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U.S. Department of Health and Human Services

Safety

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Enforcement Report for December 23, 2009

December 23, 2009
09-51

RECALLS AND FIELD CORRECTIONS:  COSMETICS - CLASS I
___________________________________

PRODUCT
4 Eye Serum Aloderma 1 Fl. Oz. / 30 ml. Recall # F-0833-2010
CODE
Lot 11680
RECALLING FIRM/MANUFACTURER
Cosmetic Specialty Labs, Inc., Lawton, OK, by telephone beginning September 30, 2009.  Firm initiated recall is ongoing.
REASON
The product has the potential to contain Pseudemonas.
VOLUME OF PRODUCT IN COMMERCE
117 units
DISTRIBUTION
OK

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
1) Peanuts Granulated, a) 5 lb, Item #0053; b) Peanuts Granulated, 10 lb, Item #0386; and c) Peanuts Granulated, 30 lb, Item #0053. The peanuts are packed in a plastic lined corrugated box. Recall # F-0650-2010;

2) Standard Nut Topping, Item #0395, packed in 10 lb plastic lined corrugated boxes. The labeling reads: Crown Select STANDARD NUT TOPPING 0395 Net Wt. 10 Lbs. (4.54 KG) Ingredients: Peanuts, Brazil Nuts, Cashews, Walnuts, Sucrose, Peanut Oil, Salt, Wheat Starch Maltodextrim. Recall # F-0651-2010
CODE
1) a) Lot # 005317108, Use By: 10/17/08; Lot # 005318408, Use By: 10/30/08; and Lot #005319708, Use By: 11/12/08; b) Lot # 08107, Use By: 08/14/08; Lot # 08113, Use By: 08/20/08; Lot #08126, Use By: 09/02/08;Lot #08134, Use By: 09/10/08; Lot #08141, Use By: 09/17/08; Lot #08150, Use By: 09/26/08; Lot #08151, Use By: 09/27/08; and Lot #08171, Use By: 10/17/08; c) Lot # G7082, Use By: 07/20/08; Lot # 8116, Use By: 08/23/08; Lot #038514808, Use By: 09/24/08; and Lot #038518408, Use By: 10/30/08;

