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U.S. Department of Health and Human Services

Safety

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Enforcement Report for December 16, 2009

December 16, 2009
09-50

RECALLS AND FIELD CORRECTIONS:  COSMETICS - CLASS II
___________________________________
PRODUCT 
1) Abbey Brown All That Jazz Silk Milk; Pure Oils of Jojoba, Bergamot, Ylang Ylang, Jasmine & Calendula Petals blended in rich milk along with Therapeutic Dead Sea Salts of Israel; packaged in 8 oz. and 16 oz. brown paper bags. Recall # F-0725-2010;

2) Abbey Brown Lavender Silk Milk; Pure Oils of Bulgarian Lavender & Rosemary blended in rich milk along with Therapeutic Dead Sea Salts of Israel & Lavender Petals; packaged in 8 oz. and 16 oz. brown paper bags. Recall # F-0726-2010;

3) Abbey Brown Mango Silk Milk; Pure Oils of Jojoba, Fresh Mango, Sweet Orange & Vanilla blended in rich milk along with Therapeutic Dead Sea Salts of Israel; packaged in 8 oz. and 16 oz. brown paper bags. Recall # F-0727-2010;

4) Abbey Brown Pear Up Silk Milk; Pure Oils of Jojoba, Fresh Pear & Cucumber blended in rich milk along with Therapeutic Dead Sea Salts of Israel; packaged in 8 oz. and 16 oz. brown paper bags. Recall # F-0728-2010;

5) Abbey Brown Rosebuds Silk Milk; Pure Oils of Jojoba, Geranium Rose & Rosewood blended in rich milk along with Therapeutic Dead Sea Salts of Israel; packaged in 8 oz. and 16 oz. brown paper bags. Recall # F-0729-2010;

6) Abbey Brown Chamomile Babe Baby Milk Bath; Essential Oils of Bulgarian Lavender, Chamomile Water infused in pure Apricot, Avocado & Macadamia Nut Oils blended together in a rich Milk, Oats, Chamomile & Lavender petals; packaged in 14 oz. clear glass bottles. Recall # F-0730-2010
CODE
There are no lot numbers. All products sold prior to 6/26/09.
RECALLING FIRM/MANUFACTURER
Debutante dba Abbey Brown Soap Artisan, Chicago, IL, by e-mail and verbally on July 11, 2009. Firm initiated recall is ongoing.
REASON
Milk Bath Powders may be contaminated with Salmonella because they were manufactured using an ingredient recalled by Plainview Milk Products Cooperative.
VOLUME OF PRODUCT IN COMMERCE
356 containers
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT 
Prairie Farms Old Recipe Candy Bar Premium Ice Cream, 56 oz (1.65 L) round cartons; UPC 0 72730-72008 4. Recall # F-0653-2010
CODE
Best by: April 14, 2008 through January 15, 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Prairie Farms Dairy Inc., Carlinville, IL, by press release on February 2, 2009. 
Manufacturer: Prairie Farms Dairy Inc., Decatur, IL. Firm initiated recall is complete.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
82,596 - 56 oz cartons
DISTRIBUTION
IL, IN, KY, MI, MO, MS, OH, TN
___________________________________
PRODUCT 
1) SUNBURST MIX sold in bulk Net wt. 25 lbs labeled Peanuts Product of USA, Raisins product of USA or South Africa. Recall # F-0656-2010;

2) SWEET & NUTTY MIX sold in bulk 25 lbs. and retail with the following brand names: Valu Time Net wt. 8 oz. 11225 04748 case count 12; Gourmet Select Net wt. 7 oz. 39277 49490 case ct. 24. Recall # F-0657-2010;

3) GOJI BERRY BLISS sold in bulk 25 lbs. Item #30202. Recall # F-0658-2010;

4) SPICY TRAIL MIX sold in bulk 20 lbs. Material #10012778. Recall # F-0659-2010;

5) SHERMAN'S HEART HEALTHY TRAIL sold in bulk 25 lbs. Recall # F-0660-2010;

6) SANTA FE TRAIL (HOT & SASSY) sold in bulk 20 lbs. Item #30265 and retail size with the following brand names: HYVEE Net wt. 6.5 oz. and Shurfine Finest Creations Net wt. 13 oz. Recall # F-0661-2010;

7) GRANOLA FRUIT & NUT sold in bulk 25 lbs. Recall # F-0662-2010;

8) ORGANIC AMBASSADOR TRAIL MIX sold in bulk 25 lbs. Item #30201. Recall # F-0663-2010;

9) Jumbo TRAIL MIX HONEY NUT CRUNCH, Net wt. 28 oz. brand Southern Grove. Recall # F-0664-2010;

10) TRAIL MIX (NUT, SEEDS & RAISINS) Brand - Southern Grove, Net wt. 1.75 oz. Recall # F-0665-2010;

11) TRAIL MIX, INDULGENT, Peanuts, Raisins, Milk Chocolate, White Chocolate, Peanut Butter Chips and Almonds, Net wt. 10 oz. Brand - Southern Grove. Recall # F-0666-2010;

12) TRAIL MIX, WHITE MOUNTAIN, Nuts, Pineapple, Cranberries and Creamy Vanilla Candies, Net wt. 1.75, Brand - Southern Grove. Recall # F-0667-2010;

13) TRAIL MIX with BRANDS HYVEE Dark Chocolate Cranberry 24 oz. and Souther Grove brand Cranberry & Nut Net wt. 10 oz. Recall # F-0668-2010;

14) Party Peanuts Roasted Net wt. 12 oz. and Salted Peanuts Net Wt. 1.75 oz. both are Southern Grove brand. Recall # F-0669-2010;

15) Spicy Peanuts Roasted Salted, Southern Grove Brand, Net wt. 12 oz. Recall # F-0670-2010;

16) Honey Roasted Peanuts, Southern Grove brand, Net wt. 1.75 oz. Recall # F-0671-2010;

17) Raisin & Nut Mix, Sunflower Seeds, Peanuts, Raisins, Soy Nuts, Brand VALU TIME, Net. wt. 8 oz. Recall # F-0672-2010;

18) GORP MIX, Net wt, 15 oz., Shurfine brand. Recall # F-0673-2010;

19) ENERGY MIX, Net wt 14 oz. Brand Shurfine. Recall # F-0674-2010;

20) CALIFORNIA MIX, Net wt. 15 oz., Shurfine Brand. Recall # F-0675-2010;

21) TRAIL MIX Raisin & Nut in the following brands:1) Shurfine, Net wt. 15 oz.; 2) HyVee brand, Trail Mix, Raisin & Nut, Net wt. 9 oz., & 28 oz.; 3) Food Club Brand TRAIL MIX, Raisin & Nut, Net wt. 32 oz.; 4) Gourmet Select, Net wt., 7 oz. Recall # F-0676-2010;

22) Cajun Mix in two brands: VALU TIME, Net wt. 6 oz. and Gourmet Select, Net wt., 6 oz. Recall # F-0677-2010;

23) TRAIL MIX, Nut & Chocolate in the following brands: 1) Southern Grove, NET Wt.'s 1.75 oz., 10 oz.; 2) HyVee, Chocolate & Nut, Net wt.'s 9 oz. & 28 oz.; 3) Food Club, Chocolate & Nut, Net Wt. 28 oz., Recall # F-0678-2010;

24) Archer Farms Brand Sweet & Salty Trail Mix, Net wt. 12 oz., UPC 008523911049. Recall # F-0679-2010
CODE
1) through 23) Sell by date codes 1-1-08 to 1-31-10;
24) Best By dates between 4-03-09 to 1-21-10
RECALLING FIRM/MANUFACTURER
American Importing Co., Inc., Minneapolis, MN, by telephone on January 29, 2009 and press release on February 2, 2009 and e-mail, letter on February 5, 2009. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3,736,466 units
DISTRIBUTION
FL, MO, IL, IA, VA, MN
___________________________________
PRODUCT 
1) Harry and David Olympia Delight Trail Mix, a) 12 oz. bags and b) 5 oz. boxes. Bagged product - The trail mix is packaged in 12 oz. clear plastic bags. UPC code is 780994604896. Boxed product - The trail mix is packaged in 5 oz tan colored paperboard boxes. UPC code is 780994737013 or 780994751262. Label reads in part: 12 oz. Bagged product - best if used by date of 3/28/08 or later. The Best if used by date is located on the lower left hand corner of the back label of the bagged product. For bags and boxes: The lot code is ink jetted on the bag and the code format is ####XXX##:##, where # = a number and X = a letter. Affected product lot codes have a 7 or 8 in the fourth digit place. Recall # F-0680-2010;

2) Harry and David Pretzel Rods packaged in a 9 oz clear plastic box with red paperboard ends and a red ribbon. SKU 919098. UPC 7 80994 66995 6. Package contains 4 chocolate coated pretzel rod products or sticks. Two of the sticks have red, green and white candies stuck to the surface. One of the sticks has red stringing and one of the sticks has green stringing. Product manufactured using PCA GA peanut products. Recall # F-0681-2010 
CODE
1) a)  best if used by date of 3/28/08 or later. Affected product lot codes have a 7 or 8 in the fourth digit place. b)  Affected product lot codes have a 7 or 8 in the fourth digit place;

2) Best by Date of 1/31/08 and 1/31/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Harry and David Operations, Inc., Medford, OR, by press release and telephone on January 30, 2009, letters on February 2, 2009, and press release on February 4, 2009. 
Manufacturer: Natures World LLC, Sumner, WA. Firm initiated recall is complete.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America (PCA) because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
70,004 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Burnt Peanuts with the following brand names: 'Eillien's' 2.5-oz 34952-00811case count 48; Eillien's 7-oz 34952-00501 case count 48; 'Blains Farm & Fleet' 16-oz (1-lb) 34952-81104 case count 24; Econo Pac 8-oz 34952-12270 case count 12; 'First Choice' 5-oz 34952-12839 case count 36; 'Mills Fleet Farm' 16-oz (1-lb) 34952-35485 case count 16; 'Supreme Choice' 9-oz 34952-57045 case count 8; Primrose 25# ITEM# 400820. All are packaged in a clear bag. Recall # F-0682-2010;

2) Harvest Mix with brands: Eillien's 15-oz, UPC 34952-12505 case count 24; Eillien's 1-lb 4-oz, UPC 34952-55622 case count 12; Blain's Farm & Fleet 1-lb 4-oz, UPC 34952-81469 cased count 12; Mills Fleet Farm 1-lb 5-oz 34952-35639 case count 12; Halloween Party Tray 34952-81819 case count 12. All of the above products contain Burnt Peanuts. All products packaged in clear bag. Recall # F-0683-2010;

3) Bridge Mix with brands: "Ellien's" 5-oz 34952-13532 case count 12, 6-oz 34952-13600 case cnt 12, 10-oz 34952-12193 case cnt 12 (priced label) & case cnt 12 (no price label), 12-oz 34952-56198 case cnt 12, 16-oz 34952-56073 case cnt 12, 16-oz 34952-55100 case cnt 12, 1-lb 5-oz 34952-57042case cnt 12; First Choice 3.5-oz 34952-12851 case cnt 36; Blain's Farm & Fleet 15-oz 34952-81174 case cnt 24 and 2-lb 4-oz 34952-81775 case cnt 16; Mills Fleet Farm 14-oz 34952-35861 case cnt 24 and 15-oz 34952-35824 case cnt 24, Royal Snacks 13.5-oz 34952-56944 case cnt 12; Supreme Choice 14-oz 34952-56847 case cnt 8; Zachary Confections 30-lb ITEM# 400549; Basket of Chocolate Tray 30-oz 34952-56983 case count 12; Holiday Chocolate Tray 80-oz 34952-56496 case cnt. 6. All are packaged in a clear wrapping except Supreme Choice is in a blue colored bag. ITEM# 400549. Recall # F-0684-2010;

4) Dark Chocolate Peanuts with brands: Mills Fleet Farm 14-oz 34952-35801 case cnt 12; Blain's Farm & Fleet 14-oz 34952-81786 case cnt 24; Blain's/Light Chocolate Tray Dark 34952-81822; Eillien's Dark/Light Chocolate Tray 33-oz 34952-56831case cnt 12. All products are packaged in a clear wrapping. Recall # F-0685-2010;

5) Dry Roasted Peanuts: Eillien's 16-oz Dry Roasted Peanuts 34952-56807; Blain's Farm & Fleet 16-oz Dry Roasted Peanuts 34952-81414; All products are packaged in clear plastic jars. Recall # F-0686-2010;

6) Eillien's Nut Topping (chopped peanuts) packaged 5-oz with UPC 34952-12971. Recall # F-0687-2010;

7) Eillien's 16-oz Honey Roasted (Sweet & Salty) Dry Roasted Peanuts 34952-56809; Blain's Farm & Fleet Honey Roasted Peanuts 34952-81413. All products are packaged in clear plastic jars. Recall # F-0688-2010;

8) Blain's Farm & Fleet Unsalted Dry Roasted Peanuts 34952-81416; All products are packaged in clear plastic jars. Recall # F-0689-2010;

9) Dry Roasted Lightly Salted Peanuts: Eillien's 16-oz Dry Roasted Lightly Salted Peanuts 34952- 56808; Blain's Farm & Fleet Lightly Salted Dry Roasted Peanuts 34952-81415; Blain's Farm & Fleet Lightly Salted Dry Roasted Peanuts 34952-81415. All products are packaged in clear plastic jars. Recall # F-0690-2010
CODE

9) Dry Roasted Lightly Salted Peanuts: Eillien's 16-oz Dry Roasted Lightly Salted Peanuts 34952- 56808; Blain's Farm & Fleet Lightly Salted Dry Roasted Peanuts 34952-81415; Blain's Farm & Fleet Lightly Salted Dry Roasted Peanuts 34952-81415. All products are packaged in clear plastic jars. Recall # F-0690-2010
CODE
1), 2), 4) All products with a sell by date prior to 1/31/10;

3) Lot Numbers T8207D, T8807E, T8107D, T8207D, T8207C, U9150D, U9150E, U9250D, T8203C All products with a sell by date prior to 1/31/10;

6) Affects all products with a sell by date prior to 2/13/10;

5), 7), 8), 9) All jars have been recalled.
RECALLING FIRM/MANUFACTURER
Eillien's Candies, Inc., Green Bay, WI, by press release on January 31, 2009, telephone, faxes and e-mails on January 30, and 31, 2009.
Manufacturer: Zachary Confections, Inc., Frankfort, IN. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,039,230-lbs
DISTRIBUTION
WI, MI, IA, IL, MN, FL, CA, ND, NY, ID, NE, WA, MT, IN, WA, OH, UT, OR & Canada
___________________________________
PRODUCT 
1) Dry Roasted Peanuts with the following brands: (1) Always Save UPC code 70038-30375 packaged in 16-oz jars and cased 12/16-oz; (2) Best Choice UPC code 70038-30380 packaged in 8-oz jars and cased 12/8 OZ JAR; (3) Centrella UPC code 70980-22545, packaged in 16 oz jars and cased 12/16-oz jars; (4) Kitty Clover UPC code 6 99430 21664, packaged in 16-oz jars and cased 12/16-oz jars; (5) additional case labels - ITEM: 36032, 2/16-oz bags; ITEM: 95010, 5-lbs, ITEM: 70038-30381, 12/16-oz jars; 'Golden Kernel Snacks' ITEM: 90627, packaged as 2/2.5 lbs. Recall # F-0691-2010;

2) Honey Roasted Peanuts: brand 'Best Choice' UPC code 70038-30383. Packaged in 16-oz jars and cased 12/16-oz jars. Recall # F-0692-2010;

3) NUT TOPPING: brand is 'Best Choice' UPC code 70038-59821, packaged in 2-oz and 12/2-oz bags. Recall # F-0693-2010;

4) Dry Roasted Peanuts/Light Salt - case label, UPC code 70038-59661, packaged 12/16-oz jars. Recall # F-0694-2010;

5) Granulated Peanuts: (1) 'Golden Kernel Snacks' ITEM: 90010, packaged 2/2.5-lbs. (2) additional case labels, ITEMS: 95009, 99010, 99024, packaged 5-lbs and 30-lbs, labeled in part as "Granulated Peanuts; ITEM: RH-90010, packaged 2/2.5-lbs. Recall # F-0695-2010;

6) Dry Roasted Peanuts Unsalted with brands: (1) 'Best Choice' UPC code 70038 22546, packaged in 16-oz jars and cased 12/16-oz jars; (2) 'Centrella", UPC code 70980 22546, packaged in 16-oz jars and cased 12/16-oz jars. Recall # F-0696-2010;

7) Standard Nut Topping: 1) brand 'DQ' Item codes: 47964, 47910, packaged in 10-lbs, 2-lb 8-oz, and 6/40-oz. 2) Golden Kernel Snacks' Items: 90606 and 90607, packaged 2.25-lbs; (3) case labels - Items: 95615 and 97602, packaged 5-lbs and 30-lbs; (4) Bakers Mix W/Peanuts/R, ITEM: RH-99487, NET WT. 30 LBS; (5) case labels - Items: RH-90606 and RH-90607, packaged 2/2.5-lbs. If a code date is used (yddd) then all products that have a code date beginning with a 7 or 8. Recall # F-0697-2010
CODE
All products with a Best By date of 1/26/10 or earlier.
RECALLING FIRM/MANUFACTURER
Schutzman, A L Co., Waukesha, WI, by press release on February 10, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Chocolate Covered Peanuts - Gurley's 2/100, UPC 0-28348-00223-4, packaged 1.5-oz. Recall # F-0698-2010;

2) Chocolate Covered Peanuts - Gurley's Golden Recipe, UPC 0-77449-49888-05, packaged 5-oz.  Recall # F-0699-2010
CODE
1) Codes: 05 DEC 09, 18 DEC 09, 19 DEC 09, 08 JAN 10, 20 JAN 10;
2) Codes: 08 DEC 09, 17 DEC 09, 15 JAN 10, 16 JAN 10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Willmar Cookie and Nut Company, Inc., Willmar, MN, by press release and letter on February 20, 2009.
Manufacturer: Zachary Confections, Inc., Frankfort, IN. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,102 lbs
DISTRIBUTION
AL, AR, CA, GA, MI, MN, MO, NC, OH, OK, NC, SD, UT, WA, WI, WV
___________________________________
PRODUCT 
1) Queso Asadero cheese. Aguascalientes Queso Asadero, Net wt. 12 oz.; UPC 9492267525. Net wt. 16 oz.; UPC 9492267523. Net wt. 10 lb. ball; no UPC. Recall F-0700-2010;

2) Queso Oaxaca cheese. Aguascalientes Queso Oaxaca, Random weight; UPC 9492267528. 10 lb. ball; no UPC. Recall # F-0701-2010;

3) Queso Fresco Authentico cheese. Aguascalientes Queso Fresco Authentico, Net wt. 8 oz.; UPC 9492267530. Net wt. 16 oz.; UPC 94922-67532. Recall # F-0702-2010;

4) Queso Requeson cheese. Sold in 1 gallon and 3 gallon pails; no UPC. Recall # F-0703-2010;

5) Morral Adobera cheese. Aguascalientes Morral Adobera, in 3 lb. packages; no UPC. Recall # F-0704-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Torres Hillsdale Country Cheese, Reading, MI, by press release and fax on June 13, 2009. Firm initiated recall is complete.
REASON
The cheese may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
GA, IL, IN, KY, MI, NC, OH, SC, TN, and WI
__________________________________
PRODUCT 
1) Queso Asadero cheese. Torres Hillsdale brand Queso Asadero cheese in 12 oz, UPC 9492267525, 16 oz, UPC 9492267523, 10 pound packages [no UPC code] plus El Jaliciense brand queso asadero cheese in 12 oz packages, UPC 8384610423 and 6 pound blocks UPC code not available. Recall # F-0705-2010;

