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U.S. Department of Health and Human Services

Safety

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Enforcement Report for July 29, 2009

July 29, 2009
09-30

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
1) Arico Natural Foods Company Peanut Butter Gluten Free * Dairy Free Cookies, 4.76 oz stand-up plastic pouch with UPC 1 82363 00022 1 and 6 packages per case. Product labeled in part, Ingredients: Organic peanut butter, four base..., organic cane sugar. Recall # F-518-9;

2) Arico Natural Foods Company Peanut Butter Dairy Free Gluten Free Cookie Bars, 1.4 oz plastic package with UPC 1 82363 00006 1 and packaged 12 pars per sleeve, 6 sleeves per case (72 bars/case). Product labeled in part, Ingredients: Organic peanut butter, flour base... organic cane sugar. Recall # F-519-9
CODE
1) Sell-by dates of 080309 and 100509 - Date code is printed on the top, front, left of each pouch (08 - month; 03 - day; 09 - year) or on the case label as 08/03/09 and 10/05/09;

2) Sell-by date of AUG0409 (04 - date; 09 -year) and code MO3098 (MO is batch of the day, 309 is Julian Date and 8 is the year). Date code is printed on the middle, back of individual bar wrapper or on the case label as 08/04/09
Recall # F-519-9  
RECALLING FIRM/MANUFACTURER
Arico Natural Foods Co., Beaverton, OR, by telephone and e-mail on January 29, 2009 and by press release and letters on January 30, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
8,502 packages
DISTRIBUTION
CA, CO , CT, FL, GA, IA, IL, IN, KY, MA, MD, NH, NJ, NY, OR, PA, TX, WA and Canada
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PRODUCT 
1) Chocolate Peanuts, Crunchy Peanuts Dipped in Rich Milk, Chocolate, net wt. 4.8 oz; Product 31-341, UPC 7518616341. Recall # F-543-9;

2) Bridge Mix Chocolate covered nuts, fruits, caramels and crèmes net wt. 5oz ., a) Product 05-503, UPC 7518605503; net wt. 8oz., b) Products 05-803 and 05-803HL, UPC 7518605803; net wt. 16 oz., c) Product 09-303, UPC 6523209303; net wt. 30 lb., d) Product 05-403, UPC 7518605403 and net wt. 30 lb., Product 05-403M, UPC 7518605403. Recall # F-544-9;

3) Fine Assorted Chocolates, net wt. 40 oz., Product 05-942, UPC 7518605942.
Recall # F-545-9;

4) Premium Chocolates Party Tray, net wt. 32 oz., Product 05-461, UPC 7518605461. Recall # F-546-9;

5) Dark Chocolate Double Dipped Peanuts, net wt. 30 lb., Product 05-648, UPC 7518605648. Recall # F-547-9;

6) a) Double Dipped Peanuts, crunchy peanuts double dipped in rich milk chocolate, Meijer brand, net wt. 5 oz. Product 04-845, UPC 4125004845; b) Zachary brand, net wt. 8 oz., Product 05-801HL, UPC 7581605801; c) Zachary brand, net wt. 16oz., Product 09-301, UPC 6523209301and net wt 30lb, Product 05-748, UPC 7518605748. Recall # F-548-9;

7) a) Milk Chocolate Perk, Caramel Nut Clusters net wt. 23 lb., Product 05-621, UPC 7518605621. b) Meijer Caramel Nut Clusters, roasted peanuts and soft caramel covered in rich milk chocolate, net wt 5 oz., Product 05-311, UPC 4125005311. Recall # F-549-9;

8) Milk Chocolate Peanut Clusters, net wt. 23 lb., Product 05-749, UPC 7518605749. Recall # F-550-9;

9) Chocolate covered peanuts, milk chocolate, Market Pantry brand, net wt. 9 oz., Product 02-349, UPC 8523902349. Recall # Recall # F-551-9
CODE
1)  Lots P8104B, P8204B, P8102F, P8203D, P8205C, P8202D, P8206C, P8206B and P8207E;

2) a) Lot O8206C and 08204D, b) Lot O9151D, c) Lot M9150E, d) Lots T8207D, T8107E, T8107D, T8207C, T8207F, T8107F, T8203C, T8103C, T8207E, U9150D, U9150E and U9250D;

3) Lots H8106C, H8107F, H8107D, H8107C, and H8107E;

4) Lot L8106E;

5) Lot F8204D;

6) a) Lots E8202B and E8209B, b) Lots N9251D and O9251D, c) Lots M9151B and E8110F, d) Lots E8102C and E8210C;

7) a) Lot E9148B, b) Lots E8202F and F8101C;

8) Lots E8204D, C8107C, C8207C, and E8104D;

9) Lots E8209D and E8202C
RECALLING FIRM/MANUFACTURER
Zachary Confections, Inc., Frankfort, IN, by press release and letter on January 31, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
43,380 cases
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) Mama Mellace's Nut Hut All Natural Cinnamon Peanuts, Net Wt. 18oz (510g) plastic jar, UPC 8 33482 00784 3. Recall # F-553-9;

2) Mama Mellace's Nut Hut Steakhouse Peanuts with Real Worcestershire Sauce, Net Wt. 18 oz (510g) plastic jar, UPC 8 33482 00747 8. Recall # F-554-9;

3) Mama Mellace's Nut Hut All Natural Sweet & Salty Peanuts, Net Wt., 18oz (510g) plastic jar, UPC 8 33482 00746 1. Recall # F-555-9;

4) Mama Mellace's Old World Treats, Mama's Savory Medley, Net Wt. 19.5 oz (553g) tray, containing Roasted & Salted Mixed Nuts, Steakhouse Peanuts, Roasted & Salted Peanuts and Chipotle Almond, UPC 8 33482 00810 9. Recall # F-556-9
CODE
1) Lot Code 9005, Best by Date 05 JAN 2010; Lot Code 9007, Best by Date 07 JAN 2010;

2) Lot Code 8310, Best by Date 05 NOV 2009;

3) Lot Code 8335, Best by Date 30 Nov 2009;

4) Lot Code 8340, Best by Date 05 DEC 2009
RECALLING FIRM/MANUFACTURER
The Nut Hut dba Mama Mellace’s, Carlsbad, CA, by telephone and letter on March 6, 2009 and by press release on March 24, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
462 cases
DISTRIBUTION
AR, MA, TX
___________________________________
PRODUCT 
1) Anna's Pantry Honey Roasted Peanuts packaged in plastic; sizes include 1.5 oz, 3 oz and 10 oz. Recall # F-557-9;

2) Anna's Pantry Cocktail Snack Mix packaged in plastic; sizes include 3 oz and 7 oz. Recall # F-558-9;

3)  Anna's Pantry Roasted and Salted Mixed Nuts packaged in plastic; sizes include 1.5 oz, 3 oz and 10 oz. Recall # F-559-9
CODE
None
RECALLING FIRM/MANUFACTURER
Anna’s Pantry LLC, Richmond, WA, by telephone on March 3, 2009 and by press release on March 7, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
14,070 packages
DISTRIBUTION
OR, WA
___________________________________
PRODUCT 
1) Honey Roasted Peanuts, Net Weight 12-oz., Item Number SETN1213. Recall # F-560-9;

2) Roasted & Salted Blanched Virginia Peanuts, 30# case. Recall # F-561-9
CODE
Product shipped on Jan 8 and Jan 20 under invoices #43786 and 43846 respectively
RECALLING FIRM/MANUFACTURER
Hines Nut Co., Dallas, TX, by press release and fax on February 2, 2009 and by fax on March 3, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
448 units and 300 cases of 30 lbs each
DISTRIBUTION
TX
___________________________________
PRODUCT 
Glutenfreeda's Frozen Cookie Dough, Peanut Envy, 1 lb (16 oz); product packaged in an oval paper tub with 12 pre-formed cookies inside, 6 pkg per case. Product is marketed in the US and Canada and retail package labeled in part, Glutenfreeda's Real Cookies!, Peanut Envy; UPC 58246 00101. Recalling # F-562-9  
CODE
Use By dates of 2/1/10 and prior. 1) Retail package use by date in format of 2.1 10; 2) case use by date in format of Feb 1 2010
RECALLING FIRM/MANUFACTURER
Glutenfreeda Foods, Inc., Burlington, WA, by press release, telephone and e-mailed, faxed or mailed letters beginning on February 25, 2009, and by press release on February 26, 2009. Firm initiated recall is complete.
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
8,676 retail units
DISTRIBUTION
Nationwide, British Columbia, Canada
___________________________________
PRODUCT 
1) Cougar Mountain Gourmet Cookies, Golden Gardens, Classic Peanut Butter Cookies. 1) 10 oz cardboard box containing 8 cookies, two plastic wrapped 4-packs per box; UPC 0 96343 85676; 2) 3.5 oz. individually cellophane wrapped cookies; UPC 0 96343 22005. Recall # F-563-9

2) Cougar Mountain Gourmet Cookies, Dark-Dipped Peanut Butter, sold in 4 oz. Individually cellophane wrapped cookies; UPC 0 96343 32002. Recall # F-564-9;

3) Cougar Mountain Gourmet Cookies, Seasonal Variety, Ballpark Cookie. Product sold as: 1) 10 oz cardboard box containing 8 cookies, two plastic wrapped 4-packs per box; UPC 0 96343 85672; 2) 3.5 oz. individually cellophane wrapped cookies; UPC 0 96343 22099. Recall # F-565-9;

4) Cougar Mountain Cookie Dough, Peanut Butter Chocolate Chunk; sold in 18 oz. paper tub, UPC 0 96343 51102. Recall # F-566-9;

5) Cougar Mountain Cookie Dough, Seasonal Variety: Ballpark Cookies. Sold as: 18 oz paper tub, UPC 0 96343 51107 and 3 lbs (48 oz) paper tubs UPC code 0 96343 51399. Recall # F-567-9;

6) Cougar Mountain Cookie Dough, Classic Peanut Butter; sold in 48 oz paper tub, UPC code 0 96343 51305. Recall # F-568-9;

7) Cougar Mountain Gourmet Cookies, Fremont Bridge Peanut Butter Chocolate Chunk; sold in 10 oz cardboard box containing 8 cookies, two plastic wrapped 4-packs per box; UPC 0 96343 85679. Recall # F-569-9
CODE
1) For all sizes: Best Before: 02/01/07 to 03/07/09;

2) Best Before: 02/01/07 to 03/07/09;

3) 1) 10 oz box: Best Before: 02/01/07 to 11/01/08; 2) 3.5 oz cookie: Best Before: 02/01/07 to 03/07/09;

4) Best Before: 03/01/07 to 04/14/09;

5) 18 oz - Best Before: 3/01/07 to 4/14/09; 3 lbs - Best Before 3/1/07 to 2/11/09;

6) Manufactured on or delivered on: 3/01/07 to 2/11/09;

7) Best Before: 2/01/07 to 3/07/09
RECALLING FIRM/MANUFACTURER
Cougar Mountain Baking, Seattle, WA, by press release and letter via e-mail, fax or mailed on February 13, 2009. Firm initiated recall is complete.
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
240,513 retail units
DISTRIBUTION
CA, OR, NY, and WA
___________________________________
PRODUCT 
1) Meijer Candy Bar Swirl with Snickers Bar Pieces, Milk Chocolate & Peanuts in Vanilla Flavored Ice Cream Swirled with Fudge, Artificial Flavor Added; a) 1.75 Qt. (56 oz.) and b) 2 Qt. (64 oz.) Square Cartons, UPC 0 41250 00167 6. Recall # F-570-9;

2) Giant Eagle Creamery Classics Monkey Business Premium Ice Cream; a rich banana flavored ice cream swirled with sweet thick chocolate fudge and mountains of chocolate covered peanuts; 1.75 Qt, (56 FL. OZ.); UPC 0 30034 03281 4. Recall # F-571-9;

3) Stroh's Mooney's Nafziger's Candy Bar Whirl Ice Cream; vanilla ice cream swirled with caramel syrup, candy bar blend including chocolate covered peanuts; 3 Gallon cardboard tubs, UPC 0 71029 03105 4. Recall # F-572-9
CODE
1) Code date: 01/06/10 or earlier; b) Code date: 09/08/09 or earlier;

