGP034132N, NGP005103H thru NGP350081H, NGP350083H, NGP350086H thru NGP350092H, NGP350094H thru NGP350414H, NGP350416H, NGP350417H, NGP350418H, NGP350419H, NGP350421H, NGP350422H, NGP350423H, NGP350424H, NGP350425H, NGP350427H, NGP350428H, NGP350429H, NGP350431H thru NGP350464H, NGP350466H, NGP350468H thru NGP350506H, NGP350509H thru NGP350576H, NGP350578H, NGP350579H, NGP350580H, NGP350581H, NGP350582H, NGP350583H, NGP350585H thru NGP350599H, NGP350601H, NGP350602H, NGP350603H, NGP350604H, NGP350606H thru NGP350814H, NGP350816H thru NGP350837H, NGP350839H thru NGP350852H, NGP350860H thru NGP350880H, NGP350882H thru NGP350905H, NGP350907H thru NGP350916H, NGP350918H thru NGP351197H, NGP351199H thru NGP351229H, NGP351231H thru NGP351258H, NGP351260H thru NGP351302H, NGP351304H thru NGP351337H, NGP351339H thru NGP351396H, NGP351398H thru NGP351456H, NGP351458H, NGP351459H, NGP351460H, NGP351461H, NGP351463H, NGP351464H, NGP351465H, NGP351467H thru NGP351497H, NGP351499H thru NGP351601H, NGP351603H thru NGP351617H, NGP351619H thru NGP351651H, NGP351653H, NGP351654H, NGP351656H thru NGP351800H, NGP351802H thru NGP351809H, NGP351811H thru NGP351824H, NGP351826H thru NGP351863H, NGP351865H, NGP351866H, NGP351868H thru NGP351904H, NGP351906H thru NGP351919H, NGP351921H thru NGP351996H, NGP351998H, NGP351999H, NGP352000H, NGP352001H, NGP352002H, NGP352003H, NGP352004H, NGP352005H, NGP352007H, NGP352009H thru NGP352149H, NGP352151H thru NGP352221H, NGP352223H thru NGP352250H, NGP352252H thru NGP352279H, NGP352281H thru NGP352403H, NGP352405H thru NGP352417H, NGP352419H thru NGP352442H, NGP352444H thru NGP352473H, NGP352475H, NGP352476H, NGP352477H, NGP352478H, NGP352480H thru NGP352548H, NGP352550H thru NGP352558H, NGP352560H, NGP352561H, NGP352562H, NGP352564H thru NGP352756H, NGP352758H thru NGP352778H, NGP352780H thru NGP352896H, NGP352898H thru NGP352918H, NGP352920H thru NGP353016H, NGP353018H thru NGP353085H, NGP353087H thru NGP353252H, NGP353254H thru NGP353296H, NGP353298H, NGP353299H, NGP353300H, NGP353301H, NGP353302H, NGP353303H, NGP353304H, NGP353305H, NGP353306H, NGP353308H thru NGP353364H, NGP353366H, NGP353367H, NGP353368H, NGP353369H, NGP353371H thru NGP353477H, NGP353479H, NGP353480H, NGP353481H, NGP353482H, NGP353484H thru NGP353505H, NGP353507H thru NGP353531H, NGP353533H thru NGP353599H, NGP353601H thru NGP353637H, NGP353639H, NGP353640H, NGP353641H, NGP353642H, NGP353643H, NGP353644H, NGP353645H, NGP353646H, NGP353647H, NGP353648H, NGP353649H, NGP353651H thru NGP353664H, NGP353666H thru NGP353739H, NGP353741H thru NGP353750H, NGP353752H, NGP353753H, NGP353754H, NGP353755H, NGP353756H, NGP353757H, NGP353758H, NGP353759H, NGP353760H, NGP353761H, NGP353763H thru NGP353789H, NGP353791H thru NGP353821H, NGP353823H, NGP353824H, NGP353825H, NGP353826H, NGP353827H, NGP353828H, NGP353830H, NGP353832H thru NGP353923H, thru NGP353947H, NGP353949H, NGP353951H, NGP353952H, NGP353953H, NGP353954H, NGP353956H, NGP353957H, NGP353958H, NGP353959H, NGP353960H, NGP353961H, NGP353962H, NGP353964H, NGP353965H, NGP353966H, NGP353967H, NGP353968H, NGP353969H, NGP353970H, NGP353971H, NGP353972H, NGP353973H, NGP353974H, NGP353976H, NGP353977H, NGP353978H, NGP353979H, NGP353980H, NGP353981H, NGP353982H, NGP353984H, NGP353985H, NGP353986H, NGP353987H, NGP353988H, NGP353989H, NGP353990H, NGP353991H, NGP353992H, NGP353993H, NGP353994H, NGP353995H, NGP353996H, NGP353999H, NGP354000H, NGP354001H, NGP354003H, NGP354004H, NGP354005H, NGP354006H, NGP354008H, NGP354010H thru NGP354031H, NGP354034H, NGP354035H, NGP354036H, NGP354037H, NGP354039H, NGP354040H, NGP354041H, NGP354042H, NGP354043H, NGP354044H, NGP354045H, NGP354046H, NGP354047H, NGP354048H, NGP354050H thru NGP354084H, NGP354086H thru NGP354174H, NGP354176H thru NGP354227H, NGP354229H thru NGP354236H, NGP354238H thru NGP354330H, NGP354332H thru NGP354343H, NGP354345H, NGP354346H, NGP354347H, NGP354348H, NGP354349H, NGP354351H thru NGP354392H, NGP354394H, NGP354395H, NGP354396H, NGP354397H, NGP354399H, NGP354400H, NGP354401H, NGP354402H, NGP354403H, NGP354404H, NGP354405H, NGP354406H, NGP354407H, NGP354408H, NGP354409H, NGP354411H, NGP354412H, NGP354413H, NGP354414H, NGP354415H, NGP354419H thru NGP354486H, NGP354487H, NGP354488H, NGP354489H, NGP354491H thru NGP354526H, NGP354531H, NGP354532H, NGP354533H, NGP354534H, NGP354535H, NGP354537H, NGP354540H, NGP354541H, NGP354542H, NGP354545H, NGP354547H, NGP354548H, NGP354549H, NGP354551H, NGP354552H, NGP354554H, NGP354555H, NGP354556H, NGP354557H, NGP354558H, NGP354568H, NGP354570H, NGP354571H, NGP354572H, NGP354573H, NGP354574H, NGP354575H, NGP354577H, NGP354579H, NGP354581H, NGP354583H, NGP354584H, NGP354586H, NGP354588H thru NGP354599H, NGP354601H thru NGP354616H, NGP354618H, NGP354621H thru NGP354645H, NGP354648H, NGP354649H, NGP354650H, NGP354651H, NGP354652H, NGP354653H, NGP354654H, NGP354655H, NGP354657H, NGP354658H, NGP354659H, NGP354662H, NGP354663H, NGP354666H, NGP354667H, NGP354668H, NGP354669H, NGP354670H, NGP354672H, NGP354673H, NGP354674H, NGP354675H, NGP354677H, NGP354679H, NGP354681H, NGP354682H, NGP354684H, NGP354687H thru NGP354744H, NGP354746H thru NGP354805H, NGP354807H thru NGP354858H, NGP354860H, NGP354861H, NGP354862H, NGP354863H, NGP354864H, NGP354865H, NGP354866H, NGP354867H, NGP354868H, NGP354869H, NGP354870H, NGP354872H, NGP354873H, NGP354874H, NGP354875H, NGP354876H, NGP354877H, NGP354878H, NGP354879H, NGP354880H, NGP354881H, NGP354882H, NGP354883H, NGP354884H, NGP354885H, NGP354886H, NGP354887H, NGP354889H thru NGP354929H, NGP354931H, NGP354933H, NGP354934H, NGP354935H, NGP354936H, NGP354937H, NGP354938H, NGP354939H, NGP354940H, NGP354941H, NGP354943H, NGP354944H, NGP354945H, NGP354946H, NGP354947H, NGP354948H, NGP354949H, NGP354950H, NGP354951H, NGP354952H, NGP354954H thru NGP354965H, NGP355002H, NGP355003H, NGP355004H, NGP355005H, NGP355006H, NGP355007H, NGP355020H, NGP355023H, NGP355027H, NGP355030H, NGP355033H, NGP355034H, NGP355042H, NGP355043H, NGP355050H, NGP355051H, NGP355056H, NGP355058H, NGP355059H, NGP355060H, NGP355061H, NGP355064H thru NGP355171H, NGP355173H, NGP355174H, NGP355175H, NGP355177H, NGP355178H, NGP355179H, NGP355180H, NGP355181H, NGP355182H, NGP355184H, NGP355185H, NGP355186H, NGP355187H, NGP355188H, NGP355190H, NGP355191H, NGP355192H, NGP355193H, NGP355194H, NGP355195H, NGP355197H, NGP355199H, NGP355200H, NGP355201H, NGP355202H, NGP355204H, NGP355205H, NGP355207H, NGP355209H, NGP355210H, NGP355211H, NGP355212H, NGP355213H, NGP355214H, NGP355215H, NGP355216H, NGP355217H, NGP355220H, NGP355221H, NGP355222H, NGP355223H, NGP355225H, NGP355226H, NGP355227H, NGP355228H, NGP355230H, NGP355231H, NGP355232H, NGP355233H, NGP355234H, NGP355236H, NGP355237H, NGP355238H, NGP355239H, NGP355241H thru NGP355260H, NGP355262H thru NGP355287H, NGP355289H thru NGP355308H, thru NGP355319H, NGP355321H thru NGP355357H, NGP355359H thru NGP355374H, NGP355376H thru NGP355397H, NGP355399H, NGP355401H, NGP355402H, NGP355403H, NGP355404H, NGP355405H, NGP355407H, NGP355408H, NGP355409H, NGP355410H, NGP355411H, NGP355412H, NGP355413H, NGP355414H, NGP355416H, NGP355417H, NGP355419H, NGP355420H, NGP355421H, NGP355422H, NGP355423H, NGP355425H thru NGP355460H, NGP355462H thru NGP355495H, NGP355497H, NGP355498H, NGP355499H, NGP355500H, NGP355502H thru NGP355522H, NGP355524H thru