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U.S. Department of Health and Human Services

Safety

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Enforcement Report for October 14, 2009

October 14, 2009
09-41

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
Pistachios in shell roasted and salted in 2 lb and 5 lb plastic bags with a twist tie labeled with a 3” x 2” gummed label on the bag stating Azure Standard Pistachios in shell. Recall # F-1354-9  
CODE
None used
RECALLING FIRM/MANUFACTURER
Azure Standard, Dufur, OR, by telephone beginning April 7, 2009 and letter dated April 14, 2009. Firm initiated recall is ongoing.
REASON
The pistachios were repacked using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
45/5 lb bags and 74/2 lb bags
DISTRIBUTION
WA, MT, AK, OR, AZ, CA, MN, ID, SD, NV, UT, IA
___________________________________
PRODUCT 
Advocare Heart Source Peanut Butter Crunch Nutritional Health Bars; bars packaged 12/1.76 oz (50g) bars per box; no UPC. Recall # F1355-9    
CODE
Lot #’s: NN0627A, NN2767B, NN3188B, NN0798B
RECALLING FIRM/MANUFACTURER
Recalling Firm: AdvoCare International, LP, Carrolton, TX, by e-mail on February 24, 2009 and on firm’s website.
Manufacturer: Nellson Nutraceutical, Inc., Irwindale, CA. 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
24,195 boxes (12 bars per box)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Walnut Baklava, Net weight 2 oz. The product is packed in clear rigid plastic containers. UPC 206518501980. Recall # F-1356-9     
CODE
All codes
RECALLING FIRM/MANUFACTURER
L & D Delights, LLC, Atlanta, GA, by telephone on/about April 2, 2009. A follow up letter on/about April 3, 2009 and by press release on April 4, 2009.  Firm initiated recall is ongoing.
REASON
Product contains undeclared peanut protein.
VOLUME OF PRODUCT IN COMMERCE
31 units (24/2 oz containers per case)
DISTRIBUTION
NJ, MA, RI, CT
___________________________________
PRODUCT 
1) Kung Pao Tofu Salad: individually packaged in varying weights and sold from firm's retail deli case(s). UPC 2 12601 60336 2. Recall # F-1357-9;

2) Spicy Peanut Chicken Yakisoba Salad: individually packaged in varying weights and sold from firm's retail deli case(s). UPC: 2 12621 00336 4. Recall # F-1358-9;

3) Pad Tai Salad: individually packaged in varying weights and sold from firm's retail deli case(s). UPC: 2 12522 00363 0. Recall # F-1359-9;

4) Self-Grind Peanut Butter made at the firm's retail location(s) from Bulk Bin Peanuts. Product labeled as: 1) Bin 98944 - "Organic Dry Roasted, No Salt Peanuts"; or 2) Bin 98426 - "No Salt Peanuts". Retail stores provides 12 oz and 20 oz plastic containers with lids. Recall # F-1360-9     
CODE
Distributed between Jan. 1, 2007 and Feb. 13, 2009. Sell by date of between approximately Jan. 6, 2007 and Feb. 18, 2009 (5 days after production)
RECALLING FIRM/MANUFACTURER
Market Of Choice, Eugene, OR, by press release on March 17, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanut product recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approximately 30,659 lbs of salad; unknown amount of peanut butter
DISTRIBUTION
OR
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PRODUCT 
1) Chocolate Bridge Mix Candy containing peanuts, 16 oz bags, sold under two labels: Omaha Steaks, sold the candy during the 2008 holiday season as part of gift box assortments marketed as the Premier Executive Collection #2238 and the Executive Collection #2241 through nationwide mail order sales. UPC 0 75049 42169 7. Recall # F-1361-9;

2) Dry Roasted Peanuts, Herman's Nut House, Omaha, NE, 40 oz can, No retail UPC. Recall # F-1362-9

3) Roasted Salted Redskins, 30-lb. case, SKU N0701. Recall # Recall # F-1363-9;

4) Mixed nut products: Party Mix Nuts - 30 lb Case, SKU 11400; Party Mix Nuts with Broken Brazils - 30 lb Case, SKU 11402; Party Mix Nuts No Brazils - 30 lb Case, SKU 11404; Party Mix Nuts - 1 lb Bag, SKU 42116; Party Mixed Nuts - 5 lb can; Party Mix Nuts - 40 oz Foodservice Can, SKU 23110; Party Mix Nuts - 40 oz can, SKU 11040. Recall # F-1364-9;

5) Granulated peanut products: Bakers Mix - 27 lb Case, SKU 07478; b) Fancy Nut Topping - 30 lb Case, SKU N0712; 07477; and Fancy Nut Topping - 40 oz Foodservice Can, SKU 23112; Fancy Nut Topping - 2 oz Bag, SKU 00071 / UPC 75049 00071 purchased prior to March 6, 2009; Granulated Peanuts, 30 lb bulk case. Recall # F-1365-9
CODE
1) Julian Code dates 07001 thru 09029;
2) Julian Codes 07298 thru 09029;
3) and 4) Julian Code dates between 07212 and 07365;
5) Julian Codes between 07206 and 09033
See product description for SKU and codes
RECALLING FIRM/MANUFACTURER
Marathon Ventures Inc., Omaha, NE, by telephone and/or e-mail during the period of Jan. 30, 2009 and Mar. 10, 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
Approximately 15,674 lb
DISTRIBUTION
Nationwide
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PRODUCT 
Fritzie Fresh Chocolate Peanuts, 8 oz bags, UPC 076056 03820. Recall # F-1366-9
CODE
Date code 08364
RECALLING FIRM/MANUFACTURER
Fritz Company, Inc., Newport, MN, by e-mail on February 13, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,920 lbs
DISTRIBUTION
MN, WI, IA, MO, ND, SD, MT
___________________________________
PRODUCT 
1) Cookie. Blue Heron Bakery Spelt Peanut Butter Chocolate Chip Cookie, 5-6 cookies packed in clear plastic bags (cello), 10 oz to 12 oz packs or sold individually and unwrapped to customers at the retail location. Recall # F-1367-9;

