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U.S. Department of Health and Human Services

Safety

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Enforcement Report for February 17, 2010

February 17, 2010                                                                                 10-06

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Fisher/Rex Sandwiches, with a seven digit code starting with 01.  A variety of prepackaged sandwiches are included in this recall. Recall # F-1085-2010
CODE
Seven digit product code starting with 01 (followed by Julian date such as 0126509). Products with a five digit product code are not subject to this recall.
RECALLING FIRM/MANUFACTURER
Fisher Rex Sandwich Co., Raleigh, NC, by press release on October 9, 2009 and by press release and telephone on October 12, 2009. Firm initiated recall is complete.
REASON
Product was found to contain Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
16,000 units
DISTRIBUTION
FL, NC, SC and VA
___________________________________
PRODUCT
Orion Brand Frozen Cooked Snow Crab Cocktail Claws, Net Wt. 3 lbs. 1.36 kg, packaged in poly bag Product of Canada Code 4053 : Small Crab Cocktail Claws Code: 45054 Medium Crab Cocktail Claws Code: 45055 Large Crab Cocktail Claws Code: 45056 X Large Crab Cocktail Claws Plant Number: 1209. Recall # F-1086-2010
CODE
Date Codes: 09205 09208 09209 09210 09211 09212
RECALLING FIRM/MANUFACTURER
Recalling Firm: Orion Seafood, Portsmouth, NH, by telephone and letter via e-mail on October 2, 2009.
Manufacturer: Pecheries Belle Ile, Saint Marie, Saint Raphael New Brunswick, Canada. Firm initiated recall is complete.
REASON
Product contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
737 cases
DISTRIBUTION
CA, FL GA, TX
___________________________________
PRODUCT
1) Alfalfa Sprouts (4 oz, 8 oz, 1 lb, 5 lb). Recall # F-1087-2010;
2) Dinner Salad (6 oz). Recall # F-1088-2010;
3) Onion Mix (4 oz). Recall # F-1089-2010
CODE
Sell by dates: June 18 to June 30
RECALLING FIRM/MANUFACTURER
Mike's Produce dba: Kowalke Family Sprouts, Los Angeles, CA, by press release on June 24, 2009. Firm initiated recall is complete.
REASON
Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
CA, NV, OR, AZ
___________________________________
PRODUCT
1) SUL TTUK with Chestnuts (rice cake with chestnuts) 10 oz styrofoam tray containing 18 rice cakes per tray. Recall # F-1120-2010;

2) White bean serl gi (rice cake with chestnuts, pumpkin and red, black, mung and pinto beans) 10 oz tray containing 8 rice cakes per tray. Recall # F-1121-2010;

3) Mo dum chal dduk (sweet rice cake with chestnuts, pumpkin, red, black, garbanzo, mung, and pinto beans) 10 oz tray containing 6 slices of rice cakes per tray. Recall # F-1122-2010;

4) Red bean chal siru (sweet rice with topped red beans), mo dum chal dduk (sweet rice cake with chestnuts, pumpkin, red, black, garbanzo, mung, and pinto beans), in jerl mi (bean powdered sweet rice cubes) 10 oz tray containing 19 rice cakes per tray. Recall # F-1123-2010;

5) sul ttuk with almonds (rice cakes topped with almonds. 10 oz tray containing 18 squares of rice cakes per tray. Recall # F-1124-2010;

6) Gimbob sushi rolls, Net. Wt. 10 oz. tray containing two rolls per tray. Recall # F-1125-2010
CODE
No codes
RECALLING FIRM/MANUFACTURER
Shining Marble Inc dba Shil La Dang, Gardena, CA, by telephone on August 28, 2009 and press release on September 2, 2009. Firm initiated recall is complete.
REASON
The recall was initiated due to undeclared allergens (chestnuts, almonds, fish, wheat and soybean).
VOLUME OF PRODUCT IN COMMERCE
176 trays
DISTRIBUTION
CA
___________________________________
PRODUCT
Fresh salmon fillets. Recall # F-1127-2010
CODE
No code
RECALLING FIRM/MANUFACTURER
Komolo NJ Corp., Ridgefield, NJ, by letter on December 4, 2009 and December 15, 2009. Firm initiated recall is ongoing.
REASON
Product found to be positive for Listeria.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY, NJ, CT, PA
___________________________________
PRODUCT
1) Tomaso's Puttanesca - Tomato, Fresh Basil, Olive & Caper Sauce, in 12 oz. plastic container (Keep refrigerated). Recall # F-1149-2010;

 2) Tomaso's Pasta Sauce - black olives, basil and garlic, in 25 oz glass jar. Recall # F-1150-2010
CODE
1) Expiration dates up until Sept 17th, 2009;
2) Production dates up until Aug 5th 2009
RECALLING FIRM/MANUFACTURER
Tomaso's Specialty Foods Inc., Blue Lake, CA, by letter on August 11, 2009 and a press release on August 28, 2009. Firm initiated recall is complete.
REASON
Undeclared Allergen-- Product contains anchovies which are not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
1) 426 units; 2) 1272 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Omo and Fu Choi brand Jumbo Green Onions in 48 ct. box, item numbers 02487403 and 02487452. Recall # F-1161-2010.
CODE
Lot numbers 40550707 and 40510707, with production dates of July 20th and July 21st 2009
RECALLING FIRM/MANUFACTURER
New Star Fresh Foods, LLC, Salinas, CA, by telephone on August 6, 2009, letters on August 7, 2009 and by press release on August 12, 2009. Firm initiated recall is complete.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
772 cartons
DISTRIBUTION
CA, MI, GA
___________________________________
PRODUCT
Five Crowns Marketing cantaloupes packed under the Majesty label. Recall # F-1162-2010
CODE
Lot Numbers: 198 1 or 198 3, Packed Dates: Nov 4, Nov 6, and Nov 10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Five Crowns Marketing, Brawley, CA, by telephone on November 18, 2009, by press release on November 20, 2009 and letter via fax between November 20 - November 23, 2009.
Manufacturer: SMT Farms, Yuma, AZ. Firm initiated recall is complete.
REASON
The product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
10,041 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Large Seedless Watermelons are stickered with the "MelonUp!" label with the PLU (Price Look Up) # 4032 and UPC # 0 33383 40240 6, in 5 or 6 count cartons. Recall # F-1163-2010
CODE
Lot Numbers: LVFA092568; AAFA094137
RECALLING FIRM/MANUFACTURER
Recalling Firm: Timco Worldwide, Davis, CA, by telephone and e-mail on November 20, 2009 and by press release on November 22, 2009.
Manufacturers: Vinedos Alta, S.A. de C.V., Hermosillo, Mexico; Agricola La Vidorama-Guaymas, Guaymas, Mexico. Firm initiated recall is ongoing.
REASON
The product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
812 cases
DISTRIBUTION
CA, TX
___________________________________
PRODUCT
Del Monte whole cantaloupe. Recall # F-1203-2010
CODE
Sold between October 5 and October 16, 2009
RECALLING FIRM/MANUFACTURER
Raley’s Distribution Center, Sacramento, CA, by a website posting and firm removed item from shelves on October 16, 2009. FDA initiated recall is complete.
REASON
The product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,120 cases
DISTRIBUTION
CA, NV
___________________________________
PRODUCT
Elegant Edibles Gourmet Pecans Amaretto, Recall # F-1223-2010
CODE
Products manufactured from May 5, 2009 to November 4, 2009
RECALLING FIRM/MANUFACTURER
Elegant Edibles, Houston, TX, by telephone on November 5, 2009. Firm initiated recall is ongoing.
REASON
Product contains undeclared almonds from pure almond extract used in the production process.
VOLUME OF PRODUCT IN COMMERCE
200 one-oz bags and one 8-oz bag
DISTRIBUTION
TX
___________________________________
PRODUCT
1) 7-Select Louisiana Hot Onion Rings, 1.625 oz (46g)plastic bags, UPC # 0-52548-05785-5; Labeled as "7-Select Onion Rings". Recall # F-1224-2010;

2) Rudolph's Louisiana Hot OnYums, 8 oz (227g) plastic bags, UPC # 0-24622-57079-6; Labeled as "Rudolph's OnYums Hot Flavored Rings". Recall # 1225-2010
CODE
1) Code Dates: FEB 26 2010, MAR 5 2010, MAR 12 2010, MAR 19 2010, MAR 26 2010, APR 2 2010, APR 9 2010, APR 16 2010, APR 23 2010, APR 30 2010;

2) Code Dates: MAR 12 2010, FEB 5 2010
RECALLING FIRM/MANUFACTURER
Rudolph Foods Co., Inc., San Bernardino, CA, by telephone and letter on January 8, 2010 and by press release on January 9, 2009. Firm initiated recall is ongoing.
REASON
Products may contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
46,644 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Fiesta 12 inch Flour Burrito Tortillas, Net Wt. 3 lb. 48 oz. 1361G. Packed 12 tortillas per package; 10 packages in a case. Product ID 167. Recall # F-1226-2010;

2) 12" Flour Tortilla Raw, sold in bulk - packed 12 tortillas per package; 10 packages in a case. Product ID 68. Recall # F-1227-2010;

3) 12-inch and 13-inch Flour Tortilla, sold in bulk - packed 12 tortillas per package; 10 packages in a case. Product ID 273, 63 and 3. Product ID 273 has UPC code 10043912232012. Recall # F-1228-2010;

4) 12" Jalapeno and Cheese Tortilla, sold in bulk - packed 12 tortillas per package; 10 packages in a case, product ID 161. Recall # F-1229-2010;

5) 12-inch and 13-inch Spinach Flavor Tortilla, sold in bulk - packed 12 tortillas per package; 10 packages in a case. Product ID 132 and 470. Recall # F-1230-2010;

6) 12-inch and 13-inch Whole Wheat Tortilla, sold in bulk - packed 12 tortillas per package; 10 packages in a case. Product ID 55 and 473. Recall # F-1231-2010;