NGP355630H, NGP355633H, NGP355634H, NGP355640H, NGP355643H, NGP355647H, NGP355653H, NGP355654H, NGP355656H, NGP355658H, NGP355661H, NGP355665H, NGP355666H, NGP355668H, NGP355671H, NGP355673H, NGP355676H, NGP355679H, NGP355680H, NGP355684H, NGP355689H, NGP355691H, NGP355692H, NGP355694H, NGP355697H, NGP355719H, NGP355721H, NGP355722H, NGP355725H, NGP355727H, NGP355728H, NGP355730H, NGP355731H, NGP355732H, NGP355734H, NGP355737H, NGP355739H, NGP355741H, NGP355742H, NGP355743H, NGP355745H, NGP355747H, NGP355749H, NGP355750H, NGP355753H, NGP355754H, NGP355755H, NGP355756H, NGP355757H, NGP355758H, NGP355759H, NGP355760H, NGP355761H, NGP355767H, NGP355768H, NGP355769H, NGP355771H, NGP355773H, NGP355776H, NGP355778H, NGP355780H, NGP355781H, NGP355782H, NGP355783H, NGP355786H, NGP355787H, NGP355794H, NGP355808H, NGP355809H, NGP355811H, NGP355812H, NGP355818H, NGP355822H, NGP355825H, NGP355830H, NGP355833H, NGP355840H, NGP355841H, NGP355843H, NGP355846H, NGP355848H, NGP355850H, NGP355852H, NGP355853H, NGP355854H, NGP355860H, NGP355863H, NGP355869H, NGP355874H, NGP355875H, NGP355876H, NGP355884H, NGP355886H, NGP355887H, NGP355888H, NGP355890H, NGP355891H, NGP355892H, NGP355893H, NGP355894H, NGP355895H, NGP355896H, NGP355897H, NGP355898H, NGP355900H, NGP355901H, NGP355902H, NGP355903H, NGP355906H, NGP355907H, NGP355908H, NGP355909H, NGP355910H, NGP355911H, NGP355913H, NGP355914H, NGP355915H, NGP355916H, NGP355917H, NGP355918H, NGP355919H, NGP355920H, NGP355921H, NGP355922H, NGP355923H, NGP355924H, NGP355926H, NGP355929H, NGP355930H, NGP355931H, NGP355934H, NGP355936H, NGP355937H, NGP355938H, NGP355939H, NGP355940H, NGP355941H, NGP355942H, NGP355943H, NGP355944H, NGP355945H, NGP355946H, NGP355948H thru NGP355962H, NGP355964H, NGP355965H, NGP355966H, NGP355967H, NGP355968H, NGP355969H, NGP355971H, NGP355973H, NGP355974H, NGP355975H, NGP355976H, NGP355977H, NGP355979H, NGP355980H, NGP355982H thru NGP356002H, NGP356004H, NGP356005H, NGP356006H, NGP356007H, NGP356008H, NGP356009H, NGP356010H, NGP356011H, NGP356012H, NGP356013H, NGP356014H, NGP356015H, NGP356016H, NGP356018H thru NGP356035H, NGP356037H, NGP356038H, NGP356042H, NGP356044H, NGP356046H, NGP356050H, NGP356051H, NGP356053H, NGP356054H, NGP356055H, NGP356056H, NGP356057H, NGP356059H, NGP356060H, NGP356061H, NGP356062H, NGP356063H, NGP356064H, NGP356065H, NGP356066H, NGP356067H, NGP356068H, NGP356070H, NGP356071H, NGP356072H, NGP356073H, NGP356074H, NGP356075H, NGP356076H, NGP356078H, NGP356079H, NGP356080H, NGP356081H, NGP356082H, NGP356083H, NGP356084H, NGP356085H, NGP356086H, NGP356087H, NGP356089H, NGP356090H, NGP356091H, NGP356092H, NGP356094H, NGP356096H, NGP356104H, NGP356105H, NGP356106H, NGP356107H, NGP356108H, NGP356109H, NGP356110H, NGP356111H, NGP356114H, NGP356116H, NGP356118H, NGP356119H, NGP356120H, NGP356121H, NGP356123H, NGP356124H, NGP356125H, NGP356126H, NGP356127H, NGP356129H, NGP356130H, NGP356133H, NGP356135H, NGP356137H, NGP356139H, NGP356143H, NGP356144H, NGP356145H, NGP356146H, NGP356147H, NGP356150H, NGP356152H, NGP356156H, NGP356157H, NGP356158H, NGP356159H, NGP356161H, NGP356163H, NGP356167H, NGP356170H, NGP356171H, NGP356172H, NGP356175H, NGP356176H, NGP356178H, NGP356224H, NGP356232H thru NGP356304H, NGP356306H, NGP356307H, NGP356309H, NGP356311H, NGP356312H, NGP356313H, NGP356316H thru NGP356327H, NGP356329H, NGP356330H, NGP356331H, NGP356332H, NGP356335H, NGP356336H, NGP356337H, NGP356338H, NGP356339H, NGP356340H, NGP356341H, NGP356342H, NGP356343H, NGP356344H, NGP356345H, NGP356347H, NGP356349H, NGP356350H, NGP356351H, NGP356352H, NGP356353H, NGP356354H, NGP356355H, NGP356356H, NGP356357H, NGP356359H, NGP356360H, NGP356361H, NGP356362H, NGP356364H, NGP356365H, NGP356368H, NGP356369H, NGP356370H, NGP356371H, NGP356372H, NGP356373H, NGP356374H, NGP356375H, NGP356376H, NGP356377H, NGP356378H, NGP356379H, NGP356381H, NGP356382H, NGP356383H, NGP356386H, NGP356387H, NGP356388H, NGP356389H, NGP356390H, NGP356391H, NGP356394H, NGP356396H, NGP356397H, NGP356400H, NGP356402H, NGP356405H, NGP356408H, NGP356409H, NGP356411H, NGP356417H, NGP356418H, NGP356419H, NGP356420H, NGP356421H, NGP356422H, NGP356423H, NGP356424H, NGP356426H, NGP356432H, NGP356433H, NGP356434H, NGP356435H, NGP356436H, NGP356439H, NGP356440H, NGP356443H, NGP356447H, NGP356448H, NGP356449H, NGP356450H, NGP356451H, NGP356453H, NGP356455H, NGP356456H, NGP356457H, NGP356459H, NGP356464H thru NGP356489H, NGP356492H, NGP356493H, NGP356496H, NGP356498H, NGP356499H, NGP356505H, NGP356507H, NGP356508H, NGP356512H, NGP356513H, NGP356516H, NGP356521H, NGP356524H, NGP356527H, NGP356532H, NGP356534H, NGP356535H, NGP356536H, NGP356542H, NGP356547H, NGP356552H, NGP356563H, NGP356564H, NGP356565H, NGP356566H, NGP356568H, NGP356569H, NGP356575H, NGP356576H, NGP356578H, NGP356579H, NGP356580H, NGP356581H, NGP356582H, NGP356600H, NGP356603H, NGP356605H, NGP356630H, NGP356631H, NGP356632H, NGP356637H, NGP356639H, NGP356641H, NGP356642H, NGP356643H, NGP356645H, NGP356646H, NGP356647H, NGP356648H, NGP356649H, NGP356652H, NGP356653H, NGP356656H, NGP356657H, NGP356660H, NGP356661H, NGP356662H, NGP356664H, NGP356668H, NGP356669H, NGP356671H, NGP356672H, NGP356673H, NGP356675H, NGP356676H, NGP356678H, NGP356680H, NGP356682H, NGP356684H, NGP356685H, NGP356686H, NGP356689H, NGP356692H, NGP356699H, NGP356700H, NGP356706H, NGP356707H, NGP356711H, NGP356714H, NGP356718H, NGP356727H, NGP356728H, NGP356731H, NGP356734H, NGP356736H, NGP356737H, NGP356739H thru NGP356765H, NGP356767H, NGP356768H, NGP356769H, NGP356770H, NGP356771H, NGP356773H thru NGP356807H, NGP356809H, NGP356810H, NGP356811H, NGP356812H, NGP356813H, NGP356814H, NGP356816H thru NGP356838H, NGP356848H, NGP356851H, NGP356852H, NGP356855H, NGP356856H, NGP356860H, NGP356863H, NGP356864H, NGP356865H, NGP356866H, NGP356869H, NGP356872H, NGP356876H, NGP356877H, NGP356881H, NGP356889H, NGP356892H, NGP356893H, NGP356894H, NGP356896H, NGP356902H, NGP356911H, NGP356912H, NGP356913H, NGP356914H, NGP356915H, NGP356916H, NGP356919H thru NGP356946H, NGP356949H thru NGP356965H, NGP356967H, NGP356968H, NGP356969H, NGP356970H, NGP356972H, NGP356973H, NGP356974H, NGP356975H, NGP356976H, NGP356977H, NGP356978H, NGP356979H, NGP356980H, NGP356981H, NGP356982H, NGP356983H, NGP356984H, NGP356986H, NGP356989H, NGP356990H, NGP356993H, NGP356994H, NGP356996H, NGP356997H, NGP356999H, NGP357002H, NGP357004H, NGP357005H, NGP357006H, NGP357009H, NGP357010H, NGP357011H, NGP357012H, NGP357015H, NGP357016H, NGP357023H, NGP357024H, NGP357039H, NGP357040H, NGP357041H, NGP357042H, NGP357043H, NGP357044H, NGP357045H, NGP357047H, NGP357056H, NGP357059H, NGP357061H, NGP357080H, NGP357086H, NGP357088H, NGP357089H, NGP357090H, NGP357091H, NGP357092H thru NGP357106H, NGP357108H thru NGP357124H, NGP357126H, NGP357128H thru NGP357191H, NGP357193H thru NGP357235H, NGP357237H thru NGP357252H, NGP357254H thru NGP357283H, NGP357286H, NGP357288H, NGP357291H, NGP357292H, NGP357294H, NGP357296H, NGP357304H, NGP357313H, NGP357314H, NGP357315H, NGP357316H, NGP357323H, NGP357335H, NGP357339H, NGP357347H, NGP357351H, NGP357355H, NGP357357H, NGP357358H, NGP357364H, NGP357379H, NGP357381H, NGP357385H, NGP357386H, NGP357388H thru NGP357407H, NGP357409H thru NGP357426H, NGP357436H, NGP357438H, NGP357441H, NGP357451H, NGP357453H, NGP357455H, NGP357456H, NGP357463H, NGP357466H, NGP357467H, NGP357468H, NGP357469H, NGP357470H, NGP357471H, NGP357472H, NGP357473H, NGP357474H, NGP357475H, NGP357478H, NGP357479H, NGP357480H, NGP357482H, NGP357483H, NGP357484H, NGP357486H, NGP357487H, NGP357488H, NGP357489H, NGP357491H, NGP357492H, NGP357494H, NGP357497H, NGP357499H, NGP357500H, NGP357501H, NGP357502H, NGP357503H, NGP357505H, NGP357506H, NGP357507H, NGP357512H, NGP357513H, NGP357514H, NGP357520H, NGP357521H, NGP357522H, NGP357523H, NGP357527H, NGP357528H, NGP357530H thru NGP357562H, NGP357564H, NGP357565H, NGP357566H, NGP357568H thru NGP357584H, NGP357586H thru NGP357607H, NGP357609H, NGP357610H, NGP357612H thru NGP357626H, NGP357635H thru NGP357705H, NGP357707H thru NGP357717H, NGP357719H, NGP357721H thru NGP357737H, NGP357740H, NGP357741H, NGP357743H, NGP357744H, NGP357745H, NGP357747H thru