2) Code dates: 07/31/09 or earlier;

3) Code: 08-269 XX:XX 17-81 (where XX:XX is the military time)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dean Foods Co Inc., Rockford, IL, by press releases on February 5, and February 6, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
35,774 - 56 oz., 25,021 - 64 oz., 869 - 3 gal.
DISTRIBUTION
IL, IN, KY, MI, ND, OH, PA, WV
___________________________________
PRODUCT 
1) Readi-Bake The Best You Can Bake, 04246 Country Peanut Butter Cookie Dough, Net Wt. 22.50 lbs (10.2 KG), Count 288-1.25 oz. (35 G) portions. UPC 0002449702466. Recall # F-573-9;

2) Sysco and Block & Barrel printed on outer package. 384/1.0 oz. Peanut Butter Cookie Dough, 0212928, Net Wt. 24 lbs. (10.89 kg); UPC 00074865937177. Recall # F-574-9;

3) Annabella's Peanut Butter Cookies, Product Code 62514, 216 Pre cut 1.5 oz. Cookies. Net Wt. 20.25 lbs., (9.19kg), Keep Frozen Below 0 degrees F. Recall # F-575-9;

4) ZAP Snack, The Leader in Value Fund Raising, Peanut Butter 48-1 oz. Ready to Bake Cookies, #563 CD. Net Wt. 3 lbs., (1.36 kg); UPC 0 73321 56300 4. Recall # F-576-9;

5) Lisa's Favorites, Fundraising, Peanut Butter Frozen Cookie Dough, 1.0 oz. Peanut Butter Cookie. Net Wt 2.5 lbs. Keep Frozen, UPC 7 18122 37465 6. Recall # F-577-9;

6) Red Apple Bakery Peanut Butter Pleasures Frozen Cookie Dough Outer Carton: 8-3 lb boxes. Inner cartons: Net Wt. 48 oz., 1.36 kg). UPC outer carton 10073321626034; Inner carton UPC 0 73321 62603 7. Recall # F-578-9; 

7) Pleasantville Farms Peanut Butter Frozen Cookie Dough, Keep Frozen, Net Wt. 2.5 lbs., UPC 7 18122 37545 5. Recall # F-579-9;

8) Helen Grace Gourmet Collection Peanut Butter Pleasures Frozen Cookie Dough, Net. Wt. 2.5 lbs. Recall # F-580-9;

9) Camden Creek Bakery 1.0 oz., UPC 0 73321 74054 2, and 1.3 oz. Break & Bake Peanut Butter Cookie Dough Product, UPC 1 00 73321 61058 3; Keep Frozen, Net Wt. 3 lbs (1.36 kg). Recall # F-581-9;
CODE
1) Code 04246, Expiration: any date ending in '08 & 1/3/09;

2) Code 212928, Expiration: any ending in '08;

3) Code 62514; Expiration: any ending in '08 and 1/3/09;

4) Code 563, Expiration: any ending in '08;

5) Code 62501, Expiration: any ending in '08;

6) Code 62603, Expiration: any ending in '08;

7) Code 76106, Expiration: any ending in '08;

8) Code 76119, Expiration: any ending in '08;

9) Code: 74054; code: 61058; code: 74014. Expiration: any ending in '08
RECALLING FIRM/MANUFACTURER
J & J Snack Foods Corp., Pennsauken, NJ, by press release and letter on February 19, 2009. Firm initiated recall is ongoing.
REASON
Products were manufactured using peanut butter recalled by Peanut Corporation of America, because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
30,390 cases
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
Tin Roof Sundae Ice Cream with Artificial Flavors Added; Vanilla ice cream with Fudge Swirl, Chocolate Covered Peanuts; half gallon (1.89L) square cartons, 6 cartons per case; the ice cream was sold under the following labels: a) IGA Tin Roof Ice Cream, UPC 0 41270 46102 3; b) Best Choice Tin Roof Sundae Ice Cream, UPC 0 70038 59617 2. Recall # F-582-9
CODE
a) Best By APR 2 2009, b) Best by APR 18 2009, Best By May 14 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dean Foods Co Inc., Rockford, IL, by press release on February 18, 2009.
Manufacturer: Driggs Farms Of Indiana, Inc., Decatur, IN. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
19,650 half gallon cartons
DISTRIBUTION
KS, MO, OK, SC
___________________________________
PRODUCT 
1) Assorted Chocolates, Net wt. 5 ounce package; Products 121 and 121R. Net wt. 8 ounce; Products 122, 122D and 122R, UPC 4482300122. Net wt. 12 ounce; Products 123 and 123DK, UPC 4482300123. Net wt. 26 ounce; Product 124, UPC 4482300124. Recall # F-583-9;

2) Hoosiers Candy, Net wt. 1.5 ounce; Product 010, UPC# 4482300011. Net wt. 3.0 ounce; Product 011, UPC# 4482300010. Net wt. 4 pound; Product 410, UPC 4482300410. Recall # F-584-9;

3) Valentine heart box candies as follows: Valentine Heart, Net wt. 14 ounce, Products 1020 and 1020R, UPC 4482310201; Velvet Heart, assorted, net wt. 8 oz., Product 1021R; Heart Box, net wt. 2 lb., no product number. Recall # F-585-9;

4) Peanut Butter Fudge, Net wt. 4.5 pounds; Product 228, UPC 4482300228. Recall # F-586-9;

5) Peanut Butter Meltaways-Dark Chocolate, Net wt. 5 lb.; Product 204D, UPC 4482302044. Recall # F-587-9;

6) Peanut Butter Meltaway, Milk Chocolate, Net wt. 5 lb.; Product 204, UPC 4482300204. Recall # F-588-9;

7) Peanut Butter Chocolate Fudge, Net wt. 4.5 lb.; Product 229, UPC 4482300229. Recall # F-589-9;

8) The South Bend Chocolate Co. Christmas gift boxes, Products CC, CCLG, CCXL and CCXXL may have included the assorted chocolate candy products under recall. Recall # F-590-9;

9) All South Bend Chocolate Co. gift boxes may have included any of the assorted chocolate candy products under recall. Recall # F-591-9
CODE
All lots (Products do not bear lot numbers.)
RECALLING FIRM/MANUFACTURER
South Bend Chocolate Company, Inc., South Bend, IN, by press release on January 18, 2009 and January 22, 2009 and by letter on January 28, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________
PRODUCT 
Cordial de Monell para la Denticion de los Ninos; Monell's Teething Cordial: Bromuro de Potasio 0.3 grms, Aceite Es. Betula 0.0099cc, Aceite Es Anis 0.0198cc, Jarabe Simple Csp 100cc. UPC 7 460840 410019, UPC 7 460840 410019. Recall # D-1766-2009
CODE
UPC code only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Castillo Distributor, Inc., Little Ferry, NJ, by letter on March 13, 2009, and press release and letter on April 9, 2009.
Manufacturer: Laboratories Mallen, Dominican Republic. Firm initiated recall is ongoing.
REASON
Unapproved Drug; product contains potassium bromide (not approved for human use in the United States).
VOLUME OF PRODUCT IN COMMERCE
4100 bottles
DISTRIBUTION
NJ, NY, CT, RI, NC, FL, MA
___________________________________
PRODUCT
1) ProSlim Plus -- 100% Natural -- Supplement for Diet Support -- 60 Capsules per bottle, packaged in a box -- Made in Japan -- UPC 4 928761 589144. Recall # D-1767-2009;

2) 3 Days fit -- 60 capsules (400 mg) per bottle, packaged in a box -- UPC 4 965831 587563. Recall # D-1768-2009;

3) Eight Factor Diet -- 60 capsules, 3 pouches per box -- Made in Japan -- UPC 4 961985 823656. Recall # D-1769-2009;

4) 24hours Diet -- 24 hours, Chain Fat Burning Reaction with Double Effects -- 60 Capsules per bottle, packaged in a box -- UPC 4 958564 525322 -- Made in Japan. Recall # D-1770-2009;

5) Slim 3in1 M-18 Royal Diet -- 90 capsules, 3 pouches per box -- UPC 4 897005 120125. Recall # D-1771-2009;

6) 3X Slimming Power -- 60 capsules per bottle, packaged in a box -- Made in Japan -- UPC 4 967845 695555. Recall # D-1772-2009;

7) Extrim Plus 24 Hours Re-Burn Formula -- 60 capsules per bottle, packaged in a box -- UPC 4 956825 856253. Recall # D-1773-2009;

8) Slim 3in1 Extra Slim Formula -- 90 capsules, 3 pouches per box – Made in Japan -- UPC 4 926385 914229. Recall # D-1774-2009;

9) Slim 3in1 Extra Slim Waist Formula -- 100% All Natural -- 90 Capsules, 3 pouches per box -- Made in Japan -- UPC 4 960052 408604. Recall # D-1775-2009;

10) Slim Express 360 C -- 90 capsules per box -- UPC 4 963652 152359; and 60 capsules per box containing 3 foil-like pouches, 20 capsules per pouch – Made in Japan. Recall # D-1776-2009;

11) Slim Express 4in1 -- 60 Capsules per bottle, packaged in a box -- Made in Japan - UPC 4 963562 412260. Recall # D-1777-2009;

12) Royal Slimming Formula -- 60 capsules per bottle, packaged in a box -- Made in Japan -- UPC 4 958587 987770. Recall # D-1778-2009;

13) Body Creator -- 100% NATURAL -- 90 capsules, 3 pouches per box – Made in France -- UPC 3 027945 861623. Recall # D-1779-2009;  

14) Slim Waistline (labeling written in Chinese) --packaged in a box -- UPC 4 925105 880219. Recall # D-1780-2009;

15) Body Shaping -- 100% Natural -- 90 capsules per box containing 3 pouches, 30 capsules per pouch – Made in France -- UPC 3 062569 747809. Recall # D-1781-2009;

16) Perfect Slim -- 100% All Natural -- 90 Capsules, 3 pouches per box. Recall # Recall # D-1782-2009;

17) Perfect Slim -- No 1. 4 -- 5X -- Super Slim Power -- 100% Natural -- 60 capsules per bottle, packaged in a box -- Made in Japan. Recall # D-1783-2009;

18) Imelda Perfect Slim -- 60 capsules per bottle, packaged in a box -- Made in Hong Kong. Recall # D-1784-2009;

19) Slim Waist Formula -- 32 capsules, 2 pouches per box. Recall # D-1785-2009;

20) Super Slimming -- 60 capsules per bottle, packaged in a box -- Made in Japan. D-1786-2009;

21) 2 Day Diet -- Japan Lingzhi -- Slimming Formula -- Fat Burner -- 60 capsules per bottle, packaged in a box – Made in Japan. Recall # D-1787-2009;

22) Powerful Slim - The slimming total effect -- No. 1 Slim. Product of Japan -- packaged in a box containing two pouches, 16 capsules per pouch. Recall # D-1788-2009;

23) Body Shaping -- 90 capsules per box, each box contains 3 pouches of 30 capsules each. Product of France. Recall # D-1789-2009;

24) Super Fat Burner -- 60 Capsules per bottle, packaged in box -- Made in Japan. Recall # D-1790-2009;

25) Slimming Formula -- A Scientific Breakthrough -- GMP -- each box contains 3 pouches – Made in Japan. Recall # D-1791-2009;

26) Slim Fast 2 -- 32 capsules, 2 pouches per box – Made in Japan. Recall # D-1792-2009;

27) Slim Fast -- 100% Natural Ingredients -- 60 Capsules, 3 pouches per box -- Made in Japan. Recall # D-1793-2009;

28) Slim up -- 120 capsules per bottle, packaged in box -- Product Developed in Japan. Recall # D-1794-2009;

29) 7 Days Diet -- 100% Cut: 4in1 -- Firming & Slimming Formula -- 60 capsules per box, 3 pouches per box -- Made in Japan. Recall # D-1795-2009;

30) Perfect Slim Up! -- Royal Slimming Powerful Capsules -- 60 capsules per bottle, packaged in a box. Recall # D-1796-2009;

31) JM Fat Reducer -- 100% Natural Herbal Essence -- 120 capsules per box, each box contains 3 foil-like pouches - 60 capsules per pouch -- UPC unknown -- Reproduction in Japan.  Recall # D-1797-2009;