2) Trail Mix. Blue Heron Bakery Mud Bay Trail Mix packed in 12 oz clear plastic bags with no UPC code. Recall # F-1368-9
CODE
None
RECALLING FIRM/MANUFACTURER
Blue Heron Bakery, Olympia, WA, by telephone on February 5, 2009 and press release on March 12, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanut butter recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approximately 23,520 cookies; trail mix - unknown
DISTRIBUTION
WA
___________________________________
PRODUCT 
Yarnell's Premium Ice Cream, Tin Roof Sundae, Pint (473 mL). Recall # F-1369-9
CODE
05-50 8080 Best by 3-20-2010; 05-50 8108 Best by 4-17-2010; and 05-50 8183 Best by 7-1-2010. Manufactured prior to 7/1/2008
RECALLING FIRM/MANUFACTURER
Yarnell Ice Cream Co., Inc., Searcy, AR, by press release and letter on June 4, 2009. 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
9,800 pints
DISTRIBUTION
AR, OK
___________________________________
PRODUCT 
1) Jacqueline's Gourmet Cookies: Peanut Butter w/ Chocolate Chunk & Peanuts, Frozen, (1210 x 1.75 oz.), Code 22517, UPC 6 81400 22517 2; Code 22515, UPC 6 81400 22515 8, (210 x 1.5 oz.). Recall # F-1370-9;

2) Jacqueline's Gourmet Cookies: Peanut Butter (210 x 1.5 oz) Code 30515; Peanut Butter (96 x 3oz) Code 30530. Recall # F-1371-9;

3) Jacqueline's Gourmet Cookies: Peanut Butter Chip (448 x .75 oz), Frozen Code 30507; Peanut Butter Chip (96 x 4.0 oz) Code 30540; Madeline's Gourmet Cookies: Peanut Butter Chip cookies (210 x 1.5 oz), Code 65605; Jacqueline's Gourmet Cookies, Peanut Butter Chip with Roasted Peanuts (180 x 1.9 oz), Code 21619. Recall # F-1372-9;

4) Jacqueline's Gourmet Cookies, Peanut Butter Chunk w/Roasted. Peanut, frozen (180 x 1.5 oz) Code 22515. Recall # F-1373-9;

5) Jacqueline's Gourmet Cookies, Peanut Butter with Roasted Peanuts (210 x 1.5 oz), Code 20515. Jacqueline's Gourmet Cookies Peanut Butter with Roasted Peanuts (150 x 2.5oz) Code 20525, UPC 6 81400 20525 9. Jacqueline's Gourmet Cookies Peanut Butter with Roasted Peanut Cookie (210 x 1.5 oz) Code 10515 Jacqueline’s Gourmet Cookies with Roasted Peanuts Sweet Temptations (150 x 2.0 oz) Code: 30520 Progressive Gourmet: Code PROG605 Peanut Butter with Roasted Peanuts (180 x 1.5 oz) Code PROG60510 Peanut Butter with Roasted Peanuts (288 x 1.0 oz) Code PROG655 Peanut Butter with Roasted Peanuts (180 x 1.5 oz) Whole Foods: Peanut Butter w/Dry Roasted. Peanuts (192 x 2.1 oz) Code 935. Recall # F-1374-9;

6) Jacqueline's Gourmet Cookies: Peanut Butter w/ Roasted Peanuts and Choc Chips (210 x 1.5oz), frozen Code 11615, UPC 6 81400 11615 9. Recall # F-1375-9
CODE
Lot codes ending in 07 and 08
RECALLING FIRM/MANUFACTURER
Jacqueline’s Wholesale Bakery, Inc., Salem, MA, by e-mail on January 30, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
23,040 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Fresh Cilantro packaged in 15 lb black plastic crates. Recall # F-1376-9     
CODE
July 13 through July 16, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sweet Superior Fruit, Ltd Co, McAllen, TX, by press release on July 18, 20009.
Manufacturer: AGROMEX DE VEGETALES, SA DE CV, Saltillo, Mexico. Firm initiated recall is complete.
REASON
Fresh Cilantro is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
104 crates
DISTRIBUTION
TX
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PRODUCT 
Market Pantry Chewy Granola Bars Chocolate Chip. The bars are individually wrapped in a box that contains 18 bars. UPC 85239 20124. The product is shipped 8 boxes per case. Recall # F-1377-9     
CODE
Best by date 18JAN2010
RECALLING FIRM/MANUFACTURER
Leclerc Foods, Inc., Montgomery, PA, by press release on May 5, 2009. Firm initiated recall is ongoing.
REASON
Product contains undeclared peanuts.
VOLUME OF PRODUCT IN COMMERCE
333 cases
DISTRIBUTION
CA, CO, GA, IL, MI, MN, NY, OR, VA, WI
___________________________________
PRODUCT 
1) Lemon Sorbetto, packaged in pint containers under the following labels: a) Espo, UPC 95069 00046, and b) Nature's Promise, UPC 88267 08968. Recall # F-1378-9;

2) Mango Sorbetto, Sorbetto by espo, packaged in pint containers, UPC 95069 00052. Recall # F-1379-9;

3) Raspberry Sorbetto, Sorbetto by espo, packaged in pint containers, UPC 95069 00056. Recall # F-1380-9;

4) Nature's Promise Strawberry Sorbetto, packaged in pint containers, UPC 88267 08970. Recall # F-1381-9
CODE
1) Code date/Lot #: a) Feb 18 11/Lot 49 and May 12 11/Lot 132; b) May 8 11/Lot 128 and June 13 11/Lot 164;

2) Code Date/Lot # - March 11 11/Lot 70 and July 1 11/Lot 182;

3) Code Date/Lot # - March 11 11/Lot 70;