NGP357760H, NGP357762H, NGP357763H, NGP357764H, NGP357765H, NGP357766H, NGP357767H, NGP357768H, NGP357770H, NGP357771H, NGP357772H, NGP357773H, NGP357775H thru NGP357791H, NGP357793H, NGP357794H, NGP357795H, NGP357797H, NGP357798H, NGP357799H, NGP357800H, NGP357801H, NGP357802H, NGP357803H, NGP357804H, NGP357806H, NGP357808H, NGP357810H, NGP357812H, NGP357813H, NGP357816H, NGP357818H, NGP357820H, NGP357822H, NGP357827H, NGP357828H, NGP357830H, NGP357833H, NGP357834H, NGP357836H, NGP357837H, NGP357840H, NGP357841H, NGP357843H, NGP357844H, NGP357845H, NGP357846H, NGP357847H, NGP357849H, NGP357853H, NGP357854H, NGP357855H, NGP357857H, NGP357858H, NGP357860H, NGP357863H, NGP357864H, NGP357865H, NGP357866H, NGP357868H, NGP357871H, NGP357873H, NGP357875H, NGP357877H, NGP357879H, NGP357880H, NGP357882H, NGP357883H, NGP357884H, NGP357885H, NGP357886H, NGP357889H, NGP357895H, NGP357896H, NGP357897H, NGP357898H, NGP357899H, NGP357901H thru NGP357925H, NGP357928H thru NGP357939H, NGP357941H, NGP357942H, NGP357943H, NGP357944H, NGP357945H, NGP357946H, NGP357948H, NGP357949H, NGP357950H, NGP357952H, NGP357953H, NGP357955H, NGP357956H, NGP357958H, NGP357960H, NGP357961H, NGP357963H, NGP357964H, NGP357967H, NGP357968H, NGP357969H, NGP357972H, NGP357973H, NGP357975H, NGP357976H, NGP357977H, NGP357978H, NGP357979H, NGP357980H, NGP357981H, NGP357982H, NGP357983H, NGP357984H, NGP357985H, NGP357986H, NGP357988H, NGP357989H, NGP357990H, NGP357991H, NGP357992H, NGP357994H, NGP357996H thru NGP358014H, NGP358016H, NGP358017H, NGP358021H, NGP358024H, NGP358026H, NGP358028H, NGP358029H, NGP358030H, NGP358033H, NGP358034H, NGP358035H, NGP358037H, NGP358039H thru NGP358053H, NGP358055H thru NGP358065H, NGP358070H thru NGP358083H, NGP358086H thru NGP358095H, NGP358097H, NGP358098H, NGP358099H, NGP358100H, NGP358101H, NGP358102H, NGP358103H, NGP358104H, NGP358105H, NGP358108H, NGP358112H, NGP358113H, NGP358116H, NGP358121H, NGP358122H, NGP358123H, NGP358124H, NGP358130H, NGP358131H, NGP358134H, NGP358135H, NGP358144H, NGP358147H, NGP358149H, NGP358152H, NGP358157H, NGP358159H, NGP358161H, NGP358163H, NGP358164H, NGP358165H, NGP358168H, NGP358174H, NGP358177H, NGP358178H, NGP358180H, NGP358184H, NGP358185H, NGP358187H, NGP358191H, NGP358192H, NGP358198H, NGP358200H, NGP358202H, NGP358209H, NGP358210H, NGP358211H, NGP358212H, NGP358213H, NGP358215H, NGP358216H, NGP358219H, NGP358220H, NGP358221H, NGP358222H, NGP358223H, NGP358225H, NGP358227H, NGP358231H, NGP358232H, NGP358234H, NGP358235H, NGP358236H, NGP358237H, NGP358238H, NGP358240H, NGP358245H, NGP358247H, NGP358249H, NGP358250H, NGP358251H, NGP358253H, NGP358254H, NGP358255H, NGP358256H, NGP358257H, NGP358260H, NGP358265H, NGP358266H, NGP358268H, NGP358269H, NGP358270H, NGP358271H, NGP358272H, NGP358275H, NGP358276H, NGP358278H, NGP358279H, NGP358285H, NGP358289H, NGP358290H, NGP358294H, NGP358297H, NGP358298H, NGP358301H, NGP358308H, NGP358309H, NGP358310H, NGP358312H, NGP358321H, NGP358325H, NGP358329H, NGP358333H, NGP358338H, NGP358347H, NGP358348H, NGP358350H, NGP358353H, NGP358358H, NGP358360H, NGP358366H, NGP358368H, NGP358375H, NGP358381H, NGP358386H, NGP358387H, NGP358391H, NGP358392H, NGP358399H, NGP358408H, NGP358411H, NGP358412H, NGP358415H, NGP358416H, NGP358417H, NGP358421H, NGP358427H, NGP358430H, NGP358436H, NGP358438H, NGP358440H, NGP358442H, NGP358443H, NGP358444H, NGP358445H, NGP358446H, NGP358447H, NGP358448H, NGP358450H, NGP358453H, NGP358454H, NGP358458H, NGP358459H, NGP358460H, NGP358464H, NGP358465H, NGP358466H, NGP358467H, NGP358468H, NGP358469H, NGP358471H, NGP358472H, NGP358473H, NGP358475H, NGP358476H, NGP358480H, NGP358485H, NGP358486H, NGP358487H, NGP358488H, NGP358490H, NGP358491H, NGP358492H, NGP358493H, NGP358495H, NGP358496H, NGP358499H, NGP358504H, NGP358505H, NGP358507H, NGP358513H, NGP358514H, NGP358516H, NGP358520H, NGP358524H, NGP358525H, NGP358526H, NGP358531H, NGP358532H, NGP358533H, NGP358543H, NGP358544H, NGP358547H, NGP358552H, NGP358557H, NGP358558H, NGP358563H, NGP358568H, NGP358569H, NGP358570H, NGP358572H, NGP358573H, NGP358577H, NGP358580H, NGP358583H, NGP358584H, NGP358585H, NGP358586H, NGP358587H, NGP358591H, NGP358592H, NGP358593H, NGP358594H, NGP358595H, NGP358596H, NGP358597H, NGP358598H, NGP358599H, NGP358600H, NGP358601H, NGP358602H, NGP358604H, NGP358605H, NGP358606H, NGP358607H, NGP358608H, NGP358609H, NGP358610H, NGP358611H, NGP358613H, NGP358614H, NGP358615H, NGP358616H, NGP358617H, NGP358618H, NGP358619H, NGP358620H, NGP358621H, NGP358622H, NGP358628H, NGP358629H, NGP358630H, NGP358633H, NGP358635H, NGP358636H, NGP358637H, NGP358639H, NGP358640H, NGP358641H, NGP358642H, NGP358643H, NGP358645H, NGP358646H, NGP358648H, NGP358649H, NGP358650H, NGP358651H, NGP358652H, NGP358653H, NGP358655H, NGP358657H, NGP358659H, NGP358660H, NGP358661H, NGP358662H, NGP358664H, NGP358665H, NGP358667H, NGP358668H, NGP358669H, NGP358670H, NGP358671H, NGP358672H, NGP358677H, NGP358680H, NGP358681H, NGP358685H, NGP358686H, NGP358689H, NGP358690H, NGP358692H, NGP358693H, NGP358696H, NGP358697H, NGP358699H, NGP358700H, NGP358702H, NGP358703H, NGP358705H, NGP358706H, NGP358707H, NGP358710H, NGP358711H, NGP358714H, NGP358716H, NGP358717H, NGP358718H, NGP358719H, NGP358721H, NGP358722H, NGP358725H, NGP358727H, NGP358729H, NGP358731H, NGP358732H, NGP358733H, NGP358734H, NGP358735H, NGP358736H, NGP358737H, NGP358739H, NGP358740H, NGP358741H, NGP358742H, NGP358743H, NGP358744H, NGP358746H, NGP358748H thru NGP358770H, NGP358772H, NGP358773H, NGP358774H, NGP358775H, NGP358776H, NGP358777H, NGP358778H, NGP358779H, NGP358781H thru NGP358792H, NGP358794H, NGP358795H, NGP358796H, NGP358798H, NGP358800H, NGP358801H, NGP358802H, NGP358804H, NGP358805H, NGP358806H, NGP358807H, NGP358809H, NGP358810H, NGP358811H, NGP358814H, NGP358815H, NGP358816H, NGP358817H, NGP358820H, NGP358821H, NGP358823H, NGP358825H, NGP358826H, NGP358827H, NGP358828H, NGP358829H, NGP358831H, NGP358832H, NGP358833H, NGP358834H, NGP358837H, NGP358838H, NGP358839H, NGP358840H, NGP358841H, NGP358842H, NGP358844H, NGP358847H, NGP358854H, NGP358859H, NGP358861H, NGP358863H, NGP358871H, NGP358872H, NGP358874H, NGP358876H, NGP358878H, NGP358880H, NGP358885H, NGP358886H, NGP358890H, NGP358892H, NGP358895H, NGP358898H, NGP358905H, NGP358907H, NGP358908H, NGP358910H, NGP358916H, NGP358917H, NGP358918H, NGP358922H, NGP358925H, NGP358926H, NGP358927H, NGP358935H, NGP358936H, NGP358937H, NGP358938H, NGP358939H, NGP358940H, NGP358941H, NGP358942H, NGP358943H, NGP358945H, NGP358946H, NGP358947H, NGP358948H, NGP358949H, NGP358950H, NGP358951H, NGP358952H, NGP358953H, NGP358955Hthru NGP358972H, NGP358974H thru NGP358994H, NGP358996H, NGP358997H, NGP358999H, NGP359000H, NGP359001H, NGP359002H, NGP359003H, NGP359004H thru NGP359044H, NGP359047H, NGP359048H, NGP359049H, NGP359050H, NGP359051H, NGP359052H, NGP359053H, NGP359055H, NGP359056H, NGP359057H, NGP359059H, NGP359060H, NGP359061H, NGP359062H, NGP359064H, NGP359065H, NGP359066H, NGP359067H, NGP359068H, NGP359069H, NGP359071H, NGP359072H, NGP359073H, NGP359074H, NGP359076H, NGP359077H, NGP359080H, NGP359081H, NGP359083H, NGP359086H, NGP359087H, NGP359088H, NGP359089H, NGP359090H, NGP359091H, NGP359095H, NGP359097H, NGP359098H, NGP359099H, NGP359100H, NGP359103H, NGP359104H, NGP359105H, NGP359106H, NGP359107H, NGP359108H, NGP359109H, NGP359110H, NGP359111H, NGP359112H, NGP359113H, NGP359114H, NGP359117H, NGP359119H, NGP359120H, NGP359121H, NGP359122H, NGP359123H, NGP359224H, NGP359225H, NGP359227H, NGP359228H, NGP359229H, NGP359230H, NGP359231H, NGP359232H, NGP359233H, NGP359234H, NGP359235H, NGP359237H thru NGP359251H, NGP359253H thru