• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Safety

  • Print
  • Share
  • E-mail

Enforcement Report for January 27, 2010

January 27, 2010
10-04

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I
___________________________________
PRODUCT
Treasure Mills Allergen Sensitive School Safe Brownie Bars; Net Wt. 40 g/1.4 oz. Ingredients: Sugar, Unbleached Whet Flour, Eggs, Chocolate Base [Cocoa, Corn Syrup, Modified Palm Oil] Shortening (Palm Modified Palm Oil) Canola Oil, Soy, Lecithin, Natural Flavor, Water, Sea Salt. 400 g - 12 brownies per box. UPC 8 05658-45800 7. Recall # F-1146-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Euro Classic Imports, Williamstown, NJ, by e-mail on July 9, 2009.
Manufacturer: Treasure Mills, Newmarket, Canada. Firm initiated recall is complete.
REASON
Undeclared Allergen: CFIS alerted the FDA of a recall of brownies made by Treasure Mills Bakery of Ontario, Canada because the product contains milk, which is not declared on the label.
VOLUME OF PRODUCT IN COMMERCE
49 cases
DISTRIBUTION
PA, VA, NJ, MD, KY, OH and DC
___________________________________
PRODUCT
Dean & DeLuca, Almond Cookies, Net Weight 6.0 oz. The almond cookies are packaged six cookies per sleeve. Each sleeve is labeled individually and packed in a tin with an assortment of other cookies. UPC 090075113088 (on the package) PROD.DT. 10.20.09 CONTROL # 102009.4 (on the shipping box). Recall # F-1151-2010
CODE
No lot codes
RECALLING FIRM/MANUFACTURER
Charleston Cookie Company LLC, Charleston, SC, by email on October 28, 2009, press release on/about November 3, 2009, and by letter on November 23, 2009. Firm initiated recall is ongoing.
REASON
Butter which contains the allergen milk was not listed in the ingredient statement.
VOLUME OF PRODUCT IN COMMERCE
1200 packages (6 cookies per package/packed in a tin containing other assorted cookies)
DISTRIBUTION
KS
___________________________________
PRODUCT
Stop Shop Simply Enjoy Pina Colada White Chocolate Gourmet Cookies, Net Wt 7 oz. Package UPC: 6 8826705538. Case UPC code is 6 8826745538. Recall # F-1152-2010
CODE
Expiration code date 1ASep 26 2009
RECALLING FIRM/MANUFACTURER
Brent & Sam's Gourmet Cookies, Inc., North Little Rock, AR, by press release on April 22, 2009.  Firm initiated recall is complete.
REASON
Product may contain undeclared pecans.
VOLUME OF PRODUCT IN COMMERCE
31 cases
DISTRIBUTION
NJ, NY, NH, ME, CT, RI
___________________________________
PRODUCT
Kroger brand Super Kids Enriched White Sandwich Bread packed in 20 oz. plastic bags, distributed in bread trays containing 10 bags per bread tray, UPC #1111000831, identified with various Use-by dates. Recall # F-1153-2010
CODE
All codes produced by the firm's Anderson, SC and/or Indianapolis, IN bakeries from 1/2/2008 to 8/19/2009, is subject to recall. For product currently in commerce & still within the Best if Used By dates, the date range would be: 8/7/2009 through 8/20/2009.
RECALLING FIRM/MANUFACTURER
Recalling Firm; Kroger Co, Cincinnati, OH, by letter on August 20, 2009 and by press release on August 21, 2009.   
Manufacturer: Kroger Bakery, Anderson, SC; Kroger Indianapolis Bakery LLP, Indianapolis, IN. Firm initiated recall is ongoing.
REASON
Enriched white sandwich bread was distributed which contains undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
896,264 loaves were distributed. Product in commerce &still within Best if Used by Dates is estimated at 12,293 loaves.
DISTRIBUTION
AL, GA, IL, IN, KY, MI, MO, NC, OH, SC, TN, and VA
___________________________________
PRODUCT
Trail mix packaged in clear plastic bags in 1/2 lb. and 2 oz. sizes. The label reads: "QUICK FIX Delicious! Dry Roasted Peanuts, Raisins, Unsweetened Carob Chips, Unsulphured Apricots, Almond, and Pecans. Recall # F-1154-2010
CODE
No code
RECALLING FIRM/MANUFACTURER
Rock Creek Nut Co., Union, OR, by telephone on December 8, 2009. Firm initiated recall is ongoing.
REASON
Product contains undeclared allergens, milk and soy that are ingredients in the carob chips.
VOLUME OF PRODUCT IN COMMERCE
33/ 2 oz and 2/ 8 oz bags
DISTRIBUTION
WA
___________________________________
PRODUCT
Hazelnuts packaged in 1 lb. plastic bags with label that reads in part: "Hazelnuts, Roasted" and price. Recall # F-1155-2010
CODE
No codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philanthropic Educational Organization Chapter DH, Eugene, OR, by email, telephone, or in person on  December 18, 1009 and December 19, 2009.  
Manufacturer: Evonuk & Daughters, Inc., Junction City, OR. Firm initiated recall is ongoing.  
REASON
The product was manufactured using hazelnuts shelled by Willamette Shelling, Inc. of Newberg, OR. These shelled hazelnuts are being recalled because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
175 lbs
DISTRIBUTION
OR
___________________________________
PRODUCT
Roasted hazelnuts packaged in 1 lb. plastic bags with label reading in part: "Hazelnuts, Roasted $7.00." Recall # F-1156-2010
CODE
No codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Philanthropic Education Organization (peo) Chapter Fo, Ashland, OR, by word of mouth, telephone, e-mail, and placards.  
Manufacturer: Evonuk & Daughters, Inc., Junction City, OR. Firm initiated recall is ongoing.
REASON
The product was manufactured using hazelnuts shelled by Willamette Shelling, Inc. of Newberg, OR. These shelled hazelnuts are being recalled because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
73 lbs
DISTRIBUTION
OR

