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U.S. Department of Health and Human Services

Safety

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Enforcement Report for March 24, 2010

March 24, 2010                                                                                        10-11

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT
Ooomamahi Vegan Burger. Recall # F-1513-2010
CODE
2/12/10
RECALLING FIRM/MANUFACTURER
Dolce LLC, Louisville, KY, by telephone on February 11, 2010. Firm initiated recall is ongoing.
REASON
All allergen sub-ingredients, soy, were not listed on the finished product labels.
VOLUME OF PRODUCT IN COMMERCE
5 vegan burgers
DISTRIBUTION
KY
___________________________________
PRODUCT
Quality Delancey brand "Chocolate Leaves" cookies, comes in a 10-oz., clear plastic container with a Gertels Uptown Inc. label on the top of the container. UPC 7 56363 15724 9. Recall # F-1514-2010
CODE
Expiration date 03/20/10
RECALLING FIRM/MANUFACTURER
Gertel’s Uptown, Inc., Brooklyn, NY, by press release on March 5, 2010 and by letter. Firm initiated recall is ongoing.
REASON
Product may contain undeclared cashews and walnuts.
VOLUME OF PRODUCT IN COMMERCE
3 containers
DISTRIBUTION
NY
___________________________________
PRODUCT
a) Nature's Reward and b) Sysco brands Iceless Green Onions, in cartons of various sizes 3,360 cartons of 4 count/2 pound, 2 count/24 bunch and 4 count/ 12 bunch bags of iceless green onions, UPC code 33383 60500, PLU 4068. Recall # F-1515-2010
CODE
a)  9CPO937E007W (original lot code). The lots may also be identified as "9CPO937" followed by all date codes between August 4 and August 22: "080409, 080509, 080609, 080709, 080809, 080909, 081009, 081109, 081209, 081309, 081409, 081509, 081609, 081709, 081809, 081909, 082009, 082109, 082209";
b) Sysco: 9CPO937E007W (original lot code). The lots may also be identified as "96CPGO07" followed by all date codes between August 4 and August 22: "080409, 080509, 080609, 080709, 080809, 080909, 081009, 081109, 081209, 081309, 081409, 081509, 081609, 081709, 081809, 081909, 082009, 082109, 082209"
RECALLING FIRM/MANUFACTURER
Steinbeck Country Produce, Salinas, CA, by letter and press release on August 28, 2009. Firm initiated recall is ongoing.
REASON
Products may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Not known

DISTRIBUTION
CA, MI, NY, TX, OH, AZ, IN, KS
___________________________________
PRODUCT
a) Chiveette and b) Dynasty brands Iceless Green Onions, 4 bags, 12 bunched green onions per bag, 4 bags per box. Recall # F-1516-2010
CODE
a) Codes 01937221, 01937223; b) Code 01937225
RECALLING FIRM/MANUFACTURER
Dynasty Farms, Inc., Salinas, CA, by telephone and fax on September 1, 2009. Firm initiated recall is ongoing.
REASON
Products may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Not known
DISTRIBUTION
WA, OR, IL, TN, MD, KY, AZ

___________________________________
PRODUCT
1) Queso Fresco cheese in vacuum packaged wheels. Label reads in part: Ingredients: Pasteurized Milk, Salt, Rennet, and Starter Culture.  Recall # F-1517-2010;

2) Panela cheese in vacuum package with green label that reads in part: Ingredients: Pasteurized Milk, Salt, Rennet, and Starter Culture. Product comes in one and three pound sizes. Recall # F-1518-2010;

3) Requeson cheese packaged in clear plastic tubs with green label that reads in part: Ingredients: Pasteurized Milk, Salt, Rennet, and Starter Culture. Product comes in one pound and 8 ounce sizes. Recall # F-1519-2010
CODE
"Mar 30 2010" "Apr 30 2010"
RECALLING FIRM/MANUFACTURER
Queseria Bendita, Yakima, WA, by press release on February 19, 2010 and by visit. Firm initiated recall is ongoing.
REASON
Products may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Approximately 7,320 lbs
DISTRIBUTION
OR, WA
___________________________________
PRODUCT
1) Broughton Citrus Punch in plastic 1 pint bottles with screw on cap and stick on label; UPC 0 70880 02130 3. Recall # F-1520-2010;

2) Broughton Fruit Punch in plastic 1/2 pint and 1 pint bottles; UPC 0 7880 02234 8. Recall # F-1521-2010;

3) Broughton Orange Juice in 1/2 and 1 pint plastic bottles; UPC 0 7880 02070 2. Recall # F-1522-2010;

4) Broughton Brewed iced Tea w/sugar added in 1 pint plastic bottles; UPC 0 7880 02063 4. Recall # F-1523-2010
CODE
1) Date code: 7/10/08, 5/13/08, 9/17/08;

2) Date codes: 1\2 Pt Fruit Punch :3/13/09, 2/10/09, 12/09/08,11/15/08, 10/07/08, 9/23/08, 8/19/08, 7/29/08, 7/1/08, 6/11/08, 5/20/08, 4/29/08: Pint: 6/16/08,3/22/08, 9/16/08;

3) Date codes: 1\2 pint orange drink:3/17/09, 2/10/09, 1/20/09, 10/7/08, 8/19/08, 7/29/08, 7/1/08, 5/20/08; 1 pint orange juice: 12/24/08, 12/19/08, 12/10/08, 12/3/08, 11/26/08, 11/19/08, 11/12/08, 10/31/08, 10/22/08, 10/20/08, 10/13/08, 10/06/08, 09/24/08, 09/16/08, 09/08/08, 9/01/08, 8/27/08, 8/20/08, 8/13/08, 07/30/08, 07/23/08, 07/16/08, 07/09/08, 07/02/09, 06/25/08, 06/16/08, 06/04/08, 05/28/08, 05/21/08, 05/14/08, 05/07/08, 04/30/08, 04/21/08, 04/17/08, 04/09/08, 04/04/08, 04/02/08, 03/24/08, 03/19/08, 03/12/08, 03/03/08, 02/27/08, 02/20/08, 02/13/08, 02/06/08, 01/30/08, 01/23/08;

4) Date codes: 12/20/08, 12/19/08, 12/13/08, 12/6/08, 12/4/08, 11/21/08, 11/08/08, 10/24/08, 10/10/08, 10/03/08, 09/26/08, 9/12/08, 9/5/08, 8/29/08, 8/15/08, 8/08/08, 8/02/08, 7/25/08, 7/12/08, 7/04/08, 6/27/08, 6/20/08, 6/07/08, 5/31/08, 5/24/08, 5/11/08, 5/3/08, 4/19/08, 4/17/08, 4/4/08, 3/24/08, 3/8/08, 2/9/08, 2/1/08
RECALLING FIRM/MANUFACTURER
Broughton Foods, LLC, Marietta, OH, by letter on February 14, 2009. Firm initiated recall is ongoing.
REASON
The product may contain undeclared milk protein.
VOLUME OF PRODUCT IN COMMERCE
1 pint = 441,736 bottles, 1/2 pint = 278,028 bottles 
DISTRIBUTION
KY, OH, VA, WV
___________________________________
PRODUCT
1)  Pimento Cheese on White, Net Wt 4 oz. Recall # F-1524-2010;
2) Chicken Salad on White, Net Wt. 4 oz. Recall # F-1525-2010;
3) Chef Salad, Net Wt. 6 oz. Recall # F-1526-2010
CODE
1) and 2) Best thru date: 02/24/10;
3) Best thru date: 02/21/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: A&A Vending Services, Augusta, GA, by visit starting February 18, 2010 and February 19, 2010 and by letter.
Manufacturer: Dixie Riverside, Inc. dba A&A Vending Services, Augusta, GA. Firm initiated recall is ongoing.
REASON
Product contains undeclared allergens, cheese or eggs.
VOLUME OF PRODUCT IN COMMERCE
7,089 units
DISTRIBUTION
GA, SC
___________________________________
PRODUCT
Wegmans Food You Feel Good About Medium Seafood Sauce in 9 ounce glass jar, UPC 77890 84032. The sell-by date is heat stamped on the label. Recall # F-1527-2010
CODE
Sell by date up to and including April 21, 2010
RECALLING FIRM/MANUFACTURER
Ed Roller, Inc. (db/a) Roller’s Horseradish, Rochester, NY, by press release and letter on March 5, 2010. Firm initiated recall is ongoing.
REASON
Product contains undeclared soy and anchovies from a sub-ingredient (Worcestershire sauce).
VOLUME OF PRODUCT IN COMMERCE
17,472 bottles
DISTRIBUTION
NY, NJ, PA, VA, MD
___________________________________
PRODUCT
Lian How brand White Sesame Seeds packed by Union International Food Co., 50 lb bags. Recall # F-1528-2010
CODE
All products
RECALLING FIRM/MANUFACTURER
Spices Industrial Group, Inc., City of Industry, CA, by press release dated March 10, 2010 and by letter. Firm initiated recall is ongoing.
REASON
The product was manufactured using sesame seeds recalled by Specialty Commodities, inc., because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
7,500 lbs
DISTRIBUTION
CA
___________________________________
PRODUCT
Ajonjoli Sesame Seeds (White Sesame Seeds) pouch; UPC 810338001330 (3.5 oz) UPC 810338000043 (1 9/16 oz) UPC 810338020027 (1 9/16 oz). Recall # F-1529-2010
CODE
No code
RECALLING FIRM/MANUFACTURER
Julia’s Spices, Inc., City of Industry, CA, by letter dated February 23, 2010 and press release dated February 25, 2010. Firm initiated recall is ongoing.
REASON
Product has the potential of being contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
7,164 units
DISTRIBUTION
UT, NV, CA, WA, ID
___________________________________
PRODUCT
Hulled Sesame Seeds. Recall # F-1530-2010
CODE
SCI Lot AD42390; MFG Lot C#34626
RECALLING FIRM/MANUFACTURER
Recalling Firm: D & C Dist. Co., Inc. (dba) Gust Picoulas Nut Co., Los Angeles, CA, by letter dated February 16, 2010.
Manufacturer: Specialty Commodities Inc., Los Angeles, CA. Firm initiated recall is ongoing.
REASON
Products may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3,700 lbs
DISTRIBUTION
CA
___________________________________
PRODUCT
Hydrolyzed Vegetable Protein composed of the following in a number of combinations and blends: Soy, Wheat and Corn, in either paste or powder forms. Recall # F-1531-2010
CODE
All products with manufacturing date on or after September 17, 2009
RECALLING FIRM/MANUFACTURER
Basic Food Flavors, Inc., North Las Vegas, NV, by letter on February 23, 2010 and e-mails and telephone. Firm initiated recall is ongoing.
REASON
Products may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Not known
DISTRIBUTION
Nationwide, Philippines, Canada, Mexico, Poland