2) Lot # 08135, Use By: 11/14/08; Lot #08136, Use By: 11/15/08; Lot #08143, Use By: 11/22/08; Lot #08155, Use By: 12/03/08; Lot #08157, Use By: 12/05/08; Lot #08171,Use By:12/19/08; Lot #08178, Use By: 12/26/08; Lot #08179, Use By: 01/07/09; and Lot #08197, Use by: 01/15/09
RECALLING FIRM/MANUFACTURER
Tarrier Foods Corp., Columbus, OH, by telephone on January 29, 2009, and by press release and letter on February 6, 2009. Firm initiated recall is ongoing.
REASON
The recalling firm repackaged and distributed peanut products manufactured from bulk peanut products which they received from Peanut Corporation of America (PCA). Peanut and peanut butter manufactured by PCA have been implicated in a recent outbreak of salmonellosis and these products may be contaminated with Salmonella Typhimurium.
VOLUME OF PRODUCT IN COMMERCE
2551 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Casino Chef Assorted Mini Cheesecake, for Black Time for Blue Jeans and in between; 30 Gourmet Mini Cheesecakes; Net Wt. 30 oz. (1 lb, 14 oz.). Packed in cartons, 10 (30 count)/Case, Net. Wt. 18.75 pounds (8.5 kg). Casino Chef Item #54472-113, UPC 30499-08053; Also sold as b) Cuisine Innovations Assorted Mini Cheesecakes, 60 pieces, for Institutional Use Only, Item #50431-708, UPC 30499-35006; and c) Presentations Assorted Cheesecake, Item #50041-951, UPC 58108-22892, Mini Cheesecakes, Keep Frozen () degrees or lower), 60 pieces approx, Net Wt., 60 oz, (3 lb 12 oz). Recall # F-0652-2010
CODE
a) 0037BON101, 0057BON101, 1077BON0101, 1087BON0101, 1097BON0101, 1137BON0101, 1417BON0101, 1427BON0101, 1447BON0101, 1457BON0101, 1497BON0101, 1507BON0101, 1527BON0101, 1647BON0101, 1797BON0101, 1907BON0101, 1917BON0101, 1927BON0101, 1937BON0101, 2017BON0101, 2047BON0101, 2187BON0101, 2197BON0101, 2207BON0101, 2217BON0101, 2227BON0101, 2327BON0101, 2337BON0101, 2347BON0101, 2357BON0101, 2367BON0101, 2447BON0101, 2487BON0101, 2607BON0101,2617BON0101, 2627BON0101, 2637BON0101, 2647BON0101, 2907BON0101, 2917BON0101, 2927BON0101, 3037BON0101, 3047BON0101, 3057BON0101, 3447BON0101, 3457BON0101, 3467BON0101, 3477BON0101, 3487BON0101, 0528BON0101, 0568BON0101, 0638BON0101, 0648BON0101, 0728BON0101, 0738BON0101, 1078BON0101, 1088BON0101, 1198BON0101, 1618BON0101, 1628BON0101, 1638BON0101, 1648BON0101, 1688BON0101, 2048BON0101, 2058BON0101, 2068BON0101, 2108BON0101, 2118BON0101, 2818BON, 2828BON 2838BON, 2878BON, 3088BON, 3098BON, 3108BON, 3118BON, 3258BON, 3288BON, 3298BON, 3308BON, 3318BON, 3368BON, 3378BON, 3648BON, 3658BON, 0059BON, 01209BON, 01309BON, 01409BON, 01509BON; b) Product Codes: 0167BON0101,0177BON0101, 0187BON0101, 0197BON0101, 0247BON0101, 0257BON0101, 1088BON0101,0297BON0101,, 0307BON0101, 0458BON0101, 0468BON0101, 2497BON0101, 2507BON0101, 2808BON, 2897BON0101, 32248BON, 3688BON; c) Product Code: 0657BON0101, 0667BON0101, 0677BON0101, 2887BON0101, 2897BON0101, 3037BON0101
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cuisine Innovations, LLC, Lakewood, NJ, by e-mail notices and letter on February 5, 2009, and by press release on February 9, 2009.  
Manufacturer: Bon Appetizers LLC, Lakewood, NJ. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approximately 14636 cases
DISTRIBUTION
NJ, CA, IL
___________________________________
PRODUCT 
Mong Lee Shang Brand Dry Bamboo Shoots, Net Wt 6 oz (170g), Product of Taiwan -- UPC 0 27035 80283 6. Nutrition Facts: Serving Size 115G, Serving Per Container 1.5. Recall # F-0829-2010
CODE
UPC code only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fine Land Corp., Brooklyn, NY, by press release and letters dated April 8, 2009.
Manufacturer: DYI Hong Co., Ltd., Taipei, Taiwan. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (325 ppm) based on sampling and analysis by New York State Department of Agriculture and Markets.
VOLUME OF PRODUCT IN COMMERCE
27 cases (60 x 6 oz. bags per case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
ZIOLOPEX brand Bakaliada Morele Suzsone (Apricots), Net Wt. 130 g (4.64 oz.), Product of Poland, UPC 5 902795 004032 -- Ingredients: apricots. The product is packaged in a flexible plastic bag and labeled mostly in Polish. Recall # F-0830-2010
CODE
Codes: 06 2010 and 081215V1C (on back of bag)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Adamba Imports Int'L, Inc., Brooklyn, NY, by letters dated September 21, 2009 and a Consumer Alert on September 24, 2009.
Manufacturer: ZiolplexSp. Zo.o. ul., Nowogrodziec, Poland. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (1167 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
140 cases (25 x 130 g packages per case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
NOSHER'S CHOICE brand JUST FRUIT, Net Wt. 9 oz. 252 g, UPC 7 27915 31503 5.  ING: Raisins, Banana Chips (Bananas, Sugar, Coconut Oil, Natural &/or Artificial Flavors) Papaya (Papaya, Sugar, Malic Acid) Pineapple (pineapple, Sugar), Apricots --- There is no Nutritional Facts panel. The product is packaged in a clear, plastic container (tub). Recall # F-0831-2010
CODE
Code Dates prior to 09/17/10 (printed on the label)
RECALLING FIRM/MANUFACTURER
America's Favorite Nosher's Inc., Brooklyn, NY, by press release on September 21, 2009. Firm initiated recall is complete.
REASON
The product contained undeclared sulfites (254 ppm) based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY
___________________________________
PRODUCT
ALEXIA***OVEN REDS Olive Oil, Sun-Dried Tomatoes & Pesto***Net Wt 15 oz 425g***INGREDIENTS: RED POTATOES, OLIVE OIL, SUNFLOWER OIL AND/OR CANOLA OIL AND/OR SAFFLOWER OIL, SEA SALT, CALOLA OIL, SUN DRIED TOMATO POWDER (TOMATO POWDER, SALT), GARLIC POWDER, SPICES, EXTRA VIRGIN OLIVE OIL, YEAST EXTRACT, ONION POWDER, NATURAL FLAVOR, NATURAL BASIL FLAVOR. Keep Frozen. Recall # F-0832-2010
CODE
Production codes: 5385912800016:00 through 538591300011:59. Sell by dates: 5385050811, 5385050911, and 5385051011. breakdown of sell by dates: "5385" is the manufacturing facility "050811" is the month, day, year (May 8, 2011)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Conagra Foods Lamb Weston, Inc., Kennewick, WA, by telephone, e-mail and press release on October 30, 2009.
Manufacturer: Dickinson Frozen Foods, Fruitland, ID. Firm initiated recall is ongoing.
REASON
Product contains an undeclared allergen, pine nuts.
VOLUME OF PRODUCT IN COMMERCE
9406 cases each containing 12 bags
DISTRIBUTION
Nationwide and Thailand
___________________________________
PRODUCT 
Ocean Mist Farms Iceless Green Onions, in 4 x 12 count cases, 2 x 24 count cases, 24 count 5.5oz Cello Bags, and 36 count 5.5 oz Cello Bags, UPC code on bag: 0-33383-60503-6, 40 count 5.5 oz Cello Bag. Recall # F-0834-2010
CODE
Trace Back Code: 95ONCP7G, Pack date and corresponding Best by date: 8/3/09, 8/26/09; 8/7/09,8/30/09; 8/8/09,8/31/09; 8/11/09,9/3/09; 8/12/09,9/4/09; 8/13/09,9/5/09
RECALLING FIRM/MANUFACTURER
California Artichoke and Vegetable Growers Corp., Castroville, CA, by telephone, e-mail and press release on September 1, 2009. Firm initiated recall is ongoing.
REASON
The product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1746 cartons
DISTRIBUTION
CA, NJ, FL, PN, WI, AK, CO, NY, MN, AZ, NC, NV, UT and Calgary, Canada.
___________________________________
PRODUCT 
Fresh & Easy Chili Lemon Flavored Pistachios 16 oz bag, B/C #5051379000486. Recall # F-0836-2010
CODE
All date codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresh And Easy, El Segundo, CA, by emails on April 7, 2009.
Manufacturer: Snak King, Corp., City Of Industry, CA. Firm initiated recall is complete.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella, Inc. because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
AZ, CA, NV
___________________________________
PRODUCT 
Kariba Farms Wheat & Gluten Free NutCrusters Coating Mix, Island Cashew-Orange; net Wt 5 oz (141 g). Product of USA. Recall # F-0837-2010
CODE
Lot A 9245
RECALLING FIRM/MANUFACTURER
Kariba Farms, Inc., Denville, NJ, by e-mail and telephone on November 5, 2009. Firm initiated recall is complete.
REASON
Cashew Orange Wheat & Gluten Free NutCrusters contained undeclared soy grits. The product was inadvertently labeled with the nutritional information and ingredient statement for a different product, Panko Orange Cashew NutCruster.
VOLUME OF PRODUCT IN COMMERCE
60/5 oz bags
DISTRIBUTION
MA, FL
___________________________________
PRODUCT 
Emerald Pistachios Roasted and Salted, 2.25 oz Laminated pouch, 12 individual sale units per carton, 6 cartons per case. Package UPC 0 10300 68389 6 Carton UPC 200 10300 06380 7 Master case UPC 400 10300 06380 1. Recall # F-0838-2010
CODE
Lot # and Best Before as follows: 09030S331S 30 JAN 10 09030G331S 30 JAN 10 09040G331S 09 FEB 10 09041D331S 10 FEB 10
RECALLING FIRM/MANUFACTURER
Diamond Foods, Inc., Stockton, CA, by press release, website, letter and telephone beginning April 8, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
918 cases
DISTRIBUTION
CA, GA, IL, IN, KY, MA, MO, MS, OH, OR, WI
___________________________________
PRODUCT 
Green Pista (raw pistachios), packaged in plastic 3.5 oz. (100 gram) bags with a FAMOUS brand label. Recall # F-0855-2010
CODE
Product supplied from January 1, 2009, to April 14, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lajuna Inc., dba Famous Food Products, Houston, TX, by fax from April 14, 2009 to April 18, 2009.
Manufacturer: Setton Pistachio of Terra Bella, Inc., Terra Bella, CA. Firm initiated recall is complete.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
80 bags of 100g each
DISTRIBUTION
TX, OK
___________________________________
PRODUCT
1) Back to Nature Nantucket Blend Almond, Pistachio, Cherry, Raisin and Cranberry Mix; trail mix; packaged in plastic film bags, 9 - 10 oz. bags per case and 28 oz. resealable bags per tray; 10 oz. bag - UPC 7 59283 31039 8, and 28 oz. bag - UPC 7 59283 00020 6. Recall # F-0922-2010;