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
265 Everyday Value Cranberry & Nut Trail Mix, Roasted Almonds, Roasted Cashews, Cranberries, Net Wt 16 oz (1 LB) 454g with ingredient statement which reads: Pistachios (Dry Roasted), Salt. Recall # F-1134-2010
CODE
Best By 9/30/2009 Lot 09279
RECALLING FIRM/MANUFACTURER
Recalling Firm: Whole Foods Market Brand 365, LLC, Austin, TX, by electronically on October 30, 2009.
Manufacturer: United Natural Trading, Edison, NJ. Firm initiated recall is ongoing.
REASON
Product has incorrect ingredient panel labeling on the back of the package. Incorrect labeling is for a pistachio product.
VOLUME OF PRODUCT IN COMMERCE
222 cases
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Choco-Pan Gourmet White Chocolate Fondant, Orange in net wt. 2 lb, 4 lb and 10 lb containers. UPC 8256900000, 8256900012 and 8256900013. Recall # F-1135-2010;

2) Choco-Pan Gourmet White Chocolate Fondant. Green, Pastel Green and Lime in net wt. 2 lb, 4 lb and 10 lb containers. UPC 8256900000, 8256900012 and 8256900013. Recall # F-1136-2010;

3) Choco-Pan Gourmet White Chocolate Fondant. Yellow and Pastel Yellow in net wt. 2 lb, 4 lb and 10 lb containers. UPC 8256900000, 8256900012 and 8256900013. Recall # F-1137-2010;

4) Choco-Pan Gourmet Dark Chocolate Fondant,  Black in net wt. 2 lb, 4 lb and 10 lb containers. UPC 8256900000, 8256900012 and 8256900013. Recall # F-1138-201;

5) Choco-Pan Gourmet White Chocolate Fondant. Red and Pink in net wt. 2 lb, 4 lb and 10 lb containers. UPC 8256900000, 8256900012 and 8256900013. Recall # F-1140-2010;
CODE
All lots shipped prior to 4/17/09
RECALLING FIRM/MANUFACTURER
Sweet Art, Inc., Indianapolis, IN, by telephone on or about April 17, 2009 and by follow-up letter. Firm initiated recall is complete.
REASON
1) The product contains undeclared food colors, including red 40, yellow 5 and yellow 6, and the undeclared preservative sodium benzoate;

2) The product contains undeclared food colors, including yellow 5 and blue 1, and the undeclared preservative sodium benzoate;

3) The product contains undeclared food color yellow 5 and the undeclared preservative sodium benzoate;

4) The product contains undeclared food colors, including blue 1, red 40, yellow 5 and yellow 6, and the undeclared preservative sodium benzoate;

5) The products contain undeclared food colors, including red 40, red 3 and yellow 6 and the undeclared preservative sodium benzoate
VOLUME OF PRODUCT IN COMMERCE
1.498
DISTRIBUTION
Nationwide, Canada, Mexico and United Kingdom
___________________________________
PRODUCT
Travelan Caplets, 30 Caplets per container, Dietary Supplement. Recall # F-1157-2010
CODE
Lot number: 0237B9
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alaven Pharmaceutical LLC, Marietta, GA, by letter on/about August 5, 2009. 
Manufacturer: Garden State Nutritionals, W Caldwell, NJ. Firm initiated recall is ongoing.
REASON
The product failed to meet stability specifications when assayed at approximately 3 months after being manufactured.
VOLUME OF PRODUCT IN COMMERCE
1,151 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Pediatric Electrolyte Oral Maintenance Solution, Unflavored Alcohol Free. 1 qt, 1.8 Fl oz (1 Liter) PET Bottle. Recall # F-1158-2010;

2) Meijer Unflavored Oral Electrolyte Solution, 33.8 fl. oz (1 Litre) in polypropylene bottles, 8 bottles per case. Recall # F-1159-2010;

3) Unflavored Oral Electrolyte Solution, 33.8 fl. oz (1 Litre) in polypropylene bottles, 8 bottles per case. Associated Brand names are: Duane Reade, Food Lion, El Mexicano, Homebest/Supervalu, Kinray, and Naturalyte. Recall # F-1160-2010
CODE
1) Lot number: UN80550;

2) Lot numbers: UN74198 and UN74230;