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
1) tasty DISH brand Milk Chocolate Almonds, Net Wt. 9.75 oz.(276g), UPC 4 44444 56461 0, Product of USA --- Ingredients: Sugar, Chocolate Liquor, Whole Milk, Cocoa Butter, Soy Lecithin and PGPR (Emulsifiers), Salt, Vanillin (Artificial Flavor), Almonds (Roasted in Cottonseed Oil), Partially Hydrogenated Palm Kernel Oil, Whey Powder, Cocoa Powder, Corn Syrup, Gum Arabic, Confectionery Glaze. --- Shares Equipment with Peanuts, Tree Nuts, Wheat, Milk, Eggs & Soy. The product is packed in a clear, hard plastic package with a 4" clear film safety shrink band. SKU 16915300. Recall # F-1467-1020;

2) tasty DISH brand Milk Chocolate Raisins, Net Wt. 11.00 oz. (311g), UPC 4 44444 56462 7. Product of USA --- Ingredients: Sugar, Chocolate Liquor, Whole Milk, Cocoa Butter, Soy Lecithin and PGPR (Emulsifiers), Salt, Vanillin (Artificial Flavor), Raisins (Treated in vegetable Oil), Partially Hydrogenated Palm Kernel Oil, Whey Powder, Cocoa Powder, Corn Syrup, Gum Arabic, Confectionery Glaze. --- Shares Equipment with Peanuts, Tree Nuts, Wheat, Milk, Eggs & Soy. The product is packed in a clear, hard plastic package with a 4" clear film safety shrink band. SKU 16915335. Recall # F-1468-2010;

3) tasty Dish brand Sour Neon Worms, Net Wt. 9.50 oz. (269g), UPC 4 44444 56460 3, Product of Brazil, Packaged in USA --- Ingredients: Glucose Syrup, Sugar, Dextrose, Gelatin, Sorbital, Titanium Dioxide, FD&C Artificial Colors (Yellow 5, Yellow 6, Blue 1 and Red 40), Artificial Flavors, Aciduants Citric Acid, and Fumaric Acid --- Shares Equipment with Peanuts, Tree Nuts, Wheat, Milk, Eggs & Soy. The product is packed in a clear, hard plastic package with a 4" clear film safety shrink band. SKU 16915289. Recall # F-1469-2010
CODE
Date on or before 11/13/09
RECALLING FIRM/MANUFACTURER
Nassau Candy, Hicksville, NY, by telephone on November 13, 2009 and press release on November 18, 2009. Firm initiated recall is complete.
REASON
Some tubs of the snack items lack the Nutrition Facts/Ingredient Statement/Allergy Warning panel on the back which lists the ingredients in the products some of which are known allergens. Additionally, the product was manufactured on equipment shared with various allergenic ingredients.
VOLUME OF PRODUCT IN COMMERCE
30,000 tubs
DISTRIBUTION
Nationwide

___________________________________
PRODUCT
The product is a frozen soup base mix packed under 2 labels as follows: 1) E.R.I. Turkey Flavored Egg Noodle Soup Base Without Meat Ingredients: Turkey Stock***hydrolyzed protein (wheat gluten, soy, corn gluten)***eggs***carrots, celery,onion, wheat flour***For Institutional Use Only Not For Retail Sale***4-3 lb. Bags Net Wt. 12 lbs.  2) Two Spoon Homestyle Soups Turkey Flavored Egg Noodle Soup Base Without Meat***Ingredients: Turkey Stock***hydrolyzed protein (wheat gluten, soy, corn gluten) ***eggs***carrots, celery,onion, wheat flour*** For Institutional Use Only Not For Retail Sale***This Box Contains Four-3 lb. Bags / Net Wt 12 lbs. Recall # F-1487-2010
CODE
1) February 28, 2008; April 3, 2008; June 6, 2008; August 28, 2008; September 25, 2008; October 30, 2008; and April 7, 2008;
2) June 6, 2008; August 28, 2008 and October 30, 2008
RECALLING FIRM/MANUFACTURER
Ivar's Seafood, soup & Sauce Co, Mukilteo, WA, by telephone and press release on April 17, 2009. Firm initiated recall is ongoing.
REASON
Soup base contains undeclared milk allergen.
VOLUME OF PRODUCT IN COMMERCE
1170 cases each containing 4-3lb pouches
DISTRIBUTION
OR, WA, ID

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
1) Imperial Sugar, Pure Cane, Old Fashioned, Dark Brown Sugar, Net Wt 50 lb (22.6 kg) and 32 oz (2 lb) 907 g, and Dixie Crystals, Pure Cane, Old Fashioned Dark Brown Sugar, Net Wt 32 oz (2 lb) 907 g. Recall # F-1488-2010;

2) Imperial Sugar, Pure Cane, Natural Light Brown Sugar, Net Wt 50 lb (22.6 kg), 32 oz (2 lb) 907 g, and Dixie Crystals, Pure Cane, Natural Light Brown Sugar, Net Wt 32 oz ( 2 lb) 907 g. Recall # F-1489-2010
CODE
1) Lots C313K, C314K, C315K, C316K, and C317K;
2) Lots: C313K, C314K, C315K, C316K, and C317K;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Imperial Sugar Co., Sugar Land, TX, by telephone and letters on January 25, 2010. 
Manufacturer: Savannah Foods Industrial, Inc., Gramercy, LA. Firm initiated recall is ongoing.
REASON
Product may contain small metal fragments.
VOLUME OF PRODUCT IN COMMERCE
126,187 units
DISTRIBUTION
LA, OK, IL, NC, TX, NE, IN, FL, AR, KS, SC GA, VA, AL, KY
___________________________________
PRODUCT
CF Chefs, Inc. Bourbon Street Sauce. Keep Refrigerated; packaged in 2,800 pound bulk totes. Recall # F-1490-2010
CODE
Code DV331, Code Dates 00410, 01410, and 01910
RECALLING FIRM/MANUFACTURER
CF Chefs, Inc., Dallas, TX, by telephone and e-mail on January 25, 2010. Firm initiated recall is complete.
REASON
Product may contain small metal fragments.
VOLUME OF PRODUCT IN COMMERCE
58,895 lbs
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Imperial Sugar, Pure Cane, Old Fashioned, Dark Brown Sugar, Net Wt 50 lb (22.6 kg) and 32 oz (2 lb) 907 g. Recall # F-1491-2010;

2) Imperial Sugar, Pure Cane, Natural Light Brown Sugar, Net Wt 50 lb (22.6 kg), 25 lb (11.34 kg), 32 oz (2 lb) 907 g. Recall # F-1492-2010;

3) Imperial Sugar, Pure Cane, Golden Medium Brown Sugar, Net Wt 50 lb (22.6 kg). Recall # F-1493-2010
CODE
Lots: C327K, C328K, and C329K
RECALLING FIRM/MANUFACTURER
Imperial Sugar Co. Sugar Land, TX, by telephone and letter via electronic mail on January 25, 2010.
Manufacturer: Savannah Foods Industrial, Inc., Gramercy, LA. Firm initiated recall is ongoing.
REASON
Product may contain small pieces of rubber.
VOLUME OF PRODUCT IN COMMERCE
77,554 units
DISTRIBUTION
TX, GA, KS, VA, OH, OK, LA, MO, IA, AR, FL, WI, IA
___________________________________
PRODUCT
Apple Bran Muffin 11001766, 1 Day Shelf Life, New Weight 17.0 oz (484 g). Recall # F-1494-2010
CODE
Lot numbers: C344-09-11 Best by 06/08/2010 and C354-09-11 Best by 06/18/2010
RECALLING FIRM/MANUFACTURER
CGI Desserts, Inc., Sugar Land, TX, by e-mail on January 25, 2010. Firm initiated recall is complete.
REASON
Potential for pieces of conveyor belt to be in brown sugar.
VOLUME OF PRODUCT IN COMMERCE
6,540 cases
DISTRIBUTION
CA, WA, OR, TX, AZ, NV, CO, MN, LA
___________________________________
PRODUCT
1) Gun Barrel Hot Sauce, Mild, Net Wt. 16 oz. (1 lb) (454g), UPC 4816371825. Recall # F-1495-2010;

2) Gun Barrel Hot Sauce, Hot, Net Wt. 16 oz. (1 lb) (454g), UPC 4816390538. Recall # F-1496-2010;

3) Gun Barrel Hot Sauce, XXX Hot, Net Wt. 16 oz. (1 lb) (454g), UPC 4816312654. Recall # F-1497-2010;

4) Wing Stop, Teriyaki Sauce, Net 128 f. oz. (1 gal.) 3.785L. Recall # F-1498-2010;

5) Wing Stop, Hawaiian Sauce, Net 128 fl. oz. (1 gal.) 3.785L. Recall # F-1499-2010;

6) Renfro's Barbecue Sauce, Net 5 Gallons (18.93L), UPC 4123500414. Recall # F-1500-2010;

7) Mrs. Renfro's Gourmet Salsas, Tequila Salsa Medium, Net Wt. 16 oz. (1 lb.) 454g. Recall # F-1501-2010;
8) Mrs. Renfro's Gourmet Salsas, Peach Salsa Mild, Net Wt. 16 oz. (1 lb.) 454g; UPC 4123500074. Recall # F-1502-2010;
9) Mrs. Renfro's Gourmet Salsas, Raspberry Chipotle Salsa Medium, Net Wt. 16 oz. (1 lb.) 454g; UPC 4123500076. Recall # F-1503-2010;
10) Mrs. Renfro's Gourmet Salsas, Chipotle Pomegranate Salsa Medium, Net Wt. 16 oz. (1 lb.) 454g; UPC 4123500080. Recall # F-1504-2010;

11) Mrs. Renfro's Gourmet Salsas, Mango Habanero Salsa Medium Hot, Net Wt. 16 oz. (1 lb.) 454g; UPC 4123500077. Recall # F-1505-2010;

12) Mrs. Renfro's Gourmet Salsas, Pineapple Salsa Medium, Net Wt. 16 oz. (1 lb.) 454g; UPC 4123500079. Recall # F-1506-2010;

13) Fat Free/Sans Lipides, Desert Pepper Trading Company, Pineapple Salsa Dananas, Medium/Mi-Fort, 473 ml, UPC 19212 10107. Recall # F-1507-2010;

14) All Natural Desert Pepper Trading Company Raspberry Chipotle Salsa Medium, Net Wt. 16 oz (454 G.); UPC 1921210106. Recall # F-1508-2010;

15) All Natural Desert Pepper Trading Company, Peach Mango Salsa Medium, Net Wt. 16 oz (454 g), UPC 19212 10102. Recall # F-1509-2010
CODE
1) Lot Codes; FL039A380;

2) Lot Codes: FL039B381;

3) Lot Codes: FL039B381;

4) Lot Codes: FA0501312, FA1401312, FK2591312, FL0991312, FL1091312, FL1791312, and FL2891312;

5) Lot Codes: FA1901310, FL0391310, FL1591310, FL2291310, and FL3191310;

6) Lot Codes: FL0194012 and FA1109012, Expiration/Use By Date: 12/03/11 through 12/29/11;

7) Lot Codes: FL0397 Best By 12/03/11 and FL299A Best By 12/29/11;