2) Oaxaca cheese. Aguascalientes queso oaxaca, 10 pound balls (label states random weight) [UPC code 9492267528] and El Jaliciense oaxaca cheese in 6 pound blocks. Recall # F-0706-2010
CODE
All packages with expiration dates from 10/29/2008 through 5/10/2009.
RECALLING FIRM/MANUFACTURER
Torres Hillsdale Country Cheese, Reading, MI, by press release on March 23, 2009 and March 24, 2009. Firm initiated recall is complete.
REASON
Possible contamination with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
AL, FL, GA, IL, IN, KY, MI, NJ, NC, OH, PA, SC, TN and WI
__________________________________
PRODUCT 
Affy Tapple Limited Edition Classic Candy Flavors Caramel Apples; 2 caramel apples per plastic package, 1 covered with candy coated chocolate pieces and 1 covered with milk chocolate crunch pieces; Net Wt not less than 12 oz. (340 g), 12 packs per case; UPC 34986 13000. Recall # F-0707-2010
CODE
Best By date of OCT 15 or earlier
RECALLING FIRM/MANUFACTURER
Affy Tapple, LLC, 6300 Gross Point Road, Niles, IL, by press release on October 3, 2009. Firm initiated recall is ongoing.
REASON
Some of the Caramel Apples may contain undeclared peanut pieces, and the label does not include a warning that the product is manufactured on shared equipment with peanuts and tree nuts.
VOLUME OF PRODUCT IN COMMERCE
1,304 cases
DISTRIBUTION
IL, MI, IN, WI, OH, KY
__________________________________
PRODUCT 
Jelly Belly 49 Flavors Jelly Beans in 7.5 oz acetate cylinder style packages with a white label on the bottom of the package. Sold in 12-7.5 oz. white cardboard carton. UPC code 071567989398. Item Number 66975. Recall # F-0708-2010
CODE
Lot numbers 090925, 090928, 090929 and 091001
RECALLING FIRM/MANUFACTURER
Jelly Belly Candy Company, Fairfield, CA, by press release on November 5, 2009 and by telephone between November 5 and 10, 2009. Firm initiated recall is ongoing.
REASON
Product contains undeclared peanut butter and peanut flour.
VOLUME OF PRODUCT IN COMMERCE
500 12x7.5 oz cases
DISTRIBUTION
Nationwide
___________________________________

PRODUCT 
Blue Bonnet Light 31% Vegetable Oil Spread packaged in 15-oz. plastic tubs, UPC 27000-00930. Recall # F-0709-2010
CODE
2247923200, Sell by MAR182010
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConAgra Inc., Omaha, NB, by press release on November 13, 2009.
Manufacturer: ConAgra Foods, Inc., Indianapolis, IN. Firm initiated recall is ongoing.
REASON
The product contains undeclared whey.
VOLUME OF PRODUCT IN COMMERCE
4,696/18-tub cases
DISTRIBUTION
Nationwide and Haiti
___________________________________
PRODUCT 
Flour Tortillas packaged in 6, 10, 11, 12, 20 and 25-count, under the brand names: Bernards Quality 8" Press Flour Tortillas, Bernards Quality 6 1/2" Press Flour Tortillas, La Bonita Flour Tortillas, La Grande Flour Tortillas, Mrs. Rios Corn Products Burrito Tortilla, and Sanitary Flour Tortillas 6 inch special. Recall # F-0710-2010
CODE
Best buy dates from 10/26/09 through 12/11/09
RECALLING FIRM/MANUFACTURER
Mrs Rios Corn Products, San Angelo, TX, by press release on October 28, 2009 and by visit on October 30, 2009. Firm initiated recall is ongoing.
REASON
The product contains undeclared whey.
VOLUME OF PRODUCT IN COMMERCE
34,969 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Chef Pierre Gourmet Lemon Meringue Pie; a frozen pie, ready to eat when thawed; Net Wt 46 Oz (2 Lb 14 Oz) 1.30 kg; CT. Lic 3810; UPC 0 32100 09293 7. Recall # F-0711-2010
CODE
Lot number 9159
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sara Lee Food and Beverage, Downers Grove, IL, by telephone and e-mailed letters dated August 28, 2009.
Manufacturer: Sara Lee Corp., Traverse City, MI. Firm initiated recall is ongoing.
REASON
The Chef Pierre Gourmet Lemon Meringue Pie labeled product actually contained chocolate meringue pie, which contains milk.
VOLUME OF PRODUCT IN COMMERCE
4,233 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Walnut Pieces Small Combo, Net Wt. 5 lbs. (80 oz); 6/5 lb. plastic bags per case; item #BI75009, Case UPC 1 00 70690 44999 8. Recall # F-0712-2010;

2) Walnut Halves & Pieces, Net Wt. 16 oz. (1 LB) 453g; 24/16 oz. plastic bags per case; item #03250, package UPC 0 41130 01174 0, case UPC 2 00 41130 98354 6. Recall # F-0713-2010;

3) Nut Topping, Net Wt 2 oz (56g); 12/2 oz. plastic bags per case; item # 02678, package UPC 0 41130 02059 9, case UPC 2 00 41130 02059 3. Recall # F-0714-2010;

4) Deluxe Nut Topping with Peanuts, Net Wt. 32 oz. (2 LB) 907g; 3/32 oz. plastic bags per case; item #18871, package UPC 0 70690 18871 5, case UPC 0 00 70690 18871 5. Recall # F-0715-2010
CODE
1) Lot 9267HH8C, Best By 09 24 10;
2) Lot 9267HB8A, Sell By 09 24 10;
3) Lot 9271HK8N, Sell By 09 28 10HK;
4) Lot 9272GN8N, Best By 06 29 10
RECALLING FIRM/MANUFACTURER
John B. Sanfilippo & Son, Inc., Elgin, IL, by press release on October 9, 2009. Firm initiated recall is ongoing.
REASON
The raw walnuts may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
170 cases
DISTRIBUTION
CO, IL, MN, NC, PA, TN, IN, IA, KY, MD, MO, NY, OH, WV
___________________________________
PRODUCT 
1) Green beans packed in # 10 cans (green beans, water, salt) under the following labels: Bunny brand Blue Lake mixed and shortcut green beans in 6 lb. 5 oz. cans (UPC 6444500193); Code brand mixed & short cut green beans in 6 lb. 5 oz. cans (UPC 1207310120); Classic Sysco brand Blue Lake cut green beans, 3 sieve in 101 oz. (6 lb. 5 oz.) cans (UPC 7486510779); Classic Sysco brand Blue Lake cut green beans, 4 sieve, in 101 oz. (6 lb. 5 oz.) cans (UPC 7486510487); ComSource brand Blue Lake cut green beans in 6 lb. 5 oz. cans (UPC 5254952333); ComSource brand Blue Lake cut green beans, 3 sieve, in 6 lb. 5 oz. cans (UPC 5254952321); ComSource Merit Excellence Food Service brand Fancy Blue Lake cut green beans, 4 sieve, in 6 lb. 5 oz. cans (UPC 5254952325); ComSource Merit Excellence Food Service brand cut Blue Lake green beans, 5 sieve in 6 lb. 5 oz. cans (UPC 5254952327); ComSource Traditional brand Blue Lake cut green beans, mixed and short cut, in 101 oz (6 lb. 5 oz.) cans (UPC 5254952359); ComSource Traditional brand cut Blue Lake green beans, 4 sieve, in 6 lb. 5 oz. cans (UPC 5254952427); ComSource Traditional brand cut Blue Lake green beans, 5 sieve, in 6 lb. 5 oz. cans (UPC 5254952429); Frosty Acres Restaurant's Pride Preferred brand Blue Lake cut green beans, 5 sieve in 101 oz. (6 lb. 5 oz.) cans (UPC 4820067451); Frosty Acres Restaurant's Pride Preferred brand mixture of Blue Lake short cut, cut green beans, in 101 oz. (6 lb. 5 oz.) cans (UPC 4820068464); Frosty Acres Restaurant's Pride Preferred brand cut Blue Lake green beans, 4 sieve in 101 oz. (6 lb. 5 oz.) cans (UPC 4820067445); Frosty Acres Restaurant's Pride Preferred brand Fancy cut Blue Lake green beans in 101 oz. (6 lb. 5 oz.) cans (UPC 4820067339); Frosty Acres Restaurant's Pride Preferred brand Fancy cut Blue Lake green beans, 3 sieve, in 101 oz. (6 lb. 5 oz.) cans (UPC 4820067373); Frosty Acres Restaurant's Pride Preferred brand Fancy cut Blue Lake green beans, 4 sieve, in 101 oz. (6 lb. 5 oz.) cans (UPC 4820067446); GFS brand cut Blue Lake green beans, mixed sieve, in 6 lb. 5 oz. cans, reorder no. 273856 (9390127385); GFS brand Fancy Blue lake cut green beans, 4 sieve, in 101 oz. (6 lb. 5 oz.) cans, reorder no. 118737 (UPC 9390111873); goodtaste brand cut green beans in 6 lb. 5 oz. cans (UPC 3683512340); Harvest Value brand cut green beans in 101 (6 lb. 5 oz.) cans, 170524 (UPC 5810801047); Harvest Value brand cut green beans, short cut in 101 oz. (6 lb. 5 oz.) cans, 173349 (UPC 5810803538); Harvest Value brand cut green beans, mixed and short cut, in 101 oz. (6 lb. 5 oz.) cans, 173619 (UPC 5810803534); Kitchen brand 5 sieve- EX.-STD. cut Blue Lake green beans in 6 lb. 6 oz. cans (no UPC code); Kitchen brand Blue Lake Mixed Cuts Green Beans in 6 lb. 6 oz. cans; Kitchen Essentials brand cut green beans, mixed sieve, in 6 lb. 6 oz. cans, reorder no. 156337 (UPC 9390115633); Monarch brand Fancy Blue Lake cut green beans, 3 sieve, in 101 oz (6 lb 5 oz) cans, 170672 (UPC 5810801040); Monarch brand Extra Fancy Blue Lake cut green beans, 4 sieve, in 101 oz. (6 lb. 5 oz.) cans, 177039 (UPC 5810811196); Monarch Premium brand Fancy Blue Lake cut green beans, 3 sieve, in 6 lb. 5 oz. cans, 173205 (No UPC code); Mount Stirling brand Blue Lake cut green beans, 5 sieve, in 6 lb. 5 oz. cans (UPC 4156033379); Necco brand cut green beans in 6 lb. 6 oz. cans (UPC 3683513340); New Era brand cut green beans in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511340); Nugget brand green beans, 4 sieve, in 101 oz. (6lb. 5oz.) (UPC 4410540023); Nugget brand cut green beans, 5 sieve in 6 lb. 5 oz. cans (UPC4410501930); Nugget brand mixed short cut green beans in 6 lb. 5 oz. cans (UPC 4410518838); Nugget brand Blue Lake cut green beans, 4 sieve, in 101 oz. (6 lb. 5 oz.) cans (UPC 4410501989); Pocahontas brand Fancy long cut green beans in 6 lb. 5 oz. cans (UPC 4156010325); Pocahontas brand Fancy Blue Lake green beans, 3 sieve, 10280, in 6 lb. 5 oz. cans (UPC 4156010280); Pocahontas brand Fancy Blue Lake cut green beans, 4 sieve, 10282, in 6 lb. 5 oz. cans (UPC 4156010282); Reliance Sysco brand mixed cut green beans in 101 oz. (6 lb. 5 oz.) cans (UPC 7486512175); Reliance Sysco brand Blue Lake cut green beans, 4 sieve, in 101 oz. (6 lb. 5 oz.) cans. (UPC 7486512172); Reliance Sysco brand Blue Lake cut green beans, 5 sieve, (in 101 oz. (6 lb. 5 oz.) cans (UPC 7486512174); Sysco brand 5096342 Imperial Blue Lake cut green beans, 3 sieve in 6 lb. 5 oz. cans (UPC 7486512136); Sysco brand 5096359 Imperial Blue Lake cut green beans, 4 sieve in 6 lb. 5 oz. cans (UPC 7486512137); US brand Fancy Blue Lake cut green beans in 101 oz. (6 lb. 5 oz.) cans, 173416 (UPC 5810811195); US brand Fancy Blue Lake cut green beans, 3 sieve, in 101 oz. (6 lb. 5 oz.) cans, 170672 (UPC 5810801040); US brand Fancy Blue Lake cut green beans, 4 sieve, 170232 in 101 oz. (6 lb. 5 oz.) cans, 170672 (UPC 5810801041); US brand cut green beans, 5 sieve, in 101 oz (6 lb 5 oz) cans, 170675 (UPC 5810801042); US brand cut green beans, mixed sieve, in 101 oz. (6 lb. 5 oz.) cans, 171132 (UPC 5810801048); USDA, label cut green beans in 6 lb. 6 oz. cans (UPC 1500101061). Recall # F- 0735-2010;

2) Green beans packed in # 10 cans, no salt added (green beans, water) under the following label: New Era brand cut Blue Lake green beans, no salt added, in 102 oz. (6 lb. 6 oz.) cans (No UPC code). Recall # F-0736-2010;

3) Green beans packed in # 10 cans (green beans, water, salt, zinc chloride) under the following labels: New Era brand Veri-Green cut green beans in 102 oz. (6 lb. 6 oz.) cans (No UPC code), and Nugget brand Veri-green cut green beans in 6 lb. 12 oz. cans (UPC 4410502101),. Recall # F-0737-2010;

4) Garbanzo beans packed in # 10 cans (garbanzo beans, water, salt, calcium chloride, EDTA) under the following labels: Classic Sysco brand Garbanzo beans in 108.0 oz (6 lb. 12 oz.) cans (UPC 7486510484); New Era brand Garbanzo beans in 108 oz. (6 lb. 12 oz.) cans (UPC 3683511684); USDA, label Garbanzo beans in 6 lb. 12 oz. cans (UPC code 1500101089); Frosty Acres Restaurant's Pride Preferred brand Fancy garbanzos "chick pea" (garbanzo beans, water, salt, calcium chloride, disodium EDTA) in 111 oz. (6 lb. 15 oz.) cans (UPC 4820068264). Recall # F-0738-2010;

5) Garbanzo beans packed in # 10 cans (garbanzo beans, water, salt, EDTA) under the following label: Code brand Fancy garbanzo beans without sulfites in 6 lb. 14 oz. cans (UPC 1207316120). Recall # F-0739-2010
CODE
1), 2) and 3) All cans with a lot code beginning with "00249", "GREEN" or "NEERG" plus any cans without a can code;

4) and 5) All cans with a code beginning with "00249" or "GARB" plus any cans without a can code.
RECALLING FIRM/MANUFACTURER
By press releases, telephone and letter beginning January 18, 2008. Firm initiated recall is complete.
REASON
These products were manufactured under conditions whereby they could be contaminated with organisms of public health concern, particularly Clostridium botulinum, an organism that produces the toxin responsible for botulism poisoning.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Asparagus (asparagus, water, salt) in # 10 cans under the following labels: Classic Sysco brand Green asparagus cuts & tips in 101 oz. (6 lb. 5 oz.) cans, UPC 7486510471; GFS brand fancy all green asparagus cuts & tips in 6 lb. 5 oz. cans, reorder no. 229601, UPC 9390122960; New Era brand asparagus cuts & spears in 108 oz. (6 lb. 12 oz.) cans, UPC 3683511220; Nugget brand asparagus cuts & tips in 6 lb. 12 oz. cans, UPC 4410503580. Recall # F-0740-2010;

2) Black beans (black beans, water, salt) in # 10 cans under the following labels: GFS brand fancy black beans in 6 lb. 12 oz. cans, reorder no. 557714, UPC 9390155771; New Era brand black beans in 108 oz. (6 lb. 12 oz.) cans, UPC 3683511692. Recall # F-0741-2010;

3) Black beans (cooked black beans, water, ferrous gluconate, calcium chloride) in # 10 cans under the following label: Frosty Acres Restaurant's Pride Preferred brand black beans in 6 lb. 15 oz. cans, UPC 4820049145. Recall # F-0742-2010;

4) Blackeye peas (blackeye peas, water, salt, calcium chloride, EDTA) in # 10 cans under the following labels: Frosty Acres Restaurant's Pride Preferred brand blackeye Peas in 6 lb. 12 oz. cans, UPC 4820049146; New Era brand black-eyed peas in 108 oz. (6 lb. 12 oz.) cans, UPC 3683511698. Recall # F-0743-2010;

5) Butter beans (lima beans, water, salt, sugar, calcium chloride, EDTA) in # 10 cans under the following label: New Era brand butter beans in 108 oz. (6 lb. 12 oz.) cans, UPC 3683511694. Recall # F-0744-2010;

6) Chili beans in # 10 cans under the following label: New Era brand chili beans in 108 oz. (6 lb. 12 oz.) cans, UPC 3683511675. Recall # F-0745-2010;

7) Mexican style chili beans (soaked red beans, water, chili seasoning, salt, corn starch, tomato paste, sugar, calcium chloride) in # 10 cans under the following label: GFS brand fancy Mexican style chili beans in 6 lb. 12 oz. cans, reorder no. 192015, UPC 9390119201. Recall # F-0746-2010;

8) Mexican style chili beans (white beans, water, corn syrup, sugar, tomato paste, salt, dextrose, onion powder, garlic powder, oleoresin paprika, natural flavors) in # 10 cans under the following label: Frosty Acres Restaurant's Pride Preferred brand fancy Mexican style chili beans in 111 oz. (6 lb. 15 oz.) cans, ;UPC 4820068534. Recall # F-0747-2010;

9) Great Northern beans (Great Northern beans, water, salt, calcium chloride, EDTA) in # 10 cans under the following labels: Classic Sysco brand Great Northern beans in 108 oz. (6 lb. 12 oz.) cans, UPC 7486510486; New Era brand Great Northern beans in 110 oz. (6 lb. 14 oz.) cans, UPC 3683511688. Recall # F-0748-2010;

10) Great Northern beans (Great Northern white beans, water, salt, natural flavors, calcium chloride) in # 10 cans under the following labels: Frosty Acres Restaurant's Pride Preferred brand fancy Great Northern beans in 110 oz. (6 lb. 14 oz.) cans. UPC 4820068288. Recall # F-0749-2010;

11) Italian green beans (Italian green beans, water, salt) in # 10 cans packed under the following labels: Classic Sysco brand green beans, Italian cut in 105 oz. (6 lb. 9 oz.) cans, UPC 7486511294; Frosty Acres Restaurant's Pride Preferred brand fancy cut Italian green beans in 105 oz. (6 lb. 9 oz.) cans, UPC 4820068390; GFS brand Italian cut green beans in 6 lb. 9 oz. cans, reorder no. 769878, UPC 9390176987; Monarch Heritage brand Italian style cut green beans in 6 lb. 5 oz. cans, 173865, No UPC code; New Era brand Italian Cut Green Beans in 108 oz. (6 lb. 12 oz.) cans, UPC 3683511342. Recall # F-0750-2010;

12) Light red kidney beans (kidney beans, water, corn sweetener, salt, calcium chloride, EDTA) in # 10 cans packed under the following labels: Classic Sysco brand light red kidney beans in 108 oz. (6 lb. 12 oz.) cans, UPC 7486510642; New Era brand light red kidney beans in 108 oz. (6 lb. 12 oz.) cans, UPC 3683511682. Recall # F-0751-2010;

13) Dark red kidney beans (kidney beans, water, corn sweetener, salt, calcium chloride, EDTA) in # 10 cans packed under the following labels: Code brand dark red kidney beans in 6 lb. 12 oz. cans, (UPC 1207316042); New Era brand dark red kidney beans in 108 oz. (6 lb. 12 oz.) cans, UPC 3683511680. Recall # F-0752-2010;