4) Code date/Lot # - May 8 11/Lot 128
RECALLING FIRM/MANUFACTURER
Hiland Roberts Ice Cream Co., Norfolk, NE, by press release on July 17, 2009 and by e-mail on July 17, 2009 and July 29, 2009. Firm initiated recall is ongoing.
REASON
The products contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
62,192/1-pt. containers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
FreshDirect Roasted Garlic Marinated Chicken Breast, Product Code WT0300301075, Ingredients: Boneless Skinless Breast of Chicken, Roasted Garlic Marinade (Water, Soybean Oil, Salt, Sugar, Roasted Garlic, Garlic Powder, Dried Spices (Garlic, Parsley, Oregano) Xanthan Gum, Natural Flavor). The roasted garlic flavor marinade - no cheese was supposed to be used on the product. Instead the natural roasted garlic flavor marinade was used which contains the following ingredients: water, Romano cheese (part skim milk, cheese cultures, salt, enzymes), soybean oil, salt sugar, roasted garlic and garlic powder, dehydrated garlic/parsley, oregano, xanthan gum, natural flavor. Recall # F-1382-9
CODE
Product sold from April 7, 2009 to April 13, 2009.
RECALLING FIRM/MANUFACTURER
Fresh Direct, Long Island City, NY, by e-mail on April 14, 2009 followed-up by telephone and letters. Firm initiated recall is complete.
REASON
The product contained undeclared milk allergen from the marinade.
VOLUME OF PRODUCT IN COMMERCE
27 units
DISTRIBUTION
NYC
___________________________________
PRODUCT 
Fresh Anaheim Peppers packed in 10-12 lb boxes. Recall # F-1384-9    
CODE
Lot number: 0801206
RECALLING FIRM/MANUFACTURER
Herring Produce, Lake Park, GA, by letter on July 1, 2009, by letter and telephone on July 3, 2009 and by press release on July 10, 2009. Firm initiated recall is ongoing.
REASON
The product may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
193 boxes (10-12 lbs)
DISTRIBUTION
FL, MA, OH
___________________________________
PRODUCT 
1) Amway Nutrilite energy bars, Vanilla Pretzel Energy Bar, net wt. 1.6 oz each, 9 bars per 14.4 oz box, SKU/UPC 10-6529. Recall # F-1385-9;    

2) Amway NUTRILITE energy bars, Peanut Butter Pretzel Energy Bar, net wt. 1.6 oz. each, 9 bars per 14.4 oz box; SKU/UPC 10-6530. Recall # F-1386-9;

3) Amway NUTRILITE energy bars, Chocolate Nut Roll Energy Bar, net wt. 1.6 oz. each, 9 bars per 14.4 oz box; SKU/UPC 10-6528. Recall # F-1387-9;

4) Amway Nutrilite energy bars, Product Intro Kit; SKU/UPC E9745. Each intro kit contains 2 of the recalled energy bars. Recall # F-1388-9;

5) Amway XS energy bars, Chocolate Nut Roll, 9 bars net wt. 1.6 oz each, total net wt. 14.6 oz; SKU/UPC 71-1842. Recall # F-1389-9
 CODE
1), 2), 3)   All lot numbers starting with an 8. The lot numbers appear on both the package and the individual bars.

4) Lots 8275BPS1, 8275BPS2, 8275BPS3, 8275MSN1, 8275MSN2 and 8275MSN3. These lot numbers appear on the kit. The bars in the recalled kits have the recalled lots listed for each flavor of recalled energy bar.

5) All lot numbers from 7197 through 7296A, (Lots 7197, 7198, 7208, 7211A, 7212A, 7212B, 7213A, 7213B, 7228A, 7228B, 7229A, 7176A, 7277A, 7282A, 7295A and 7296A)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Access Business Group LLC, Ada, MI, by press release on January 23, 2009 and February 4, 2009 and by email and letter on or about January 23, 2009 and February 5, 2009. 
Manufacturer: Belmont Confections Inc., Youngstown, OH. Firm initiated recall is complete.
REASON
The product was manufactured using peanut paste recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approximately 530,000 bars
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) NutriSystem Peanut Butter Granola Bar "Breakfast Time" 1.41 oz or 40 g. The product is sold as a breakfast item to consumer enrolled in the weight loss program. The UPC is 632674320162. Recall # F-1390-9;

2) NutriSystem Peanut Butter Granola Bar/Barre Granola Au Beurre D'Arachide 40 g. The product is sold as a breakfast item to consumer enrolled in the weight loss program. The UPC is 632674370167. This product is sold exclusively in Canada. Recall # F-1391-9
CODE
1) Lot numbers TC08158A, TC08188A, TC09158A, TC09168A, TC09178A, TC11148A, TC11178A, TC03198A, TC04178A, TC05128A, TC05148A, TC05158A, TC05168A, TC06028A, TC06108A, TC06128A, TC06138A, TC06168A, TC06178A, TC07038A, TC07078A, TC07088A, TC08148A, and TC091108A;