3) Lot numbers: FT71483 FT80536 UN71469 UN73137 UN73619 UN74360 UN80201 UN80464 UN81123 UN81177 UN81277 UN81416 BB70861 CO71302 MA71191 UN71224 UN71469 FT71483 FT72438 FT72463 FT72740 FT73298 FT80572 GR71779 GR80079 UN71057 UN71579 UN71854 UN72544 UN72809 UN73389 UN73503 UN73780 UN74138 UN74360 UN80057 UN80163 UN80201 UN80274 UN80464 UN80726 UN80775 UN80809 UN80856 UN81042 UN81177 UN81241 UN81509 UN81567 UN81697 UN81750 FT70847 FT71832 FT73563 FT74276 FT80642 UN70872 UN71057 UN71224 UN71469 UN71540 UN72480 UN72940 UN73018 UN73503 UN73828 UN74041 UN74360 UN74406 UN80329 UN80690 BB71420 BB71754 BB72794 BB80371 BB80791 BB81003 BB81233 FT71103 FT71483 FT71514 FT72438 FT73069 FT80394 FT80536 FT80880 FT81112 FT81720 GR71184 GR73287 GR73957 GR81318 UN71133 UN71224 UN71469 UN71540 UN71579 UN71854 UN72120 UN72223 UN72382 UN73137 UN73152 UN73405 UN73648 UN80092 UN80145 UN80274 UN80409 UN80775 UN81042 UN81123 UN81223 UN81750 BB70861 BB72970 BB73935 FT71159 FT72740 FT74224 GR72016 GR73581 GR74102 UN70821 UN72120 UN72243 UN72382 UN73228 UN73678 UN73691 UN73828 UN73874 UN74138 UN81042 AP71441 CH81265 CO71629 CO72511 CO73358 CO81090 FT70891 FT71943 FT72664 FT73796 FT81072 GR71651 GR81738 HO71819 MA72025 MA72173 MA81291 PA74471 PA81258 UN73330 UN81633 UN81697 CO71302 PA71499 UN72697 BB71754 BB80371 FT71739 FT81156 GR72016 UN70953 UN72120 UN72697 UN73105 UN73260 UN73405 UN73421 UN74406 UN80329 UN81782 FT71103 UN70953 UN72838 UN73421 UN73731 UN73811 BB81198 BB71754 FT71739 BB71754 BB73590 BB80371 BB80606 FT71103 FT71159 FT71268 FT71739 FT73180 FT81156 UN70953 UN72838 UN73421 UN74406 UN81061 BB71754 BB81198 FT71739 FT81156 UN81061 UN81166 FT71268 FT71943 FT73180 FT81156 BB71284 BB71754 AP73976 AP80680 BB72794 BB72987 BB73095 BB73590 BB73935 BB80606 BB80748 BB81233 BB81525 FT71268 FT80955 GR72016 GR73375 GR81218 GR81485 GR81649 UN70872 UN70953 UN72838 UN73260 UN73731 UN73900 UN80145 UN80464 UN80726 UN80856 UN80984 UN81061 UN81100 UN81123 UN81166 UN81223 UN72120 UN72838 UN73105 UN73421 UN73900 UN81451 UN81750 UN81782 GR72016 UN70953 UN72838 UN73260 BB71284 BB80911 PA71499 UN70953 UN71540 UN72697 UN80464 UN80726 UN80856 AP73976 BB71284 BB73095 CO71302 PA71499 UN72120 UN73105 UN80329 CO71302 GR72016 UN72697 UN73260 UN73405 UN73619 UN73811 UN80856 UN81451 FT81156 GR81649 UN71540 BB71284 BB71754 BB80911 FT71268 FT80831 FT80880 GR72016 PA71499 UN72120 UN72261 UN72288 UN73405 UN73421 UN80145 UN80464 UN81123 UN81166 UN81399 BB72987 FT71103 GR72016 UN73105 UN80145 UN81451 FT80955 BB71284 BB80748 BB80911 FT71514 FT71943 GR72016 GR81649 UN72084 UN73260 UN73811 UN74406 UN80464 UN81567 FT81156 UN81061 AP73976 FT71159 GR72016 UN80856 UN81061 FT71739 UN70953 UN72120 FT73180 FT81156 GR72016 PA71499 UN72838 UN73260 UN80329 UN81567 BB72794 UN80145 FT71103 FT71159 FT71268 PA71499 PA81032 UN70953 UN72288 UN72697 UN73105 UN73137 UN73405 UN73421 UN73811 UN73900 UN74406 UN80145 UN80329 UN80464 UN81061 UN81123 UN81223 UN81451 UN81567 UN73405 UN73421 BB71284 BB71754 BB72987 BB80606 BB80911 BB81198 BB81233 BB81525 FT80831 GR72016 GR81218 GR81649 UN72697 UN72838 UN80145 UN80464 UN80726 UN81123 UN81328 BB71029 BB71253 BB71754 BB72044 BB72065 BB72531 BB72970 BB72987 BB73185 BB73199 BB73436 BB73547 BB73705 BB73841 BB73888 BB74018 BB74056 BB74119 BB74326 BB80024 BB80499 FT71043 FT71159 FT71351 FT71514 FT71671 FT71897 FT72139 FT72156 FT72318 FT72438 FT72503 FT72908 FT72958 FT73069 FT73216 FT73489 FT73533 FT73720 FT74080 FT74453 FT80116 FT80350 FT80447 FT80482 FT80516 FT80923 FT80941 FT81665 GR73520 GR80041 UN71958 UN73605 UN80180 UN80201 UN80930 UN70872 UN71469 UN72084 AP72690 FT71565 FT80256 FT81112 GR72925 FT70808 FT71897 FT72763 FT80572 GR72720 GR81485 UN72697 UN72809 UN73874 UN80809 UN81416
RECALLING FIRM/MANUFACTURER
Perrigo Florida Inc., Lake Worth, FL, by letter on December 29, 2008 and on March 31, 2009. Firm initiated recall is ongoing.
REASON
Pediatric Electrolyte Solution is contaminated with Pseudomonas fluorescens and Serratia fonticola.
VOLUME OF PRODUCT IN COMMERCE
94,259 cases
DISTRIBUTION
Nationwide, Dominican Republic and Belize
___________________________________
PRODUCT
College Inn No MSG Chicken Broth 14.5 oz cans. The product is shipped 24 cans per tray/case. Recall # F-1167-2010
CODE
All dates. Lot Codes: LC8252VV Best By 12/8/2010, LC8291VV Best By 1/17/2011, LC8303VV Best By 1/29/2011, LC8304VV Best By 1/30/2011, LC9012VV Best By 4/12/2011, LC9013VV Best By 4/13/2011, LC9014VV Best By 4/14/2011, LC9042VV Best By 5/11 /2011, LC9043VV Best By 5/12/2011, LC9050VV Best By 5/19/2011, LC9127VV Best By 8/7/2011, 9140PF LC Best By 8/20/2011, 9147PF LC Best By 8/27/2011, 9194PF LC Best By 10/13/2011, 9195PF LC Best By 10/14/2011, 9204PF LC Best By 10/23/2011, 9205PF LC Best By 10/24/2011, 9236PF LC Best By 11/24/2011, 9237PF LC Best By 11/25/2011, 9238PF LC Best By 11/26/2011, 9239PF LC Best By 11/27/2011, and 9240PF LC Best By 11/28/2011
RECALLING FIRM/MANUFACTURER
DelMonte Corp., Pittsburgh, PA, by press release on December 4, 2009 and by letter on December 5, 2009. 
Manufacturer: Bay Valley Foods, LLC, Pittsburgh, PA. Firm initiated recall is ongoing. 
REASON
Cans labeled as NO MSG Chicken Broth actually contains a different product, Chicken Broth, which has MSG and hydrolyzed wheat gluten protein.
VOLUME OF PRODUCT IN COMMERCE
235,002 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
1) Choco-Pan Gourmet White Chocolate Fondant. Blue and Pastel Blue in net wt. 2 lb, 4 lb and 10 lb containers. UPC  8256900000, 8256900012 and 8256900013. Recall # F-1139-2010;