14) Dark red kidney beans (dark red kidney beans, water, corn syrup, salt, calcium chloride) in # 10 cans packed under the following label: Frosty Acres Restaurant's Pride Preferred brand fancy dark red kidney beans in 111 oz. (6 lb. 15 oz.) cans, UPC 4820068171. Recall # F-0753-2010;

15) Lima beans (lima beans, water, and salt) in # 10 cans packed under the following labels: GFS brand medium lima beans in 6 lb. 12 oz. cans, reorder no. 118796, UPC 9390111879; New Era brand lima beans in 108 oz. (6 lb. 12 oz.) cans, UPC 3683511696. Recall # Recall # F-0754-2010;

16) Pinto beans (pinto beans, water, salt, calcium chloride, EDTA) in # 10 cans packed under the following labels: Frosty Acres Restaurant's Pride Preferred brand fancy pinto beans in 111 oz. (6 lb. 15 oz.) cans, UPC 4820068939; New Era brand pinto beans in 108 oz. (6 lb. 12 oz.) cans, UPC 3683511686. Recall # F-0755-2010;

17) Red beans (red beans, water, salt) in # 10 cans packed under the following label: New Era brand red beans in 6 lb. 12 oz. cans, no UPC. Recall # F-0756-2010;

18) Red beans (red beans, water, salt, calcium chloride, EDTA) in # 10 cans packed under the following labels: Classic Sysco brand red beans in 110 oz. (6 lb. 14 oz.) cans, UPC 7486510638; Frosty Acres brand Fancy red beans in 6 lb. 12 oz. cans, UPC 4820069023. Recall # F-0757-2010;

19) Vegetarian beans (white beans, water, cane syrup, tomato paste, corn syrup, salt, vinegar, calcium chloride, onion powder, paprika, spice, natural flavorings) in # 10 cans packed under the following label: New Era brand Vegetarian beans in 108 oz. (6 lb. 12 oz.) cans, UPC 3683511670. Recall # Recall # F-0758-2010; 

20) Vegetarian beans in tomato sauce (white beans, water, corn syrup, sugar, tomato paste, salt, dextrose, onion powder, garlic powder, oleoresin paprika and natural flavorings) in # 10 cans packed under the following label: Frosty Acres Restaurant's Pride Preferred brand fancy vegetarian beans in tomato sauce in 112 oz (7 lb.) cans, UPC 4820069161.  Recall # F-0759-2010;

21) Wax beans (wax beans, water, salt) in # 10 cans packed under the following label: Classic Sysco brand cut wax beans (wax beans, water, salt) in 101 oz. (6 lb. 5 oz.) cans, UPC 7486511434; Code brand Fancy cut wax beans, 4 sieve, in 6 lb. 5 oz. cans, UPC 1207310183; GFS brand fancy cut wax beans 4 sieve (wax beans, water, salt) in 6 lb. 5 oz. cans, UPC 9390111883; Kitchen Essentials brand cut wax beans mixed sieve in 6 lb. 5 oz. cans, UPC 9390127445; Necco brand cut wax beans in 6 lb. 6 oz. cans, UPC 3683513440; New Era brand cut wax beans in 102 oz. (6 lb. 6 oz.) cans, UPC 3683511440; Reliance Sysco cut wax beans 4 sieve in 6 lb. 5 oz. cans, UPC 7486512190; Reliance Sysco wax beans mixed and short cuts in 6 lb. 5 oz. cans, UPC 7486512231. Recall # F-0760-2010;

22) Pumpkin, solid pack, packed in # 10 cans and sold unlabeled. Recall # F-0761-2010
CODE
1) All lot codes beginning with "00249" plus any cans without a lot code;

2) and 3) All lot codes beginning with "00249" or "BLACK" plus any cans without a lot code;

4) All lot codes beginning with "00249" or "BEP" plus any cans without a lot code;

5) All lot codes beginning with "00249" or "LIMA" plus any cans without a lot code;

6), 7) and 8) All lot codes beginning with "00249" or "CHILI" plus any cans without a lot code;

9) and 10) All lot codes beginning with "00249" or "NORTH" plus any cans without a lot code;

11) All lot codes beginning with "00249" or "ITAL" plus any cans without a lot code;

12) All lot codes beginning with "00249" or "LRKID" plus any cans without a lot code;

13) and 14) All lot codes beginning with "00249" or "DRKID" plus any cans without a lot code;

15) All lot codes beginning with "00249" or "LIMA" plus any cans without a lot code;

16) All lot codes beginning with "00249" or "PINTO" plus any cans without a lot code;

17) and 18) All lot codes beginning with "00249" or "RED" plus any cans without a lot code;

19) and 20) All lot codes beginning with "00249" or "VEG" plus any cans without a lot code;

21) All lot codes beginning with "00249" or "WAX" plus any cans without a lot code;

22) Lot code beginning with "00249" or "PUMP" plus cans without a lot code, but limited to product sold to one Michigan broker in 2007
RECALLING FIRM/MANUFACTURER
New Era Canning Co., New Era, MI, by press release, telephone and letter beginning on February 7, 2009. Firm initiated recall is complete.
REASON
Solid pack pumpkin is not likely to support the growth and toxin formation by Clostridium botulinum; however, if the can has loose seams, it may become contaminated post-processing with spoilage organisms that are not likely to pose a hazard to health.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT 
UPSTATE FARMS brand BLENDED NON FAT YOGURT, PEACH, a) Net wt. 4 oz., UPC 0 78800 112926 and b) Net wt. 8 oz., UPC 0 78800 11300 8. Recall # F-0654-2010
CODE
a) Best By 09/22/09, Best By 10/11/09, Best By 10/18/09, Best By 10/30/09; b) Best By 09/24/09, Best By 10/12/09, Best By 10/09/09, Best By 10/26/09, Best By 11/02/09
RECALLING FIRM/MANUFACTURER
Upstate Niagara Cooperative, Inc., Buffalo, NY, by letters dated September 21, 2009. Firm initiated recall is ongoing.
REASON
The peach yogurt contains undeclared FD&C Yellow #6 (Sunset Yellow FCF) based on FDA sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
4 oz./16,732 cases, 8 oz./3952 cases
DISTRIBUTION
CA, CT, FL, GA, IA, IL, IN, MD, MO, NC, NJ, NY, OH, PA, TN, UT, VA, WA
___________________________________
PRODUCT 
Henry and Henry, Poppy Butter, Net Weight 22 lbs (9.98 kg). The product is packed in bulk plastic pales. Item code 20421504. Recall # F-0655-2010
CODE
Lot #0916200451
RECALLING FIRM/MANUFACTURER
Recalling Firm: H. C. Brill Company Inc., Tucker, GA, by letter on/about August 21, 2009.
Manufacturer: H. C. Brill Company, Inc., Lancaster, NY. Firm initiated recall is complete.
REASON
Potential contamination of foreign material.
VOLUME OF PRODUCT IN COMMERCE
353 pails
DISTRIBUTION
CO, IL, MN, OH, TX and WI
___________________________________
PRODUCT 
Vermont Village Organic Peach Applesauce, 24 oz jars. Recall # F-0723-2010
CODE
Lot # "Best by 19MAY12" UPC # 0-84648099928-5
RECALLING FIRM/MANUFACTURER
Village Cannery Of Vermont, Inc., South Barre, VT., by e-mail on September 4, 2009. Firm initiated recall is ongoing.
REASON
Applesauce contains elevated patulin.
VOLUME OF PRODUCT IN COMMERCE
170 cases
DISTRIBUTION
NH, VT
___________________________________
PRODUCT 
365 Organic Applesauce unsweetened, 4-4oz (113g) Bowls; Net WT 16 oz; UPC 99482-42723. Recall # F-0724-2010
CODE
Best By 27 May 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market Brand 365, Llc, Austin, TX, by e-mail on September 8, 2009. 
Manufacturer: Village Cannery Of Vermont, Inc., South Barre, VT. Firm initiated recall is ongoing.
REASON
Applesauce contains elevated patulin.
VOLUME OF PRODUCT IN COMMERCE
356 cases (12 each)
DISTRIBUTION
KY, MD, OH, PA, DC, VA, NJ, CA, WA, OR, and Reno NV

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I
___________________________________
PRODUCT 
Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate (Mixed Salts of a Single Entity Amphetamine Product), CII, 20mg tablets, 100 count bottles, Rx only, NDC 0555-0973-02; Tablets are oval shaped and peach colored, debossed with b/973 on one side and 2/0 on the other side. Recall # D-134-2010   
CODE
Lot 311756, Exp 05/12
RECALLING FIRM/MANUFACTURER
Barr Laboratories Inc., Forest, VA, by letter on August 12, 2009 and by press release on August 13, 2009. Firm initiated recall is ongoing.
REASON
Tablet Thickness: Some tablets exceed weight specifications and may deliver more than the intended dose.
VOLUME OF PRODUCT IN COMMERCE
9,826 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT 
DERMADROX OINTMENT (aluminum hydroxide) pH Balanced Skin Protectorant, Net wt 4 oz. (113 gm) jars, NDC 54162-221-04. Recall # D-135-2010
CODE
Lot # 906135, Cat # DA4, EXP. Date 07/11
RECALLING FIRM/MANUFACTURER
Geritrex Corp., Mount Vernon, NY, by fax on October 27, 2009. Firm initiated recall is ongoing.
REASON
Mispacked; boxes labeled to contain jars of Dermadrox Ointment may also contain jars of Hydrophor Ointment.
VOLUME OF PRODUCT IN COMMERCE
55 cases (660 pieces)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
PREMPRO (conjugated estrogens/medroxyprogesterone acetate tablets) 0.3 mg/1.5 mg, Rx only. One carton contains 3 EZ-DIAL Dispensers of 28 tablets each. NDC 0046-0938-09, One EZ-DIAL Dispenser contains 28 cream PREMPRO Tablets containing 0.3 mg of the conjugated estrogens found in PREMARIN & 1.5 mg of medroxyprogesterone acetate. Recall # D-136-2010
CODE
Lot D57070, Exp September 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals Philadelphia, PA, by letters on November 30, 2009.
Manufacturer: Pfizer, Rouses Point, NY and Wyeth Pharmaceuticals Co., Guayama, PR. Firm initiated recall is ongoing.
REASON
Failed Dissolution Specification
VOLUME OF PRODUCT IN COMMERCE
21,060 cartons of 3 dispensers
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0006-10
CODE
Unit: 72K745234
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on June 12, 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 Irradiated. Recall # B-0012-10
CODE
Unit: W068509200378
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by letter dated April 8, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed. 
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0099-10
CODE
Unit: W06910911368
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services, Inc., Jackson, MS, by facsimile on July 27, 2009. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MS
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0100-10;
2) Recovered Plasma. Recall # B-0101-10
CODE
1) and 2) Unit: 17LZ09689
RECALLING FIRM/MANUFACTURER
The American National Red Cross – North Central Region, Saint Paul, MN, by telephone on December 29, 2008 and Electronic and facsimile on December 30, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WI, IL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0102-10
CODE
Unit: 17GJ52279
RECALLING FIRM/MANUFACTURER
The American National Red Cross – North Central Region, Saint Paul, MN, by facsimile on January 20, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0103-10
CODE
Unit: W090709002302
RECALLING FIRM/MANUFACTURER
Blood Bank Of The Redwoods, Santa Rosa, CA, by facsimile on February 24, 2009. Firm initiated recall is complete.
REASON
Blood product, which yielded a platelet count that was below the acceptable limit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
PA
___________________________________
PRODUCT 
Source Plasma. Recall # B-0201-10
CODE
Unit: 08FNCG1699
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fayetteville, NC, by facsimile on April 13, 2009. Firm initiated recall is complete.
REASON
Blood product, for which physical examination was undocumented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0203-10 
CODE
Unit: W120609077637
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by facsimile on July 7, 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
MI
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-0204-10;  
2) Cryoprecipitated AHF Pooled. Recall # B-205-10;
3) Recovered Plasma. Recall # B-206-10
CODE
1), 2), and 3) Unit: W03940856056400
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc., St Petersburg, FL, by facsimile on July 24, 2009. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0207-10
CODE
Unit: W115909052823
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by electronic mail on July 31, 2009. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma. B-0208-10
CODE
Units: TQ079586 and TQ079175
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma, Corp., Knoxville, TN, by facsimile on June 24, 2009. Firm initiated recall is complete.
REASON
Blood products, which were not properly quarantined after receiving post donation information concerning a history of incarceration, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Cornea. Recall # B-0255-10
CODE
Units: FM125034OS, FM125034OD
RECALLING FIRM/MANUFACTURER
Michigan Eye-Bank, Ann Arbor, MI, by letter dated August 13, 2009. Firm initiated recall is complete.
REASON
Human tissue for transplantation, collected from a donor who was not properly evaluated for hemodilution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
OH
___________________________________
PRODUCT 
Plasma Frozen. Recall # B-0271-10
CODE
Unit: Q05925
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by facsimile on December 3, 2008. Firm initiated recall is complete.
REASON
Blood product, which was not tested for HIV/HCV NAT, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0272-10
CODE
Unit: 6347949
RECALLING FIRM/MANUFACTURER
Ogden Medical Center, Inc., Ogden, UT, by letter dated May 21, 2007. Firm initiated recall is complete.
REASON
Blood product, which was labeled leukoreduced, but exceeded the acceptable limit for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UT
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0274-10
CODE
Unit: 50T11789
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, OH, by facsimile and electronic notification on June 18, 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
MI
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0276-10
CODE
Unit: W127809201517 (2 units)
RECALLING FIRM/MANUFACTURER
Tacoma Pierce County Blood Bank, Tacoma, WA, by telephone and letter dated July 22, 2009. Firm initiated recall is complete.  
REASON
Platelets, inappropriately prepared by splitting the product into two storage bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NY
___________________________________
PRODUCT 
Source Plasma. Recall # B-0278-10
CODE
Units: 382088968, 382088654, 382087257, 382087107, 382086332, 382085975, 382085199, 382084221, 382083908, 382083255, 382082480, 382082075, 382081564, 382081154, 382082527, 382080794, 382080315, 382079417, 382078985, 382078733, 382077722, 382077470, 382076856, 382076698, 382076251, 382075946, 382075292, 382074482, 382073690, 382072801, 382074859, 382072319, 382072290
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Tuscaloosa, AL, by facsimile on April 15, 2008. 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
33 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-0299-10  
CODE
Unit: 72L024115
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers Inc., Huntsville, AL, by fax on July 17, 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
___________________________________
PRODUCT 
Source Plasma. Recall # B-0305-10
CODE
Units: 384029371, 384029010, 384028050
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Phoenix City, AL, by facsimile on February 18, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received the MMR vaccine within two weeks of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-0306-10
CODE
Unit: 379061877
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Lafayette, LA, by facsimile on November 20, 2007. 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 
Source Plasma. Recall # B-0307-10
CODE
Units: 08DILF6323, 08DILF6101, 08DILF4718, 08DILG3705, 08DILG2142, 08DILG1480, 08DILF9502, 08DILF8651, 08DILF7799, 08DILF6904, 08DILF6976, 08DILH1922, 08DILG5546, 08DILF3754, 08DILF4139, 08DILF3686, 08DILG4923, 08DILF3196, 08DILC6735, 08DILF2943, 08DILC7473, 08DILE6564, 08DILF2100, 08DILF3189, 08DILD1401, 07DILF2382, 08DILF0331, 08DILC8670, 07DILF3251, 08DILC7836, 08DILD2123, 08DILD2977, 08DILD2961, 08DILE0792, 08DILE0918, 08DILE1492, 08DILE2443, 08DILE9895
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioLife Plasma Services L.P., Deerfield, IL, by facsimile on April 6, 2009.
Manufacturer: BioLife Plasma Services, L.P., Dekalb, IL. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
38 units
DISTRIBUTION
CA, Austria
___________________________________
PRODUCT 
Source Plasma. Recall # B-0309-10
CODE
Units: 3580026886, 3580026800, 3580026400, 3580026294, 3580025888, 3580025826, 3580025490, 3580025391, 3580025022, 3580024957, 3580024622, 3580024574, 3580024304, 3580024256, 3580023929, 3580023751, 3580023579, 3580023353, 3580023237, 3580023003, 3580022892, 3580022644, 3580022538, 3580022291, 3580022174, 3580021956, 3580021832, 3580021488, 3580021356, 3580021008, 3580020858, 3580020490, 3580020368
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Champaign, IL, by facsimile on August 21, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of drug use, were distributed.
VOLUME OF PRODUCT IN COMMERCE
33 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-0310-10
CODE
Units: 3550007144, 3550007344
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Bloomington, IL, by facsimile on September 16, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who may have received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-0311-10
CODE
Units: 382079862, 382079267, 382078878, 382076395, 382075910, 382075227, 382074459, 382073511, 382060952, 382059639, 382051634, 382049373, 382049109, 382037645, 382037594, 382062398
RECALLING FIRM/MANUFACTURER
Recalling Firm: Talecris Plasma Resources, Inc., Research Triangle Park, NC, by facsimile on March 28, 2008.
Manufacturer: Talecris Plasma Resources, Inc., Tuscaloosa, AL. 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
16 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-0312-10
CODE
Unit: 2812103
RECALLING FIRM/MANUFACTURER
Hoxworth Blood Center UC Medical Center, Cincinnati, OH, by letter dated April 23, 2008. Firm initiated recall is complete.
REASON
Blood product, mislabeled as s antigen negative, and distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OH
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. B-0316-10
CODE
Unit: W037908132050
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA, by letter dated April 10, 2009. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who provided history of residency in a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IA

 RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 

___________________________________
PRODUCT 
Platelets Pheresis- 7 d Leukocytes Reduced. 300 ml containing approx. 40 ml ACD-A Volunteer Donor, AB Rh Positive. Recall # B-0076-10
CODE
Unit: 9912994
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone on October 7, 2007. Firm initiated recall is complete.
REASON
Platelets, with an initial positive Bact ALERT, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Source Plasma. Recall # B-0202-10
CODE
Unit: 08FWIE1478
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fond Du Lac, WI, by facsimile on May 15, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-0256-10
CODE
Unit: 267103884
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc., Scottsdale, AZ, by fax and telephone on November 27, 2007.
Manufacturer: United Blood Services, Texarkana, TX. Firm initiated recall is complete. 
REASON
Red Blood Cells, with clot in the product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells, Leukocytes Reduced, Washed. Recall # B-0270-10
CODE
Units: W140507002393, W140507002409B
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Children's Hospital Association Blood Bank B120, Denver, CO, by facsimile and telephone on June 6, 2007.  
Manufacturer: The Children's Hospital Assoc. Transfusion Medicine Services, Aurora, CO. Firm initiated recall is complete.
REASON
Blood products, which were washed with an incorrect solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CO
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0273-10
CODE
Unit: 50T11789
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Toledo, OH, by facsimile and electronic notification on June 18, 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

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Heartstart FR2+ automated external defibrillator Models M3860A and M3840A are equipped with an ECG Module. M3860A is under the Philips label and M3840A is under the Laerdal label. 4 model (catalog) numbers are affected: M3860A, M3861A, M3840A, and M3841A. Specifics for each code: M3860A: Philips Heartstart FR2+ Defibrillator with ECG Module (various languages) M3861A: Philips Heartstart FR2+ Defibrillator Text Display, No ECG Module (various languages). M3840A: Laerdal Branded Heartstart FR2+ Defibrillator with ECG Module (various languages). M3841A: Laerdal Branded Heartstart FR2+ Defibrillator Text Display, No ECG Module (various languages). The following letter codes are used in conjunction with the catalog numbers to indicate language of Instructions for Use (IFU) and FR2+ voice prompts: ABA=U.S. English; ABU=U.K. English; ABD=German; ABE=Spanish; ABF=French; ABH=Dutch; ABI=Hong Kong; ABJ=Japanese; ABN=Norwegian; ABO=Taiwanese; ABS=Swedish; ABX=Finland; ABZ=Italian; AB2=China; and AC4=Portugal. Additional (non-language related) letter codes for product: A01=Product with TSO (Technical Standard Order) approved battery; and RF=Service Replacement. Recall # Z-0063-2010;