2) Planters 100% Natural Harvest Almond Orchard Blend Almonds, Raisins, Cranberries & Pistachios, Net Wt. 9.75 oz. (276g); trail mix; packaged in plastic film bags; UPC 0 29000 01322 3. Recall # F-0923-2010;

3) Planters Trail Mix - Mixed Nuts & Raisins, Net Wt. 6 oz. (170g); trail mix; packaged in plastic film bags; UPC 0 29000 07879 6. Recall # F-0924-2010;

4) Planters NUT-trition Digestive Health Mix, Pistachios, Almonds, Cranberries, Granola & Cherries; trail mix; packaged in fiberboard cans; Net Wt. 9 oz. (255g), UPC 0 29000 01246 2 and Net Wt. 10 oz., UPC 0 29000 01245 5. Recall # F-0925-2010;

5) Back to Nature 100% Natural Cashew, Almond & Pistachio Mix, Sea Salt Roasted; mixed nuts; packaged in plastic film bags, 9 - 10 oz. bags per case; UPC 7 59283 31020 6. Recall # F-0926-2010;

6) Planters Pistachio Mix Made With Pistachios, Peanuts & Almonds, Net Wt. 2.7 oz. (76g); mixed nuts; packaged in plastic film bags; UPC 0 29000 01252 2. Recall # F-0927-2010;

7) Planters Pistachio Lovers Mix, Pistachios with Jumbo Cashews & Almonds; mixed nuts; packaged in fiberboard cans; Net Wt. 6 oz. (170g), UPC 0 29000 01023 9 and Net Wt. 21 oz., UPC 0 29000 01192 2. Recall # F-0928-2010;

8) Planters 100% Natural Harvest Pistachio Grove Blend, Pistachios, Peanuts, Almonds & Cashews, Net Wt. 10 oz. (283g); mixed nuts; packaged in plastic film bags; UPC 0 29000 01321 6. Recall # F-0929-2010;

9) Planters NUT-trition Heart Healthy Mix, Peanuts, Almonds, Pistachios, Pecans, Walnuts & Hazelnuts (Filberts); mixed nuts; packaged in 1.5 oz. plastic film Go-Pak bags, 5 Go-Paks per 7.5 oz. box and in 9.75 oz., 11.5 oz. and 21 oz. fiberboard cans; Net Wt. 7.5 oz. (210g), UPC 0 29000 01358 2; Net Wt. 9.75 oz. (975g) - UPC 0 29000 05957 3, 11.5 oz. (326g) - UPC 0 29000 01048 2 and 21 oz. - UPC 29000 01108. Recall # F-0930-2010;