NGP359262H, NGP359264H, NGP359265H, NGP359266H, NGP359267H, NGP359268H, NGP359270H, NGP359271H, NGP359272H, NGP359274H, NGP359276H, NGP359280H, NGP359281H, NGP359290H, NGP359291H, NGP359298H, NGP359300H, NGP359302H, NGP359303H, NGP359305H, NGP359310H, NGP359313H, NGP359314H, NGP359320H, NGP359323H. NGV000236R thru NGV000334R, NGV000557N thru NGV028001N, NGV300002H thru NGV445681H, NGV445683H, NGV445685H thru NGV445700H, NGV445702H, NGV445703H, NGV445704H, NGV445705H, NGV445707H tru NGV445727H, NGV445729H, NGV445730H, NGV445731H, NGV445732H, NGV445734H thru NGV445776H, NGV445778H thru NGV445792H, NGV445795H thru NGV445834H, NGV445836H thru NGV445939H, NGV445941H thru NGV445960H, NGV445962H thru NGV445975H, NGV445977H, NGV445978H, NGV445979H, NGV445980H, NGV445981H, NGV445982H, NGV445983H, NGV445984H, NGV445985H, NGV445987H, NGV445988H, NGV445989H, NGV445990H, NGV445991H, NGV445992H, NGV445993H, NGV445994H, NGV445996H thru NGV446009H, NGV446011H, NGV446012H, NGV446014H thru NGV446052H, NGV446054H, NGV446055H, NGV446056H, NGV446057H, NGV446058H, NGV446059H, NGV446060H, NGV446061H, NGV446063H thru NGV446135H, NGV446137H, NGV446138H, NGV446139H, NGV446140H, NGV446141H, NGV446142H, NGV446143H, NGV446144H, NGV446146H thru NGV446175H, NGV446177H, NGV446178H, NGV446179H, NGV446180H, NGV446182H thru NGV446362H, NGV446364H thru NGV446375H, NGV446377H thru NGV446398H, NGV446407H, NGV446408H thru NGV446437H, NGV446439H thru NGV446502H, NGV446504H thru NGV446718H, NGV446720H, NGV446721H, NGV446722H, NGV446724H, NGV446725H, NGV446726H, NGV446728H thru NGV446749H, NGV446751H thru NGV446768H, NGV446770H thru NGV446803H, NGV446805H, NGV446806H, NGV446807H, NGV446808H, NGV446809H, NGV446810H, NGV446811H, NGV446812H, NGV446813H, NGV446814H, NGV446817H, NGV446818H, NGV446819H, NGV446820H, NGV446822H, NGV446823H, NGV446824H, NGV446825H, NGV446826H, NGV446827H, NGV446828H, NGV446829H, NGV446831H thru NGV446918H, NGV446920H thru NGV446955H, NGV446957H thru NGV447159H, NGV447161H thru NGV447212H, NGV447214H thru NGV447227H, NGV447229H, NGV447231H thru NGV447249H, NGV447251H thru NGV447274H, NGV447276H, NGV447277H, NGV447278H, NGV447279H, NGV447280H, NGV447281H, NGV447282H, NGV447283H, NGV447284H, NGV447285H, NGV447286H, NGV447288H thru NGV447298H, NGV447300H, NGV447301H, NGV447302H, NGV447303H, NGV447304H, NGV447305H, NGV447306H, NGV447307H, NGV447308H, NGV447309H, NGV447310H, NGV447311H, NGV447313H, NGV447314H, NGV447315H, NGV447316H, NGV447318H, NGV447319H, NGV447321H thru NGV447337H, NGV447339H, NGV447340H, NGV447341H, NGV447343H, NGV447344H, NGV447346H, NGV447347H, NGV447348H, NGV447350H, NGV447351H, NGV447352H, NGV447353H, NGV447354H, NGV447355H, NGV447356H, NGV447357H, NGV447358H, NGV447359H, NGV447360H, NGV447361H, NGV447364H, NGV447365H, NGV447366H, NGV447367H, NGV447368H, NGV447369H, NGV447371H, NGV447372H, NGV447374H, NGV447375H, NGV447377H, NGV447378H, NGV447379H, NGV447380H, NGV447381H, NGV447382H, NGV447383H, NGV447384H, NGV447385H, NGV447387H, NGV447389H, NGV447390H, NGV447391H, NGV447392H, NGV447393H, NGV447394H, NGV447395H, NGV447396H, NGV447397H, NGV447398H, NGV447399H, NGV447401H, NGV447402H, NGV447403H, NGV447404H, NGV447407H thru NGV447423H, NGV447425H thru NGV447530H, NGV447532H thru NGV447547H, NGV447549H thru NGV447923H, NGV447925H thru NGV447967H, NGV447969H thru NGV448122H, NGV448124H thru NGV448152H, NGV448154H thru NGV448211H, NGV448213H thru NGV448229H, NGV448231H thru NGV448294H, NGV448296H thru NGV448311H, NGV448313H thru NGV448323H, NGV448325H thru NGV448391H, NGV448393H thru NGV448456H, NGV448458H, NGV448461H thru NGV448470H, NGV448472H, NGV448473H, NGV448474H, NGV448475H, NGV448476H, NGV448477H, NGV448478H, NGV448479H, NGV448481H, NGV448484H, NGV448485H, NGV448487H, NGV448489H, NGV448490H, NGV448491H, NGV448492H, NGV448493H, NGV448494H, NGV448496H, NGV448497H, NGV448498H, NGV448501H, NGV448502H, NGV448505H, NGV448506H, NGV448507H, NGV448508H, NGV448510H, NGV448511H, NGV448512H, NGV448513H, NGV448515H, NGV448517H, NGV448518H, NGV448520H, NGV448521H, NGV448522H, NGV448523H, NGV448524H, NGV448527H, NGV448528H, NGV448529H, NGV448530H, NGV448531H, NGV448537H thru NGV448595H, NGV448597H, NGV448598H, NGV448599H, NGV448601H thru NGV448631H, NGV448633H, NGV448634H, NGV448635H, NGV448636H, NGV448637H, NGV448638H, NGV448641H, NGV448647H, NGV448650H, NGV448653H, NGV448656H, NGV448657H, NGV448659H, NGV448660H, NGV448661H, NGV448662H, NGV448663H, NGV448664H, NGV448665H, NGV448667H, NGV448668H, NGV448670H, NGV448671H, NGV448672H, NGV448674H, NGV448675H, NGV448677H, NGV448681H, NGV448682H, NGV448683H, NGV448684H, NGV448687H, NGV448688H, NGV448689H, NGV448690H, NGV448692H, NGV448693H, NGV448694H, NGV448696H, NGV448698H, NGV448699H, NGV448700H, NGV448701H, NGV448702H, NGV448703H, NGV448704H, NGV448705H, NGV448706H, NGV448707H, NGV448708H, NGV448709H, NGV448711H thru NGV448730H, NGV448732H thru NGV448788H, NGV448790H, NGV448791H, NGV448792H, NGV448793H, NGV448794H, NGV448795H, NGV448796H, NGV448797H, NGV448798H, NGV448800H, NGV448802H, NGV448803H, NGV448804H, NGV448805H, NGV448806H, NGV448808H, NGV448809H, NGV448810H, NGV448811H, NGV448812H, NGV448813H, NGV448814H, NGV448817H, NGV448819H, NGV448820H, NGV448822H, NGV448824H, NGV448828H, NGV448829H, NGV448832H, NGV448833H, NGV448834H, NGV448836H, NGV448837H, NGV448839H, NGV448841H, NGV448842H, NGV448844H, NGV448846H, NGV448847H, NGV448849H, NGV448850H, NGV448851H, NGV448852H, NGV448855H, NGV448859H, NGV448861H, NGV448862H, NGV448863H, NGV448865H, NGV448866H, NGV448867H, NGV448870H, NGV448872H, NGV448874H, NGV448875H, NGV448876H, NGV448877H, NGV448879H thru NGV448892H, NGV448894H, NGV448896H thru NGV448932H, NGV448934H, NGV448936H, NGV448937H, NGV448938H, NGV448939H, NGV448940H, NGV448941H, NGV448942H, NGV448943H, NGV448944H, NGV448946H, NGV448947H, NGV448948H, NGV448949H, NGV448950H, NGV448951H, NGV448952H, NGV448953H, NGV448954H, NGV448956H, NGV448957H, NGV448958H, NGV448960H thru NGV449003H, NGV449005H, NGV449006H, NGV449007H, NGV449008H, NGV449009H, NGV449010H, NGV449011H, NGV449013H thru NGV449038H, NGV449040H thru NGV449126H, NGV449128H, NGV449130H thru NGV449160H, NGV449162H, NGV449163H thru NGV449342H, NGV449344H, NGV449345H, NGV449348H, NGV449349H, NGV449350H, NGV449351H, NGV449352H, NGV449353H, NGV449354H, NGV449355H, NGV449356H, NGV449357H, NGV449358H, NGV449359H, NGV449360H, NGV449362H, NGV449363H, NGV449366H, NGV449367H, NGV449368H, NGV449369H, NGV449371H, NGV449373H, NGV449376H, NGV449377H, NGV449380H, NGV449381H, NGV449382H, NGV449383H, NGV449384H, NGV449385H, NGV449386H, NGV449387H, NGV449388H, NGV449392H, NGV449393H, NGV449394H, NGV449395H, NGV449396H, NGV449398H, NGV449400H, NGV449403H, NGV449404H, NGV449405H, NGV449406H, NGV449409H, NGV449422H, NGV449443H, NGV449447H, NGV449464H, NGV449491H, NGV449506H, NGV449510H, NGV449511H, NGV449512H, NGV449513H, NGV449514H, NGV449515H, NGV449517H, NGV449518H, NGV449519H, NGV449521H, NGV449522H, NGV449524H, NGV449526H, NGV449527H, NGV449528H, NGV449529H, NGV449532H, NGV449533H, NGV449535H, NGV449536H, NGV449537H, NGV449538H, NGV449539H, NGV449540H, NGV449543H, NGV449545H, NGV449546H, NGV449547H, NGV449549H, NGV449551H, NGV449553H, NGV449555H, NGV449556H, NGV449557H, NGV449558H, NGV449559H, NGV449560H, NGV449561H, NGV449562H, NGV449563H, NGV449564H, NGV449565H, NGV449566H, NGV449568H, NGV449569H, NGV449571H, NGV449572H, NGV449573H, NGV449576H, NGV449577H, NGV449578H, NGV449579H, NGV449580H, NGV449581H, NGV449582H, NGV449583H, NGV449584H, NGV449585H, NGV449586H, NGV449587H, NGV449589H, NGV449590H, NGV449591H, NGV449594H, NGV449596H, NGV449598H, NGV449599H, NGV449600H, NGV449601H, NGV449605H, NGV449606H, NGV449607H, NGV449608H, NGV449609H, NGV449610H, NGV449611H, NGV449612H, NGV449615H, NGV449616H, NGV449618H, NGV449619H, NGV449620H, NGV449621H, NGV449623H, NGV449624H, NGV449625H, NGV449626H, NGV449628H