2) Lot number TC03198A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nutrisystem Research, Horsham PA, by press release on January 21, 2009 followed by telephone and e-mail.
Manufacturer: Tsudis Chocolate Co., Pittsburgh, PA. Firm initiated recall is complete.
REASON
The products were manufactured using peanut butter recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
473,793 bars
DISTRIBUTION
CA, CT, DE, IL, IN, KY, MA, MO, OK, RI, TX, VT, and WA
___________________________________
PRODUCT 
Reser's Fine Foods Thai Noodle Salad. Product is bulk 5 lb tubs labeled in part, UPC 0 71117 14225 9; keep refrigerated. Product is packaged 2 -5 lb tubs per case. Recall # F-1392-9   
CODE
Use By Dates of 03/1/09 and 03/8/09
RECALLING FIRM/MANUFACTURER
Reser’s Fine Foods, Inc., Beaverton, OR, by press release and telephone, and e-mail on February 27, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
236 tubs
DISTRIBUTION
OR, WA, IL, ND, MT, ID, CA, SD, Alberta, British Columbia, Canada
___________________________________
PRODUCT 
Arrowhead Mills Organic Stone Ground Wheat Flour, Net Wt 32 oz (2 lbs) 907g. Item AM47242. Recall # F-1393-9
CODE
Lot number: 06OCT09
RECALLING FIRM/MANUFACTURER
Arrowhead Mills, Inc., Hereford, TX, by press release and letter on February 19, 2009. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
675 cases, 12 bags per case
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
Cilantro, UPC 033383801049 purchased; bunches have white twist tie with pink lettering "Cilantro". Recall # F-1394-9
CODE
Case lot number 118122, purchased between July 20 and July 27, 2009.
RECALLING FIRM/MANUFACTURER
Frontera Produce Ltd, Edinburg, TX, by e-mail and telephone on July 26, 2009 and by press release on July 28, 2009. Firm initiated recall is ongoing.
REASON
Product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,140 cases
DISTRIBUTION
TX, OK, CO, LA, NM
___________________________________
PRODUCT 
Romaine Lettuce, whole, bulk or plastic wrapped. Recall # F-1395-9
CODE
Lot 51380
RECALLING FIRM/MANUFACTURER
Tanimura & Antle, Inc., Salinas, CA, by telephone and e-mail on July 20, 2009 and by press release on July 21, 2009. Firm initiated recall is ongoing.
REASON
Product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Instant Nonfat Dry Milk fortified with vitamins A&D in one-quart envelopes. Ingredients: Nonfat Dry Milk, Vitamin A Palmitate, Vitamin D3. Packaged under the following brands and configurations: 1) Americas Choice, 5 envelopes, UPC:54807-29490, Net Wt 16 oz (454g); 2) Pathmark, 5 pre-Measured Envelopes, UPC 41240-10080, Net Wt 1 lb (454g), 10 Pre-Measured Envelopes, UPC 41240-10082, Net Wt 2lb (907g); 3) Stop & Shop, 5 envelopes, UPC 21120-00056, Net Wt 16 oz (454g), 10 envelopes UPC:21120-00052, Net Wt 32 oz (907g); 4) Giant, 3 envelopes, UPC 88267-07833, Net Wt 9.l6 oz (272g), 10 envelopes, UPC 88267-07832, Net Wt 32 oz (907g); 5) Food Lion makes 3 quarts, UPC 35826-03577, Net Wt 9.6 oz (272 g); 6) Saco 10 envelopes, UPC 41756-00100, Net Wt. 2 lbs (907g); 7) Laura Lynn, makes 3 quarts, UPC 86854-00502, Net Wt 9.6 oz (272 g); 8) White Rose 10 envelopes, UPC 74807-30290, Net Wt 32 oz (907g); 9) Foodtown 10 envelopes, UPC 11153-18610, Net Wt 32 oz (907 g); 10) Hannaford makes 10 quarts, UPC 41268-11345, Net Wt 32 oz (907 g); 11) Key Foods 10 envelopes, UPC 73296-15674, Net Wt 32 oz (907 g); 12) Krasdale 10 envelopes, UPC 75130-54686, Net Wt 32 oz (907 g); 13) Weis 10 envelopes, UPC 41497-27050, Net Wt 32 oz (907g); 14) Great Value 10 pouches, UPC 78742-35218, Net Wt 2lb (907 g); 15) Best Yet 10 envelopes, UPC 42187-41164, Net Wt 32 oz (907 g) 16) Big Y 10 envelopes, UPC 18894-95632, Net Wt 32 oz (907 g); 17) Food Club 10 envelopes, UPC 36800-95615, Net Wt 32 oz (907 g); 18) MEIJER 10 envelopes, UPC 41250-96746, Net Wt 32 oz (907 g); 19) Sturm Village Farm makes 3-1 Quart Servings, UPC 70893-02142, Net Wt 9.6 oz (272 g); 20) Sturm Village Farm-MI Vaquita, 10 quarts, UPC 70893-00200, Net Wt 32 oz (907 g). Recall # F-1396-9
CODE
1) Lot code: FEB0411S, FEB0511S, JAN2111S; 2) Lot code: JAN2111S, FEB0311S; 3) Lot code: FEB0511S, FEB1211S; 4) Lot code: FEB0511S, FEB0911S, JAN2111S; 5) Lot code: FEB1611S; 6) Lot code: FEB1911, JAN2111; 7) Lot code: FEB0511S; 8) Lot code: FEB0311S; 9) Lot code: FEB1911S, JAN2111S; 10) Lot code: FEB0911S, JAN2111S; 11) Lot code: FEB1011S; 12) Lot code: FEB0911S; 13) Lot code: FEB1211S, FEB1911S; 14) Lot code: 012611, 012711, 012811, 012911, 020211, 020311, 021011, 021111, 021211, 021711, 021811; 15) Lot code: FEB0911S, JAN2111S; 16) Lot code: JAN2111S; 17) Lot code: JAN2111S; 18) Lot code: FEB0911S, FEB1011S; 19) Lot code: FEB1611S; 20) Lot code: FEB0311S, FEB0411S
RECALLING FIRM/MANUFACTURER
Sturm Foods, Inc., Manawa, WI, by telephone and e-mails on June 30, 2009 and by press release on July 9, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
17,381
DISTRIBUTION
AR, CA, IL, MA, ME, MI, MN, NC, NJ, NY, OR, PA, WI, PR

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
1) Goldline SENNA-GEN Tablets brand of Standard Senna Concentrate equivalent to 8.6 mg of Sennosides Natural Vegetable Stimulant Laxative 1000 and 100 count Tablets.  NDC 0182-1093-10 (1000 count bottle) and NDC 0182-1093-01(100 count bottle) IVAX SENNA-GEN Tablets brand of Standard Senna Concentrate equivalent to 8.6 mg of Sennosides Natural Vegetable Stimulant Laxative 100 (10X10) unit dose tablets. NDC 0812-8215-89 (100 count bottle). Recall # D-001-2010;