10) Planters NUT-trition Heart Healthy Mix, Peanuts, Almonds, Pistachios, Pecans, & Hazelnuts (Filberts); mixed nuts; packaged in 1.5 oz. plastic film tubes, 12 tubes per retail carton and 6 - 1.5 oz. Go-Nuts bags per retail carton; Net Wt. 1.5 oz. (42g) tubes, UPC 0 29000 01270 7 in retail carton - UPC 29000 01570, and Net Wt. 1.5 oz. (42g) Go-Nuts, UPC 0 29000 01266 0. Recall # F-0931-2010;

11) Planters Pecan Lovers Mix, Pecans with Jumbo Cashews & Pistachios; mixed nuts; packaged in fiberboard cans; Net Wt. 5.5 oz. (156g), UPC 0 29000 01022 2 and Net Wt. 19 oz., UPC 0 29000 01091. Recall # F-0932-2010;

12) Planters Dry Roasted Pistachios, packaged in 1.75 oz. (49g) plastic film tubes, 12 tubes per retail carton and 16 oz. bags; Net Wt. 1.5 oz. (42g) tubes, UPC 0 29000 01274 5 in retail carton - UPC 29000 015275 2, and Net Wt. 16 oz. bags - UPC 0 29000 07774 4. Recall # F-0933-2010;

13) Planters Holiday Collection Deluxe Whole Cashews, Extra Large Virginia Peanuts, In-Shell Pistachios, 3 - 6 0z. (170 g) bags/ Net Wt. 1 lb 2 oz (18 oz.) 510g Seasonal Variety Red Tin; UPC 0 29000 01315 5 (red with white snow flakes) and 0 29000 01302 5 (red with white swirls tin). Recall # F-0934-2010
CODE
1) Best By dates between 05 29 09 and 12 12 09;
2) Best By dates between 05 29 09 and 12 20 09;
3) Best By dates between 04 29 09 and 11 20 09;
4) Best By dates between 03 30 09 and 10 21 09;
5) Best By dates between 08 27 09 and 03 20 10;
6) Best By dates between 08 27 09 and 03 20 10;
7) Best By dates between 08 22 10 and 03 15 11;
8) Best By dates between 08 27 09 and 03 20 10;
9) Best By dates between 05 29 09 and 12 20 09; Best By dates between 08 22 10 and 03 15 11;
10) Best By dates between 06 28 09 and 01 19 10; Best By dates between 08 27 09 and 03 20 10;
11) Best By dates between 08 22 10 and 03 15 11;
12) 1.75 oz. - Best By dates between 06 28 09 and 01 19 10; 16 oz. - Best By dates between 08 27 09 and 03 20 10;
13) Best By dates between 05 29 09 and 12 20 09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kraft Foods, Inc., Northfield IL, by press release on March 25, 2009 and March 31, 2009.
Manufacturers: Georgia Nut Distribution, Niles, IL;
Planters Co., Fort Smith, AR;
Planters, Division of Kraft Foods, Inc., Suffolk, VA. Firm initiated recall is complete.
REASON
The products were manufactured using pistachios that have been recalled by Setton because they may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
849,675 cases
DISTRIBUTION
Nationwide, including Puerto Rico, and internationally to Anguilla, Nigua, Argentina, Rubea, Bahamas, Belize, British West Indies, Canada, Curacao, Dominican Republic, Grenada, Guam, Jamaica, Mexico, Philippines, St. Kits, St. Lucia, St. Marten, St. Vincent & the Grana dines and Turks & Calicos Islands

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT 
Paradise Bakery & Cafe Fire Roasted Tomato Soup, Net Wt: 32 lbs. (14.51 kg). Recall # F-0636-2010
CODE
Lot Number 29409
RECALLING FIRM/MANUFACTURER
CTI Foods dba Chefco Foods, Arlington, TX, by telephone on November 3, 2009. Firm initiated recall is ongoing.
REASON
The product may contain undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
800 pounds
DISTRIBUTION
UT
___________________________________
PRODUCT
Torres Hillsdale Country Cheese, Torres Muenster; Torres Hillsdale Country Cheese, Brick; Queso Quesadilla Michigan Cheese; Torres Hillsdale Country Cheese, Farmer's Cheese. Recall # F-0637-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Torres Hillsdale Country Cheese, Reading, MI, by press release and fax on June 22, 2009. Firm initiated recall is complete.
REASON
Products were manufactured under insanitary conditions, which could lead to micro-contamination.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
GA, IL, IN, KY, MI, MO, NC, OH, PA, TN, WI
___________________________________
PRODUCT
1) Barry Farm Brand Vital Gluten Flour in 1 lb. and 5 lb. clear plastic bags. Recall # F-0817-2010;

2) Barry Farm Brand Organic Graham Flour in 1 lb. and 5 lb. clear plastic bags. Recall # F-0818-2010;

3) Barry Farm Brand Organic Kamut Flour in 1 lb. and 5 lb. clear plastic bags. Recall # F-0819-2010;

4) Barry Farm Brand Organic Spelt Flour in 1 lb. and 5 lb. clear plastic bags. Recall # F-0820-2010;

5) Barry Farm Brand Triticale Flour in 1 lb. and 5 lb. clear plastic bags. Recall # F-0821-2010;

6) Barry Farm Brand Organic White Spelt Flour in 1 lb. and 5 lb. clear plastic bags. Recall # F-0822-2010;