7) 13-inch Chili Pepper Tortilla, sold in bulk - packed 12 tortillas per package; 10 packages in a case. Product ID 471. Recall # F-1232-2010;
CODE
1) Date of November 30, 2009 through December 20, 2009;
2) through 7) Sold November 9 through November 30, 2009
RECALLING FIRM/MANUFACTURER
La Espiga De Oro, Inc., Houston, TX, by press release, telephone and letters on November 30, 2009. Firm initiated recall is complete.
REASON
Product may contain undeclared whey (milk).
VOLUME OF PRODUCT IN COMMERCE
35,930 packages of 12
DISTRIBUTION
TX, LA, CO
___________________________________
PRODUCT
No - MSG Season Salt, Contains: Salt, Pepper, Sugar, Onion and other Spices, Global Spice Specialty Food Service, San Antonio TX 78216 (210) 949-0622; packaged in Clear Polyethylene plastic container, Net Wt. 2 lb (908g.); Net Wt. 5 lb (2270 g.); Net Wt. 8 lb (3632 g.); and 50 lb. cases with no labeling change. Labeling for 50 lb. reads Adams Flavors Foods & Ingredients, Seasoning Salt, Product Code CT295B, Ingredients: Salt, Black Pepper, Sugar, Onion, Garlic, Spices, Spice Extractives, Less than 1% Propylene Glycol as Mixing Aid. New Wt 50.00 lbs. (22.68 KGS.) Recall # F-1233-2010
CODE
No coding
RECALLING FIRM/MANUFACTURER
Recalling Firm: Global Spice Specialty Foods, LLC, San Antonio, TX, by telephone on August 10, 2009.
Manufacturer: Adams Extract & Spice LLC, Gonzales, TX. Firm initiated recall is complete.
REASON
Product has the potential to contain Salmonella.
VOLUME OF PRODUCT IN COMMERCE
342 lbs
DISTRIBUTION
TX
___________________________________
PRODUCT
EUROPA brand Knot Rolls, Net Wt. 22 oz. clear plastic bag, 6 rolls per bag, UPC 6 32108 10005 6. Recall # F-1241-2010
CODE
"SELL BY" date of September 2nd through September 15th, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Better Buns, Inc., New Hyde Park, NY, by visit on September 14, 2009 and by press release on September 18, 2009.
Manufacturer: Palagonia Bakery, Brooklyn, NY. Firm initiated recall is complete.
REASON
The product contained undeclared eggs. NYK-DO received a complaint regarding a consumer that experienced an allergic reaction after consuming part of the product. The consumer has known allergies to eggs, all tree nuts, peanuts, and shellfish.
VOLUME OF PRODUCT IN COMMERCE
3,407 bags
DISTRIBUTION
NY State
___________________________________
PRODUCT
Jayleaf Specialties Baby Spinach in 4 lb bag (inside a case). Recall # F-1250-2010
CODE
Code date 71404
RECALLING FIRM/MANUFACTURER
Jayleaf Suprema Packing Facility, Hollister, CA, by letter on December 9, 2009. California initiated recall is complete.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,362 cases
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Cajun style catfish. It is vacuum packed and sold in a display tray with plastic overwrap in a 12 oz package. It is also sold in a 5 lb bulk bags with labeling to be applied at retail level. Perishable. The first five digits of the UPC code are 48079. The last five digits of the UPC vary. Recall # F-1251-2010;

2) Lemon Pepper Marinated Catfish. It is vacuum packed and sold in a display tray with plastic overwrap in a 12 oz package. It is also sold in a 5 lb bulk bags with labeling to be applied at retail level. Perishable. The first five digits of the UPC code is 48078. The last five digits of the UPC vary. Recall # F-1252-2010
CODE
There is no lot number on these products. The firm applies a 7 day shelf life to the product. Product manufactured on 11/16/09 would have a "sell by 11/23/09" label. The firm is recalling all product.
RECALLING FIRM/MANUFACTURER
Superior Foods Company, Grand Rapids, MI, by press release and letter dated November 17, 2009. FDA initiated recall is ongoing.
REASON
1) Product contains soy and milk. The soy is declared on the label. The firm is recalling for undeclared soy and milk. The recall press release and consumer letter had an error that the soy was undeclared when in fact soy was declared on the label.

2) Product contains soy and FD &C yellow # 5. These ingredients are not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
1) 603 lbs; 2) 456 lbs
DISTRIBUTION
MI, OH, IN
___________________________________
PRODUCT
1) Kirkland Organic Brown Eggs packaged in 18 count cartons, sold in Costco Stores. Recall # F-1253-2010;

2) O Organic Grade A Large Brown Eggs sold in Safeway and Pak 'N' Sav stores. Recall # F-1254-2010
CODE
1) Expiration dates and plant code can be found on the end of the carton and are written as follows: April 1 062 35 P1776 and April 8 069 35P1776;

2) Expiration dates and plant code can be found on the end of the carton and are written as follows: April 1 062 35 P1776
RECALLING FIRM/MANUFACTURER
Den Dulk Poultry Farms, LLC, Ripon, CA, by telephone and letter on March 18, 2009 and by press release on March 20, 2009. Firm initiated recall is ongoing.
REASON
Eggs maybe contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1) 960 cartons; 2) 150 cartons
DISTRIBUTION
CA, NV

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
1) GreenWise Natural Chocolate Flavor Whey Protein Powder 15.5 oz. UPC 41415-55077: Chocolate flavor label states "Contains: NO MILK". Recall # F-1023-2010;

2) GreenWise Vanilla Whey Protein Powder 13 oz. UPC 41415-54977. (Label does not declare milk). Recall # F-1024-2010
CODE
1) Units: 905036, 905037, 905038, 905039;
2) Units: 906022, 906023, 906024, 906025
RECALLING FIRM/MANUFACTURER
Arizona Nutritional Supplements Inc., Chandler, AZ, by telephone on July 6, 2009. Firm initiated recall is ongoing.
REASON
The product lists whey as an ingredient but does not list milk as the source of whey as required by Food Allergen Labeling and Consumer Protection Act (FALCPA).
VOLUME OF PRODUCT IN COMMERCE
Vanilla: 906022-1800; 906023-1824; 906024-1752; 906025-624. Chocolate: 905036-1824; 905037-1824; 905038-1824; 905039-528
DISTRIBUTION
SC, AL, FL, GA, TN 
___________________________________
PRODUCT
1) Milk Chocolate Toy Soldier. Net Wt 3.5 ounces or 99.2 grams. In plastic tray inside a cardboard box. Item # 1018, NO UPC. Recall # F-1112-2010;

2) Milk chocolate spoon. Plastic spoon covered in chocolate. The spoon is in a clear plastic cellophane wrapper. No UPC. Recall # F-1113-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
The South Bend Chocolate Company, Inc., South Bend, IN, by telephone and letter dated November 2, 2009. FDA initiated recall is ongoing.
REASON
This product contains soy lecithin which is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
2689 toy soldiers & 5570 chocolate spoons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Durhams Ellis Peanuts Hot & Spicy, Net Wt. 1 lb (16 oz), Exp Date: Aug 2010, Sep 2010, and Oct 2010, UPC 0-73042-62033-8. Recall # F-1114-2010

2) Durhams Ellis Fiesta Mix, Net Wt. 1 lb (16 oz), UPC 0-73042-70000-90000-9. Recall # F-1115-2010
CODE
Exp Date: Aug 2010, Sep 2010, and Oct 2010
RECALLING FIRM/MANUFACTURER
Dollins Pecan Co, Inc., Comanche, TX, by letter on October 28, 2009.  Firm initiated recall is ongoing.
REASON
Product may contain undeclared Soy Lecithin and undeclared color Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
600 lbs
DISTRIBUTION
TX, NM, OK
___________________________________
PRODUCT
Assorted Candies/Duvalin, packaged under the following brand names: Terry's Super Markets, La Azteca Meat Market Carniceria Panageria Taqueria, Supermercados Marelos, El Gordo Candies, and Celaya Meat Market Candies. Net Wt 2.5 oz (70.88 g) or Net Wt 2 1/2 oz (70.86g). UPC Codes: 1826702162, 1826706162, 1826708162, 1826703162, and 1826707162. Package is a clear cellophane bag with cardstock-weight multi-color labels folded and stapled over the top. Recall # F-1128-2010
CODE
No lots
RECALLING FIRM/MANUFACTURER
Mendoza Food Products, Dallas, TX, by visit beginning April 17, 2009. Firm initiated recall is ongoing.
REASON
Product labeling does not list soy lecitin, and only declares lecitain. Product also contains undeclared FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
6,684 units
DISTRIBUTION
TX, OK
___________________________________
PRODUCT
White Corn Mi Panchito Tortilla Mexicana Low Fat NO Cholesterol, UPC 57003 00002. Net Wt. 80 oz (5 lbs 2.27Kg) Recall # F-1129-2010
CODE
Lot 121509
RECALLING FIRM/MANUFACTURER
La Autentica Foods, Inc., Hialeah, FL, by telephone on August 4, 2009.  Firm initiated recall is ongoing.
REASON
Products contain undeclared food colors in labeling.
VOLUME OF PRODUCT IN COMMERCE
55 cases
DISTRIBUTION
FL
___________________________________
PRODUCT
Superior Catfish Products Lemon Pepper Catfish #10 and #15 packages. Recall # F-1131-2010
CODE
Product exp. 11/24/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Acquired Holding Inc., Buckner, KY, by telephone on November 24, 2009. 
Manufacturer: Superior Fish Products, Macon, MS. Firm initiated recall is ongoing.
REASON
Products has an undeclared ingredient -yellow number #5.
VOLUME OF PRODUCT IN COMMERCE
3 packages
DISTRIBUTION
KY
___________________________________
PRODUCT
Bush Permicol Synthetic Food Color Preparation, Orange Red Powder IH 7802, Net: 100 g. Recall # F-1132-2010
CODE
06/2009 Lot 978
RECALLING FIRM/MANUFACTURER
Recalling Firm: Atlantic Food & Spices, Inc., Dallas, TX, by letter on November 20, 2009.
Manufacturer: Mallya Fine - Chem Pvt. Ltd., Bangalore, India. Firm initiated recall is ongoing.
REASON
Product contains carmoisine, an unapproved color.
VOLUME OF PRODUCT IN COMMERCE
49 tins
DISTRIBUTION
TX
___________________________________
PRODUCT
Plait Biscuits Brand Name: Banh Quai Cheo. Item# 102287 Item# 102287A
Recall # F-1133-2010
CODE
No lot numbers
RECALLING FIRM/MANUFACTURER
ROXY Trading Inc., Azusa, CA, by letters on November 17, 2009 and November 18, 2009. Firm initiated recall is ongoing.
REASON
Product contains Rhodamine B, formerly certifiable as D&C Red #19 (CI 45170), detected and confirmed by original and check analysis. Rhodamine B is a non-permitted color additive.
VOLUME OF PRODUCT IN COMMERCE
34,176 cases
DISTRIBUTION
CA, HI, OK, DC
___________________________________
PRODUCT
La Autentica Foods, Inc. Tortilla Chips. Packed in plastic bags net weight 80 ounces (5lbs) per bag. Six packages per case. Ingredients: Specially Stoned Ground Corn treated with Lime, Water, Sodium Propionate, Monocalcium Phosphate, Potassium Sorbate, fumaric Acid to preserve Freshness. Colored Chips: Artificial Coloring added UNLESS specified otherwise. Recall # F-1143-2010
CODE
01/2010, 02/2010
RECALLING FIRM/MANUFACTURER
La Autentica Foods, Inc., Hialeah, FL, by telephone on August 7, 2009. Firm initiated recall is ongoing.
REASON
Product contains undeclared food colors Blue: red #40, blue #1, yellow #'s 5 & 6; Red: pure Red 40; Casiline Orange Blend: Orange color FDA #5 + #6 + Red #40; Green: Yellow #5 & Blue # 1.
VOLUME OF PRODUCT IN COMMERCE
38 cases
DISTRIBUTION
FL and the Cayman Islands
___________________________________
PRODUCT
Product is mahi-mahi. Frozen, vacuum packed in 6 oz portions, skin on, boneless. Production code: S3158A and S3158B. Recall # F-1164-2010
CODE
Lot #: 46218
RECALLING FIRM/MANUFACTURER
Recalling Firm: Interbay Food Co., Woodinville, WA, by visit on October 27, 2009 and by fax.
Manufacturer: Ocean Beauty Seafoods Inc., Seattle, WA. Firm initiated recall is ongoing.
REASON
Product is decomposed.
VOLUME OF PRODUCT IN COMMERCE
368 cases, each 10lbs
DISTRIBUTION
WA, and 1 Coast Guard vessel, and 1 National Oceanic and Atmospheric Administration vessel
___________________________________