32) SlimBurn -- 15 Minutes Overall Burning Fat -- 60 capsules per bottle, packaged in a box -- Made in Japan. Recall # D-1798-2009;

33) 21 Double Slim -- No. 1 -- 60 Capsules per bottle, packaged in a box. Recall # D-1799-2009;

34) Trim Plus 2 (Trim 2 Plus) -- 60 Capsules per bottle, packaged in a box. Recall # D-1800-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Universal A.B.C. Beauty Supply International, Inc., Brooklyn, NY, by letters dated December 31, 2008 and press release on April 20, 2009 followed by telephone and letters during the week of April 27, 2009. Firm initiated recall is ongoing.
REASON
Unapproved new drug, the dietary supplement was found to contain sibutramine, an FDA approved drug for weight loss based on FDA sampling and analysis.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
1) PROMETHAZINE, 25MG, Promethazine Suppositories, Mfg. G&W. Recall # D-1658-2009;

2) ONDANSETRON, ODT 4MG, Equiv: ZOFRAN 4MG ODT, Mfg. GPI. Recall # D-1659-2009;
 
3) POLYMYXIN B SULF VL INJECTION, 500MU, Mfg. BED, Recall # D-1660-2009;

4) DOCUSATE Na, 100MG, DOCUSATE SODIUM CAP, Mfg. IVX. Recall # D-1661-2009;

5) CLONIDINE Transderm. Patch, Catapres-TTS-2, 0.2mg/Day, Mfg. BOE, Recall # D-1662-2009;

6) CYCLOBENZAPRINE, 10MG, TABLET, Mfg. UDL. Recall # D-1663-2009;

7) NALTREXONE, sub: REVIA, 50MG TAB, Mfg EON, NDC 00185-0039-30. Recall # D-1664-2009;

8) TAMOXIFEN CIT, 10MG TAB, Mfg IVX. Recall # D-1665-2009;

9) GLEEVEC, IMATINIB MESYL., 100MG TAB, Mfg NVT. Recall # D-1666-2009;

10) NIASPAN E-R, NIACIN E-R, 500MG TABLET, Mfg KOS, NDC 60598-0140-01. Recall # D-1667-2009;

11) VERAPAMIL ER, 120MG CAP, Mfg MYL, NDC 00378-6320-01. Recall # D-1668-2009;

12) AVITENE 70X35 sheet, Mfg. MPI. Recall # D-1669-2009;

13) HYDROXYZINE HCl, sub: ATARAX, 25MG TABLET, Mfg VPI. Recall # D-1670-2009;

14) EPIVIR, LAMIVUDINE, 300MG TAB, Mfg. GSK. Recall # D-1671-2009;

15) HEPSERA, Adefovir Dipivoxil 10mg, 10MG TAB, Mfg. NEX. Recall # D-1672-2009;

16) COUMADIN INJ, WARFARIN, 5MG VIAL, Mfg. BRI. Recall # D-1673-2009;

17) ECOTRIN EC, ASPIRIN, 500MG TAB, Mfg GSK, NDC 49692-0903-78. Recall # D-1674-2009;

18) DETROL, TOLTERODINE, 1MG TAB, Mfg. PFZ, Recall # D-1675-2009;

19) EFFEXOR, VENLAFAXINE, 75MG TAB, Mfg WYE, NDC 00008-0704-07. Recall # D-1676-2009;

20) KU-ZYME CAP, Mfg SWZ, NDC 00091-4122-01. Recall # D-1677-2009;

21) ELDEPRYL, SELEGILINE HCl, 5MG CAP, Mfg SOM, NDC 39506-0022-60. Recall # D-1678-2009;

22) PRIMAQUINE PHOSPHATE, 26.3MG (=15MG BASE), TAB, Mfg BAY. Recall # D-1679-2009;

23) PRIMIDONE, 250MG TABLET, Mfg QLT. Recall # D-1680-2009;

24) ANUCORT-HC, HYDROCORTISONE ACETATE, 25MG SUP, Mfg. G&W. Recall # D-1681-2009;

25) HECTOROL, DOXERCALCIFEROL, 2.5MG CAP, Mfg G/C, NDC 64894-0825-50. Recall # D-1682-2009;

26) BUPROPION, 150MG TABLET, Mfg. SDZ, NDC 00105-0415-01. Recall # D-1683-2009;

27) TERAZOSIN HCl, sub: HYTRIN, 2MG CAP, Mfg A-C, NDC 60505-0116-00. Recall # D-1684-2009;

28) PREDNISOLONE, 15MG/5ML SYRUP 5ML, Mfg. PMA, NDC 00121-0687-16. Recall # D-1685-2009;

29) TRITAL DM, DM/CHLORPHEN/PE, 15/4/10/5ML SF LIQUID, Qty 5ML, MFG: TML, NDC 51991-0131-16. Recall # D-1686-2009;

30) LACT-AID, LACTASE, TAB, Mfg. MCN, NDC 00045-0910-60. Recall # D-1687-2009;

31) IRON 47.5MG TAB, SLOW FE 47.5MG, Mfg. NVT, NDC 30083-0125-74. Recall # D-1688-2009;

32) SIMETHICONE, sub: GAS-X, 125MG SOFTGEL, Mfg. GDD, NDC 00113-0428-65. Recall # D-1689-2009;

33) ACETAMINOPHEN, PEDIATRIC, 120MG SUPPOSITORY, Mfg. GDL, NDC 00182-1662-11. Recall # D-1690-2009;

34) SALT TABLET, SODIUM CHLORIDE, USP, 1GM TAB, Mfg CMC, NDC 00223-1760-01. Recall # D-1691-2009;

35) VITAMIN B-12, CYANOCOBALAMIN, 500MCG TAB, Mfg NVC, NDC 79854-0200-60. Recall # D-1692-2009;

36) NAPROXEN SOD, 550MG TAB, Mfg. TEV, NDC 00093-0537-10. Recall # D-1693-2009;

37) THERAVITE, MULTIVITAMIN, LIQUID 5ML, Mfg. GDL, NDC00182-6107-37. Recall # D-1694-2009;

38) IBUPROFEN, 800MG TAB, Mfg. QLT, NDC, 00603-4020-21. Recall # D-1695-2009;

39) IBUPROFEN, 400MG TAB, Mfg. QLT, NDC, 00603-4018-21. Recall # D-1696-2009;

40) SODIUM BICARBONATE, 650MG (10GR) TAB, Mfg. RUG, NDC 00536-4544-10. Recall # D-1697-2009;

41) ASPIRIN BUFF, ASA/Ca CARB/Mg, 325MG TAB, Mfg. GDL, NDC 00182-1909-01. Recall # D-1698-2009;

42) ISOSORBIDE MONO EXTENDED-RELEASE, 120MG TAB, Mfg W-P. Recall # D-1699-2009;

43) CYCLOGYL 2%, CYCLOPENTOLATE, OPHTHALMIC SOLUTION, Mfg. ALC. Recall # D-1700-2009;

44) SYNTHROID, LEVOTHYROXINE SODIUM, 50MCG TAB, Mfg ABB, NDC 00074-04552-13. Recall # D-1701-2009;

45) OXCARBAZEPINE, 300MG TAB, Mfg BRK, NDC 51991-0293-01. Recall # D-1702-2009;  

46) DOXAZOSIN MESYLATE, sub: CARDURA, 2MG TAB, Mfg ETH, NDC 58177-0267-04. Recall # D-1703-2009;

47) BETA-CAROTENE, 25000IU CAP, Mfg. NVC, NDC 79854-0100-11. Recall # D-1704-2009;  

48) SELENIUM, 50MCG TAB, Mfg GDL, NDC 00182-1138-01. Recall # D-1705-2009;

49) Dexfol, generic: Diatx, TAB, Mfg. RIS, NDC 64980-0128-09.  Recall # D-1706-2009;

50) LODOSYN, CARBIDOPA, 25MG TAB, Mfg. BRI, NDC 00056-0511-68. Recall # D-1707-2009;

51) DILATRATE SR, ISOSORBIDE DN SR, 40MG CAP, Mfg SWZ, NDC 00091-0920-01. Recall # D-1708-2009;  

52) AMITRIPTYLINE HCl, 25MG TAB, Mfg MYL, NDC 00378-2625-01. Recall # D-1709-2009;

53) LOTREL, AMLODIPINE/BENAZEPRIL, 5/10MG CAP, Mfg NVT, NDC 000-0405-05. Recall # D-1710-2009;

54) ONDANSETRON ODT, sub: ZOFRAN ODT, 8MG TAB, Mfg. GPI, NDC 68462-0158-13. Recall # D-1711-2009;

55) HYOSCYAMINE SUBLINGUAL, 0.125MG TAB, Mfg ETH, NDC 58177-0255-04. Recall # D-1712-2009;

56) DOXAZOSIN, DOXAZOSIN MESYLATE, 4MG TAB. Mfg A-C, NDC 60505-0095-00. Recall # D-1713-2009;

57) LOTENSIN, BENAZEPRIL HCL, 20MG TAB, Mfg. NVT, Recall # D-1714-2009;

58) NOREL DM, DM/CHLORPHEN/PHEN, 15/4/10MG/5ML, 5ML, Mfg. USP, NDC 52747-0410-00. Recall # D-1715-2009;

59) VENLAFAXINE HCL, 50MG TABLET, Mfg TEV, NDC 00093-7381-01. Recall # D-1716-2009;

60) DILT-XR, DILTIAZEM HCl ER, 240MG CAP, Mfg. A-C, NDC 60505-0016-06. Recall # D-1717-2009;

61) CASCARA SAGRADA, 50MG/15ML SYRUP, Qty 5ML, MFG: CYP, NDC 60258-0959-16. Recall # D-1718-2009;  

62) METOPROLOL SUC ER, EXTENDED RELEASE, 50MG TAB, Mfg AZC, NDC 00186-7301-05. Recall # D-1719-2009;

63) HYDROXYZINE PAM, sub: VISTARIL, 25MG CAP, Mfg WAT, NDC 00591-0800-01. Recall # D-1720-2009;

64) ANAPROX DS, NAPROXEN SOD, 550MG TAB, Mfg. ROC, NDC 00004-6203-01. Recall # Recall # D-1721-2009;

65) TORSEMIDE, sub: DEMADEX, 5MG TAB, Mfg A-C, NDC 60505-0232-01. Recall # D-1722-2009;

66) DESIPRAMINE HCl, 100MG TAB, Mfg A/P. Recall # D-1723-2009;

67) HALOPERIDOL LACTATE, INJECTION, 5MG/ML VIAL, Mfg. GES. Recall # D-1724-2009;

68) PAROXETINE HCl, 10MG TAB, Mfg A-C, NDC 60505-0097-01. Recall # 1725-2009;

69)METHIMAZOLE, 5MG TAB, Mfg SDZ, NDC 00185-0205-01. Recall # D-1726-2009;

70) AMILORIDE/HCTZ, 5MG/50MG TAB, Mfg MYL, NDC 00378-0577-01. Recall # D-1727-2009;

71) LORATADINE, sub: CLARITIN, 5MG/5ML SYRUP, 5ML, Mfg. TAR, NDC 51672-2073-08. Recall # D-1728-2009;

72) VITAMIN E, 1000 IU CAP, Mfg. NVC, NDC 79854-0900-40. Recall # D-1729-2009;

73) CALCIUM CARBONATE, TAB, 600MG, Mfg. MAJ, NDC 00904-3232-52. Recall # D-1730-2009;

74) ANACIN, ASPIRIN/CAFFEINE, 400/32MG TAB, Mfg H-C, NDC 00573-0200-25. Recall # D-1731-2009;

75) LACT-AID FAST ACT, LACTASE, 9000 UNIT TAB, Mfg. MCN. Recall # D-1732-2009;

76) MAALOX MINT SUSP, MAG & ALHYDROX/SIMETH, 200/200/20MG/5ML, Qty 30ML, MFG: NVT, NDC 00067-0330-62. Recall # D-1733-2009;

77) PSEUDOEPHEDRINE HCl, 30MG/5ML SYRUP, Qty 5ML, MFG: PMA, NDC 00121-0421-04. Recall # D-1734-2009; 

78) ULTRASE MT18, PANCRELIPASE EC, CAP, Mfg. S/I. Recall # D-1735-2009;