2) Goldline SENNA-S Tablets (brand of Standardized Senna Concentrate Equivalent to 8.6 mg Sennosides and Docusate Sodium 50 mg) Natural Vegetable Laxative and Stool Softner 1000 tablets. NDC 0182-1113-10 (1000 Tablets) and NDC 0182-1113-01 (100 Tablets) IVAX SENNA-S Tablets (brand of Standardized Senna Concentrate Equivalent to 8.6 mg Sennosides and Docusate Sodium 50 mg) Natural Vegetable Laxative and Stool Softner 100 Count Unit Dose Tablets. NDC 0182-8642-89 (1000 Tablets). Recall # D-002-2010;
CODE
1) 100 Ct Unit Dose, IVAX Label A019UA, A025UA, C040UA, A019UA, A025UA, C040UA 100 Ct bottles, Goldline Label 89A019U, 89A021U, 89A033T, 89A127U, 89A129U, 89B047T, 89B048T, 89B049T, 89D135U, 89E034U, 89F012U, 89F013U, 89F062U, 89G100U, 89G103T, 89G105T, 89J103T, 89K031S, 89K031T, 89K064S, 89K108S, 89K109S, 89M099S 1000 count bottles, Goldline Label 89A020U, 89A128U, 89C081U, 89D031U, 89D104T, 89E003U, 89F010U, 89F037S, 89F059U, 89F061U, 89G017U, 89G102T, 89G103T, 89H099T, 89J102T, and 89J104T;

2) 100 Ct Unit Dose, IVAX Label 89A156U, 89A156UA, 89B046U, 89B046UA, 89G119T, 89G119TA, 89C019T, 89C019TA--- 100 Ct bottles, Goldline Label 89A115U, 89D071U, 89F102S, 89J019S, 89L019S, 89A156UA, 89D072U, 89F103S, 89J063S, 89L081T, 89B045U, 89D074U, 89F104SM 89J064S, 89M026T, 89B062T, 89D081U, 89F007T, 89J065S, 89M062S, 89B064T, 89D104U, 89G019U, 89J105T, 89M071T, 89M065T, 89D105U, 89G115T, 89J125T, 89M072T, 89D034U, 89D108T, 89G119T, 89K113S, 89D035U, 89D109T, 89H053U, 89L018S--- 1000 CT bottles Goldline Label 89A112U, 89A115U, 89B057T, 89B060T, 89B061T, 89D107T, 89D109T, 89D110T, 89F016U, 89F018U, 89F019U, 89F020U, 89F021U, 89F022U, 89G116T, 89G117T, 89G118T, 89G122T, 89H017U, 89H020U, 89H021U, 89H044T, 89H054U, 89J124T, 89K033S, 89K034S, 89L018S, 89L039U, 89L040U, 89M095T, 89M096T
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ivax Pharmaceuticals, Weston, FL, by letter on April 16, 2009.
Manufacturer: Time-Cap Laboratories, Inc., Farmingdale, NY. Firm initiated recall is ongoing.
REASON
Undeclared ingredient; may contain undeclared excipients anhydrous lactose and tartaric acid.
VOLUME OF PRODUCT IN COMMERCE
1,521,771
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Ranitidine Tablets, USP 150 mg, Rx only. Packaged in 60 count bottles: NDC 0904-5261-52, and 500 count bottles NDC 0904-5261-40. Recall # D-003-2010;

2) Gemfibrozil Tablets, USP, 600 mg, Rx only. Packaged in 60 count bottles: NDC 0904-5379-52 and 500 count bottles: NDC 0904-5379-40. Recall # D-004-2010;

3) Gabapentin Capsules, 300 mg, 270 count bottles, Rx only, NDC 0904-5632-53. D-005-2010;

4) Metformin Hydrochloride Extended Release Tablets 500 mg, 60 count bottles, Rx only, NDC 68645-120-59. Recall # D-006-2010
CODE
1) 60 count bottles: Lot numbers L-1564, Exp. 11/2009; L-1625C, Exp. 02/2010; L-1663A, Exp. 02/2010; and L-1653, Exp. 02/2010; 500 count bottles: Lot numbers L-1564A, Exp. 11/2009; L-1625, Exp. 02/2010; L-1625A, Exp. 02/2010; L-1625B, Exp. 02/2010; L-1663, Exp 02/2010; and L-1653A, Exp. 02/2010;

2) 60 count bottles: Lot numbers L-1853 and L-1916, Exp. date 02/2011; 500 count bottles: Lot number L-1859, Exp. 02/2011;

3) Lot numbers L-1529, Exp. 11/2009, and L-1858, Exp. 02/2011;