PRODUCT
MARDEX brand Tuna Steaks, 6oz frozen Wild-caught Product of Ecuador Ingredients: Tuna, Carbon Monoxide (Added to Preserve Color). Product code: 87554. Recall # F-1165-2010
CODE
Production date codes: 113-09-2 , 114-09-2, 140-09-2, 147-09-2, 148-09-2, 154-09-2, 166-09-2, 167-09-2, 168-09-2, 169-09-2, 174-09-2 and 175-09-2
RECALLING FIRM/MANUFACTURER
Recalling Firm: Slade Gorton & Company, Inc., Boston, MA, by telephone on December 4, 2009 and by letter on December 7, 2009.
Manufacturer: Mardex, Manta, Ecuador. Firm initiated recall is ongoing.
REASON
Product contains histamines above the action limit of 50 ppm.
VOLUME OF PRODUCT IN COMMERCE
557 cases (net wt 10 lbs)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Elf Herring Fillets in Real Sour Cream; refrigerated herring in cream sauce, ready to eat; packaged in 8 oz. glass jars, 6 jars per case and 12 oz. glass jars,6 jars per case and 12 jars per case; UPC 0 73302 23111 3 (8 oz. jar) and 0 73302 22111 4 (12 oz. jar). Recall # F-1240-2010
CODE
Best is used before 12/APR/10 or earlier
RECALLING FIRM/MANUFACTURER
Vita Food Products, Inc., Chicago, IL, by press release on November 24, 2009. Firm initiated recall is ongoing.
REASON
Product contains undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
373 cases - 6/8 oz., 828 cases - 6/12 oz., 1,836 cases - 12/12 oz.
DISTRIBUTION
CA, FL, GA, MD, MA, MI, MN, ND, TX, WI
___________________________________
PRODUCT
Fresh & Local Chicken Parmesan Sub. Recall # F-1249-2010
CODE
Sell by dates: Wednesday, November 11th, Thursday, November 12th and Friday, November 13th
RECALLING FIRM/MANUFACTURER
LSG SkyChefs, Inc., Denver, CO, by telephone on November 11, 2009. Firm initiated recall is complete.
REASON
Sandwiches were prepared using uncooked breaded chicken strips.
VOLUME OF PRODUCT IN COMMERCE
172 sandwiches
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
All  Natural Ocho Rios Isinglass Net Wt 1/4 oz (7g). Ingredients: Pure Isinglass (AGAR-AGAR). UPC 7 37605 88822 0. Product is packed in *celopack* 1/4 oz packets. Recall # F-1130-2010
CODE
No Codes - All products is being recalled.
RECALLING FIRM/MANUFACTURER
Ocho Rios-Miami, Inc., Miami FL, by letter beginning October 13, 2009. Firm initiated recall is ongoing.
REASON
Product tested positive for sulfites. Sulfites is not declared on the product labeling.
VOLUME OF PRODUCT IN COMMERCE
264 packets (1/4 oz)
DISTRIBUTION
FL, GA, MO, Bahamas

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Pilocarpine Hydrochloride Tablets 5 mg, Rx only, 100 Tablets Sandoz; NDC 0781-5100-01. Recall # D-329-2010
CODE
Lot: 100535; Exp.: Mar 2011
RECALLING FIRM/MANUFACTURER
Corepharma LLC, Middlesex, NJ, by letter on January 26, 2010. Firm initiated recall is ongoing.
REASON
One lot of Pilocarpine Hydrochloride Tablets, 5 mg may contain out of specification tablets for weight and thickness.
VOLUME OF PRODUCT IN COMMERCE
9851 bottles of 100 tablets
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
1) Milk of Magnesia Mint Flavor saline laxative packed in 12 oz and 26 oz bottles. OTC. Packaged under the following labels: CVS Milk of Magnesia, NDC 59779-332-40, and 59779-332-35; Equaline Milk of Magnesia fresh mint, NDC 41163-322-40, 41163-332-35; Good Neighbor Pharmacy Milk of Magnesia Saline Laxative Fresh Mint, NDC 24385-332-40; Good Sense Milk Of Magnesia Fresh Mint, NDC 0113-0332-40; Hannaford Milk of Magnesia Mint Flavor, NDC 41268-332-40; HyVee Milk of Magnesia Mint Flavor, NDC 42507-332-40; Kroger Milk of Magnesia Mint Flavor, NDC 30142-332-40; Leader Milk of Magnesia Mint, NDC 37205-834-40; The Medicine Shoppe Milk of Magnesia Mint Flavor, NDC 49614-332-40; Meijer Milk of Magnesia Mint Flavor, NDC 41250-332-40, 41250-332-35; Publix Milk of Magnesia Mint, NDC, 56062-332-40; Safeway Mint Flavor Milk of Magnesia, NDC 21130-332-40; Sun Mark Milk of Magnesia Mint Flavor, NDC 49438-688-44, 49348-688-39; TopCare Milk Of Magnesia Mint Flavor,  NDC 36800-332-40; Western Family Milk of Magnesia Fresh Mint, NDC 55313-332-40. Recall # D-323-2010;

2) Milk of Magnesia Original saline laxative in 12 oz bottles. Packed under the following labels: CVS Milk of Magnesia, NDC 59779-396-40; Equaline Milk of Magnesia, NDC 41163-396-40; GoodSense Milk of Magnesia, NDC 0113-0396-40; Good Neighbor Pharmacy Milk of Magnesia, NDC 24385-396-40; Hannaford Milk of Magnesia, NDC 41268-396-40; Healthy Accents Milk of Magnesia, NDC 55316-396-40; HyVee Milk of Magnesia, NDC 42507-396-40; Kroger Milk of Magnesia, NDC 30142-396-40; Leader Milk of Magnesia, NDC 37205-883-40; The Medicine Shoppe Milk of Magnesia, NDC 49614-339-40; Publix Milk of Magnesia, NDC 56062-396-40; Sunmark Milk of Magnesia, NDC 49348-687-39; TopCare Milk of Magnesia, NDC 36800-396-40; Western Family Milk of Magnesia, NDC 5531--396-40. Recall # D-324-2010
CODE
1) Lots: Milk of Magnesia Mint flavor: 9CK0061, 9CK0234, 9CK0408, 9CK0508, 9CK0655, 9DK0072, 9DK0211, 9DK0377, 9DK0388, 9DK0513, 9DK0629, 9EK0025, 9EK0129, 9EK0174, 9EK0405, 9EK0421, 9EK0466, 9EK0528, 9EK0539, 9FK0046, 9FK0066, 9FK0257, 9FK0272, 9FK0427, 9FK0443, 9FK0522, 9FK0632, 9FK0633, 9FK0695, 9GK0050, 9GK0056, 9GK0309, 9GK0321, 9GK0438, 9GK0532, 9GK0669, 9GK0675, 9HK0107, 9HK0286, 9HK0314, 9HK0375, 9HK0390, 9HK0532, 9HK0610, 9HK0673, 9JK0125, 9JK0167, 9JK0265, 9JK0543, 9JK0592, 9KK0083, 9KK0095, 9KK0311, 9LL0432, 9KK0534, 9KK0592, 9LK0003, 9LK0027, 9LK0154, 9LK0313, and 9LK0396;