79) CHOLINE MAG TRISALIC, 750MG TAB, Mfg. C-P. Recall # D-1736-2009;

80) NICOTINE POLACRILEX, 2MG GUM, Mfg. RUG. Recall # D-1737-2009;

81) MONOPRIL, FOSINOPRIL, 20MG TAB, Mfg BRI, NDC 00087-0609-42, Recall # D-1738-2009;

82) ERYTHROMYCIN, ERYTHROMYCIN BASE, 250MG TAB, Mfg ABB, NDC 00074-6326-13. Recall # D-1739-2009;

83) OMEPRAZOLE DR, 20MG CAP, Mfg RED, NDC 55111-0158-01. Recall # D-1740-2009;

84) FARESTON, TOREMIFENE CITRATE, 60MG TAB, Mfg GTX, NDC 11399-0005-30. Recall # D-1741-2009;

85) ATENOLOL, SUB: TENORMIN, 100MG TAB, Mfg SNZ, NDC 00781-1507-01. Recall # D-1742-2009;

86) FUROSEMIDE, sub: LASIX, 80MG TAB, Mfg MYL, NDC 00378-0232-01. Recall # D-1743-2009;

87) DILTIAZEM HCl, sub: CARDIZEM, 30MG TAB, Mfg MYL, NDC 00378-0023-01. Recall # D-1744-2009;

88) RIBAVIRIN, 200MG CAP, Mfg. MAL, NDC 004406-2260-84. Recall # D-1745-2009;

89) METOPROLOL/HCTZ, sub: Lopressor HCTZ, 50/25MG TAB, Mfg MYL, NDC 00378-0424-01. Recall # D-1746-2009;

90) BENAZEPRIL/HCTZ, 20/25MG TAB, Mfg SNZ, NDC 00185-0277-01. Recall # D-1747-2009;

91) ANAGRELIDE HCl, 1MG CAP, Mfg. MYL. Recall # D-1748-2009;

92) SOLU-CORTEF, HYDROCORTISONE Na SUC, 1000MG/8ML, INJECTION, Mfg. PFZ. Recall # D-1749-2009;

93) PERPHEN/AMITRIP, 4 MG-50 MG TABS, Mfg MYL, NDC 00378-0073-01. Recall # D-1750-2009;

94) GLYBURIDE/METFORM, sub: GLUCOVANCE, 1.25/250MG TAB, Mfg ACT, NDC 00228-2751-11. Recall # D-1751-2009;

95) FERROUS SULFATE ELIXIR, 220(44) MG/5ML, Qty 5ML, MFG: RUG, NDC 00536-0650-85. Recall # D-1752-2009;

96) ACYCLOVIR, 800MG TAB, Mfg TEV, NDC 00093-8947-01. Recall # D-1753-2009;

97) THYROID, 65MG (1GR) TAB, Mfg. MAJ, NDC 00904-0761-60. Recall # Recall # D-1754-2009;

98) ATENOLOL, 50MG TAB, Mfg SNZ, NDC 00781-1506-01, Recall # D-1755-2009;

99) ARAVA, LEFLUNOMIDE, 20MG TAB, Mfg AVE, NDC 00088-2161-30, Recall # D-1756-2009;

100) QUINAPRIL HCl, 40MG TAB, Mfg API, NDC 62037-0534-90, NDC 62037-0534-90. Recall # D-1757-2009;

101) DILTIAZEM, 60MG TAB, Mfg MYL, NDC 00378-0045-01. Recall # D-1758-2009;

102) LIDOCAINE/EPI-PHRINE, 2/0.001% VIAL 20ML, Mfg. MOS. Recall # D-1759-2009;

103) METRONIDAZOLE, 500MG TAB, Mfg PLV, NDC 50111-0334-01. Recall # D-1760-2009;

104) Metoprolol Tart, 100MG TAB, Mfg C-P, NDC 57664-0167-08. Recall # Recall # D-1761-2009;

105) THEO-24, THEOPHYLLINE E-R, 100MG CAP, Mfg UCB, NDC 50474-0100-01. Recall # D-1762-2009  
CODE
1) Mfg. Lot 052607018, Exp. 04/01/09;
2) Mfg. Lot 010147003, Exp. 04/01/09;
3) Mfg. Lot 1151981, Exp. 08/01/10;
4) Mfg. Lot 27020375C, Exp. 02/01/09;
5) Mfg. Lot 0613753, Exp. 09/01/09;
6) Mfg. Lot 7B834, Exp. 02/01/09;
7) Mfg. Lot MK061978, Exp 01/22/09;
8) Mfg. Lot BEA22A, Exp 01/31/09;
9) Mfg. Lot F0031, Exp 01/23/09;
10) Mfg. Lot 7028738, Exp 01/24/09;
11) Mfg. Lot 1S1406, Exp 01/28/09;
12) Mfg. Lot WBRLND53, Exp. 12/01/10;
13) Mfg. Lot T155H07A, Exp 01/28/09;
14) Mfg. Lot R259734, Exp 01/28/09;
15) Mfg. Lot TGL006A, Exp 01/28/09;
16) Mfg. Lot 00201708, Exp. 05/01/10;
17) Mfg. Lot 7F14, Exp 01/29/09;
18) Mfg. Lot 48PWW, Exp. 07/01/09;
19) Mfg. Lot C29681, Exp 01/30/09;
20) Mfg. Lot 7611801, Exp 02/03/09;
21) Mfg. Lot 3S2218, Exp 02/03/09;
22) Mfg. Lot 248907F, Exp 02/04/09;
23) Mfg. Lot T072J07A, Exp 02/04/09;
24) Mfg. Lot 050307038, Exp.11/01/10;
25) Mfg. Lot YE2007, Exp 02/05/09;
26) Mfg. Lot ML071620, Exp 02/05/09;
27) Mfg. Lot HK5381, Exp 02/05/09;
28) Mfg. Lot 7K35, Exp.02/06/09;
29) Mfg. Lot A807, EXP. 02/06/09;
30) Mfg. Lot MN07091, Exp.12/01/09;
31) Mfg. Lot 10040391, Exp. 05/01/10;
32) Mfg. Lot 7JE0873, Exp. 02/01/09;
33) Mfg. Lot 7ET0186, Exp. 05/01/10;
34) Mfg. Lot 64623A, Exp 02/04/09;
35) Mfg. Lot 7JC64, Exp 01/23/09
36) Mfg. Lot 35301374A, Exp01/27/09;
37) Mfg. Lot 706683, Exp. 02/04/09;
38) Mfg. Lot HD11107, Exp 02/05/09;
39) Mfg. Lot HD18207, Exp 02/04/09;
40) Mfg. Lot 433807, Exp 02/05/09;
41) Mfg. Lot P44949, Exp 02/10/09;
42) Mfg. Lot 6504601, Exp. 02/06/09
43) Mfg. Lot 127687F, Exp. 04/01/09;
44) Mfg. Lot 60270A8, Exp10/11/09;
45) Mfg. Lot 321571, Exp 02/06/09;
46) Mfg. Lot 84314, Exp 02/06/09;
47) Mfg. Lot 7J056, Exp 02/07/09;
48) Mfg. Lot 8714994104, Exp 02/06/09;
49) Mfg. Lot 84704, Exp 02/10/09;
50) Mfg. Lot U7005, Exp 02/07/09;
51) Mfg. Lot ML061334, Exp 01/01/09;
52) Mfg. Lot 1P3093, Exp 02/10/09;
53) Mfg. Lot F0339, Exp 02/12/09;
54) Mfg. Lot 010157006, Exp. 11/01/09
55) Mfg. Lot 90187, Exp 03/26/09;
56) Mfg. Lot HP0142, Exp 03/26/09;
57) Mfg. Lot F0104, Exp 03/27/09;
58) Mfg. Lot 60212, Exp.02/01/09;
59) Mfg. Lot 03V007, Exp 03/31/09;
60) Mfg. Lot HR0360, Exp 03/31/09;
61) Mfg. Lot 29225W, EXP. 03/31/09;
62) Mfg. Lot MK0066, Exp03/31/09,
63) Mfg. Lot 3064138, Exp 03/31/09;
64) Mfg. Lot E8603B, Exp 03/31/09
65) Mfg. Lot HM1572, Exp 03/31/09
66) Mfg. Lot ML070168, Exp 04/01/09;
67) Mfg. Lot 07E102, Exp. 05/01/10
68) Mfg. Lot HM6415, Exp 04/01/09;
69) Lot MK072627, Exp 04/01/09;
70) Mfg. Lot 3001926, Exp 04/01/09;
71) Mfg. Lot L7018, Exp.04/02/09;
72) Mfg. Lot 7GB21, Exp 03/28/09;
73) Mfg. Lot 41016403, Exp.03/28/09;
74) Mfg. Lot 07H138, Exp 04/04/09;
75) Mfg. Lot MNO7117, Exp. 03/01/10;
76) Mfg. Lot 10044532, EXP.04/08/09;
77) Mfg. Lot 7F46, EXP. 04/03/09;
78) Mfg. Lot L070464A, Exp 04/04/09;
79) Mfg. Lot 80143A, Exp 04/04/09;
80) Mfg. Lot 2NH07089, Exp. 08/01/09;
81) Mfg. Lot 7F29793, Exp 04/04/09;
82) Mfg. Lot 51671AF21, Exp 04/04/09;
83) Mfg. Lot C72617, Exp 04/04/09;
84) Mfg. Lot G11408231, Exp 04/01/09;
85) Mfg. Lot 169781, Exp 04/04/09;
86) Mfg. Lot 3S2304, Exp 04/07/09;
87) Mfg. Lot 3002704, Exp 04/07/09;
88) Mfg. Lot MG4897, Exp 04/07/09;
89) Mfg. Lot 3002488, Exp 04/07/09;
90) Mfg. Lot MK073048, Exp 04/07/09;
91) Mfg. Lot 1S0772, Exp 04/08/09;
92) Mfg. Lot 0AFK0, Exp. 07/01/12;
93) Mfg. Lot 3000592, Exp 04/08/09;
94) Mfg. Lot 635K72, Exp 04/08/09;
95) Mfg. Lot 730778, EXP. 04/08/09;
96) Mfg. Lot 35302125A, Exp 04/08/09;
97) Mfg. Lot M081T, Exp 04/08/09;
98) Mfg. Lot 168019, Exp 04/09/09;
99) Mfg. Lot 7DA7C, Exp 04/09/09;
100) Mfg. Lot 83238A, Exp 03/01/09;
101) Mfg. Lot 3003127, Exp 04/09/09;
102) Mfg. Lot 60291EV, Exp. 03/01/09;
103) Mfg. Lot 305706, Exp 04/10/09;
104) Mfg. Lot 80506A, Exp 04/10/09;
105) Mfg. Lot C060724, Exp 04/10/09
RECALLING FIRM/MANUFACTURER
Advantage Dose LLC, Shreveport, LA, by telephone, electronic mail, and letter beginning November 26, 2008. Firm initiated recall is ongoing.
REASON
Not in conformance with cGMPs.
VOLUME OF PRODUCT IN COMMERCE
2,635,663 unit doses
DISTRIBUTION
AR, GA, IL, LA, MS, MO, OK, TX

