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U.S. Department of Health and Human Services

Safety

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Enforcement Report for February 24, 2010

February 24, 2010                                                                                 10-07

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Pierino Jumbo shells with cheese, frozen, in 24 oz. red and green plastic bags. UPC 3910633334. Recall # F-1271-2010
CODE
Expiration date prior to 1/20/11
RECALLING FIRM/MANUFACTURER
Pierino Frozen Foods, Inc., Lincoln Park, MI, by telephone on February 3, 2010. Firm initiated recall is ongoing.
REASON
Product contains eggs which are undeclared on the product label.
VOLUME OF PRODUCT IN COMMERCE
36,000 units (3,000 cases)
DISTRIBUTION
MI, WV, OH, PA, IN, CO, TX, KY, NC, VA, FL
___________________________________
PRODUCT
Kroger Hazelnut Spread with cocoa packed in 13 oz (368g) jars. The product is distributed in shipping cases and each case contains 12 jars. The label reads: PRODUCT OF ITALY. UPC #11110 87825. Recall # F-1274-2010
CODE
Sell By Date: March 2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger Co., Cincinnati, OH, by e-mail on October 19, 2009.
Manufacturer: Nutkao Srl, Canova, Di Govone, Italy. Firm initiated recall is ongoing.
REASON
The product contains undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
65 cases/12/13 oz. jars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Carob Peanut Butter Cup, Net Wt. 1 oz., Dairy Free, UPC 0 36664 00200 5. Ingredients: corn and barley malt, palm kernel oil, carob, soy lecithin, dry roasted unbalanced peanuts, salt. Recall # F-1283-2010;

2) Carob Almond Butter Cup, Net Wt. 1 oz., Dairy Free, UPC 0 36664 00201 2. Ingredients: corn and barley malt, palm kernel oil, carob, soy lecithin, dry roasted unbalanced almonds. Recall # F-1284-2010;

3) Carob Mint Crème Cup, Net Wt. 1 oz. (29g), Dairy Free, UPC 0 36664 00202 9. Ingredients: corn/ barley malt, palm kernel oil, carob, soy lecithin, brown rice syrup, organic palm oil, mint oil. Recall # F-1285-2010;

4) Carob Brown Rice Crunch, Net Wt. 1.6 oz., Dairy Free, UPC 0 36664 00300 2. Ingredients: Carob confectionary coating (Extract of corn & malt, fractionated palm kernel oil, carob powder and lecithin), brown rice. Recall # F-1286-2010;

5) Carob Peanut Butter Squares, Net Wt. 1.6 oz., Dairy Free, UPC 0 36664 00301 9. Ingredients: Carob confectionary coating (Extract of corn & malt, fractionated palm kernel oil, carob powder and lecithin), peanut butter, salt. Recall # F-1287-2010;

6) Crispy Carob Peanut Butter Squares, Net Wt. 1.6 oz., Dairy Free, UPC 0 36664 00303 3. Ingredients: Carob confectionary coating (Extract of corn & malt, fractionated palm kernel oil, carob powder and lecithin), peanut butter, crisp brown rice, salt. Recall # F-1288-2010;

7) Simple Foods brand Carob Coated Rice Cakes, All Natural-Caffeine Free-Dairy Free – Sodium Free – No Partially Hydrogenated Oils, UPC 0 36664 00400 9. Product of USA --- INGREDIENTS: Carob Cakes, Extract of corn and barley malt, fractionated palm kernel oil, carob powder, soy lecithin, and brown rice. Recall # F-1289-2010;  

8) Simple Foods brand Carob Mint Coated Rice Cakes, Net Wt. 6.50 oz (182g), All Natural-Caffeine Free-Dairy Free – Sodium Free – No Partially Hydrogenated Oils, UPC 0 36664 00401 6, Product of USA --- INGREDIENTS: Carob Mint Rice Cakes, Extract of corn and barley malt, fractionated palm kernel oil, carob powder, soy lecithin, and brown rice. Recall # F-1290-2010;

9) Simple Foods brand Carob Almond Butter Coated Rice Cakes, Net Wt. 6.50 oz (182g). All Natural-Caffeine Free-Dairy Free – Sodium Free – No Partially Hydrogenated Oils, UPC 0 36664 00402 3. Product of USA --- INGREDIENTS: Carob Almond Butter Rice Cakes, Extract of corn and barley malt, fractionated palm kernel oil, carob powder, soy lecithin, and brown rice. Recall # F-1291-2010
CODE
No code
RECALLING FIRM/MANUFACTURER
Simple Foods, Inc., Tonawanda, NY, by press release on December 11, 2009 and December 15, 2009. Firm initiated recall is ongoing.
REASON
The product may contain undeclared traces of milk, a known allergen.
VOLUME OF PRODUCT IN COMMERCE
18,686 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Roasted Salted Pistachios; Net Wt. 8 oz. UPC 790429 22903; or 10 oz. UPC 790429 21368, plastic bag. Recall # F-1298-2010
CODE
Best By Dates through 12/22/2009
RECALLING FIRM/MANUFACTURER
International Foodsource, LLC, Dover, NJ, by press release, e-mail and or fax on April 7, 2009. Firm initiated recall is complete.
REASON
Product received from Setton Farms, CA, and has the possibility to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
75,625 pounds
DISTRIBUTION
ME, NJ, NY, PA, Fl, IA, MN, KS, TX, CO and AZ
___________________________________
PRODUCT
1) Kariba Farms Natural CranPistachio Mix, packaged in: 1) a) 3 oz. UPC 76285101925; b) 5 oz. UPC 76285104230; c) 8 oz. UPC 76285101880; d) Bulk UPC 76285101925. Recall # F-1299-2010;

2) Kariba Farms Roasted Shelled salted Pistachio a) 3 oz., UPC 76285101466; b) 8 oz., UPC 7685101456. Recall # F-1300-2010;

3) Kariba Farms Natural Shelled Pistachios, No salt Added, a) 8 oz. bag, UPC 7685101456 and b) 25 lb bulk, UPC 76285101920. Recall # F-1331-2010
CODE
1) a) Lots A-9002, A-9040, A-9072, A-9078, A-9078K, A-8323, A-8311, A8326, A-8350; b) Lots A-9031 A-9053K; c) Lots A-8301K, A-8352K; d) Lots A-9083K, A-9002, A-9040, A-9072, A-9085, A8350, A-8352K;

2) a) Lots A-9028K, A-8343K; b) Lots 902880213, 836480213;