4) Lot numbers 090298, Exp. 02/2010; 090666, Exp. 05/2010; 090667, Exp. 05/2010; 090896, Exp. 06/2010; 090898, Exp. 06/2010; 090899, Exp. 06/2010; 090901, Exp. 06/2010; and 090905, Exp. 06/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Legacy Pharmaceutical Packaging LLC, Earth City, MO, by e-mail on September 4, 2009 and letters on September 9, 2009.
Manufacturer: Apotex, Inc, North York Ontario, Canada. Firm initiated recall is ongoing.
REASON
Product recalled due to non-compliance with Good Manufacturing Practices.
VOLUME OF PRODUCT IN COMMERCE
94,904 (60 count); 14,169 (270 count); and 4,042 (500 count) bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Paroxetine Hydrochloride USP tablets, 40 mg, UD 100 (10x10) tablets per carton, Rx only, NDC 63739-408-10. Recall # D-007-2010
CODE
Lot # 00062092, Exp 12/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Mckesson Packaging Services, Concord, NC, by letter on/about September 22, 2009.
Manufacturer: Apotex Corp. Weston, FL. Firm initiated recall is ongoing.
REASON
CGMP Deviations: Product is being recalled due to significant cGMP violations observed at the manufacturer (Apotex).
VOLUME OF PRODUCT IN COMMERCE
103 cartons (100 tablets per carton)
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Ortho ProVue, Product Code MTS213784. Recall # B-1268-09
CODE
Software Versions 2.16 and below
RECALLING FIRM/MANUFACTURER
Recalling Firm: Micro Typing Systems, Inc., Pompano Beach, FL, by letters dated June 25, 2007, September 17, 2007 and November 16, 2007.
Manufacturer: Diagnostic Grifols, Parets Del Valles, Spain. Firm initiated recall is ongoing.
REASON
Software, with an anomaly (Versions 2.16 and below) affecting transmission of results from the Ortho ProVue using a bi-directional Laboratory Information System (LIS) interface, was distributed.
VOLUME OF PRODUCT IN COMMERCE
558 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) Red Blood Cells, Leukocytes Reduced. Recall # B-1299-09;
2) Plasma Frozen Within 24 Hours After Phlebotomy (FP24). Recall # B-1300-09
CODE
1) and 2) Unit: W037909133936
RECALLING FIRM/MANUFACTURER
Blood Center of Iowa, Des Moines, IA, by telephone on July 9, 2009 and letter on July 20, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA, NB
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1306-09
CODE
Unit: 72K090262
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 
Cornea. Recall # B-1416-09
CODE
Units: CM117326OS, FM117326OD
RECALLING FIRM/MANUFACTURER
Michigan Eye-Bank, Ann Arbor, MI, by letter dated March 25, 2009. Firm initiated recall is complete.
REASON
Human Corneal tissues, recovered from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IL, MI
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1512-09;
2) Platelets Pooled Leukocytes Reduced Irradiated. Recall # B-1513-09
CODE
1) and 2) Unit: W141608399836
RECALLING FIRM/MANUFACTURER
Puget Sound Blood Center and Program, Seattle, WA, by letter dated April 14, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
WA
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1515-09
CODE
Units: W038308015093 (2 units)
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, IA, by letter dated April 27, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who lived in an HIV Group O risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MO
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1529-09
CODE
Unit: W036909924335 (Part 1)
RECALLING FIRM/MANUFACTURER
Blood Bank of Delmarva, Inc., Newark, DE, by telephone on April 3, 2009 and by letter dated May 15, 2009. Firm initiated recall is complete.
REASON
Blood product, which exceeded the acceptable limit for platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
DE
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1607-09
CODE
Unit: 12C47179
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by telephone on July 19, 2005 and by letter dated July 25, 2005.
Manufacturer: American Red Cross Carolinas Blood Services Region, Charlotte, NC. Firm initiated recall is complete.
REASON
Blood product, which was labeled as negative for the C red cell antigen, but was collected from a donor who subsequently tested positive for C antigen, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1610-09
CODE
Units: 12KW19332 (2 units)
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by telephone on April 6, 2008 and by follow-up letter on April 7, 2008.
Manufacturer: Double Red Cell Collections-Mobiles-Carolinas Region, Winston-Salem, Winston Salem, NC. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1611-09
CODE
Unit: 12L05824
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by telephone and letter on February 1, 2008.
Manufacturer: American Red Cross Carolinas Blood Services Region, Charlotte, NC. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1612-09
CODE
Unit: 8411962
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, Inc., East Orange, NJ, by telephone on November 12, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1615-09;
2) Plasma Frozen. Recall # B-1616-09
CODE
1) and 2) Unit: 12LS09353
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Charlotte, NC, by telephone, fax and letter on September 1, 2007.
Manufacturer: Whole Blood Collections-Mobiles-Carolinas Region, Asheville, Asheville, NC. Firm initiated recall is complete
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
1) Platelets. Recall # B-1617-09;
2) Red Blood Cells. Recall # B-1618-09
CODE
1) Unit: 1689661;
2) Units: 1689661 and 1670944
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by letter on May 12, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Hawaii
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1619-09;
CODE
Unit: 55H16904
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by e-mail, facsimile and telephone on March 31, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AR
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1682-09
CODE
Unit: 72K773675
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on June 10, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1683-09
CODE
Unit: 72K761652
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on May 28, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL

___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1685-09
CODE
Unit: 72K693927
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on June 4, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1686-09
CODE
Unit: 72K737283
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Mobile, AL, by facsimile on May 26, 2009.
Manufacturer: LifeSouth Community Blood Centers, Montgomery Region, Montgomery, AL. 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 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1700-09
CODE
Units: W0352090949241, W0352090949242
RECALLING FIRM/MANUFACTURER
Baylor University Medical Center Transfusion Services, Dallas, TX, by telephone on April 25, 2009. Firm initiated recall is complete.
REASON
Blood products, which tested positive for red cell antigens, but were labeled as testing negative for red cell antigens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1712-09
CODE
Unit: 72K505564
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on June 18, 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

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1620-09
CODE
Unit: 55H16904
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by e-mail, facsimile and telephone on March 31, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1657-09
CODE
Units: W036509084120, W036509084123, W036509084125, W036509084126, W036509084110, W036509084112, W036509084113, W036509084114, W036509084115, W036509084116, W036509084118, W036509084119
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Monroe, LA, by facsimile on June 30, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from donors whose vital signs were measured using an instrument that did not have annual quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
LA, AR

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

___________________________________
PRODUCT 
1) Medtronic Indura 1P Intrathecal Catheter, model 8709SC, Method of Sterilization: Ethylene Oxide. The implanted infusion system components consist of a Medtronic pump and a model 8709SC Catheter. The catheter connects to the pump at the catheter port. Contents: 81.4-cm Catheter with length markers and guide wire, 15 T-guage introducer needle, Sutureless pump connector with attached 7.6-cm catheter and connector pin, Transparent strain-relief sleeves, Anchors. This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space. Recall # Z-2073-2009;

2) Medtronic Intrathecal Catheter, model 8731SC, Method of Sterilization: Ethylene Oxide. The 8731SC catheter is a two-piece catheter with a thin-walled spinal segment and a thicker-walled pump segment. These segments connect to each other with a connector pin. The pump segment connects to the pump with a sutureless pump connector. Contents: 38.1-cm spinal segment with length markings and guide wire 66-cm pump segment, separate connector pin, 15 T-guage introducer needles, Transparent strain-relief sleeves, opaque strain-relief sleeves, V-wing anchors. This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space. Recall # Z-2074-2009;
 
3) Medtronic Intrathecal Catheter Pump Segment Revision Kit, model 8596SC, Method of Sterilization: Ethylene Oxide. Contents: 66-cm-pump segment with attached sutureless pump connector, Spinal segment strain-relief sleeves, Pump Segment strain-relief sleeves, connector pin. This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space. Recall # Z-2075-2009;