2) Heartstart FR2+ automated external defibrillator models M3861A and M3841A are NOT equipped with the ECG Module. Model M3861A is under the Philips label and M3841A is under the Laerdal label. Recall # Z-0062-2010
CODE
1) Following serial numbers listed as follows: M3860A=U.S. Distribution M3861A=U.S. Distribution M3860A=Canadian Distribution M3861A=Canadian Distribution M3860A=International, not including Canada M3861A=Interantional, not including Canada Laerdal=M3840A and M3841A=all international M3860A U.S. DISTRIBUTION: 0108267575, 0807248065, 0807248798, 0807249110, 0807250145, 0907253534, 0907254125, 0907254417, 0907254602, 0108267741, 0807248084, 0807248802, 0807249112, 0807250147, 0907253540, 0907254127, 0907254421, 0907254603, 0307230176, 0807248100, 0807248804, 0807249113, 0807250166, 0907253544, 0907254129, 0907254423, 0907254604, 0507237301, 0807248160, 0807248806, 0807249116, 0807250177, 0907253546, 0907254132, 0907254425, 0907254605, 0507237302, 0807248166, 0807248815, 0807249118, 0807250179, 0907253548, 0907254133, 0907254427, 0907254606, 0507237303, 0807248168, 0807248827, 0807249122, 0807250198, 0907253552, 0907254136, 0907254429, 0907254607, 0507237304, 0807248172, 0807248830, 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0907254492, 0907254634, 0507237679, 0807248319, 0807248901, 0807249175, 0807250344, 0907253792, 0907254183, 0907254494, 0907254638, 0507237682, 0807248323, 0807248902, 0807249177, 0807250349, 0907253806, 0907254187, 0907254498, 0907254696, 0507237686, 0807248327, 0807248905, 0807249181, 0807250354, 0907253832, 0907254189, 0907254500, 0907254804, 0507237699, 0807248337, 0807248907, 0807249183, 0807250362, 0907253836, 0907254191, 0907254505, 0907254806, 0507237700, 0807248391, 0807248912, 0807249185, 0807250367, 0907253844, 0907254195, 0907254507, 0907254810, 0507237704, 0807248412, 0807248917, 0807249192, 0807250377, 0907253882, 0907254215, 0907254509, 0907254826, 0507237765, 0807248456, 0807248922, 0807249194, 0807250378, 0907253885, 0907254223, 0907254511, 0907254836, 0507237816, 0807248468, 0807248923, 0807249196, 0807250385, 0907253886, 0907254225, 0907254512, 0907254901, 0507237846, 0807248472, 0807248924, 0807249200, 0807250388, 0907253887, 0907254227, 0907254513, 0907254903, 0507237848, 0807248474, 0807248926, 0807249205, 0807250390, 0907253889, 0907254229, 0907254517, 0907254905, 0607239532, 0807248476, 0807248930, 0807249207, 0807250392, 0907253893, 0907254231, 0907254518, 0907254907, 0607239882, 0807248480, 0807248932, 0807249225, 0807250398, 0907253895, 0907254233, 0907254520, 0907254909, 0607239884, 0807248482, 0807248933, 0807249226, 0807250446, 0907253899, 0907254239, 0907254522, 0907254911, 0607239886, 0807248490, 0807248935, 0807249227, 0807250915, 0907253901, 0907254241, 0907254524, 0907254913, 0607239888, 0807248492, 0807248938, 0807249231, 0907252699, 0907253906, 0907254243, 0907254526, 0907254915, 0607239910, 0807248496, 0807248940, 0807249237, 0907252731, 0907253921, 0907254245, 0907254528, 0907254917, 0607239911, 0807248509, 0807248944, 0807249239, 0907253237, 0907253923, 0907254247, 0907254530, 0907254919, 0607239953, 0807248512, 0807248948, 0807249241, 0907253241, 0907253926, 0907254257, 0907254532, 0907254921, 0607239994, 0807248517, 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0907254981, 0707244388, 0807248695, 0807249031, 0807250042, 0907253499, 0907254104, 0907254395, 0907254590, 0907254983, 0707244494, 0807248699, 0807249033, 0807250059, 0907253502, 0907254108, 0907254396, 0907254591, 0907254985, 0707245904, 0807248732, 0807249035, 0807250079, 0907253503, 0907254111, 0907254397, 0907254592, 0907254987, 0707246078, 0807248734, 0807249037, 0807250097, 0907253504, 0907254114, 0907254399, 0907254593, 0907254989, 0707246276, 0807248736, 0807249039, 0807250101, 0907253507, 0907254115, 0907254401, 0907254594, 0907254991, 0807247654, 0807248750, 0807249041, 0807250103, 0907253512, 0907254116, 0907254403, 0907254595, 0907254993, 0807247692, 0807248754, 0807249043, 0807250109, 0907253520, 0907254117, 0907254405, 0907254596, 0907254995, 0807247809, 0807248756, 0807249045, 0807250113, 0907253524, 0907254119, 0907254407, 0907254597, 0907254997, 0807247811, 0807248758, 0807249101, 0807250117, 0907253526, 0907254120, 0907254409, 0907254598, 0908287926, 0807248037, 0807248764, 0807249106, 0807250129, 0907253528, 0907254121, 0907254411, 0907254599, 0908287992, 0807248059, 0807248766, 0807249107, 0807250135, 0907253530, 0907254122, 0907254413, 0907254600, 1007255537, 0807248063, 0807248768, 0807249109, 0807250144, 0907253532, 0907254123, 0907254415, AND 0907254601.

================================================== M3861A U.S. DISTRIBUTION: 0108267721, 0807248357, 0907253438, 0907254101, 0907254280, 0907254452, 0907254699, 0907254819, 0108267727, 0807248359, 0907253485, 0907254103, 0907254282, 0907254454, 0907254700, 0907254820, 0308273383, 0807248361, 0907253487, 0907254106, 0907254284, 0907254456, 0907254701, 0907254821, 0507237606, 0807248373, 0907253488, 0907254109, 0907254288, 0907254458, 0907254702, 0907254822, 0507237614, 0807248379, 0907253489, 0907254110, 0907254290, 0907254460, 0907254703, 0907254824, 0507237737, 0807248381, 0907253491, 0907254112, 0907254291, 0907254464, 0907254704, 0907254825, 0507237897, 0807248399, 0907253495, 0907254113, 0907254293, 0907254466, 0907254705, 0907254827, 0607239687, 0807248460, 0907253496, 0907254126, 0907254294, 0907254468, 0907254706, 0907254828, 0607239744, 0807248514, 0907253519, 0907254128, 0907254296, 0907254470, 0907254707, 0907254829, 0607239756, 0807248518, 0907253538, 0907254130, 0907254298, 0907254472, 0907254708, 0907254830, 0607239890, 0807248525, 0907253542, 0907254134, 0907254300, 0907254474, 0907254709, 0907254831, 0607239947, 0807248531, 0907253557, 0907254135, 0907254302, 0907254476, 0907254710, 0907254832, 0607239957, 0807248533, 0907253611, 0907254138, 0907254304, 0907254478, 0907254711, 0907254833, 0607240006, 0807248539, 0907253660, 0907254145, 0907254306, 0907254480, 0907254712, 0907254835, 0607240106, 0807248564, 0907253667, 0907254147, 0907254308, 0907254490, 0907254713, 0907254838, 0607240112, 0807248583, 0907253668, 0907254148, 0907254310, 0907254502, 0907254714, 0907254840, 0607240124, 0807248595, 0907253669, 0907254149, 0907254312, 0907254506, 0907254715, 0907254841, 0607240126, 0807248634, 0907253671, 0907254151, 0907254314, 0907254510, 0907254717, 0907254843, 0607240521, 0807248645, 0907253672, 0907254152, 0907254316, 0907254514, 0907254718, 0907254844, 0607241459, 0807248684, 0907253674, 0907254154, 0907254318, 0907254523, 0907254719, 0907254846, 0607241461, 0807248702, 0907253682, 0907254155, 0907254320, 0907254534, 0907254720, 0907254847, 0607241469, 0807248739, 0907253692, 0907254156, 0907254322, 0907254567, 0907254721, 0907254849, 0607241473, 0807248916, 0907253700, 0907254157, 0907254326, 0907254584, 0907254722, 0907254850, 0607241475, 0807248937, 0907253717, 0907254158, 0907254330, 0907254588, 0907254725, 0907254851, 0607241591, 0807248945, 0907253724, 0907254159, 0907254332, 0907254614, 0907254726, 0907254854, 0607241595, 0807248947, 0907253725, 0907254160, 0907254334, 0907254618, 0907254727, 0907254856, 0607241597, 0807248997, 0907253728, 0907254161, 0907254336, 0907254622, 0907254728, 0907254860, 0607241605, 0807250127, 0907253732, 0907254162, 0907254338, 0907254624, 0907254729, 0907254862, 0607241866, 0807250131, 0907253734, 0907254164, 0907254339, 0907254629, 0907254730, 0907254864, 0607241868, 0807250133, 0907253736, 0907254168, 0907254340, 0907254631, 0907254731, 0907254866, 0607241872, 0807250137, 0907253738, 0907254177, 0907254341, 0907254633, 0907254732, 0907254868, 0607241878, 0807250143, 0907253740, 0907254178, 0907254342, 0907254635, 0907254733, 0907254870, 0607241880, 0807250149, 0907253763, 0907254180, 0907254343, 0907254636, 0907254734, 0907254871, 0607241882, 0807250150, 0907253773, 0907254181, 0907254357, 0907254637, 0907254735, 0907254872, 0607241884, 0807250151, 0907253783, 0907254182, 0907254359, 0907254639, 0907254736, 0907254873, 0607241886, 0807250153, 0907253790, 0907254184, 0907254360, 0907254640, 0907254737, 0907254874, 0607241888, 0807250155, 0907253798, 0907254186, 0907254362, 0907254641, 0907254738, 0907254875, 0607241890, 0807250156, 0907253800, 0907254188, 0907254367, 0907254642, 0907254739, 0907254877, 0607242129, 0807250157, 0907253818, 0907254190, 0907254368, 0907254644, 0907254740, 0907254878, 0607242133, 0807250161, 0907253822, 0907254192, 0907254369, 0907254646, 0907254741, 0907254879, 0607242135, 0807250164, 0907253824, 0907254194, 0907254370, 0907254647, 0907254747, 0907254880, 0607242139, 0807250172, 0907253830, 0907254197, 0907254372, 0907254648, 0907254748, 0907254881, 0607242141, 0807250174, 0907253838, 0907254198, 0907254373, 0907254649, 0907254749, 0907254883, 0607242149, 0807250178, 0907253842, 0907254202, 0907254374, 0907254651, 0907254750, 0907254884, 0607242166, 0807250182, 0907253848, 0907254204, 0907254375, 0907254652, 0907254751, 0907254885, 0607242168, 0807250190, 0907253896, 0907254206, 0907254376, 0907254656, 0907254753, 0907254886, 0607242170, 0807250192, 0907253897, 0907254208, 0907254377, 0907254658, 0907254754, 0907254887, 0607242172, 0807250200, 0907253898, 0907254210, 0907254378, 0907254660, 0907254755, 0907254888, 0607242377, 0807250207, 0907253900, 0907254212, 0907254379, 0907254661, 0907254756, 0907254889, 0707245469, 0807250246, 0907253908, 0907254214, 0907254380, 0907254662, 0907254757, 0907254891, 0707245624, 0807250248, 0907253909, 0907254216, 0907254381, 0907254663, 0907254758, 0907254893, 0707246066, 0807250256, 0907253910, 0907254230, 0907254382, 0907254664, 0907254759, 0907254895, 0807247650, 0807250260, 0907253912, 0907254232, 0907254384, 0907254665, 0907254760, 0907254897, 0807248038, 0807250278, 0907253913, 0907254234, 0907254386, 0907254666, 0907254761, 0907254899, 0807248041, 0807250282, 0907253933, 0907254236, 0907254388, 0907254667, 0907254762, 0907254922, 0807248075, 0807250286, 0907253938, 0907254240, 0907254390, 0907254668, 0907254765, 0907254924, 0807248077, 0807250288, 0907253940, 0907254242, 0907254398, 0907254669, 0907254767, 1007255202, 0807248097, 0807250290, 0907253943, 0907254244, 0907254400, 0907254670, 0907254769, 1007256655, 0807248099, 0807250292, 0907253944, 0907254246, 0907254402, 0907254671, 0907254771, , 0807248103, 0807250294, 0907253948, 0907254248, 0907254404, 0907254672, 0907254773, , 0807248109, 0807250296, 0907253955, 0907254249, 0907254406, 0907254673, 0907254774, , 0807248121, 0807250302, 0907253961, 0907254250, 0907254408, 0907254674, 0907254775, , 0807248123, 0807250308, 0907253963, 0907254251, 0907254410, 0907254675, 0907254777, , 0807248125, 0807250316, 0907253977, 0907254252, 0907254412, 0907254676, 0907254779, 0807248129, 0807250318, 0907254001, 0907254253, 0907254414, 0907254677, 0907254781, 0807248131, 0807250322, 0907254003, 0907254254, 0907254416, 0907254678, 0907254783, 0807248133, 0807250326, 0907254006, 0907254256, 0907254418, 0907254679, 0907254787, 0807248135, 0807250346, 0907254009, 0907254258, 0907254420, 0907254680, 0907254789, 0807248137, 0807250366, 0907254017, 0907254260, 0907254422, 0907254681, 0907254791, 0807248139, 0807250387, 0907254027, 0907254262, 0907254424, 0907254683, 0907254793, 0807248141, 0807250395, 0907254045, 0907254264, 0907254426, 0907254684, 0907254795, 0807248143, 0807251069, 0907254047, 0907254265, 0907254428, 0907254685, 0907254797, 0807248145, 0907251325, 0907254049, 0907254266, 0907254430, 0907254686, 0907254799, 0807248147, 0907253257, 0907254055, 0907254267, 0907254432, 0907254687, 0907254801, 0807248162, 0907253259, 0907254059, 0907254268, 0907254434, 0907254688, 0907254803, 0807248164, 0907253265, 0907254061, 0907254269, 0907254436, 0907254689, 0907254805, 0807248170, 0907253275, 0907254065, 0907254270, 0907254438, 0907254690, 0907254807, 0807248214, 0907253323, 0907254067, 0907254271, 0907254440, 0907254691, 0907254809, 0807248317, 0907253404, 0907254073, 0907254272, 0907254442, 0907254693, 0907254811, 0807248325, 0907253418, 0907254089, 0907254273, 0907254444, 0907254694, 0907254813, 0807248339, 0907253421, 0907254091, 0907254274, 0907254446, 0907254695, 0907254814, 0807248351, 0907253432, 0907254093, 0907254276, 0907254448, 0907254697, 0907254815, 0807248355, 0907253434, 0907254100, 0907254278, 0907254450, 0907254698, AND 0907254816. M3860A CANADA DISTRIBUTION: 0607240550, 0707243439, 0707243892, 0807246607, 0807246609, 0807246615, 0807246637, 0807248842, 0807248908, 0807248968, 0807249278, 0807249282, 0807249296, 0807250176, 0807250811, 0907253718, 0907253796, 0907254275, 0907254279, 0907254364, 0907254366, 0907254496, 0907254548, 0907254570, AND 0907254610. ============================================= ============================================== 

M3861A CANADA DISTRIBUTION: 0607239912, 0807250320, 0907253701, 0907253726, 0907254023, 0907254105, 0907254141, 0907254153, AND 0907254504. M3860A INTERNATIONAL-NOT INCLUDING CANADA: 0108267591, 0108267701, 0108267705, 0108267715, 0108267723, 0507236763, 0507237318, 0507237325, 0507237333, 0507237369, 0507237377, 0507237391, 0507237393, 0507237409, 0507237410, 0507237460, 0507237504, 0507237506, 0507237527, 0507237547, 0507237551, 0507237668, 0507237676, 0507237778, 0507237803, 0507237805, 0507237808, 0507237824, 0507237826, 0508275018, 0607239952, 0607239954, 0607239956, 0607239958, 0607240008, 0607240013, 0607240021, 0607240029, 0607240037, 0607240039, 0607240043, 0607240045, 0607240047, 0607240049, 0607240051, 0607239952, 0607239954, 0607239956, 0607239958, 0607240008, 0607240013, 0607240021, 0607240029, 0607240037, 0607240039, 0607240043, 0607240045, 0607240047, 0607240049, 0607240051, 0607240105, 0607240167, 0607240171, 0607240205, 0607240259, 0607240272, 0607240306, 0607240316, 0607240318, 0607240320, 0607240322, 0607240323, 0607240332, 0607240334, 0607240346, 0607240356, 0607240360, 0607240365, 0607240370, 0607240372, 0607240374, 0607240376, 0607240380, 0607240809, 0607240811, 0607240864, 0607240878, 0607240880, 0607240882, 0607240886, 0607240904, 0607241005, 0607241471, 0607241876, 0607241894, 0607242365, 0607242466, 0707243291, 0707243340, 0707243399, 0707243444, 0707243838, 0707244007, 0707244013, 0707244020, 0707244024, 0707244039, 0707244041, 0707244044, 0707244399, 0707244405, 0707244408, 0707244483, 0707244485, 0707244493, 0707244503, 0707245561, 0707245706, 0707245707, 0707245708, 0707245712, 0707245714, 0707246252, 0807248019, 0807248023, 0807248053, 0807248055, 0807248061, 0807248072, 0807248078, 0807248119, 0807248127, 0807248204, 0807248216, 0807248224, 0807248228, 0807248232, 0807248236, 0807248244, 0807248255, 0807248259, 0807248261, 0807248263, 0807248265, 0807248269, 0807248271, 0807248273, 0807248275, 0807248277, 0807248283, 0807248285, 0807248287, 0807248289, 0807248291, 0807248293, 0807248297, 0807248302, 0807248307, 0807248345, 0807248347, 0807248367, 0807248369, 0807248420, 0807248422, 0807248424, 0807248428, 0807248430, 0807248434, 0807248436, 0807248438, 0807248440, 0807248446, 0807248452, 0807248462, 0807248464, 0807248478, 0807248488, 0807248668, 0807249047, 0807249063, 0807249204, 0807249276, 0807249303, 0807249601, 0807249605, 0807249609, 0807249611, 0807249614, 0807249615, 0807249616, 0807249617, 0807249619, 0807249620, 0807249621, 0807249623, 0807249624, 0807249626, 0807249627, 0807249628, 0807249630, 0807249632, 0807249633, 0807249634, 0807249635, 0807249636, 0807249637, 0807249638, 0807249639, 0807249640, 0807249641, 0807249642, 0807249643, 0807249645, 0807249646, 0807249647, 0807249648, 0807249649, 0807249652, 0807249655, 0807249659, 0807249672, 0807249674, 0807249676, 0807249681, 0807249685, 0807249688, 0807249689, 0807249699, 0807249749, 0807249802, 0807249804, 0807249807, 0807249816, 0807249818, 0807249822, 0807249828, 0807249830, 0807249834, 0807249836, 0807249844, 0807249866, 0807249868, 0807249870, 0807249872, 0807249874, 0807249876, 0807249882, 0807249886, 0807249888, 0807249890, 0807249892, 0807249894, 0807249901, 0807249903, 0807249904, 0807249905, 0807249907, 0807249911, 0807249912, 0807249913, 0807249915, 0807249917, 0807249919, 0807249921, 0807249925, 0807249933, 0807249935, 0807249937, 0807249957, 0807249977, 0807249979, 0807249981, 0807249995, 0807249999, 0807250077, 0807250116, 0807250168, 0807250170, 0807250187, 0807250218, 0807250560, 0807250562, 0807250590, 0807250647, 0807250651, 0807250913, 0807250927, 0807250943, 0807250945, 0807250947, 0807250955, 0907253219, 0907253245, 0907253251, 0907253262, 0907253267, 0907253269, 0907253271, 0907253272, 0907253278, 0907253280, 0907253281, 0907253283, 0907253319, 0907253321, 0907253325, 0907253327, 0907253394, 0907253794, 0907254025, 0907254131, 0907254146, 0907254235, 0907254237, 0907254287, 0907254419, 0907254654, 0907254742, 0907254746, 0907254766, 0907254782, 0907254788, 0907254794, 0907254896, 0907254906, 0907254908, 0907254912, 0907254914, 0907254916, 0907254960, 0907254964, 0907254966, 0907254968, 0907254970, 0907254971, 0907254999, 0907255003, 0907255007, 0907255013, 0907255028, 0907255045, 0907255057, 0907255061, 0907255065, 0907255067, 0907255069, 0907255071, 0907255073, 0907255077, 0907255081, 0907255085, 0907255087, 0907255089, 0907255091, 0907255095, 0907255108, 0907255110, 0907255113, 0907255116, 0907255118, 0907255120, 0907255121, 0907255122, 0907255136, 0907255141, 0907255163, 0907255165, 1007255210, 1007255218, 1007255231, 1007255233, 1007255237, 1007255241, 1007255243, 1007255249, 1007255267, 1007255271, 1007255301, 1007255303, 1007255305, 1007255307, 1007255313, 1007255317, 1007255319, 1007255323, 1007255371, 1007256663, 1007256675, 1007256677, 1007256679, 1007256681, 1007256683, 1007256704, 1007256767, 1007256773, 1007256777, 1007256781, 1007256787, 1007256793, 1007256795, 1007256799, 1007257012, 1007257014, 1007257016, 1007257063, 1007257071, 1007257073, 1007257006, 1207267451, 1207267455, AND 1207267459.