8) Lot Codes: FL0394 Best By 12/03/11, FL1795 Best By 12/17/11, FL2895 Best By 12/28/11, and FA0706 Best By 01/07/12;

9) Lots FL0396 Best by 12/03/11, FL1797 Best By 12/17/11, and FA1106 Best By 01/11/12;

10) Lot Codes: FL0795 Best By 12/07/11 and FL2998 Best By 12/29/11;

11) Lot Codes FL0396 Best By 12/03/11, FL1797 Best By 12/17/11, FA0502 Best By 01/05/12, and FA1104 Best By 01/11/12;

12) Lot Codes FL0795 Best By 12/07/11 FL1593 Best By 12/15/11, and FL 2998 Best By 12/29/11;

13) Lot Codes: FL22930001 and FA 19050001;

14) Lot Codes FL22930001 and FA 19050001;

15) Lot Codes: FK30930001, FL21950001, FL29920001, FA06030001, FA12040001, and FA18040001
RECALLING FIRM/MANUFACTURER
Renfro Foods, Inc., Fort Worth, TX, by e-mail and letter on January 26, 2010. Firm initiated recall is ongoing.
REASON
Products may contain small metal fragments.
VOLUME OF PRODUCT IN COMMERCE
27,139 cases and 54 pails
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Maui Foods International, Maui Morning Gourmet Muffin Batter, No Preservatives - 100% Natural Ingredients, Net Weight: 18 lbs., Keep Frozen. Recall # F-1510-2010;

 2) Maui Foods International, Blueberry Gourmet Muffin Batter, No Preservatives - 100% Natural Ingredients, Net Weight: 18 lbs., Keep Frozen. Recall # F-1511-2010
CODE
1) Code #122992;
2) Code # 123090
RECALLING FIRM/MANUFACTURER
Maui Foods International, Inc., Dallas, TX, by letter on March 12, 2010. Firm initiated recall is ongoing.
REASON
Product may contain small pieces of a food grade conveyor belt.
VOLUME OF PRODUCT IN COMMERCE
324 /18 lb pails
DISTRIBUTION
MI, TX, GA, CA, CO
___________________________________
PRODUCT
Salmon Cakes and Sauce. Recall # F-1512-2010
CODE
2/12/10
RECALLING FIRM/MANUFACTURER
Dolee LLC, Louisville, KY, by telephone on February 11, 2010. Firm initiated recall is ongoing.
REASON
All allergen sub-ingredients, milk and wheat, were not listed on the finished product labels.
VOLUME OF PRODUCT IN COMMERCE
7 salmon cakes
DISTRIBUTION
KY

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Oxygen Compressed U. S. P. UN 1072, Gas: 7782-44-7, Oxygen 2, is stored in B, C, D and E-size tanks, Rx only. Recall # D-367-2010 
CODE
B-TANKS: Serial numbers with dates: 2632 11/1/2009; 4929 11/1/2009; 5454 11/1/2009; 681 11/3/2009; 1098 11/3/2009; 2488 11/3/2009; 2490; 11/3/2009; 3154 11/3/2009; 4313 11/3/2009; 5096 11/3/2009; 5336 11/3/2009; 851 11/4/2009; 1095 11/4/2009; 1250 11/4/2009; 2061 11/4/2009; 3074 11/4/2009; 3580 11/4/2009; 3674 11/4/2009; 3929 11/4/2009; 4409 11/4/2009; 4503 11/4/2009; 4553 11/4/2009; 4567 11/4/2009; 4783 11/4/2009; 4946 11/4/2009; 4949 11/4/2009; 84 11/5/2009; 844 11/5/2009; 1057 11/5/2009; 1144 11/5/2009; 1148 11/5/2009; 1228 11/5/2009; 3462 11/9/2009; 3698 11/9/2009; 3926 11/9/2009; 4224 11/9/2009; 4359 11/9/2009; 4398 11/9/2009; 4410 11/9/2009; 4675 11/9/2009; 4751 11/9/2009; 5087 11/9/2009; 5141 11/9/2009; 5147 11/9/2009; 5260 11/9/2009; 5435 11/9/2009; 1018 11/10/2009; 3438 11/10/2009; 3682 11/10/2009; 3851 11/10/2009; 3858 11/10/2009; 3889 11/10/2009; 3980 11/10/2009; 3990 11/10/1009; 4598 11/10/2009; 5006 11/10/2009; 5312 11/10/2009; 5323 11/10/2009; 922 11/11/2009; 981 11/11/2009; 1835 11/11/2009; 1863 11/11/2009; 2510 11/11/2009; 2911 11/11/2009; 3276 11/13/2009; 3277 11/13/2009; 3427 11/13/2009; 3491 11/13/2009; 3503 11/13/2009; 3504 11/13/2009; 3634 11/13/2009; 3667 11/13/2009; 3772 11/13/2009; 3780 11/13/2009; 3801 11/13/2009; 3817 11/13/2009; 3828 11/13/2009; 3888 11/13/2009; 4255 11/13/2009; 4334 11/13/2009; 4459 11/13/2009; 4471 11/13/2009; 4489 11/13/2009; 4496 11/13/2009; 4501 11/13/2009; 4563 11/13/2009; 4581 11/13/2009; 4604 11/13/2009; 4608 11/13/2009; 4613 11/13/2009; 4629 11/13/2009; 4641 11/13/2009; 4664 11/13/2009; 4669 11/13/2009; 4704 11/13/2009; 4755 11/13/2009; 5415 11/17/2009; 5440 11/17/2009; 811 11/18/2009; 1007 11/18/2009; 1052 11/18/2009; 1240 11/18/2009; 1321 11/18/2009; 1984 11/18/2009; 2209 11/18/2009; 2700 11/18/2009; 3283 11/18/2009; 3891 11/18/2009; 3928 11/18/2009; 3957 11/18/2009; 3970 11/18/2009; 4244 11/18/2009; 4293 11/18/2009; 4309 11/18/2009; 4583 11/18/2009; 4632 11/18/2009; 4636 11/18/2009; 4694 11/18/2009; 4746 11/18/2009; 4804 11/18/2009; 4860 11/18/2009; 4937 11/18/2009; 4964 11/18/2009; 5138 11/18/2009; 5156 11/18/2009; 5246 11/18/2009; 5259 11/18/2009; 5268 11/18/2009; 2190 11/5/2009; 2379 11/5/2009; 2704 11/5/2009; 3055 11/5/2009; 3233 11/5/2009; 3468 11/5/2009; 3508 11/5/2009; 3659 11/5/2009; 3855 11/5/2009; 3856 11/5/2009; 3909 11/5/2009; 3915 11/5/2009; 3958 11/5/2009; 4102 11/5/2009; 4295 11/5/2009; 4329 11/5/2009; 4344 11/5/2009; 4438 11/5/2009; 4512 11/5/2009; 4521 11/5/2009; 4590 11/5/2009; 4687 11/5/2009; 4789 11/5/2009; 5227 11/5/2009; 5393 11/5/2009; 2 11/6/2009; 3 11/6/2009; 967 11/6/2009; 1004 11/6/2009; 1440 11/6/2009; 2069 11/6/2009; 2583 11/6/2009; 2831 11/6/2009; 2931 11/6/2009; 3053 11/11/2009; 3265 11/11/2009; 3593 11/11/2009; 3601 11/11/2009; 3861 11/11/2009; 3865 11/11/2009; 3933 11/11/2009; 4239 11/11/2009; 4413 11/11/2009; 4702 11/11/2009; 4757 11/11/2009; 4782 11/11/2009; 4976 11/11/2009; 5325 11/11/2009; 5364 11/11/2009; 5366 11/11/2009; 5444 11/11/2009; 5446 11/11/2009; 125 11/12/2009; 147 11/12/2009; 199 11/12/2009; 502 11/12/2009; 517 11/12/2009; 548 11/12/2009; 641 11/12/2009; 643 11/12/2009; 767 11/12/2009; 1042 11/12/2009; 1438 11/12/2009; 1459 11/12/2009; 1478 11/12/2009; 1880 11/12/2009; 1982 11/12/2009; 2010 11/12/2009; 4756 11/13/2009; 4797 11/13/2009; 4948 11/13/2009; 4996 11/13/2009; 5105 11/13/2009; 5111 11/13/2009; 5136 11/13/2009; 5171 11/13/2009; 5257 11/13/2009; 5264 11/13/2009; 5280 11/13/2009; 58 11/16/2009; 428 11/16/2009; 511 11/16/2009; 537 11/16/2009; 1017 11/16/2009; 1455 11/16/2009; 2461 11/16/2009; 2939 11/16/2009; 2976 11/16/2009; 3136 11/16/2009; 3237 11/16/2009; 3654 11/16/2009; 3669 11/16/2009; 3672 11/16/2009; 3912 11/16/2009; 3952 11/16/2009; 4353 11/16/2009; 4695 11/16/2009; 4828 11/16/2009; 5107 11/16/2009; 5221 11/16/2009; 5233 11/16/2009; 5324 11/16/2009; 5373 11/18/2009; 5432 11/18/2009; 235 11/19/2009; 245 11/19/2009; 506 11/19/2009; 1078 11/19/2009; 1979 11/19/2009; 2648 11/19/2009; 3029 11/19/2009; 3287 11/19/2009; 3514 11/19/2009; 3827 11/19/2009; 4249 11/19/2009; 4267 11/19/2009; 4578 11/19/2009; 4615 11/19/2009; 4744 11/19/2009; 4773 11/19/2009; 4926 11/19/2009; 4940 11/19/2009; 4970 11/19/2009; 5085 11/19/2009; 5125 11/19/2009; 5272 11/19/2009; 5282 11/19/2009; 5289 11/19/2009; 5323 11/19/2009; 5439 11/19/2009; 5443 11/19/2009; 5458 11/19/2009; 5243 11/19/2009; 4301 11/19/2009; 3061 11/6/2009; 3295 11/6/2009; 3396 11/6/2009; 4230 11/6/2009; 4264 11/6/2009; 4388 11/6/2009; 4467 11/6/2009; 4481 11/6/2009; 4492 11/6/2009; 4505 11/6/2009; 4511 11/6/2009; 4558 11/6/2009; 4573 11/6/2009; 4621 11/6/2009; 4660 11/6/2009; 5003 11/6/2009; 5086 11/6/2009; 5099 11/6/2009; 5102 11/6/2009; 5219 11/6/2009; 5237 11/6/2009; 5414 11/6/2009; 5441 11/6/2009; 5457 11/6/2009; 302 11/9/2009; 657 11/9/2009; 2380 11/9/2009; 3418 11/9/2009; 2029 11/12/2009; 2470 11/12/2009; 2598 11/12/2009; 2818 11/12/2009; 3221 11/12/2009; 3304 11/12/2009; 3431 11/12/2009; 3762 11/12/2009; 4383 11/12/2009; 4479 11/12/2009; 4666 11/12/2009; 4667 11/12/2009; 4815 11/12/2009; 4861 11/12/2009; 4996 11/12/2009; 5238 11/12/2009; 5245 11/12/2009; 140 11/13/2009; 168 11/13/2009; 1313 11/13/2009; 1322 11/13/2009; 1434 11/13/2009; 1826 11/13/2009; 2011 11/13/2009; 2665 11/13/2009; 3126 11/13/2009; 3234 11/13/2009; 3243 11/13/2009; 5271 11/16/2009; 5357 11/16/2009; 26 11/17/2009; 43 11/17/2009; 71 11/17/2009; 266 11/17/2009; 547 11/17/2009; 611 11/17/2009; 644 11/17/2009; 655 11/17/2009; 1211 11/17/2009; 1230 11/17/2009; 1342 11/17/2009; 1622 11/17/2009; 1986 11/17/2009; 2204 11/17/2009; 2833 11/17/2009; 2848 11/17/2009; 3217 11/17/2009; 3235 11/17/2009; 3291 11/17/2009; 3369 11/17/2009; 3516 11/17/2009; 3668 11/17/2009; 4441 11/17/2009; 4795 11/17/2009; 5115 11/17/2009; and 5253 11/17/2009. C-TANKS: Serial numbers and dates: 2093 11/10/2009; 267 11/11/2009; 287 11/11/2009; 348 11/11/2009; 1465 11/11/2009; 1725 11/11/2009; 2156 11/11/2009; 2227 11/11/2009; 2242 11/11/2009; 2650 11/11/2009; 3337 11/11/2009; 3341 11/11/2009; 2809 11/12/2009; 479 11/16/2009; 36 11/17/2009; 61 11/17/2009; 1513 11/17/2009; 1672 11/17/2009; 2150 11/17/2009; 2628 11/17/2009; 3193 11/17/2009; 3343 11/17/2009; 3512 11/17/2009; 3531 11/17/2009; 5400 11/17/2009; 275 11/18/2009; 282 11/18/2009; 339 11/18/2009; 492 11/18/2009; 1212 11/18/2009; 2224 11/18/2009; 2631 11/18/2009; 2647 11/18/2009; 2849 11/18/2009; 3203 11/18/2009; 489 11/19/2009; and 817 11/19/2009.
D-TANKS: Serial numbers and dates: 161 11/17/2009; 736 11/17/2009; 1530 11/17/2009; 1940 11/17/2009; 3006 11/17/2009; 4077 11/17/2009; and 4364 11/17/2009.
E-TANKS: Serial numbers and dates: 4872 11/3/2009; 5072 11/3/2009; 1034 11/5/2009; 1163 11/5/2009; 1414 11/5/2009; 2118 11/5/2009; 2681 11/5/2009; 2921 11/5/2009; 3545 11/5/2009; 5046 11/5/2009; 4891 11/6/2009; 2071 11/9/2009; 4235 11/9/2009; 5013 11/9/2009; 5201 11/9/2009; 136 11/10/2009; 1921 11/10/2009; 2137 11/10/2009; 2909 11/10/2009; 3563 11/10/2009; 3775 11/10/2009; 4038 11/10/2009; 5398 11/10/2009; 1694 11/11/2009; 1883 11/11/2009; 1904 11/11/2009; 2045 11/11/2009; 2211 11/11/2009; 2530 11/11/2009; 2556 11/11/2009; 2559 11/11/2009; 2703 11/11/2009; 2760 11/11/2009; 2869 11/11/2009; 3184 11/11/2009; 3307 11/11/2009; 3708 11/11/2009; 4031 11/11/2009; 5030 11/11/2009; 2314 11/12/2009; 2322 11/12/2009; 3095 11/12/2009; 3569 11/12/2009; 3757 11/12/2009; 4889 11/12/2009; 4890 11/12/2009; 5076 11/12/2009; 5497 11/12/2009; 2263 11/13/2009; 2294 11/13/2009; 2331 11/13/2009; 2989 11/13/2009; 5037 11/13/2009; 5475 11/13/2009; 2230 11/15/2009; 3183 11/15/2009; 1335 11116/2009; 1714 11/16/2009; 1714 11/16/2009; 4742 11/16/2009; 5011 11/16/2009; 5208 11/16/2009; 5427 11/16/2009; 1781 11/17/2009; 2552 11/17/2009; 5019 11/17/2009; 5036 11/18/2009; 292 11/19/2009; 3190 11/19/2009; and 4905 11/19/2009
RECALLING FIRM/MANUFACTURER
Special Care Home Oxygen & Medical Equipment, Inc., Richardson, TX, by letter on November 23, 2009. Firm initiated recall is ongoing.
REASON
CGMP Deviations:Oxygen product has no purity test documentation and cylinder labels did not reflect current address of the manufacturer.
VOLUME OF PRODUCT IN COMMERCE
651 cylinders
DISTRIBUTION
TX
___________________________________
PRODUCT
OctreoScan, Kit for the Preparation of Indium In-111 Pentetreotide, 10 mL Reaction Vial containing 10 mcg lyophilized Pentetreotide, 10-mL Indium In-111 Chloride Sterile Solution Vial containing 1.1 mL of 111 MBq/ml (3. 0 mCi/mL) aqueous Indium In-111 chloride, RX only. NDC 0019-9050-40. Recall # D-368-2010
CODE
Lot #050-0002, Exp date 11JAN10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mallinckrodt Inc., Hazelwood, MO, by letter dated January 7, 2010.
Manufacturer: Mallinckrodt Inc., Maryland Heights, MO. Firm initiated recall is complete.
REASON
Lack of Efficacy: The product is not performing within acceptable production specifications (radiochemical purity).
VOLUME OF PRODUCT IN COMMERCE
119 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Fluconazole, sterile liquid, 200 mg/100 mL (2 mg/mL), 6 x 100 mL vials per box, Rx only, NDC: 0143-9899-01. Recall # D-370-2010
CODE
Lot 092112.1, Exp 6/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-ward Pharmaceutical Corp., Eatontown, NJ, by letters on January 8, 2009.
Manufacturer: Hikma Farmaceutica, (Portugal) S.A., Fervenca, Terrugen, Portugal. Firm initiated recall is ongoing.
REASON
Product Lacks Stability: Assay results for Fluconazole Injection 200 mg/100mL, lot number 092112.1 had out of specification assay results, both high and low, at 3 month stability testing.
VOLUME OF PRODUCT IN COMMERCE
1456 boxes / 6 x 100ml vials per box
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Sea Pure 100% Natural Sheer Lotion SPF 15; 1.7 FL oz / 50 mL plastic bottles, OTC facial moisturizer with Zinc Oxide 5.0% sunscreen. Made in U.S.A.; sold in the following sizes: a) 1.7 FL oz / 50 mL plastic bottles, 6 per case, U.S. label - sku 100-00256-000 (H70-131), UPC 7 64505 00256 2; Canada label - sku 300-00256-000, UPC 7 64505 00256 2; b) .27 FL oz / 8 mL plastic tube (sample), 350 tubes per case, sku 100-05256-000; The 1.7 FL oz bottles are also sold as a component of the following kits: a) Sea Pure Tester Kit (Skincare - US - English), sku 100-09994-000, UPC 7 64505 09994 4; b) Sea Pure Tester Kit (Skincare - Canada - English), sku 100-09997-000, UPC 7 64505 09997 5; c) Sea Pure Tester Kit (Skincare - Canada - French), sku 100-09996-000, UPC 7 64505 09996 8; d) CVS Beauty 360 Sea Pure Tester Kit; sku 100-738892-000. Recall # D-366-2010
CODE
Lot 090812A02; lot 090812A02; lot 090812A02
RECALLING FIRM/MANUFACTURER
H2O Plus, L.P., Chicago, IL, by letters dated January 22, 2010. Firm initiated recall is ongoing.
REASON
Error with Regard to Preservative: The lotion has the potential for preservative failure, which would allow mold growth to occur.
VOLUME OF PRODUCT IN COMMERCE
8,653 1.7 fl oz bottles; 12,718 .27 fl oz tubes
DISTRIBUTION
Nationwide, Canada, Chile, Hong Kong, Malaysia and Mexico