3) a) Lots 902880213, 836480213; b) Lots A-8323K, A-8339K
RECALLING FIRM/MANUFACTURER
Kariba Farms, Inc., Denville, NJ, by letters on April 15, 2009 and press release on April 22, 2009. Firm initiated recall is complete.
REASON
Product was manufactured using pistachios supplied by Setton Farms, Terra Bella, CA, that are currently under recall due to possible salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
528.50 pounds
DISTRIBUTION
CA, DC, DE, MA, MD, NJ, NJ, OH, PA, TN, TX and VA
___________________________________
PRODUCT
1) King Nut Tube nut Red Pistachio 72/1.25 oz. Tube nut film/case, UPC Bag 38445 00024. Recall # F-1301-2010;  

2) King Nut Extra large Red Pistachio 64 oz poly bag, UPC 38445 88764. F-1302-2010;

3) King Nut Holiday Pistachio 6/10 oz Clear Cello Bags/case UPC 74870 00023. Recall # F-1303-2010;

4) King Nut Pistachios Red R/S 24/10 oz Clear Tub/case, UPC Case 38445 73509, UPC Tub 38445 73609. Recall # F-1304-2010;

5) Petersons Red Pistachios 13 oz pouch, UPC 74870 10285. Recall # F-1305-2010;

6) King Nut Holiday Star Tin 13.5 oz tin, UPC 38445 99017. Recall # F-1306-2010;

7) King Nut Holiday Star Tin 2 lb 10 oz tin UPC 38445 99018. Recall # F-1307-2010;

8) King Nut Treasure Trio 2 lbs 14 oz, King Nut, 2 lb 14 oz, UPC 38445 99089, 3 assorted stacked cellos. Recall # F-1308-2010;

9) King Nut Treasure Tower 5 lbs 14 oz, UPC 38445 99090, 6 assorted stacked cellos. Recall # F-1309-2010;

10) King Nut Garlic Pistachios 12/3 oz plastic bag/case, UPC Bag 38445 30214, Bag with Header card. Recall # F-1310-2010;

11) Peterson's Garlic Pistachios 13 oz pouch, UPC 74870 10218. Recall # F-1311-2010;

12) Setton Farms Red Roasted & Salted 25lb case, UPC 34325 62009 2. Recall # F-1312-2010
CODE
1) Code Dates 8308, 8309, 8330, 9005, 9028, 9048, 9063;

2) Code Dates 8309, 8339;

3) All date codes;

4)  Best by: 06/09/09, 06/20/09, 07/05/09, 07/22/09;

5) Date codes 8290, 9014, 9075;

6), 7), 8), 9) All date codes;

10) Code Dates 8312, 8318, 8354, 8358, 9035, 9036, 9056, 9057, 9083;

11) 12) All date codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kanan Enterprises, Solon, OH, by press release and letters on April 7, 2009.
Manufacturer: Setton Pistachio Co., Inc., Terra Bella, CA. Firm initiated recall is ongoing.
REASON
The product was manufactured using pistachios recalled by Setton pistachios of Terra Bella, CA, because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
14,345 POUNDS
DISTRIBUTION
CA, CO, FL, IN, KY, MD, MI, NJ, NY, OH, PA, VT, WV
___________________________________
PRODUCT
It's Delish Dry Roasted and Salted Pistachios packaged in a) 3.5 oz (UPC 7-99137-20602), b) 7 oz (UPC 7-99137-20604), and c) 10 oz (UPC 7-99137-20601) clear plastic retail bag. Secondary packaging and shipping is in a brown, corrugated cardboard box - 12 or 24 bags per case. Recall # F-1313-2010
CODE
a) Lot # 11065768, c-031709, c-031209, c-031009, and c-030909; b) Lot # 02075768, c-031609, and c-031209; c) Lot # 02075768, c-031509, c-031209, c-031009, and c-030909
RECALLING FIRM/MANUFACTURER
Mave Enterprises, Inc., N Hollywood, CA, by letters on or about April 21, 2009 and press release on April 22, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using pistachios recalled by Setton Pistachios of Terra Bella, CA, because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
500 cases/3.5 oz. bag; 314 cases/7 oz. bag; 820 cases/10 oz. bags
DISTRIBUTION
CA, NV, WA

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
1) Bears, Macadamia, Milk, 100-00501, 5.000 lb. Packaged in cardboard box for bulk retail sale. Recall # F-1258-2010;

2) Bears, Macadamia, Dark, 100-00502, 5.310 lb. Packaged in cardboard box for bulk retail sale. Recall # F-1259-2010;

3) Bears, Macadamia, White, 100-00503, 5.520 lb. Packaged in cardboard box for bulk retail sale. Recall # F-1260-2010;

4) Clusters, Macadamia, Milk, 120-00501, 3.630 lb. Packaged in cardboard box for bulk retail sale. Recall # F-1261-2010;

5) Clusters, Macadamia, Dark, 120-00502, 3.040 lb. Packaged in cardboard box for bulk retail sale. Recall # F-1262-2010;

6) Clusters, Macadamia, MK, S-F, 120-00506, 4.360 lb. Packaged in cardboard box for bulk retail sale. Recall # F-1263-2010
CODE
1) Lot 100-00501;
2) Lot 100-00502;
3) Lot 100-00503;
4) Lot 120-00501;
5) Lot 120-00502;
6) Lot 120-00506;
RECALLING FIRM/MANUFACTURER
Rocky Mountain Chocolate Factory, Durango, CO, by telephone and e-mail on August 14, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using roasted macadamia nuts recalled by Orchard Valley Harvest, Inc. of Paterson, CA, because they had the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
334 boxes/ approx. 310 pounds
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) The product is raw halibut pieces that are vacuum packed in clear plastic in 5 lb units with 2 5 lb units per box. The box is labeled in part: "***KEEP REFRIGERATED OR FROZEN***HALIBUT PIECES***10#***". There is no lot number associated with the product. However the firm uses an item code that is printed on the top left corner of a label affixed to the master carton. The item code for halibut pieces is 2148. Recall # F-1264-2010