___________________________________
PRODUCT 
Fluocinonide Cream, USP 0.05%, a) 15 gram (NDC 51672-1253-1) and b)120 gram (NDC 51672-1253-4), Rx only, packaged in aluminum tubes. Recall # D-1802-2009
CODE
a) Lot # 6E134(Exp. Date: May 2009), Lot # G6091(Exp. Date: Jul 2009), Lot # I6030 (Exp. Date: Sep 2009), Lot # K6042 (Exp. Date: Nov 2009), Lot # L6034 (Exp. Date: Dec 2009), Lot # D7085 (Exp. Date: Apr 2010), Lot # G7044 (Exp. Date: Jul 2010), Lot # I7107 (Exp. Date: Sep 2010), Lot # L7057 (Exp. Date: Dec 2010), Lot # B8039 (Exp. Date: Feb 2011), Lot # B8041(Exp. Date: Feb 2011), Lot # D8115 (Exp. Date: Apr 2011), Lot # F8028 (Exp. Date: Jun 2011), Lot # F8029 (Exp. Date: Jun 2011), Lot # H8028 (Exp. Date: Aug 2011), Lot # I8049 (Exp. Date: Sep 2011), Lot # K8114 (Exp. Date: Nov 2011), and Lot # L8070 (Exp. Date: Dec 2011);
b) Lot # 6E134 (Exp. Date: May 2009), Lot # J6079 (Exp. Date: Oct 2009), Lot # H7088 (Exp. Date: Aug 2010), Lot # B8041 (Exp. Date: Feb 2011), Lot # H8028 (Exp. Date: Aug 2011), and Lot # J8025 (Exp. Date; Oct 2011)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY, by letter on May 26, 2009.
Manufacturer: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada. Firm initiated recall is ongoing.
REASON
Exceeded Content Uniformity Specifications; 18 month stability.
VOLUME OF PRODUCT IN COMMERCE
a) 928,617 units; b) 36,278 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Nicomide Tablets (nicotinamide, zinc, copper, folic acid) Each tablet contains Nicotinamide USP 750 mg, Zinc Oxide USP 25 mg, Cupric Oxide 1.5 mg and Folic Acid USP 500 mcg, 60 count bottles, Rx, NDC 65880-792-60. Recall # D-1803-2009
CODE
Lot Numbers: 70973A1 (Exp 1112009) 70974A1 (Exp 1112009) 71055A1 (Exp 1212009)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dusa Pharmaceuticals, Inc., Wilmington, MA, by fax and letter on April 8, 2009.
Manufacturer: Actavis Totowa LLC, Little Falls, NJ. Firm initiated recall is ongoing.
REASON
Failed Dissolution Specifications (zinc)
VOLUME OF PRODUCT IN COMMERCE
63,366 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
1) Leukine (sargramostim), 500 mcg/mL, multiple use vial, Rx only, NDC# 50419-050-99. Recall # D-1763-2009

2) Leukine sargramostim 5 x 500mcg/mL***liquid injection, contains preservative Sterile Rx only - 5 multiple use vials. NDC 50419-050-30. Recall # D-1764-2009; 

3) Leukine sargramostim 5 x 500mcg/mL***liquid injection, contains preservative Sterile Rx only - 5 multiple use vials. NDC 50419-050-30. Recall # D-1765-2009
CODE
1) Lot #B13957, Expiration Date: November 2009;
2) Lot #B13958, Expiration Date: November 2009;
3) Lot #B12964, Expiration Date: October 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bayer HealthCare Pharmaceuticals Inc., Wayne, NJ, by letter on March 23, 2009.  
Manufacturer: Hospira Inc., Mc Pherson, KS. Firm initiated recall is ongoing.  
REASON
Product does not meet stability specification.
VOLUME OF PRODUCT IN COMMERCE
48,960 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Elitek (rasburicase) for Intravenous Infusion, 7.5 mg/vial, packaged with diluent ampule, Rx only, NDC 0024-5151-75. Recall # D-1801-2009  
CODE
Lot 0016A, Exp 05/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sanofi-Aventis U.S. LLC, Bridgewater, NJ, by letters dated March 16, 2009.
Manufacturer: Sanofi-Aventis U.S. LLC, Saint Louis, MO. Firm initiated recall is ongoing.
REASON
The outer carton contained an incorrect expiration date. The inner components were correctly labeled.
VOLUME OF PRODUCT IN COMMERCE
887 cartons
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
1) Plasma Frozen within 24 hours (FP24). Recall # B-1124-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1125-09
CODE
1) and 2) Unit; 19LJ47548
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by facsimile, letter and telephone on March 18, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
KY, TN
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1263-09
CODE
Unit: 1703286
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter dated April 7, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was taking the drug Proscar, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
HI
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1272-09
CODE
Units: 9006353, 9006896
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA, by letter on March 12, 2008. Firm initiated recall is complete.
REASON
Blood products, which did not meet the acceptable product specifications for release, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1273-09
CODE
Unit: 003LF38493
RECALLING FIRM/MANUFACTURER
American National Red Cross, Douglasville, GA, by telephone and electronic mail on March 6, 2007 and a follow-up letter dated March 10, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1275-09
CODE
Unit: 012GL89482
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone on June 26, 2007.
Manufacturer: American Red Cross Blood Services, Ashville, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1281-09;
2) Platelets Leukocytes Reduced. Recall # B-1282-09;
3) Recovered Plasma. Recall # B-1283-09
CODE
1) Units: 1974540, W044108025910;
2) Unit: W044108025910;
3) Units: W044108025910, 1974540
RECALLING FIRM/MANUFACTURER
Siouxland Community Blood Bank, Sioux City, IA, by letter and email on February 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
Austria, IA
___________________________________
PRODUCT 
Platelets Pheresis. Recall # B-1287-09
CODE
Unit: W047009343090
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island City, NY, by telephone on April 20, 2009 and by follow-up letter dated May 13, 2009. Firm initiated recall is complete.
REASON
Blood product, labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NY
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1302-09
CODE
Unit: 72K093842
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on March 6, 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 
Platelets Pheresis Leukocytes Reduced. Recall # B-1303-09
CODE
Unit: 72J815532
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on March 6, 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 
Platelets Pheresis Leukocytes Reduced. Recall # B-1304-09
CODE
Unit: 72K156360
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on March 9, 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 
Platelets Pheresis Leukocytes Reduced. Recall # B-1305-09
CODE
Unit: 72J818731
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on March 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 
Platelets Pheresis Leukocytes Reduced. Recall # B-1307-09
CODE
Unit: 72K137081
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on March 24, 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 
Platelets Pheresis Leukocytes Reduced. Recall # B-1308-09
CODE
Unit: 72K061764
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by fax on March 26, 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 
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1318-09
CODE
Unit: W071208036524
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated February 25, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
1) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1319-09;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1320-09
CODE
1) Unit: 5035392;
2) Units: 5035685 (split product); 5035634 (split product); 5035304 (split product); W066509506484 (split product); 5035961; 5035874 (split product)
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by fax on February 19, 2009 and March 10, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
AK
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1322-09
CODE
Unit: W036509023544 (split product)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by telephone on March 11, 2009. Firm initiated recall is complete.
REASON
Blood products, labeled leukoreduced with the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
LA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Haemonetics MCS+8150 Two unit filtered red cell disposable set, Product List Number: 832F, Classification Name: Automated Blood Cell Separator (GKT). Recall # B-1190-09
CODE
Lot Number: LO8160
RECALLING FIRM/MANUFACTURER
Haemonetics Corporation, Braintree, MA, by letter dated March 11, 2009. Firm initiated recall is ongoing.
REASON
Blood bags sets, missing Codabar product code label on second red cell bag, were distributed.
VOLUME OF PRODUCT IN COMMERCE
624 sets
DISTRIBUTION
MS, TX, WI
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1274-09
CODE
Unit: 003LF38493
RECALLING FIRM/MANUFACTURER
American National Red Cross, Douglasville, GA, by telephone and electronic mail on March 6, 2007 and a follow-up letter dated March 10, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1276-09
CODE
Unit: 012GL89482
RECALLING FIRM/MANUFACTURER
American Red Cross, Carolinas Blood Services Region, Charlotte, NC, by telephone on June 26, 2007.
Manufacturer: American Red Cross, Asheville, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1321-09
CODE
Unit: W036908263628
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by letter dated March 24, 2009. Firm initiated recall is complete.
REASON
Blood product, labeled as an AS-5 product but with insufficient red cell preservative solution added, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
DE

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
Amico E-Cylinder Canister Holder is used to hang E-Cylinders (pressurized gas canisters) from a boom. Product typically used in the surgical setting. Catalog/Product Number: 0682-001-111 and 0682-000-449. Recall # Z-1569-2009
CODE
All E-Cylinder canister holders shipped between 01 JAN 05 and 27 SEP 06
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Communications Corp., Flower Mound, TX, by letter dated May 19, 2009. 
Manufacturer: Amico Corp., Richmond Hill, Canada. Firm initiated recall is ongoing.
REASON
Design flaw on the E-Cylinder canister holder may result in early fatigue and failure of the bracket screws, which could cause the cage to become detached from its mount and fall.
VOLUME OF PRODUCT IN COMMERCE
66 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) Tri-State Centurion Venous Access Port Kits, Qty/case 20, sterile, Code No./Reorder KNV80. Each kit contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill 100U/mL Heparin Lock Flush Syringe, 10mL, REF # 8881590121. Recall # Z-1571-2009;

2) Tri-State Centurion CVC Bundles, Qty/case 10, sterile, Code no./Reorder DT10710. Each bundle contains 3 sterile heparin flush injection solutions as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125. Recall # Z-1572-2009;

3) Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder DT9405B. Each tray contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125. Recall # Z-1573-2009;

4) Tri-State Centurion Port Blood Draw Trays, Qty/case 20, sterile, Code no./reorder DT9410B. Each tray contains 1 sterile heparin flush prefilled syringe as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125. Recall # Z-1574-2009;

5) Tri-State Centurion Port Access Trays, Qty/case 20, sterile, Code no./reorder KNV50. Each tray contains 1 sterile heparin flush injection solution as follows: Tyco Healthcare Monoject Prefill100U/mL Heparin Lock Flush Syringe, 5mL, REF # 8881590125. Recall # Z-1575-2009
CODE
1) Kit lots 802188 and 802198. Heparin flush lot 7113064;

2) Bundles lots 801288 and 811127. Heparin flush lots 7041194 and 7113154;

3) Tray lots 801218 and 803178. Heparin flush lots 7082284 and 7113154;

4) Tray lots 801148, 810297 and 812187. Heparin flush lot 7041194;

5) Tray lots 801148, 801158 and 811127. Heparin flush lots 7072064 and 7082284
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-State Hospital Supply Corp., Howell, MI, by letter dated April 8, 2008. 
Manufacturer: Mallinckrodt Canada, Inc., Pointe-Claire, Canada. Firm initiated recall is complete.
REASON
The kits contain Monoject pre-fill heparin lock flush syringes, which were recalled by the manufacturer due to contamination.
VOLUME OF PRODUCT IN COMMERCE
910 kits
DISTRIBUTION
IN, MS, OH, TN
___________________________________
PRODUCT 
XoranConnect, software version 4.1.0.6. A web-based software which provides online multi-planar image viewing, offsite data storage, administrative reporting tools, and teleradiology workflow. Server designed to store and serve stored imaging content on a RAID5 storage device. Recall # Z-1577-2009
CODE
Software version 4.1.0.6
RECALLING FIRM/MANUFACTURER
Xoran Technologies, Inc., Ann Arbor, MI, by letter dated February 9, 2009. Firm initiated recall is complete.
REASON
An incorrect patient name label may appear on the screen displaying the selected patient’s scan.
VOLUME OF PRODUCT IN COMMERCE
14
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) TumorLoc software application, Software Versions: 23.1.1, 20.7.13, and 20.8.15 for use on the GEMINI TF 16 and GEMINI TF 64 Slice PET/CT Systems, Catalog Numbers: 882470 - GEMINI TF 16 Slice; 882471 - GEMINI TF 64 Slice; and 882473 - GEMINI TF 16 Slice Base Configuration. Model Numbers: 4535 679 83931 - GEMINI TF 16 Slice; 4535 679 94741 - GEMINI TF-64 Slice and 4535 674 41711 - GEMINI TF 16 Slice Base Configuration. Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy. Recall # Z-1578-2009;

2) TumorLoc Software Application, Software versions: 23.1.1, 20.7.13, and 20.8.15. This is an option available for purchase for use on the GEMINI GXL 16 Slice PET/CT System (contains EBW 455011002031 as an accessory), Catalog #882410, Model Number: 4535 679 71891. CT host. 2.2. Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy. Recall # Z-1579-2009;

3) TumorLoc Software Application for the EBW (Extended Brilliance Workstation, Model # 455011002031, sold as an accessory for the GEMINI PET/CT Systems running CT software versions 3.5.x. , CT host 2.2. Tumor Localization is an application used in radiation oncology departments for localizing target volumes for radiation therapy planning. It includes exclusive features for viewing Respiratory Correlated CT data sets and analyzing motion of target and surrounding anatomy. Recall # Z-1580-2009
CODE
1) GEMINI TF 16 Slice, Serial Numbers: 7035, 7052, 7093, 7096, 7123, 7128, and 7133; GEMINI TF 16 Slice base configuration, Serial Number: 7150; and GEMINI TF 64 Slice, Serial Numbers: 7007, 7088, 7103, 7126, and 7132;