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0677-10
CODE
Unit: 2594131
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter dated October 22, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0679-10
CODE
Unit: 6846521
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida’s Blood Centers, Inc., Orland, FL, by telephone and letter on September 8, 2009.
Manufacturer: Florida’s Blood Centers, Inc., Winter Springs, FL. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who visited a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0682-10
CODE
Unit: W071209040570
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated September 21, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who provided a history of travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0683-10
CODE
Units: W088409000550 (double collection); 1736861 (double collection); W088409000706; 1704195 (double collection); 1703897 (double collection)
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter dated September 4, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who provided a history of travel to a malarial risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
HI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0684-10
CODE
Unit: W088409000989
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter dated September 18, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who provided a history of travel to a malarial area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
HI
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0685-10
CODE
Unit: 9010157, 9010664
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA, by letter dated August 27, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0686-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0687-10;
3) Platelets Pooled Leukocytes Reduced. Recall # B-0688-10
CODE
1) Unit: W120609260582;
2) Unit: W120609261319;
3) Units: W120609380817, W120609382134
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by facsimile dated September 2, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had traveled to areas that are endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
MI
___________________________________
PRODUCT
1) Red Blood Cells (Apheresis) Leukocytes Reduced Irradiated. Recall # B-0705-10;

2) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0706-10
CODE
1) Unit: W047009226621A;
2) Units: W047009361053A, W047009361053B, W047009371142, W047009226621B
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by letters dated September 15, 2009 and October 15, 2009. Firm initiated recall is complete.
REASON
Blood products, which did not meet the minimum requirement for red blood cell recovery and were not tested for residual white blood cell count, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
NY
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0707-10
CODE
Unit: W071209040517
RECALLING FIRM/MANUFACTURER
Medic Inc, Knoxville, TN, by letter dated September 11, 2009. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly tested for syphilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0708-10
CODE
Unit: W141609433256
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated August 31, 2009.
Manufacturer: Puget Sound Blood Center and Program, Lynnwood, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT
1) Red Blood Cells. Recall # B-0710-10;
2) Recovered Plasma. Recall # B-0711-10;
3) Red Blood Cells Leukocytes Reduced. Recall # B-0712-10;
4) Fresh Frozen Plasma. Recall # B-0713-10
CODE
1) Units: W126907242485, W126907245107, W126908244746, W126908246493, W126909261093, W126909242843;

2) Units: 2429775, W126907242485, W126908244746, W126908246493, W126909261093, W126909242843;

3) Units: 2429775, W126908247162;

4) Unit: W126908247162
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by letter dated December 12, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of exposure to an individual with hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
GA, FL, Austria
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0714-10;
2) Platelets Leukocytes Reduced. Recall # B-0715-10
CODE
1) and 2) Unit: 72L32546X
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on October 13, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0716-10;
2) Fresh Frozen Plasma. Recall # B-0717-10
CODE
1) and 2) Unit: 024KW66716
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Louisville, KY, by facsimile on August 25, 2009 and by letter dated October 28, 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
KY, IN
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0718-10
CODE
Units: W118809301433, W118809420817, W118809420799, W118809420804
RECALLING FIRM/MANUFACTURER
The Blood Alliance, Inc., Jacksonville, FL, by telephone on August 4, 2009. Firm initiated recall is complete.
REASON
Blood products, which were leukoreduced by filtration beyond the allowable time limit, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA, FL