2) The product is raw salmon meat vacuum packed in clear plastic in 5 lb units with 2 5 lb units per box. The box is labeled in part: "***KEEP REFRIGERATED OR FROZEN***BULK SALMON MEAT***10#***" There is no lot number associated with the product. However the firm uses an item code that is printed on the top left corner of a label affixed to the master carton. The item code for bulk salmon meat is 6910. Recall # F-1265-2010
CODE
Processing date: 01/01/09 through 10/14/09
RECALLING FIRM/MANUFACTURER
Tri City Meats, Inc., Meridian, ID, by telephone on October 15, 2009. Firm initiated recall is ongoing.
REASON
Vacuum packed product is labeled "Keep Refrigerated or Frozen" however, refrigeration may not be sufficient to prevent formation of Clotridium botulinum in this product.
VOLUME OF PRODUCT IN COMMERCE
157 boxes of halibut; 14 boxes of salmon
DISTRIBUTION
ID
___________________________________
PRODUCT
1) Sugar Cookies (Torticas) w/Sprinkles packaged 14 per container: ELCOTORO, TORTICAS Guaranteed Fresh 10/28/2009 Net Wt. 18 oz, (1 lb 2 oz) SOLSUN SWEETS, TORTICAS Guaranteed Fresh 10/28/2009 Net Wt 18 oz (1 lb 2 oz). Recall # F-1266-2010;

2) Cornbread (Pan de Maiz) packaged as a single loaf or as a 20 oz container: COTORRO, Pan de Maiz/Cornbread Guaranteed Fresh, 8/29/2009 Net Wt 20 oz (1 lb 4 oz) SOLSUN SWEETS Pan de Maiz/Cornbread Guaranteed Fresh, 8/29/2009 Net Wt. 20 oz (1 lb 4 oz). Recall # F-1267-2010;

3) Biscuits, packaged 14 per container cotorro Pan de San Francisco Guaranteed Fresh, 10/28/2009 Net Wt 18 oz, (1 lb 2 oz) SOLSUN SWEETS Pan de San Francisco Guaranteed Fresh, 10/28/2009 Net Wt 18 oz, (1 lb 2 oz). Recall # F-1268-2010
CODE
All codes
RECALLING FIRM/MANUFACTURER
Solsum Corp., Hialeah, FL, by letter on/about July 30, 2009. Firm initiated recall is ongoing.
REASON
Products contain undeclared colors.
VOLUME OF PRODUCT IN COMMERCE
1078 Sugar Cookies; 546 Biscuits; 566 Cornbread
DISTRIBUTION
FL
___________________________________
PRODUCT
Harry London Gourmet Pecan Caramel Stars 4.62 oz box. Recall # F-1269-2010
CODE
Lot 9238-1
RECALLING FIRM/MANUFACTURER
Fannie May Confection Brands Inc., North Canton, OH, by letters on January 4, 2010. Firm initiated recall is ongoing.
REASON
Undeclared allergen the ingredient statement did not contain Wheat or FD&C colors red #40 yellow #5 and Blue #1
VOLUME OF PRODUCT IN COMMERCE
3,310 boxes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
fresh&easy Pumpkin Cheesecake Pie, 40 oz., UPC: 5051379033712 labeled as fresh&easy Pumpkin Pie, 40 oz., UPC: 50513790008628. Recall # F-1272-2010
CODE
Enjoy by date of NOV. 21
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fresh and Easy, El Segundo, CA, by e-mail on November 18, 2009.
Manufacturer: Bonerts Slice of Pie, Santa Ana, CA. Firm initiated recall is ongoing.
REASON
Pies may contain undeclared pecans.
VOLUME OF PRODUCT IN COMMERCE
456 pies
DISTRIBUTION
AZ, CA, NV
___________________________________

PRODUCT
Panda Trading and Manufacturing brand Fish Roll ("Cha Ca Cuon"), vacuum-packed fried fish paste, 12 oz plastic bag, UPC Code: 0 95589 20349 2, Storage instructions state KEEP REFRIGERATED. Recall # F-1273-2010
CODE
No codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gary Systems Corp., Baldwin Park, CA, by telephone on November 11, 2009 and by letter on November 16, 2009.
Manufacturer: Shanghai Mou Kei Foods Co., Ltd., Shanghai, China. Firm initiated recall is ongoing.
REASON
Product contains undeclared soybean oil.
VOLUME OF PRODUCT IN COMMERCE
1,050 bags
DISTRIBUTION
CA
___________________________________
PRODUCT
Flour tortillas in clear plastic bags labeled in part: "FLOUR TORTILLAS***Hermanas TORTILLAS DE HARINA 10 Count Net Wt. 16 oz. (1 Lb.) 454 gr.***Ingredients: Unbleached Wheat Flour, Niacin, Reduced Iron, Thiamine Mononitrate, Riboflavin, Folic Acid, Water, Vegetable Shortening (Partially Hydrogenated Soybean and/or Cottonseed Oil), Butter, Salt, Baking Powder, Calcium Propionate. Recall # F-1275-2010
CODE
03120
RECALLING FIRM/MANUFACTURER
Tortilleria 4 Hermanas, Hillsboro, OR, by telephone on January 21, 2010. Firm initiated recall is complete.
REASON
Product contains undeclared allergens milk and soy.
VOLUME OF PRODUCT IN COMMERCE
40 bags each containing 10 tortillas
DISTRIBUTION
OR
___________________________________
PRODUCT
The Farmer's Market, Butter & Garlic Croutons, packed in 5oz stand up foil pouches, UPC 3003430159, Product number 31214. Recall # F-1276-2010
CODE
Best if Used By date range May 29, 2009 through January 22, 2010
RECALLING FIRM/MANUFACTURER
Sugar Foods, Corp., Villa Rica, GA, by telephone and e-mail on April 28, 2009 and by press release on May 1, 2009. Firm initiated recall is ongoing.
REASON
Product's label lists natural flavor and butter oil as ingredients, but fails to declare their source, milk, as required by FALCPA.
VOLUME OF PRODUCT IN COMMERCE
4,797 cases/12 5 oz packages per case
DISTRIBUTION
Northeast US
___________________________________
PRODUCT
1) Caribou Coffee All Natural Gourmet Drinking Milk Chocolate, 12 oz. SKU #7145. Recall # F-1277-2010;

2) Caribou Coffee All Natural Gourmet Drinking White Chocolate, 12 oz. SKU #7146. Recall # F-1278-2010;

3) Caribou Coffee All Natural Gourmet Drinking Dark Chocolate, 12 oz. SKU #7146. Recall # F-1278-2010
CODE
1) Lot: 927903, 928001;
2) Lot: 927901, 928301, 928602;
3) Lot: 927901
RECALLING FIRM/MANUFACTURER
Caribou Coffee, Minneapolis, MN, by e-mail and telephone on November 13, 2009. Firm initiated recall is ongoing.
REASON
Missing allergen and ingredient information on the tins.
VOLUME OF PRODUCT IN COMMERCE
9,348 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Milk Chocolate Coffee Beans; chocolate covered coffee bean candy; Net Wt. 10 LB (4.53 kg) poly-lined bulk box; item 70.00.CBM, UPC 0 87017 67002 0. Recall # F-1280-2010;

