• 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 May 12, 2010

May 12, 2010                                                                                        10-18

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
___________________________________
PRODUCT 
1) Sausage 'n Cheese Logs Gift Box, Gift #11. A sharp cheddar with almond log, a ranch with almond log and two all-beef sausages (salami and original). Net wt. 1 lb, 14 oz. Recall # F-2007-2010;

2) Cheese Logs & Cutting Board, Gift #87. 2-10 oz. cheese logs: Sharp Cheddar with Almond and Ranch with Almond Net wt 1 lb. 4 oz combined with a hardwood cutting board (11 3/4 inches x 8 inches). Recall # F-2008-2010;

3) Smorgasbord Cheese & Sausage Gift Box, Gift #325. Natural Aged Cheddar and Colby Cheese, zesty Original Mesquite Smoked Salami and Garlic Beef Sausages, tangy mustards, one nut-covered Sharp Cheddar Cheese Log and Crunchy Bar Snack Mix. Net wt. 3 lb. 3 oz. Recall # F-2009-2010;

4) Wisconsin Cheese Log Trio, Gift #365. Bacon, Ranch and Sharp Cheddar with almond cheese logs, Net. Wt. 1 lb. 14 oz. Recall # F-2010-2010;

5) Two Cheese Logs, Gift #411 and Gift #509, Ranch and Sharp Cheddar with almond cheese logs. 10 oz. each, Net Wt. 1 lb 4 oz. Recall # F-2011-2010;

6)  Cheese Ball Trio, Gift # 441. Sharp Cheddar, Ranch and Bacon Cheddar cheese balls rolled in chopped almonds. Net Wt. 1 lb. 14 oz. Snacker Pack, Gift #751. Three blocks of natural brick, Colby and aged cheddar cheeses, salami and garlic all-beef sausages, Sharp cheddar, Cheddar & Blue, Old Hickory, and Cheddar & Bacon cheese spreads, almond-coated Sharp Cheddar cheese log. Net Wt. 2 lbs. 11 oz. Recall # F-2012-2010;

7) Snacker Pack, Gift #751. Three blocks of natural brick, Colby and aged cheddar cheeses, salami and garlic all-beef sausages, Sharp cheddar, Cheddar & Blue, Old Hickory, and Cheddar & Bacon cheese spreads, almond-coated Sharp Cheddar cheese log. Net Wt. 2 lbs. 11 oz. Recall # F-2013-2010;

8) Cheese Balls & Sausages, Gift # 876. Two 11 oz All-Beef Original Sausages, 10 oz Sharp Cheddar, Bacon Cheddar and Ranch cheese balls rolled in chopped almonds. Net Wt. 3 lb. 4 oz. Recall # F-2014-2010
CODE
1) Lot number: 247711, 251049, 251820, 252751, 253370;

2)  Lot numbers: 250095, 251006, 252740, 253359;

3)  Lot number: 247715, 250527, 251265, 252303;

4) Lot number: 247721, 250529, 251809, 252291, 252794, 253223;

5) Gift #411, Lot number: 247895, 249164, 251342, 252255, 253228; Gift #509 Lot number: 247876, 249788, 251775, 253259;

6) Lot number: 247722, 249351, 251764, 252806;

7) Lot numbers: 248112, 249177, 250109, 251358, 252294;

8) Lot numbers: 247884, 249179, 251019, 251768, 252715, 253355
RECALLING FIRM/MANUFACTURER
The Wisconsin Cheeseman, Inc., PO Box 1, Madison, WI., by press release and letter beginning on January 20, 2010. Firm initiated recall is on going.
REASON
Wisconsin Cheeseman is recalling cheese log/cheese ball products in conjunction with the voluntary recall initiated by Parkers Farm, Inc. Parkers Farm believes some of its food items have the potential to be contaminated with Listeria monocytogenes bacteria.
VOLUME OF PRODUCT IN COMMERCE
8,248 gift baskets
DISTRIBUTION
Nationwide and Canada

___________________________________
PRODUCT 
1) #16525 Artificial Chicken Pan Drip #RF-1020701, packaged in 50-lb. bags. Recall # F-2015-2010;

2) #17945 Bean & Cheese Burrito RF0960701, packaged in 50-lb. bags. Recall # F-2016-2010;

3) Red Hot Burritto Seasoning #17954 RF2990701, packaged in 50-lb. bags. Recall # F-2017-2010;

4) Circle B Smoke Sausage #S1444 MM0290911, packaged in 41.5-lb. bags. Recall # F-2018-2010;

5) Circle B Weiner S1441 w/o Mustard MM1900803, packaged in 50-lb. bags. Recall # F-2019-2010;

6) Schwan's Gravy Mix DP-2470401, packaged in 25.5-lb. bags. Recall # F-2020-2010;

7) Philly Steak Seasoning #SW-0550911, packaged in a 20-lb. box, a 30-lb. bag, and in 50-lb. bags. Recall # F-2021-2010;

8) WalMart ISP Pump DP-2320401, packaged in 37.5-lb. bags. Recall # F-2022-2010;

9) Dan's Prize Chef's Post Roast Rub DP-2400901, packaged in 25-lb. bags. Recall # F-2023-2010
CODE
1) Lots 12090904, 12020904, 11190909, and 11130903;
2) Lot 01271006;
3) Lot 01211008;
4) Lot 01121009;
5) Lot 01121005;
6) Lot 01071006;
7) Lot 02221012 (50-lb. bags), lot 01271009 (20-lb. box and 30-lb. bag);
8) Lots 01151002 and 01071004;
9) Lot 01211003
RECALLING FIRM/MANUFACTURER
BlendTech Inc., Wichita, KS, by e-mails on February 26, 2010, March 3, 2010 and March 5, 2010. Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
36,029 lbs
DISTRIBUTION
MN, OK, KS, and WA
___________________________________
PRODUCT 
1) Pringles Family Faves Taco Night Super Stack. Recall # F-2024-2010;

2) Pringles Restaurant Cravers Cheeseburger Super Stack. Recall # F-2025-2010
CODE
1) "Best By" date 03/2011, 04/2011, and 05/2011;
2) "Best By" date 02/2011 and 04/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Procter & Gamble Co., Cincinnati, OH, by their recall portal or by letter on March 3, 2010.  
Manufacturer: Proctor & Gamble Mfg Co., Jackson, TN.   Firm initiated recall is ongoing.
REASON
The product was manufactured using hydrolyzed vegetable protein recalled by Basic Food Flavors, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
76,766 Cases
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
1) Follow Your Heart BBQ Braised Tofu, 10 oz, Barcode: 0-49568-01001-4; Follow Your Heart BBQ Braised Tofu, 8 lb, 0-49568-07025-4. Recall # F-2026-2010;

2) Follow Your Heart Cheezy Garlic Pasta, 8 oz, Barcode: 0-49568-01006-9; Follow Your Heart Cheezy Garlic Pasta, 7 lb, 0-49568-04006-6. Recall # F-2027-201;

3) Follow Your Heart Curried Tofu, 10 oz, Barcode: 0-49568-01010-6; Follow Your Heart Curried Tofu with Rice, 7 lbs, Barcode: 0-49568-04011-0. Recall # F-2028-2010;

4) Follow Your Heart Heartsmart Burger, 7 oz, Barcode: 0-49568-01098-4. Recall # F-2029-2010;

5) Follow Your Heart Kung Pao Tofu, 10 oz, Barcode: Follow Your Heart Kung Pao Tofu with Rice, 7 lbs. Recall # F-2030-2010;

6) Follow Your Heart Savory Tofu Sauté, 10 oz, Barcode: 0-49568-01038-0; Follow Your Heart Savory Tofu Sauté, 7 lbs, Barcode: 0-49568-04014-1. Recall # F-2031-2010;

7) Follow Your Heart Smoked "Chicken" Pasta, 8 oz, Barcode: 0-49568-01076-2; Follow Your Heart Smoked "Chicken" Pasta, 7 lb, Barcode: 0-49568-04076-9. Recall # F-2032-2010;

8) Follow Your Heart Sweet & Sour Tofu, 10 oz, Barcode: 0-49568-01430-2; Follow Your Heart Sweet & Sour Tofu, 7 lb, Barcode: 0-49568-04430-9. Recall # F-2033-2010;

9) Follow Your Heart Thai Peanut Tofu, 10 oz, Barcode: 0-49568-01028-1; Follow Your Heart Thai Peanut Tofu Wrap, 12 oz, Barcode: 0-49568-01034-2; Follow Your Heart Thai Peanut Braised Tofu, 8 lb, Barcode: 0-49568-04407-1. Recall # F-2034-2010;

10) Follow Your Heart Texas Tofu, 10 oz, Barcode: 0- 49568-01037-3. Recall # F-2035-2010;

11) Follow Your Heart Veggie Burrito with Cheese, 12 oz, Barcode: 0-49568-01070-0. Recall # F-2036-2010;

12) Follow Your Heart Beef Al Jus, 224 oz. Recall # F-2037-2010;

13) Follow Your Heart Organic Creamy Ranch Dressing: 12 oz, Barcode: 0-49568-66012-7; 32 oz, Barcode: 0-49568-66032-5; 128 oz, Barcode: 0-49568-66128-5. Recall # F-2038-2010;