2) Choco-Pan Gourmet White Chocolate Fondant. Purple and Pastel Purple in net wt. 2 lb, 4 lb and 10 lb containers. UPC 8256900000, 8256900012 and 8256900013. Recall # F-1141-2010;

3) Choco-Pan Gourmet White Chocolate Fondant. Hot Pink in net wt. 2 lb, 4 lb and 10 lb containers. UPC 8256900000, 8256900012 and 8256900013. Recall # F-1142-2010
CODE
All lots shipped prior to 4/17/09
RECALLING FIRM/MANUFACTURER
Sweet Art, Inc., Indianapolis, IN, by telephone on or about April 17, 2009 and by follow-up letter. Firm initiated recall is complete.
REASON
1) The product contains the undeclared food colors, including blue 1 and red 3, and the undeclared preservative sodium benzoate;

2) The products contain undeclared food colors, including red 3 and blue 1 and the undeclared preservative sodium benzoate;

3) The product contains the undeclared food color red 3 and the undeclared preservative sodium benzoate
VOLUME OF PRODUCT IN COMMERCE
628
DISTRIBUTION
Nationwide, Canada, Mexico and United Kingdom
___________________________________
PRODUCT
College Inn Chicken Broth 14oz cans. The product is shipped in 12 pack carton. Recall # F-1166-2010
CODE
Carton Code 922299, Can Lot Code L99222 Best By 11/10/2011, Carton Code 922699, Can Lot Code L99226 Best By 11/14/2011, Carton Code 925799, Can Lot Code L99257 Best By 12/14/2011, Carton Code 926199, Can Lot Code L99261 Best By 12/18/2011, Carton Code 926799, Can Lot Code L99267 Best By 12/24/2011, Carton Code 927199, Can Lot Code L99271 Best By 12/28/2011, Carton Code 927899, Can Lot Code L99278 Best By 1/5/2012, Carton Code 931599, Can Lot Code L99315 Best By 2/11/2012, and Carton Code 931799, Can Lot Code L99317 Best By 2/13/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: DelMonte Corp., Pittsburgh, PA, by electronic communication on December 4, 2009.  
Manufacturer: Bay Valley Foods, LLC, Mendota, IL. Firm initiated recall is ongoing.  
REASON
Cans labeled as Chicken Broth actually contain a different product, No MSG Chicken Broth.
VOLUME OF PRODUCT IN COMMERCE
37,918 cans
DISTRIBUTION
NJ, NY

 RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT
Enbrel (etanercept) SureClick Autoinjector, 50 mg/mL, For Subcutaneous Use Only, Rx only. a) NDC 58406-445-04: 4 single- use prefilled autoinjectors per carton, b) NDC 58406-445-01: 1 single-use prefilled autoinjector. Recall # D-327-2010
CODE
a) 1005228, exp 3/2011; 1006109, exp 5/2011; 1010348, exp 6/2011; 1005945, exp 3/2011; 1007963, exp 5/2011; 1010349, exp 11/2011; 1005946, exp 3/2011; 1007964, exp 6/2011; 1010570, exp 9/2011; 1006035, exp 4/2011; 1009200, exp 5/2011; 1011162, exp 12/2011; 1006091, exp 2/2011; 1009201, exp 5/2011; 1011235, exp 1/2012; 1006092, exp 4/2011; 1009202, exp 6/2011; 1011236, exp 1/2012; 1006095, exp 4/2011; 1009203, exp 6/2011; 1011237, exp 2/2012; 1006100, exp 4/2011; 1009206, exp 10/2011; 1011875, exp 2/2012; 1006106, exp 5/2011; 1009726, exp 11/2011; 1012737, exp 2/2012; 1006107, exp 5/2011; 1010346, exp 4/2011; 1006108, exp 5/2011; 1010347, 5/2011; b) 1006119, exp 4/2011; 1006771, exp 5/2011; 1006774, exp 6/2011; 1007225, exp 4/2011; 1007795, exp 4/2011; 1010351, exp 12/2011
RECALLING FIRM/MANUFACTURER
Amgen Manufacturing, Limited, Juncos, PR, by letter on September 14, 2009 and January 18, 2010. Firm initiated recall is ongoing. 
REASON
Lack of Assurance of Sterility: Syringe barrel flange that slightly deviated from the center line of the syringe barrel, resulted in broken or cracked syringes.
VOLUME OF PRODUCT IN COMMERCE
2,948,741 syringes
DISTRIBUTION
Nationwide

 RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
1) Formo Cresol Solution, Contains Formaldehyde - 48.5%, Cresol, 48.5%, 1 fl oz (30 mL), Rx only, For Dental Use. a) Sultan, Ref # 0010601FG --- b) Henry Schien, Model # 1710601FG --- c) Henry Schien Model number CN10601FG --- d) Super Dent, Model # 14106011A. Recall # D-325-2010;

2) Dry Socket Remedy contains Benzocaine, Guaiacol and Balsam Peru, 1.Fl oz (30ml), Rx only, For Dental Use Only. Recall # D-326-2010
CODE
1) a) Lot numbers: 090925909, 110925952, 0111090122, 0111090130, 0311090319, 0311090321, 0411090421, 0610080614, 0610080616, 0610080617, 1010081024, 1110081113, 1210081209, 04110904211, 07100807031, 08100808141, 08110908131, 10100810242; b) lot numbers: 090925908, 090925909, 0311090321, 0810080813, 0810080814, 0811090810, 0811090813, 1110081112, 03110903191, 031109030201, 08110908101, 10100810241, 11100811121; c) Lot numbers: 110925952, 0710080703; d) Lot numbers: 090925908, 0311090320, 0811090813, and 1110081113;

2) Lot numbers: 0110090109; 0110090112; 01100901121; all expire January 2010
RECALLING FIRM/MANUFACTURER
DSHealthcare Inc. dba Sultan Health Care, Hackensack, NJ, by telephone/e-mail on September 30, 2009 and by letters beginning on October 9, 2009.
Manufacturer: Dentsply Caulk, Milford, DE. Firm initiated recall is ongoing.
REASON
Subpotent: During 12-month stability testing point the products failed to meet their specifications for active ingredients.
VOLUME OF PRODUCT IN COMMERCE
1) 48,477; 2) 272
DISTRIBUTION
Nationwide

  RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0072-10
CODE
Unit: 003LL67221
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by telephone on February 9, 2009. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as being crossmatch compatible, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0113-10
CODE
Units: 38GM12721, 38GM13710
RECALLING FIRM/MANUFACTURER
The American National Red Cross Indiana–Ohio Region, Fort Wayne, IN, by electronic notification on July 30, 2009 and by letter dated July 31, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN 
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0186-10
CODE
Unit: 4367549 (2 units)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc. Orlando, FL, by telephone on March 26, 2009. Firm initiated recall is complete.
REASON
Blood products, which did not meet the minimum requirement for Red Blood Cell volume, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0228-10
CODE
Unit: 003P73912
RECALLING FIRM/MANUFACTURER
The American National Red Cross – Southern Region, Douglasville, GA, by facsimile on September 24, 2008 and by letter dated October 3, 2008. Firm initiated recall is complete.
REASON
Blood product, for which documentation of irradiation was not complete, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
1) Fresh Frozen Plasma. Recall # B-0394-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0395-10
CODE
1) and 2) Unit: 268338720
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Systems, Inc. Scottsdale, AZ, by facsimile on October 11, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Platelets Pheresis Leukocytes Reduced. Recall # B-0396-10;
2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-0397-10
CODE
1) and 2) Unit: 9936941
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc. Orlando, FL, by telephone on March 26, 2009. Firm initiated recall is complete.
REASON
Platelets, inappropriately prepared by splitting the product into two storage bags instead of one, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-0398-10
CODE
Unit: 1627618
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific – Irwin Center, San Francisco, CA, by facsimile on September 11, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for variant Creutzfeldt - Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0399-10
CODE
Unit: W071209044106
RECALLING FIRM/MANUFACTURER
Medic, Inc. Knoxville, TN, by telephone on September 8, 2009 and by letter dated September 8, 2009. Firm initiated recall is complete.
REASON
Blood product, which failed quality control testing for platelet count and pH, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0402-10
CODE
Units: W036509017759 (2 units)
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by letter dated August 27, 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
LA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0420-10;
2) Recovered Plasma. Recall # B-0421-10
CODE
1) and 2) Unit: W03940913635100
RECALLING FIRM/MANUFACTURER
Florida Blood Services, Inc. St Petersburg, FL, by fax and e-mail on August 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donating, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0422-10
CODE
Unit: W090709019337
RECALLING FIRM/MANUFACTURER
Blood Bank of the Redwoods, Santa Rosa, CA, by fax on August 3, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0423-10
CODE
Unit: W036709401981
RECALLING FIRM/MANUFACTURER
Central Illinois Community Blood Center, Springfield, IL, by fax and letter on July 8, 2009. 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
IL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0424-10
CODE
Unit: W117009217470
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone and letter on July 10, 2009. 
Manufacturer: Blood Centers of the Pacific, Redding, CA. Firm initiated recall is complete.  
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0425-10
CODE
Unit: W117009182404
RECALLING FIRM/MANUFACTURER
Blood Center Of The Pacific, San Francisco, CA, by letter on July 28, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0426-10
CODE
W117009317897( part 1 and 2)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Blood Centers of the Pacific, San Francisco, CA, by telephone and letter on July 2, 2009. 
Manufacturer: Blood Centers Of The Pacific, Fairfield, CA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT
Recovered Plasma. Recall # B-0114-10
CODE
Units: 38GM12721, 38GM13710
RECALLING FIRM/MANUFACTURER
The American National Red Cross Indiana–Ohio Region, Fort Wayne, IN, by electronic notification on July 30, 2009 and by letter dated July 31, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for testing positive for the human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0180-10;
2) Plasma Frozen within 24 hours (FP24). Recall # B-0181-10
CODE
1) and 2) Units: 6845812, 6831284
RECALLING FIRM/MANUFACTURER
Recalling Firm: Florida's Blood Centers, Inc., Orlando, FL, by letter dated June 30, 2009 and by telephone on July 6, 2009. 
Manufacturer: Florida's Blood Centers, Inc., Sebring, FL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
FL
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-0392-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0393-10
CODE
1) Unit: 20KK70691;
2) Unit: 20KK70699
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by telephone on April 14, 2009, by facsimile on May 8, 2009, and e-mail on May 12, 2009. Firm initiated recall is complete.
REASON
Blood products, which may have reached unacceptable temperatures during shipment, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UT, MO