2) Sugar Free Chocolate Flavored Peanuts; chocolate covered peanut candy; Net Wt. 10 lb (4.53 kg) poly-lined bulk box; item 70.30.S/L, UPC 0 87017 67038 9. Recall # F-1281-2010;

3) No Sugar Added Chocolate Raisins; chocolate covered raisin candy; Net Wt. 10 lb (4.53 kg) poly-lined bulk box; item 70.60.S/L, UPC 0 87017 67068 6. Recall # F-1282-2010
CODE
All lots shipped prior to 12/3/09
RECALLING FIRM/MANUFACTURER
Georgia Nut Co., Skokie, IL, by letters dated December 8, 2009. Firm initiated recall is ongoing.
REASON
The bulk product labels do not state that the lecithin was derived from soy.
VOLUME OF PRODUCT IN COMMERCE
4,640 – 10 lb. boxes
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Set of 2 - 7 oz stainless steel Hip Flasks with Funnel, The Sportsman's Guide catalog item number 0106920. Recall # F-1294-2010
CODE
None
RECALLING FIRM/MANUFACTURER
CSN, Inc., Minneapolis, MN, by e-mail beginning March 9, 2009. Firm initiated recall is ongoing.
REASON
The recalled flasks have a presence of lead in the solder joints.
VOLUME OF PRODUCT IN COMMERCE
9,427 sets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Elements 1.5 Gallon Glass Beverage Dispenser with Metal Spigot and Stand, Model/Item # 5029611, UPC 028225167421, by International Silver Company. Product of China. Recall # F-1296-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lifetime Brands, Inc., Garden City, NY, by letter dated May 1, 2008.
Manufacturer: Zibo Zhaohai Light Industrial, Shandong, China. Firm initiated recall is ongoing.
REASON
Private laboratory testing revealed that the metal spigot/valve contained 36,490 ppm lead (microwave digestion analysis not leachable lead).
VOLUME OF PRODUCT IN COMMERCE
376 units
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT
Libipower Plus Capsules, Natural Male Stimulant, 650 mg herbal blend, packaged in 1 capsule blister packs. Recall # D-333-2010
CODE
Lot Numbers: XHT890, Exp. 09/2010 & FIK531, Exp. 06/2011
RECALLING FIRM/MANUFACTURER
HALOTECO, Santa Monica, CA, by letters dated June 25, 2009 and press release on July 13, 2009. Firm initiated recall is ongoing.
REASON
Marketed without an approved NDA/ANDA: product found to contain tadalafil which is the active ingredient of an FDA approved drug for Erectile Dysfunction (ED).
VOLUME OF PRODUCT IN COMMERCE
Approximately 15,000 capsules
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Effexor (Venlafaxine hydrochloride) Extended Release 37.5 mg, 75 mg, and 150 mg Capsules, RX only, Manufactured by Zach Systems A.1. La Croix Cadeau B.P. Avrille Cedex, France 49424, Distributed by Wyeth Pharmaceutical Company Guyama, PR 00785. NDC for Effexor XR Extended-Release Capsules are NDC 0008-0837-20 37.5 mg - Bottle of 15 NDC 0008-0837-21 37.5 mg - Bottle of 30 NDC 0008-0837-22 37.5 mg - Bottle of 90 NDC 0008-0833-20 75 mg - Bottle of 15 NDC 0008-0833-21 75 mg - Bottle of 30 NDC 0008-0833-22 75 mg - Bottle of 90 NDC 0008-0833-03 75 mg - Carton of 10 Redipak blister strips of 10 NDC 0008-0836-20 150 mg - Bottle of 15 NDC 0008-0836-21 150 mg - Bottle of 30 NDC 0008-0836-22 150 mg - Bottle of 90 NDC 0008-0836-03 150 mg - Carton of 10 Redipak blister strips of 10 Unit size: Effexor XR Extended-Release Capsules NDC 0008-0837-20 37.5 mg - Bottle of 15 NDC 0008-0837-21 37.5 mg - Bottle of 30 NDC 0008-0837-22 37.5 mg - Bottle of 90 NDC 0008-0833-20 75 mg - Bottle of 15 NDC 0008-0833-21 75 mg - Bottle of 30 NDC 0008-0833-22 75 mg - Bottle of 90 NDC 0008-0833-03 75 mg - Carton of 10 Redipak blister strips of 10 NDC 0008-0836-20 150 mg - Bottle of 15 NDC 0008-0836-21 150 mg - Bottle of 30 NDC 0008-0836-22 150 mg - Bottle of 90 NDC 0008-0836-03 150 mg - Carton of 10 Redipak blister strips of 10 Shipping Unit Size: 96 Bottles per case or 12 cartons of 10 Redipak blister strips of 10 capsules each per case. Type of Packaging: Plastic bottles containing 15, 30, 90 capsules; cartons of 10 Redipak blister strips of 10 capsules each. Recall # D-133-2010
CODE
D44210 (Exp Oct-10), D55950 (Exp Oct-10), D24262 (Exp Jul-11), C94009 (Exp Jul-11), C35138 (Exp Aug-10), C35139 (Exp Aug-10), C41328 (Exp Sep-10), C41329 (Exp Oct-10), C50306 (Exp Aug-10), C50307 (Exp Aug-10), C59523 (Exp Jan-11), C59524 (Exp Jan-11), C59526 (Exp Feb-11), C59530 (Exp Feb-11), C70592 (Exp Feb-11), C87937 (Exp Jan-11), C95682 (Exp Mar-11), C95699 (Exp Mar-11), D13622 (Exp Jul-11), D15930 (Exp Jun-11), D15931 (Exp Jun-11), D15932 (Exp Jul-11), D24603 (Exp Sep-11), D29149 (Exp Oct-11), C40448 (Exp Mar-11), C40449 (Exp Mar-11), C40451 (Exp Mar-11), C46681 (Exp Aug-10), C46685 (Exp Aug-10), C46688 (Exp Aug-10), C46861 (Exp Sep-10), C51385S (Exp Oct-10),C59184 (Exp Oct-10), C72564 (Exp Oct-10), C79438 (Exp Dec-10), C87911 (Exp Dec-10), C87912 (Exp Feb-11), C87913 (Exp Feb-11), C87914 (Exp Feb-11), D07619 (Exp Jun-11), D07620 (Exp Jul-11), D07621 (Exp Jul-11), D29150 (Exp Oct-11), D29151 (Exp Oct-11), D44256 (Exp Nov-11), D44259 (Exp Nov-11), D47414 (Exp Dec-11), D66746 (Exp Feb-12), D68004 (Exp Mar-12), D74751 (Exp Feb-12), D86901 (Exp May-12), C81860 (Exp Jan-11), C46773 (Exp Aug-10), C83940 (Exp Dec-10), C23201 (Exp Jul-10), C23205 (Exp Jul-10), C30294 (Exp Aug-10), C30298 (Exp Aug-10), C36097 (Exp Feb-11), C40978 (Exp Mar-11), C41039 (Exp Mar-11), C41066 (Exp Mar-11), C46797 (Exp Sep-10), C46799 (Exp Oct-10), C59189 (Exp Oct-10), C79426 (Exp Dec-10), C79427 (ExpDec-10), C87825 (ExpJan-11), C87827 (ExpJan-11), C87848 (Exp Feb-11), C87853 (Exp Feb-11), C87859 (Exp Feb-11), C87860 (Exp Mar-11), D07625 (Exp Jun-11), D07626 (Exp Jun-11), D07627 (Exp Jul-11), D07629 (Exp Jul-11), D29069 (Exp Oct-11), D29153 (Exp Oct-11), D29154 (Exp Oct-11), D29155 (Exp Oct-11), D34439 (Exp Jun-11), D37378 (Exp Nov-11), D37380 (Exp Jan-11), D88962 (Exp Feb-12), C28511S (Exp Jul-10), C28512S (ExpJul-10), C28513S (Exp Aug-10), C28514S (Exp Aug-10), C28515S (Exp Aug-10), C28517S (Exp Aug-10), C36428S (Exp Aug-10), C47303S (Exp Aug-10), C47304S (Exp Aug-10), C47305S (Exp Aug-100, C47306S (Exp Aug-10), C47307S (Exp Aug-10), C47308S (Exp Aug-10), C51439S (Exp Sep-10), C51440S (Exp Sep-10), C51441S (Exp Oct-10), C51442S (Exp Oct-10), C51443S (Exp Oct-10), C51444S (Exp Oct-10), C70036S (Exp Dec-10), C70037S (Exp Dec-10), C70328S (Exp Jan-11), C79627S (Exp Jan-11), C79628S (Exp Jan-11), C79629S (Exp Feb-11), C79630S (Exp Feb-11), C79631S (Exp Feb-11), C79632S (Exp Feb-11), C88186S (Exp Feb-11), C88187S (Exp Feb-11), C88188S (Exp Feb-11), C88189S (Exp Feb-11), C88190S (Exp Mar-11), C88192S (Exp Mar-11), C88193S (Exp Mar-11), C88195S (Exp Mar-11), C95708S (Exp Jun-11), C95862S (Exp Jun-11), C95863S (Exp Jun-11), D03417S (Exp Jun-11), D03422S (Exp Aug-11), D03424S (Exp Aug-11), D22794S (Exp Aug-11), D28165S (Exp Oct-11), D28166S (Exp Oct-11), D28197S (Exp Oct-11), D29003S (Exp Oct-11), D37029S (Exp Dec-11), D65167S (Exp Feb-12), D65170S (Exp Mar-12), D65171S (Exp Mar-12), C95854S (Exp Jun-11), C88194S (Exp Mar-11), C24657 (Exp Dec-10), C79353 (Exp Dec-10), C59181 (Exp Oct-10), C30317 (Exp Aug-10), C87427 (Exp Jan-11), D44262 (Exp Oct-11), C30329 (Exp Jul-10), C59182 (Exp Oct-10), C79360 (Exp Dec-10), C98393 (Exp Feb-11)
RECALLING FIRM/MANUFACTURER
Wyeth Pharmaceuticals Co., Guayama, PR, by visit beginning November 19, 2009. Firm initiated recall is ongoing.
REASON
Cross Contamination With Other Products: Firm is recalling Effexor extended release lots because of a potential cross-contamination issue at one of their API suppliers.
VOLUME OF PRODUCT IN COMMERCE
10,554,952 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Amlodipine Besylate Tablets, 5 mg, 1000-count bottle, Rx only, NDC 31722-238-10. Recall # D-332-2010
CODE
Lot: 10906374
RECALLING FIRM/MANUFACTURER
InvaGen Pharmaceuticals, Inc., Hauppauge, NY, by letter dated January 25, 2010, by FedEx, e-mail and fax. Firm initiated recall is ongoing.
REASON
Labeling: Incorrect or Missing Package Insert
VOLUME OF PRODUCT IN COMMERCE
1,484 bottles
DISTRIBUTION
Nationwide

 RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0243-10
CODE
Units: 268858362, 269731413
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AR, by facsimile on April 12, 2007. 
Manufacturer: Blood Systems, Inc., Hot Springs, AR. 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
AR
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0454-10;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0455-10
CODE
1) and 2) Units: 9525499, 9497008
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Leesburg, FL, by telephone on July 6, 2009 and by letter dated July 6, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0466-10
CODE
Unit: 268854359
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AR, by telephone or electronic notification on October 23, 2006. 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
TX   
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0468-10
2) Plasma Frozen. Recall # B-0469-10
CODE
1) and 2) Units: 20W51165, 20W56140
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by facsimile on August 15, 2008 and by letter dated August 15, 2008. 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, UT
___________________________________
PRODUCT
1) Red Blood Cells for further manufacturing use. Recall # B-0475-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0476-10
CODE
1) Unit: 55FH41569;
2) Unit: 55FL05464
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Little Rock, AR, by telephone on December 17, 2007 and December 19, 2007 and by facsimile on December 19, 2007. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI, TN
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0479-10
CODE
Unit: 5357443
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated February 22, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCXJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0480-10;
2) Platelets. Recall # B-0481-10
CODE
1) Units: 3231282, 3098099;
2) Unit: 3098099
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated February 29 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0482-10
CODE
Units: 5756636, 5687682
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated April 2, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0483-10
CODE
Unit: 9352817
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated April 3, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0484-10
CODE
Unit: 4295834
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on April 22, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0498-10
CODE
Unit: 017GW18739
RECALLING FIRM/MANUFACTURER
The American National Red Cross – North Central Region, Saint Paul, MN, by email and fax on July 15, 2009 and by follow up letter on August 19, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
SC 
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0589-10
CODE
Units: 02X02518, 02X02518, 02KP01978, 02XP01978, 02X02917, 02X02917, 02X02588, 02X02588
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Wichita, KS, by telephone on August 7, 2009 and by facsimile transmission on September 11 and 13th, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from deferred donors, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
TX, OK, MO, KS
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0619-10
CODE
Unit: 011FK28849
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by fax on January 22, 2009 and February 3, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT
Red Blood Cells (Apheresis). Recall # B-0671-10
CODE
Unit: W065609028948 (double collection)
RECALLING FIRM/MANUFACTURER
Bergen Comm Reg Blood Center, Paramus, NJ, consignees by telephone on August 19, 2009. Firm initiated recall is complete.
REASON
Blood products, not stored at proper temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0709-10
CODE
Unit: 2526137
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter dated October 16, 2009. 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
KY