14) Trader Joe's Organic Creamy Ranch Dressing and Dip, 12 oz, Barcode: 0069-6890. Recall # F-2039-2010;

15) Follow Your Heart Low Fat Veggie Burrito, 12 oz, Barcode: 0-49568-01069-4. Recall # F-2040-2010;

16) Follow Your Heart Curried Tofu, 10 oz, Barcode: 0-49568-01010-6. Recall # F-2041-2010;

17) Follow Your Heart Curried Tofu with Rice, 7 lb, Barcode: 0-49568-04011-0. Recall # F-2042-2010;

18) Follow Your Heart Thai Peanut Tofu Wrap, 12 oz, Barcode: 0-49568-01034-2. Recall #
F-2043-2010;

19) Follow Your Heart Thai Peanut Braised Tofu, 8 lb Barcode: 0-49568-04407-1. Recall # F-2044-2010
CODE
1) USE BY DATES: 11/10/09 through 03/09/10;
2) USE BY DATES: 11/10/09 through 03/06/10;
3) USE BY DATES: 11/10/09 through 03/09/10;
4) USE BY DATES: 11/10/09 through 03/19/10;
5) USE BY DATES: 11/10/09 through 03/08/10;
6) USE BY DATES: 11/10/09 through 03/10/10 0- 49568-011038-0 and 0-49568-04014-1;
7) USE BY DATES: 11/10/09 through 03/14/10;
8) USE BY DATES: 11/10/09 through 03/08/10;
9) USE BY DATES: 11/10/09 through 03/12/10;
10) USE BY DATES: 11/10/09 through 03/12/10;
11) USE BY DATES: 11/10/09 through 03/05/10;
12) USE BY DATES: 11/10/09 through 03/19/10;
13) USE BY DATES: JUN 14 10, JUN 21 10;
14) USE BY DATES: JUN 13 10;
15) USE BY DATES: 11/10/09 through 03/05/10;
16) USE BY DATES: 11/10/09 through 03/09/10;
17) USE BY DATES: 11/10/09 through 03/09/10;
18) USE BY DATES: 11/10/09 through 03/11/10;
19) USE BY DATES: 11/10/09 through 03/08/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Earth Island, Chatsworth, CA, by telephone and letter via fax on February 26, 2010.
Manufacturer: Gold Coast Ingredients, Inc., CA. Firm initiated recall is ongoing.
REASON
Earth Island is conducting a voluntary recall on its distribution of the following Follow Your Heart brand products as a precautionary measure due to possible Salmonella contamination of a natural flavor from one of our suppliers. The recalled products contain natural flavor supplied by Basic Food Flavors of Las Vegas, Nevada.
VOLUME OF PRODUCT IN COMMERCE
21,498 lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Instant Beef Soup- white sealed pouch with black labeling. MIDAS Foods International American Saucery *** net. wt. 0.213 lbs. AS493060 Pouches packed in cardboard box and labeled in black print as: "Directions: *** Ingredients *** Contains 15-0.213 lb. Pouches Mfg. Date: MAR 10, 2010-01 *** Best Before SEP 2010 *** Code: AS493060 *** MiDAS Foods International American Saucery ***". Recall # F-2045-2010;

2) Instant Beef Stroganoff Sauce - 10 lb plastic bag packaged in a cardboard box with black lettering on the label. Recall # F-2046-2010
CODE
1) Lot: AS493060;
2) Lot: AS605010
RECALLING FIRM/MANUFACTURER
Michigan Dessert Corp., Oak Park, MI, by telephone, letter and/or e-mail on April 22, 2010. Firm initiated recall is ongoing.
REASON
Firm distributed product with HVP (hydrolyzed vegetable protein) and the product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1) 51.4 lb; 2) 10.2 lb
DISTRIBUTION
FL, TN

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT 
1) John Frieda Luxurious Volume Full Splendor Conditioner Flexible tubes a) 8.45 fl oz Item Number 1317300; Tube UPC 7 17226 13173 8; Case UPC 107 17226 13173 5 & b) 1.5 fl oz Item Number 1332900; Tube UPC 7 17226 13329 9; Case UPC 107 17226 13329 6. Recall # F-2000-2010;

2) John Frieda Brilliant Brunette Shine Release Moisturizing Conditioner Item Number 1172802 - 8.45 fl oz, Tube UPC 7 17226 013102 Case UPC 107 17226 01310 9. Recall # F-2001-2010;

3) John Frieda Brilliant Brunette Shine Release Daily Conditioner Item Number 1172602 - 8.45 fl oz. Tube UPC 7 17226 013089, Case UPC 107 17226 01308 6. Recall # F-2002-2010;

4) John Frieda Sheer Blonde Highlight Activation Daily Conditioner for Darker Shades Item Number 1171702 - 8.45 fl oz; Tube UPC 7 17226 505140. Recall # F-2003-2010;

5) John Frieda Sheer Blonde Highlight Activating Daily Conditioner for Lighter Shades, Item Number 1171602 - 8.45 fl oz; Tube UPC 7 17226 505133; Case UPC 107 17226 50513 0.
Recall # F-2004-2010
CODE
1) a) Lot Codes Z032126ZZ, Z032226ZZ, Z033126ZZ; b) Lot Codes Z032206ZZ, Z033106ZZ;
2) Lot #'s: Z025126ZZ, Z025226ZZ, Z050126ZZ, Z050226ZZ;
3) Lot #'s: Y336226ZZ, Y337126ZZ, Z06226ZZ
4) Lot #'s: Z018126ZZ, Z018226ZZ
5) Lot #'s: Z036126ZZ, Z061126ZZ, Z061226ZZ
RECALLING FIRM/MANUFACTURER
KAO Brands Co., Cincinnati, OH, by letters on March 29, 2010. Firm initiated recall is ongoing.
REASON
Micro results above specification limits of less than 10 cfu/gram. Results range from 32 cfu/gram to 28,000 cfu/gram.
VOLUME OF PRODUCT IN COMMERCE
1,449 cs/24/1.5 oz tubes & 50,361 cs/6/8.45 oz tubes
DISTRIBUTION
Nationwide, Dominican Republic, Ecuador, Panama, South Africa

___________________________________
PRODUCT 
1) Frozen hash brown potatoes manufactured under the following product names and labels: (1) Mr. Dell's Shredded Hash Browns, Original Potato Shreds, 30- and 64-oz. plastic bags; (2) Mr. Dell's Southern Style Hash Browns, Diced Potatoes, 32-oz. plastic bags; (3) Best Choice Hashbrowns, Shredded Potatoes, 30- and 64-oz. plastic bags; (4) Best Choice Hashbrowns, Southern Style, 32-oz. plastic bags; (5) Our Family Hash Browns, Shredded Potatoes, 30-oz. plastic bags; (6) Our Family Hash Browns, Southern Style Potatoes, 32-oz. plastic bags; (7) Hy-Top All Natural Shredded Hashbrown Potatoes, 30-oz. plastic bags; (8) Schnucks Hash Browns, Shredded Potatoes, 24-oz. plastic bags; (9) Schnucks Hash Browns, Southern-Style Potatoes, 32-oz. plastic bags; (10) Laura Lynn Shredded Hash Browns, 30-oz plastic bags; (11) Market Basket Country Style Hash Browns, Shredded, 30-oz. plastic bags; (12) Cub Foods Shredded Hash Brown Potatoes, 30-oz. plastic bags; (13) Flavorite Shredded Hash Brown Potatoes, 30-oz. plastic bags; (14) IGA Shredded Hashbrown Potatoes, 30-oz. plastic bags; (15) Shop 'n Save Shredded Hash Brown Potatoes, 30-oz. plastic bags; (16) Richfood Shredded Hash Brown Potatoes, 30-oz. plastic bags; (17) Giant Eagle Country Style Shredded Hash Brown Potatoes, 30-oz. and 4-lb. plastic bags; (18) Giant Eagle Southern Style Diced Hash Brown Potatoes, 32-oz. and 5-lb. plastic bags; (19) Lowes Foods Country Style Hash Browns, 30-oz. plastic bags; (20) Shop Rite Hashbrowns Frozen Potatoes, 32-oz. plastic bags; (21) Food Club Shredded Hash Browns, 30-oz. plastic bags; (22) Food Club Southern Style Hash Browns, 32-oz. plastic bags; (23) ShurFine Country Style Hash Browns Shredded Potatoes, 30-oz. plastic bags; (24) Shurfine Hash Browns, Southern Style Potatoes, 32-oz. plastic bags; (25) Best Yet Country Style Hash Browns, 30-oz. plastic bags; (26) Southern Home Shredded Hashbrowns Potatoes, 30-oz. plastic bags; (27) Hannaford Shredded Hash Browns, country style shredded potatoes, 30-oz. plastic bags; (28) Hannaford Hash Browns, southern style diced potatoes, 32-oz. plastic bags; (29) Side Liners Shredded Hash Browns Potatoes, 24-oz. plastic bags; (30) Mr. Dell's Chef's Choice Premium Quality IQF Hash Browns, 18-lb. cases, 6/48-oz. unlabeled bags/case; (31) Mr. Dell's Chef's Choice Premium Quality IQF Country Chunks, 24-lb. cases, 6/64-oz. unlabeled bags/case; (32) Mr. Dell's Chef's Choice Premium Quality IQF American Slice, 18-lb. cases, 6/48-oz. unlabeled bags/case; (33) Mr. Dell's Chef's Choice Premium Quality IQF One Inch Dice, 24-lb. cases, 6/64-oz. unlabeled bags/case; (34) Chefs Choice Premium Quality IQF Diced Potatoes, 6/80-oz. unlabeled bags/case; (35) Owen's 1" Diced Potatoes, packaged in 30-lb. bulk cases labeled as Mr. Dell's All Natural Frozen Vegetables; (36) Boyles 1/4" D Potatoes, packaged in 32-lb. bulk cases labeled as Mr. Dell's All Natural Frozen Vegetables; (37) Bulk Shreds, packaged in bulk cases labeled as Mr. Dell's All Natural Frozen Vegetables; and (38) Sun Valley 3/8" Dice Potatoes, packaged in bulk cases labeled as Mr. Dell's All Natural Frozen Vegetables. Recall # F-2005-2010;