7) Barry Farm Brand Organic Unbleached All Purpose Flour in 1 lb. and 5 lb. clear plastic bags. Recall # F-0823-2010;

8) Barry Farm Brand Organic Unbleached Hi Gluten Flour in 1 lb. and 5 lb. clear plastic bags. Recall # F-0824-2010;

9) Barry Farm Brand Organic Unbleached Bread Flour in 1 lb. and 5 lb. clear plastic bags. Recall # F-0825-2010
CODE
1) Code 091123;
2) Code N5724;
3) Code N3051;
4) Code 090060;
5) Code B1541;
6) Coded 091165;
7) Code M001;
8) Code H102;
9) Code B6096
RECALLING FIRM/MANUFACTURER
Recalling Firm: Barry Farm Foods, Wapakoneta, OH, by letters on September 15, 2009.
Manufacturer: Heartland Mills, Marienthal, KS. Firm initiated recall is ongoing.
REASON
The firm decided to recall the wheat flour products they repack that do not declare "wheat" on the finished product labels.
VOLUME OF PRODUCT IN COMMERCE
4,393 lbs
DISTRIBUTION
Nationwide, Canada, UK, and Qatar
___________________________________
PRODUCT 
Duane Reade brand prenatal vitamins, 220 tablets, dietary supplement, PROD. No. 17519, UPC 6 39194 03665 The product is labeled in part, "UNIQUELY NY DR SINCE 1960 *** prenatal vitamins *** a unique vitamin & mineral formula for pregnant & lactating women *** 220 tablets | dietary supplement. Recall # F-0835-2010
CODE
Lot numbers 419212-04, 420584-01 and 420587-02
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.S. Nutrition, Ronkonkoma, NY, by telephone on November 3, 2009 and letters dated November 5, 2009.
Manufacturer: NBTY Manufacturing, LLC, Bohemia, NY.  Firm initiated recall is ongoing.
REASON
The label failed to contain accidental iron overdose warning as required by 21CFR101.17(e).
VOLUME OF PRODUCT IN COMMERCE
1,841 bottles
DISTRIBUTION
NY

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
Hostess Scary Cakes Monster Cakes, Frosted Chocolate Cake with Creamy Filling, 8 unlabeled individually clear cellophane-wrapped cakes per retail box, box net weight 14 oz. Recall # F-0638-2010
CODE
Best By OCT 22 087 267 (followed by a time stamp)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Interstate Brands Corp Hdqtrs, Kansas City, MO, by e-mail and telephone ion October 9, 2009.
Manufacturer: Interstate Brands Corp., Biddeford, ME. Firm initiated recall is complete.
REASON
Retail Boxes labeled as Monster Cakes actually contained a different product, Sno Balls, which had undeclared coconut.
VOLUME OF PRODUCT IN COMMERCE
50-100 retail boxes
DISTRIBUTION
NC, VA, SC, FL, GA, AL

  RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
Source Plasma. Recall # B-0085-10
CODE
Units: 6150251553, 6150250378, 6150246137, 6150252678
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Evans, CO, by letter dated May 12, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
Switzerland, Germany
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0288-10
CODE
Unit: M141609572674
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on August 21, 2009.
Manufacturer: Puget Sound Blood Center and Program, Silverdale, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0348-10
CODE
Units: 4171518, 4168605
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers - Lake Park, Lake Park, FL, by letter dated May 19, 2009.
Manufacturer: Florida's Blood Centers, Inc., Stuart, FL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0350-10
CODE
Unit: 011GS15519
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by telephone on May 29, 2009 and facsimile on June 13, 2009. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-0352-10
CODE
Unit: 033FP71042 (Parts 1 & 2)
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by telephone on July 15, 2009 and by facsimile on July 31, 2009. 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
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0353-10
CODE
Unit: W035209157807N (2 units)
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on July 17, 2009 and by letter dated August 24, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX

 RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 

___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0125-10
CODE
Unit: W036509002237
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Baton Rouge, LA, by facsimile on July 13, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from donors for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-0275-10
CODE
Unit: 13FM37679
RECALLING FIRM/MANUFACTURER
American Red Cross, Southeastern Michigan Region, Detroit, MI, by telephone on June 9, 2009 and by letter dated July 4, 2009. Firm initiated recall is complete.
REASON
Blood product, incorrectly labeled as to red cell antigen type, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MI

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT 
Reinforced Catheter Introducer System, 5 per carton. The product is sold under the Cordis Crossover and Cardiovascular Systems Inc (CSI) ViperSheath labels. Recall # Z-0120-2010
CODE
Cordis lot numbers - U0000025, U0000026, U0000027, U0000028, U0000029, U0000030, U0000031, U0000032, U0000033, U0000034, U0000035, U0000036, U0000037, U0000038, U0000039, U0000040, U0000041, U0000042, U0000043, U0000044, U0000045, U0000046, U0000047, U0000048, U0000049, U0000050, U0000051, U0000052, U0000053, U0000054, U0000055, U0000056, U0000057, U0000058, U0000059, U0000060, U0000061, and U0000062. CSI lot numbers - S28117, S28118, S28119, S28127, S28150, S28151, S28727, S28728, S28777, S28778, S28779, S28787, S28804, S28898, S28945, S28967, S29174, S29175, and S29528
RECALLING FIRM/MANUFACTURER
Thomas Medical Products Inc., Malvern, PA, by letter dated October 22, 2009. Firm initiated recall is ongoing.
REASON
Sheath may break or fracture which may cause vessel damage or require surgical intervention to retrieve catheter pieces.
VOLUME OF PRODUCT IN COMMERCE
17,236 units
DISTRIBUTION
FL, MN