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
TrailBlazer Support Catheter,  Rx Only, Sterile EO. US Model Numbers: SC-014-135, SC-018-090, SC-035-065, SC-035-135, SC-014-150, SC-018-150, SC-035-090, and SC-035-150. Intended to guide and support a guide wire during access of the vasculature.
Recall # Z-0497-2010
CODE
Lot numbers: 7828282, 7792290, 7792584, 7805570, 7805797, 7806392, 7820252, 7790666, 7791887, 7803307, 7835331, 7822400, 7822593, 7800446, 7800555, 7800756, 7800779, 7800809, 7801822, 7801875, 7803305, 7803306, 7820273, 7834779, 7834845, 7824905, and 7832205
RECALLING FIRM/MANUFACTURER
Ev3, Inc., Plymouth, MN, by letter dated November 6, 2009. Firm initiated recall is ongoing.
REASON
The TrailBlazer" Support Catheter may crack near the radiopaque marker band at the distal end of the device during use. Cracking of the catheter shaft in this location can result in material separation, and potential embolization.
VOLUME OF PRODUCT IN COMMERCE
70 devices
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1610. Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. Recall # Z-0273-2010;

2) Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1613. Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. Recall # Z-0274-2010;

3) Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1616. Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. Recall # Z-0275-2010;

4) Bard Magnum Disposable Biopsy Core Needle 16 gauge, Catalog Number: MN1620. Bard Magnum Disposable Biopsy Core Needle is intended for use in obtaining biopsies from soft tissues such as liver, kidney, prostate, breast, spleen, lymph nodes and various soft tissue tumors. Recall # Z-2076-2010
CODE
1) Lot Number: REQI0640 REQJ0110 REQK0190 REQK0376 REQK0818 REQL0207 RERA0671 RERB0028 RERB0580 RERC0286 RERD0535 RERE0157 RERE0679 RERE0825 RERG0081 RERH0338 RERH0484 RERH1054 RERI0145 RERI0583 RERJ0007 RERJ0564 RERK0165 RERK0261 RERK0706 RERL0186 RESA0227 RESA0230 RESA0822 RESB0375 RESB0978 RESC0424 RESD0095 RESD0591 RESE0372 RESF0027 RESF0558 RESF0725 RESG0412 RESH0055 RESH0717 RESI0709 RESK0646 Lot Number REQI0640 REQJ0110 REQK0190 REQK0376 REQK0818 REQL0207 RERA0671 RERB0028 RERB0580 RERC0286 RERD0535 RERE0157 RERE0679 RERE0825 RERG0081 RERH0338 RERH0484 RERH1054 RERI0145 RERI0583 RERJ0007 RERJ0564 RERK0165 RERK0261 RERK0706 RERL0186 RESA0227 RESA0230 RESA0822 RESB0375 RESB0978 RESC0424 RESD0095 RESD0591 RESE0372 RESF0027 RESF0558 RESF0725 RESG0412 RESH0055 RESH0717 RESI0709 RESK0646 and RETC0214;

2) Lot Number: REQI0632 REQJ0353 REQK0281 REQK0377 RERA0355 RERB0142 RERC0031 RERD0071 RERD0117 RERE0156 RERE0547 RERG0317 RERH0719 RERI0584 RERK0426 RERL0187 RESA0699 RESB0560 RESC0584 RESD0592 RESE0373 RESF0560 RESG0181 RESH0718 RESI0438 RESJ0549 RESJ0550 RETB0903 and RETB0904;