================================================================= 

M3861A INTERNATIONAL-NOT INCLUDING CANADA: 0108267589, 0507236701, 0507236709, 0507236711, 0507236713, 0507236715, 0507236717, 0507236719, 0507236721, 0507236723, 0507236725, 0507236729, 0507236731, 0507236733, 0507236735, 0507236737, 0507236739, 0507236741, 0507236743, 0507236745, 0507236753, 0507236755, 0507236757, 0507236777, 0507236785, 0507236791, 0507236795, 0507236799, 0507237051, 0507237057, 0507237063, 0507237067, 0507237069, 0507237073, 0507237075, 0507237077, 0507237079, 0507237081, 0507237083, 0507237089, 0507237093, 0507237095, 0507237097, 0507237099, 0507237119, 0507237122, 0507237123, 0507237125, 0507237127, 0507237129, 0507237131, 0507237133, 0507237135, 0507237167, 0507237169, 0507237179, 0507237181, 0507237193, 0507237224, 0507237226, 0507237230, 0507237232, 0507237234, 0507237236, 0507237238, 0507237244, 0507237248, 0507237260, 0507237295, 0507237297, 0507237308, 0507237310, 0507237327, 0507237331, 0507237339, 0507237361, 0507237367, 0507237371, 0507237385, 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1007257360.

======================================= LAERDAL M3840A AND M3841A: 0607240946, 0807246508, 0807249629, 0807249657, 0807249705, 0807249939, 0807249989, 0108267713, 0607240924, 0907253243, 0108267745, 0108267749, 0507237315, 0507237337, 0507237351, 0507237458, 0507237463, 0507237472, 0508275051, 0508275053, 0508275055, 0508275061, 0508275063, 0508275065, 0508275067, 0508275069, 0508275071, 0508275099, 0607240057, 0607240063, 0607240311, 0607240313, 0607240388, 0607240390, 0607240392, 0607240398, 0607240400, 0607240404, 0607240515, 0607240685, 0607240807, 0607240817, 0607240862, 0607240866, 0607240870, 0607240872, 0607240874, 0607240884, 0607240888, 0607240890, 0607240896, 0607240902, 0607240912, 0607240997, 0607240999, 0607241001, 0807248822, 0807248824, 0807248858, 0807248860, 0807248884, 0807248886, 0807248888, 0807248892, 0807248950, 0807248973, 0807248977, 0807248981, 0807248985, 0807248995, 0807248999, 0807249001, 0807249003, 0807249005, 0807249009, 0807249011, 0807249021, 0807249104, 0807249117, 0807249120, 0807249124, 0807249176, 0807249202, 0807249203, 0807249214, 0807249216, 0807249218, 0807249220, 0807249224, 0807249228, 0807249232, 0807249236, 0807249240, 0807249242, 0807249244, 0807249246, 0807249261, 0807249271, 0807249277, 0807249281, 0807249286, 0807249290, 0807249300, 0807249301, 0807249327, 0807250564, 0807250576, 0807250580, 0807250582, 0807250588, 0807250594, 0807250604, 0807250610, 0807250625, 0807250629, 0807250659, 0807250663, 0807250901, 0807250923, 0807250961, 0507236781, 0507236783, 0507237360, 0507237408, 0507237501, 0507237505, 0807248032, 0807248152, 0807248329, 0807248333, 0807248335, 0807248353, 0807248365, 0807248371, 0807248375, 0807248395, 0807248820, 0807248850, 0807248852, 0807248854, 0807248868, 0807248876, 0807248878, 0807248925, 0807248931, 0807248941, 0807248949, 0807248965, 0807248987, 0807249102, 0807249108, 0807249140, 0807249164, 0807249166, 0807249168, 0807249172, 0807249180, 0807249188, 0807249193, 0807249199, 0807249215, 0807249235, 0807249251, 0807249253, 0807249259, 0409300614, 0507237356, 0507237473, 0507237475, 0507237485, 0507237491, 0507237495, 0507237523, 0607240071, 0607241142, 0607241148, 0607241463, 0707243385, 0707243825, 0807248082, 0807248086, 0807248090, 0807248092, 0807248105, 0807248113, 0108267755, 0507237317, 0507237320, 0507237324, 0507237329, 0507237335, 0507237338, 0507237340, 0507237343, 0507237345, 0507237347, 0507237349, 0507237395, 0507237403, 0507237477, 0507237478, 0507237489, 0607238324, 0607239962, 0607239964, 0607240095, 0607240097, 0607240108, 0607240110, 0607240219, 0607240223, 0607240257, 0607240266, 0607240307, 0607240335, 0607240391, 0607240393, 0607240395, 0607240534, 0607240536, 0607241023, 0607241025, 0607241027, 0607241029, 0607241134, 0607241136, 0607241146, 0707243401, 0707243437, 0707243459, 0707243465, 0707243823, 0707243833, 0707243889, 0707243946, 0707243964, 0707243998, 0707244003, 0707244177, 0807248073, 0807248091, 0807248101, 0807248158, 0807248174, 0807248178, 0807248202, 0807248208, 0807248242, 0807248341, 0807248343, 0807248450, 0807248508, 0807248534, 0807248536, 0807248541, 0807248571, 0807248579, 0807248688, 0807248705, 0807248711, 0807248713, 0807248723, 0807248727, 0807248741, 0807248747, 0807248749, 0807248755, 0907253247, 0907253253, 0907253261, 1007257077, 0807250941, 0308273587, 0308273589, 0308273591, 0308273595, 0507237328, 0507237344, 0507237413, 0507237535, 0507237609, 0507237670, 0507237703, 0507237735, 0507237781, 0507237798, 0507237832, 0507237837, 0507237838, 0507237854, 0507237860, 0507237870, 0507237891, 0508275012, 0508275014, 0508275016, 0508275020, 0508275024, 0508275026, 0508275028, 0508275030, 0508275032, 0508275036, 0508275049, 0508275057, 0508275059, 0508275073, 0508275075, 0508275077, 0508275079, 0508275081, 0508275083, 0508275085, 0508275087, 0508275089, 0508275091, 0508275093, 0508275095, 0508275097, 0508275101, 0508275103, 0508275105, 0607238011, 0607238020, 0607238032, 0607238238, 0607238260, 0607238326, 0607238328, 0607238647, 0607238657, 0607238661, 0607238675, 0607238679, 0607238687, 0607238691, 0607238693, 0607238699, 0607239001, 0607239187, 0607239960, 0607240009, 0607240011, 0607240017, 0607240019, 0607240141, 0607240153, 0607240155, 0607240159, 0607240161, 0607240165, 0607240169, 0607240181, 0607240310, 0607240340, 0607240813, 0607240825, 0607240827, 0607240829, 0607240831, 0607240833, 0607240835, 0607240843, 0607240855, 0607240857, 0607240861, 0607240881, 0607240898, 0607240900, 0607240926, 0607240930, 0607240932, 0607240936, 0607240938, 0607240940, 0607240952, 0607240956, 0607240958, 0607240960, 0607240962, 0607240966, 0607240968, 0607240970, 0707244715, 0707244824, 0707244830, 0707244832, 0707244870, 0707244894, 0707244904, 0807249941, 0807249945, 0907252534, 0507237736, 0807248674, 0807248906, 0807248943, 0807249015, 0807249085, 0807249087, 0807249095, 0807249625, 0807249631, 0807249644, 0807249654, 0807249656, 0807249660, 0807249677, 0807249679, 0807249694, 0807249703, 0807249769, 0807249771, 0807249906, 0807249908, 0807249927, 0807249958, 0807249959, 0807249961, 0807249975, 0807249983, 0807249985, 1207267284, 0507237741, 0507237777, 0507237841, 0507237883, 0607238242, 0607238244, 0707244856, 0707244878, 0508275047, 0607240061, 0607240394, 0607240396, 0607241032, 0607241038, 0707243381, 0707243383, 0707243422, 0707243432, 0707243433, 0707243460, 0707243467, 0707243855, 0707243865, 0707243877, 0707243879, 0707243881, 0707243885, 0707243890, 0707243896, 0707244864, 0807250528, 0807250538, 0807250540, 0807250572, 0807250574, 0807250637, 0807250848, 0807250907, 0907254015, 0907254752, 0907254764, 0907254768, 0907254770, 0907254776, 0907254784, 0907254786, 0907254790, 0907254792, 0907254796, 0907254798, 0907254800, 0907254834, 0907254882, 0907254890, 0907254894, 0907254898, 0907254902, 0907254904, 0907254932, 0907254934, 0907254936, 0907254938, 0907254940, 0907254942, 0907254944, 0907254946, 0907254948, 0907254950, 0907254952, 0907254954, 0907254956, 0907254958, 0907254962, 0907254972, 0907254974, 0907254976, 0907254978, 0907254980, 0907254982, 0907254984, 0907254988, 0907254990, 0907254992, 0907254994, 0907254996, 0907254998, 0907255000, 0907255001, 0907255005, 0907255009, 0907255011, 0907255017, 0907255026, 0907255039, 0907255047, 0907255049, 0907255051, 0907255053, 0907255055, 0907255059, 0907255063, 0907255079, 0907255093, 0907255101, 0907255103, 0907255104, 0907255105, 0907255107, 0907255109, 0907255111, 0907255112, 0907255114, 0907255115, 0907255119, 0907255123, 0907255124, 0907255125, 0907255128, 0907255129, 0907255130, 0907255131, 0907255132, 0907255133, 0907255134, 0907255161, 0108269537, 0507237595, 0507237603, 0507237620, 0507237687, 0507237691, 0507237702, 0507237747, 0507237751, 0507237793, 0507237795, 0507237811, 0507237835, 0507237843, 0507237845, 0507237847, 0507237884, 0507237886, 0507237922, 0507237924, 0507237933, 0507237938, 0507237948, 0507238000, 0507238005, 0607238012, 0607238014, 0607238017, 0607238018, 0607238019, 0607238021, 0607238035, 0607238046, 0607238059, 0607238060, 0607238070, 0607238083, 0607238094, 0607238096, 0607238427, 0607239344, 0607239346, 0607239406, 0607239414, 0607239508, 0607242373, 0607242375, 0707243436, 0707243438, 0707243442, 0707243813, 0707243856, 0707243864, 0707243898, 0807247353, 0807247355, 0807248393, 0807248898, 0807248903, 0807248904, 0807248909, 0807248910, 0807248915, 0807248918, 0807248928, 0807248929, 0807248936, 0807248939, 0807248942, 0807248946, 0807248951, 0807248953, 0807248954, 0807248955, 0807248956, 0807248957, 0807248959, 0807248960, 0807248963, 0807248966, 0807248970, 0807248976, 0807248983, 0807248991, 0807248993, 0807249007, 0807249178, 0807249182, 0807249184, 0807249186, 0807249190, 0807249208, 0807249209, 0807249210, 0807249211, 0807249212, 0807249213, 0807249219, 0807249221, 0807249222, 0807249223, 0807249229, 0807249230, 0807249233, 0807249234, 0807249238, 0807249248, 0807249250, 0807249252, 0807249254, 0807249256, 0807249260, 0807249263, 0807249264, 0807249265, 0807249266, 0807249268, 0807249269, 0807249274, 0807249275, 0807249279, 0807249283, 0807249285, 0807249287, 0807249288, 0807249289, 0807249291, 0807249292, 0807249293, 0807249295, 0807249297, 0807249298, 0807249299, 0807250840, 0907253246, 0907253248, 0907253250, 0907253252, 0907253254, 0907253256, 0907253258, 0907253260, 0907253266, 0907253268, 0907253270, 0907253274, 0907253276, 0907253282, 0907253288, 0907253292, 0907253294, 0907253296, 0907253298, 0907253300, 0907253302, 0907253304, 0907253306, 0907253310, 0907253312, 0907253314, 0907253316, 0907253318, 0907253320, 0907253322, 0907253324, 0907253326, 0907253328, 0907253330, 0907253331, 0907253332, 0907253333, 0907253334, 0907253335, 0907253336, 0907253338, 0907253339, 0907253340, 0907253341, 0907253342, 0907253388, 0907253390, 0907253392, 0907253396, 0907253405, 0907253415, 0907253417, 0907253419, 0907253423, 0907253433, 0907253439, 0907253443, 0907253445, 0907253459, 0907253461, 0907253465, 0907253467, 0907253469, 0907253471, 0907253473, 0907253479, 0907253481, 0907253483, 0907253501, 0907253505, 0907253509, 0907253511, 0907253517, 0907253521, 0907253523, 0907253525, 0907253543, 0907253547, 0907253555, 0907253597, 0907253599, 0907254013, 0607239913, 0607240402, 0807246506, 0907253217, 0907253277, 1007257075, 0308273599, 0507237326, 0507237366, 0507237499, 0507237950, 0508275022, 0607238649, 0607238682, 0607239903, 0607239905, 0607240023, 0607240033, 0607240147, 0607240149, 0607240157, 0607240195, 0607240197, 0607240201, 0607240350, 0807248042, 0807248050, 0807248305, 0807249622, 0807249993, 0908288146, 0908288152, 0607240928, 0607240944, 0108267577, 0108267709, 0108267739, 0108267743, 0108267753, 0507237195, 0507237197, 0507237199, 0507237330, 0507237358, 0507237373, 0507237375, 0507237433, 0507237444, 0507237450, 0507237481, 0507237493, 0607240059, 0607240065, 0607240067, 0607240069, 0607240099, 0607240136, 0607240138, 0607240309, 0607240329, 0607240333, 0607240337, 0607240359, 0607240361, 0607240367, 0607240382, 0607240384, 0607240659, 0607240667, 0608278912, 0807246502, 0807246621, 0807246639, 0807246641, 0807246643, 0807248685, 0807248744, 0807248772, 0807248818, 0807248834, 0807248847, 0807248872, 0807248880, 0807248882, 0807248890, 0807248919, 0807249125, 0807249146, 0807249152, 0807249154, 0807249156, 0807249174, 1207267276, 1207267280, 1207267282, 1207267286, 1207267290, 1207267292, 1207267294, 1207267296, 1207267298, 1207267409, 1207267411, 1207267415, 1207267419, 1207267441, 1207267449, 1207267453, 1207267457, 1207267463, 1207267465, 1207267471, 0807248927, 0807249701, 0807249923, 0907253244, 0907253255, 0907253286, 0907253403, 0807249267, AND 0807249273;

2) The following letter codes are used in conjunction with the catalog numbers to indicate language of Instructions for Use (IFU) and FR2+ voice prompts: ABA=U.S. English; ABU=U.K. English; ABD=German; ABE=Spanish; ABF=French; ABH=Dutch; ABI=Hong Kong; ABJ=Japanese; ABN=Norwegian; ABO=Taiwanese; ABS=Swedish; ABX=Finland; ABZ=Italian; AB2=China; and AC4=Portugal. Additional (non-language related) letter codes for product: A01=Product with TSO (Technical Standard Order) approved battery; and RF=Service Replacement
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Seattle, WA, by press release on September 28, 2009 and letters on October 1, 2009. Firm initiated recall is ongoing.
REASON
A potential exists for a component failure, which, if it occurs, could result in the inability to deliver therapy.
VOLUME OF PRODUCT IN COMMERCE
5808 units
DISTRIBUTION
Nationwide, Canada, Australia, Austria, Bulgaria, China, Finland, France, Germany, Gibraltar, Great Britain, Hong Kong, India, Indonesia, Ireland, Italy, Japan, Jordan, Lebanon, Malaysia, Mexico, Netherlands, Norway, Portugal, Singapore, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, and United Arab Emirates
___________________________________
PRODUCT
Guider XF Softip Guide Catheter. The device is intended to facilitate placement of interventional devices into the neurovascular system. UPN/Model numbers: H965100420/10042, H965100430/10043, H965100440/10044, H965100460/10046, H965100470/10047, H965100480/10048, H965100500/10050, H965100510/10051, H965100520/10052, M003100620/10062, M003100630/10063, M003100640/10064, M003101420/10142, M003101430/10143, M003101440/10144, M003101460/10146, M003101470/10147, M003101480/10148, M003101500/10150, M003101510/10151, M003101520/10152, M003101620/10162, M003101630/10163 and M003101640/10164. Recall # Z-0107-2010
CODE
Batch numbers numerous. Please contact Boston Scientific Corporation for specific lot codes.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Fremont, CA, by letter on October 6, 2009.
Manufacturer: Boston Scientific Corp., Maple Grove, MN. Firm initiated recall is ongoing.
REASON
Product degradation-- a polymer portion of the distal section of the catheter may degrade prematurely, leading to potential systemic embolization of particulates with ischemic complications.
VOLUME OF PRODUCT IN COMMERCE
94,296 units
DISTRIBUTION
Nationwide, Argentina, Australia, Austria, Azerbaijan, Bahrain, Belgium, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Georgia, Germany, Great Britain, Greece, Honduras, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Jordan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Macau, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Nicaragua, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, South Africa, South Korea, Spain, Sri Lanka, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Tobago, Tunisia, Turkey, Ukraine, UAE, Uruguay, Venezuela, Vietnam and Yemen
___________________________________
PRODUCT
Coloplast Titan OTR Inflatable Penile Prosthesis, 18cm scrotal Bioflex cylinder set w/OTR Pump, P/N QSR9181400. Sterile EO. Indicated for male patients suffering from erectile dysfunction who are considered to be candidates for implantation of a penile prosthesis. Recall # Z-0171-2010
CODE
Lot 1919244
RECALLING FIRM/MANUFACTURER
Coloplast Manufacturing, US, LLC, Minneapolis, MN, by letter dated October 2009. Firm initiated recall is ongoing.
REASON
Coloplast determined that a portion of Titan OTR pumps were manufactured using a process that where validation activities were not completed. The Titan OTR pumps were made to our standard product specifications and have passed all in-process testing to ensure mechanical reliability of these pumps. Coloplast is not recommending product explant because there are no identified risks since the product has been manufactured utilizing identical materials and processes compared to the existing Titan OTR pumps.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Apligraf (draftskin) packaging. Indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers and for the treatment of full-thickness neuropathic diabetic foot ulcers. Recall # Z-0181-2010
CODE
Lot: GS0909.01.01.1A, Expiration Date: October 8, 2009. Unit Numbers: 7-12, 16-50, 52-59, 61-66 and 68-73
RECALLING FIRM/MANUFACTURER
Organogenesis, Inc., Canton, MA, by letter dated September 28, 2009. Firm initiated recall is complete.
REASON
Unit contaminated with Staphylococcus epidermidis.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Siregraph CF X-Ray System, Model Number: 4466033. Intended use: X-Ray, Fluoroscopic, Image-intensified. Recall # Z-0189-2010
CODE
Serial Numbers: 1506, 1528, 1529, 1539, 1544, 1568, 1633, 1821, 1841, 1864, 1877, 2020, 2023, and 2126
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter dated September 11, 2009.
Manufacturer: Siemens Medical Solutions Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON
Possible injury to hand/fingers.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
NOVEL SPINAL SPACER SYSTEM, Part Number(s): a) 64817-010, b) 64817-012, c) 64817-013, d) 64817-014, e) 64817-107, f) 64113-012, g) 64113-010, h) 64765-109, i) 64733-124. Spinal fixation system consisting of various shapes or varying sizes to accommodate individual patient pathology. Recall # Z-0190-2010
CODE
a) Lot Number(s): 623549; b) Lot Number(s): 623551; c) Lot Number(s): 623552; d) Lot Number(s): 623553; e) Lot Number(s): 623584; f) Lot Number(s): 623619; g) Lot Number(s): 623620; h) Lot Number(s): 623909; i) Lot Number(s): 623778
RECALLING FIRM/MANUFACTURER
Alphatec Spine, Inc., Carlsbad, CA, by telephone on May 13, 2009. Firm initiated recall is ongoing.
REASON
Due to a deficiency in the process validation related to the machine that manufactured these parts, Alphatec would like to have the parts returned to them so that they may perform an additional inspection of each implant.
VOLUME OF PRODUCT IN COMMERCE
37 devices
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-106 (M001171060). EQL/20/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Recall # Z-0194-2010;

2) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-108 (M001171080). EQL/27/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Recall # Z-0195-2010;

3) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-110 (M001171100). EQL/33/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Recall # Z-0196-2010;

4) Boston Scientific Equalizer Balloon Catheter, Order No./REF 17-112 (M001171120). EQL/40/7/2/100. Sterilized using Ethylene Oxide. Single Use Only. Recall # Z-0197-2010 
CODE
1) Lot: 11637077, 11676784, 11740302, 11811184, 11864634, 11889228, 11960754, 12043982, 12156054, 12170193, 12240685, 12240686, 12311172, 12363749, 12397168, 12397177, 12442594, 12442595, 12490333, 12512652, 12530896, 12535289, 12535290, 12556163, 12567338, 12567339, 12582186, 12603422, 12605776, 12652788, 12652791, 12720339;

2) Lot: 11624018, 11624019, 11638187, 11643049, 11643050, 11657067, 11686940, 11712547, 11721526, 11735828, 11740301, 11747702, 11750848, 11785940, 11788316, 11788317, 11803308, 11803309, 11825804, 11825805, 11875441, 11880429, 11884123, 11889229, 11889231, 11892721, 11902172, 11955040, 11960757, 11973983, 11975227, 11975228, 11981135, 11981137, 11992147, 11996765, 12065122, 12065123, 12084934, 12133497, 12133645, 12147787, 12163202, 12163203, 12189809, 12189810, 12189811, 12195813, 12195814, 12215330, 12227668, 12277652, 12280627, 12293199, 12293420, 12293421, 12315905, 12315906, 12315907, 12325752, 12329910, 12347602, 12347604, 12363753, 12397167, 12424299, 12442596, 12459664, 12490330, 12490331, 12494202, 12523132, 12523133, 12523134, 12530895, 12535287, 12535288, 12546340, 12546341, 12546342, 12556161, 12556162, 12567441, 12567442, 12577711, 12577712, 12577713, 12582627, 12617288, 12617289, 12617290, 12622441, 12622442, 12625396, 12625397, 12702153, 12709943, 12709944, 12709945, 12714571, 12720334;

3) Lot: 11612503, 11613167, 11649850, 11664333, 11675647, 11679806, 11687184, 11703304, 11703305, 11706256, 11706257, 11721527, 11747701, 11748426, 11748427, 11753300, 11818319, 11822020, 11822021, 11823536, 11823537, 11838168, 11872757, 11880388, 11892722, 11894939, 11895181, 11895182, 11905798, 11942328, 11960758, 11973985, 11975229, 11975230, 11981138, 11981139, 11984930, 11992156, 11996764, 12003798, 12003799, 12060855, 12060857, 12065124, 12133643, 12140443, 12143888, 12143890, 12147789, 12159640, 12167057, 12183330, 12185881, 12215326, 12215327, 12227669, 12235732, 12235733, 12235734, 12280629, 12299197, 12299198, 12299199, 12303046, 12303579, 12307240, 12319312, 12319313, 12319314, 12351534, 12351536, 12397165, 12397166, 12400869, 12400870, 12400871, 12419731, 12423640, 12424849, 12424850, 12424851, 12432156, 12438763, 12438764, 12438765, 12438766, 12438767, 12442597, 12535285, 12535286, 12582189, 12582625, 12590510, 12598481, 12598482, 12598483, 12598484, 12617284, 12617285, 12625391, 12625392, 12625393, 12636765, 12636766, 12640395, 12640396, 12640397, 12640398, 12640399, 12685132, 12709946, 12709947;  

4) Lot: 12156055, 12186592, 12186593, 12186594, 12186596, 12186599, 12227670, 12227671, 12274315, 12303573, 12322322, 12330756, 12330757, 12331003, 12331005, 12331006, 12331007, 12331008, 12368967, 12379423, 12383688, 12397162, 12442599, 12442640, 12442780, 12459665, 12459666, 12526737, 12535281, 12535282, 12535283, 12535284, 12582188, 12605774, 12617283, 12687684, 12702148, 12702149, 12702553
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove, MN, by letter dated September 29, 2009.
Manufacturer: Boston Scientific Cork, Ltd, Cork, Ireland. Firm initiated recall is ongoing.
REASON
Boston Scientific is initiating a Recall Removal of numerous batches/lots of Equalizer Occlusion Balloon Catheter because the sterile barrier in the packaging of the affected product may be compromised. The outer pouch seal may be breached. If a compromised seal is not detected and a sterility-compromised catheter is used clinically, there is a risk of adverse health consequences.
VOLUME OF PRODUCT IN COMMERCE
9,800 units
DISTRIBUTION
Nationwide, Algeria, Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Jordan, Lithuania, Luxembourg, Malaysia, Morocco, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, Serbia, Slovenia, South Korea, Spain, Sweden, Switzerland, Thailand, Tunisia, Turkey, United Arab Emirates
___________________________________
PRODUCT 
1) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 9 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-09 The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0199-2010;

2) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 11 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0200-2010;

3) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 13 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0201-2010;

4) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 16 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0202-2010;

5) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, left, 19 MM height, use with baseplate size 00 or 0, sterile; REF 00-5424-010-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0203-2010;

6) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 9 MM height, use with baseplate size 1 or 2, sterile; REF 00-5424-011-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0204-2010;

7) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 11 MM height, use with baseplate size 1 or 2, sterile; REF 00-5424-011-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0205-2010;

8) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 13 MM height, for use with baseplate size 1 or 2 sterile; REF 00-5424-011-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0206-2010;

9) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 16 MM height, for use with baseplate size 1 or 2 sterile; REF 00-5424-011-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0207-2010;

10) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, left, 19 MM height, for use with baseplate size 1 or 2 sterile; REF 00-5424-011-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0208-2010;

11) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 9 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0209-2010;

12) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 11 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0210-2010;

13) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 13 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0211-2010;

14) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left, 16 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0212-2010;

15) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, left,19 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5424-013-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0213-2010;

16) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 9 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0214-2010;

17) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 11 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0215-2010;

18) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 13 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0216-2010;

19) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 16 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0217-2010;

20) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 00,0, right, 19 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5424-020-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0218-2010;

21) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1 or 2, right, 9 MM height, for use with baseplate size 1, 2, sterile; REF 00-5424-021-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0219-2010;

22) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 11 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0220-2010;

23) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 13 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0221-2010;

24) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 16 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0222-2010;

25) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5424-021-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0223-2010;

26) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 9 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0224-2010;

27) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 11 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0225-2010;

28) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 13 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0226-2010;

29) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 16 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0227-2010;

30) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, congruent, Size 3,4,5, right, 19 MM height, for use with baseplate size 3, 4, or 5, sterile; REF 00-5424-023-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0228-2010;

31) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 9 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0229-2010;

32) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 11 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0230-2010;

33) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 13 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0231-2010;

34) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 16 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0232-2010;

35) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, left, 19 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-010-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0233-2010;

36) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 9 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0234-2010;

37) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 11 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0235-2010;

38) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 13 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0236-2010;

39) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 16 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0237-2010;

40) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, left, 19 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-011-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0238-2010;

41) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 9 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0239-2010;

42) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 11 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0240-2010;

43) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 13 MM height, for use with baseplate size 3, 4 or 5, sterile;  REF 00-5428-013-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0241-2010;

44) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 16 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0242-2010;

45) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, left, 19 MM height, for use with baseplate size 3, 4 or 5, sterile; REF 00-5428-013-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0243-201;

46) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 9 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0244-2010;

47) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 11 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0245-2010;

48) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 13 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Recall # Z-0246-2010;

49) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 16 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0247-2010;

50) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 19 MM height, for use with baseplate size 00 or 0, sterile; REF 00-5428-020-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0248-2010;

51) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 9 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0249-2010;

52) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 11 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0250-2010;

53) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 13 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0251-2010;

54) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 16 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0252-2010;

55) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 1,2, right, 19 MM height, for use with baseplate size 1 or 2, sterile; REF 00-5428-021-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0253-2010;

56) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 9 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-09. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0254-2010;

57) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 11 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-11. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0255-2010;

58) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 13 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-13. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0256-2010;

59) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 16 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0257-2010;

60) Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 3,4,5, right, 19 MM height, for use with baseplate size 3,4 or 5, sterile; REF 00-5428-023-19. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals. Recall # Z-0258-2010
CODE

1)  Lots: 60930892, 60947723, 60954146, 60954147, 60958265, 60958284, 60988214, 61001538, 61005431, 61012248, 61023607, 61027911, 61036361, 61045090, 61058607, 61064796, 61069402, 61075249, 61085866, 61091187, 61096344, 61101443, 61114171 and 61136939;

2) Lots: 60930893, 60947729, 60954138, 60954148, 60958267, 60964475, 60971780, 60987831, 60992913, 61001539, 61005445, 61023608, 61036333, 61036334, 61036362, 61058581, 61058608, 61069403, 61075250, 61085867, 61091188, 61096345, 61101444 and 61114172;

3) Lots: 60943097, 60943098, 60958268, 60964476, 60971781, 60988215, 60992914, 60992915, 61001540, 61005432, 61012249, 61036335, 61036336, 61036363, 61058609, 61064797, 61069404, 61075251, 61085868, 61091189, 61101445 and 61114161;

4) Lots 60943101, 60964477, 60971773, 60971774, 60971776, 60971782, 60988217, 60992916, 60992917, 60992918, 61001541, 61005446, 61017689, 61036337, 61036364, 61051466, 61058610, 61069405, 61075252, 61085869, 61091190, 61096346, 61106547 and 61157808;

5) Lots 61078741 and 61157812;

6) Lots 60947730, 60954139, 60954149, 60954312, 60954313, 60964478, 60975030, 60981786, 60981799, 60987818, 60987832, 60988218, 60992919, 60992920, 60992922, 61001542, 61001543, 61005433, 61005447, 61017690, 61023609, 61027913, 61027914, 61036365, 61036366, 61045091, 61051467, 61058611, 61064798, 61069406, 61075235, 61078742, 61078743, 61085870, 61091175, 61091191, 61096347, 61101446, 61101447, 61101448, 61106548, 61114162, 61114173, 61117029, 61117030, 61117031, 61117032, 61117043, 61117049, 61126520 and 61126521;

7) Lots 60916390, 60916392, 60916393, 60916424, 60930896, 60947731, 60954140, 60954150, 60958269, 60964459, 60964479, 60981787, 60981801, 60987819, 60987833, 60987834, 60992923, 60992924, 61001544, 61005434, 61005448, 61023610, 61027878, 61036338, 61036367, 61036368, 61051468, 61064799, 61069407, 61075236, 61078744, 61078745, 61091176, 61091192, 61091193, 61101449, 61101450, 61106550, 61114163, 61114174, 61117033, 61117050 and 61122282;

8) Lots 60911931, 60916425, 60930897, 60947732, 60954151, 60958261, 60958270, 60964480, 60975032, 60981788, 60981803, 60988219, 60992925, 60992926, 60992927, 61001545, 61023593, 61023594, 61027879, 61036339, 61036369, 61051469, 61064801, 61069408, 61075237, 61078746, 61091177, 61096348, 61096349, 61101451, 61106551, 61114175 and 61117044;

9) Lots 60943103, 60954152, 60964460, 60975017, 60975018, 60975033, 60980756, 60980757, 60980758, 60981804, 60992928, 60992929, 60993907, 60993908, 61017691, 61036340, 61036371, 61051470, 61064802, 61069409, 61078747, 61078748, 61091178, 61096350, 61101452 and 61114176;

10) Lot 61139728;

11) Lots 60911919, 60911932, 60916426, 60930898, 60947734, 60954141, 60954142, 60954153, 60958271, 60964481, 60981789, 60981805, 60987820, 60988220, 60992930, 60992931, 60992932, 61001546, 61017692, 61023595, 61023611, 61027915, 61036373, 61045092, 61045093, 61064803, 61069410, 61075238, 61078749, 61091179, 61091180, 61096351, 61101453, 61101454, 61106552, 61114177, 61117034, 61117045, 61122283 and 61136935;

12) Lots 60911920, 60911933, 60916427, 60930899, 60947724, 60954154, 60958272, 60964461, 60964482, 60981790, 60981806, 60987821, 60987835, 60992933, 60992934, 61001547, 61001548, 61023596, 61023612, 61036342, 61045076, 61051471, 61058582, 61064804, 61069411, 61078750, 61078751, 61096352, 61096353, 61101455, 61106553, 61114164, 61117035 and 61136934;

13) Lots 60943105, 60943106, 60954155, 60958273, 60975034, 60981807, 60987822, 60988221, 60992935, 60992936, 61001549, 61017693, 61027881, 61036343, 61045077, 61051472, 61064805, 61069412, 61075239, 61078752, 61091181, 61096354, 61101456, 61106554 and 61136936;

14) Lots 60930889, 60933722, 60933723, 60943107, 60943108, 60975019, 60980759, 60980760, 60980761, 60981791, 60981808, 60992937, 60992938, 61001550, 61017694, 61027882, 61036344, 61045078, 61051473, 61069413, 61069419, 61078753, 61091182, 61096355, 61101457 and 61106555;

15) Lots 61096356 and 61157824;

16) Lots 60943109, 60943110, 60947725, 60954156, 60958274, 60971777, 60971783, 60988222, 60992939, 61001551, 61005435, 61012256, 61017695, 61027916, 61045079, 61051474, 61058612, 61058613, 61069414, 61075253, 61085871, 61091194, 61096357, 61106556, 61114165, 61114178 and 61136937;

17) Lots 60911923, 60930902, 60947736, 60954143, 60954157, 60958275, 60958276, 60971778, 60971784, 60987836, 60992940, 60992941, 61005436, 61012257, 61017696, 61023613, 61045080, 61051475, 61058614, 61058615, 61075240, 61075254, 61085872, 61091195, 61096358, 61106557 and 61114184;

18) Lots 60958277, 60964462, 60971779, 60971785, 60987837, 60992942, 60992943, 61001552, 61012258, 61017697, 61023614, 61036345, 61045081, 61058616, 61058617, 61075241, 61078754, 61085873, 61091196, 61106558, 61114166 and 61117051;

19) Lots 60943113, 60943114, 60971772, 60971775, 60971786, 60987823, 60988224, 60992944, 60992945, 60992946, 61005437, 61017698, 61023615, 61036346, 61045082, 61051476, 61058618, 61058619, 61078755, 61085874, 61091197, 61096359, 61106559 and 61114185;

20) Lots 61085875 and 61157831;

21) Lots 60930904, 60943115, 60943116, 60947738, 60954144, 60954158, 60958278, 60964463, 60964464, 60964465, 60975020, 60975035, 60981792, 60981809, 60987824, 60987825, 60988225, 60992947, 60992948, 60992949, 60992950, 60992951, 60992952, 60992953, 60993909, 60993910, 61005438, 61017699, 61023597, 61023616, 61027883, 61027917, 61036347, 61045083, 61051477, 61051478, 61058583, 61064806, 61069415, 61075242, 61078756, 61078757, 61085876, 61091183, 61096360, 61096361, 61101458, 61101459, 61106560, 61106561, 61106562, 61114167, 61114179, 61117036, 61117037, 61117038, 61117046, 61117052, 61122284, 61122285, 61126522 and 61126523;

22) Lots 60916402, 60930905, 60932814, 60932815, 60947739, 60954159, 60958279, 60964466, 60964467, 60975036, 60975042, 60981810, 60987826, 60987838, 60992954, 60992955, 60992956, 60992957, 60992958, 60993931, 61005439, 61017700, 61023598, 61027884, 61036348, 61036349, 61045084, 61051479, 61058584, 61069416, 61069420, 61075243, 61078758, 61085877, 61091184, 61096362, 61101460, 61101461, 61106563, 61106564, 61114180, 61117039, 61117047, 61126524 and 61126525;
 
23) Lots 60932817, 60947726, 60947740, 60954160, 60958280, 60964468, 60975037, 60981811, 60987827, 60988226, 60992959, 60992960, 60992961, 61001553, 61005440, 61017701, 61027885, 61036350, 61036354, 61045085, 61051480, 61064807, 61069417, 61075244, 61078759, 61085878, 61096363, 61101462, 61106565, 61114168 and 61117040;

24) Lots 60932819, 60954145, 60958262, 60964470, 60975021, 60975022, 60975038, 60975043, 60980762, 60980763, 60980764, 60981812, 60992962, 60993933, 60993934, 61017702, 61017703, 61036355, 61045086, 61051481, 61064808, 61069418, 61078760, 61085879, 61096364, 61101463, 61106566 and 61114181;

25) Lots 61096365 and 61139734;

26) Lots 60932820, 60932821, 60943117, 60943118, 60947727, 60958263, 60958281, 60964471, 60975039, 60975044, 60981813, 60987828, 60988227, 60992963, 60992964, 60992965, 60992966, 61001554, 61005441, 61017704, 61023599, 61027887, 61027918, 61036356, 61051482, 61051483, 61064809, 61064810, 61075245, 61078761, 61085880, 61091185, 61096366, 61101464, 61106567, 61106568, 61114169, 61117041, 61117042, 61117053, 61122286 and 61136938;

27) Lots 60943119, 60943120, 60958264, 60958282, 60964472, 60964473, 60975046, 60981814, 60987829, 60987839, 60992967, 60992968, 60992969, 60992970, 61001555, 61005442, 61017705, 61027888, 61036357, 61036358, 61045087, 61051484, 61064811, 61064812, 61075246, 61078762, 61085881, 61096367, 61101465, 61106569, 61106570, 61114182, 61117048 and 61122287;