2) Lots: 9CK0653, 9DK0071, 9DK0209, 9DK0375, 9DK0511, 9EK0023, 9EK0172 9EK0407, 9EK0524, 9FK0042, 9FK0254, 9FK0255, 9FK0424, 9FK0520, 9FK0693, 9GK0048, 9GK0307, 9GK0435, 9GK0667, 9HK0105, 9HK0284, 9HK0374, 9HK0531, 9HK0672 9JK0123, 9JK0183, 9JK0241, 9JK0378, 9JK0540, 9KK0080 and 9DKK0545. Expirations from 11/2011 through 9/2012
RECALLING FIRM/MANUFACTURER
L. Perrigo Co., Allegan, MI, by letter dated December 15, 2009. Firm initiated recall is ongoing.
REASON
Misbranded; the amount of calcium and magnesium per tablespoon are understated in the "Other information" box on the Drug Facts statement (magnesium content is listed as 160mg/15ml when it should be listed as of 520mg/15ml; the calcium content is listed as 5mg/15ml instead of 20mg/15ml).
VOLUME OF PRODUCT IN COMMERCE
397,800 bottles of mint flavor; 324,876 bottles of original flavor
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, Rx only. Package consists of 3 pouches, each includes one EZ-DIAL Dispensers of 28 tablets each. NDC 0046-0938-09. Recall # D-330-2010
CODE
Lot C83323 (EXP March 2010) and Lot D82196 (EXP December 2010)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Philadelphia, PA, by letters dated January 15, 2010. Firm initiated recall is ongoing.
REASON
These lots do not conform to the dissolution specifications for conjugated estrogens as specified in the firm's New Drug Application (NDA) for PREMPRO.
VOLUME OF PRODUCT IN COMMERCE
49,156 cartons of 3 dispensers
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0057-10
CODE
Units: 9866519 ( parts 1, 2 and 3)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on August 21, 2007. Firm initiated recall is complete.
REASON
Blood products, with platelet count below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0456-10
CODE
Unit: 72L049263
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers, Mobile, AL, by facsimile on July 4, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Irradiated. Recall # B-0457-10
CODE
Units: W053109101363, W053109101388
RECALLING FIRM/MANUFACTURER
Johnston Memorial Hospital, Abingdon, VA, by letter dated July 14, 2009. Firm initiated recall is complete.
REASON
Blood products, labeled with an incorrect expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
1) Cryoprecipitated AHF. Recall # B-0461-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0462-10
CODE
1) and 2) Unit: W051708612396
RECALLING FIRM/MANUFACTURER
Rhode Island Blood Center, Providence, RI, by letter dated July 1, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0477-10
CODE
Unit: 8780839
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by email on February 12, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0478-10
CODE
Unit: 5687823
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by email on March 14, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0497-10
CODE
Units: 2094633 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Siouxland Community Blood Bank, Sioux City, IA, by fax on July 10, 2009 and by follow-up letter on July 23, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0522-10
CODE
Unit: 72L447020
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by facsimile on August 17, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0523-10
CODE
Unit: 72L447100
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by facsimile on August 17, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Source Plasma. Recall # B-0537-10
CODE
Units: 09LWYA9277; 09LWYA8055
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Laramie, WY, by fax on May 15, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose physical exam was not performed on schedule, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-0539-10
CODE
Unit: 08ATXB6930
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Austin TX, by fax on March 16, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose physical exam was incomplete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0540-10
CODE
Unit: W127809202181
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone and Blood Product Recall form on August 24, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet concentration below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-0541-10;

2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0542-10
CODE
1) and 2) Unit: P71012
RECALLING FIRM/MANUFACTURER
Blood Assurance Inc., Chattanooga, TN, by telephone on May 6, 2009. Firm initiated recall is complete.
REASON
Blood products, with insufficient plasma to support the platelet concentration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT
Source Plasma. Recall # B-0547-10
CODE
Units: LC0552329, LC0552460, LC0553052, LC0553582, LC0554005, LC0554294, LC0554820
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, NM, by facsimile April 8, 2009 and by e-mail on October 30, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0548-10
CODE
Unit: OL0147232
RECALLING FIRM/MANUFACTURER
DCI Biologicals Orlando LLC, Orlando, FL, by facsimile on June 19, 2009, June 22, 2009, and June 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who may have received a piercing within 12 months of donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
United Kingdom
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0549-10
CODE
Unit: W087609552844
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc., Richmond, VA, by telephone on September 10, 2009 and by facsimile on September 12, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the medication Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0552-10
CODE
Unit: W11630947744900
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by facsimile on August 26, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred for testing reactive for the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Platelets. Recall # B-0553-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0555-10
CODE
1) and 2) Unit: 01Q96169
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by facsimile and electronic notification on July 30, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA, NY
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0556-10
CODE
Unit: W047009231738
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by letter dated August 11, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT
Source Plasma. Recall # B-0557-10
CODE
Units: WF0268463, WF0268828, WF0268955, WF0269325, WF0269777, WF0270204, WF0270305, WF0270853, WF0271144, WF0271523, WF0271768
RECALLING FIRM/MANUFACTURER
DCI Biologicals Wichita Falls, LLC, Wichita Falls, TX, by facsimile on August 14, 2009 and by e-mail on October 23, 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
11 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0559-10
CODE
Unit: 50LM14971
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by facsimile and electronic notification on September 2, 2009. 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
OH
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0560-10
CODE
Unit: 72L377130
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by facsimile on August 21, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Source Plasma. Recall # B-0570-10
CODE
Units: 4100278739, 4100264688, 4100260947, 4100257384
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma Inc., Kansas City, MO, by telephone/facsimile on August 31, 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
IL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0571-10;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0572-10
CODE
1) and 2) Unit: 29FK74396
RECALLING FIRM/MANUFACTURER
American National Red Cross, Mid Atlantic Region, Norfolk, VA, by telephone on August 13, 2009 and August 14, 2009 and by letter dated August 14, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0573-10
CODE
Unit: 72L153736
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers Inc - Birmingham Region, Birmingham, AL, by facsimile on August 14, 2009, Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0574-10;
2) Fresh Frozen Plasma. Recall # B-0576-10;
3) Red Blood Cells. Recall # B-0577-10
CODE
1) Unit: W127808504135;
2) and 3) Units: W127808103244; W127808800172
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by letter dated June 4, 2009 and electronic notification on June 5, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor taking the drug Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
WA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0579-10
CODE
Unit: W127809101016
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by e-mail on June 2, 2009 and letter dated June 2, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the drug Finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Washington
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0591-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0592-10
CODE
1) Unit: 6168822;
2) Units: 6213165; 6168822
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on December 30, 2008, January 7, 2009 and January 14, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug Finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0594-10
CODE
Units: W067308111731; W067308102199
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by letters dated April 13, 2009 and June 18, 2009. 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
TX
___________________________________
PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-0598-10
CODE
Unit: 72L400242
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by fax on July 28, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0605-10;
2) Fresh Frozen Plasma. Recall # B-0606-10
CODE
1) and 2) Unit: 6185780
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on September 18, 2009, September 25, 2009, October 5, 2009 and October 27, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the drug finasteride, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall B-0607-10;
2) Cryoprecipitated AHF. Recall # B-0608-10
CODE
1) and 2) Unit: 22FS54674
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax on August 8, 2009 and follow-up letters dated August 12, 2009 and September 22, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NJ, PA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0612-10
CODE
Units: 17FR68932;17GR85292
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by fax on December 19, 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
MN
___________________________________
PRODUCT
Source Plasma. Recall # B-0613-10
CODE
Units: 06HMSB4588; 06HMSB4372; 06HMSB3635; 06HMSB3430; 06HMSB2955; 06HMSB2766; 06HMSB2330
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services LP, Hattiesburg, MS, by fax on April 20, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced . Recall # B-0616-10
CODE
Unit: 0129722
RECALLING FIRM/MANUFACTURER
LifeShare Community Blood Services, Elyria, OH, by fax on February 16, 2009. 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
OH
___________________________________
PRODUCT
Platelets Pooled Leukocytes Reduced. Recall # B-0617-10
CODE
Unit: Y25824
RECALLING FIRM/MANUFACTURER
Community Blood Center of Carolinas, Charlotte, NC, by telephone on March 6, 2009 and fax on March 6, 2009 and March 24, 2009. Firm initiated recall is complete.
REASON
Pooled product, which included a unit that tested positive for anti-HBc, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
CA, IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0620-10
CODE
Unit: W115909080214 
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by fax on March 13, 2009 and March 18, 2009. The 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, Austria
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0624-10;  

2) Platelets Pheresis Leukocytes Reduced. Recall # B-0625-10
CODE
1) Units: 17FE40558P1; 17FE40558P2; 17FE40608P1; 17FE40608P2; 17FE40637P1; 17FE40637P2;

2) Units: 17FE40552P1; 17FE40552P2; 17FE40552P3; 17FE40584; 17FE40599; 17FE40624; 17FE40637P3; 17FE40648P1; 17FE40648P2; 17FE40663P1;  17FE40663P2; 17FE40663P3
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by telephone on January 19, 2009 and fax on February 3, 2009. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced which did not meet the requirements for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
18 units
DISTRIBUTION
MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0630-10
CODE
Unit: W117009192589
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco,  CA, by letter dated October 1, 2009.
Manufacturer: Blood Centers of the Pacific- Peninsula Center, Millbrae, CA. 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
CA
___________________________________

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0631-10
CODE
Units: W117009221081; W117009218558
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone on September 11, 2009 and follow up letter dated September 14, 2009.
Manufacturer: Blood Centers of the Pacific - Shasta Blood Center, Redding CA. 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
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0632-10
CODE
Unit: W115909251922
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by e-mail on October 6, 2009. 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
CA
___________________________________
PRODUCT
Red Blood Cells, Recall # B-0644-10
CODE
Unit: 4255602
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated September 24, 2009. 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
OH
__________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0645-10
CODE
Unit: 72L555356
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on September 2, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0465-10
CODE
Units: 017KM56923, 017KM65482
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by letter dated October 11, 2006. Firm initiated recall is complete.
REASON
Red Blood Cells, mislabeled as negative for the Fy (b) antigen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MD, MN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0538-10
CODE
Units: 3505464; 3505465
RECALLING FIRM/MANUFACTURER
Upstate New York Transplant Services, Inc., Buffalo, NY, by telephone on June 19, 2009 and fax on June 22, 2009. Firm initiated recall is complete.
REASON
Blood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0543-10
CODE
Unit: 6216791
RECALLING FIRM/MANUFACTURER
HemaCare Corp., Van Nuys, CA, by telephone on May 21, 2009. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0554-10
CODE
Unit: 01Q96169
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by facsimile and electronic notification on July 30, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0558-10
CODE
Unit: 50LM14971
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Western Lake Erie Region, Toledo, OH, by facsimile and electronic notification on September 2, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0575-10
CODE
Unit: W127808504135
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by letter dated June 4, 2009 and electronic notification on June 5, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the drug Finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0578-10
CODE
Unit: W127809101016
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by e-mail on June 2, 2009 and letter dated June 2, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the drug Finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall # B-0593-10
CODE
Unit: 72J574707
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers - Montgomery Region, Montgomery, AL, by fax on January 19, 2008. Firm initiated recall is complete.
REASON
Blood product, labeled with an extended expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0604-10
CODE
Unit: 6224234
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on September 18, 2009, September 25, 2009, October 5, 2009 and October 27, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the drug finasteride, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0609-10
CODE
Unit: 22FS54674
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by fax on August 8, 2009 and follow-up letters dated August 12, 2009 and September 22, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0610-10;
2) Red Blood Cells. Recall # B-0611-10
CODE
1) and 2) Unit: W126908224361
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by letter dated March 19, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tissue allograft within a year of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0614-10
CODE
Unit: 011FH16040
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Saint Louis, MO, by telephone on 04/16/09 and follow-up letter dated 04/21/09. Firm initiated recall is complete.
REASON
Blood product, with insufficient red cell preservative solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0621-10
CODE
Unit: W115909080214 
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by fax on March 13, 2009 and March 18, 2009. The 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, Austria
___________________________________
PRODUCT
Source Plasma. Recall # B-0646-10
CODE
Units: TA2076054; TA2080402; TA2076284; TA2080090
RECALLING FIRM/MANUFACTURER
DCI Biologicals Texarkana, LLC, Texarkana, AR, by fax on September 1, 2009 and e-mail on November 16, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who failed to disclose application of a tattoo, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
1) EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic catheter 100 cm, REF EC1001. The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta. Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure. Recall # Z-0084-2010;

2) EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65. The device is a 10.5Fr wirewound, three-lumen catheter with a balloon near its tip for occluding the ascending aorta. Indicated for use in patients undergoing cardiopulmonary bypass surgery. The catheter occludes the ascending aorta, vents the aortic root and allows delivery of cardioplegia solution to arrest the heart. The pressure lumen allows monitoring of the aortic root pressure. Recall # Z-0085-2010
CODE
1) Lot #/Expiration date: 581130/Aug-09; 582944/ Aug-09; 591423/Aug-09; 591424/Nov-09; 598990/Sept-09; 598992/Nov-09; 604411/Oct-09; 605844/Dec-09; 606674/Dec-09; 606676/Jan-10; 607104/Feb-10; 608371/Feb10; 608375/Feb-10; 608377/Feb-10; 608379/Mar-10; 618753/Mar-10; 623151/Mar-09; 624601/Mar-10; 624602/Apr-10; 628961/Apr-10; 628962/Apr-10; 630344/May-10; 634975/Jun-10; 634976/Jun-10; 643171/May-10;; 644544//Jun-10; 644545/Jul-10; 644546/Jul-09; 651860/Jul-10; 651861/Aug-10; 651862/Aug-10; and 651865/Sep-10;

2) Lot #/Expiration date: 610810/Feb-10; 638667/Jun-10; 643626/Jun-10; and 651863/Aug-10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Edwards Lifesciences Research Medical, Inc.  Midvale, UT, by letter, dated September 29, 2009.
Manufacturer: Accellent, Inc., Laconia, NH. Firm initiated recall is ongoing.
REASON
Spontaneous balloon rupture during use of the product.
VOLUME OF PRODUCT IN COMMERCE
2,737 units
DISTRIBUTION
Nationwide, Europe, Canada, Australia, and Thailand
___________________________________
PRODUCT
Pointe Scientific Liquid Glucose (HEXO) Reagent Set; Catalog #'s G7517-120,G7517-120, G7517-500, and G7517-1L; 8-G7517-120, 8-G7517-500, 3-G7517-L, 7-G7517-500 and 7-G7517-1000. (Clinical chemistry) Pointe Scientific Liquid Glucose (HEXO) is used for the quantitative determination of glucose in serum. Recall # Z-0104-2010
CODE
All lots beginning with the numbers 814301, 820502, 823901, 826801, 829401, 814301, 820502, and 831502.
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by press release on October 30, 2009 and by letters on October 19, 2009 and November 2, 2009. Firm initiated recall is ongoing.
REASON
There is a loss of linearity. The product fails to maintain linearity specification of 500 mg/dL.
VOLUME OF PRODUCT IN COMMERCE
400 kits plus 59 liters and 15 vials
DISTRIBUTION
Nationwide, Israel, Mexico, South Africa, and West Indies
___________________________________
PRODUCT
1) Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system. Recall # Z-0108-2010;

2) Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system. Recall # Z-0109-2010;

3) Synthes USA, TI Synex (TM) II Central Body 21mm - 29mm, Catalog number 04.808.003. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system. Recall # Z-0110-2010;

4) Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system. Recall # Z-0111-2010;

5) Synthes USA, TI Synex (TM) II Central Body 29mm - 44mm, Catalog number 04.808.005. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system. Recall # Z-0112-2010;

6)  Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number 04.808.006. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system. Recall # Z-0113-2010;

7) Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system.  Recall # Z-0114-2010;

8) Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system. Recall # Z-0115-2010;

9)  Synthes USA, TI Synex (TM) II Central Body 71mm - 97mm, Catalog number 04.808.009. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system. Recall  # Z-0116-2010;

10) Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog number 04.808.010. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system. Recall # Z-0117-2010;

11)  Synthes USA, TI Synex (TM) II Central Body 97mm - 123mm, Catalog number 04.808.011. Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma. To be used with Synthes supplemental internal fixation system. Recall # Z-0118-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Synthes USA (HQ), Inc., West Chester, PA, by letter dated September 23, 2009.
Manufacturer: Synthes GMBH, Oberdorf, Switzerland. Firm initiated recall is ongoing.
REASON
Loss of device height
VOLUME OF PRODUCT IN COMMERCE
2,275 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Stryker Instruments Navigation System II- CART; Stryker REF 7700-100-000. Intended to be used as a component of the Navigation System II. Recall # Z-0122-2010;

2) Stryker Instruments Navigation System II PC SPC-1 Assembly; REF 7700-101-201. The Stryker Navigation System II is a computer-aided surgery platform, supporting surgeons to perform surgical interventions. Recall # Z-0123-2010
CODE
1) Serial number range 100715 through 100735;
2) Serial number K7P00F6000
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI,  by letter dated October 23, 2009 and Press release on November 3, 2009.
Manufacturer: Stryker Leibinger GMBH & CO. KG – Navigation, Freiburg Im Breisgau, Germany. Firm initiated recall is ongoing.
REASON
Multiple software-related malfunctions may occur. The device may suddenly stop working, the screen may freeze, the screen may only be updated very slowly, the unit may not respond to user input, or the unit may only respond to user very slowly.
VOLUME OF PRODUCT IN COMMERCE
23 units
DISTRIBUTION
FL, KA, KY, MA, MI, NJ, PA, SC, TX, WA, Australia, China, Germany, Japan, Korea, Switzerland, and the United Kingdom
___________________________________
PRODUCT
Thomas Medical Products Safesheath CSG (Coronary Sinus Guide) Hemostatic Tear away Introducer System with Infusion Side Port, for the introduction of various types of pacing or defibrillator leads and catheters. The product is shipped 5 per carton. Catalog numbers: CSG/MSP-00-09, CSG/90-09, CSG-KR-90-09, CSG/WORLEY-1-09, CSG-WORLEY-Bcor-1-09, CSG/WORLEY/L/Bcor-1-09, CSG/WORLEY-2-09, CSG/WORLEY/Bcor-2-09, CSGMSP0009M, CSGWORLEY109M, CSGWORL19M, CSGWORBC19M, CSGWORLBC19M, CSGWORBC29M, CSG/Worley/BCor-1-07, CSG/Worley/BCor-2-07, CSG/WORLEY/BCOR-M-09, and CSG/Worley/R-1-09. Recall # Z-0661-2010
CODE
Lot numbers: S16716, S17215, S17216, S17248, S17349, S17447, S17448, S17449, S17478, S17596, S17640, S17675, S17789, S17790, S17795, S17864, S18000, S18004, S18290, S18291, S18336, S18337, S18352, S18529, S18535, S18593, S18670, S18725, S18736, S18744, S18745, S18861, S18862, S18952, S18962, S18974, S19051, S19060, S19135, S19153, S19161, S19173, S19174, S19175, S19196, S19262, S19264, S19290, S19291, S19292, S19409, S19428, S19450, S19564, S19742, S19743, S19756, S19757, S19906, S19959, S19961, S19966, S19991, S20007, S20019, S20101, S20154, S20170, S20297, S20298, S20331, S20491, S20494, S20505, S20704, S20713, S20848, S21002, S21071, S21115, S21128, S21236, S21557, S21650, S21651, S21652, S21695, S22085, S22160, S22216, S22228, S22229, S22244, S22282, S22302, S22367, S22368, S22371, S22396, S22397, S22491, S22675, S22676, S22746, S23020, S23021, S23022, S23052, S23092, S23103, S23111, S23112, S23225, S23384, S23387, S23388, S23402, S23403, S23492, S23507, S23508, S23543, S23618, S23795, S23926, S23927, S23956, S24026, S24027, S24101, S24174, S24175, S24341, S24353, S24354, S24355, S24619, S24620, S24772, S24800, S24852, S24906, S24907, S24931, S24951, S24956, S24958, S24978, S25050, S25051, S25052, S25082, S25097, S25121, S25140, S25141, S25142, S25239, S25241, S25323, S25324, S25353, S25404, S25433, S25469, S25486, S25487, S25494, S25497, S25590, S25590X1, S25594, S25720, S25721, S25806, S25807, S25896, S26039, S26039X1, S26040, S26040X1, S26088, S26095, S26183, S26183X1, S26345, S26554X1, S26570X1, S26576, S26635X1, S26636X1, S26637X1, S26752, S26754, S26833, S26834, S26912, S27030, S23031, S27032, S27056, S27057, S27186, S27242, S27321, S27504, S27610, S27611, S27617, S27646, S27670, S27876, S27895, S27913, S27914, S27924, S27952, S28054, S28214, S28215, S28232, S28272, S28273, S28283, S28326, S28360, S28391, S28460, S28485, S28564, S28576, S28731, S28808, S28894, S28939, S29270, S29492, S29669, S29736, S29766, S29767, S29813, S29823, S29879, S30059, S20357, S30060, S30258, S99009X1, S99010X1, S99011X1, and S99052X1
RECALLING FIRM/MANUFACTURER
Thomas Medical Products, Inc., Malvern, PA, by e-mail on December 23, 2009 and by press release on January 29, 2010. Firm initiated recall is ongoing.
REASON
Radiopaque sheath tip may fracture.
VOLUME OF PRODUCT IN COMMERCE
60,982 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) BD Q-Syte, Luer Access Split-Septum, 0.10 ml, Sterile EO, REF 385100. Recall # Z-0750-2010;

2) BD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, Sterile EO, Assembled in Mexico, REF 385101. Recall # Z-0751-2010;

3) BD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, Sterile EO, REF 385102. Recall # Z-0752-2010;