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT 
1) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, nonsterile; REF 00-2490-001-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0375-2010;

2) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, tall, nonsterile; REF 00-2490-001-05. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0376-2010;

3) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, standard, 0.512" wide, nonsterile; REF 00-2490-001-10. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0377-2010;

4) Zimmer Natural Nail System, Tibial Targeting Guide Handle, small, nonsterile; REF 00-2490-005-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0378-2010;

5) Zimmer Natural Nail System, Tibial Targeting Guide Handle, tall, nonsterile; REF 00-2490-005-03. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0379-2010;

6) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, nonsterile; REF 00-2490-008-00. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0380-2010;

7) Zimmer Natural Nail System, Antegrade Femoral Targeting Guide Handle, small, 0.512" wide, nonsterile; REF 00-2490-008-10. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0381-2010;

8) Zimmer Natural Nail System, Antegrade Femoral Interlock Module, standard, nonsterile; REF 00-2490-001-03. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0382-2010;

9) Zimmer Natural Nail System, Antegrade Femoral Recon Module, standard, nonsterile; REF 00-2490-001-08. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0383-2010;

10) Zimmer Natural Nail System, Antegrade Femoral interlock Module, tall, nonsterile; REF 00-2490-001-53. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0384-2010;

11) Zimmer Natural Nail System, Antegrade Femoral Interlock Module, small, nonsterile; REF 00-2490-008-03. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0385-2010;

12) Zimmer Natural Nail System, Antegrade Femoral Recon Module, small, nonsterile, REF 00-2490-008-08. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0386-2010;

13) Zimmer Natural Nail System, REF 00-2490-005-04. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0387-2010;

14) Zimmer Natural Nail System, REF 00-2490-000-11. The device is used to drill into the proximal tibia or distal femur for placement of screws that stabilize the position of an intramedullary nail implant. The targeting guide instrumentation serves to assist the surgeon in precisely drilling into the bone and through holes that are located in the proximal and distal portion of the nail implant. After these holes are drilled, screws are placed into the holes to hold the implant in place in the bone. Recall # Z-0388-2010
CODE
1) Lots 61219397, 61228025 and 61277887;
2) Lot 61221481;
3) Lot 61291761;
4) Lots 61161115, 61170213, 61219945, 61256543, 61233590 and 61256542;
5) Lots 61161122, 61175552, 61217393, 61248664 and 61233593;
6) Lot 61227883;
7) Lot 61297069;
8) Lots 00111581, 61229463, 61232451, 61284938 and 61284939;
9) Lots 61221482, 61241809 and 61248640;
10) Lot 61221483;
11) Lot 61227882;
12) Lot 61227880;
13) Lots 61161124 and 61170214;
14) Lot 61161453
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by e-mail on July 1, 2009, August 5, 2009, August 6, 2009, and by letter dated September 14, 2009. Firm initiated recall is ongoing.
REASON
The guides may come apart during use, some guides may experience surface cracking, guide handles and modules may not target the femoral nail holes accurately and the instruments may not be able to be assemble together due to a change in the threading method used.
VOLUME OF PRODUCT IN COMMERCE
327 units
DISTRIBUTION
Nationwide, France, Germany, Italy, Switzerland and United Kingdom
___________________________________
PRODUCT
1) Scorpio CR Basic Femur with Posts. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 70-3007R. Recall # Z-0466-2010;

2) Scorpio CR Waffle Femur Lfit with posts. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 70-4107R. Recall # Z-0467-2010;

3) Scorpio PS Basic Femur. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 71-3003L, and Catalog number 71-3005R. Recall # Z-0468-2010;

4) Scorpio PS Femur Waffle Posts with LfIt. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 71-4505L, and Catalog number 71-4505R. Recall # Z-0469-2010;

5) Scorpio NRG Cruciate Retaining Femoral, Left/Right # 5. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 80-4405L, and Catalog number 80-4405R. Recall # Z-0470-2010;

6) Scorpio NRG Cruciate Retaining Femoral, Right # 7. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 80-4407R. Recall # Z-0471-2010;

7) Scorpio NRG Cruciate Retaining Femoral, Left # 8. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 80-4408L. Recall # Z-0472-2010;

8) Scorpio NRG Posterior Stabilized Femoral, #3 Left. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog Number 81-4403L. Recall # Z-0473-2010;

9) Scorpio NRG Posterior Stabilized Femoral. # 4 left/right. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 81-4404L, and Catalog number 81-4404R. Recall # Z-0474-2010;

10) Scorpio NRG Posterior Stabilized Femoral, # 5 Left. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 81-4405L. Recall # Z-0475-2010;

11) Scorpio NRG Posterior Stabilized Femoral, # 7 left/right. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog number 81-4407L and Catalog number 81-4407R. Recall # Z-0476-2010;