28) Lots 60943121, 60943122, 60958283, 60964474, 60975047, 60981815, 60987830, 60992971, 60992972, 60992973, 61005443, 61023601, 61027889, 61036359, 61045088, 61058585, 61064813, 61064814, 61075247, 61078763, 61085882, 61096368, 61101466, 61106571 and 61114183;

29) Lots 60975024, 60975025, 60975040, 60980765, 60980766, 60980767, 60992974, 60992975, 60992976, 61005444, 61017706, 61027890, 61036360, 61045089, 61058586, 61064815, 61075248, 61085883, 61091186, 61096369, 61106572 and 61114170;

30) Lots 61101467 and 61157838;

31) Lots 60947756, 60947758, 60954113, 60954115, 60954128, 60958287, 60958296, 61017813, 61017834, 61036377, 61036391, 61045095, 61058621, 61058645, 61065051, 61069421, 61075283, 61078795, 61091198, 61091206, 61101468, 61106574, 61106603, 61117054 and 61136943;

32) Lots 60943126, 60947745, 60947759, 60947760, 60947761, 60954116, 60954129, 60958288, 60958297, 60987857, 60992977, 61001556, 61005450, 61012266, 61023686, 61023687, 61036392, 61058622, 61058623, 61058646, 61075257, 61075284, 61085884, 61091207, 61091208, 61101469, 61106575, 61114187, 61126528 and 6136944;

33) Lots 60954130, 60958298, 60964493, 60971787, 60988242, 60992978, 60992979, 60992980, 61005451, 61012267, 61023688, 61023689, 61036393, 61058624, 61058647, 61065052, 61075258, 61075285, 61085885, 61091209, 61096370, 1101470 and 61106604;

34) Lots 60958299, 60971788, 60971789, 60971790, 60981860, 60987840, 60992981, 60992982, 60992983, 60992984, 61001557, 61012268, 61023690, 61023691, 61036394, 61045096, 61058648, 61065053, 61075259, 61075286, 61085886, 61091210, 61096371, 61101471 and 61117055;

35) Lots 60943132, 60958301, 60971791, 60971792, 60971793, 60987841, 60988243, 60992985, 60992986, 60992987, 61012269, 61017814, 61023692, 61036395, 61045097, 61058625, 61058649, 61065054, 61075287, 61085887, 61091211, 61101472 and 61106605;

36) Lots 60947746, 60947747, 60947762, 60947763, 60947764, 60947765, 60947766, 60947767, 60954117, 60954118, 60954131, 60958289, 60958302, 60975048, 60975049, 60987858, 60987859, 60992988, 60992989, 61001558, 61005452, 61005453, 61017815, 61017835, 61027919, 61027920, 61036396, 61036397, 61045098, 61045099, 61045101, 61045102, 61058626, 61065055, 61069422, 61069423, 61069442, 61075260, 61078764, 61078765, 61078796, 61091199, 61091201, 61096372, 61096373, 61101473, 61101474, 61101475, 61114188, 61114189, 61114190, 61117056, 61117057, 61117058, 61117059, 61117060, 61126529, 61126555 and 61139735;

37) Lots 60941610, 60941611, 60947748, 60947768, 60947769, 60947770, 60947771, 60947772, 60954114, 60954119, 60954132, 60958290, 60958303, 60964494, 60975050, 60975051, 6981862, 60987842, 60987860, 60987861, 60992990, 60992991, 60992992, 60992994, 61001559, 61001560, 61005454, 61005455, 61017816, 61027921, 61027922, 61036378, 61036398, 61036399, 61045103, 61045104, 61058628, 61058629, 61065056, 61069424, 61075261, 61078766, 61078767, 61085888, 61085889, 61091212, 61096374, 61096375, 6101476, 61101477, 61101478, 61106576, 61114191, 61114192, 61117061, 61117062, 61122288, 61126530 and 61126531;

38) Lots 60947749, 60947773, 60947774, 60954120, 60954133, 60958291, 60958304, 60964495, 60975052, 60975054, 60981864, 60987843, 60987862, 60992995, 60992996, 60992997, 60992998, 60992999, 60993001, 61001561, 61005456, 61017817, 61027924, 61027926, 61027928, 61036401, 61036402, 61045105, 61058630, 61065057, 61069425, 61075262, 61078768, 61078769, 61085890, 61096376, 61096377, 61096378, 61101479, 61101480, 61114193, 61114194, 61117063, 61117064 and 61122289;

39) Lots 60941616, 60964484, 60964496, 60975055, 60975057, 60975059, 60980768, 60980769, 60980770, 60981866, 60993002, 60993003, 60993004, 61005457, 61017818, 61027930, 61027932, 61036406, 61036407, 61058631, 61058632, 61065058, 61069426, 61078770, 61085891, 61085892, 61096379, 61101481, 61101482, 61114195 and 61117065;

40) Lots 60958305, 60964497, 60975060, 60975061, 60980771, 60980772, 60980773, 60981868, 60993005, 60993006, 61001562, 61023693, 61027934, 61036408, 61045106, 61051488, 61065059, 61069427, 61078771, 61091202, 61096380, 61101483 and 61114196;

41) Lots 60932788, 60937764, 60937765, 60958306, 60981870, 60988244, 60993007, 60993008, 60993009, 61001563, 61005458, 61017819, 61017836, 61036379, 61036409, 61045107, 61045108, 61051489, 61065060, 61069428, 61069443, 61075263, 61078772, 61078797, 61096381, 61096382, 61101484, 61106577, 61114197, 61114198, 61117066, 61122290, 61126556 and 61136945;

42) Lots 60937767, 60958307, 60964498, 60981872, 60987863, 60993010, 60993011, 60993012, 60993013, 61001564, 61005459, 61017820, 61027936, 61036380, 61036410, 61045109, 61051490, 61065061, 61069429, 61075264, 61078773, 61085893, 61096383, 61096384, 61101485, 61106579, 61114199, 61117067, 61117068 and 61136946;

43) Lots 60937769, 60964499, 60981874, 60987844, 60988245, 60993014, 60993015, 60993016, 60993017, 61005460, 61005461, 61017821, 61036381, 61036382, 61036411, 61051491, 61058633, 61065062, 61075265, 61078774, 61085894, 61096385, 61096386, 61101486, 61106580, 61114201 and 61117069;

44) Lots 60943133, 60943134, 60975062, 60981875, 60987845, 60993018, 60993019, 60993020, 60993021, 61001565, 61023694, 61027938, 61027940, 61036383, 61036412, 61045110, 61051492, 61065063, 61069430, 61078775, 61085895, 61096387, 61096388, 61106581, 61114202 and 60937774;

45) Lots 60975063, 60975064, 60980774, 60980775, 60980776, 60993022, 60993023, 60993024, 61023695, 61027941, 61036384, 61036413, 61051493, 61058634, 61065064, 61075266, 61078776, 61096389, 61096390, 61106582 and 61114203;

46) Lots 60954121, 60954122, 60954134, 60958308, 60971794, 60988246, 60993025, 61001566, 61005462, 61017822, 61023696, 61036414, 61045111, 61051494, 61065065, 61069431, 61075267, 61075288, 61085896, 61091213, 61091214, 61101487, 61106583, 61114216 and 61126557;

47) Lots 60943136, 60954123, 60954135, 60958292, 60958309, 60971795, 60987864, 60993026, 60993027, 61005463, 61012279, 61017823, 61023697, 61036415, 61045112, 61051495, 61065066, 61069432, 61075268, 61075289, 61085897, 61091215, 61091216, 61101488, 61106606, 61114217 and 61136947;

48) Lots 60947751, 60930884, 60947776, 60954124, 60954136, 60958310, 60964501, 60971796, 60988248, 60993028, 60993029, 60993030, 61001567, 61005464, 61012280, 61023698, 61023699, 61036416, 61045113, 61051496, 61065067, 61075269, 61078777, 61085898, 61091217, 61096391, 61101489, 61106607 and 61114218;

49) Lots 60971797, 60971801, 60981877, 60987846, 60988249, 60993031, 60993032, 60993033, 60993034, 61001568, 61012281, 61017824, 61023701, 61036417, 61045114, 61051497, 61065068, 61069433, 61078778, 61085899, 61091218, 61091219, 61101490 and 61114204;

50) Lots 60943140, 60964502, 60971798, 60971799, 60981879, 60987847, 60993035, 60993036, 60993037, 60993038, 61012282, 61017825, 61023702, 61036418, 61045115, 61051498, 61065069, 61075270, 61078779, 61091220, 61096392 and 61106584;

51) Lots 60942684, 60942685, 60942686, 60947752, 60954125, 60954137, 60958311, 60964485, 60964486, 60964503, 60975065, 60981881, 60981883, 60987848, 60987849, 60988250, 60993039, 60993040, 60993041, 60993042, 60993043, 60993044, 60993045, 61001569, 61005465, 61005466, 61017826, 61017837, 61027942, 61027943, 61027944, 61036419, 61036420, 61045116, 61045117, 61051499, 61058635, 61058636, 61065070, 61069434, 61069435, 61069444, 61075271, 61078780, 61078781, 61085901, 61091203, 61091221, 61091222, 61096393, 61101491, 61106585, 61106586, 61106587, 61114205, 61114206, 61117070, 61117071, 61117072, 61117073, 61122291, 61122292, 61126550 and 61126558;

52) Lots 60930886, 60942687, 60942688, 60942689, 60954126, 60958293, 60958312, 60964487, 60964488, 60964489, 60964504, 60975066, 60975067, 60980777, 60980778, 60980779, 60981884, 60981886, 60993046, 60993047, 60993048, 60993049, 60993050, 60993051, 60993052, 61001570, 61001571, 61005467, 61005468, 61017827, 61027945, 61036385, 61036386, 61036421, 61036422, 61051501, 61051503, 61058637, 61065071, 61069436, 61069437, 61075272, 61078782, 61078783, 61085902, 61085903, 61091223, 61096394, 61101492, 61101493, 61106588, 61106589, 61114207, 61114208, 61117074, 61117075, 61117076, 61117077, 61122293 and 61122294;

53) Lots 60942691, 60942692, 60947753, 60954127, 60958294, 60958313, 60964490, 60964491, 60964505, 60981888, 60981890, 60987850, 60987851, 60988251, 60993053, 60993054, 60993055, 60993056, 60993057, 60993058, 61001572, 61001573, 61005469, 61017828, 61023703, 61027946, 61036387, 61036423, 61036424, 61051504, 61051505, 61051506, 61065072, 61069438, 61075273, 61078784, 61078785, 61085904, 61091224, 61096395, 61096396, 61101494, 61106590, 61106591, 61114209, 61117078, 61117079 and 61122295;

54) Lots 60942694, 60942695, 60964506, 60975068, 60975069, 60980780, 60980781, 60980782, 60981891, 60981892, 60981893, 60993059, 60993060, 60993061, 61001574, 61017829, 61023704, 61036388, 61036425, 61036426, 61051507, 61051508, 61065073, 61069439, 61078786, 61085905, 61091204, 61091225, 61101495, 61106592, 61114210 and 61117080;

55) Lots 60942696, 60942697, 60942698, 60975071, 60980783, 60980784, 60980785, 60981894, 60993062, 60993063, 60993064, 61001575, 61017830, 61023705, 61036389, 61036427, 61051509, 61065074, 61069440, 61078787, 61085906, 61091226, 61106593 and 61114211;

56) Lots 60937775, 60937776, 60964507, 60981895, 60987852, 60987853, 60988252, 60993065, 60993066, 60993067, 60993068, 61001576, 61005470, 61005471, 61017831, 61027947, 61027948, 61036428, 61036429, 61051510, 61058639, 61069441, 61069445, 61075274, 61078788, 61078789, 61085907, 61091227, 61096397, 61096398, 61106594, 61106595, 61114212, 61117081, 61117082, 61126551, 61136941 and 61136948;

57) Lots 60964492, 60964508, 60981896, 60987854, 60987855, 60987865, 60993069, 60993070, 60993071, 60993072, 61001577, 61005472, 61023707, 61023708, 61027949, 61036430, 61051511, 61051512, 61058640, 61069446, 61075275, 61075276, 61078790, 61085908, 61091228, 61096399, 61101496, 61106596, 61114213, 61117083, 61122296 and 61136949;

58) Lots 60933716, 60933717, 60964509, 60981897, 60987856, 60988253, 60993073, 60993074, 60993075, 61001578, 61005473, 61023710, 61027950, 61027951, 61045118, 61051513, 61058641, 61058642, 61075277, 61075278, 61078791, 61085909, 61091205, 61091229, 61096401, 61106597, 61106598, 61114214, 61122297 and 61136942;

59) Lots 60933719, 60975072, 60975073, 60975074, 60975075, 60980786, 60980787, 60980788, 60980789, 60980790, 60981898, 61001579, 61017832, 61023712, 61027952, 61045119, 61051514, 61058643, 61065075, 61075279, 61075280, 61078792, 61085910, 61091230, 61101497, 61106599, 61114215 and 61136950;

60) Lots 60943141, 60943142, 60975076, 60980791, 60980792, 60980793, 60981899, 60993076, 60993077, 61017833, 61023713, 61036390, 61045120, 61051515, 61065076, 61075281, 61075282, 61078793, 61091231, 61101498, 61106601 and 61117084
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by letter dated October 8, 2009. Firm initiated recall is ongoing.
REASON
The surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.
VOLUME OF PRODUCT IN COMMERCE
26,404 units
DISTRIBUTION
Nationwide, Austria, Belgium, France, Germany, Japan, Spain, Switzerland
___________________________________
PRODUCT
1) GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI GXL, 16 Slice and 6 Slice scanning device configurations. Model Numbers: 4535-679-71891 and 4535-6797591, 510(k) #K051170. Catalog Numbers: 882390 and 882410. Recall # Z-0260-2010;

2) GEMINI PET/CT Systems Upper Patient Pallet for the GEMINI TF, 16, 64, and 16 Base Slice configurations, Model Numbers: 4535 679 83931, 4535 679 94741, and 4535-674 41711, 510(k) #K052640; Catalog Numbers: 882470, 882471, and 882473. Recall # Z-0261-2010
CODE
1) Serial Numbers: 4190 and 4191;
2) Serial Numbers: 7096, 7139, 7144, 7145, 7146, 7148, 7149, 7150, and 7151
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter on January 26, 2009. Firm initiated recall is complete.
REASON
Upper patient pallet component of the recalling firm's Gemini PET/CT system may be thinner than normally required which may reduce the product's load bearing capacity, resulting in cracking under less than the designed full-load weight.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
OH, GA, MI, CA, Germany, France Japan, and South Korea
___________________________________
PRODUCT
Intramedullary Skeletal Kinetic Distractor (ISKD) is an internal limb lengthening device consisting of a telescoping Internal Limb Lengthener, Locking Screws, Instrumentation and an external hand-held Monitor; catalog numbers: T10-215-265, T10-215-265NS, T10-255-305, T10-255-305NS, T10-255-335, T10-300-350, T10-300-350NS, T12-215-265, T12-245-295, T12-255-305, T12-255-305NS, T12-255-335, T12-300-350, T12-380-380, F12-255-305, F12-255-305NS, F12-255-335, F12-255-335NS, F12-300-350, F12-300-350NS, F12-300-380, F12-300-380NS, F12-345-395, F12-345-395NS, F12-345-425, and F12-345-425NS. Recall # Z-0262-2010
CODE
All lot and serial numbers are being recalled.
RECALLING FIRM/MANUFACTURER
Orthofix, Inc., McKinney, TX, by letter on October 9, 2009. Firm initiated recall is ongoing.
REASON
ISKD lengthening device has the potential for not pre-distracting.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL, MD, TN, OH, NY, CA, GA, Mexico Italy, Canada
___________________________________
PRODUCT 
Norian CRS Rotary Mixer Cement 10cc sterile. Catalog number 614.10.01S. Recall # Z-0269-2010
CODE
Lot number N996352
RECALLING FIRM/MANUFACTURER
Synthes USA (HQ), Inc., West Chester, PA, by teleconference on September 14, 2009 and letter dated September 17, 2009. Firm initiated recall is ongoing.
REASON
Non-conforming material - increased set time. Potential clinical ramifications associated with increased set time and decreased strength includes extrusion of unset material and fragmentation of cured material. The risk of Norian fragmentation post cure increases with a larger defect and a thicker layer of product.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CO, KS, MA, MO, NY, SC, TX, UT, WA
___________________________________
PRODUCT 
Biomet K-Wire/Trocar Point, both ends/Dia. 045, length: 9 in., certified stainless steel, sterile; REF 35-351534. Internal fixation devices intended to aid in the alignment and stabilization of fractures to the skeletal system until healing has occurred. The devices can also be used as instrument accessories to stabilize cut blocks and can serve as guide wires while using reamers. Recall # Z-0367-2010
CODE
Lot 087190
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated August 6, 2009. Firm initiated recall is ongoing.
REASON
Packages labeled as having a .045 inch diameter trocar point actually contain a diamond point with a diameter of .062 inches.
VOLUME OF PRODUCT IN COMMERCE
19 units
DISTRIBUTION
FL, PA
___________________________________
PRODUCT 
1) Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 4mm Catheters; Part Numbers: D-1257-01 & D-1257-02. Recall # Z-0368-2010; 

2) Biosense Webster NaviStar RMT Diagnostic/Ablation Steerable Tip 8mm DS Catheters; Part Numbers: D-1259-01 & D-1259-02. Recall # Z-0369-2010
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: BioSense Webster, Inc., Chihuahua, Mexico, by letter on October 6, 2008.
Manufacturer: BioSense Webster, Inc., Irwindale, CA. Firm initiated recall is complete.
REASON
Biosense Webster reported that one of the Printed Circuit Board (PCB) components used in the NAVISTAR (R) RMT Catheters, may cause the ablation catheter icon to shift on the map viewer when RF energy is being applied. The icon then returns to the correct position after the RF application is stopped. However, this movement is only observed on the map viewer and there is no actual movement of the catheter tip. Testing indicates that for shifts of less than approximately 25mm, there is no display of an error message or any other indication that the CARTO RMT System/catheter is malfunctioning and therefore, the user, attempting a linear ablation in the location displayed on the CARTO RMT screen, may ultimately apply RF energy to an unintended locations. This would only be applicable for lesions being created during a linear ablation and would not apply to a focal lesion ablation since the icon returns to the true position between RF applications and location is typically verified using the ECG. This condition does not impact any other ancillary visualization equipment. A shift in the ablation catheter icon can be detected by paying close attention to the location of the ablation catheter icon on the map viewer when applying RF energy. Consistent with the CARTO (R) RMT System manual, it is also recommended to check the position of the catheter by observing the electrograms prior to applying RF energy.
VOLUME OF PRODUCT IN COMMERCE
4,739 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Zimmer Dynesys top-loading cutter, spacer; REF 07.01284.001. Recall # Z-0370-2010
CODE
All lots. Lots 60859166, 60859167, 61085708. 60970745, 61024375, 61024376 and 61123514
RECALLING FIRM/MANUFACTURER
Recall # Zimmer Inc., Warsaw, IN, by letter dated May 20, 2009. 
Manufacturer: Zimmer Spine, Inc., Minneapolis, MN. Firm initiated recall is ongoing.
REASON
The spacer cutter may jam during surgery, preventing use of the instrument and causing surgical delay.
VOLUME OF PRODUCT IN COMMERCE
177 units
DISTRIBUTION
Nationwide, Austria, Belgium, Canada, Italy, Netherlands, Singapore, Spain, Switzerland and United Kingdom
___________________________________
PRODUCT 
Oxinium Femoral Head, 36 MM OD-3, 12/14 Taper, REF 71343603. Recall # Z-0389-2010
CODE
Lot Numbers: 08BM09885, 08EM06396, 08FM14910, 08HM10480, 08KM07754, 08KM12526, 08HM03206, 08GM03007R, 08EM19444, 08EM19445, 08EM19446, 08EM20186, 08FM00231, 08RM00242, 08FM03526, 08FM04628, 08FM05689, 08FM06247, 08FM14906, 08FM17347, 08FM22085, 08FM22087, 08GM03007, 08GM03489, 08GM06660, 08GM11382, 08GM11425, 08GM12094, 08GM13061, 08GM17805, 08GM18609, 08HM02631, 08HM03926, 08HM10037, 08HM13107, 08HM13118, 08HM16147, 08HM16150, 08HM17621, 08HM18516, 08JM00370, 08JM04970, 08JM04971, 08JM05505, 08JM05506, 08JM08122, 08JM09041, 08JM11262, 08JM14571, 08JM15417, 08JM19246, 08JM19247, 08JM19248, 08JM20328, 08JM21716, 08JM21717, 08JM21718, 08KM03713, 08KM07732, 08KM14807, 08KM20680, 08KM23716, 08LM01328, 08LM02300, 08LM11759, 08LM12842, and 08LM13924
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Memphis, TN, by letter on January 23, 2009. Firm initiated recall is ongoing.
REASON
Radius at the end of the taper of the femoral implant is smaller than specification. This error could result in the tapers not locking fully or properly on femoral stems or in causing impingement and/or increased wear debris. The deficiency may not be noticed by the user. Impingement and/or wear debris may lead to revision.
VOLUME OF PRODUCT IN COMMERCE
925 units
DISTRIBUTION
Nationwide, Switzerland, Dubai, Brazil, Canada, South Africa, Australia, Belgium, Spain, Thailand Turkey, Costa Rica, Denmark, India, Italy, and France
___________________________________
PRODUCT 
1) AlMER ENDOFEMORAL 4MM OFFSET (PURPLE) Part Number 72201714. The product is an orthopedic device. Recall # Z-0415-2010;

2) AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device. Recall # Z-0416-2010;

3) AIMER ENDOFEMORAL 6MM OFFSET (GREEN) Part Number 72201716. The product is an orthopedic device. Recall # Z-0417-2010 
CODE
1) Lot Number 50278012;
2) Lot Number 502780141;
3) Lot Number 50278014
RECALLING FIRM/MANUFACTURER
Smith & Nephew, Inc., Endoscopy Div., Mansfield, MA, by letter on September 3, 2009. Firm initiated recall is ongoing.
REASON
Device may have improper Laser Marking, 4mm device may be marked as 6mm and 6mm device may be marked as 4mm.
VOLUME OF PRODUCT IN COMMERCE
134 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Canada, Costa Rica, Dubai, Finland, France, Germany, Great Britain, Netherlands, Norway, Portugal, Spain, Sweden, and Switzerland
___________________________________
PRODUCT 
Philips Lifeline Personal Help Button Pendant Classic and Slimline Style. Recall # Z-0419-2010
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Philips Lifeline, Inc., Farmingham, MA, by letters on September 21, 2009. Firm initiated recall is ongoing.
REASON
Pendant Personal Help Button neck cord may not break away and if not will present a potential choking risk.
VOLUME OF PRODUCT IN COMMERCE
750,000 units
DISTRIBUTION
Nationwide, Canada
___________________________________
PRODUCT 
Kuschall K Junior Manual wheelchair. Model Numbers: 0806281234, 0806893858, 0806135534, 0806161578, 0806237627, 0806268153, 0806268154, 0806309590, 0806315524, 0806351557, 0806568768, 0806591793. 0806670117, 0806724855, 0806731287, 0806773921, 0807007811, 0807019897, 0807062866, 0807110193. Recall # Z-0421-2010
CODE
Model numbers only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Invacare Corp., Elyria, OH, by telephone and letter on June 15, 2009.
Manufacturer: Kuschall Design AG, Allschwil, Switzerland. Firm initiated recall is ongoing.
REASON
The handle has been breaking at a calculated weight of 65kg which may have serious consequences (broken bones) depending on the circumstances of the break (e.g., user on ramps, hills, etc.).
VOLUME OF PRODUCT IN COMMERCE
14 wheelchairs
DISTRIBUTION
CA, CO, MN, NJ, OR, PA, TX, VA, Canada

___________________________________
PRODUCT 
HeartMate 12 volt sealed lead acid Battery Clips that are components of the HeartMate II LVAS (PMA P060040) and the HeartMate XVE LVAS (PMA P920014) Systems. The HeartMate II and the HeartMate XVE LVAS are intended for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from non-reversible left ventricular failure. The HeartMate XVE LVAS is also indicated for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and who are not candidates for cardiac transplantation. The HeartMate II and XVE LVAS are intended for use both inside and outside the hospital, for transportation of Ventricular Assist Device (VAD) patients via ground ambulance, fixed-wing aircraft or helicopter. The devices consist of an implantable blood pump connected to an external System Controller by a percutaneous lead. The external controller is powered by AC electrical power, via the Power Module or Power Base Unit, or by battery power with a pair of rechargeable HeartMate batteries. Two batteries are used simultaneously for power. The LVAS is also designed to operate on a single battery, facilitating battery changes without interruption of VAD support. Recall # Z-0422-2010
CODE
Lot numbers are visible on the clips: 458560206, 581080207, 581080507, 34331720107, 34404690108, 34532990109, 343317201407, 34331720207, 34331720507, 34404690208, 34404690308, 34404690408, 34432810108, 34450070108, 34477720108, 34570570109, 34577730109, and 34331720307
RECALLING FIRM/MANUFACTURER
Thoratec, Corp., Pleasanton, CA, by letter dated October 14, 2009. Firm initiated recall is ongoing.
REASON
Patient reports alerted Thoratec that during the process of disconnecting power leads from the battery clips, the threaded connector of the battery clip housing was observed to be loose, and in some cases dislodged from the battery clip housing. The problem affects HeartMate 12V SLA Battery Clips including those used for the HeartMate II LVAS and HeartMate XVE systems. If not detected and handled correctly, this may interfere with the ability to connect the system to a power source, and subsequently to interrupt pump function.
VOLUME OF PRODUCT IN COMMERCE
8,194 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Tornier, LMP-50 (Lesser Metatarsal Phalangeal Implant), Size 50, Sterile EO. The Lesser Metatarsal Phalangeal Joint Implant is indicated for: Partial or complete dislocation of the lesser metatarsophalangeal joint. Recall # Z-0455-2010
CODE
Lot number: K10747, K10677, and K10510
RECALLING FIRM/MANUFACTURER
Recall Firm: Tornier, Inc., Edina, MN, by letter dated April 3, 2009.  
Manufacturer: Kinamed Inc., Camarillo, CA. Firm initiated recall is ongoing.
REASON
Mislabeled product due to a product mix-up. The package label indicated that the product was a model LMP-50 however the product inside the package was Tornier FGT-50 implant (Primus Flexible Great Toe Implant With Grommetts).
VOLUME OF PRODUCT IN COMMERCE
77 units
DISTRIBUTION
CA, FL, MD, MI, NJ, OH, PA, and France
___________________________________
PRODUCT 
GE Centricity PACS (Picture Archiving and Communication System) RA1000 Workstation software; The Centricity PACS is used to receive, store, distribute, display, manipulate, edit and annotate images throughout a clinical environment. Recall # Z-0456-2010
CODE
Software versions 1.0.x, 2.0.x, 2.1.x, and 3.0.x.
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solutions, Barrington, IL, by letters dated September 23, 2009. Firm initiated recall is ongoing.
REASON
There are potential safety issues, including misdiagnosis or delay in treatment, associated with the use of GE Centricity PACS RA1000 Workstation software that may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
1,188 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Denmark, Ecuador, Egypt, France, Germany, Hong Kong, Ireland, Israel, Italy, Japan, Korea, Kuwait, Lebanon, Malaysia, Malta, Mexico, Netherlands, New Zealand, Portugal, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Turkey and United Kingdom
___________________________________
PRODUCT 
Nonin Model 7600B cerebral oximeter pod. Used with the Nonin Model 7600 Regional Oximeter with Equanox Technology and Bluetooth Wireless Technology. Recall # Z-0458-2010
CODE
Serial numbers: 500814470, 500814472, 500814474, 500814478, 500814480, 500814484, 500823139, 500823145, 500823146, 500823154, 500823159, 500823161, 500823164, 500823166, 500823172, 500823174, 500823175, 500823176, 500823181, 500823182, 500849316, 500849318, 500849321, 500849325, 500849331, 500849333, 500849336, 500849337, 500849338, 500849342, 500849343, 500849344, 500849347, 500849348, 500849349, 500849350, 500849351, 500849353, 500849356, 500849357, 500849358, 500849360, 500849361, 500849366, 500849367, 500849368, 500849369, 500849370, 500849372, 500849373, 500849375, 500849378, 500849380, 500849386, 500849387, 500849388, 500849389, 500849390, 500857060, 500857061, 500857064, and 500874926
RECALLING FIRM/MANUFACTURER
Nonin Medical, Inc., Plymouth, MN, by on October 23, 2009. Firm initiated recall is ongoing.
REASON
A malfunction was detected with one of the components that, under rare circumstances, may result in the overheating of the POD. This overheating, while unlikely to occur, has the potential to cause a burn if the POD is in direct contact with the patient.
VOLUME OF PRODUCT IN COMMERCE
134 units
DISTRIBUTION
LA, MN, NC, NY and Canada, Germany, Italy, Netherlands, and United Kingdom
___________________________________
PRODUCT 
1) Bath Safe Adjustable Shower Seat, Without Back and Arms, Catalog number 727142001. Recall # Z-0459-2010;

2) Bath Safe Adjustable Shower Seat, With Arms, Model numbers 727142020, 727142021, and MDS89750R. Recall # Z-0460-2010;

3) Bath Safe Adjustable Shower Seat, With Back, Catalog number 727142101. Recall # Z-0461-2010;

4) Bath Safe Adjustable Shower Seat, With Arms and Back, Catalog numbers 727142120, 727142121, 727142124, and MDS89755R. Recall # Z-0462-2010;

5) Bath Safe Adjustable Transfer Bench, Catalog numbers 727142500, 727142501, and MDS86960R. Recall # Z-0463-201;

6) Shower Seat, Non-rotating, Catalog number 727152000. Recall # Z-0464-2010;

7) Shower Seat, Rotating, Catalog number 727152100. Recall # Z-0465-2010
CODE
Devices are not identified with a lot code. Inventories received between May 1, 2009 and July 7, 2009 is being recalled.
RECALLING FIRM/MANUFACTURER
Nutech Manufacturing Corp., Pocomoke City, MD, by letter, telephone and e-mail on July 9, 2009. Firm initiated recall is ongoing.
REASON
Safety chair used in shower/bath may not meet specifications for weight load.
VOLUME OF PRODUCT IN COMMERCE
3,627 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Maquet Accessories, Connection Bracket. Catalogue # 1180.36A0. An accessory component for the MAGNUS operating table system. Used to mount head positioning accessories. Recall # Z-0480-2010
CODE
No serial or lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Maquet, Inc., Bridgewater, NJ, by letters on October 22, 2009.
Manufacturer: Maquet Aktiengesellschaft, Rastatt, Germany. Firm initiated recall is ongoing.
REASON
Product monitoring has determined that the connection bracket shows potential mechanical play at the OR table interface for some procedures. This is due to the hole in the lock washer, which is responsible for locking the accessory to the OR table, being too large.
VOLUME OF PRODUCT IN COMMERCE
9 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
TempSpan Dual-Cure Temporary Crown and Bridge Material, Part number N69AD, The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated. Recall # Z-0482-2010
CODE
Lot number: 191691
RECALLING FIRM/MANUFACTURER
Jeneric/Pentron, Wallingford, CT, by letter on October 22, 2009. Firm initiated recall is ongoing.
REASON
Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst.
VOLUME OF PRODUCT IN COMMERCE
58 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Axiom Artis MP, Model number 5904466 angiographic x-ray systems. Recall # Z-0483-2010;

2) Axiom Artis dMP, Model number 7555365 angiographic x-ray systems. Recall # Z-0484-2010;

3) Axiom Artis Zee Multi-purpose, Model number 10094139 angiographic x-ray systems. Recall # Z-0485-2010
CODE
1) Serial numbers: 20003, 20015, 20016, 20033, 20037, 20050, 20052, 20053, 20056, 20074, 20076, 20081, 20082, 20086, 20087, 20097, 20100, 20102, 20114, 20129, 20136, 20140, 20141, 20143, 20157, 20165, 20170, 20171, 20172, 20175, 20178, 20180, 20181, 20182, 20183, 20185, 20188, 20202, 20205, 20207, 20208, 20209, 20217, 20220, 20230, 20233, 20238, 20242, 20243, 20249, 20250, 20254, 20258, 20264, 20265, 20281, 20282, 20294, 20295, 20303, 20313, 20321, 20322, 20325, 20334, 20338, 20339, 20343, 20348, and 20363;

2) Serial numbers: 57004, 57008, 57009, 57012, 57016, 57024, 57041, 57045, 57054, 57072, 57073, 57076, 57077, 57089, 57098, 57105, 57111, 57116, 57117, 57124, 57144, 57155, 57156, 57171, 57183, 57187, 57188, 57189, 57193, 57198, 57201, and 57204;

3) Serial numbers: 157136, 157139, 157146, 157156, 157164, 157165, 157168, 157169, 157184, 157213, and 157215
RECALLING FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc., Malvern, PA, by letter on October 27, 2009.
Manufacturer: Siemens Medical Solutions, Inc., Erlangen, Germany. Firm initiated recall is ongoing.
REASON
C-arm may tilt.
VOLUME OF PRODUCT IN COMMERCE
113 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Elements Gutta Percha and Elements RealSeal Cartridges; Part Number: 972-1002, 972-1003, 972-2001, 972-2002. Recall # Z-0488-2010
CODE
Lot Numbers: 06 0959663, 06 0957595, 07 0987641, 08 0992277, 05 0941553, 05 0948690, 06 0955241, 07 0977947, 07 0987642, 08 0992278, 08 0998612
RECALLING FIRM/MANUFACTURER
Sybronendo, Orange, CA, by letter on November 06, 2009. Firm initiated recall is ongoing.
REASON
The recall was initiated because during the manufacturing process of the affected units, the molding process resulted in lock nuts that did not have the level of acceptability required, and therefore, may not withstand the pressures exhibited by the Elements Obturation Unit with which the cartridges are used. More specifically, there exists a possibility that if the lock nut were to fail, the cartridge could fall out onto patients or users and could cause a burn.
VOLUME OF PRODUCT IN COMMERCE
5,046 units
DISTRIBUTION
Nationwide, Canada, Chile, China, Ecuador, Guatemala, Hong Kong, Japan, Malaysia, Singapore, Taiwan and Venezuela
___________________________________
PRODUCT 
Zodiac Polyaxial Spinal Fixation System. Part Number: 62665-50. Recall # Z-0491-2010
CODE
Lot Number: 617945
RECALLING FIRM/MANUFACTURER
Alphatec Spine, Inc., Carlsbad, CA, by telephone on October 16, 2008. Firm initiated recall is complete.
REASON
Alphatec Spine recently discovered that this lot of screws has the incorrect length laser etched on one side of the screw body. As a result, they are conducting a voluntary recall of the Zodiac Titanium cannulated polyaxial screw 6.5 mm x 50 mm L.
VOLUME OF PRODUCT IN COMMERCE
56 units
DISTRIBUTION
AZ, CA, FL, TX
___________________________________
PRODUCT 
ILLICO Posterior Thoracolumbar Access Retractor, Part Number: 73520. The ILLICO Posterior Thoracolumbar Access Retractor is an instrument that is intended for use in a minimally invasive approach for surgical procedures. The retractor allows retraction of tissue through combination of articulating blades. Device will serve to provide access for surgeons to surgical site. Recall # Z-0498-2010
CODE
Lot number: 5271901
RECALLING FIRM/MANUFACTURER
Alphatec Spine, Inc., Carlsbad, CA, by telephone on January 28, 2009. Firm initiated recall is complete.
REASON
The recall was initiated after Alphatec Spine received a complaint on the ILLICO Posterior Thoracolumbar access retractor. It was reported that one of the retractor arms in the retractor broke during surgery.
VOLUME OF PRODUCT IN COMMERCE
14 units
DISTRIBUTION
AZ, CA, OR, TX, Tokyo, Japan
___________________________________
PRODUCT 
Zimmer Dental AdVent Implant System, Abutment, Tapered, Rx, sterile; REF AVACT. Recall # Z-0499-2010
CODE
Lot numbers: 61233652, 61238956, 61245049, 61252577, 61256798, 61263053, 61314067 and 61341224
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN, by telephone on or about November 6, 2009.
Manufacturer: Zimmer Dental, Inc., Carlsbad, CA. Firm initiated recall is complete.
REASON
The devices may not meet specifications, which may result in fracturing during tightening of the component.
VOLUME OF PRODUCT IN COMMERCE
738 units
DISTRIBUTION
OH, Canada, France
___________________________________
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-1091-2010
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
Biomet, Inc., Warsaw, IN, by letter dated September 9, 2009. 
Manufacturer: Biomet sports Medicine, Inc., Ontario, CA. Firm initiated recall is ongoing.
REASON
These 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

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III
___________________________________
PRODUCT 
1) Advance (R) Canal Filling Stem Extension, REF: KSP1-2140, Diameter 11mm, Length 140mm, 1 each, Sterile R, (For use with cement only), Single Use Only, (Ti6A14V). Recall # Z-0492-2010;

2) Advance (R) Canal Filling Stem Extension, REF: KSP1-2140, Diameter 13mm, Length 140mm, 1 each, Sterile R, (For use with cement only), Single Use Only, (Ti6A14V). Recall # Z-0493-2010
CODE
1) Lot numbers: 098705608 and 098705609;
2) Lot number: 098705612
RECALLING FIRM/MANUFACTURER
Wright Medical Technology, Inc., Arlington, TN, by telephone on September 22, 2009 and letters dated October 9, 2009. Firm initiated recall is complete.
REASON
Titanium used in the recalled devices was discovered to have internal microstructure conditions of alloy segregation, primary alpha and/or a transformed beta matrix in some of the heat lots. The absence of alloying elements results in an area with less strength. For those instances where the product has been implanted, there is the potential increased risk of failure for these patients.
VOLUME OF PRODUCT IN COMMERCE
32 units
DISTRIBUTION
Nationwide, Columbia, Brazil, Portugal, UK, Belgium, Austria, Greece

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
___________________________________
PRODUCT 
Antibacterial Sulfamethazine Sustained Release Calf Bolus (72 hours). NADA 120-615. Net Contents: 50 boluses. Each Bolus Contains: Sulfamethazine (formulated in a sustained release base) 123.8 grains (8.02 grams). Labeled under the following labels: 1) AGRIpharm Supra Sulfa III. Product No. 1SUS018 8SUS033-1101. 2) Bimeda Sustain III. Product no. 1SUS033 8SUS025-1004. Recall # V-014-2010
CODE
Lot 13330220
RECALLING FIRM/MANUFACTURER
Bimeda, Inc., Le Sueur, MN, by letter dated November 10, 2009. Firm initiated recall is ongoing.
REASON
During routine stability testing, Sustain Calf Lot 13330220 was discovered to have failed dissolution testing. Some of the boluses dissolve faster than the specification of not more than 60% dissolved in 15 minutes.
VOLUME OF PRODUCT IN COMMERCE
1200 units ( Agripharm 50 count); 1053 units ( Bimeda 50 count)
DISTRIBUTION
NE, MO, IA, MN, OH, KS, TX

END OF ENFORCEMENT REPORT FOR DECEMBER 16, 2009

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