thru NGV449641H, NGV449645H, NGV449648H, NGV449655H, NGV449656H, NGV449658H, NGV449659H, NGV449660H, NGV449661H, NGV449662H, NGV449663H, NGV449664H, NGV449665H, NGV449669H, NGV449671H, NGV449674H, NGV449680H, NGV449681H, NGV449682H, NGV449687H, NGV449688H, NGV449691H, NGV449693H, NGV449697H, NGV449698H, NGV449703H, NGV449704H, NGV449710H, NGV449713H, NGV449716H, NGV449718H, NGV449719H, NGV449723H, NGV449727H, NGV449734H, NGV449735H, NGV449737H, NGV449738H, NGV449739H, NGV449745H, NGV449750H, NGV449751H, NGV449754H, NGV449759H, NGV449760H, NGV449763H, NGV449765H, NGV449771H, NGV449774H, NGV449777H, NGV449782H, NGV449784H, NGV449790H, NGV449793H, NGV449794H, NGV449796H, NGV449807H, NGV449809H, NGV449814H, NGV449817H, NGV449818H, NGV449823H, NGV449825H, NGV449828H, NGV449831H, NGV449833H, NGV449834H, NGV449835H, NGV449836H, NGV449837H, NGV449839H, NGV449844H, NGV449848H, NGV449851H, NGV449852H, NGV449856H, NGV449860H, NGV449863H, NGV449864H, NGV449873H, NGV449876H, NGV449877H, NGV449885H, NGV449888H, NGV449892H, NGV449896H, NGV449904H, NGV449905H, NGV449907H, NGV449908H, NGV449910H thru NGV449927H, NGV449929H, NGV449930H, NGV449932H, NGV449933H, NGV449934H, NGV449935H, NGV449936H, NGV449938H, NGV449939H, NGV449940H, NGV449941H, NGV449942H, NGV449943H, NGV449944H, NGV449945H, NGV449946H, NGV449947H, NGV449949H, NGV449950H, NGV449952H, NGV449953H, NGV449954H, NGV449955H, NGV449956H, NGV449957H, NGV449958H, NGV449959H, NGV449963H, NGV449965H, NGV449966H, NGV449968H, NGV449970H, NGV449971H, NGV449972H, NGV449973H, NGV449974H, NGV449975H, NGV449976H, NGV449977H, NGV449978H, NGV449980H, NGV449981H, NGV449982H, NGV449983H, NGV449984H, NGV449985H, NGV449987H, NGV449988H, NGV449991H, NGV449992H, NGV449993H, NGV449994H, NGV449995H, NGV449997H, NGV449998H, NGV449999H, NGV450000H, NGV450001H, NGV450003H thru NGV450034H, NGV450036H, NGV450037H, NGV450038H, NGV450039H, NGV450041H, NGV450042H, NGV450043H, NGV450044H, NGV450045H, NGV450046H, NGV450047H, NGV450048H, NGV450049H, NGV450051H, NGV450052H, NGV450053H, NGV450054H, NGV450055H, NGV450056H, NGV450057H, NGV450058H, NGV450059H, NGV450060H, NGV450061H, NGV450063H, NGV450064H, NGV450066H, NGV450067H, NGV450068H, NGV450069H, NGV450071H, NGV450072H, NGV450074H, NGV450076H, NGV450077H, NGV450078H, NGV450079H, NGV450080H, NGV450081H, NGV450082H, NGV450083H, NGV450084H, NGV450085H, NGV450086H, NGV450088H thru NGV450110H, NGV450112H, NGV450113H, NGV450117H, NGV450118H, NGV450119H, NGV450125H, NGV450127H thru NGV450201H, NGV450204H, NGV450206H, NGV450207H, NGV450208H, NGV450211H, NGV450212H, NGV450213H, NGV450214H, NGV450217H, NGV450218H, NGV450219H, NGV450220H, NGV450221H, NGV450223H, NGV450224H, NGV450225H, NGV450227H, NGV450229H, NGV450230H, NGV450234H, NGV450235H, NGV450236H, NGV450237H, NGV450242H, NGV450243H, NGV450244H, NGV450248H, NGV450249H, NGV450250H, NGV450251H, NGV450252H, NGV450253H, NGV450256H, NGV450259H, NGV450260H, NGV450262H, NGV450265H, NGV450266H, NGV450267H, NGV450268H, NGV450269H, NGV450270H, NGV450272H, NGV450273H, NGV450275H, NGV450278H, NGV450279H, NGV450280H, NGV450281H, NGV450282H, NGV450284H, NGV450285H thru NGV450302H, NGV450304H, NGV450306H, NGV450308H, NGV450309H, NGV450310H, NGV450311H, NGV450312H, NGV450314H, NGV450315H, NGV450316H, NGV450317H, NGV450319H, NGV450320H, NGV450321H, NGV450322H, NGV450323H, NGV450324H, NGV450325H, NGV450326H, NGV450327H, NGV450328H, NGV450329H, NGV450330H, NGV450331H, NGV450332H, NGV450335H, NGV450337H, NGV450338H, NGV450339H, NGV450341H, NGV450342H, NGV450343H, NGV450345H, NGV450347H, NGV450350H, NGV450352H, NGV450354H, NGV450355H, NGV450356H, NGV450357H, NGV450358H, NGV450359H, NGV450360H, NGV450363H, NGV450365H, NGV450366H, NGV450367H, NGV450368H, NGV450371H, NGV450372H, NGV450373H, NGV450374H, NGV450376H, NGV450377H, NGV450379H, NGV450380H, NGV450384H, NGV450385H, NGV450387H, NGV450390H, NGV450391H, NGV450394H, NGV450395H, NGV450396H, NGV450398H, NGV450399H, NGV450402H, NGV450404H, NGV450405H, NGV450406H, NGV450407H, NGV450408H, NGV450409H, NGV450411H, NGV450413H, NGV450415H, NGV450417H, NGV450418H, NGV450419H, NGV450420H, NGV450421H, NGV450422H, NGV450423H, NGV450424H, NGV450426H, NGV450427H, NGV450428H, NGV450429H, NGV450430H, NGV450431H, NGV450432H, NGV450433H, NGV450434H, NGV450435H, NGV450436H, NGV450438H, NGV450442H, NGV450446H, NGV450448H, NGV450450H, NGV450451H, NGV450452H, NGV450454H, NGV450455H, NGV450456H, NGV450457H, NGV450460H, NGV450461H, NGV450464H, NGV450465H, NGV450469H, NGV450472H, NGV450474H, NGV450478H, NGV450479H, NGV450485H, NGV450486H, NGV450488H, NGV450489H, NGV450490H, NGV450491H, NGV450492H, NGV450493H, NGV450494H, NGV450496H, NGV450497H, NGV450498H, NGV450500H, NGV450503H, NGV450511H, NGV450513H, NGV450516H, NGV450518H, NGV450519H, NGV450520H, NGV450521H, NGV450522H, NGV450523H, NGV450524H, NGV450525H, NGV450528H, NGV450533H, NGV450534H, NGV450535H, NGV450536H, NGV450538H, NGV450547H, NGV450548H, NGV450549H, NGV450551H, NGV450553H, NGV450554H, NGV450555H, NGV450556H, NGV450557H, NGV450558H, NGV450563H, NGV450565H, NGV450566H, NGV450567H, NGV450568H, NGV450570H, NGV450572H, NGV450573H, NGV450574H, NGV450576H, NGV450580H, NGV450582H, NGV450583H, NGV450584H, NGV450585H, NGV450586H, NGV450587H, NGV450588H, NGV450589H, NGV450592H, NGV450594H, NGV450595H, NGV450597H, NGV450600H, NGV450601H, NGV450602H, NGV450603H, NGV450604H, NGV450605H, NGV450606H, NGV450608H, NGV450609H, NGV450612H, NGV450615H, NGV450616H, NGV450617H, NGV450618H, NGV450619H, NGV450621H, NGV450622H, NGV450623H, NGV450625H, NGV450626H, NGV450633H, NGV450634H, NGV450637H, NGV450638H, NGV450639H, NGV450640H, NGV450641H, NGV450642H, NGV450643H, NGV450644H, NGV450646H thru NGV450664H, NGV450666H thru NGV450675H, NGV450677H, NGV450678H, NGV450680H, NGV450681H, NGV450682H, NGV450683H, NGV450684H, NGV450686H, NGV450688H, NGV450689H, NGV450692H, NGV450693H, NGV450694H, NGV450696H, NGV450697H, NGV450700H, NGV450701H, NGV450702H, NGV450703H, NGV450704H, NGV450705H, NGV450706H, NGV450708H, NGV450709H, NGV450710H, NGV450711H, NGV450712H, NGV450713H, NGV450714H, NGV450715H, NGV450716H, NGV450717H, NGV450718H, NGV450720H, NGV450721H, NGV450723H, NGV450724H, NGV450725H, NGV450726H, NGV450727H, NGV450728H, NGV450729H, NGV450730H, NGV450732H, NGV450733H, NGV450735H, NGV450736H, NGV450738H, NGV450739H, NGV450740H, NGV450742H, NGV450744H, NGV450745H, NGV450747H, NGV450749H, NGV450750H, NGV450751H, NGV450753H, NGV450754H, NGV450755H, NGV450756H, NGV450758H, NGV450759H, NGV450760H, NGV450761H, NGV450763H, NGV450764H, NGV450766H, NGV450767H, NGV450768H, NGV450770H, NGV450771H, NGV450772H, NGV450773H, NGV450774H, NGV450775H, NGV450778H, NGV450779H, NGV450780H, NGV450781H, NGV450782H, NGV450785H, NGV450792H, NGV450794H, NGV450796H, NGV450798H, NGV450799H, NGV450800H, NGV450801H, NGV450803H, NGV450805H, NGV450807H, NGV450809H, NGV450811H, NGV450812H, NGV450813H, NGV450814H, NGV450815H, NGV450816H, NGV450817H, NGV450818H, NGV450819H, NGV450820H, NGV450821H, NGV450822H, NGV450824H, NGV450825H, NGV450826H, NGV450827H, NGV450828H, NGV450829H, NGV450830H, NGV450832H, NGV450833H, NGV450834H, NGV450835H, NGV450836H, NGV450837H, NGV450838H, NGV450839H, NGV450840H, NGV450841H, NGV450842H, NGV450843H, NGV450845H thru NGV450859H, NGV450861H, NGV450863H, NGV450864H, NGV450866H, NGV450869H, NGV450870H, NGV450871H, NGV450872H, NGV450874H, NGV450883H, NGV450884H, NGV450885H, NGV450889H, NGV450891H, NGV450895H, NGV450899H, NGV450900H, NGV450904H, NGV450905H, NGV450906H, NGV450907H, NGV450914H, NGV450915H, NGV450921H, NGV450923H, NGV450926H, NGV450928H, NGV450930H, NGV450934H, NGV450938H, NGV450939H, NGV450942H, NGV450947H, NGV450950H, NGV450951H, NGV450952H, NGV450954H, NGV450959H, NGV450960H, NGV450961H, NGV450963H, NGV450964H, NGV450965H, NGV450966H, NGV450967H, NGV450968H, NGV450970H, NGV450976H, NGV450979H, NGV450981H