4) Medtronic Sutureless Pump Connector Revision Kit, model 8578, Method of Sterilization: Ethylene Oxide. The 8578 revision kit catheter connects to the catheter interface with a connector pin and strain-relief sleeve. The catheter interface connects to the pump with a sutureless pump connector. The 8578 revision kit is for use with 8709 and 8709SC catheters. Contents: Catheter interface with attached sutureless pump connector, catheter, connector pin and strain-relief sleeve. This is a component of an implantable drug infusion system, which consists of a drug infusion pump and a catheter. The drug infusion system stores and delivers parenteral drugs to the intrathecal space. Recall # Z-2076-2009
CODE
No lot or serial number specific
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Neuromodulation, Minneapolis, MN, by letter on August 14, 2009.
Manufacturer: Medtronic Neuromodulation, Columbia Heights, MN. Firm initiated recall is ongoing.
REASON
Current labeling for Medtronic Sutureless Connector (SC) catheters and revision kits (hereafter referred to as SC catheters) incorrectly states that SC catheters are compatible with Medtronic IsoMed constant-flow infusion pumps. SC catheters are compatible with Medtronic SynchroMed II and SynchroMed EL pumps. Medtronic has determined that SC catheters are not compatible with IsoMed pumps. A physical interference between the SC catheter connector and the IsoMed pump prevents the SC catheter from completely connecting to the IsoMed pump even though it may appear to be connected and feel secure. This incompatibility is a design issue and is not related to implant technique. Incomplete connection may result in catheter disconnection from the IsoMed pump or an occlusion at the connection site which could lead to drug underdose, drug withdrawal or other clinically significant manifestations. Connection of an SC catheter to an IsoMed pump does not damage the IsoMed pump.
VOLUME OF PRODUCT IN COMMERCE
20,000 units
DISTRIBUTION
Nationwide, and Algeria, Aruba, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Norway, Poland, Portugal, Reunion, Romania, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, United Kingdom and Vatican City

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
Sybaritic, NannoLight MP50. Model Numbers and Description: 1.) 304207-MP 220 Volt, Multi-Platform configuration (able to attach optional laser handpiece when purchased separately), Subassembly (unit only, no safety glasses, owner's manual, etc. included); 2.) 404207 Completed unit (safety glasses, owner's manual, etc. included), glossy finish, 220 Volt; 3.) 404207-MP Completed unit, matte finish, 220 Volt, Multi-Platform configuration; 4.) 404207-B Completed unit, matte finish, 220 Volt; 5.) 404207-USAB Completed unit, matte finish, 220 Volt, USA-style power cord; 6.) 404208-B Completed unit, matte finish, 110 Volt; and 7.) 404208-MP Completed unit, matte finish, 110 Volt, Multi-Platform configuration. The NannoLight Intense Pulsed Light System is indicated for use in surgical, aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery and dermatology. Recall # Z-1444-2009
CODE
Serial Numbers: 272102 280103 280104 280105 280901 281004 280810 280506 280509 280609 280808 280809 281304 280801 280206 280301 280306 280207 280402 280702 280703 280403 280405 280701 280706 280210 280303 280805 280802 280108 280208 280302 280508 280604 280906 280908 280909 280910 281001 280804 280905 280209 280803 280409 280510 280610 280401 280709 280806 280708 280307 280807 280904 281005 280902 280304 280503 280507 and 281204. Serial numbers submitted 4/22/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Sybaritic, Inc., Bloomington, MN, by letter dated April 15, 2008
Manufacturer: Beijing Top Laser Technology Co., Ltd., Beijing, China. Firm initiated recall is ongoing.  
REASON
An issue with the 585nm filter used with the NannoLight MP50. The filter may cause unwanted burning and should not be used for vascular lesion treatments.
VOLUME OF PRODUCT IN COMMERCE
59 units
DISTRIBUTION
WA, CA, MN, FL, AR, Poland, Thailand, Chile, Canada, Korea, Azerbaijan, India, Spain, Argentina, Russia, Greece, Philippines, Jordan, Turkey, Mexico, Uruguay, Belgium, Lebanon, Bulgaria and Singapore
___________________________________
PRODUCT 
1) Plastic Radiolucent Coaxial for 10gx118 (Catalog VC10118P). Recall # Z-1879-2009;

2) Plastic Radiolucent Coaxial for 10g x 140mm (VC10140P). Recall # Z-1880-2009;

3) MR Coaxial 10g x 140mm (VC10140MR). Recall # Z-1881-2009;

4) MR Coaxial 10g x 118mm (VC10118MR). Recall # Z-1882-2009
CODE
1) Lot Numbers: HUSA1667, HUSA1668, HUSA1669, HUSA1670, HUSA1671, HUSC1173, HUSC1174, HUSC1175, HUSC1176, HUSC1527, HUSC1528, HUSC1529, HUSC1530, HUSC1531, HUSC1532. HUSC1533, HUSC1535, HUSC1536, HUSC1537, HUSC1072, HUSC1078, HUSC1859, HUSC1074, HUSC1074, HUSC1075, HUSC1076, HUSC1077, HUSD2650, HUSD2651, HUSD2652, HUSD2653, HUSD2654, HUSD2655, HUSD2656, HUSG0389, HUSG0390, HUSG0391, HUSG0591, HUSG0592, HUSG0593, HUSG0594, HUSG0595, HUSG0596, HUSI1060, HUSI1061, HUSI1062, HUSI1063, HUSI1064, HUSJ0192, HUSJ0193, HUSJ0194, HUSJ 0195 and HUSJ0196;

2) Lot Numbers: HUSE0106, HUSG0392, HUSG0608, HUSH0853 and HUSH1534;

3) Lot Numbers: HUSC1247, HUSC 1566, HUSE0137, HUSE0138, HUSG0599 and HUSH1234;