___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0719-10;
2) Platelets Pooled Leukocytes Reduced. Recall # B-0720-10;
3) Fresh Frozen Plasma. Recall # B-0721-10
CODE
1), 2), and 3) Unit: 033GM43188
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Farmington, CT, by facsimile on August 24, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
CT
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0722-10
CODE
Unit: 09FK81518
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Omaha, NB, by facsimile and electronic notification on September 8, 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
NJ  
___________________________________
PRODUCT
Source Plasma. Recall # B-0724-10
CODE
Unit: 0411423854
RECALLING FIRM/MANUFACTURER
ZLB Bioplasma, Inc., Oak Park, MI, by letter dated September 10, 2009. Firm initiated recall is complete. 
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0725-10
CODE
Unit: 024KR40984
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Louisville, KY, by letter dated March 21, 2008, by electronic notification on March 21, 2008, and by letter dated August 15, 2008. 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
IN  
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0727-10
CODE
Unit: 017GN51518
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by facsimile on September 2, 2009 and by letters dated September 2, 2009 and October 29, 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
NJ   
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0729-10
CODE
Unit: 50Y22377
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, OH, by facsimile and electronic notification on March 24, 2009, and by letter dated March 24, 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
Red Blood Cells Leukocytes Reduced. Recall # B-0731-10
CODE
Unit: 041FN78294
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by facsimile or electronic notification on January 30, 2009.
Manufacturer: American Red Cross Blood Services Alabama Region, Huntsville, AL. 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
FL 
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0733-10
CODE
Units: 2326534, 2528224
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter dated June 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was taking the medication mercaptopurine, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY
___________________________________
PRODUCT
Surround System software. Recall # B-0737-10
CODE
Surround software versions 4.1, 4.2, 4.2.1, 4.2.2, 4.4, 4.5, 4.6 and 4.7
RECALLING FIRM/MANUFACTURER
Haemonetics Software Solutions, Rosemont, IL, by e-mail on July 25, 2008. Firm initiated recall is ongoing.
REASON
Software, with a defect or glitch, was distributed.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
DC, FL, HI, IL, IN, IA, LA, MI, MN, MO, NJ, NC, OH, OR, PA, RI, SC, TN, TX, WA, Canada, Hong Kong, PRC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT
Source Plasma. Recall # B-0681-10
CODE
Units: SQ092956, SQ092940
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank, Inc. of Wisconsin, Madison, WI, by facsimile dated October 19, 2009. Firm initiated recall is complete.
REASON
Source plasma, collected from a donor who subsequently tested negative for HCV and HIV NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0689-10
CODE
Unit: 4351667
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute – Sylvan N Goldman Center, Oklahoma City, OK, by facsimile on August 21, and August 31, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a previously deferred donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0723-10 
CODE
Unit: 09FK81518
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Omaha, NB, by facsimile and electronic notification on September 8, 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-0726-10
CODE
Unit: 024KR40984
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Louisville, KY, by letter dated March 21, 2008, by electronic notification on March 21, 2008, and by letter dated August 15, 2008. 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-0728-10
CODE
Unit: 017GN51518
RECALLING FIRM/MANUFACTURER
The American National Red Cross - North Central Region, Saint Paul, MN, by facsimile on September 2, 2009 and by letters dated September 2, 2009 and October 29, 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-0730-10
CODE
Unit: 50Y22377
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, OH, by facsimile and electronic notification on March 24, 2009, and by letter dated March 24, 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-0732-10
CODE
Unit: 041FN78294
RECALLING FIRM/MANUFACTURER
Recalling Firm: American Red Cross Blood Services, Birmingham, AL, by facsimile or electronic notification on January 30, 2009.
Manufacturer: American Red Cross Blood Services Alabama Region, Huntsville, AL. 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

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I
___________________________________
PRODUCT
1) MAC (TM) Two Lumen Central Venous Access Kit with ARROWg+ard Blue (R) Access Device, Integral Hemostasis Valve, Sharps Safety Features and Maximal Barrier Precautions for use with 7 - 7.5 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte). Product number ASK-21242-UVA2. Recall # Z-0783-2010;

2) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue (R) Sheath, Integral Hemostasis Valve/Side Port, Sharps Safety Features and Maximal Barrier Precautions for use with 7.5 - 8 Fr Catheters. The product is shipped in cases containing 5 catheters (contains Q-Syte). Product number ASK-29803-SJH. Recall # Z-0784-2010;

3) Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases containing 5 catheters (contains Q-Syte). Product number ASK-42703-SJH. Recall # Z-0785-2010;

4) Two-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. The product is shipped in cases containing 5 catheters (contains Q-Syte). Product number ASK-42802-SHB. Recall # Z-0786-2010;

5) Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte); Product number ASK-45703-SHB. Recall # Z-0787-2010;

6) Multi-Lumen Central Venous Catheterization Kit with Blue Flex-Tip(R), ARROWg+ard Blue PLUS (R) Catheter, Sharps Safety Features and Maximal Barrier Precautions. (contains Q-Syte). Recall # Z-0788-2010
CODE
1) Lot numbers RF9068459 and RF9060775;
2) Lot numbers RF9044900 and RF9068155;
3) Lot numbers RF9055789 and RF9071896;
4) Lot numbers: RF9068926;
5) Lot numbers: RF9071258 and RF9069621;
6) Lot numbers: RF9056115, RF9056743, and RF9060775
RECALLING FIRM/MANUFACTURER
Arrow International, Inc., Reading, PA, by letter dated November 24, 2009. Firm initiated recall is ongoing.
REASON
Q-Syte Component contained in kits was recalled by manufacturer due to the potential for embolism if used with a central venous catheter.
VOLUME OF PRODUCT IN COMMERCE
530 kits
DISTRIBUTION
GA, MD, VA
___________________________________
PRODUCT
Pump Fill Kit DT10175. Contents: 1 CSR Wrap, 2 Gloves, 1 Fenestrated Drape, 1 Extension Line Approx. Priming Vol.: 0.3mL, 1 Syringe, 1 Needle, 1 CholoraPrep(R), 1 TRAY The recalled Exel Huber Needles are used to access subcutaneously implanted ports used for the withdrawal of blood samples and infusion of medication. The firm places the recalled needles in pump fill kit. Recall # Z-1140-2010
CODE
Lot numbers: 911127, 901218, 908258, 2008091590, 2008111790, 2009011290, 2009062290, 2009090790, 2009100590 and 2009112390
RECALLING FIRM/MANUFACTURER
Recalling Firm: Centurion Medical Products, Howell, MI, by letter dated January 26, 2010. 
Manufacturer: Exelint International Co., Culver City, CA. Firm initiated recall is ongoing.
REASON
The needles that are labeled as non-coring could core 60-72% of the time.
VOLUME OF PRODUCT IN COMMERCE
880 kits
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT
Biomet 5.5 mm peek Allthread PEEK Knotless Anchor, knotless, sterile; REF 904842P. Intended to be implanted for fixation of bone fractures and for bone reconstructions. Recall # Z-0191-2010
CODE
All lots. Lot Numbers: 006120, 006130, 006150, 310980, 457500, 457510, 457520, 528050, 549180, 597000, 597010, 689520, 689530, 689540, 843100, 843140, 933310 and 933320
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN, by letter dated September 9, 2009.
Manufacturer: Biomet Sports Medicine, Ontario, CA. Firm initiated recall is ongoing.
REASON
Anchors may be difficult to remove, or may not detach from the inserter shaft.
VOLUME OF PRODUCT IN COMMERCE
894 units
DISTRIBUTION
Nationwide and Belgium

___________________________________
PRODUCT
1) Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 911, 912, 917 and Modular P; Catalog no. 03800504190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers. Recall # Z-0970-2010;

2) Roche/Hitachi cobas ONLINE TDM Gentamicin for Roche analyzer models 917 and Modular P; Catalog no. 03500241190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers. Recall # Z-0971-2010;

3) Roche/Hitachi GENT2 ONLINE TDM Gentamicin for Roche cobas c 501 analyzer systems; Catalog no. 04490843190. The product is used for in vitro diagnostic reagent for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers. Recall # Z-0972-2010
CODE
1) Lot Numbers: 15617800, 15622600, 15616900 and 15621900;
2) Lot Numbers 15622600, 15617800, 15616900 and 15816200;
3) Lot Numbers 15621900, 15617800, 15622600, 15616900, 15816200 and 15815600
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Operations, Inc., Indianapolis, IN, by letter dated October 7, 2009. Firm initiated recall is ongoing.
REASON
A high recovery of the assay may be generated, which would lead to an underdosage of gentamicin being administered to the patient.
VOLUME OF PRODUCT IN COMMERCE
13,187 kits
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Oxoid CM0225 Brain Heart Infusion IVD. The product is used for the cultivation of streptococci, pneumococci, meningococci and other fastidious organisms and is suitable for blood culture work. Recall # Z-0979-2010
CODE
Lot numbers: 762134, Exp. 2014.04.30; 793640, Exp. 2014.07.31; and 819693, Exp. 2014.10.31
RECALLING FIRM/MANUFACTURER
Recalling Firm: Remel, Inc., Lenexa, KS, by letters dated December 21, 2009 
Manufacturer: Oxoid, Ltd., Basingstoke, United Kingdom. Firm initiated recall is ongoing.
REASON
Product failure - Failure to grow quality control strains of Streptococcus pneumoniae.
VOLUME OF PRODUCT IN COMMERCE
105 bottles
DISTRIBUTION
FL, NY, MO, DE, PA
___________________________________
PRODUCT
Mainline Confirms hCG Urine Pregnancy Test Catalog # 6008C. Recall # Z-1018-2010
CODE
Lot numbers: 25310 and 25831
RECALLING FIRM/MANUFACTURER
Mainline Technology, Inc., Ann Arbor, MI, by letters dated October 7, 2009. Firm initiated recall is ongoing.
REASON
Lack of assurance of safety and efficacy: unapproved for marketing in the U.S., non-compliance with cGMP regulations and no stability data to support labeled expirations dates.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide, Belgium and Switzerland
___________________________________
PRODUCT
1) Calcium Reagent Set. Pointe Scientific Liquid Hitachi Calcium Reagent Set; Catalog #'s HC902-576 and HC902-1000. Calcium Reagent Set for repackaging, Catalog # HC902-SAM-911. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers. Recall # Z-1041-2010;

2) Calcium (CPC) R1 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R1 Reagent Set; Catalog #'s HC402-R1. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R1. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers. Recall # Z-1042-2010;