2) Frozen hash brown potatoes with onions and peppers manufactured under the following product names and labels: (1) Mr. Dell's O'Brien Hash Browns with Peppers and Onions, 24-oz. plastic bags; (2) Best Choice Potatoes O'Brien with Onions and Peppers, 28-oz. plastic bags; (3) Hy-Top All Natural O'Brien Potatoes with Onions and Peppers, 24-oz. plastic bags; (4) Schnucks Hash Browns, Western-Style Potatoes, packaged in 28-oz. plastic bags; (5) Giant Eagle Western Style Diced Hash Brown Potatoes, 28-oz. plastic bags; and (6) Food Club Potatoes O'Brien, 28-oz. plastic bags. Recall # F-2006-2010
CODE
1) Product numbers 1 thru 2, 7, 20, 29, and 34 - All products dated prior to 1/7/2012 and/or the code begins with a "9"; Product numbers 3 thru 6, 8 thru 9, 11 thru 19, 21 thru 28, and 30 thru 33 - All products dated prior to 7/7/2011 and/or the code begins with a "9"; Product numbers 10 and 35 thru 37 - All products dated prior to 1/7/2012 and/or the code begins with a "9";

2) Product numbers 1 and 3 - All products dated prior to 1/7/2012 and/or the code begins with a "9"; Product numbers 2, and 4 thru 6 - All product dated prior to 7/7/2011 and/or the code begins with a "9"
RECALLING FIRM/MANUFACTURER
Mr Dell Foods Inc., Kearney, MO, by letters, e-mails and telephone beginning January 7, 2010. Firm initiated recall is ongoing.
REASON
Some of the product may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
23,542,234 lbs.
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
Breyers Food Service Parlor Oreo Cookies and Cream Ice Cream, 3 gallons (11.35)L; Breyers Food Service Vanilla Bean Ice Cream: Unilever Item No. 20102, Unit UPC 077567201027; Case SCC-14 No.: 1007756201024;  3 gallons (11.36), Cookies and Cream: Unilever Item No. 20175, Unit UPC 077567201751; Case SCC-14 No. 10077567201758. Recall # F-2047-2010
CODE
a) Lot Code SEP1711 GDT 12-454
RECALLING FIRM/MANUFACTURER
Unilever United States, Inc., Englewood Cliffs, NJ, by letters and e-mails on April 23, 2010.
Manufacturing: Conopco, Inc., Clearwater, FL. Firm initiated recall is ongoing.
REASON
A limited number of 3 gallon tub of ice cream have a lid describing the product as"Breyers Food Service Parlor Oreo Cookies & Cream", and the tub portion of the package describes the product as "Breyers Food Service Vanilla Bean" Ice Cream. The product inside is Oreo Cookies and Cream ice cream and the ingredient statement for the vanilla does not declare wheat or soy lecithin.
VOLUME OF PRODUCT IN COMMERCE
1503 cases (1 tub per case)
DISTRIBUTION
AR, FL, GA, IL, KS, KY, MS, MO, NC, OK, SC and TX
___________________________________
PRODUCT 
Pumpkin Pecan Streusel Pie, net wt 30.O oz (1.88 lb), Item 95118, UPC 2-95118-20399-7. Product is packaged in a 30 oz plastic clamshell container. Recall # F-2048-2010
CODE
Lot 002-95118-00000  
RECALLING FIRM/MANUFACTURER
Publix Bakery Plant, Lakeland, FL, by e-mail on December 29, 2009. Firm initiated recall is complete.
REASON
The name of the product describes the product as "Pumpkin Pecan Streusel Pie." The ingredient statement on the label does not declare pecan, which is an ingredient in the pie.
VOLUME OF PRODUCT IN COMMERCE
6,152 pies
DISTRIBUTION
AL, FL, GA, TN, SC
___________________________________
PRODUCT 
1) Mazelle's Desserts Strawberry Cake packaged as follows: Brown cardboard base and white cardboard collar, wrapped in clear freezer plastic bag, in white cardboard unit box. There are two unit boxes per brown cardboard master case. UPC Code 85538300029. The product is labeled in part: KEEP REFRIGERATED PROPER HANDLING INSTRUCTIONS Store frozen at 0 or below. Thaw at refrigerated temperatures of 38 or below 4-6 hours before serving. Do not thaw at room temperature. Store unused portions under refrigeration. Expiration 10 days after thawing. Recall # F-2049-2010;

2) Mazelle's Desserts Cappuccino Pie in a 72 oz box with a brown cardboard base and white cardboard collar, wrapped in clear freezer plastic bag, in white cardboard unit box. There are two unit boxes per brown cardboard master case. The storage instructions are KEEP REFRIGERATED Store frozen at 0 degrees or below. Thaw at refrigerated temperatures of 38 degrees or below 4-6 hours before serving. Do not thaw at room temperature. Store unused portions under refrigeration. Expiration 10 days after thawing. UPC Code 85538300028. Recall # F-2050-2010;

3) Mazelle's Desserts Variety Pack #4. The unit size is a 200 oz. master case containing in part 25 2oz. Lemon Barzs. The product is packaged in a small cardboard unit box approximately 10"x10"x2". There are four unit boxes per brown cardboard master case. Storage instructions are to store frozen (0 degrees or below). The expiration date is 1 year if kept frozen; 10 days after thawing. UPC Code 85538300082. Recall # F-2051-2010
CODE
UPC Code only
RECALLING FIRM/MANUFACTURER
Cheesecake Royale, Inc., Dallas, TX, by e-mail on April 12, 2010 and by e-mail or letter on April 13, 2010. Firm initiated recall is ongoing.
REASON
Pans used for baking product may have been coated with a releasing agent which contains soy flour, an allergen. The finished product did not list soy as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
Strawberry Cake: 228 cases; Cappuccino Pie: 462 cases; Variety Pack #4: 290 cases
DISTRIBUTION
TX, FL, NC, AR

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II
___________________________________
PRODUCT 
Spironolactone Tablets, USP 25 mg, 100-count bottle (NDC 0603-5763-21), 500-count bottle (NDC 0603-5763-28), Rx only. Recall # D-497-2010
CODE
Lot T118F09A, exp 08/2011; Lot T118F09B, exp 08/2011
RECALLING FIRM/MANUFACTURER
Vintage Pharmaceuticals LLC, Huntsville AL, by letter dated April 2, 2010. Firm initiated recall is ongoing.  
REASON
Subpotent (Single Ingredient Drug): out of specification (OOS) stability results for assay 94.2% (specification 95.0-105.0%) at the 6-month time point.
VOLUME OF PRODUCT IN COMMERCE
20,413 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Motrin IB (Ibuprofen) Tablets USP 200mg, Pain Reliever/Fever Reducer (NSAID), a) 24-count bottle , NDC 50580-109-02, UPC 300450463029; b) 50-count bottle , NDC50580-109-03, UPC 300450463036; c) 100-count bottle, NDC 50580-109-04, UPC 300450463043; d) 100+25-count bottle, NDC 50580-109-29, UPC 300450463296; e) 100+50-count bottle, NDC 50580-109-75, UPC 300450463753, OTC. Recall # D-510-2010;

2) Motrin IB (Ibuprofen) Tablets USP 200mg Coated Caplets, Pain Reliever/Fever Reducer (NSAID), a) 24-count bottles, NDC 50580-110-03, UPC 300450481030; b) 24+6-count bottle, NDC 50580-110-64, UPC 300450481641; c)50-count bottle, NDC 50580-110-02, UPC 300450481023; d) 100- count bottle, NDC 50580-110-01, UPC 3004850481016; e) 100+25-count bottle, NDC 50580-110-95, UPC 300450481955; f) 100+50-count bottle, NDC 50580-110-75, UPC 300450481757; g) 225-count bottle, NDC 50580-110-62, UPC 300450481627; h) 300-count bottle, NDC 50580-110-37, UPC 300450481375, OTC. Recall # D-511-2010;

3) Motrin Junior Strength for ages 6-11 (Ibuprofen ) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Grape Flavored Chewable Tablets, 24-count bottle, NDC 50580-909-24, UPC 300450909244, OTC. Recall # D-512-2010; 