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________

PRODUCT
Abbott m2000 Bar Code Scanner, SCC (list 06L89-01) for the m2000rt, m2000sp and m24sp Instruments. Recall # B-0463-10
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Abbott Molecular Inc., Des Plaines, IL, by letters dated November 4, 2009. Firm initiated recall is ongoing.
REASON
Bar Code Scanners, which under certain conditions could cause misidentification of patient sample IDs, were distributed.
VOLUME OF PRODUCT IN COMMERCE
113 units – Nationwide, 399 units - Internationally
DISTRIBUTION
Nationwide and internationally to Algeria, Argentina, Armenia, Australia, Austria, Bahrain, Belgium, Brazil, Bulgaria, Canada, Cambodia, Cameroon, China, Chile, Colombia, Costa Rica, Croatia, Egypt, Estonia, Finland, France, Germany, Greece, Honduras, Hong Kong, India, Indonesia, Ireland, Israel, Italy, Japan, Kenya, Libya, Malaysia, Mali, Mexico, Mozambique, Netherlands, New Zealand, Oman, Pakistan, Panama, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, Uganda, Ukraine, United Kingdom, Venezuela, Vietnam and Zambia
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0464-10
CODE
Unit: 032GN40673 (double collection)
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Madison, WI, by letter dated December 8, 2006.
Manufacturer: Whole Blood - Green Bay, Green Bay, WI. Firm initiated recall is complete.
REASON
Red Blood Cells, possibly manufactured with an excess anticoagulant, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0467-10
CODE
Unit: 268854359
RECALLING FIRM/MANUFACTURER
Blood Systems, Inc., Scottsdale, AR, by telephone or electronic notification on October 23, 2006. 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
Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0499-10
CODE
Unit: 017GW18739
RECALLING FIRM/MANUFACTURER
The American National Red Cross – North Central Region, Saint Paul, MN, by email and fax on July 15, 2009 and by follow up letter on August 19, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0580-10
CODE
Units: 017FE07831, 017FE07833, 017FE07833 (split product)
RECALLING FIRM/MANUFACTURER
The American National Red Cross – North Central Region, Saint Paul, MN, by telephone on August 28, 2006 and fax on August 30, 2009. Firm initiated recall is complete.
REASON
Blood products, documented as being out of controlled storage for more than 30 minutes, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WI, MN
___________________________________
PRODUCT
Influenza A (H1N1) 2009 Monovalent Vaccine. Recall # B-0587-10
CODE
Units: UT030CA, UT023DA, UT028CB, and UT028DA
RECALLING FIRM/MANUFACTURER
Sanofi Pasteur, Inc., Swiftwater, PA, by telephone on December 7, 2009. Firm initiated recall is ongoing.
REASON
Influenza A (H1N1) 2009 Monovalent Vaccine, with antigen content lower than the specification limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
887,020 doses
DISTRIBUTION
CA, GA, OH, TN
___________________________________
PRODUCT
Recovered Plasma. Recall # B- 0595-10
CODE
Unit: KS70187
RECALLING FIRM/MANUFACTURER
Inova Health Care Services, Blood Donor Services, Sterling, VA, by fax on January 14, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who received a bone graft within one year of donating, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0618-10
CODE
Unit: 011FK28849
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by fax on January 22, 2009 and February 3, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) AC Power Cords, shipped between 06/2005 and 05/2009. These cords were used in the following infusion pump models: Nutrimix, Q-Vue, Q2, Q2 Plus, Ox4, PCA, PCA II, PCA 3, Lifecare PCA, Lifecare 4100, Plum XL 3, Plum XL3M, Plum XL3D, Plum A+/ Plum A+3, and Gemstar Docking Station devices. AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0011-2010;

2) Acclaim Encore Infusion Pump, List # 12569-04-03 (veterinary), 12237 04-15, 12273-04-51; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0012-2010;

3) Flexiflo Quantum Enteral Pump, List number 50596; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0013-2010;

4) GemStar AC Wall (Mains) adapter, 90-260 volts, universal, list # 13072-04-01; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0014-2010;

5) GemStar Docking Station (90-260 volts), list numbers 13075-04-01, 13075-04-03, 13075-04-05, 13075-04-07; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0015-2010;

6) LifeCare PCA Plus II, list #01950-04-03, 01950-04-05, 01950-04-07, 01950-04-51; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0016-2010;

7) LifeCare PCA 3, list #s 12384-04-01, 12384-04-03, 12384-04-05, 12384-04-07, 12384-04-09, 12384-04-51; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0017-2010;

8) LifeCare PCA with Hospira Mednet, list numbers 20709-04-01, 20709-04-03, 20709-04-51, 20709-04-53, 20709-04-77; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0018-2010;

9) Nutrimix Micro Compounder, List #s 11365-04-01, 11365-04-03, 11365-04-05; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0019-2010;

10) Omniflow 4000 Plus, List numbers 40051-04-05, 40051-04-07, 40051-04-09, 40051-04-51; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0020-2010;

11) Plum LifeCare 5000 (Plum 1.6) with Dataport, list #s 02507-04-11, 02507-04-51; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0021-2010;

12) Plum A+ Infusion System (veterinary), list #s 60529-04-01, 60529-04-03, 60529-04-05; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0022-2010;

13) Plum A+3, list #s 12348-04-03, 12348-04-05, 12348-04-07, 12348-04-51; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0023-2010;

14) Plum A+ v.11.X, list #s 12391-04-01, 12391-04-03, 12391-04-05, 12391-04-11, 12391-04-51; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0024-2010;

15) Plum A+ v.10.3, list #s 11971-04-01, 11971-04-03, 11971-04-05, 11971-04-07, 11971-04-51; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0025-2010

16) Plum A+3 v.11.X, list #s 12618-04-01, 12918-04-03, 12618-04-05, 12618-04-51, 12618-04-07, 12618-04-53; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0026-2010;