12) Scorpio NRG Posterior Stabilized Femoral, #9 left. The Scorpio Femoral Components are a knee component that is utilized in total knee arthroplasty (TKA). The femoral component is attached to the bottom of the femoral bone and provides the bearing surface to the tibial insert. Catalog Number 81-4409L, Recall # Z-0477-2010
CODE
1) 1) Lot code MHHR5W;
2) Lot code MHHDME;
3) Lot code MHHK2X and lot code MHH378;
4) Lot code MHHT6L and lot codes L MHHL20 and MHHR6;
5) Lot codes MHJ1HW and MHJ4RV and Lot codes: MHE4E0 and MHJ4RW;
6) Lot code MHJ09J;
7) Lot code MHH8J4;
8) Lot codeMHEJ9R;
9) Lot code MHHDR0 and lot code MHHN7J;
10) Lot code MHHKXX;
11) Lot code MHHEY8 and lot codes: MHHAEV and MHHM4K;
12) Lot code MHHK14
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on October 2, 2009. Firm initiated recall is ongoing.
REASON
It was determined that a change made in the dimensions of the collar component of the packaging resulted in the inner blister material being overstretched causing a potential hole in the sterile barrier system.
VOLUME OF PRODUCT IN COMMERCE
77 units
DISTRIBUTION
MA, NJ, IN, MI, CA, PA, Hong Kong, Germany, Netherlands, Japan, Korea, Switzerland, Malaysia, the United Kingdom
___________________________________
PRODUCT 
Protg EverFlex" Self-Expanding Biliary Stent System (for United States distribution). 6 x 150mm, Model # PRB35-06-150-080. Sterile EO, Rx only. Protg EverFlex" Self-Expanding Peripheral Stent System (for Outside United States distribution). 6 x 100mm, Model Number PRP35-06-100-080. Sterile EO, Rx only. In the United States, the stent is intended as a palliative treatment of malignant neoplasms in the biliary tree. Outside the United States, it is intended indicated for use in occlusions, lesions at high risk for abrupt closure or threatened closure following percutaneous transluminal angioplasty (PTA) or lesions believed to be at high risk for restenosis following PTA in the common and external iliac, superficial femoral, proximal popliteal, or subclavian arteries. Recall # Z-0478-2010
CODE
US Lot # 7821740 and Outside US Lot # 7821736
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by letters on November 9, 2009. Firm initiated recall is ongoing.
REASON
ev3 has determined that a lot of 150mm Protg EverFlex Biliary Stent System contains a 100mm length Self-Expanding stent. The implantation of a stent 50mm shorter than expected may not cover the full length of the target lesion and may require subsequent intervention.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
TX, FL, Germany, France and United Kingdom
___________________________________
PRODUCT 
Zimmer Gender Solutions Nexgen Complete Knee Solution, Legacy Knee- Posterior Stabilized, Gender Solutions Female, Femoral Component, option, LPS-flex, size C, right, for cemented use only; REF 00-5764-013-52. Recall # Z-0501-2010
CODE
Lot 61042477
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter dated November 12, 2009. Firm initiated recall is ongoing.
REASON
The inner package may interfere with the outer seal, resulting in lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
Nationwide, Korea and Switzerland
___________________________________
PRODUCT 
1) Alphatec Spine Solanas Titanium Pedicle Screw, Part Number 63035-12. Recall # Z-0502-2010;

2) Alphatec Spine Solanas Titanium Pedicle Screw Part Number 63035-14. Recall # Z-0503-2010
CODE
1) Lot Numbers: 624239, 624240;
2) Lot Numbers: 624241, 624242, 625418
RECALLING FIRM/MANUFACTURER
Alphatec Spine, Inc., Carlsbad, CA, by telephone on August 5, 2009. Firm initiated recall is ongoing.
REASON
Alphatec Spine discovered that the affected lots were not manufactured correctly in that the screw body portion of the assembly has only 22.5 degrees of angulation in the east-west plane instead of the designed 38-40 degrees.
VOLUME OF PRODUCT IN COMMERCE
321 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Merit Medical Systems, Inc. Connection Tube label reading in part: Connecting Tube 12" Sterile K10-04129, Catalog number K10-04129 Connection tubing can be used with any drainage catheter and drainage bag. Recall # Z-0510-2010; 

2) Merit Medical Systems, Inc. Connection tubes label reading in part: Connecting Tube w/ Stopcock 12" Catalog number K10-04131 LOT F720653 Connection tubing can be used with any drainage catheter and drainage bag. Recall # Z-0511-2010;

3) Merit Medical Systems, Inc. Monarch Inflation Syringe label reading in part: Monarch Catalog number IN2130 for inflation and deflation of interventional devices. Recall # Z-0512-2010;

4) Merit Medical Systems, Inc. Monarch Inflation Syringe Catalog number IN2230 for inflation and deflation of interventional devices. Recall # Z-0513-2010;

5) Merit Advance Angiographic Needle label reading in part: Majestik Series Angiographic Needles 20 G Catalog number AN20T52C for the introduction of vascular access devices. Recall # Z-0514-2010;

6) Merit Medical CT Transfer Set, REF/CAT No: TS120 Catalog #TS120/A - Transfer Set with filtered Sosa spike. Used to transfer contrast or saline into a sterile injector syringe. Recall # Z-0515-2010;

7) Merit Medical Systems, Inc. CT Transfer Set REF/CAT NO.: TS220. Recall # Z-0516-2010;

8) Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. Recall # Z-0517-2010;

9) Merit Medical Systems, Inc. Prelude Short Sheath Introducer REF/CAT No.: PSS-6F-4-018MT Prelude SHORT SHEATH INTRODUCER 21G 6F-SMT 4 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. Recall # Z-0518-2010;

10) Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. Recall # Z-0519-2010;

11) Merit Medical Systems, Inc. Medallion Syringe REF/CAT No.: MSS111-LB Indicated for use in cardiology and radiology procedures. Recall # Z-0520-2010;