4) Motrin Junior Strength for ages 6-11 (Ibuprofen) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Easy-to-Swallow Caplets, 24-count bottle, NDC 50580-498-24, UPC 300450498243, OTC. Recall # D-513-2010;

5) Motrin Junior Strength for ages 6-11 (Ibuprofen) Tablets, 100mg, Pain Reliever/Fever Reducer (NSAID), Orange Flavored Chewable Tablets, 24-count bottle, NDC 50580-207-24, UPC 300450494245, OTC. Recall # D-514-2010
CODE
1) a) Lot # ABA003, Exp 11/30/2011; ADA258, Exp 2/28/2012; AFA309, Exp 3/31/2012; and AJA055, Exp 5/31/2012; b) Lot # ABA004, ABA152, Exp 11/30/2011; AFA228, Exp 3/31/2012; AHA024, Exp 4/30/2012; AJA007, Exp 5/31/2012; and AJA243 4/30/2012; c) Lot # AEA078, AEA261, Exp 3/31/2012 and AFA241, Exp 4/30/2012; d) Lot # AFA017 Exp 4/30/2012; and AJA168, Exp 1/31/2012; e) Lot # ALA109, Exp 7/31/2012;

2) a) Lot # AAA435, ABA369, Exp 11/30/2011; ADA174, Exp 2/28/2012; AHA026, and AJA006, Exp 4/30/2012; b) Lot # ADA246, Exp 2/28/2012; c) Lot # ABA153, Exp 10/31/2011; ABA541, Exp 12/31/2011; ADA173, Exp 2/28/2012; and AHA025, Exp 4/30/2012; d) Lots # ABA019, Exp 11/30/2011; ACA469, Exp 12/31/2011; ADA245, Exp 2/28/2012; AEA260, Exp 3/31/2012; AFA015, Exp 4/30/2012; AJA049, and AJA186, Exp 6/30/2012; e) Lot # ADA287, Exp 2/28/2012; and AFA016, Exp 4/30/2012; f) Lot # ABA538, Exp 0/31/2011; AJA023 and AJA120, Exp 6/30/2012; g) Lot # 24526, Exp 12/31/2009; 24544 ,24604, Exp 1/31/2010; 24591, Exp 3/31/2010; 24634, Exp 5/31/2010; 24687, 24762, Exp 7/31/2010; 24795, Exp 9/30/2010; 24794, 24818, Exp 11/30/2010; 24864, Exp 1/31/2011; 24905, 24915, Exp 2/28/2011; 24935, 24939, Exp 3/31/2011; 25013, Exp 4/30/2011; 24977, Exp 5/31/2011; 25044, 25980, Exp 6/30/2011; 25996, 26051, Exp 8/31/2011; 26085, Exp 10/21/2011; 26134, 26192, Exp 11/30/2011; 26241, 26335, Exp 1/31/2012; 26423, 26455, Exp 4/30/2012; 26508, Exp 6/30/2012; 26533, Exp 8/31/2012; h) Lot # ACA442, ACA759, ADA018, Exp Date 1/31/2012; ADA419, Exp Date 2/28/2012; AFA098, AFA112, AHA034, AHA068, ALA359, Exp Date 4/30/2012; ALA254, AMA177, AMA350, Exp Date 8/31/2012; APA217, Exp Date 9/30/2012; SEA208, Exp Date 3/31/2011; SFA184, SFA259, SHA107, Exp Date 4/30/2011; SJA131, SLA162, Exp Date 6/30/2011; SLA049, SMA013, SMA082, Exp Date 7/31/2011; and SSA157 Exp Date 9/30/2011;

3) Lot # ADM006, Exp Date 2/28/2011; ADM052, Exp Date 3/31/2011; AFM016, AFM350, Exp Date 5/31/2011; AHM420, Exp Date 6/30/2011; AJM346, ALM344, Exp Date 7/31/2011; ALM399, AMM379, Exp Date 9/30/2011; APM303, APM418, Exp Date 10/31/2011; APM429, Exp Date 11/30/2011; and SLM084, Exp Date 8/31/2010;

4) Lot # AJM322, Exp Date 7/31/2012; and APM348, Exp Date 10/31/2012;

5) a) Lot # ADM013, AFM024, Exp Date 3/31/2011; AHM402, Exp Date 6/30/2011; AJM345, ALM326, Exp Date 7/31/2011; ALM456, AMM381, Exp Date 9/30/2011; APM306, Exp Date 10/31/2011; and APM421, Exp Date 11/30/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, by website posting on November 6, 2009, press release on December 18, 2009 and letters on November 9, 2009, December 18, 2009 & January 15, 2010.
Manufacturer: Mcneil Healthcare, LLC, Las Piedras, PR. Firm initiated recall is ongoing.
REASON
Chemical Contamination: The product recall was initiated after identifying an uncharacteristic smell and taste associated with the presence of a chemical called 2,4,6,-tribromoanisole. The source of this chemical is believed to be from the breakdown of a chemical compound used to treat the wood pallets that are used for the transportation and storage of packaging materials.
VOLUME OF PRODUCT IN COMMERCE
11,728,152 bottles
DISTRIBUTION
Nationwide, Puerto Rico, Canada, Uruguay, Fiji, Dominican Republic, Trinidad, Guatemala, Jamaica, Guam, and UAE

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT 
1) Acetasol HC (Hydrocortisone and Acetic Acid) Otic Solution, USP, Rx Only, 10 mL. NDC #0472-0882-82. Recall # D-516-2010;

2) Hydrocortisone and Acetic Acid Otic Solution USP, Rx only, 10 mL, NDC 45963-412-61. Recall # D-517-2010
CODE
1) Lot numbers: L904031, Exp 05/10; L905006, Exp 06/10; L906005, Exp 07/10; L908096, Exp 01/10 and L911011, Exp 12/10;

2) Lot numbers: L906074, Exp 07/10; L907008, Exp 08/10; L908096, Exp 10/10; and L911011, Exp 12/10
RECALLING FIRM/MANUFACTURER
Actavis Mid Atlantic LLC, Lincolnton, NC, by letter on/about April 24, 2010. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: Out-of-specification (OOS) stability results for hydrocortisone related compounds.
VOLUME OF PRODUCT IN COMMERCE
152,688 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
DVM Hand Cleanser, Foaming Hand Cleanser, 0.375% triclosan, 18 -fl. oz bottles and 1-gallon jugs, OTC only, a) 18-fl. oz. bottles (NDC 59130-161-32), and b) 1-gal. jugs (NDC 59130-161-05). Recall # D-518-2010
CODE
a) Lot numbers 072252427, Exp date Jul-12; 073233204, Exp date Dec-10; 073613466, Exp date Jan-11; 080233678, Exp date Feb-11; and 080724100, Exp date Apr-11; b) Lot numbers, 072252429, Exp date Jul-12; 073233205, exp date Dec-10; 073613467, Exp date Jan-11; 080233679, Exp date Feb-11; 080724101, Exp date Apr-11; 080724108, Exp date Apr-11; 082685749, Exp date Oct-11; 083116131, Exp date Nov-11; 083646455, Exp date Jan-12; 090330301, Exp date Feb-12; 090850680, Exp date Apr-12; and 091040800, Exp date May-12  
RECALLING FIRM/MANUFACTURER
TEVA Animal Health Inc., Saint Joseph, MO, by letters dated September 4, 2009 and October 26, 2009. Firm initiated recall is ongoing.
REASON
cGMP Deviation: The product was not manufactured in conformance with GMP'S.
VOLUME OF PRODUCT IN COMMERCE
44,862 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Pancuronium Bromide Injection 4 mg/2 mL (2 mg/mL) 2 mL Vials (NDC 0703-2812-01), packaged in 25 Vials per carton (NDC 0703-2812-04), Rx only. Recall # D-519-2010;

2) Pancuronium Bromide Injection 10 mg/5 mL (2 mg/mL) 5 mL Multiple Dose Vial (NDC 0703-2823-01), packaged in 25 Vials per carton (NDC 0703-2823-04), Rx only. Recall # D-520-2010;

3) Pancuronium Bromide Injection 10mg/10 mL (1 mg/mL) 10 mL Multiple Dose Vial (NDC 0703-2804-01), packaged in 10 Vials per carton (NDC 0703-2804-03), Rx only. Recall # D-521-2010
CODE
1) Lot numbers: 07D127 Exp 4/2010 and 31303336B Exp 8/2011;
2) Lot numbers: 07E128 Exp 5/2010 and 07P132 Exp 11/2010;
3) Lot numbers: 07K118 Exp 8/2010 and 08A118 Exp 1/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter dated March 16, 2010.  
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. Firm initiated recall is ongoing.      
REASON
Impurities/Degradation Products: These products are being recalled because they do not meet specification for related substances.
VOLUME OF PRODUCT IN COMMERCE
561,075 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT 
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1144-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1145-10
3) Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1146-10;
4) Red Blood Cells. Recall # B-1147-10
CODE
1) 9882855 (part b and c), 9876902, 9878395, 9878394 (part a and b), 9884646, 9884642, 5237081, 9885208 (part a, b and c), 9885205, 9882765 (part a, b and c), 9885203, 9932172, 9932227;