thru NGV451007H, NGV451011H, NGV451013H, NGV451014H, NGV451015H, NGV451016H, NGV451017H, NGV451019H, NGV451020H, NGV451021H, NGV451024H, NGV451027H, NGV451029H, NGV451031H, NGV451034H, NGV451035H, NGV451037H, NGV451038H, NGV451039H, NGV451040H, NGV451041H, NGV451042H, NGV451043H, NGV451044H, NGV451045H, NGV451046H, NGV451047H, NGV451051H, NGV451052H, NGV451055H, NGV451056H, NGV451058H, NGV451059H, NGV451060H, NGV451062H, NGV451065H, NGV451066H, NGV451068H, NGV451073H, NGV451075H, NGV451076H, NGV451077H, NGV451078H, NGV451080H, NGV451082H, NGV451083H, NGV451084H, NGV451085H, NGV451087H, NGV451088H, NGV451089H, NGV451090H, NGV451092H, NGV451093H, NGV451094H, NGV451097H, NGV451099H, NGV451100H, NGV451102H, NGV451103H, NGV451104H, NGV451106H, NGV451107H, NGV451108H, NGV451111H, NGV451112H, NGV451114H, NGV451115H, NGV451116H, NGV451119H, NGV451120H, NGV451121H, NGV451122H, NGV451123H, NGV451125H, NGV451126H, NGV451127H, NGV451130H, NGV451132H, NGV451133H, NGV451135H, NGV451139H, NGV451142H, NGV451143H, NGV451145H, NGV451148H, NGV451149H, NGV451150H, NGV451151H, NGV451152H, NGV451153H, NGV451154H, NGV451155H, NGV451158H, NGV451160H, NGV451161H, NGV451163H, NGV451164H, NGV451165H, NGV451169H thru NGV451183H, NGV451185H thru NGV451212H, NGV451214H, NGV451215H, NGV451216H, NGV451217H, NGV451218H, NGV451219H, NGV451220H, NGV451221H, NGV451222H, NGV451224H, NGV451225H, NGV451226H, NGV451227H, NGV451228H, NGV451229H, NGV451230H, NGV451231H, NGV451232H, NGV451234H thru NGV451248H, NGV451250H, NGV451252H, NGV451253H, NGV451254H, NGV451255H, NGV451256H, NGV451257H, NGV451259H, NGV451260H, NGV451261H, NGV451262H, NGV451264H, NGV451265H, NGV451266H, NGV451267H, NGV451268H, NGV451269H, NGV451270H, NGV451271H, NGV451272H, NGV451273H, NGV451274H, NGV451278H, NGV451280H, NGV451281H, NGV451282H, NGV451283H, NGV451284H, NGV451285H, NGV451286H, NGV451287H, NGV451290H, NGV451292H, NGV451293H, NGV451295H, NGV451296H, NGV451297H, NGV451298H, NGV451299H, NGV451300H, NGV451303H, NGV451304H, NGV451305H, NGV451306H, NGV451307H, NGV451308H, NGV451309H, NGV451310H, NGV451311H, NGV451312H, NGV451313H, NGV451314H, NGV451316H, NGV451317H, NGV451318H, NGV451319H, NGV451320H, NGV451321H, NGV451322H, NGV451324H, NGV451326H, NGV451327H, NGV451328H, NGV451329H, NGV451331H, NGV451332H, NGV451335H, NGV451337H, NGV451339H, NGV451340H, NGV451341H, NGV451343H, NGV451349H, NGV451350H, NGV451351H, NGV451352H, NGV451354H, NGV451356H, NGV451358H, NGV451363H, NGV451364H, NGV451365H, NGV451366H, NGV451369H, NGV451371H, NGV451372H, NGV451373H, NGV451374H, NGV451375H, NGV451376H, NGV451377H, NGV451378H, NGV451380H, NGV451382H, NGV451385H, NGV451386H, NGV451387H, NGV451389H, NGV451391H, NGV451392H, NGV451395H, NGV451397H, NGV451399H, NGV451401H, NGV451405H, NGV451407H, NGV451413H, NGV451415H, NGV451418H, NGV451419H, NGV451420H, NGV451421H, NGV451422H, NGV451423H, NGV451424H, NGV451425H, NGV451426H, NGV451430H, NGV451431H, NGV451436H, NGV451437H, NGV451439H, NGV451440H, NGV451441H, NGV451442H, NGV451444H, NGV451445H, NGV451446H, NGV451447H, NGV451449H, NGV451450H, NGV451451H, NGV451452H, NGV451453H, NGV451455H, NGV451456H, NGV451457H, NGV451458H, NGV451459H, NGV451460H, NGV451461H, NGV451462H, NGV451463H, NGV451465H, NGV451468H, NGV451469H, NGV451470H, NGV451472H, NGV451473H, NGV451474H, NGV451475H, NGV451476H, NGV451477H, NGV451480H, NGV451481H, NGV451482H, NGV451483H, NGV451487H, NGV451488H, NGV451489H, NGV451490H, NGV451491H, NGV451492H, NGV451493H, NGV451496H, NGV451498H, NGV451503H, NGV451504H, NGV451505H, NGV451506H, NGV451507H, NGV451508H, NGV451509H, NGV451510H, NGV451511H, NGV451512H, NGV451513H, NGV451514H, NGV451516H thru NGV451603H, NGV451605H thru NGV451640H, NGV451642H thru NGV451707H, NGV451709H, NGV451710H, NGV451711H, NGV451713H, NGV451714H, NGV451719H, NGV451721H, NGV451725H, NGV451728H, NGV451741H, NGV451742H, NGV451752H, NGV451762H, NGV451765H, NGV451768H, NGV451777H, NGV451781H, NGV451786H, NGV451787H, NGV451795H, NGV451799H, NGV451801H, NGV451804H, NGV451806H, NGV451808H, NGV451809H, NGV451811H, NGV451817H, NGV451822H, NGV451824H, NGV451825H, NGV451826H, NGV451827H, NGV451829H, NGV451833H, NGV451836H, NGV451837H, NGV451838H, NGV451839H, NGV451841H, NGV451843H, NGV451844H, NGV451845H, NGV451847H, NGV451848H, NGV451849H, NGV451850H, NGV451851H, NGV451852H, NGV451853H, NGV451856H, NGV451857H, NGV451858H, NGV451859H, NGV451861H, NGV451862H, NGV451864H, NGV451868H, NGV451869H, NGV451870H, NGV451873H, NGV451874H, NGV451876H, NGV451878H, NGV451879H, NGV451880H, NGV451881H, NGV451882H, NGV451883H, NGV451884H, NGV451885H, NGV451887H, NGV451888H, NGV451889H, NGV451890H, NGV451891H, NGV451892H, NGV451893H, NGV451894H, NGV451896H, NGV451898H, NGV451899H, NGV451900H, NGV451901H, NGV451902H, NGV451903H, NGV451904H, NGV451905H, NGV451908H, NGV451909H, NGV451910H, NGV451912H, NGV451913H, NGV451914H, NGV451917H, NGV451918H, NGV451919H, NGV451922H, NGV451923H, NGV451924H, NGV451926H, NGV451928H, NGV451929H, NGV451930H, NGV451931H, NGV451933H, NGV451934H, NGV451936H, NGV451937H, NGV451939H, NGV451941H, NGV451942H, NGV451943H, NGV451944H, NGV451946H, NGV451947H, NGV451948H, NGV451951H thru NGV451962H, NGV451964H, NGV451965H, NGV451966H, NGV451968H, NGV451969H, NGV451971H, NGV451976H, NGV451977H, NGV451981H, NGV451982H, NGV451984H, NGV451986H, NGV451988H, NGV451990H, NGV451991H, NGV451992H, NGV451993H, NGV451994H, NGV451997H, NGV451998H, NGV451999H, NGV452001H, NGV452002H, NGV452003H, NGV452008H, NGV452009H, NGV452010H, NGV452011H, NGV452213H, NGV452214H, NGV452215H, NGV452216H, NGV452219H, NGV452220H, NGV452221H thru NGV452231H, NGV452233H, NGV452235H, NGV452236H, NGV452238H, NGV452239H, NGV452240H, NGV452241H, NGV452242H, NGV452243H, NGV452244H, NGV452246H thru NGV452259H, NGV452261H, NGV452262H, NGV452263H, NGV452264H, NGV452265H, NGV452266H, NGV452267H, NGV452269H, NGV452270H, NGV452271H, NGV452272H, NGV452273H, NGV452274H, NGV452275H, NGV452276H, NGV452277H, NGV452279H, NGV452280H, NGV452281H, NGV452282H, NGV452283H, NGV452284H, NGV452285H, NGV452287H, NGV452288H, NGV452289H, NGV452290H, NGV452291H, NGV452292H, NGV452293H, NGV452294H, NGV452295H, NGV452296H, NGV452297H, NGV452298H, NGV452299H, NGV452300H, NGV452302H, NGV452304H, NGV452305H, NGV452306H, NGV452307H, NGV452308H, NGV452309H, NGV452310H, NGV452314H, NGV452315H, NGV452316H, NGV452317H, NGV452318H, NGV452321H, NGV452322H, NGV452323H, NGV452324H, NGV452325H, NGV452326H, NGV452327H, NGV452329H, NGV452330H, NGV452333H, NGV452336H, NGV452338H, NGV452340H, NGV452343H, NGV452346H, NGV452347H, NGV452348H, NGV452349H, NGV452350H, NGV452351H, NGV452353H, NGV452359H, NGV452361H, NGV452364H, NGV452365H, NGV452367H, NGV452370H, NGV452371H, NGV452374H, NGV452375H, NGV452376H, NGV452377H, NGV452379H, NGV452380H, NGV452384H, NGV452385H, NGV452390H, NGV452393H, NGV452396H, NGV452397H, NGV452405H, NGV452407H, NGV452409H, NGV452410H, NGV452411H, NGV452412H, NGV452414H, NGV452415H, NGV452416H, NGV452423H, NGV452524H, NGV452527H, NGV452528H, NGV452530H, NGV452531H, NGV452532H, NGV452533H, NGV452534H, NGV452535H, NGV452536H, NGV452538H, NGV452539H, NGV452541H, NGV452542H, NGV452543H, NGV452544H, NGV452545H, NGV452546H, NGV452547H, NGV452548H, NGV452549H, NGV452550H, NGV452552H, NGV452553H, NGV452554H, NGV452556H, NGV452557H, NGV452558H, NGV452560H, NGV452561H, NGV452563H thru NGV452584H, NGV452586H, NGV452587H, NGV452589H thru NGV452613H, NGV452615H, NGV452617H, NGV452618H, NGV452620H, NGV452621H, NGV452623H. AMENDED: NGV452898H, NGP360022H, NGP360204H.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic, Inc. – Neuromodulation, Minneapolis, MN, by letter beginning July 05, 2011 and by press release on July 08, 2011.