4) Lot Numbers: HUSC1250, HUSC1587, HUSC1588, HUSC1589, HUSD2646, HUSD2647, HUSD2648, HUSF1690, HUSH0816, HUSI0216 and HUSK1723
RECALLING FIRM/MANUFACTURER
Bard Peripheral Vas, Tempe, AZ, letter dated March 27, 2009. Firm initiated recall is ongoing.
REASON
Some Vacora 10G Plastic Coaxial Cannulas may leave a small metal filament in the breast or the sample obtained post procedure.
VOLUME OF PRODUCT IN COMMERCE
10,385 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
1) Baxter Minicap Extended Life PD Transfer Set (6") with Twist Clamp; six sets per carton; product code 5C4482. The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture. Recall # Z-1893-2009;

2) Baxter Minicap Extended Life PD Transfer Set Extra Short (4") with Twist Clamp; six sets per carton; product code 5C4483. The set is used in disconnect applications and cycler applications where aseptic connections and disconnections are performed at the transfer set/cycler juncture. Recall # Z-1894-2009
CODE
1) Lot number: H09E19059;
2) Lot number: H09E18044
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Corp., Round Lake, IL, by telephone, fax or e-mail and letters dated July 2, 2009.
Manufacturer: Baxter Healthcare Corp., Mountain Home, AR. Firm initiated recall is ongoing.
REASON
The peritoneal dialysis transfer set has a defective white sleeve twist clamp. The twist clamp will not open or close completely, which could cause leakage and lead to peritonitis.
VOLUME OF PRODUCT IN COMMERCE
3,150 units
DISTRIBUTION
AR, IL, MI, NC, TN, VA, El Salvador
___________________________________
PRODUCT 
Owner Manual Modifications for PlasmaPro Plasma Pump Model PP-05. No labeling or Packaging. Used with Asahi Plasma Separators to perform therapeutic plasma exchange. Recall # Z-1897-2009
CODE
All units sold
RECALLING FIRM/MANUFACTURER
Apheresis Technologies, Inc., Palm Harbor, FL, by letter February 11, 2009. Firm initiated recall is ongoing.
REASON
Apheresis Technologies, Inc. is taking the following Corrective Action: Modification of the Owners Manual Only for the PlasmaPro Plasma Pump Model PP-05. Operator's Manual will modify tubeset loading instructions so as to reduce possible loading error which might result in the tube being pulled into the pump head.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Vertier Surgical Table, an AC powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback system. Part Numbers: 0788100000 Standard table, 0788100001 Standard table with 5th wheel, 0788100000S SIDNE-enabled standard table, and 0788100001S SIDNE-enabled 5th wheel table. Recall # Z-1899-2009
CODE
Lot Numbers: 080111-43525, 080111-43526, 080111-43527, 080111-43528, 080118-43529, 080118-43530, 080118-43531, 080118-43532, 080118-43533, 080118-43537, 080118-43538, 080811-54955, 080811-54956, 080811-54957, 080811-54958, 080811-54959, 080811-54961, 080811-54962, 080811-54963, 080811-54964, 080811-54965, 080811-54966, 080811-54967, 080811-54968, 080811-54985, 080811-54986, 080811-54987, 080811-54988, 080811-54989, 080811-54998 and 080811-55002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Communications Corp., Flower Mound, TX, by letter dated November 13, 2008.
Manufacturer: Merivaara Corp., Lahti, Finland. Firm initiated recall is ongoing.
REASON
Surgical tables were produced using an unapproved tilt frame bushing.
VOLUME OF PRODUCT IN COMMERCE
31 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Boston Scientific (1) Flexima Regular Biliary Catheter System with RO Marker, 8 FR (2.7 mm) with Glidex hydrogel Coating Locking Pigtail and Radiopaque Marker, REF /Catalog No. 27-260 UPN; M001272600, Use before 2011-11, Sterilized with Ethylene Oxide Gas, Single Use Only. The catheter is designed for external and internal percutaneous drainage of the biliary system. Recall # Z-1901-2009
CODE
Lot Number: 12203269
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove, MN, letter dated July 1, 2009. 
Manufacturer: Boston Scientific Corp., Spencer, IN. Firm initiated recall is ongoing.
REASON
The labeling on the device does not match the labeling on the product packaging. Specifically, the packaging pouch for the product and outer carton labeling reflect that the device is a Flexima Biliary Catheter, which is correct, but the heat shrink inscription directly below the hub on the device indicates that it is a Flexima Nephrostomy device. The most likely consequence that is reasonably expected to occur as a result of this labeling issue is a clinically insignificant delay of the procedure if the physician decides to use another product/catheter.
VOLUME OF PRODUCT IN COMMERCE
79 units
DISTRIBUTION
Nationwide, Spain, Finland and Netherlands
___________________________________
PRODUCT 
ConceiveEase ™, Fertility Friendly Lubricant. Intended Use: Personal Lubricant. Recall # Z-1904-2009
CODE
Lot Number: WK0608
RECALLING FIRM/MANUFACTURER
Memphis Fertility Laboratory, Inc., Memphis, TN, by telephone and letter on July 10, 2009. Firm initiated recall is complete.
REASON
Product was marketed without a 510(k).
VOLUME OF PRODUCT IN COMMERCE
800 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Adapt AO, Akreos Advanced Optics Aspheric Lens. Recall # Z-1911-2009
CODE
Lot Numbers: 1829803, 1829803, 1829814, 1829823 and 1829824
RECALLING FIRM/MANUFACTURER
Bausch & Lomb, Inc., Rochester, NY, by telephone, telefax and letter beginning December 8, 2009. Firm initiated recall is ongoing.
REASON
Affected lenses were inadvertently shipped to Bausch & Lomb's European Logistics Center (ELC) prior to release authorization. Initial testing indicated the product did not meet release criteria for endotoxin limits.
VOLUME OF PRODUCT IN COMMERCE
158 units
DISTRIBUTION
Algeria, Belgium, Bulgaria, Croatia, Germany, Hungary, Ireland, Israel, Italy, Mexico, Portugal, Spain, Thailand and United Kingdom

END OF ENFORCEMENT REPORT FOR OCTOBER 14, 2009

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