2) Units: 4990797, 5238698, 4973455, 4973460, 497349, 4987780, 4987781, 4960348, 5233807, 4960359, 4960349, 4960344, 5233827, 4987178, 4987776, 4997524, 4997575, 4997525, 4997578, 4987185, 4997574, 5235495, 4987184, 4994336, 4994314, 4994330, 4993835, 4993831, 4993830, 4994329, 5235498, 5234245, 5234242, 4994328, 4994317, 4981389, 5236688, 4985719, 5238723, 4985859, 4985830, 5237628, 4985858, 5237625, 5237629, 5238731, 5237611, 4982010, 5238711, 4981114, 4982002, 4982001, 5237612, 5237817, 4990801, 5238707, 5238713, 4990798, 7228345, 4994319, 5236297, 5235490, 4994326, 4985835, 5236295, 5236293, 5236296, 5236294, 5232393, 5232402, 5232399, 5232400, 5232395, 5232396, 5232394, 728365, 7228364, 7228393, 7228661;

3) Units: 9884637 (part 1 and 2), 9884038 (part 1 and 2), 9884039 (part 1 and 2);

4) Unit: 9051913
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on June 26, 2006. Firm initiated recall is complete.
REASON
Blood products, not tested for HIV and HCV NAT, were distributed.
VOLUME OF PRODUCT IN COMMERCE
105 units
DISTRIBUTION
FL

___________________________________
PRODUCT 
Red Blood Cells Apheresis, Leukocytes Reduced, Irradiated. Recall # B-1150-10
CODE
Units: 38C14502, 38C21609, 38C28703, 38FK38377, 38FM66963, 38FV36816, 38KT34643, 38KT40423, 38KT40430, 38KT45599, 38KW00793, 38KW04397, 38KW08996, 38KW09458, 38KW16238, 38LC95517
RECALLING FIRM/MANUFACTURER
American National Red Cross Indiana-Ohio Region, Fort Wayne, IN, by telephone on January 30, 2007 and by follow-up letter dated January 30, 2007. Firm initiated recall is complete.
REASON
Red Blood Cells, mislabeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
IN
___________________________________
PRODUCT 
Source Plasma. Recall # B-1151-10
CODE
Units: LC0516598, LC0516908, LC0517538, LC0517781, LC0518554, LC0518735, LC0519382, LC0519544, LC0520194, LC0520398, LC0528587, LC0528968, LC0529253, LC0529769
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, NM, by letter dated March 15, 2007. Firm initiated recall is complete.
REASON
Source Plasma, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
8.769 Liters (14 units)
DISTRIBUTION
NY, CA
___________________________________
PRODUCT 
Red Blood Cells, Leukocytes Reduced. B-1152-10
CODE
Units 38GZ07400 (split unit)
RECALLING FIRM/MANUFACTURER
American National Red Cross Indiana-Ohio Region, Fort Wayne, IN, by telephone on December 28, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
IN
___________________________________
PRODUCT 
Human Corneas. Packaging of the corneas reads in part: "***LIONS EYE BANK of OREGON Cornea OD 2009-1769.CNOD***Single Patient Use Only-Not Sterile***" (OD indicates the right eye.) "***LIONS EYE BANK of OREGON Cornea OS 2009-1769.CNOS***Single Patient Use Only-Not Sterile***" (OS indicates the left eye.). Recall # B-1153-10
CODE
"2009-1769.CNOD" indicating the year the tissue was recovered, the donor number, the type of tissue (cornea) and the right eye.
RECALLING FIRM/MANUFACTURER
Lions Eye Bank Of Oregon, Portland, OR, by telephone on February 23, 2010 follow up e-mail and letter on February 24, 2010. Firm initiated recall is ongoing.
REASON
Human Corneal Tissue, recovered from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas, 1 left and 1 right
DISTRIBUTION
VA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1158-10;
2) Platelets. Recall # B-1159-10
CODE
1) and 2) Unit: W044609202193
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on September 25, 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
MO, TX
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1162-10;
2) Recovered Plasma. Recall # B-1163-10;
3) Source Leukocyte. Recall # B-1164-10
CODE
1), 2), 3) Unit: 4916905
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on October 21, 2009 and November 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred for a history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
NJ, TX

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1165-10
CODE
Unit: W044109013373
RECALLING FIRM/MANUFACTURER
Siouxland Community Blood Bank, Sioux City, IA, by letter dated October 12, 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
SC
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1166-10;
2) Fresh Frozen Plasma. Recall # B-1167-10;
3) Platelets Leukocytes Reduced, Recall # B-1168-10
CODE
19GH76830
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN,  by facsimile on November 12, 2009 and by letter dated November 12, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
TN, KY, IN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1169-10
CODE
Unit: 3180945
RECALLING FIRM/MANUFACTURER
Community Blood Center, Dayton, OH, by letter dated November 24, 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
OH
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1170-10
CODE
Unit: W045009096098
RECALLING FIRM/MANUFACTURER
Community Blood Center Of Greater Kansas City, Kansas City, MO, by letter dated November 19, 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
MO
___________________________________
PRODUCT 
1) Fresh Frozen Plasma. Recall # B-1171-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1172-10;
3) Recovered Plasma. Recall # B-1173-10
CODE
1) Unit: W045006099990;
2) Units: W045006099990, W045009075246;
3) Units: W045009029873, W045009075246
RECALLING FIRM/MANUFACTURER
by e-mail on October 9, 2009 and by letter dated October 14, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of exposure to hepatitis B, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
CA, KS, Austria, MO

___________________________________
PRODUCT 
1) Platelets Pheresis 7-d Leukocytes Reduced Irradiated. Recall # B-1175-10;

2) Platelets Pheresis 7-d Leukocytes Reduced. Recall # B-1176-10
CODE
Unit: 9955933
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on February 19, 2008. Firm initiated recall is complete
REASON
Blood products, labeled with an extended expiration date, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Source Plasma. Recall # B-1179-10
CODE
Units: 377068395, 377068073, 377067522, 377067221, 377058179, 377057309, 377055953, 377054553, 377053631, 377053200, 377052782
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Anderson, IN, by fax on August 20, 2009. Firm initiated recall is complete.
REASON
Blood products, collected using an abbreviated screening process, for which the donor was not eligible, were distributed
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Source Plasma. Recall # B-1180-10
CODE
Units: 3260005168, 3260005420, 3260005774
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Lake Charles, LA, by fax on August 20, 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
3 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall #  B-1184-10
2) Platelets. Recall # B-1185-10
3) Red Blood Cells. Recall # B-1186-10;
4) Whole Blood. Recall # B-1187-10
CODE
1) W069109100281, W069108100835 (4 aliquots), 0706098 (4 aliquots), 6776139, 6283198 (4 aliquots), 4048734, 4030469, 4011960, 1979811, 1946529, 1870761, 1846276, 1790025, 1752559;

2) Units: 1870761, 1624278, 1547471, 1519503, 1484310;

3) Units: 1624278, 1606263, 1585497, 1547471, 1519503, 1484310;

4) Unit: 1505591
RECALLING FIRM/MANUFACTURER
Mississippi Blood Services Inc., Jackson, MS, by facsimile beginning on 05/01/2009 to 09/16/2009. Firm initiated recall is complete.
REASON
Blood products collected from a donor who warranted deferral due to travel in a malaria risk area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
35 units
DISTRIBUTION
MS

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1161-10
CODE
Unit: W072109001956
RECALLING FIRM/MANUFACTURER
Southern California Permanente Medical Group, San Diego, CA, by telephone on November 11, 2009 and by letter dated November 11, 2009.  Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at risk for Leishmaniasis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1177-10
CODE
Units: 3250010232, 3250004750
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources, Inc., Sioux Falls, SD, by fax on November 5, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC

___________________________________
PRODUCT 
Source Plasma. Recall # B-1181-10
CODE
Units: 351040499, 351040877, 351041338, 351041838, 351042035, 351042594, 351042965, 351044082, 351044443, 351045096, 351036858, 351036892
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Louisville, KY, by fax on February 29, 2008. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1182-10
CODE
Units: 1948231(part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida Georgia Blood Alliance, Inc., Jacksonville, FL, by fax on September 27, 2005. Firm initiated recall is complete.
REASON
Blood products, for which the quality control testing for total component hemoglobin was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1183-10
CODE
Units: 72F955707, 72F663145
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers Inc - Birmingham Region, Birmingham, AL, by facsimile on July 16, 2008. Firm initiated recall is complete.
REASON

VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
AL
___________________________________
PRODUCT 
Source Plasma. Recall # B-1188-10
CODE
TQ069887, TQ069583, TQ069070, TQ068689, TQ067849, TQ067563, TQ067136, TQ066875, TQ066289, TQ066013, TQ065366, TQ064958, TQ064363, TQ063712, TQ063435, TQ062870, TQ062590, TQ062039, TQ060954, TQ060578, TQ059936, TQ059630, TQ058843 and TQ058522
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN, by facsimile on 04/08/2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS I
___________________________________
PRODUCT 
1) Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 4 DCT, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1462-2010;

2) Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 6 DCT, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1463-2010;

3) Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 8 DCT, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1464-2010;

4) Shiley Disposable Cannula Low Pressure Cuffed Tracheostomy Tube, 10 DCT, Assembled in Mexico, Tyco Healthcare Group LP, Nellcor Puritan Bennett Division, Pleasanton, CA. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1465-2010;

5) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 FEN, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1466-2010;

6) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 FEN, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1467-2010;

7) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 FEN, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1468-2010;

8) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 FEN, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1469-2010;

9) Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 4 DFEN, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1470-2010;

10) Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 6 DFEN, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1471-2010;

11) Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 8 DFEN, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1472-2010;

12) Shiley Disposable Cannula Fenestrated Low Pressure Cuffed Tracheostomy Tube, 10 DFEN, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1473-2010;

13) Shiley Percutaneous Dual Cannula Tracheostomy Tube, 6 PERC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1474-2010;

14) Shiley Percutaneous Dual Cannula Tracheostomy Tube, 8 PERC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1475-201;

15) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 FEN-S, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1476-2010;

16) Shiley Fenestrated Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 FEN-S, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1477-2010;

17) Shiley Low Pressure Cuffed Tracheostomy Tube, 4 LPC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1478-2010;

18) Shiley Low Pressure Cuffed Tracheostomy Tube, 6 LPC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1479-2010;

19) Shiley Low Pressure Cuffed Tracheostomy Tube, 8 LPC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1480-2010;

20) Shiley Low Pressure Cuffed Tracheostomy Tube, 10 LPC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1481-2010;

21) Shiley Single Cannula Cuffed Tracheostomy Tube, 5 SCT, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1482-2010;

22) Shiley Single Cannula Cuffed Tracheostomy Tube, 6 SCT, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1483-2010;

23) Shiley Single Cannula Cuffed Tracheostomy Tube, 7 SCT, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1484-2010

24) Shiley Single Cannula Cuffed Tracheostomy Tube, 8 SCT, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1485-2010;

25) Shiley Single Cannula Cuffed Tracheostomy Tube, 9 SCT, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1486-2010;

26) Shiley Single Cannula Cuffed Tracheostomy Tube, 10 SCT, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1487-2010

27) Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 4 LPC-S, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1488-2010;

28) Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 6 LPC-S, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1489-201;

29) Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 8 LPC-S, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1490-2010;

30) Shiley Low Pressure Cuffed Tracheostomy Tube with Evacuation Line, 10 LPC-S, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1491-2010;

31) Shiley Cuffed Pediatric Tracheostomy Tube, 4.0 PDC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall  Z-1492-2010;

32) Shiley Cuffed Pediatric Tracheostomy Tube, 4.5 PDC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1493-2010;

33) Shiley Cuffed Pediatric Tracheostomy Tube, 5.0 PDC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1494-2010;

34) Shiley Cuffed Pediatric Tracheostomy Tube, 5.5 PDC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1495-2010;

35) Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.0 PLC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1496-2010;

36) Shiley Cuffed Long Pediatric Tracheostomy Tube, 5.5 PLC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1497-2010;

37) Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.0 PLC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1498-2010;

38) Shiley Cuffed Long Pediatric Tracheostomy Tube, 6.5 PLC, Assembled in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1499-2010;

39) Shiley Specialized Tracheostomy Tube, MSCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1500-2010;

40) Shiley Specialized Tracheostomy Tube, M5SCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1501-2010;

41) Shiley Specialized Tracheostomy Tube, M5.5SCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1502-2010;

42) Shiley Specialized Tracheostomy Tube, M6SCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1503-2010;

43) Shiley Specialized Tracheostomy Tube, M6.5SCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1504-2010;

44) Shiley Specialized Tracheostomy Tube, M7SCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1505-2010;

45) Shiley Specialized Tracheostomy Tube, M7.5SCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1506-2010;

46) Shiley Specialized Tracheostomy Tube, M8SCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1507-2010;

47) Shiley Specialized Tracheostomy Tube, M9SCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1508-2010;

48) Shiley Specialized Tracheostomy Tube, M10SCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1509-2010;

49) Shiley Specialized Tracheostomy Tube, MPDC, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1510-2010;

50) Shiley Specialized Tracheostomy Tube, M4.0PDC, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1511-2010;

51) Shiley Specialized Tracheostomy Tube, M5.5PDC, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1512-2010;

52) Shiley Specialized Tracheostomy Tube, MPLC, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1513-2010;

53) Shiley Specialized Tracheostomy Tube, M5.5PLC, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1514-2010;

54) Shiley Specialized Tracheostomy Tube, MFEN, Sterile EO, Made in Mexic. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1515-2010;

55) Shiley Specialized Tracheostomy Tube, M6FEN, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1516-2010;

56) Shiley Specialized Tracheostomy Tube, M8FEN, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1517-2010;

57) Shiley Specialized Tracheostomy Tube, MLPC, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1518-2010;

58) Shiley Specialized Tracheostomy Tube, M6LPC, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1519-2010;

59) Shiley Specialized Tracheostomy Tube, M8LPC, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1520-2010;

60) Shiley Specialized Tracheostomy Tube, MDCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1521-2010;

61) Shiley Specialized Tracheostomy Tube, M6DCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1522-2010;

62) Shiley Specialized Tracheostomy Tube, M8DCT, Sterile EO, Made in Mexico. Intended for bypass of upper airway obstructions, provide long term ventilation, support and/or manage tracheal/bronchial secretions. Recall # Z-1523-2010
CODE
1) Lot Numbers: 0810002426 through 0908000766;
2) Lot Numbers: 0810002428 through 0908000773;
3) Lot Numbers: 0810002433 through 0908000787;
4) Lot Numbers: 0811000171 through 0908000765;
5) Lot Numbers: 0811001522 through 0908000767;
6) Lot Numbers: 0810002445 through 0908000776;
7) Lot Numbers: 0810002447 through 0908000256;
8) Lot Numbers: 0811001364 through 0908000233;
9) Lot Numbers: 0811001526 through 0908000235;
10) Lot Numbers: 0810002448 through 0908000774;
11) Lot Numbers: 0811000185 through 0908000789;
12) Lot Numbers: 0812000028 through 0908000232;
13) Lot Numbers: 0810002450 through 0908000782;
14) Lot Numbers: 0810002453 through 0908000797;
15) Lot Numbers: 0811000211 through 0907001570;
16) Lot Numbers: 0811001529 through 0908000791;
17) Lot Numbers: 0810002441 through 0908000768;
18) Lot Numbers: 0810002442 through 0908000780;
19) Lot Numbers: 0810000069 through 0908000792;
20) Lot Numbers: 0811001521 through 0907001560;
21) Lot Numbers: 0906000823 through 0907001067;
22) Lot Numbers: 0903001835 through 0908000124;
23) Lot Numbers: 0903000809 through 0908002300;
24) Lot Numbers: 0903000810 through 0908001215;
25) Lot Numbers: 0905001770 through 0907001068;
26) Lot Numbers: 0907002007 through 0908001339;
27) Lot Number: 0905000105;
28) Lot Numbers: 0810002449 through 0906000342;
29) Lot Numbers: 0901002066 through 0907002156;
30) Lot Numbers: 0812000912 through 0907000367;
31) Lot Numbers: 0903000859 through 0908001790;
32) Lot Numbers: 0903000861 through 0908000693;
33) Lot Numbers: 0903000862 through 0908001208;
34) Lot Numbers: 0903000863 through 0908001211;
35) Lot Numbers: 0903000865 through 0907001065;
36) Lot Numbers: 0903001839 through 0907001066;
37) Lot Numbers: 0903000866 through 0908001213;
38) Lot Numbers: 0903000867 through 0907001525;
39) Lot Numbers: 0904000093 through 0912001647;
40) Lot Numbers: 0907000415 through 0908002263;
41) Lot Numbers: 0907000880 through 0907002499;
42) Lot Numbers: 0904000093 through 0908002249;
43) Lot Numbers: 0904000511 through 0908000714;
44) Lot Numbers: 0904000118 through 0908001971;
45) Lot Numbers: 0904000602 through 0908001068;
46) Lot Numbers: 0904000132 through 0910001376;
47) Lot Numbers: 0904001119 through 0912001647;
48) Lot Numbers: 0904001545 through 0905000593;
49) Lot Numbers: 0905001247 through 0908000752;
50) Lot Numbers: 0904001545 through 0905000593;
51) Lot Number: 0905000552;
52) Lot Number: 0905000553;
53) Lot Number: 0905000553;
54) Lot Numbers: 0908001420 through 0910000004;
55) Lot Numbers: 0908001420 through 0912000048;
56) Lot Numbers: 0909000850 through 0912000048;
57) Lot Numbers: 0908001982 through 0912000321;
58) Lot Numbers: 0908001982 through 0912000321;
59) Lot Numbers: 0909000673 through 0911001672;
60) Lot Numbers: 0911000199 through 0911000221;
61) Lot Numbers: 0911000221;
62) Lot Numbers: 0911000199
RECALLING FIRM/MANUFACTURER
Recalling Firm: Nellcor Puritan Bennett Inc. (dba Covidien Ltd), Boulder, CO, by letter dated April 13, 2010.
Manufacturer: MMJ S.A de C.V., Juarez, Mexico. Firm initiated recall is ongoing.
REASON
Inflatable cuff Tracheostomy tubes may leak air, resulting in inadequate ventilation.
VOLUME OF PRODUCT IN COMMERCE
444,140 units (US)
DISTRIBUTION
Nationwide, Australia, Belgium, Brazil, Canada, Chile, Colombia, Honduras, Japan, Mexico, Panama, Singapore and Uruguay