3) Calcium (CPC) R2 Reagent Set. Pointe Scientific Liquid Calcium (CPC) R2 Reagent Set; Catalog #'s HC402-R2. Calcium CPC Hitachi Reagent Set for repackaging, Catalog # 3-HC902-R2. The product is used for the quantitative determination of calcium in serum on Hitachi analyzers. Recall # Z-1043-2010  
CODE
All lots containing 813401 as part of the lot number
RECALLING FIRM/MANUFACTURER
Pointe Scientific, Inc., Canton, MI, by letter dated November 11, 2009. Firm initiated recall is ongoing.
REASON
Non-compliance with the Good Manufacturing Practice regulations, as the manufacturing process for this product had not been validated.
VOLUME OF PRODUCT IN COMMERCE
54 sets plus 30 L
DISTRIBUTION
Nationwide, Chile, India, Republic of Yemen and Trinidad
___________________________________
PRODUCT
Zimmer NexGen Complete Knee Solution Minimally Invasive Solutions Procedures Trabecular Metal Technology Tibial Tray, fixed bearing, size 8, sterile; REF 00-5954-057-02. The product is used as an implant for knee replacement. Recall # Z-1064-2010
CODE
All lots. Lots 00111134, 60747593, 60747594, 60752676, 60752677, 60760248, 60768076, 60821507, 60824004, 60830411, 60830412, 60845351, 60850604, 60852670, 60852671, 60860895, 60866613, 60872311, 60879050, 60892605, 60900745, 60907449, 60917234, 60922494, 60938889, 60938890, 60947027, 60947028, 60963035, 60963036, 60963037, 60963039, 60983254, 61015851, 61028168, 61033723, 61033724, 61068387, 61068388, 61068389, 61074754, 61074755, 61084771, 61096604, 61116246, 61116247, 61137056, 61143427, 61149041, 61157940, 61173295, 61193516, 61193520, 61198179, 61204038, 61215644, 61225562, 61235612, 61240323, 61248321, 61259184, 61263170, 61272449, 61285508, 61298201, 61306497, 61280371, 61315873, 61319581 and 61329266
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by e-mails on December 1, 2009, December 2, 2009 and December 3, 2009 and by letter on December 9, 2009. Firm initiated recall is ongoing.
REASON
The titanium portion of the implant may separate from the trabecular metal material.
VOLUME OF PRODUCT IN COMMERCE
846 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Canada, Denmark, France, Germany, Italy, Saudi Arabia, Spain, Sweden, Switzerland and the United Kingdom.
___________________________________
PRODUCT
Hill-Rom TotalCare Bed; Model P1900. The product is used as an AC powered adjustable hospital bed. Recall # Z-1065-2010
CODE
Serial numbers K285AM5539 through K310AM5864. Serial numbers K310AM5857 , K296AM5635 , K296AM5629 , K295AM5623 , K306AM5779 , K306AM5777 , K303AM5747 , K303AM5741 , K300AM5677 , K300AM5675 , K299AM5654 , K299AM5651 , K302AM5718 , K301AM5715 , K301AM5712 , K301AM5710 , K301AM5709 , K301AM5707 , K301AM5705 , K301AM5704 , K301AM5702 , K301AM5700 , K301AM5696 , K301AM5695 , K300AM5693 , K300AM5690 , K300AM5686 , K300AM5682 , K299AM5660 , K299AM5653 , K296AM5647 , K296AM5643 , K299AM5656 , K299AM5652 , K302AM5725 , K302AM5723 , K302AM5719 , K301AM5714 , K301AM5698 , K300AM5688 , K299AM5663 , K299AM5658 , K302AM5735 , K302AM5733 , K302AM5731 , K302AM5729 , K302AM5726 , K302AM5724 , K302AM5722 , K302AM5720 , K302AM5716 , K301AM5713 , K301AM5708 , K301AM5706 , K300AM5691 , K294AM5594 , K303AM5761 , K303AM5748 , K303AM5739 , K303AM5760 , K303AM5759 , K303AM5758 , K303AM5757 , K303AM5756 , K303AM5755 , K303AM5754 , K303AM5753 , K303AM5752 , K303AM5751 , K303AM5750 , K303AM5749 , K303AM5738 , K296AM5648 , K296AM5645 , K296AM5642 , K306AM5780 , K306AM5776 , K303AM5740 , K302AM5737 , K302AM5734 , K302AM5732 , K302AM5730 , K302AM5728 , K302AM5721 , K300AM5678 , K300AM5676 , K300AM5674 , K299AM5669 , K299AM5666 , K299AM5665 , K299AM5662 , K296AM5644 , K296AM5641 , K296AM5639 , K296AM5637 , K296AM5631 , K295AM5619 , K308AM5812 , K307AM5797 , K306AM5775 , K306AM5772 , K306AM5771 , K306AM5770 , K306AM5769 , K306AM5768 , K306AM5767 , K306AM5766 , K306AM5765 , K306AM5764 , K306AM5763 , K299AM5671 , K299AM5668 , K299AM5667 , K299AM5664 , K299AM5661 , K299AM5659 , K299AM5655 , K303AM5746 , K303AM5745 , K303AM5744 , K303AM5742 , K294AM5599 , K294AM5584 , K300AM5687 , K300AM5692 , K300AM5689 , K300AM5685 , K300AM5683 , K300AM5673 , K299AM5670 , K302AM5727 , K294AM5595 , K294AM5593 , K294AM5591 , K294AM5590 , K294AM5587 , K299AM5650 , K296AM5649 , K296AM5640 , K296AM5638 , K296AM5636 , K296AM5634 , K296AM5630 , K296AM5628 , K295AM5625 , K295AM5624 , K295AM5622 , K295AM5621 , K295AM5620 , K295AM5618 , K295AM5616 , K295AM5614 , K295AM5612 , K295AM5611 , K295AM5609 , K295AM5607 , K294AM5605 , K294AM5604 , K294AM5600 , K294AM5596 , K294AM5586 , K294AM5585 , K294AM5583 , K294AM5582 , K294AM5579 , K294AM5578 , K299AM5589 , K294AM5601 , K294AM5598 , K294AM5603 , K294AM5592 , K302AM5717 , K301AM5711 , K301AM5699 , K301AM5697 , K300AM5684 , K300AM5672 , K301AM5703 , K301AM5701 , K296AM5646 , K294AM5588 , K294AM5581 , K294AM5580 , K296AM5633 and K295AM5627
RECALLING FIRM/MANUFACTURER
Hill-Rom, Inc, Batesville, IN, by letter dated January 4, 2010. Firm initiated recall is ongoing.
REASON
The controls for nurse call, bed movement and entertainment functions on the intermediate rail may fail to function.
VOLUME OF PRODUCT IN COMMERCE
185 units
DISTRIBUTION
Australia, Canada, France, Germany, Mexico, United Arab Emirates and United Kingdom
___________________________________
PRODUCT
Electri-Cord AC Power Cords, IEC 60320 Coupler, Product Reorder Number 21-2145-01 only for use with Smiths Medical CADD®-Solis ambulatory infusion pumps, Model 2100. These cords were sold as an accessory for these pumps under Manufacturing Number A23.164.098.0A, Electri-Cord part Number PC2000403. Electri-Cord AC Power Cords are accessories for use with the CADD®-Solis Ambulatory Infusion Pump. These power cords allow users to run the pump via AC power rather than battery power. The CADD®-Solis pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/ surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both. Recall # Z-1082-2010
CODE
Lot # 0068858-1-1
RECALLING FIRM/MANUFACTURER
Smiths Medical ASD, Inc., Saint Paul, MN, by letter dated January 27, 2010. Firm initiated recall is ongoing.
REASON
Potential for the power cord's prongs to crack and fail at/or inside the plug. Other medical device manufacturers have reported incidents of sparking, charring, and fires from the affected power cords used with their devices. Smiths Medical has received no reports of incidents regarding the use of the affected Electri-Cord power cords with their devices.
VOLUME OF PRODUCT IN COMMERCE
62 units
DISTRIBUTION
KY, OH and Canada
___________________________________
PRODUCT
1) Femoral Sponge 10 inches REF 206-715, Rx Sterile. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction. Recall # Z-1104-2010;

2) Bio-Prep Bone Preparation Kit with Merocel sponge for use in total hip arthroplasty. REF 206-730, Rx, Sterile. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction. Recall # Z-1105-2010;

3) Advanced Cement Mixing Bio-Prep Cement Application Kit, Rx, Sterile, REF 306-563S10. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction. Recall # Z-1106-2010;

4) ACM with Femoral Brush and Femoral Sponge, Rx, Sterile, REF 306-705-000S8. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction. Z-1107-2010;

5) ACM Bio-Prep with Merocel pkg/6, Rx, Sterile, REF 0306-708-000S4. The femoral sponge is an absorbent that is used to dry the intramedullary canal prior to the application of bone cement. The suction effectively absorbs blood and fluid from the canal. It may provide swabbing/scrubbing action during suction. Recall # Z-1108-2010
CODE
1) Lot numbers: 743288, 743289, 743330, 743331, 743332, 743333, 743362, 743363, 743364, 743365, 743378, 743379, 743380, 743381, 743390, 743391, 743400, 743402, 743403, 743404, 743405, 743418, 743419, 743420, 743421, 743422, 743423, 743445, 743446, 743447, 743448 and 743449;

2) Lot numbers: 04230CE2, 04257CE2, 04286CE2, 04310CE2, 04334CE2, 05004CE2, 05041CE2, 05109CE2, 05200012, 05222012, 05292012, 05346012, 06038012, 06128012, 06172012, 06241012, 06268012, 06313012, 06348012, 07022012, 07031012, 07053012, 07081012, 07106012, 07136012, 07177012, 07192012, 07219012, 07253012, 07276012, 07320012, 07341012, 08010012, 08043012, 08063012, 08095012, 08127012, 08162012, 08177012, 08203012, 08249012, 08296012, 08325012, 08351012, 09040012, 09075012, 09106012 and 09138012;

3) Lot numbers: 06292012, 07297012, 07354012 and 08164012;

4) 4) Lot number:  05068CS2 and 05210012;