12) Merit Medical GmbH, Unomedical Ltd., Catheter Fixation Device StayFIX Fixation Device for Percutaneous Catheters Used to secure catheters in place without the use of sutures, reducing the exposure of sharps and sharp-related accidents. Recall # Z-0521-2010;

13) Merit Medical Systems, Inc. Futura Safety Scalpels, Futura Safety Scalpel REF/CAT No SMS210 Used for cutting tissue in surgical and laboratory procedures. Recall # Z-0522-2010;

14) Merit Medical Systems, Inc. Pressure Infusor Bag MERITMEDICAL 500 ml Pressure Infusor Bag Catalog number PIB500 Used to apply pressure to a sealed bag of sterile fluid. Recall # Z-0523-2010;

15) Merit Medical systems, Inc, Convenience Kit REF/CAT #: K09-07692 Revision A, Custom Kit. Recall # Z-0524-2010
CODE
1) Lot # F709636;
2) Lot # F720653
3) Lot # F730935;
4) Lot # F730934;
5) Lot # F611693;
6) Lot # D918208;
7) Lot # D923107;
8) Lot # F696474;
9) Lot # F732268S1;
10) Lot # F712835;
11) Lot # F733058;
12) Lot # 9H4824;
13) Lot # D914622;
14) Lot # 9H42824;
15) Lot # F726849
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by telephone and letter on September 29, 2009. Firm initiated recall is ongoing.
REASON
Potential sterility breach caused by excessive shipment damage.
VOLUME OF PRODUCT IN COMMERCE
352 units
DISTRIBUTION
AL, LA, MO, KY, TN, GA
___________________________________
PRODUCT
Abbott Spine Sequoia dorsal height & revision tool, non-sterile; REF 3367-1. Surgical instrument for pedicle screw system. Recall # Z-0554-2010
CODE
Lots 47PN, 47PP, 49HK, 49HL and 57WL
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated August 17, 2009.
Manufacturer: Zimmer Spine Austin, Inc., Austin, TX. Firm initiated recall is ongoing.
REASON
The tip of the instrument may fracture during use.
VOLUME OF PRODUCT IN COMMERCE
215 units
DISTRIBUTION
Nationwide, Belgium and New Zealand
___________________________________
PRODUCT 
Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-6AL-4V Alloy, sterile; REF 5220-62-01. Recall # Z-0555-2010
CODE
Lot 07878240
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter dated February 25, 2009 and by e-mail on February 26, 2009.
REASON
Smaller diameter screws than required were included in the package.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
CT, IN, PA, Australia, Serbia, Spain, Switzerland and the United Kingdom
___________________________________
PRODUCT 
1) Stryker Howmedica Osteonics, Super SecurFit HA Hip Stem; Sterile Arc Deposited, V40 taper Not for use with 16mm heads. Catalog numbers: J6051-0425, J0651-0525, J6051-0625. Recall # Z-0556-2010;

2) Stryker Howmedica Osteonics, Primary Super SecurFit Stems, Sterile; Arc Deposited, V40 taper Not for use with 16mm heads. Catalog Number: J6054-XXXX. Recall # Z-0557-2010
CODE
All lots with an expiry prior to August 2013
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letters on January 14, 2009.
Manufacturer: Stryker Ireland, Ltd., Orthopedics, Carrigtohill, County Cork, Ireland. Firm initiated recall is ongoing.
REASON
Stryker Orthopedics became aware that there may be difficulty in mating stem to implantation/extraction instrument.
VOLUME OF PRODUCT IN COMMERCE
786 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Zimmer/CAS Power Cord, Sesamoid Plasty, NA; REF 20-8000-070-12. The device is the power cord component for the Sesamoid Plasty CAS workstation which connects the workstation to the power mains. Recall # Z-0558-2010
CODE
Serial numbers SP014, SP015, SP019 through SP022, SP025 through SP033, SP035, SP038, SP039, SP043, SP044, SP047, SP049, SP052, SP057, SP058, SP060, SP061, SP062, SP064, SP065, SP069, SP072, SP074 through SP083, SP089, SP090, SP091, SP093, SP094, SP098, SP099, SP121, SP124, SP125, SP127, SP128, SP131 through SP135, SP151 through SP154, SP157, SP175, SP176, SP183, SP184, SP185, SP190 and SP198
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by letter dated November 2, 2009.
Manufacturer: Zimmer CAS, Montreal, Canada. Firm initiated recall is ongoing.
REASON
The power cord female receptacle is not recessed sufficiently and may present a shock hazard.
VOLUME OF PRODUCT IN COMMERCE
71 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT 
E-Z CLEAN Non Stick Cautery Tip. Label reads in part: CAT/REF 0029M E-Z CLEAN NON STICK CAUTERY TIP***STERILE *** Expiration Date: 2104-07***" The device is intended to conduct monopolar electrosurgical energy from an electrosurgical generator to target tissue during general surgical procedures. This device is intended to be used whenever monopolar electrosurgical cutting and coagulation are indicated. Recall # Z-0486-2010
CODE
Lot Number: 91469
RECALLING FIRM/MANUFACTURER
Megadyne Medical Products, Inc., Draper, UT, by letter dated October 13, 2009. Firm initiated recall is ongoing.
REASON
Product labels reference an incorrect expiration date. Expiration date referenced on labels is 2104-07 instead of 2014-07.
VOLUME OF PRODUCT IN COMMERCE
324 units
DISTRIBUTION
CA, FL, NE, LA, MT, OK, OR, PA, SC and UT and New Zealand

END OF ENFORCEMENT REPORT FOR DECEMBER 23, 2009

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