___________________________________
PRODUCT

1) GE, 1011-9000-000 Aisys Anesthesia Machine and Monitor. Recall # Z-1526-2010;

2) GE, 1009-9002-000 Avance Anesthesia Machine and Monitor. Recall # Z-1527-2010
CODE
1) Serial Numbers: ANAN00814, ANAN00815, ANAN00825, ANAN00830, ANAN00831, ANAN00831, ANAN00832, ANAN00833, ANAN00834, ANAN00835, ANAN00836, ANAN00837, ANAN00838, ANAN00839, ANAN00873;

2) Serial Numbers: ANBN01180, ANBN01187, ANBN01200, ANBN01201, ANBN01211, ANBN01212, ANBN01213, ANBN01220, ANBN01223, ANBN01224, ANBN01250, ANBN01266, ANBN01284, ANBN01285, ANBN01286, ANBN01287, ANBN01288, ANBN01289
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, LLC, Waukesha, WI, by letter dated March 12, 2010.
Manufacturer: Datex - Ohmeda, Inc., Madison, WI. Firm initiated recall is ongoing.
REASON
Unanticipated shut-down: A specific lot of GE Healthcare Aisys and Avance machines control board wiring harness have a defect, which can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
VOLUME OF PRODUCT IN COMMERCE
33 devices
DISTRIBUTION
CA, FL, TN, Canada, Denmark, Finland, France, Italy, Saudi Arabia, South Africa, Spain, United Arab Emirates, United Kingdom

RECALLS AND FIELD CORRECTIONS:  DEVICES - CLASS II
___________________________________
PRODUCT 
Optovue RTVue Optical Coherence Tomography (OCT), Model-RT100 with software versions 3.0.x.x and higher. The RTVue is an optical coherence tomography system indicated for the in vivo imaging and measurement of the retina, retinal nerve fiber layer, optic disk, and for cornea and anterior eye scans as an aid in the diagnosis and management of retinal disease. Recall # Z-1131-2010
CODE
Serial Numbers from 10005 to 11805 (serial number are sequential)
RECALLING FIRM/MANUFACTURER
Optovue Inc., Fremont, CA, by letter on January 8, 2010. Firm initiated recall is ongoing.
REASON
Marketed without proper 510(k) -- No 510(k) clearance for Optovue RTVue Model-RT100 with Software Versions 3.0.x.x and higher which includes the Normative Database.
VOLUME OF PRODUCT IN COMMERCE
591 devices
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Leksell GammaPlan. Leksell GammaPlan is designed for use with the Leksell Gamma Knife. The Leksell GammaPlan is intended to be used for planning the dosimetry of treatments in stereotactic radiosurgery and stereotactic radiation therapy. It processes the inputs of the health care professional (Neurosurgeons, Radiation Therapists and Radiation Physicists) such that the desired radiation dose is provided by the Leksell Gamma Knife to a precisely defined target area within the cranium. Recall # Z-1134-2010
CODE
Units: 4113, 4115, 4142, 4148, 4158, 4160, 4176, 4191, 4193, 4195, 4207, 4208, 4300, 4302, 4303, 4306, 4308, 4309, 4313, 4314, 4319, 4326, 4328, 4329, 4332, 4333, 4337, 4339, 4340, 4341, 4342, 4343, 4344, 4346, 4349, 4352, 4353, 4354, 4363, 4366, 4824, 4830,5000, 5003, 5019, 5023, 5026, 5034, 6004, 6006, 6008, 6009, 6010, 6011, 6012, 6014, 6015, 6016, 6020, 6021, 6022, 6023, 6025, 6029, 6030, 6032, 6034, 6035, 6036, 6037, 6047, 6049
RECALLING FIRM/MANUFACTURER
Recalling Firm: Elekta, Inc., Norcross, GA, by letter dated November 21, 2008 and January 28, 2009.
Manufacturer: Elekta Instrument AB, Stockholm, Sweden. Firm initiated recall is ongoing.
REASON
Although the co-registration looks good during the verification step in the co-registration dialog, the obtain transformation may include an error that depends on the voxel sizes and acquisition parameters of the co-registered image studies.
VOLUME OF PRODUCT IN COMMERCE
72 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Xact 9 mm x 20 mm x 136 cm (Part Number 82089-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease. Recall # Z-1152-2010;

2) Xact 10 mm x 20 mm x 136 cm (Part Number 82099-01) The Xact Carotid Stent System, used in conjunction with Emboshield Embolic Protection System is indicated for the improvement of the lumen diameter of carotid arteries in patients considered at high risk for adverse events from carotid endarterectomy who require percutaneous carotid angioplasty and stenting for occlusive artery disease. Recall # Z-1153-2010
CODE
1) Lot Number: 9011951;
2) Lot Number: 9020551
RECALLING FIRM/MANUFACTURER
Abbott Vascular-Cardiac Therapies dba Guidant Corp., Temecula, CA, by telephone and visit beginning March 19, 2009. Firm initiated recall is complete.
REASON
The product was distributed prior to approval of a PMA supplement for a manufacturing line move between sites. There are no product quality issues associated with this action.
VOLUME OF PRODUCT IN COMMERCE
49 units
DISTRIBUTION
GA, NY, IN, LA, MA, PA

___________________________________
PRODUCT 
CircuCool Fluid Circulation Pump used in the Chilli Cooled Ablation System, Model Number M00480050. The Chilli Cooled Ablation System is indicated for cardiac electrophysiological mapping, delivering diagnostic pacing stimuli and radiofrequency ablation of mappable ventricular tachycardias attributable to ischemic heart disease or cardiomyopathy in patients who have failed drug therapy. Recall # Z-1156-2010
CODE
Serial numbers: A9003399 to A9003418, B08003046 to B08003050, B08004180 to B08004209, D08003578 to D08003597, E09002815 to E09002839, G08002514 to G08002533, and K08005118 to K08005137
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., San Jose, CA, by letter on September 22, 2009.  
Manufacturer: Barnant Co. Barrington, IL. Firm initiated recall is ongoing.
REASON
Product failure-- Product may cease operation as a result of potential speed control board failure when the device is shut off, and may not turn back on. A component on the circuit board fails unexpectedly because of a power surge, causing a diode to burn out.
VOLUME OF PRODUCT IN COMMERCE
75 units
DISTRIBUTION
Nationwide, Spain, France, Germany, Italy, Russia, Poland, the Netherlands, Israel and Belgium
___________________________________
PRODUCT 
1) Philips Heartstart FRx automated external defibrillator (AED), Model 861304. Recall # Z-1193-2010;

2) Philips Heartstart (HS1) Onsite Automated External Defibrillator (AED) Catalog number M5066A. Recall # Z-1194-2010;

3) Heartstart (HS1) Laerdal brand onsite Automated External Defibrillator, Model M5067A.  
Recall # Z-1195-2010;