17) Plum A+3 Infusion System with Hospira Mednet, list # 20678-04-01, 20678-04-03, 20678-04-51, 20678-04-77, 20678-04-81, 20678-04-05, 20678-04-53; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0027-2010;

18) Plum A+ Infusion System with Hospira Mednet, list #s 20679-04-01, 20679-04-03, 20679-04-05, 20679-04-51, 20679-04-77, 20679-04-79, 20679-04-81, 20792-04-01, 20792-04-03, 20792-04-05, 20792-04-51, 20792-04-53, 20792-04-77, 20792-04-79, 20792-04-81, 20792-04-83, 207929-04-87, 20792-04-55; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0028-2010;

19) Plum XL, list numbers 11555-04-01, 11555-04-03, 11555-04-05; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0029-1010;

20) Plum XLD, list numbers 11859-04-01, 11859-04-03, 11859-04-05, 11859-04-07, 11859-04-09, 11859-04-11, 11859-04-13, 11859-04-51, 12570-04-01 (veterinary). AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0030-2010;

21) Plum XL 3, list #s 11781-04-01, 11781-04-03, 11781-04-05. AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0031-2010;

22) Plum XL3M, List numbers 11845-04-03, 11845-04-05, 11845-04-07, 11845-04-11, and 11845-04-13. AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0032-2010;

23) Plum XLM, list #s 11846-04-03, 11846-04-05, 11846-04-07. AC power cords Part Numbers: 826-85559-001, 826-85559- 003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0033-2010;

24) Plum XL3D, list #s 11855-04-01, 11855-04-03, 11855-04-05, 11855-04-07; AC power cords Part Numbers: 826-85559-001, 826-85559-003, 826-85559-008, 826-85559-010, and 826-96057-003. Recall # Z-0034-2010
CODE
AC Power Cords, shipped between 06/2005 and 05/2009
RECALLING FIRM/MANUFACTURER
Hospira, Inc., Morgan Hill, CA, by press release and letter on August 14, 2009. Firm initiated recall is ongoing.
REASON
Fire/Shock hazard – A component used in the device may cause sparks/flashes and poses a fire and shock hazard.
VOLUME OF PRODUCT IN COMMERCE
204,999 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Model ST-400 Solafeet Foot portable tanners; Solafeet, Inc. Use: feet tanner. Recall # Z-0608-2010
CODE
All codes associated with Model ST-400
RECALLING FIRM/MANUFACTURER
Solafeet, Inc., Sarasota, FL, by letters September 8, 2009. Firm initiated recall is ongoing.
REASON
Product failed to have a label that contained a recommended exposure schedule; the operator's manual provided inadequate instructions for use; and label implication may result in overexposure.
VOLUME OF PRODUCT IN COMMERCE
72 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) University Health System Custom Cardiac Cath Pack, K09T-02178, Srterile EO. Intended for fluid management convenience when catheterization is required. Recall # Z-0744-2010;

2) Custom Cardiac Cath Pack Kit, K09-08945, Sterile EO. Intended for fluid management convenience when catheterization is required. Recall # Z-0745-2010;

3) Custom Angiographic Kit, K09-MS3084, Sterile EO. Intended for fluid management convenience. Recall # Z-0746-2010;

4) Jeanes Hospital Custom Cath Procedure Tray, K09T-08945, Sterile EO. Intended for fluid management convenience when catheterization is required. Recall # Z-0747-2010;

5) Jeanes Hospital Custom Cath Procedure Tray, K09T-08945A, Sterile EO. Intended for fluid management convenience when catheterization is required. Recall # Z-0748-2010
CODE
1) Lot numbers: V622183, V630959, V650165;
2) Lot number: F565427;
3) Lot numbers: F581652, F591227, F606011, F612723, F639875, F643160, F650472, F667884.
4) Lot number: V553545;
5) Lot numbers: V568982, V573596
RECALLING FIRM/MANUFACTURER
Merit Medical Systems, Inc., South Jordan, UT, by telephone and letter beginning January 29, 2009. Firm initiated recall is ongoing.
REASON
A manufacturing defect may prevent adequate sterilization of the entire device.
VOLUME OF PRODUCT IN COMMERCE
910 units
DISTRIBUTION
PA, TX, Japan
___________________________________
PRODUCT
RX ACCULINK Carotid Stent System, 10x40 mm, Product Number: 1011344-40. Indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy who require carotid revascularization. Recall # Z-0749-2010
CODE
Lot Number: 9081851
RECALLING FIRM/MANUFACTURER
Abbott Vascular-Cardiac Therapies dba Guidant Corp., Temecula, CA, by letter beginning October 1, 2009. Firm initiated recall is ongoing.
REASON
The affected lot may not meet our quality specifications for catheter shaft tensile strength.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Triathlon Total Stabilizer Femoral Component; Size # 2 for Use with TS Components; Sterile. The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. Catalog number: 5512-F-201. Recall # Z-0757-2010;

2) Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile. The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. Catalog number: 5512-F-301. Recall # Z-0758-2010; 

3) Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile. The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. Catalog number: 5512-F-402. Recall # Z-0759-2010; 

4) Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile. The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. Catalog number: 5512-F-501. Recall # Z-0760-2010;

5) Triathlon Total Stabilizer Femoral Component; For Use with TS Components; Sterile. The Triathlon Total Knee System components are intended for use in primary and revision total knee arthroplasty to alleviate pain and restore function. Catalog number: 5512-F-502. Recall # Z-0761-2010
CODE
1) Lot code XDRZR1;
2) Lot coded: XKYG, XKYH, YBTHR1 and YEUAR1;
3) Lot codes: XAWZ and YGYP;
4) Lot codes: XAVN, XAVP and XBAL;
5) Lot codes: XDESR1 and XKWG
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated December 10, 2009. Firm initiated recall is ongoing.
REASON
Triathlon TS femoral components may have been damaged during manufacturing, possibly preventing the assembly of a stem extension.
VOLUME OF PRODUCT IN COMMERCE
45 units
DISTRIBUTION
Nationwide, Australia, UK and Canada
___________________________________
PRODUCT
MRI Eclipse 1.5T System Model #781230. The 1.5T Magnetic Resonance Imaging system intended for use with clinical/radiologic diagnostic imaging applications. Recall # Z-0780-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland), Inc., Cleveland, OH, by letter dated December 4, 2009 and visit. Firm initiated recall is ongoing.
REASON
Polymeric RF connector block on the tabletop overheated and eventually ignited during scanning due to combination of arcing of electrical components associated with the RF trap assembly located below the connector and flame rating of the connector block material.
VOLUME OF PRODUCT IN COMMERCE
290 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Stryker Xia Precision System; Jam Shidi 10 Gauge 9 inch; Sterile. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation. Catalog number: 48237110. Recall # Z-0789-2010;