3) Lot Number: REQI0629 REQJ0343 REQJ0532 REQK0096 REQK0816 REQK1003 REQL0205 RERA0274 RERA0460 RERB0017 RERB0780 RERC0826 RERE0097 RERE0818 RERG0080 RERH0564 RERI0055 RERI0585 RERJ0009 RERK0116 RERK0428 RERK0627 RERL0541 RESA0700 RESB0562 RESC0423 RESD0593 RESE0615 RESF0033 RESF0705 RESG0180 RESH0546 RESI0285 RESI0441 RESI0736 RESJ0139 RESJ0639 RESJ0672 RETA0569 RETB0187 RETB0214 and RETB0794;

4) Lot Number: REQJ0345 REQJ0534 REQK0287 REQK0817 REQK0993 RERA0224 RERA0592 RERA0755 RERB0582 RERC0904 RERD0210 RERD0711 RERF0404 RERG0082 RERH0917 RERJ0373 RERJ0643 RERJ0809 RERK0686 RERL0053 RESA0701 RESB0563 RESC0344 RESD0594 RESF0030 RESF0561 RESG0255 RESH0054 RESH0719 RESH0934 RESI0737 RESL0557 RETA0352 and RETB0215
RECALLING FIRM/MANUFACTURER
Bard Peripheral Vascular Inc., Tempe, AZ, by letter on October 08, 2009.  Firm initiated recall is ongoing.
REASON
The recall was initiated after the firm determined that some Magnum Disposable Biopsy Core Needle 16 gauge lots may exhibit an exposed sample chamber, due to extended stylet length resulting from a loose hub connection. The exposed sample chamber will typically result in an inability to obtain the biopsy sample. In the majority of reported cases, there was no injury to the patient or user. When used in highly vascular organs, the exposed sample chamber may, in rare instances, result in trauma or puncture to neighboring tissue and lead to subsequent bleeding as initiated.
VOLUME OF PRODUCT IN COMMERCE
334,701 units
DISTRIBUTION
Nationwide and internationally to Canada, Mexico, Algeria, Andorra, Austria, Bahrain, Belarus, Belgium, Croatia, Cyprus, Czech Republic Denmark, Finland, France, French, Guiana, Germany, Gibraltar, Greece, Hungary, Ireland, Israel, Italy, Ivory Coast Kenya, Kuwait, Latvia, Lebanon, Luxembourg, Malta, Martinique, Mauritius, Morocco, Netherlands, New Caledonia, Nigeria, Norway, Oman, Poland, Portugal, Republic of Kosovo, Republic of Macedoni, Reunion, Romania Russia Saudi Arabia. Senegal Serbia, Seychelles, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Tunisia, Turkey, Ukraine, United Arab. Emirates United Kingdom Australia New Zealand Canada Japan Bangladesh, China, Hong Kong, India, Indonesia, Korea, Malaysia, Pakistan, Singapore, Sri Lanka Taiwan, Thailand, Vietnam, Argentina, Bahamas, Barbados, Brazil, Chile, Colombia, Dominican Republic, Mexico, Peru and Suriname
___________________________________
PRODUCT
Stelkast Unicondylar Knee Femoral Component SC2462-1. Used for moderate joint impairment from painful arthritis (rheumatoid, osteo and/or post-traumatic; revision of failed unicompartmental knee implant or other procedure; and alternative to tibial osteotomy in patients with unicompartmental arthritis. Recall # Z-0371-2010
CODE
Lot number 20210-100108
RECALLING FIRM/MANUFACTURER
Stelkast Co, Mcmurray, PA, by telephone on May 5-19, 2009. Firm initiated recall is complete.
REASON
Incorrect size markings on component.
VOLUME OF PRODUCT IN COMMERCE
20 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) SureSigns Patient Monitors (VM3, VM4. VM6. VM8): VM3 3/5 lead ECG/SPo2, Respiration Bedside Patient Monitor with 8.4"display VM4 3 Lead ECG, NBP, SPo2, optional Predictive Temp Bedside Patient Monitor with 8.4" display VM6 3/5 Lead ECG, NBP, Temp, optional SPo2 Bedside Patient Monitor with 8.4" display or 3/5 Lead ECG, NBP, Temp, optional SPo2 option IBP Bedside Patient Monitor with 8.4" display VM8 3/5 Lead ECG, NBP, Temp, IPB, ET CO2, SPo2 Bedside Patient Monitor with 10" display or 3/5 Lead ECG, NBP, Temp, IPB, SPo2 Bedside Patient Monitor with 10" display Part number: VM3: 863077, 453564041661, 453564050161, VM4: 863063, 453564024371, 453564021961, 453564024401, 453564021971 VM6: 863064,863065, 453564024421, 453564022001, 453564024441 VM8: 453564022041, 863066, 863068, 453564022081, 453564024461, 453564024481 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. Recall # Z-0372-2010;

2) SureSigns Vital Signs Monitors (VS3)-Vital Signs Viewer Central Viewing Station View up to 12 VM monitors at 1 time Part number: 863069, 863070, 63071, 863072, 863073, 863074, 453564041251, 453564041261, 453564041271, 453564041281, 453564041291, 453564041301 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. Recall # Z-0373-2010;