4) BD Q-Syte Vial Access Adapter, 0.16 ml, Sterile EO, REF 385108. Recall # Z-0753-2010;

5) MPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, Sterile EO, REF 385150. Recall # Z-0754-2010;

6) MPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, Sterile EO, REF 385151. Recall # Z-0755-2010;

7) MPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, Sterile EO, REF 385164. Recall # Z-0756-2010
CODE
1) Lot Numbers 8268863, 8269020, 8275798, 8308321, 8308323, 8309553, 8331937, 8331940, 8354558, 9007921, 9009643, 9009646, 9028838, 9035029, 99035032;

2) Lot numbers: 8305510, 8331944;

3) Lot numbers: 8305511, 8308330, 8354561, 9012072;

4) Lot numbers: 9007918, 9035042, 9035044;

5) Lot numbers: A1967, A1979, A2056;

6) Lot numbers: A1950, A2399;

7) Lot number: A1951
RECALLING FIRM/MANUFACTURER
Becton Dickinson Medical Systems, Sandy, UT, by letter on October 28, 2009. Firm initiated recall is ongoing.
REASON
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
VOLUME OF PRODUCT IN COMMERCE
1,275,200 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
Edwards Lifesciences Fogaty Occlusion Catheter Ref # 62080822F. The product is intended for use in Temporary Vessel Occlusion. Recall # Z-0002-2010
CODE
Lots 58315682 58315684 58319564 58323527 58329182 58329183 58330839 58331170 58337676 58339525 58344788 58404076 58404077 58412886 58423180 58425421 58430853 58432662 58437558 58439309 58442706 58448659 58450729 58457786 58461586 517BC705 58475993 58481176 58483920 58488640 58492016 58495186 58495187 58502966 58507300 58515391 58517396 58521823 58524823 58527272 58530759 58537870 58537877 58551761 58568073 58578112 58578113 58580168 58581724 58588472 58592000 517BC706 58597273 58599730 58604851 58605887 58613048 58616823 58618748 58620574 58623035 58629084 58632507 58651514 58652960 58659509 58664309 58669996 58669998 58672855 58679236 58679860 58684904 58685420 58689629 58692796 58696610 517BC706A 58698652 58714764 515A1101 515A1102 515E3348 515H4785 515J5246 515K5874 515K5875 515L6221 516C8181 516D8613 516D8614 516E9154 516E9155 516F9635 516F9636 516G0232 516H0993 516H0994 516J1347 516J1348 516K1910 516K1911 516L2483 516L2484 516M2875 516M2876 517A3353 517A3354 517B3889 517B3890 517CC149 517CC150 517CC151 517CC889 517CC890 517CC891 517D4948 517E5557 517F6110 517F6111 517F6112 517G6621 517G6622 517G6623 517G6623A 517H7139 517H7140 6U11L2232
RECALLING FIRM/MANUFACTURER
Recalling Firm: Edwards Lifesciences, LLC, Irvine, CA, by letter dated June 29, 2009.
Manufacturer: Edwards Lifesciences Technology SARL, Anasco, PR. Firm initiated recall is ongoing.
REASON
Several complaints were the two parts of the tubular package became loose under the shrink wrap that holds the DFU on the packaging tube.
VOLUME OF PRODUCT IN COMMERCE
9,548 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
HeartStart MRx (M3535A/M3536A) Defibrillator/Monitor. The HeartStart MRx/MRxE is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. Recall # Z-0003-2010
CODE
Serial numbers within the following range: US00533518 through US00535118
RECALLING FIRM/MANUFACTURER
Philps Healthcare, Inc., Andover, MA, by letter on August 21, 2009. Firm initiated recall is ongoing.
REASON
Incorrect default configuration settings, insufficient battery power as the user may not be alerted that no battery is installed or that a low battery condition exists prior to disconnecting from AC or DC power.
VOLUME OF PRODUCT IN COMMERCE
1,523 units
DISTRIBUTION
Nationwide and Internationally
___________________________________

PRODUCT
Boston Scientific Liberte Monorail and Over-the-Wire Coronary Stent Systems to be relabeled as VeriFLEX". The Liberte Coronary Stent System consists of a balloon expandable stainless steel stent, pre-mounted on either a Liberte Monorail (MR) or Liberte Over-the-Wire (OTW) delivery system. The Liberte system comes in stent diameters of 2.25, 2.50, 2.75, 3.00, 3.50, 4.00, 4.50 and 5.00 mm and stent lengths of 8, 12, 16, 20, 24, 28 and 32 mm. The stent is mounted on the balloon between two radiopaque markers which, in conjunction with fluoroscopy, aid in the placement of the systems balloon segment and stent. The balloon enables high pressure inflations and can be used for post-stent dilatation. Recall # Z-0068-2010
CODE
Material Batch H7493893412270 9049696 H7493893412270 9057624 H7493893412270 9099450 H7493893412270 9139074 H7493893412270 9160483 H7493893412270 9177875 H7493893412270 9212698 H7493893412270 9221778 H7493893412270 9235733 H7493893412270 9257349 H7493893412270 9274750 H7493893412270 9277036 H7493893412270 9282376 H7493893412270 9288532 H7493893412270 9290586 H7493893412270 9320112 H7493893412270 9332653 H7493893412270 9348388 H7493893412270 9364745 H7493893412270 9378322 H7493893412270 9389266 H7493893412270 9390059 H7493893412270 9399941 H7493893412270 9427159 H7493893412270 9432301 H7493893412270 9445410 H7493893412270 9472517 H7493893412270 9480396 H7493893412270 9501174 H7493893412270 9504831 H7493893412270 9517449 H7493893412270 9576210 H7493893412270 9604165 H7493893412270 9610472 H7493893412270 9618910 H7493893412270 9652695 H7493893412270 9686092 H7493893412270 9753243 H7493893412270 9784939 H7493893412270 9811927 H7493893412270 9813792 H7493893412270 11025525 H7493893412270 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H7493893532270 9100396 H7493893532270 9176163 H7493893532270 9257984 H7493893532270 9300531 H7493893532270 9304119 H7493893532270 9488683 H7493893532270 9498866 H7493893532270 9576494 H7493893532270 9752352 H7493893532270 11013634 H7493893532270 11091854 H7493893532270 11125131 H7493893532270 11181773 H7493893532270 11269995 H7493893532270 11420142 H7493893532270 11510312 H7493893532270 11624581 H7493893532270 11660561 H7493893532270 11875349 H7493893532270 12033686 H7493893532270 12279289 H7493893532270 12472710 H7493893532270 12618122 H7493893532270 12705977 H7493893532300 9028900 H7493893532300 9083674 H7493893532300 9085522 H7493893532300 9175555 H7493893532300 9213555 H7493893532300 9232124 H7493893532300 9258448 H7493893532300 9275733 H7493893532300 9369027 H7493893532300 9411429 H7493893532300 9468061 H7493893532300 9556440 H7493893532300 9599671 H7493893532300 9702848 H7493893532300 9748164 H7493893532300 9816501 H7493893532300 11019402 H7493893532300 11059943 H7493893532300 11076418 H7493893532300 11123300 H7493893532300 11184994 H7493893532300 11231487 H7493893532300 11332394 H7493893532300 11359346 H7493893532300 11420187 H7493893532300 11438072 H7493893532300 11485746 H7493893532300 11514023 H7493893532300 11666888 H7493893532300 11692142 H7493893532300 11758875 H7493893532300 11832792 H7493893532300 11899640 H7493893532300 11933406 H7493893532300 12026826 H7493893532300 12103878 H7493893532300 12139562 H7493893532300 12158388 H7493893532300 12369716 H7493893532300 12454309 H7493893532300 12530284 H7493893532300 12601108 H7493893532300 12669959 H7493893532300 12761662 H7493893532350 9151256 H7493893532350 9190191 H7493893532350 9230013 H7493893532350 9251312 H7493893532350 9257975 H7493893532350 9258371 H7493893532350 9296015 H7493893532350 9332638 H7493893532350 9343054 H7493893532350 9373175 H7493893532350 9526254 H7493893532350 9574699 H7493893532350 9647069 H7493893532350 9731138 H7493893532350 9824453 H7493893532350 11025356 H7493893532350 11060137 H7493893532350 11099521 H7493893532350 11126850 H7493893532350 11171852 H7493893532350 11245374 H7493893532350 11310362 H7493893532350 11372519 H7493893532350 11438561 H7493893532350 11475102 H7493893532350 11544596 H7493893532350 11620111 H7493893532350 11703113 H7493893532350 11776708 H7493893532350 11872449 H7493893532350 11928574 H7493893532350 12046104 H7493893532350 12140026 H7493893532350 12194063 H7493893532350 12380466 H7493893532350 12510029 H7493893532350 12561311 H7493893532350 12696766 H7493893532350 12860926 H7493893532400 9048620 H7493893532400 9123393 H7493893532400 9172786 H7493893532400 9214101 H7493893532400 9252020 H7493893532400 9265280 H7493893532400 9285368 H7493893532400 9334701 H7493893532400 9364737 H7493893532400 9488682 H7493893532400 9507190 H7493893532400 9528926 H7493893532400 9567489 H7493893532400 9611261 H7493893532400 9752042 H7493893532400 11010715 H7493893532400 11033808 H7493893532400 11073795 H7493893532400 11101659 H7493893532400 11133655 H7493893532400 11182371 H7493893532400 11213217 H7493893532400 11253055 H7493893532400 11349453 H7493893532400 11420186 H7493893532400 11480411 H7493893532400 11546599 H7493893532400 11655618 H7493893532400 11726204 H7493893532400 11784578 H7493893532400 11895101 H7493893532400 11953752 H7493893532400 12027069 H7493893532400 12112542 H7493893532400 12140027 H7493893532400 12253789 H7493893532400 12396892 H7493893532400 12537233 H7493893532400 12677179 H7493893532400 12781168 H7493893532450 9049357 H7493893532450 9144797 H7493893532450 9243360 H7493893532450 9252067 H7493893532450 9277168 H7493893532450 9305429 H7493893532450 9325457 H7493893532450 9538724 H7493893532450 9561858 H7493893532450 9618396 H7493893532450 11002678 H7493893532450 11034411 H7493893532450 11083597 H7493893532450 11127217 H7493893532450 11178828 H7493893532450 11253439 H7493893532450 11321813 H7493893532450 11380305 H7493893532450 11448716 H7493893532450 11526552 H7493893532450 11761590 H7493893532450 11882902 H7493893532450 12061524 H7493893532450 12140515 H7493893532450 12463742 H7493893532450 12643560 H7493893532500 9073116 H7493893532500 9243354 H7493893532500 9277169 H7493893532500 9334416 H7493893532500 9380145 H7493893532500 9517600 H7493893532500 9556795 H7493893532500 9559816 H7493893532500 9643139 H7493893532500 11013628 H7493893532500 11060138 H7493893532500 11102015 H7493893532500 11219420 H7493893532500 11326035 H7493893532500 11369375 H7493893532500 11441554 H7493893532500 11546727 H7493893532500 11762231 H7493893532500 11914954 H7493893532500 12044353 H7493893532500 12178533 H7493893532500 12491896 H7493893532500 12670905 H749389358270 9123186 H749389358270 9127226 H749389358270 9277294 H749389358270 9292676 H749389358270 9403397 H749389358270 9633444 H749389358270 9752389 H749389358270 11015346 H749389358270 11072930 H749389358270 11159521 H749389358270 11285373 H749389358270 11428920 H749389358270 11474835 H749389358270 11645384 H749389358270 11810201 H749389358270 12059808 H749389358270 12139176 H749389358270 12658716 H749389358300 9195044 H749389358300 9241961 H749389358300 9256437 H749389358300 9276521 H749389358300 9289508 H749389358300 9334924 H749389358300 9367266 H749389358300 9411313 H749389358300 9417373 H749389358300 9529342 H749389358300 9566369 H749389358300 9633281 H749389358300 9696779 H749389358300 9726514 H749389358300 9753072 H749389358300 11038376 H749389358300 11065419 H749389358300 11129298 H749389358300 11250485 H749389358300 11377228 H749389358300 11444710 H749389358300 11544595 H749389358300 11703101 H749389358300 11772762 H749389358300 11869771 H749389358300 11944475 H749389358300 12121945 H749389358300 12229148 H749389358300 12380097 H749389358300 12498178 H749389358300 12638200 H749389358300 12827009 H749389358350 9304730 H749389358350 9323392 H749389358350 9340511 H749389358350 9575019 H749389358350 9615937 H749389358350 9696431 H749389358350 9726887 H749389358350 11038127 H749389358350 11073796 H749389358350 11101372 H749389358350 11133815 H749389358350 11188762 H749389358350 11269996 H749389358350 11369276 H749389358350 11481008 H749389358350 11676444 H749389358350 11784446 H749389358350 11910868 H749389358350 11979638 H749389358350 12186040 H749389358350 12361773 H749389358350 12537062 H749389358350 12670762 H749389358350 12811513 H749389358400 9037299 H749389358400 9136807 H749389358400 9191915 H749389358400 9227935 H749389358400 9277270 H749389358400 9301223 H749389358400 9362924 H749389358400 9373111 H749389358400 9554899 H749389358400 9558191 H749389358400 11018796 H749389358400 11117628 H749389358400 11166726 H749389358400 11213218 H749389358400 11271563 H749389358400 11293313 H749389358400 11448713 H749389358400 11518134 H749389358400 11706694 H749389358400 11822060 H749389358400 11907627 H749389358400 12055882 H749389358400 12124876 H749389358400 12140334 H749389358400 12458343 H749389358400 12703852
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove, MN, by letter dated September 18, 2009. 
Manufacturer: Boston Scientific Ireland, Ltd., Galway, Ireland. Firm initiated recall is ongoing.
REASON
Boston Scientific initiated a field correction for the Liberte Bare-Metal coronary stent products. They have received reports from cardiac cath labs that TAXUS Liberte Paclitaxel-Eluting (TAXUS Libert Drug-Eluting) coronary stents have been inadvertently selected when the interventional cardiologist intended to implant a Liberte Bare-Metal stent, and Libert Bare-Metal stents have been inadvertently selected when the interventional cardiologist intended to implant a TAXUS Libert Drug-Eluting stent. Selecting the wrong device may present a risk of serious injury, including death. Because of the importance of accurate device selection to patient safety, Boston Scientific are renaming the Liberte Bare-Metal stent. The new name is VeriFlex" Bare-Metal. Representatives from Boston Scientific will be visiting all impacted health care facilities to re-label the outer boxes of all existing Libert Bare-Metal stents held in inventory, to reflect the new name.
VOLUME OF PRODUCT IN COMMERCE
391,769 units
DISTRIBUTION
Nationwide
___________________________________