5) Lot numbers: 05257012 and 08129012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI, by letter dated January 21, 2010.
Manufacturer: Hydrofera, LLC, Willimantic, CT. and Stryker Puerto Rico, LTD, Arroyo, PR. Firm initiated recall is ongoing.
REASON
The firm did not have packaging validation to support the labeled shelf life. There is potential for a breach in sterility specific to the sterile packaged femoral sponge which may result in a non-sterile product.
VOLUME OF PRODUCT IN COMMERCE
9,257 units
DISTRIBUTION
Nationwide, Canada, Mexico, Australia, Brazil, Switzerland, Japan, Netherlands, England, UK, Sweden, Hong Kong, Korea, Malaysia, Singapore, Argentina, Spain, and Italy
___________________________________
PRODUCT
PrecisePLAN 2.15 Treatment Planning System. The product is used to plan multiple beam radiation therapy treatments. Recall # Z-1109-2010
CODE
Lot numbers: 0800690C208F, 0800690C2228, 0800690C934D. 080069107C11, 08006907BB7F, 08006907B074, 08006907B129, 08006907BB7D, 0800690E964F, 0800690EA07F, 08006909355C, 08006902E7CF, 08006907BEE0, 08006909DA0F, 0800690A4565, 080069100F06, 080069103003, 080069103015, 080069103265, 08006910326F, 08006907B051, 08006910178B, 0800690A9B6B, 0800690A466D, 08006908EFB4, 080069090A10, 0800690977C2, 08006909D8DE, 08006909D8DA, 0800690937B1, 08006908EDF3, 0800690A02F6, 0800690ABEC5, 0800690761D4, 0800690C2229, 0800690AC55A, 0800690A2865, 0800690A25BA, 0800690AB1EE, 080069087078, 0800690883D0, 0800690E984E, 08006905C04D, 0800690A02F3, 0800690A47CF, 0800690C1E5A, 0800690EAE97, 08006906D9B0, 08006906D94E, 0800691050D5, 0800690AB49C, 0800690C9357, 0800690AC0A3, 0800690ABEE0, 0800690C1DF2, 0800690C21B1, 0800690ABF4D, 0800690A0FE1, 080069AB4C1, 0800690906AE, 08006907F138, 08006909F10F, 080069090953, 080069EC1DD, 0800690883CB, 0800690A0FF6, 0800690A0FEF, 0800690C9148, 0800690A8793, 0800690A02F5, 08006902E9E0, 08006902E7D1, 0800690C9B7B, 08006902E7F8, 0800690E8CA9, 08006902EA0A, 0800690E7279, 0800690761D1, 0800690841C6, 08006908ED1C, 080069105594, 0800690C0D48, 0800691064DE, 080069087740, 0800690937BB, 080069090260, 08006907CA1C, 08006905E180, 08006905E6BA, 0800690ED67D, 08009607D4EF, 08006907D6B8, 08006907BB82, 08006910762B, 08006910762A, 08006907BB8E, 08006902E7F0, 080069077BB7, 0800690C54B2, 0800690A73DA, 08006909FA29, 0800690978E3, 08006907CA22, 08006907999A, 0800690CECEA, 0800690CDF04, 0800690909AB, 08006902E925, 08006910001E, 08006910623A, 08006910624F, 080069079BB3, 0800690761CF, 08006907DADE, 0800690E72DF, 08006908A3A8, 0800690A02FD, 08006902EB35, 0800691003D7, 080069107262, 0800690E7F53, 08006909D80B, 08006905E498, 08006905E63C, 0800690A0BA5, 0800690ED72E, 0800690ED90E, 08006905A8E6, 080069086F94,0800690883CD, 080069088319, 0800690EBC3A, 0800690EBBFF, 0800690EBFCA, 0800690A8830, 0800690A8841, 080069076231, 08006907622F, 0800690C90F4, 08006902E918, 080069107342, 080069088273, 08006909F50B, 0800690977ED, 08006907C7A1, 080069076BF4, 0800690C9B17, 0800690C2B4E, 08006905C433, 08006905BE74, 08006905E723, 08006905A225, 0800690883C8, 08006909673B, 0800690C9AA2, 08006907BB7E, 08006907023, 08006908706A, 08006909F1BB, 08006909EFA6, 080069099D13, 0800690A2863, 0800690A0FE4, 08006908847A, 080069088463, 0800690A0FE5, 08006909F507, 0800690CED1C, 08006907BEDF, 08006905BA2D, 0800690CE165, 08006905EB6E, 080069087A27, 0800690C6356, 0800690E9F8A, 0800690E9AB7, 0800690E82C4, 0800690E7283, 0800690EADC5, 0800690EACE8, 0800690EA40C, 0800690EA365, 080069099D0A, 080069086F92, 0800691077E0, 0800690C2168, 080069090841, 08006908F51D, 080069086630, 0800690907F5, 0800690907CD, 080069104115, 0800690A854C, 0800690A4677, 0800690A37AE, 080069106B53, 08006910816B, 0800690EAFCF, 0800690CDDA2, 0800690E72F7, 08006909FD0C, 08006909FD1B, 0800690A4670, 08006907BB89, 0800690A9DOE, 0800690A87F2, 08006907BB55, 0800690840A8, 080069087720, 080069076227, 08006908EC10, 0800690937B9, 0800690BD8A4, 080069132DDF, 080069134331, 0800691048A5, 0800690A2507, 0800690E9A67, 0800690A85E1, 0800690A8F4C, 0800690A1438, 0800690A13FB, 0800690A90FD, 0800690E6CF9, 080069102A57, 0800690EC864, 0800690909B4, 080069A0FE2, 0800690A8E1F, 080069100F95, 080069098EF6, 0800690C1745, 08006909D95A, 0800690A740E, 0800690A7410, 0800690AC55B, 0800690ACA88, 08006909D93B, 080069097A4D, 080069097A4E, 0800690A02FC, 0800690A47CE, 0800690A47E5, 0800690A47AE, 0800691050AF, 0800690A97D1, 0800690A1DC6, 08006907BEB2, 0800690A8F6D, 0800690A8F4F, 0800690EAF6D, 0800690EB40C, 08006907BB6D, 0800690CF7A2, 0800691003C3, 080069100455, 0800690ED7DF, 0800690CE157, 0800690EB787, 0800690ED7CO, 08006910560F, 08006910561E, 080069105607, 0800690ED967, 080069106136, 0800691075FB, 080069107C1F, 080069108174, 08006910762C, 0800690F6E74, 08006902E8DB, 0800690A85FB, 0800690949E1, 080069107CB2, 80069104499, 80069100706, 0800690C1E69, 08006910621E, 0049434409 and 1116245379
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by important notice dated May 8, 2007 and September 30, 2008.  
Manufacturer: Elekta Oncology Systems (Fmrl Philipps), West Sussex, UK. Firm initiated recall is ongoing.  
REASON
The new "DICOM CT with Body Outline" method to create a patient case in PrecisePLAN 2.15 may produce incorrect results for some customers, given several input conditions encountered in the field. Discontinue use of this method of creating a patient case until FCO 772 00 540 064, (entitled "Update for Patient creation method using DICOM CT with Body Outline"), is received from Elekta to update this utility. This problem only applies to customers using the "DICOM CT with Body Outline" method of creating a patient case and this option is only available in release 2.15 of PrecisePLAN. The "DICOM CT" method in release 2.15 and previous releases of PrecisePLAN is not affected by this problem (see User Manual section 3.2.2). The Field Change Order details the prerequisites and installation instructions for upgrading PrecisePLAN users to the new release, 2.16 (Linux customers) or 2.12 (SGI customers).
VOLUME OF PRODUCT IN COMMERCE
280 units
DISTRIBUTION
Nationwide and France
___________________________________
PRODUCT
The Martel Printer is an accessory to the i-STAT Portable clinical Analyzer (model 300). The i-STAT Analyzer is used by trained medical professionals for running a variety of clinical chemistry tests and test panels contained in i-STAT test cartridges. These tests include Hematocrit, glucose, blood urea nitrogen, sodium, potassium, chloride, ionized calcium, blood gases (oxygen, carbon dioxide, and pH), Creatinine, lactate and activated clotting time. List number 06F23-91/111300; Abbott list number: 06F23-91. Recall # Z-1133-2010
CODE
Serial numbers between 20091081 and 241248976
RECALLING FIRM/MANUFACTURER
Abbott Point of Care, Inc., Princeton, NJ, by letter dated October 2009. Firm initiated recall is ongoing.
REASON
Some Martel Printers used with the i-STAT 1 system have the potential of being damaged due to the use or rechargeable battery packs that do not contain a fuse.
VOLUME OF PRODUCT IN COMMERCE
5,224 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Philips Switched Internal Defibrillator Paddles (used with Philips HeartStart XL and HeartStart MRx monitor/defibrillators) Models: M4741A - Extra Large Switched internal Paddles M4742A - Large Switched internal Paddles M4743A - Medium Switched internal Paddles M4744A - Small Switched internal Paddles. Recall # Z-1135-2010
CODE
Units with date codes (mmyy) of 0908, 1008, 1108, 1208 (Units manufactured by Philips between September 1, 2008 and December 30, 2008)
RECALLING FIRM/MANUFACTURER
Philips Healthcare, Inc., Andover, MA, by letter on January 25, 2010. Firm initiated recall is ongoing.
REASON
Paddle shock switch may fail to actuate and delay or prevent delivery of defibrillation therapy.
VOLUME OF PRODUCT IN COMMERCE
1,592 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
PTS Panels Lipids Panel test strips for self-testing or professional use with CardioChek P-A analyzers; Catalog # 1710. Recall # Z-1136-2010
CODE
Lot number: P814; exp. 9/2/09
RECALLING FIRM/MANUFACTURER
Polymer Technology Systems, Inc., Indianapolis, IN, by letter dated June 5, 2009. Firm initiated recall is complete.
REASON
Exhibits under-recovery of all analytes.
VOLUME OF PRODUCT IN COMMERCE
Not available
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT
1) Modified Novy Cornual Cannulation Set with clear tip, G17558, REF J-NCS-504070, Cook OB/GYN. Recall # Z-1137-2010;

2) Modified Novy Cornual Cannulation Set with clear tip, G17558, REF J-NCS-504070, Cook OB/GYN. Recall # Z-1138-2010
CODE
1) Units: U1707021, U1716443, U1718282, U1718283, U1721655, U1739397, U1752842, U1755314, U1755769, U1834419, U1834420, U1834421, UF1748711, UF1758368, and UF1758369;

2) Units: U1705449, U1707347, U1709250, U1711011, U1714331, U1734602, U1737151, U1743919, U1746659, U1746660, U1755767, U1772781, U1772782, U1791573, U1792176, U1793188, U1799467, U1825725, U1825726, U1841365, U1862710 and U1863536
RECALLING FIRM/MANUFACTURER
Cook Women’s Health, Spencer, IN, by letters dated January 8, 2010. Firm initiated recall is ongoing.
REASON
The distal tip may separate from the catheter while the catheter is in the patient.
VOLUME OF PRODUCT IN COMMERCE
721 units
DISTRIBUTION
Nationwide, Ireland, China, Canada, India, Australia, Hong Kong
___________________________________
PRODUCT
remel A.C.T. II Sterile Pack Tube, Collection and Transport System, Ref 12402, 10/pk, each Tyvek pouch contains 1 tube of medium and 1 rayon-tipped sterile swab. Product is a sterile system recommended for use in qualitative procedures for the collection of clinical specimens and transport to the laboratory for microbiological culture of anaerobic, facultative, and aerobic organisms. Recall # Z-1139-2010
CODE
Lot number: 834019, Exp. 2010.10.27
RECALLING FIRM/MANUFACTURER
Remel, Inc., Lenexa, KS, by letter dated January 18, 2010. Firm initiated recall is ongoing.
REASON
Pouch may be inadequately heat sealed compromising sterility.
VOLUME OF PRODUCT IN COMMERCE
154/10-package containers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Neutralect Diathermy Cable, Unomedical Ltd., Ref code 3508M, and Ref Code 3405M. No expiration dates. Recall # Z-1142-2010
CODE
Lot numbers: 568229, 568588, 568784, 569128, 620731, 621058, 621143, 621453, 621608, 622599, 622890
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConvaTec, Skillman, NJ, by letters on January 22, 2010.
Manufacturer: Unomedical, Ltd. Stonehouse, Glos, UK. Firm initiated recall is ongoing.
REASON
Mislabeling: Boxes labeled with the order code 3508M may contain a cable for the order code 3405M, and boxes labeled with order code 3405M may contain a cable for order code 3508M.
VOLUME OF PRODUCT IN COMMERCE
1,270 cables
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Ventana Pathway anti-Her-2/NEU (4B5) Rabbit Monoclonal Primary Antibody (Pathway HER2 (4B5); Model Number: 790-2991, in vitro diagnostic. Recall # Z-1146-2010
CODE
Lot number: 680957
RECALLING FIRM/MANUFACTURER
Ventana Medical Systems, Inc., Tucson, AZ, by letter on September 17, 2009. Firm initiated recall is ongoing.
REASON
Light staining inconsistencies.
VOLUME OF PRODUCT IN COMMERCE
433 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Paraffin Pretreatment Reagent Kit II; each kit contains the following: 5 x 50 mL Pretreatment Solution (sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer II (0.2N HCl), 5 x 250 mg Protease I (Pepsin, lyophilized, activity 1:3000 to 1:3500); Abbott Molecular Inc; list 07J02-002, part number 32-801210. invitro diagnostic. Recall # Z-1147-2010;