Manufacturers: Medtronic Neuromodulation, Columbia Heights, MN;
Medtronic Puerto Rico Operations Co., Juncos, PR. Firm initiated recall is ongoing.
REASON
Medtronic is updating information regarding the potential for reduced battery performance that can lead to sudden loss of therapy in a small percentage of Medtronic Model 8647 SynchroMed II pumps that was communicated with Healthcare providers in July 2009. The purpose of the current communication is to provide updated information regarding the scope and occurrence of this issue and to emphasize previously communicated patient management recommendations. Medtronic is not retrieving the device from the field or recommending prophylactic replacement of the pump.
VOLUME OF PRODUCT IN COMMERCE
139,653 (105,002 US and 34,651 OUS)
DISTRIBUTION
Nationwide and Internationally
RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Intuitive Surgical da Vinci Si Surgical System (IS3000); Product Usage: Intended to assist in the accurate control of Intuitive Surgical Endoscopic Endo Wrist Instruments and Accessories. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended for use for trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use. Recall # Z-2930-2011
CODE
Serial numbers: SH0019 SH0021 SH0028 SH0037 SH0039 SH0042 SH0059 SH0061 SH0062 SH0063 SH0071 SH0078 SH0082 SH0084 SH0085 SH0086 SH0095 SH0099 SH0103 SH0111 SH0112 SH0114 SH0116 SH0117 SH0118 SH0120 SH0125 SH0126 SH0127 SH0130 SH0131 SH0135 SH0143 SH0148 SH0150 SH0155 SH0156 SH0160 SH0176 SH0177 SH0180 SH0193 SH0208 SH0210 SH0220 SH0221 SH0222 SH0224 SH0225 SH0228 SH0246 SH0251 SH0252 SH0256 SH0258 SH0270 SH0271 SH0273 SH0285 SH0286 SH0291 SH0303 SH0305 SH0307 SH0308 SH0312 SH0314 SH0320 SH0328 SH0332 SH0335 SH0336 SH0340 SH0342 SH0343 SH0344 SH0363 SH0369 SH0373 SH0378 SH0380 SH0381 SH0388 SH0393 SH0408 SH0411 SH0412 SH0416 SH0434 SH0441 SH0443 SH0447 SH0448 SH0449 SH0463 SH0464 SH0465 SH0467 SH0469 SH0470 SH0482 SH0483 SH0491 SH0495 SH0497 SH0500 SH0506 SH0511 SH0516 SH0517 SH0518 SH0528 SH0531 SH0533 SH0534 SH0543 SH0547 SH0555 SH0557 SH0558 SH0560 SH0565 SH0570 SH0574 SH0579 SH0585 SH0589 SH0591 SH0600 SH0608 SH0618 SH0620 SH0625 SH0627 SH0630 SH0631 SH0639 SH0644 SH0653 SH0657 SH0658 SH0659 SH0660 SH0663 SH0664 SH0665 SH0668 SH0671 SH0672 SH0680 SH0687 SH0691 SH0692 SH0696 SH0697 SH0701 SH0705 SH0706 SH0708 SH0712 SH0713 SH0721 SH0729 SH0730 SH0741 SH0744 SH0747 SH0762 SH0764 SH0774 SH0798 SH0807 SH0813 SH0834 SH0900 USG172 USG317 USG484 USG702 USG713 USG718 USG775 USG806
RECALLING FIRM/MANUFACTURER
Intuitive Surgical, Inc., Sunnyvale, CA, by letter dated July 1, 2011. Firm initiated recall is ongoing.
REASON
Potential failure of the retention component of the Master Tool Manipulator (MTM) of the Intuitive Surgical da Vinci Si Surgical System which could cause uncontrolled movement.
VOLUME OF PRODUCT IN COMMERCE
183 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) RUSCH, GB: Female Catheter, All Purpose PVC, 08 Fr. 18 cm, Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product Number: 238300080. Recall # Z-2932-2011;
2) RUSCH, GB: Female Catheter, All Purpose PVC, 10 Fr. 18 cm, Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238300100,. Recall # Z-2933-2011;
3) RUSCH, GB: Female Catheter, All Purpose PVC, 12 Fr. 18 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238300120. Recall # Z-2934-2011;
4) RUSCH, GB: Female Catheter, All Purpose PVC, 14 Fr. 18 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238300140. Recall # Z-2935-2011;
5) RUSCH, GB: Female Catheter, All Purpose PVC, 16 Fr. 18 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238300160. Recall # Z-2936-2011;
6) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 10 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500100, Recall # Z-2937-2011;
7) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 12 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500120, Recall # Z-2938-2011;
8) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 14 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500140. Recall # Z-2939-2011;
9) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 16 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500160, Recall # Z-2940-2011;
10) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 18 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500180. Recall # Z-2941-2011;
11) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 20 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500200. Recall # Z-2942-2011;
12) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 22 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500220. Recall # Z-2943-11;
13) RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 40 Fr. 40 cm. Product Usage: Catheter that is inserted through the urethra and used to pass fluids to or from the urinary tract. Product number: 238500240. Recall # Z-2944-2011
CODE
1) Lot Numbers: 082827-1, 120007, 122274, 122275, 123171, 124446, 129582, 130627, 142572, 318007, 322167, 335514,338383, 340211, 342044, 350053, 350054, 350055, 359272, 359989 and 405523;
2) Lot numbers: 18754, 19225, 19910, 22276, 22277, 25562, 103029, 105439, 113974, 116419, 118754, 119225, 119910, 122276, 122277, 123172, 125562, 142573, 142574, 310434, 322168, 335515, 340212, 342045, 346326, 350056, 359273, 359990, 378591, 378592, 379600, 380079, 380255, 380289, 384500, 390490, 391728, 405524 and 411563;
3) Lot numbers: 102727, 105235, 106285, 113977, 113977-1, 116421, 117539, 117596, 118055, 119407, 121555, 122279, 122741, 122742, 127595, 127596, 129921, 130638, 132295, 142577, 142578, 142686, 145826, 224511, 310436, 322170, 335516, 335517, 339565, 340215, 342048, 342049, 346327, 350057, 350058, 351722, 355193, 355194, 359275, 359991, 380181, 381731, 407775 and 238300120;
4) Lot numbers: 12011, 102728, 105236, 105237, 106237, 106300, 111799, 116422, 117536, 117537, 118157, 118757, 118758, 119911, 121011, 122270, 122279, 122279-1, 134622, 135867, 138384, 140684, 142580, 142581, 142689, 145829, 242221, 310437, 318009, 322171, 325864, 335519, 338391, 340217, 342051, 342052, 350060, 350061, 350062, 351724, 355195, 358832, 359276, 359277, 359992, 378594, 378595, 378596, 379601, 380257, 380258, 380259, 380290, 381735, 384505 and 405525;
5) Lot numbers: 105239, 106310, 117539, 121015, 122282, 125566, 125567, 129933, 130643, 130644, 140687, 140688, 142583, 142584, 310438, 316859, 322176, 335522, 340219, 342055, 342056, 346328, 350064, 350065, 350066, 351725, 355196, 359278, 359993, 378598, 391729, 397697 and 405526;
6) Lot numbers: 18737, 19895, 19896, 35859, 103020, 106237, 118335, 118737, 119895, 119896, 122249, 133393, 135859, 142555, 142669, 145805, 145806, 260307, 310421, 342128, 355186, 371394, 375302, 378564, 379599, 381716, 382379, 390479, 391750 and 852858;
7) Lot numbers: 06082, 34209, 103023, 105425, 106243, 118052, 119399, 119400, 121547, 121548, 122736, 127590, 127591, 132131, 134609, 135860, 138375, 140667, 141201, 142559, 142560, 142672, 310423, 317993, 322169, 335503, 338375, 340209, 342030, 342031, 350046, 359265, 359984, 380069, 380178, 380261, 381718, 381719, 384488 and 841934;
8) Lot numbers: 105100, 105253, 105400, 106253, 116413, 117513, 118337, 118741, 119902, 120999, 122253, 122279, 122553, 134611, 135861, 138377, 140672, 140673, 142564, 142565, 142675, 145814, 145815, 224514, 264209, 310427, 317998, 322172, 325863, 335505, 335506, 352863, 359268, 359985, 370073, 370074, 371402, 371403, 375214, 378570, 378571, 378572, 378573, 379602, 380072, 380262, 380264, 384492, 391737, 391738, 393279 and 868438;
9) Lot number: 103025, 105435, 105436, 106259, 117519, 117520, 118338, 118746, 119905, 121003, 122259, 128092, 130584, 130585, 133405, 133406, 134614, 135864, 139551, 142679, 142680, 151954, 242224, 310429, 322173, 335419, 342037, 342038, 350050, 350051, 351716, 355192, 358830, 359270, 359986, 370078, 370079, 371410, 371411, 375215, 378579, 378580, 378581, 379603, 380075, 380265, 381726, 384496, 390488, 393281 and 405519;
10) Lot numbers: 115011, 117525, 118749, 119908, 139556, 142682, 145821, 321992, 335513, 342041, 359271, 364044, 370082, 371414, 380177, 380254, 381728 and 874602;
11) Lot numbers: 20738, 105238, 107182, 119909, 122270, 146707, 346325, 359987, 378585, 380253, 391781, 397691, 405522 and 809627;
12) Lot numbers: 108305, 140250, 142683, 153802, 276286, 359988, 370083, 375047 and 378586;
13) Lot numbers: 118753, 268558, 351721 and 378587
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex Medical, Durham, NC, by letter dated June 30, 2011.