2) Serial Numbers: 4149, 4150, and 4173;

3) Serial Numbers: 7909, 8940, 8804, 9019, 10331, 10348, 10701, 11555, 55110, 55172 and 55180
RECALLING FIRM/MANUFACTURER
Philips Medical Systems (Cleveland) Inc., Cleveland, OH, by letter dated February 12, 2009. Firm initiated recall is ongoing.
REASON
A software anomaly in the TumorLoc software for the firm's Brilliance CT scanners was discovered. The same software anomaly was subsequently determined to be present in the firm's GEMINI PET/CT units. The software defect results in a potential for data to be lost during reconstruction of images in which slices can either be discarded, or interleaved based upon their series ID.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
Nationwide and Columbia, Germany, France, Netherlands, Canada, Belgium and Slovenia
___________________________________
PRODUCT 
ASC2000 Ambulatory Surgical Table. Model #MTS110003. The device is used to provide complete and flexible positioning for surgical procedures. Recall # Z-1597-2009
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp., Mentor, OH, by letter dated April 17, 2009. 
Manufacturer: Mediland Enterprise, Corp., Tauyen Hsien, Taiwan. Firm initiated recall is ongoing. 
REASON
Repetitive rubbing of the hydraulic hoses against the interior of the stainless steel shroud may result in the rupture of the hydraulic hoses causing loss of control of the table surface.
VOLUME OF PRODUCT IN COMMERCE
412 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Duracon Total Knee, A-P Lipped Tibial Insert; 11MM Sterile; Product No. 6642-1-611. The device is used to replace bearing surface if the proximal tibia in order to relieve pain, instability and/or restriction of motion due to degenerative joint disease, failed previous prosthesis or trauma. The tibial inserts are designed to accommodate the posterior cruciate ligament if it is present. These components are intended for implantation with bone cement only. Recall # Z-1601-2009
CODE
Lot Code: 17800601
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics Corp., Mahwah, NJ, by letter on May 5, 2006. Firm initiated recall is complete.
REASON
A box packaged and labeled as a Duracon Total Knee Duration A-P Lipped Tibial Insert 11MM may actually contain a 9MM insert.
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
AL, OH, MN, NM, and CA
___________________________________
PRODUCT 
1) DERMALIFE Spa Jet 2G System. Part #E30006-01 - Spa Jet 2G; Assay w/Pedestal. This is the Spa Jet product including the 2 optional pedestals which the unit can sit on top of. Part #E30006 - Spa Jet 2G; 220V, 50/60Hz. 15A. This is the Spa Jet product without the 2 optional pedestals which the unit can sit on top of. Recall # Z-1602-2009;

2) Dermalife Spa Feng Shui 2G. Part #E30007-100 is: Spa-Feng Shui 2G; 100V 50/60Hz. This is the Spa Feng Shui product without the 2 optional pedestals which the unit can sit on top of, in a 100V version which was produced specifically for our Japanese consignee to meet Japan's specialized 100V electrical requirements. Part #E30007-200 is: Spa-Feng Shui 2G; 200V 50/60Hz. This is the Spa Feng Shui product without the 2 optional pedestals which the unit can sit on top of, in a 200V version which was produced specifically for our Japanese consignee to meet Japan's specialized 200V electrical requirements. Part #E30007-01 - Feng Shui 2G; Assay w/Pedestal. This is the Spa Feng Shui product including the 2 optional pedestals which the unit can sit on top of. Recall # Z-1603-2009;

3) Dermalife Spa-Oceana 2G System. Part #E30008-01 - Spa-Oceana 2G; Assay. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. Part #E30008 - Spa-Oceana 2G; 220V, 50/60HZ-15A. This is the Spa Oceana product along with a kit of products such as cleaner, aroma therapy concentrate, etc. that is slightly different than the kit of products included in Part #E30008-01 above. Recall # Z-1604-2009;

4) DERMALIFE Takara. Part #E30006-02 - Takara; Renew 2G, w/Pedestal. This is the Spa Jet product re-named for Takara Belmont, identical to Part #E30006-01 other than the stickers on the unit. Recall # Z-1605-2009
CODE
1) PART E30006 SERIAL NUMBERS: G1070442568, G1070452567, G1060942061, G1061252308, G106064921, G106065928, G10606891, G1061142252, G1061152287, G1061152288, G1061242302, G1070352519, G1061142238, G1061142247, G1061142270, G1061152265, G1061252301, G1061252306, G1070342543, G1060942112, G1061142292, G1061152267, G1070142402, G1070242450, G1070252451, G1070342515, G1070342524, G1070342527, G1070352537, G1070342554, G1070352562, G1070442582, G1070452591, G106075989, G1061042162, G1061042189, G1061052180, G1061052183, G1061052185, G1061052193, G1070542653, G106125312, G1060852039, G1061142239, G1061152237, G1061152251, G1070342508, G1070342511, G1070352514, G1070352555, G1070452580, G1070452586, G1040452600, G106034717, G106054836, G106055876, G106055877, G106055881, G106065924, G106074984, G106074990, G106075988, G106075992, G1060842008, G1060842010, G1060842015, G1060842041, G1060852012, G1060852051, G1060942072, G1060942111, G1060942116, G1060952064, G1060952065, G1060952087, G1060952117, G1060952122, G1061042134, G1061042179, G1061042184, G1061042187, G1061042191, G1061042208, G1061052132, G1061052133, G1061052138, G1061052142, G1061052143, G1061052147, G1061052154, G1061052163, G1061052188, G1061052194, G1061052207, G1061052215, G1061142218, G1061142246, G1061142262, G1061142264, G1061142276, G1061152222, G1061152233, G1061152241, G1061152242, G1061152253, G1061152254, G1061152256, G1061152272, G1061152274, G1061152297, G1061152298, G1061242300, G1061242305, G1061242314, G1061242315, G1061252319, G1061252320, G1070142374, G1070142375, G1070142377, G1070142397, G1070142403, G1070142410, G1070142413, G1070142415, G1070142419, G1070142427, G1070152360, G1070152361, G1070152368, G1070152388, G1070152418, G1070152420, G1070152424, G1070152425, G1070152426, G1070152428, G1070242452, G1070242470, G1070242480, G1070252443, G1070252449, G1070252453, G1070252478, G1070252479, G1070252485, G1070342494, G1070342499, G1070342510, G1070342531, G1070342535, G1070342539, G1070342541, G1070342559, G1070342561, G1070352489, G1070352496, G1070352497, G1070352500, G1070352504, G1070352530, G1070352538, G1070352546, G1070352560, G1070442565, G1070442569, G1070442597, G1070452563, G1070452564, G1070452566, G1070452579, G1070452583, G1070452594, G1070542654, G1060952107, G1070142398, G1070152401, G1070552671, G1070552684, G106074991, G1061042181, G1061042198, G1061052209, G1061052210, G1061052216, G1061142217, G1061142226, G1061142231, G1061142243, G1061142245, G1061152221, G1061152229, G1061152230, G1061152234, G1070142423, G1070242475, G1070342503, G1070342525, G1070352507, G1070352520, G1070352522, G1070352523, G1070352526, G1070352534, G106044763, G106045769, G106054827, G106054844, G106054848, G106054878, G106055834, G106055840, G106055841, G106055881, G106054875, G106054896, G106055893, G106055894, G106054882, G106064923, G106064927, G106065933, G406055869 and G106054870; and PART E30006-01 SERIAL NUMBERS: G1060852047, G1061142255, G1061152260, G1061152261, G1061152271, G1061152275, G1060852059, G1060842045, G1060852034, G1061242321, G1061252313, G106852043 and G1060852009;

2) Part E30007, Serial Numbers: G20601042211, G206035726, G2070352502, G206034722, G206054897, G206064937, G206064948, G206065935, G206075975, G2070142370, G2070152369, G2070152379, G2070542647, G2060742004, G2061152227, G2061152295, G2070242438, G2070242445, G2070242456, G2070252439, G2070252459 and G2070242457; and Part E30007-01, Serial Numbers: G206074977, G2060952073, G2060942062 and G2060952069; and Part E30007-100, Serial Numbers: G2070142380 and G2070152372; and Part E30007-200, Serial Number: G2070242466;

3) Part E30008, Serial Numbers: G4061142236, G4060942128, G4061052135, G4061042136, G4070142436, G4070452585, G4070252464, G4061242317, G406124307, G406124311, G4061142281, G4070242474, G4070242486, G4070342498, G4070352528, G4061142257, G4061152258, G4061152273, G4070152376, G4070252458, G407044578, G4070342548, G4060842048, G4060852049, G4061152294, G4061252303, G4061252310, G4070242461, G4060952067, G40701424121, G4070152381, G4070152387, G4070342521, G4070352544, G4070552656, G4070552644, G406055898, G4060942068, G4061042145, G4061042214, G4061052149, G4061142244, G4061242326, G4061142299, G4070342506, G4070442577, G4060852053, G4060942074, G4061142259, G4061152228, G4061152240, G4061155248, G4070142363, G4070152400, G4070152408, G4070152437, G4070252463, G4070252473, G4070342517, G4070352495, G4070342529, G4060852019, G4061042186, G4061052212, G4061142224, G4061152220, G4070242448, G4070252442, G4070252484, G4070252487, G4070342491, G4070352505, G4070352509 and G4070352516; and Part E30008-01, Serial Numbers: G406052055, G4061252322, G4060852052, G4070142352, G4061052190, G4061042206, G4061242342, G4061042156, G4061052173, G4061052201, G4061252318, G4060852056 and G4060842058;

4) Serial Numbers: G1061142263, G1061142291, G1061242316, G1061252324, G1070142367, G1061142263, G1061142291, G1061242316, G1061252324 and G1070142367
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sybaritic, Inc., Bloomington, MN, by letter dated April 15, 2008.
Manufacturer: Sybaritic Spa Consulting OU, Marjamas, Estonia. Firm initiated recall is ongoing.
REASON
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in writing to FDA. Sybaritic, Inc. conducted a recall on DERMALIFE 2G equipment (SpaJet, Spa Oceana, Spa Feng Shui) because of IR Fan failure which resulted in the overheating and failure of the IR emitter and surrounding assembly.
VOLUME OF PRODUCT IN COMMERCE
363 units
DISTRIBUTION
CA, IA, MN, NE, NJ, NY, TX and WA and countries of Macedonia, Hungary, Greece, South Africa, Italy, Hong Kong, United Arab Emirates, Greece, Croatia, Australia, Kuwait, Turkey, Mexico, Belgium, England, Barbados, France, Japan, Lebanon, Moldova, Poland, Portugal, Romania, Russia, Spain and Thailand
___________________________________
PRODUCT 
1) Stryker Mantis Rod Inserter; Non Sterile. The MANTIS Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disk disease, spodylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion. The Mantis Rod Inserter Assemblies are distributed packaged with a Mantis Rod Inserter Shaft. Rod Inserter Shafts supplies with the Mantis Fod Inserter Assembly, Catalog Number: 48284050. Z-1611-2009;

2) Stryker Mantis Rod Inserter Inner Shaft; Non Sterile. The Mantis Spinal System is intended for posterior, non-cervical pedicle fixation for the following indications: degenerative disk disease, spodylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis and failed previous fusion. Mantis Rod inserter Shafts supplied separately, Catalog Number: 48284051. Recall # Z-1612-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by letter dated April 29, 2009.
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.
REASON
The Mantis Rod Inserter Shaft was found to have deformation of the stainless steel split sphere when subjected to high forces, prohibiting the user from being able to grip the rod implantation and the split sphere may separate and fall into the patient.
VOLUME OF PRODUCT IN COMMERCE
1) 175 units; 2) 387 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Biomet Biolox-Delta Modular Ceramic Head, 28 mm head diameter, plus 5 neck, type 1, taper, sterile; Catalog Number: 12-115112. A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. Recall # Z-1613-2009;