PRODUCT
1) SYNTHES 2.0MM SCREW MANIPULATION FORCEPS, Catalog #SD397.300. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthographic surgery. Recall # Z-0075-2010;

2) SYNTHES BENDING PLIERS - STRAIGHT FOR CRANIOFACIAL/ORTHOGNATHIC PL, Catalog # SD347.967. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthographic surgery. Recall # Z-0076-2010;

3) SYNTHES PLATE HOLDING FORCEPS, Catalog # SD347.900. Recall # Z-0077-2010;

4) SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/39MM, Catalog # SD448.003. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthographic surgery. Recall # Z-0078-2010;

5) SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/42MM, Catalog # SD448.004. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthographic surgery. Recall # Z-0079-2010;

6) SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/45MM, Catalog # SD448.005. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthographic surgery. Recall # Z-0080-2010;

7) SYNTHES TI MATRIXMANDIBLE SAGITTAL SPLIT PL 1.5MM THK/4H/48MM, Catalog # SD448.006. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthographic surgery. Recall # Z-0081-2010;

8) SYNTHES 2.0MM DRILL BIT STRYKER J-LATCH/60MM, Catalog # 317.853. Synthes Titanium Matrix Mandible Sagittal Plates and Instruments are intended for general use in orthographic surgery. Recall # Z-0082-2010
CODE
1) Lot # 6021104;
2) Lot # T937332;
3) Lot # T937853;
4) Lot # 6051568;
5) Lot # 6051575;
6) Lot # 6051576;
7) Lot # 6051577;
8) Lot # N64648, 6082633, and 6107223
RECALLING FIRM/MANUFACTURER
Synthes USA, West Chester, PA, by letter on September 4, 2009. Firm initiated recall is ongoing.
REASON
The customized plate instruments do not have a cleared premarket notification.
VOLUME OF PRODUCT IN COMMERCE
136 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Siemens ARTISTE syngo RT Therapist, model/part #8162815; syngo RT Therapist Assist, model/part #8162807; Therapist Express Basic, model/part #8151289 and Therapist Express Assist Systems model/part #8151289. Recall # Z-0121-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter, dated September 10. 2009. Firm initiated recall is ongoing.
REASON
A failed data transfer is possible that may result in data not being recorded in the interfaced system.
VOLUME OF PRODUCT IN COMMERCE
97 units
DISTRIBUTION
Nationwide, Spain, Germany, Poland, Australia, Malaysia, New Zealand, the UK, India, Ireland, Egypt, Italy, Belgium, Republic of Korea, and Canada
___________________________________
PRODUCT
ARCHITECT i2000 System and ARCHITECT i2000 SR wash buffer and wash zone mechanism grounding kit. ARCHITECT System is designed to perform automated chemistry tests utilizing photometry and potentiometric technology; and immunoassay tests utilizing chemiluminescent microparticle assay detection technology. Wash Zone Mechanism Grounding Kit Part Number 7-201369-01; Concentrated Wash Buffer 1 L and l0 L. Recall # Z-0132-2010
CODE
List Number 8C89-01; List Number 3M74-01 and 3M74-02; List Number 6C54-58; List number 6C54-88
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Inc., Irving, TX, by letter on July 17, 2009. Firm initiated recall is ongoing.
REASON
Under certain conditions, the product's wash buffer containing sodium azide can come in contact with the wash zone mechanism ground cables on either of the two wash zones. The copper in the ground strap may corrode and form an unstable chemical substance (metal azide) that may be sensitive to direct pressure and impact.
VOLUME OF PRODUCT IN COMMERCE
4,546 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Stryker Imaging, Guardian Services Software, Part Number 0240-009-430 with Part Numbers 0240-020-013 and 0240-020-022 (Office PACS Power). Intended use is to act as a medical data backup and disaster recovery plan. Recall # Z-0134-2010
CODE
All accounts that have OfficePACS Power and are enrolled in Guardian Services backup.
RECALLING FIRM/MANUFACTURER
Stryker Imaging, Flower Mound, TX, by letter dated August 18, 2009. Firm initiated recall is ongoing.
REASON
Firm has determined Guardian Services does not contain 100% data backup for 12 OfficePACS Power customers on a daily basis.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Olsen Medical, Midas Touch Needle Electrode, with Modified Tip. Model Numbers: a) 30-1011, b) 30-1012, c) 30-1013, d) 30-1014 and e) 30-6011. Recall # Z-0140-2010
CODE
a) Lot Numbers: 011898, 012733, 012988 and 013373; b) Lot Number: 012244; c) All lots; d) Lot Numbers: 011668, 011970 and 012997; and e) Lot Numbers: 012565, 012800 and 012983
RECALLING FIRM/MANUFACTURER
Kentucky Packaging Service LP, Louisville, KY, by letter beginning September 24, 2009. Firm initiated recall is ongoing.
REASON
There were inconsistencies noticed on the insulation overlap. The electrode has a large diameter shaft that transitions to a smaller diameter shaft. The 1st layer of insulation which covers the small diameter shaft overlaps with the 2nd layer of insulation that covers the larger diameter shaft. On some electrodes it appears that the overlap is too short to cover the transition which makes this area vulnerable to insulation damage.
VOLUME OF PRODUCT IN COMMERCE
3,617 Pieces
DISTRIBUTION
AZ, FL, IA, MD, MO, NM, OR, NV, TN, TX and VA
___________________________________
PRODUCT
ABL 80 CO-OX System, software versions 1.30 and 1.31 Additional Product Codes: CEM, CGA, CGZ, GHS, GKR, GLY, JFP, JGS, JIX, JJY, JPI The ABL 80 CO-OX System is a portable, automated analyzer that measures pH, blood gases, electrolytes, glucose and oximetry in whole blood. The ABL 80 CO-OX System is intended for use by trained technologists, nurses, physicians and therapists. It is intended for use in a laboratory environment, near patient or point-of-care setting. Recall # Z-0150-2010
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Sendx Medical Inc., Carlsbad, CA, by letter September 20, 2009. Firm initiated recall is ongoing.
REASON
A potential error contained in V1.30 and V1.31 software for the ABL 80 CO-OX platform. The error can occur if the analyzer is set to automatically upload patient records to Radiance or an HIS/LIS system. This can result in the reporting of incorrect results for one or more CO-OX derived parameters. Incorrect results can be displayed on the screen and the sample printout. All measured values will report correctly, only the CO-OX derived parameters listed below are at risk of being reported incorrectly: HCT p50 p50(T) p50(st) pO2 (a)/FO2(I) pO2(a,T)/FO2(I) pO2 pO2(x,T) BO2 DO2 Qt VO2 FShunt FShunt (T) Q V(B) ctO2
VOLUME OF PRODUCT IN COMMERCE
317 units
DISTRIBUTION
OH, Germany, France, Spain, United Kingdom, Poland, Austria, Italy, Tokyo, Australia, and Denmark
___________________________________
PRODUCT
Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter insertion kits. Recall # Z-0161-2010
CODE
Lot Number: MAVV890, exp 2014/07
RECALLING FIRM/MANUFACTURER
Medical Components, Inc dba MedComp., Harleysville, PA, letter dated September 2, 2009. Firm initiated recall is ongoing.
REASON
Mislabeled as right are actually left.
VOLUME OF PRODUCT IN COMMERCE
100 trays
DISTRIBUTION
AR, FL, KS, LA, MO, PA, TN, TX and Austria
___________________________________
PRODUCT
Byrd Screw, 2.0X6MM SD, Model Number: 01-0264 Product labeling reads in part as follows: REF: 01-0264, QTY,UOM 00001, BYRD SCREW, 2 OX6MM SELF-DRILLING, 12CM, (4-3/4) (L), STAINLESS STEEL, LOT 999999, (01) 00841036007157(10)999999(13)090201(30)13, 2009-02, ***NON-STERILE PRODUCT***DD 14 03 1. Instrument used to pull up the broken bone, so it is flush and can be plated fixated. The Byrd screw is then removed. Recall # Z-0169-2010
CODE
Lot # 091807107
RECALLING FIRM/MANUFACTURER
Biomet Microfixation, Inc., Jacksonville, FL, by letters on February 19, 2009. Firm initiated recall is ongoing.
REASON
Byrd Screw, Self Drilling, may break during usage. BIOMET has determined that the parts were not correctly processed by the vendor, i.e. that the parts were not hardened in the final processing and that lead to weaker than acceptable material.
VOLUME OF PRODUCT IN COMMERCE
22 units
DISTRIBUTION
AZ, CA, GA, IL, IN, NM, NY, TX, VA, PR and Canada
___________________________________
PRODUCT
1) HANAULUX 2004 IXL cupola, P/N: 56076868. Intended to provide visible illumination for the surgical field or for the examination of the patient. Recall # Z-0182-2010;