Manufacturer: Unomedical s.r.o., Michalovce, Slovakia. Firm initiated recall is ongoing.
REASON
Pin holes were detected in the packaging therefore sterility of the device can not be guaranteed.
VOLUME OF PRODUCT IN COMMERCE
14,378,890 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
CAPIOX Flexible Venous Reservoirs, 1500 mL, product codes: CXFVR1500X and CXFVRI500XC, used singly or packaged as components in cardiovascular procedure trays labeled in part *** Product Usage: The reservoir bag is intended for use as a blood collection and storage device during cardiopulmonary bypass procedures. The device is intended for use in conjunction with blood-gas oxygenators in the extra-corporeal circuit. The device may be used in procedures lasting up to 6 hours. Recall # Z-2950-2011
CODE
Lot NE13, (used as single units); kit lot numbers NC21 R, ND21 R, NF02, and NF02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Terumo Cardiovascular Corp, Elkton, MD, by letter dated July 20, 2011.
Manufacturers: Terumo Cardiovascular Corp., Elkton, MD;
Terumo Cardiovascular Systems Corp., Ashland, MA. Firm initiated recall is ongoing.
REASON
Reservoir blood bag used in cardiovascular procedures may leak.
VOLUME OF PRODUCT IN COMMERCE
253 reservoir bags
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
a) XT125 Photopheresis Procedural Kit for use with the UVAR XTS Instrument; b) XT001 Photopheresis Procedural Kit for use with the UVAR XTS Instrument Single-use, disposable, closed system with sterile fluid pathways. The device collects the buffy coat (leukocyte-enriched blood) from the patient in a discontinuous flow process and intermittently returns the remaining plasma and erythocytes to the patient. Recall # Z-2994-2011
CODE
a) X752-X760 and Y701-Y753; and b) X919 and Y901-Y911
RECALLING FIRM/MANUFACTURER
Therakos, Inc., Raritan, NJ, by letter dated March 31, 2011. Firm initiated recall is ongoing.
REASON
Increased complaints were received of tubing leaks at the junction between the tubing and Fluid Logic Module plastic ports of the kits.
VOLUME OF PRODUCT IN COMMERCE
13,239 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Katzen" Infusion Wire, 0.035 in x 180 cm, UPN Product No. M001461930, RED Catalog No. 46-193, Made in USA 8600. Intended for the infusion of therapeutic agents (i.e., heparin, saline, thrombolytic agents, etc) in the peripheral vasculature. The wire allows for the delivery of agents in either a "pulse -spray" or "slow weep" technique. Recall # Z-3053-2011
CODE
Batch/Lot Description: 14270326
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp, Maple Grove, MN, by letter dated August 1, 2011.
Manufacturer: Boston Scientific Corp, Miami, FL. Firm initiated recall is ongoing.
REASON
Boston Scientific is voluntarily recalling one lot/batch of Katzen" Infusion Wires because we have identified that the label on the carton and the inner pouch indicated an incorrect device length. The labels indicate a device length of 180cm while the actual device length is 145cm.
VOLUME OF PRODUCT IN COMMERCE
33 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Vortex MP Port Single Titanium Port with Attached (5Fr) Silicone Catheter, Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. Catalog number: MP-P5SAT. Recall # Z-3071-2011;
2) Vortex MP Port Single Titanium Port with Attachable (5Fr) Silicone Catheter. Indicated for central venous placement (either peripheral or chest placement) when patient therapy requires repeated venous access for injection or infusion therapy and/or venous blood sampling. Catalog number: MP-P5SDT. Recall # Z-3072-2011;
3) Habib, 4x Kit, Bipolar Resection Device RITA (Radiofrequency Ablation Devices). Intended to be used to assist in coagulation of tissue during intraoperative surgical procedures. Catalog number: 4401. Recall # Z-3073-2011;
CODE
1) Batch numbers: 513795 and 514961;
2) Batch numbers: 513796 and 517058;
3) Batch number: 511828, 511831, 511833, 513066, 513788, 513999, 514624, 515274, and 516914;
4) Batch number: 511829, 511830, 513063 513519 and 513789RECALLING FIRM/MANUFACTURER
Angiodynamics, Inc., Manchester, GA, by letter dated August 30, 2010. Firm initiated recall is ongoing.
REASON
The labeling contains errors which result in the products being misbranded.
VOLUME OF PRODUCT IN COMMERCE769 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
GemStar Li-Ion Docking Station; a lithium ion battery powered docking station for use with GemStar Infusion Pumps; The docking station for the GemStar pump is used to provide an alternate power source, acting either as a direct current battery backup, or as an alternating current power source when the docking station is plugged into AC power. The docking station also serves as a stand in which to place the GemStar during pump operation. Recall # Z-3107-2011
CODE
List Numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07, 13075-24-01, 13075-24-03, 13075-24-05 and 13075-24-07, Note: list numbers with xxxxx-04-xx are for U.S., Canada, Japan, Netherlands and Singapore, while those with xxxxx-24-xx are for international distribution only.
List Number 13075-04-01, batch numbers 15047G1, 15048G1, 15050G1, 17100G1, 19140G1, 19142G1, 19157G1, 20165G1, 20180G1, 21183G1, 21196G1, 21197G1, 62001L2, 63001L2, 68002L2, 69002L2, 73002L2 and 78001L2; List Number 13075-04-03, batch numbers 26289G1, 27314G1, 27324G1, 30375G1, 34499G1, 34601G1, 34603G1, 34605G1, 34606G1, 34608G1, 35615G1, 40764G1, 40765G1, 40766G1 and 41804G1; List Number 13075-04-05, batch numbers 41802G1, 44848G1, 44854G1, 45879G1, 45879G101, 45879G1R, 45884G1, 46910G1, 47916G1, 47936G1, 48960G1, 51031G1, 51032G1, 60285G1, 84824G1, 84827G1, 84831G1 and 85844G1; List number 13075-04-07, batch numbers 75679G1, 7698G1, 77698G101, 77715G1, 77715G101, 78734G1, 80774G1, 81784G1, 82789G1 and 87880G1; List number 13075-24-01, batch numbers 10899G1, 10910G1, 10917G1, 10930G1, 14010G1, 15046G1, 16060G1, 19141G1, 19144G1, 19145G1, 19146G1, 19147G1, 19148G1, 19149G1, 20171G1, 21191G1, 21203G1, 26289G1, 64001L2, 68001L2, 69001L2, 71001L2 and 73001L2; List number 13075-24-03, batch numbers 26289G1, 26294G1, 27325G1, 31397G1, 35620G1, 35621G1, 36634G1, 36636G1, 36638G1, 37667G1, 39739G1, 41786G1, 54114G1, 74001L2, 78002L2, 80001L2, 82001L2, 85308G1, 86319G1, 87340G1, 88358G1, 88366G1, 90442G1 and 92486G1; List number 13075-24-05, batch numbers 19141G1, 45878G1, 47915G1, 48961G1, 50020G1, 51021G1, 51022G1, 51028G1, 51030G1, 53081G1, 53082G1, 54098G1, 54113G1, 54114G1, 55125G1, 55126G1, 55135G1, 56158G1, 56170G1, 59230G1, 59231G1, 60258G1, 60272G1, 60284G1, 61307G1, 63318G1, 64345G1, 64354G1, 73634G1, 73636G1, 74647G1, 84828G1, 84828G1R, 84830G1 and 84830G1R; List number 130752407, batch numbers 75680G1, 75681G1, 75682G1, 76686G1, 77694G1, 77694G1R, 77695G1, 77695G1R, 77696G1, 77697G1, 77712G1, 77712G1R, 77713G1, 77714G1, 78735G1, 78735G1R, 78736G1, 78736G1R, 78737G1, 80775G1, 80775G1R, 82799G1, 82799G1R, 82802G1, 82802G1R, 93962G1, 93962G1R, 94973G1, 94973G1R, 95981G1, 95981G1R, 95985G1, 95985G1R, 96004G1, 96004G1R, 96989G1, 96989G1R, 96996G1, 96996G1R, 97013G1, 97013G1R, 97017G1 and 97017G1R
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letter dated August 1, 2011.
Manufacturer: Hospira Inc., Morgan Hill, CA;
Hospira, Inc., San Diego, CA. Firm initiated recall is ongoing.
REASON
Hospira has received reports of sparking, smoking, charring and electrical shock when using the GemStar Docking Station due to fluid ingress into the docking station.
VOLUME OF PRODUCT IN COMMERCE
18,000 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT
Philips Medical: 865047 IntelliVue Clinical Information Portfolio Release D.03 865209 IntelliVue Clinical Information Portfolio Release E.00 and E.01 865300 IntelliVue Clinical Information Portfolio NICU Link Intended for use in data collection, storage, and management with independent bedside devices, and ancillary systems that are connected either directly or through networks. It is indicated for use by healthcare providers whenever there is a need for generation of a patient record and computation of drug dosage. Recall #Z-3111-2011
CODE
Software version: D.03, E.0, or E.01 of the software
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, letter dated July 2011. Firm initiated recall is ongoing.
REASON
Under certain circumstances, edits to an order can result in unintended scheduled interventions on the IntelliVue Clinical Information Portfolio. A patient may receive interventions or additional medication doses that are not intended.
VOLUME OF PRODUCT IN COMMERCE
454 units
DISTRIBUTION
Nationwide and Internationally
END OF ENFORCEMENT REPORT FOR SEPTEMBER 7, 2011
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