2) Biomet Modular TTPA Ceramic Head, 28 mm head diameter plus 5 mm neck, sterile; Catalog Number: RD115112. A hip joint metal/ceramic/polymer semiconstrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. Recall # Z-1614-2009
CODE
1) Lot Numbers: 114380, 175490, 229000, 310710, 342670, 385840, 403940, 467870, 484970, 572770, 641430, 705380, 761420 and 792280;

2) Lot Numbers: 013270, 042510, 057180,067670, 076650, 131750, 282060, 351770, 438750, 482870, 522930, 550250, 676690, 748960, 768980, 783590, 927280 and 953430
RECALLING FIRM/MANUFACTURER
Recalling Firm: Biomet, Inc., Warsaw, IN, by letter dated March 16, 2009.
Manufacturer: CeramTec Medical Products Division, Alumina Ceramic Comp. Mf, Plochingen, Germany. Firm initiated recall is ongoing.
REASON
The firm has received reports of fractured heads, requiring revision surgery.
VOLUME OF PRODUCT IN COMMERCE
335 devices
DISTRIBUTION
AZ, AL, AR, CA, CO, FL, IL, IN, KY, KS, MA, MI, LA, NY, SD, GA, MN, PA, NJ, MD, MI, OH, ME, TX, WA, WI and VA and countries of Australia, Belgium, Canada, Costa Rica, Finland, Netherlands and South Wales
___________________________________
PRODUCT 
Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile; Model Number: 9982-15-18. Cement-less total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques. Devices placed in femoral canal. A variety of stem and body components are provided to achieve fixation and restore joint kinematics. Recall # Z-1615-2009
CODE
Lot Number: 60698102
RECALLING FIRM/MANUFACTURER
Zimmer Inc., Warsaw, IN, by telephone on May 15, 2009 and letter dated May 21, 2009. Firm initiated recall is ongoing.
REASON
The threads on the screw are incomplete/non-functional.  
VOLUME OF PRODUCT IN COMMERCE
10 units
DISTRIBUTION
IA, NE, CA and countries of Canada, Switzerland, United Kingdom, Hungary, Netherlands and Slovakia

___________________________________
PRODUCT 
1) Triathlon Revision Instruments; 1,2,7,8 TGC Upper Tray; Non Sterile, For total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures. Catalog Numbers: 6543-8-014, 6543-8-015. Recall # Z-1618-2009;

2) Triathlon Revision Instruments, 3-6 TCG Upper Tray; Non Sterile; for total knee arthroplasty procedures involving Triathlon Total Stabilizer components. The trays sterilize and transport instruments needed for such procedures. Catalog Number: 6543-8-014. Recall # Z-1619-2009
CODE
None
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter dated May 15, 2009. Firm initiated recall is ongoing.
REASON
The screen print for the Valgus Adapter catalog numbers on the Triathlon Trial Cutting Guide Instrument Trays is incorrect.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) Guidant Contak Renewal 3 CRT-D Model H170; 3CRT-D, Model H175; 3HE CRT-D, Model H177; 3HE CRT-D, Model H179; 4CRT-D REF H190; 4CRT-D REF H195; 4HE CRT-D REF H197; 4HE CRT-D REF H199; 4AVT CRT D, REF M177; 4AVT HE CRT-D REF 179. Cardiac Resynchronization Therapy Defibrillator, Sterile EO. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. Recall # Z-1620-2009;

2) Guidant Vitality DS VR Model T135 VR; EL Model T127 DR; 2ICD Model T165 DR; 2ICD Model T175 VR; 2EL ICD Model T167 DR; 2 EL ICD Model T177 VR; DS Model T125 DR. Implantable Cardioverter Defibrillator, Sterile Lot. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. Recall # Z-1621-2009;
CODE
1) Model #H170: Serial Numbers: 361904, 363420, 363895, 364293, 364294, 364349, 364350, 364470, 364480, 364485, 364486, 364494, 364510, 364539, 364617 and 364621; and Model #H175: Serial Numbers: 312616, 312962, 312965, 312973, 313064, 315207, 315209, 315212, 315213, 315219, 315227, 315238, 315248, 315251, 315265, 315398, 315431, 315446, 316045, 316064 and 316123; and Model #H177: Serial Numbers: 281692, 282937, 284803, 284874, 284896, 285009, 285019, 285091, 285110, 285111, 285120, 285134 285332 and 285357; and Model #H179: Serial Numbers: 111439, 112977, 113822, 113910, 114275, 114375, 114394, 114488, 114503, 114506, 114515, 114523, 114652, 114680, 114682 and 114714; and Model #H190: Serial Numbers: 312166, 311764, 311803, 311894, 312164 and 312177; and Model #H195: Serial Numbers: 352084, 353252, 353389, 351230, 353157 and 353388; and Model #H197: Serial Numbers: 310113, 310253, 310651, 310335, 310337, 310339, 310342, 310357, 310361, 310442, 310464, 310465, 310518, 310660, 310691, 310696, 310814, 310933 and 311096; and Model #H199: Serial Numbers: 321405, 321060, 321415, 321423, 321478, 321489, 321494, 321498 and 321689; and Model #M177: Serial Numbers: 200050 and 200051; and Model #M179: Serial Numbers: 200098, 200099 and 200033;

2) Model #T125: Serial Numbers: 115369, 115371, 115379, 115380, 115381, 115402, 115404, 115406, 115407, 115411, 115412, 115415, 115416, 115417, 115418, 115419, 115420, 115421, 115422, 115423, 115426, 115428, 115430, 115431, 115435, 115438, 115439, 115441, 115502, 115503, 115507, 115514, 115517, 115518, 115520, 115527, 115529, 115531, 115533, 115534, 115536, 115538, 115539, 115540, 115541, 115552, 115553, 115554, 115555, 115556, 115557, 115559, 115562, 115565, 115566, 115568, 115569, 115571, 115573, 115574, 115577, 115579, 115581, 115585, 115586, 115587, 115588, 115589, 115590, 115592, 115593, 115594, 115596, 115598, 115599, 115600, 115601, 115603, 115606, 115608, 115633, 115634, 115635, 115638, 115671, 115675, 115690, 115691, 115695, 115697, 115698, 115780, 115842, 115843, 115847, 115851, 115854, 115856, 115857, 115858, 115861, 115862, 115863, 115868, 115872, 115873, 115874, 115875, 115877, 115880, 115881, 115887, 115890, 115891, 115965, 116111, 116587, 116594, 116684, 115403, 115607 and 115636; and Model #T127: Serial Numbers: 103080, 103081, 103082, 103083, 103084, 103086, 103090, 103091, 103092, 103095, 103096, 103097, 103098, 103100, 103101, 103104, 103105, 103106, 103108, 103110, 103111, 103113, 103115, 103116, 103117, 103119, 103120, 103121, 103123, 103125, 103128, 103129, 103133, 103134, 103135, 103138, 103139, 103141, 103142, 103143, 103144, 103145, 103150, 103151, 103152, 103155, 103156, 103157, 103159, 103160, 103165, 103168, 103171, 103172, 103176, 103177 and 103178; and Model #T135: Serial Numbers: 943611, 943613, 943614, 943615, 943631, 943632, 943633, 943634, 943635, 943636, 943638, 943639, 943641, 943642, 943643, 943644, 943645, 943648, 943651, 943652, 943653, 943663, 943665, 943675, 943677, 943679, 943682, 943685, 943715 and 944338; and Model #T165: Serial Numbers: 111413, 111415, 111416, 111417, 111418, 111419, 111422, 111425, 111432, 111436, 111438, 111440, 111442, 111445, 111447, 111450, 111452, 111466, 111469, 111471, 111472, 111479, 111481, 111482, 111483, 111485, 111499, 111501, 111503, 111504, 111507, 111514, 111515, 111516, 111538, 111540, 111544, 111545, 111546, 111547, 111548, 111549, 111553, 111556, 111557, 111626, 111629, 111630, 111631, 111632, 111633, 111634, 111637, 111638, 111640, 111641, 111643, 111644, 111645, 111646, 111652, 111659, 111666, 111668, 111670, 111672, 111677, 111678, 111679, 111681, 111683, 111690, 111693, 111694, 111695, 111698, 111700, 111701, 111702, 111703, 111704, 111706, 111707, 111708, 111709, 111710, 111711, 111713, 111716, 111717, 111718, 111719, 111722, 111723, 111724, 111726, 111727, 111730, 111731, 111734, 111736, 111737, 111738, 111739, 111747, 111749, 111750, 111752, 111753, 111754, 111756, 111757, 111778, 111802, 111804, 111807, 111810, 111819, 111821, 111838, 111839, 111842, 111843, 111844, 111846, 111847, 111850, 111851, 111852, 111853, 111861, 111863, 111864, 111865, 111867, 111872, 111873, 111874, 111875, 111876, 111878, 111879, 111880, 111881, 111883, 111884, 111887, 111889, 111891, 111893, 111895, 111896, 111897, 111898, 111899, 111900, 111901, 111902, 111903, 111906, 111914, 111918, 111919, 111920, 111921, 111923, 111924, 111926, 111927, 111929, 111931, 111932, 111934, 111935, 111936, 111938, 111940, 111941, 111942, 111943, 111944, 111945, 111947, 111948, 111950, 111951, 111952, 111953, 111955, 111956, 111957, 111964, 111965, 111966, 111969, 111971, 111974, 111977, 111978, 111981, 111984, 111988, 111993, 111996, 111999, 112000, 112001, 112002, 112003, 112004, 112005, 112006, 112007, 112008, 112009, 112012, 112013, 112014, 112016, 112018, 112021, 112022, 112023, 112025, 112028, 112030, 112032, 112033, 112038, 112040, 112049, 112050, 112051, 112053, 112054, 112056, 112057, 112058, 112059, 112061, 112065, 112067, 112068, 112069, 112070, 112071, 112072, 112076, 112077, 112078, 112081, 112083, 112084, 112085, 112089, 112090, 112092, 112093, 112099, 112104, 112107, 112111, 112114, 112115, 112117, 112127, 112131, 112132, 112133, 112135, 112137, 112138, 112139, 112140, 112143, 112144, 112145, 112149, 112150, 112152, 112159, 112161, 112162, 112219, 112237, 112240, 112242, 112244, 112247, 112322, 112341, 112350, 112352, 112353, 112354, 112355, 112357, 112359, 112360, 112364, 112634, 112658, 112751, 112777, 112782, 112785, 112786, 112810, 112875, 112879, 113101, 113150, 113301, 113796, 111421, 111448, 111470, 111477, 111484, 111489, 111500, 111541, 111554, 111555, 111651, 111662, 111669, 111696, 111699, 111714, 111715, 111801, 111805, 111806, 111845, 111870, 111871, 111882, 111885, 111888, 111890, 111894, 111997, 112017, 112036, 112039, 112041, 112048, 112055, 112080, 112086, 112087, 112088, 112096, 112097, 112098, 112102, 112105, 112113, 112129, 112141, 112151, 112160, 112238, 112351, 112473, 112474, 112476 and 112491; and Model #T167: Serial Numbers: 103886, 103888, 103890, 103903, 103907, 103912, 103913, 103915, 103917, 103920, 103925, 103926, 103928, 103930, 104268, 104303, 104356, 104357, 104360, 104419, 104423, 104488, 104490, 104502, 104583, 103905, 103906, 103914, 103916, 103927, 104096, 104269, 104420, 104496 and 104497; and Model #T175: Serial Numbers: 110174, 110177, 110178, 110180, 110181, 110198, 110247, 110318, 110321, 110322, 110323, 110324, 110325, 110326, 110327, 110330, 110331, 110345, 110347, 110351, 110354, 110356, 110357, 110358, 110361, 110362, 110364, 110365, 110368, 110372, 110374, 110375, 110378, 110381, 110387, 110429, 110432, 110433, 110435, 110437, 110441, 110443, 110445, 110446, 110447, 110459, 110461, 110462, 110471, 110473, 110474, 110475, 110479, 110482, 110483, 110487, 110488, 110492, 110497, 110498, 110540, 110543, 110544, 110548, 110554, 110562, 110565, 110566, 110567, 110571, 110572, 110573, 110574, 110576, 110577, 110579, 110580, 110581, 110582, 110583, 110589, 110590, 110591, 110592, 110597, 110602, 110603, 110605, 110606, 110607, 110608, 110609, 110612, 110617, 110618, 110619, 110620, 110621, 110623, 110625, 110626, 110628, 110698, 110699, 110740, 110741, 110744, 110747, 110756, 110793, 110857, 110858, 110859, 110860, 110862, 110865, 110867, 110871, 110877, 111296, 111993, 110245, 110246, 110248, 110296, 110320, 110344, 110348, 110359, 110369, 110373, 110379, 110384, 110430, 110434, 110439, 110444, 110451, 110455, 110456, 110460, 110463, 110478, 110489, 110490, 110493, 110494, 110496, 110511, 110542, 110559, 110594, 110694, 110700, 110702, 110739, 110743, 110745, 110750, 110751, 110753, 110754, 110755, 110758, 110787, 110790, 110795, 110796, 110797, 110854, 110868, 110870, 110881, 110933, 112361, 110290, 110388, 110442 and 110484; and Model #T177: Serial Numbers: 104009, 104012, 104013, 104016, 104019, 104021, 104033, 104039, 103990, 103992, 103993, 103998, 103999, 104000, 104004, 104005, 104007, 104008, 104011, 104015, 104018, 104022, 104027, 104028, 104031, 104034, 104040, 104051 and 104052
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific CRM, Corp., Saint Paul, MN, by letter dated March 4, 2009.
Manufacturer: Guidant Ireland, Clomel, Ireland. Firm initiated recall is ongoing.
REASON
In April 2007, Boston Scientific CRM communicated with physicians regarding the potential for reduced Elective Replacement Indicator (ERI) to Battery End of Life (EOL) time in a subset of implantable defibrillators due to degradation of a low-voltage capacitor. Since that time, the April 2007 advisory population has not experienced any clinically significant changes to either the rate of occurrence or patient management recommendations. A second population (March 2009) has been identified consisting of approximately 900 active ICDs and CRT-Ds (RENEWAL 3/HE, RENEWAL 4/HE, RENEWAL 3 RF/HE, RENEWAL 4 RF/HE, RENEWAL 4 AVT/HE & VITALITY DS DR/VR, VITALITY EL, VITALITY AVT, VITALITY 2 DR/VR, VITALITY 2 EL DR/VR, VITALITY DR HE), manufactured with capacitors from the same supplier that may be subject to the same failure mechanism. No devices from this population have been registered as implanted after April 2007, and the mean age of those remaining implanted is 38 months. No devices in this subset remain available for implant.
VOLUME OF PRODUCT IN COMMERCE
1383 units
DISTRIBUTION
Nationwide and countries of Argentina, Australia, Austria, Belgium, Brazil, Canada, Denmark, Finland, France, Germany, Greece, Ireland, Italy, Japan, Lebanon, Netherlands, New Zealand, Polynesia, Portugal, Spain, Switzerland, Turkey and United Kingdom
___________________________________
PRODUCT 
1) ConforMIS iUni ( Unicondylar Knee System ) Left Medial Implant Kit Product Code: M57220600010. For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component. Recall # Z-1622-2009;