2) Stryker Xia Precision System; Jam Shidi 10 Gauge 5 inch; Sterile. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation. Catalog number: 48237105. Recall # Z-0790-2010;

3) Stryker Xia Precision System; Jam Shidi 11 Gauge 5 inch; Sterile. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation. Catalog Number: 48237115. Recall # Z-0791-2010;

4) Stryker Xia Precision System; Jam Shidi 13 Gauge 5 inch; Sterile. Intended for use as a manual surgical instrument during percutaneous posterior, non-cervical pedicle fixation. Catalog number: 48237135. Recall # Z-0792-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by letter dated January 15, 2010.
Manufacturer: Angiotech Manan Medical, Wheeling, IL. Firm initiated recall is ongoing.
REASON
Stryker Spine received reports of packaging failures during shipping for the Jam Shidi instruments, which may compromise the sterility of the product.
VOLUME OF PRODUCT IN COMMERCE
2,727 – all sizes
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Reamer T-Handle; Non- Sterile. Intended for use in orthopedic surgery to interface with various cutting instruments and drivers. Catalog Number: 1101-2100. Recall # Z-0793-2010;

2) Navigation Reamer T-handle; Non Sterile. Intended for use in orthopedic surgery to interface with various cutting instruments and drivers. Catalog Number: 2124-2100. Recall # Z-0794-2010
CODE
1) Lot Codes: SZK01, SZK02, SZK03, SZK06 and SZL01;
2) Lot Codes: ALZH05 and ALZE32
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated August 8, 2005. Firm initiated recall is complete.
REASON
Stryker Orthopedics learned that the T-handles have the potential to not engage and not attach to the reamer properly.
VOLUME OF PRODUCT IN COMMERCE
1) 273 units; 2) 22 units
DISTRIBUTION
Nationwide and International
___________________________________
PRODUCT
Scorpio PS Femoral Waffle (No post) and LFIT; Use only with Scorpio PS Tibial Bearing inserts and Scorpio Patellas, Stryker Orthopaedics. Intended for cemented application to replace the articulating surface of the distal femur. Scorpio (no post) with LFIT: Product code 72-4107-L. Recall # Z-0795-2010
CODE
Lot Code: JKWMHD
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated July 7, 2007. Firm initiated recall is complete.
REASON
Stryker Orthopaedics became aware that a box packaged and labeled as a Scorpio PS Femoral Waffle (No Post) with LFIT, may actually contain a Scorpio Femoral Waffle (With Post) and LFIT.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide and France
___________________________________
PRODUCT
Depth Gauge; Catalog Number: 703707. This product is sold separately or as part of Kit # 990256. The depth gauge is an instrument in the VariAx Elbow System. Depth gauges are tools used intra-operatively, to aid in correct screw selection. They can be used with a plate, or directly on bone. Recall # Z-0796-2010
CODE
Lot code: U09984 VariaAx Elbow System Instrument Set - kitted, material transaction lots # U23151, U24021, U25906 and U29985 all contain one piece of the affected recalled catalog number.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter dated December 22, 2009.
Manufacturer: Stryker Trauma AG, Selzach, Switzerland. Firm initiated recall is ongoing.
REASON
The Depth Measuring Gauges have 5 scale marking instead of the required 4 scale markings.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
2-Channel Laryngeal Surface Electrode (Model LSE500DCS and LSE500DCL) For use as a Surgical stimulator/locator for recurrent laryngeal nerve. Recall # Z-0798-2010
CODE
Lot numbers 113008, 054409, 096709
RECALLING FIRM/MANUFACTURER
Recalling Firm: Neurovision Medical Products Inc, Ventura, CA, by letter dated January 7, 2010.
Manufacturer: R & D Medical Products Inc., Lake Forest, CA. Firm initiated recall is ongoing.
REASON
This recall has been initiated due to conductive glue used to attach the lead wire to electrode, which has been found in a small number of electrodes, to cause a short circuit in one of the channels. This is due to migration of the adhesive from one pad to the other creating an electrical short. Use of one of these defective electrodes could lead to a failure to monitor. Our investigation has concluded that the existing defect has a small likelihood of putting a patient at risk due to (1) the ease in identifying any defective product prior to use and (2) that any short circuit will be apparent to a licensed IOM clinician when plugged into a monitor. We have received calls from two of our customers with this complaint.
VOLUME OF PRODUCT IN COMMERCE
4,143 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: VETENIARY - CLASS II
___________________________________
PRODUCT
1) V6400 Invasive Pressure Monitor uses WW3005 power cord. Electri-Cord. Recall # V-033-2010;
2) V9200 Advisor Vital Signs Monitor utilizes the power cord WW3005. Recall # V-034-2010;
3) V8400 Capnocheck Capnometer utilizes the power cord 8404 for its battery charger. Recall # V-035-2010
CODE
1) Power cord # WW3005;
2) Power cord # WW3005;
3) Power cord # 8404
RECALLING FIRM/MANUFACTURER
Smiths Medical PM, Inc., Waukesha, WI, by letter dated January 12, 2010. Firm initiated recall is ongoing. 
REASON
Smiths Medical is conducting a voluntary recall of a limited number of medical device AC power cords, for use with BCI 3180 Pulse Oximeter(Human), 9200 Advisor Vital Signs Monitor(Human or Veterinary), 8400 Capnocheck II Capnometer(Human or Veterinary) and V6400 Invasive Pressure Monitor (Veterinary). The affected Electri-Cord AC power cords are equipped with a plug that has prong and ground-pin insert design and a black plastic bridge connecting the terminal prongs on the plug. The FDA has reported that two medical device manufactures have reported incidents of sparking, charring, and fires from the affected power cords used with their devices. Smiths medical has received no reports of incidents regarding the use of the affected Electric-Cord power cords with their devices.
VOLUME OF PRODUCT IN COMMERCE
1358 cords for all devices (1032 US, 326 OUS) (871 Human, 487 Vet), (Cord # 8404 5 Vet & 325 Human), (Cord # WW3005 482 Vet & 546 Human)
DISTRIBUTION
Nationwide, Canada, and Greece

END OF ENFORCEMENT REPORT FOR FEBRUARY 24, 2010

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