2) HANAULUX 2005 I cupola, P/N: 56076865. Intended to provide visible illumination for the surgical field or for the examination of the patient. Recall # Z-0183-2010;

3) HANAULUX 2005 IXL cupola, P/N: 56076869. Intended to provide visible illumination for the surgical field or for the examination of the patient. Recall # Z-0184-2010;

4) HANAULUX 2004-2005 TV Spring Arm, P/N: 569002998. Intended to provide visible illumination for the surgical field or for the examination of the patient. Recall # Z-0185-2010;

5) XTEN DF cupola, P/N: 567800999. Intended to provide visible illumination for the surgical field or for the examination of the patient. Recall # Z-0186-2010;

6) XTEN LED Video DF cupola, P/N: 567801999. Intended to provide visible illumination for the surgical field or for the examination of the patient. Recall # Z-0187-2010;

7) XTEN LED DF cupola, P/N: 567815999. Intended to provide visible illumination for the surgical field or for the examination of the patient. Recall # Z-0188-2010
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letters dated October 7, 2009.
Manufacturer: Maquet S.A., Orleans Cedex 2, France. Firm initiated recall is ongoing.
REASON
Several reports have been received regarding one model of spring arm (Acrobat 200 series) in combination with surgical light from various Manufacturers. All incidents pertain to a crack on the front joint of the Acrobat arm.
VOLUME OF PRODUCT IN COMMERCE
940 systems
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Revolution Blood Pump, "revOlution Centrifugal pump Catalog # 050300000***Rx ONLY. Intended for use in cardiopulmonary bypass procedures. Recall # Z-0192-2010;

2) Revolution Blood Pump with PC Coating, "revOlution Centrifugal pump Catalog # 050300700***Rx ONLY. Intended for use in cardiopulmonary bypass procedures. Recall # Z-0193-2010
CODE
1) Lot numbers: 0905220163, 0905220166, 0906240182, and 0906240185;
2) Lot number: 0905220164
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sorin Group USA, Inc., Arvada, CO, by letter dated September 25, 2009.  
Manufacturer: Sorin Group Italia SRL, Milano, Italy. Firm initiated recall is ongoing.
REASON
A weakness in the plastic packaging tray could cause the tray to crack; compromising product sterility.
VOLUME OF PRODUCT IN COMMERCE
1,064 units
DISTRIBUTION
Nationwide, Canada, Japan and Europe
___________________________________
PRODUCT
STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm. Intended for local illumination of the operating and examination area of the patient in treatment rooms. Part Number: YG18568. Recall # Z-0414-2010
CODE
Serial Numbers: Year 2002 - 0111 072 XXXXX to 0111 122 XXXXX; Year 2003-0111 013 XXXXX to 0111 123 XXXXX; Year 2004-0111 014 XXXXX to 0111 124 XXXXX; Year 2005-0111 015 XXXXX to 0111 125 XXXXX; and Year 2006-0111 016 XXXXX to 0111 066 XXXXX - (XXXXX means every 5-digit serial number).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor OH, by letters dated September 11, 2009.  
Manufacturer: Drager Medical AG & Co. KGAA, Luebeck, Germany. Firm initiated recall is ongoing.
REASON
(4) reported international cases received where a welded seam at the joint of the spring-loaded arm of the Drger SOLA 500/700 surgical light broke as a result of a crack that had slowly developed over time. The STERIS Harmony LL 500/700 surgical light is a Private Label version of the Drger SOLA 500/700 surgical light.
VOLUME OF PRODUCT IN COMMERCE
388 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Discovery CT 750 HD model numbers: 5232083, 5232083-2, 5232083-3, and 5232083-4. For head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall # Z-0668-2010;

2) LightSpeed VCT 7.2 Vision model numbers: 5212920-300 console used with 5129909, 5129909-5, and 5129909-11 gantry. For head, whole body, cardiac and vascular X-ray Computed Tomography applications. Recall # Z-0669-2010
CODE
Serial numbers for the mentioned model numbers manufactured from May 2009 to November 2009.
RECALLING FIRM/MANUFACTURER
GE Healthcare, Wauwatosa, WI, by letter on October 1, 2009. Firm initiated recall is ongoing.
REASON
Failure to properly document the CTDI in the Technical Reference or User Manual.
VOLUME OF PRODUCT IN COMMERCE
111 units
DISTRIBUTION
Nationwide
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PRODUCT
Biomet bone mulch screw, 10.5mm x 20 mm, TI-6AL-4V alloy, sterile, REF 907320. Recall # Z-0779-2010
CODE
Lot numbers: 918790, 918800 and 110700
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated December 22, 2009. Firm initiated recall is ongoing.
REASON
The screw may not have the hex dimension inside of the head of the screw, which will prevent the device from being implantable. This may cause a delay in the procedure while another screw is obtained.
VOLUME OF PRODUCT IN COMMERCE
169 units (92 U.S.; 77 internationally)
DISTRIBUTION
AR, CA, DE, FL, KY, MI, MO, NY, PA, SD, TX, WA, WI, Chile, Germany, Italy, Japan and Norway
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PRODUCT
1) FilteredFlo Cardiac Blanket. The device is used to distribute heated air around a patient (for patient warming). Product # 82542; Catalog # 542.  Recall # Z-0781-2010;

2) TempPad Cold Therapy Pad. The device is used for localized temperature therapy including hand, elbow, arm, foot, ankle, leg, or knee. a) Part #: 50625, Catalog number: 510-US; b) Part #: 50633, Catalog #: 510-USS; c) Part #: 50627, Catalog #: 814-US; d) Part # 50634, Catalog # 814-USS; e) Part #: 50628, Catalog #: 1112-US; f) Part #:50635, Catalog #: 1112-USS; g) Part #: 50629, Catalog #: 1215-US; h) Part #: 50137, and Catalog #: CT-99. Recall # Z-0782-2010
CODE
1) Lot #: 07279, 07280, 07424 & 08813;

2) a) Lot #: 08296, 08529, 08530, 08531, 08674, 08759, 08826, 08952, 09052, 09166, 09422, 09423; b) Lot #: 08537, 08675, 08953; c) Lot #: 08610; d) Lot #: 08611, 08919, 09466; e) Lot #'s: 08382, 08411, 08475, 08476, 08477, 08557, 08583, 08657, 08666, 08667, 09486, 08668, 08707, 08771, 08810, 08874, 08903, 08971, 09037, 09088, 09089, 09149, 09225, 09251, 09285, 09313, 09314, 09327, 09360, 09361, 08320; f) Lot #'s: 08410, 08514, 08606, 08673, 08708, 08772, 08802, 08868, 08954, 09017, 09066, 09067, 09195, 09253, 09254, 09295, 09377, 09378, 09485, 08331; g)  Lot #'s: 08395, 08584, 08669, 08732, 08917, 08989, 09107, 09218;  h) Lot #'s: 08332, 08353, 08438, 08538, 08607, 08608, 08706, 08725, 08773, 08837, 08851, 08879, 08933, 08970, 09010, 09086, 09087, 09143, 09144, 09157, 09294, 09329, 09362, 09379 and 08423
RECALLING FIRM/MANUFACTURER
Cincinnati Sub-Zero Products, Inc., Cincinnati, OH, by letters on November 14, 2009 and December 10, 2009. Firm initiated recall is ongoing.
REASON
Product is labeled as "Sterile" During the production process it was observed that the sterilizer equipment was creating incomplete seals in the packaging materials. When the seal is compromised, the sterility of the product inside the package cannot be assured.
VOLUME OF PRODUCT IN COMMERCE
90,492 units
DISTRIBUTION
Nationwide and Internationally

END OF ENFORCEMENT REPORT FOR FEBRUARY 17, 2010

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