2) Paraffin Pretreatment Reagent Kit III; each kit contains the following: 5 x 50 mL Pretreatment Solution (1N sodium thiocyanate - NaSCN), 5 x 62.5 mL Protease Buffer III (50 mM Tris base, pH 8.0 5 mM Calcium Chloride - 2H2O 0.1% SDS), 5 x 9.0 mg Protease III (Proteinase K, 35 <= x <= 38 Units/mg) 2 x 200 mL Protease Stop Solution (0.01N hydrochloric acid - HCl); Abbott Molecular Inc; list 07J02-003, part number 32-801230. invitro diagnostic. Recall # Z-1148-2010
CODE
1) Lot numbers: 420563, 420008 and 418294;
2) Lot numbers: 420063 and 418669
RECALLING FIRM/MANUFACTURER
Abbott Molecular, Des Plaines, IL, by letters dated January 21, 2010. Firm initiated recall is ongoing.
REASON
The Paraffin Pretreatment Reagent kits do not have any hazardous or MSDS information included in their labeling.
VOLUME OF PRODUCT IN COMMERCE
322 kits
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
Bond-1 Primer/Adhesive. The intended use of this device is adhesion to dentin of various polymeric filling materials (composites) used with other conditioners or combination of conditioners for bonding of composite to metal including amalgam, gold, semi-precious and non-precious alloys, porcelain and glass and luting of same to Dentin and Enamel. Recall # Z-1150-2010
CODE
Lot numbers: 186620, 190582 and 190985
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sybron Dental Specialties, Orange, CA, by letter on August 24, 2009.
Manufacturer: Pentron Clinical Technologies, Wallingford, CT. Firm initiated recall is ongoing.
REASON
Some of the material has been found to be gelled and therefore becomes unusable.
VOLUME OF PRODUCT IN COMMERCE
1,400 units
DISTRIBUTION
Nationwide, Canada, Netherlands, Sweden, Taiwan and Thailand
___________________________________
PRODUCT
Piccolo Comprehensive Metabolic Panel Reagent Disc, 10-pack box, for use with the Piccolo Blood Chemistry Analyzer or Piccoloxpress Chemistry Analyzer, Catalog No. 400-0028. Medical device for use in the in vitro quantitative determination of alanine aminotransferase (ALT), albumin, alkaline Phosphatase (ALP), aspartate aminotransferase, calcium, chloride, creatinine, glucose, potassium, sodium, total bilirubin, total carbon dioxide, total protein, and blood urea nitrogen in heparinized whole blood, heparinized plasma or serum. Recall # Z-1155-2010
CODE
Lot number: 9284AC2, accidentally labeled as 9285AC2, Exp. Date 7/9/2010
RECALLING FIRM/MANUFACTURER
Abaxis, Inc., Union City, CA, by letter dated November 16, 2009. Firm initiated recall is ongoing.
REASON
Wrong barcode applied to a lot of items, which may result in incorrect calibration factors and results.
VOLUME OF PRODUCT IN COMMERCE
1,010 units
DISTRIBUTION
Nationwide, Canada, EU and Asia
___________________________________
PRODUCT
Elekta SL Series/Precise Digital Accelerator. The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. a) Model SL15; b) Model SL18; c) Model SL25; d) Model PRECISE ACC; e) Model SYNERGY PLAT; f) Model SL20; g) Model SL75/5; h) Model SL1+; i) Model SL1; j) Model SL75/20. Recall # Z-1159-2010
CODE
a) Serial Nos. 105102, 105333, 105481, 105279, 1054424, 105325, 105364, 105387, 105291, 105280, 105261, 105297, 105355, 105386, 105342, 105367; b) Serial Nos. 105213, 105392, 105395, 105326, 105203, 105369, 105284, 105153, 105166, 105324, 105265, 105320, 105177, 105305, 105122, 105199, 105359, 105366, 105126, 105363, 105178, 105233; c) Serial Nos. 105013, 105204, 105245, 105373, 105376, 105275, 105277, 105127, 105196, 105393, 105186, 105217, 105210, 105117, 105137, 105215105194, 105195, 105228, 105236, 105235, 105104, 105240, 105368; d) Serial Nos. 105992, 105894, 105563, 105806, 105902, 105627, 105706, 105785, 105821, 105871, 105648, 105655, 105882, 105960, 105754, 105886, 105606, 105585, 105731, 105989, 105727, 105782, 151075, 151077, 151098, 105841, 151099, 105630, 151014, 105895, 105816, 105864, 105846, 1055559, 105657, 105853, 105854, 105829, 151016, 105660, 105844, 105890, 105621, 105587, 151035, 105580, 105809, 105644, 105593, 105705, 105699, 105803, 105723, 105647, 105898, 105369, 105949, 105868, 105998, 105637, 105837, 105636, 105716, 105717, 151029, 105759, 105770, 105772, 105776, 105925, 105568, 105650, 105591, 105929, 105584, 105624, 105941, 105666, 108573, 105926, 105646, 105676, 105260, 105773, 105936, 105872, 105678, 151159, 151030, 105910, 105969, 151015, 105812, 105796, 105950, 105881, 105859, 105728, 105561, 105590, 105612, 105567, 105744, 105566, 105879, 105828, 105856, 105918, 105555, 105610, 105883, 105914, 105990, 105586, 151154, 105649, 105565, 105564; e) Serial Nos. 151033, 151216, 151173, 151053, 105826, 151200, 151201, 151116, 151025, 151160, 105982, 151256, 151076, 151110, 151008, 151093, 151229, 105932, 151143, 151038, 151059, 151260, 151130, 151024, 151214, 151167, 151051, 151176, 151080, 151104, 151259, 151238, 151084, 105984, 151155, 151156, 151157, 151074, 151266, 151134, 151141, 151055, 151073, 151178, 151168, 151151; f) Serial Nos. 105285, 105093, 105321, 105358, 105286, 105295, 105249, 105274, 105288, 105381, 105403, 105323, 105319, 105312, 105316, 105257, 105267, 105207, 105057, 105351, 105327, 105273, 105185, 105339, 105300, 105187, 105382, 105154; g) Serial Nos. 103137, 103172, 103174, 103092, 103091, 103130, 103131, 103124, 103394, 103099, 103159, 103081, 103384, 103026, 103053, 103050, 103110, 103001, 103177, 103161, 103030, 103084, 103064, 103055, 103154, 103399, 103346, 103375, 103027, 103386; h) Serial Nos. 105447, 105465, 105518, 105528, 105514, 105478, 105466, 105519, 105498, 105453, 105492, 105467, 105445, 105452; i) Serial Nos. 105475, 105521, 105549, 105494, 105437, 105503, 105530, 105544, 105488, 105515, 105482, 105532; j) Serial Nos. 273, 266, 269, 274
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated November 18, 2005.
Manufacturer: Elkta Oncology Systems (Fmrl Phillipps), Crawley, West Sussex, UK. Firm initiated recall is complete.
REASON
Customer reported larger than expected variations in wedge factory with gantry rotation.
VOLUME OF PRODUCT IN COMMERCE
315 units
DISTRIBUTION
Nationwide, Canada, Mexico
___________________________________
PRODUCT
Thermoflect Product Line including items for adults and pediatrics. Recall # Z-1175-2010
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Encompass Group LLC, McDonough, GA, by letters on/about December 23, 2009 and press release on/about December 26, 2009.
Manufacturer: Encompass Therapeutic Support Systems dba BG - North America, Glendale, CA. Firm initiated recall is ongoing.
REASON
The products are not compatible for use in the Magnetic Resonance Imaging (MRI) environment.
VOLUME OF PRODUCT IN COMMERCE
700,000 units (of various product lines)
DISTRIBUTION
Nationwide and Switzerland
___________________________________
PRODUCT
Image Consultant (IC) Software. Recall # Z-1176-2010
CODE
Not coded
RECALLING FIRM/MANUFACTURER
Recalling Firm: R. O. Golden & Co., Inc., Elkins Park, PA, by letters on February 5, 2010.
Manufacturer: Unique Media, Canton, PA. Firm initiated recall is ongoing.
REASON
Software not validated.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
AL, FL, LA, MA, NC, OK, OR, PA, TX, WI, WA

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS III
___________________________________
PRODUCT
PTS Panels LDL Cholesterol test strips for professional use with CardioChek P-A test systems; Catalog No. 1753. For the quantitative measurement of LDL cholesterol in whole blood. Recall # Z-1132-2010
CODE
Lots L771, exp. 12/04/08 and L781, exp. 12/17/2008
RECALLING FIRM/MANUFACTURER
Polymer Technology Systems, Inc., Indianapolis, IN, by letter dated May 29, 2009. Firm initiated recall is complete.
REASON
The expiration date was extended by 20 weeks without justification.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
BIO-RAD 425-2020 Autoimmune EIA Anti-Cardiolipin IgM, 96 Tests...2010 02 16. Positive Control included in lot is identified as "REF 425-2025". in vitro diagnostic. Recall # Z-1145-2010 
CODE
LOT CL-863; LOT CPM-591
RECALLING FIRM/MANUFACTURER
Bio-Rad Laboratories, Inc., Hercules, CA, by letter on July 14, 2009. Firm initiated recall is ongoing.
REASON
The firm received customer complaints of microbial contamination in Positive Controls in its Anti-Cardiolipin IgM Test Kit Lot CL-863v.
VOLUME OF PRODUCT IN COMMERCE
213 units
DISTRIBUTION
Nationwide, Australia, Canada, France, Italy, Korea, Mexico, Panama, Singapore, and Trinidad

END OF ENFORCEMENT REPORT FOR MARCH 24, 2010

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