2) ConforMIS iUni ( Unicondylar Knee System ) iUni Right Medial Implant Kit Product Code : M57220600020. For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component. Recall # Z-1623-2009;

3) ConforMIS iUni (Unicondylar Knee System iUni Right Lateral Implant Kit Product Code: M57220600040. For cemented use only. System consists of femoral and tibial components. The femoral component is CoCrMo personalized on its sub-chondral and articular surfaces to match patient's anatomy. For use in one compartment of the osteoarthritic knee to replace the damaged area of the articular surface in patients with evidence of inadequate healthy bone for support of the implanted component. Recall # Z-1624-2009
CODE
1) Serial Numbers: 2565, 2686, 2685, 2308, 2739, 2728, 2299, 2726, 2681 and 2521;

2) Serial Numbers: 2571, 2706, 1755, 2665, 1757 and 2749;

3) Serial Number: 1853
RECALLING FIRM/MANUFACTURER
Conformis Inc., Burlington, MA, by letter dated April 23, 2009. Firm initiated recall is ongoing.
REASON
Microscopic cracks potential for pre-mature revisions in patients implanted with the system.
VOLUME OF PRODUCT IN COMMERCE
17 units
DISTRIBUTION
CA, LA, MI, TX, and Germany
___________________________________
PRODUCT 
1) Symbia S Series SPECT System; Single-Photon Emission Computed Tomography; Part number 8717741. Recall # Z-1648-2009;

2) Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System; a) Part number 8717733; b) Part number 10275007; c) Part number 1075008; d) Part number 10275009; e) Part number 10275010. Recall # Z-1649-2009
CODE
1) Serial numbers: 1001, 1002, 1003, 1005, 1006, 1014, 1052, 1066, 1070, 1073, 1074, 1081, 1085, 1108, 1109, 1110, 1112, 1113, 1117, 1118, 1119, 1120, 1123, 1124, 1126, 1128, 1129, 1131, 1132, 1137, 1138, 1142, 1144, 1148, 1159, 1161, 1162, 1163, 1167, 1171, 1172, 1173, 1174, 1176, 1177, 1179, 1180, 1183, 1186, 1187, 1189, 1192, 1196, 1197, 1198, 1200, 1201, 1203, 1204, 1205, 1206, 1207, 1211, 1212, 1214, 1215, 1216, 1217, 1218, 1223, 1224, 1225, 1227, 1229, 1230, 1231, 1236, 1239, 1240, 1241, 1242, 1243, 1244, 1245, 1246, 1248, 1249, 1252, 1253, 1254, 1257, 1258, 1259, 1262, 1263, 1264, 1266, 1267, 1268, 1270, 1271, 1272, 1274, 1276, 1281, 1282, 1285, 1287, 1288, 1291, 1292, 1293, 1295, 1296, 1298, 1299, 1300, 1301, 1302, 1303, 1304, 1305, 1306, 1308, 1309, 1310, 1311, 1312, 1313, 1314, 1316, 1318, 1319, 1322, 1323, 1327, 1328, 1329, 1332, 1334, 1336, 1337, 1340, 1341, 1343, 1346, 1347, 1348, 1349, 1350, 1351, and 1352;

2) a) Serial numbers: 1019, 1020, 1021, 1023, 1041, 1042, 1043, 1052, 1054, 1067, 1072, 1073, 1077, 1090, 1091, 1103, 1106, 1109, 1121, 1125, 1127, 1128, 1135, 1138, 1140, 1147, 1150, 1153, 1157, 1158, 1162, 1163, 1168, 1169, 1170, 1171, 1173, 1174, 1175, 1178, 1180, 1181, 1184, 1187, 1191, 1193, 1194, 1196, 1198, 1199, 1202, 1204, 1208, and 1210; b) serial numbers: 1001, 1006, 1007, 1009, 1011, 1012, 1014, 1015, 1018, 1023, 1026, 1029, 1030, 1032, 1034, 1035, 1038, 1039, 1040, 1041, 1043, 1044, 1053, 1057, 1058, 1059, 1060, 1061, 1064, 1065, 1069, and 1071; c) serial numbers: 1002, 1003, 1009, 1010, 1011, 1017, 1018, 1019, 1020, 1023, 1024, 1031, 1035, 1038, 1041, 1047, 1055, 1056, 1057, 1058, 1063, 1065, 1066, 1069, 1071, and 1076; d) serial numbers: 1008, 1013, 1015, 1017, 1019, 1020, 1022, 1024, 1026, 1027, 1028, 1029, 1030, 1032, 1034, 1039, 1040, 1044, 1046, 1047, 1050, 1051, 1054, 1055, and 1056; e) serial numbers: 1001, 1002, 1003, 1004, 1006, 1007, 1008, 1010, 1011, 1012, and 1013
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions U.S.A. Inc., Hoffman Estates, IL, by letters dated January 20, 2009. Firm initiated recall is ongoing.
REASON
Patient injury can occur when the patient is lying on the patient bed and the automatic collimator exchanger is undergoing a collimator change operation at the launch of an acquisition workflow. Detector motions required for this change can cause collision with the patient or pallet if it is in brain scan position, i.e. the patient or pallet is into the field of view.
VOLUME OF PRODUCT IN COMMERCE
297 units
DISTRIBUTION
Nationwide, and Australia, Austria, Canada, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Ireland, Italy, Japan, Korea, Kuwait, Netherlands, Norway, Poland, Portugal, Qatar, Saudi Arabia, South Africa, Spain, Sweden and Switzerland

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS I

___________________________________
PRODUCT
Raw Fancy Virginia Peanuts in the Shell, intended for feeding wild birds. The product is distributed under the Wild Birds Unlimited (WBU) brand label and is packed in a 25 lb. mesh bag. Item #20410, SKU Numbers: 2963, 4963, and 411. Recall # V-233-2009
CODE
Lot #2015
RECALLING FIRM/MANUFACTURER
Recalling Firm: Burkmann Feeds LLC, Glasgow, KY, by press release and e-mail on April 14, 2009 and by letter on April 15, 2009. 
Manufacturer: Severn Peanut Company Inc., Severn, NC. Firm initiated recall is ongoing.
REASON
The firm received positive test results for salmonella testing of their whole raw peanuts. The test results were reported by the Kentucky Department of Regulatory Services following an inspection of Burkmann by Kentucky State personnel.
VOLUME OF PRODUCT IN COMMERCE
349 x 25 lb bags
DISTRIBUTION
AL, AR, FL, GA, KS, KY, LA, MI, MO, MS, NC, NM, OH, PA, SC, TN, TX, VA, and WV

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

___________________________________
PRODUCT 
1) Individual Container: Bimeda, Sustain III Calf Bolus, Antibacterial Sulfamethazine, Sustained Release Calf Bolus (72 hrs), NADA120-615, Product No. 1SUS032 8SUS019-1004, Net contents 25 Boluses, Each Bolus contains: Sulfamethazine (Formulated in a sustained released base), 123.8 grains (8.02 grams). Intended for oral administration to ruminating replacement calves (calves over (1) month old that are not on an all-milk diet). Outer Container: Bimeda, Sustain III Calf Bolus, Antibacterial Sulfamethazine, Sustained Release Calf Bolus (72 hrs), Product No. 1SUS032 8SUS032-1004, Net contents 12 x 25 Boluses. Recall # V-249-2009;

2) Individual Container: Bimeda, Sustain III Calf Bolus, Antibacterial Sulfamethazine, Sustained Release Calf Bolus (72 hrs), NADA120-615, Product No. 1SUS033 8SUS025-1004, Net contents 50 Boluses, Each Bolus contains: Sulfamethazine (Formulated in a sustained released base) 123.8 grains (8.02 grams). Intended for oral administration to ruminating replacement calves (calves over (1) month old that are not on an all-milk diet). Outer Container: Bimeda, Sustain III Calf Bolus, Antibacterial Sulfamethazine, Sustained Release Calf Bolus (72 hrs), Net contents 6 x 50 Boluses, 1SUS033, 8SUS034-1004. Recall # V-250-2009;

3) Individual Container; Agripharm, Supra III" Calf Bolus, Antibacterial, NADA120-615, Product No. 1SUS017, 8SUS020-1101, Net contents 25 Boluses, Each Bolus contains: Sulfamethazine (Formulated in a sustained released base) 123.8 grains (8.02 grams). Intended for oral administration to ruminating replacement calves (calves over (1) month old that are not on an all-milk diet). Outer Container: Agripharm, Supra III" Calf Bolus, Antibacterial, 76051, NADA120-615, Product No. 1SUS017, 8SUS8826-1101, Net contents 12 x 25 Boluses. Recall # V-251-2009
CODE
Lot: I3330221, Exp date 3/13
RECALLING FIRM/MANUFACTURER
Bimeda, Inc. Le Sueur, MN, by letter dated June 19, 2009. Firm initiated recall is ongoing.
REASON
During routine stability testing, Sustain Calf Lot I3330221 was discovered to have failed dissolution testing. The specification is that the boluses are less 60% dissolved after 15 minutes of stirring in the dissolution liquid, The failing boluses were 61% dissolved after 15 minutes stirring in the dissolution liquid. 
VOLUME OF PRODUCT IN COMMERCE
3760 units
DISTRIBUTION
WI, MO, IA, MN, KS, KY, NE, TX, NL, IA

END OF ENFORCEMENT REPORT FOR JULY 29, 2009

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