3) SureSigns Vital Signs Viewer (VSV):Spot Check Vital Signs Monitor with NBP (options to include Predictive Temperature only; SPo2 only; SPo2 and Recorder only; SPo2 and Predictive Temperature only; or SPo2, Predictive Temperature, and Recorder Part Number: 863067 and 453564041491 The SureSigns VM3, VM4, VM6, VM8 and VS3 monitors are used for monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics, and neonates in healthcare environments. Additionally, the monitor is intended for use in transport situations within a healthcare facility. Recall # Z-0374-2010
CODE
1) Software Versions: A.01.51, A.01.45, A.01.42, A.01.40, A.00.58, A.00.55, A.00.52, A.00.51, and A.00.41;

2) Software Versions: A.02.33, A.01.18, A.00.34, A.00.28, and A.00.26;

3) Software Versions: A.00.48, and A.00.4O
RECALLING FIRM/MANUFACTURER
Philips Healthcare Inc., Andover, MA, by letter dated October 2009. Firm initiated recall is ongoing.
REASON
Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker.
VOLUME OF PRODUCT IN COMMERCE
49,648 units
DISTRIBUTION
Nationwide, Canada, Afghanistan, Albania, Algeria, Angola, Argentina, Austria, Australia, Bahrain, Bosnia & Herzegovina, Bangladesh, Belgium, Bulgaria, Bahrain, Bolivia, Brazil, Switzerland, Chile, China, Colombia, Costa Rica, Croatia/Hrvatska, Cyprus, Czech Republic, Germany, Denmark, Dominican Republic, Algeria, Ecuador, Estonia, Egypt, Spain, Finland, France, Gabon, Ghana, Great Britain, French Guiana, Guadeloupe, Greece, Guatemala, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Iceland, Italy, Iraq, Jordan, Japan, Jamaica Republic of Korea, Kenya, Kosovo, Kuwait, Lebanon, Sri Lanka, Lithuania, Luxembourg, Latvia, Libyan Arab Jamahiriya, Morocco, Norway, New Zealand, Republic of Moldova, Macau, Malawi, Mali, Malta, Martinique, Mauritius, Mexico, Malaysia, Namibia, Nepal, Netherlands,Nicaragua, Nigeria, Norway, Philippines, Pakistan, Oman, Panama, Peru, Poland, Puerto Rico, Palestinian Territories, Portugal, Qatar, Romania, Republic of Serbia, Russian Federation, Saudi Arabia, Sweden, Singapore, Slovenia, Slovakia, Spain, Sri Lanka, Switzerland, El Salvador, Tanzania, Thailand, Tunisia, Turkey, Taiwan, Uganda, Venezuela, Vietnam, South Africa, and Zimbabwe United Arab Emirates
___________________________________
PRODUCT
Hocoma Lokomat-System with Pediatric Module Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a, V5.0x. Powered exercise equipment used to apply automated locomoter training for hemiplegic and paraplegic patients. Recall # Z-0590-2010
CODE
Software Versions: V4.30, V4.31, V4.31a, V4.31b, V4.31c, V4.32, V4.32a and V5.0x
RECALLING FIRM/MANUFACTURER
Hocoma AG, Zuerich, Switzerland, by letter dated May 27, 2009. Firm initiated recall is ongoing.
REASON
Changes to the stored "sensitivity" values may occur and leads to higher limits in the force and trajectory deviation.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Bausch & Lomb SoFlex SE Foldable Intraocular Lens. UPC 4001404, Rx Only, STERILE. Intraocular lens indicated for primary implantation for visual correction in adult patients where the cataractous lens has been removed by phacoemulsification. The lens is intended for placement in the capsular bag. Model Number: LI61SE. Recall # Z-0591-2010
CODE
Lot Number: 4916928
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb Inc., Rochester, NY, by telephone beginning November 19, 2009 and by follow-up letter dated November 23, 2009.
Manufacturer: Bausch & Lomb Surgical, Inc., Clearwater, FL. Firm initiated recall is ongoing.
REASON
Bausch & Lomb is recalling their Silicone L161SE Intraocular Lens Lot 4916928 (23.5D) after receiving three customer complaints for what appears to be opacification of the intraocular lens. The opacification occurred within one week of implantation. In each reported case the surgeon explanted the lens.
VOLUME OF PRODUCT IN COMMERCE
85 lenses
DISTRIBUTION
Nationwide, Canada, and Taiwan
___________________________________
PRODUCT
Biomet 2.9 Micromax L-15 suture anchor, flexible long shaft, #2 blue/white maxbraid, PLLA/PGA L-15, sterile; REF 905456. Intended for use in soft tissue reattachment procedures in the shoulder, wrist, elbow and knee. Recall # Z-0611-2010
CODE
Lot number: 695710
RECALLING FIRM/MANUFACTURER
Biomet, Inc., Warsaw, IN, by letter dated December 11, 2009. Firm initiated recall is ongoing.
REASON
The anchor label states it contains a flexible shaft, but this lot actually contains a rigid shaft.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
AL
___________________________________
PRODUCT
Tornier Arthro Tunneler. For transossous fixation of tendons to bone in rotator cuff repair. Catalog Number: SMB000101. Recall # Z-0656-2010
CODE
Lot Numbers: 09K1, 09J5, 09J6, 09K3, 09K4, & 09K5
RECALLING FIRM/MANUFACTURER
TAG Medical Corp., Naharia, Israel, by letter dated December 4, 2009. Firm initiated recall is ongoing.
REASON
Device failed to deploy the distal loop.
VOLUME OF PRODUCT IN COMMERCE
60 units
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR JANUARY 27, 2010

###

RSS Feed for FDA Enforcement Report [what is RSS?]