4) Heartstart HS1 Defibrillator Model M5068A. Recall # Z-1196-2010
CODE
1) 1) DOMESTIC UNIT SERIAL NUMBERS - B09J-00860, B09J-00792, B09J-00810, B09J-00877, B09J-00878, B09J-00793, B09J-01110, B09J-00849, B09J-01016, B09J-01196, B09J-01299, B09J-00855, B09J-00805, B09J-01193, B09J-00896, B09J-00824, B09J-00821, B09J-00823, B09J-00825, B09J-00835, B09J-02749, B09J-00794, B09J-00856, B09J-00889, B09J-00891, B09J-00897, B09J-01005, B09J-01012, B09J-01197, B09J-01230, B09J-01269, B09J-01279, B09J-00791, B09J-00818, B09J-00875, B09J-01082, B09J-01100, B09J-01260, B09J-01010, B09J-01018, B09J-01021, B09J-01022, B09J-01108, B09J-01114, B09J-01120, B09J-01080, B09J-01014, B09J-01298, B09J-01300, B09J-01257, B09J-00872, B09J-00803, B09J-00804, B09J-00868, B09J-01013, B09J-01019, B09J-01020, B09J-01123, B09J-01258, B09J-00786, B09J-00817, B09J-00790, B09J-00816, B09J-01122, B09J-01162, B09J-00789, B09J-00795, B09J-00798, B09J-00806, B09J-00807, B09J-00808, B09J-00842, B09J-00847, B09J-00879, B09J-00892, B09J-01002, B09J-01003, B09J-01006, B09J-01007, B09J-00813, B09J-00819, B09J-00820, B09J-00853, B09J-00884, B09J-01015, B09J-01139, B09J-01252, B09J-01259, B09J-00787, B09J-01253, B09J-01303, and B09J-00898. I INTERNATIONAL UNIT SERIAL NUMBERS - B09J-02902, B09J-02630, B09J-02914, B09J-02920, B09J-02921, B09J-01243, B09J-02588, B09J-02802, B09J-02911, B09J-02929, B09J-02918, B09J-02398, B09J-02744, B09J-02922, B09J-02935, B09J-01078, B09J-01341, B09J-01348, B09J-01349, B09J-01350, B09J-01364, B09J-01365, B09J-01369, B09J-01373, B09J-01375, B09J-01388, B09J-01390, B09J-01391, B09J-01392, B09J-01393, B09J-01395, B09J-01396, B09J-01397, B09J-01398, B09J-01399, B09J-01401, B09J-01402, B09J-01403, B09J-01407, B09J-01409, B09J-01411, B09J-01414, B09J-01424, B09J-01425, B09J-01428, B09J-01440, B09J-01443, B09J-01460, B09J-01461, B09J-01462, B09J-01463, B09J-01501, B09J-01515, B09J-01516, B09J-01520, B09J-01523, B09J-01524, B09J-01530, B09J-01531, B09J-01532, B09J-01533, B09J-01534, B09J-01535, B09J-01544, B09J-01545, B09J-01546, B09J-01547, B09J-01548, B09J-01549, B09J-01601, B09J-01602, B09J-01603, B09J-01604, B09J-01605, B09J-01606, B09J-01607, B09J-01630, B09J-01636, B09J-01637, B09J-01639, B09J-01640, B09J-01641, B09J-01642, B09J-01646, B09J-01647, B09J-01648, B09J-01651, B09J-01659, B09J-01660, B09J-01662, B09J-01664, B09J-01667, B09J-01668, B09J-01677, B09J-01678, B09J-01680, B09J-01681, B09J-01682, B09J-01683, B09J-01685, B09J-01687, B09J-01688, B09J-01689, B09J-01690, B09J-01691, B09J-01695, B09J-01696, B09J-01699, B09J-01700, B09J-01701, B09J-01702, B09J-01703, B09J-01704, B09J-01705, B09J-01706, B09J-01709, B09J-01712, B09J-01715, B09J-01716, B09J-01717, B09J-01718, B09J-01719, B09J-01720, B09J-01721, B09J-01722, B09J-01723, B09J-01724, B09J-01725, B09J-01726, B09J-01727, B09J-01728, B09J-01729, B09J-01730, B09J-01731, B09J-01733, B09J-01734, B09J-01735, B09J-01737, B09J-01738, B09J-01739, B09J-01740, B09J-01741, B09J-01742, B09J-01743, B09J-01744, B09J-01745, B09J-01746, B09J-01747, B09J-01748, B09J-01749, B09J-01750, B09J-01751, B09J-01752, B09J-01753, B09J-01754, B09J-01755, B09J-01756, B09J-01757, B09J-01758, B09J-01759, B09J-01760, B09J-01761, B09J-01762, B09J-01765, B09J-01766, B09J-01768, B09J-01769, B09J-01770, B09J-01771, B09J-01772, B09J-01773, B09J-01775, B09J-01776, B09J-01777, B09J-01778, B09J-01779, B09J-01780, B09J-01781, B09J-01782, B09J-01784, B09J-01785, B09J-01786, B09J-01787, B09J-01788, B09J-01789, B09J-01792, B09J-01793, B09J-01794, B09J-01795, B09J-01796, B09J-01797, B09J-01798, B09J-01800, B09J-01802, B09J-01803, B09J-01804, B09J-01807, B09J-01809, B09J-01828, B09J-01831, B09J-01832, B09J-01834, B09J-01836, B09J-01837, B09J-01838, B09J-01841, B09J-01842, B09J-01843, B09J-01844, B09J-01845, B09J-01856, B09J-01870, B09J-01871, B09J-01872, B09J-01873, B09J-01874, B09J-01875, B09J-01876, B09J-01877, B09J-01878, B09J-01879, B09J-01880, B09J-01882, B09J-01883, B09J-01884, B09J-01885, B09J-01888, B09J-01891, B09J-01893, B09J-01894, B09J-01897, B09J-01898, B09J-01899, B09J-01901, B09J-01902, B09J-01903, B09J-01904, B09J-01905, B09J-01906, B09J-01907, B09J-01908, B09J-01909, B09J-01910, B09J-01911, B09J-01912, B09J-01913, B09J-01914, B09J-01915, B09J-01917, B09J-01918, B09J-01920, B09J-01928, B09J-01930, B09J-01932, B09J-01942, B09J-01944, B09J-01946, B09J-01948, B09J-01949, B09J-01950, B09J-01951, B09J-01953, B09J-01954, B09J-01955, B09J-01956, B09J-01957, B09J-01958, B09J-01959, B09J-01962, B09J-01963, B09J-01964, B09J-01970, B09J-01971, B09J-01972, B09J-01976, B09J-01980, B09J-01982, B09J-01987, B09J-01988, B09J-01992, B09J-01994, B09J-01995, B09J-01997, B09J-02001, B09J-02003, B09J-02004, B09J-02005, B09J-02006, B09J-02007, B09J-02008, B09J-02009, B09J-02011, B09J-02012, B09J-02018, B09J-02020, B09J-02021, B09J-02023, B09J-02029, B09J-02031, B09J-02046, B09J-02047, B09J-02050, B09J-02051, B09J-02057, B09J-02060, B09J-02061, B09J-02063, B09J-02064, B09J-02065, B09J-02066, B09J-02067, B09J-02069, B09J-02092, B09J-02101, B09J-02103, B09J-02106, B09J-02109, B09J-02121, B09J-02122, B09J-02132, B09J-02133, B09J-02134, B09J-02135, B09J-02137, B09J-02143, B09J-02146, B09J-02148, B09J-02149, B09J-02154, B09J-02156, B09J-02161, B09J-02162, B09J-02168, B09J-02171, B09J-02179, B09J-02261, B09J-02263, B09J-02265, B09J-02269, B09J-02272, B09J-02273, B09J-02276, B09J-02278, B09J-02280, B09J-02281, B09J-02320, B09J-02328, B09J-02333, B09J-02416, B09J-02426, B09J-02429, B09J-02519, B09J-02527, B09J-02528, B09J-02530, B09J-02531, B09J-02532, B09J-02535, B09J-02539, B09J-02543, B09J-02545, B09J-02546, B09J-02547, B09J-02553, B09J-02559, B09J-02830, B09J-02831, B09J-02949, B09J-01335, B09J-01339, B09J-01344, B09J-01346, B09J-01502, B09J-01504, B09J-01505, B09J-01509, B09J-01511, B09J-01517, B09J-01521, B09J-01525, B09J-01526, B09J-01528, B09J-01672, B09J-01673, B09J-01694, B09J-01698, B09J-01096, B09J-01191, B09J-01231, B09J-01232, B09J-01236, B09J-01237, B09J-01238, B09J-01242, B09J-01249, B09J-01250, B09J-01306, B09J-01307, B09J-01308, B09J-01309, B09J-01311, B09J-01312, B09J-01314, B09J-01316, B09J-02386, B09J-02396, B09J-02448, B09J-02746, B09J-02803, B09J-02906, B09J-02917, B09J-02923, B09J-02932, B09J-01248, B09J-01305, B09J-01310, B09J-01313, B09J-01315, B09J-01320, B09J-01321, B09J-01322, B09J-01324, B09J-01325, B09J-01326, B09J-01328, B09J-01329, B09J-01330, B09J-01333, B09J-01336, B09J-01337, B09J-01340, B09J-01342, B09J-01343, B09J-01097, B09J-01240, B09J-01241, B09J-01245, B09J-01079, B09J-01332, B09J-01334, B09J-01338, B09J-01347, B09J-01503, B09J-01508, B09J-01510, B09J-01514, B09J-01522, B09J-01666, B09J-01671, B09J-02497, B09J-02631, and B09J-02647;

2) DOMESTIC UNIT SERIAL NUMBERS - A09J-01665, A09J-01237, A09J-02203, A09J-01279, A09J-01353, A09J-01284, A09J-01227, A09J-01593, A09J-01236, A09J-01238, A09J-01667, A09J-02140, A09J-02230, A09J-02238, A09J-01351, A09J-02218, A09J-01183, A09J-01232, A09J-01275, A09J-01277, A09J-01280, A09J-01283, A09J-01285, A09J-01286, A09J-01289, A09J-01290, A09J-01291, A09J-01654, A09J-01663, A09J-01669, A09J-01670, A09J-01727, A09J-02002, A09J-02139, A09J-02147, A09J-02148, A09J-02149, A09J-02202, A09J-02208, A09J-02211, A09J-02213, A09J-02219, A09J-02222, A09J-02224, A09J-02225, A09J-02226, A09J-02227, A09J-02228, A09J-02229, A09J-01354, A09J-01656, A09J-01664, A09J-02201, A09J-01229, A09J-01230, A09J-01287, A09J-01651, A09J-01652, A09J-01653, A09J-01657, A09J-01659, A09J-01660, A09J-01662, A09J-01666, A09J-01668, A09J-01225, A09J-01226, A09J-01231, A09J-01235, A09J-01329, A09J-01339, A09J-01356, A09J-01358, A09J-01655, A09J-01658, A09J-01661, A09J-01674, A09J-01675, A09J-01701, A09J-01708, A09J-01710, A09J-02102, A09J-02138, A09J-01153, A09J-01424, A09J-01426, A09J-01732, A09J-01733, A09J-01734, A09J-01736, A09J-02214, A09J-02221, A09J-02239, A09J-01292, A09J-01296, A09J-01297, A09J-01331, A09J-02235, and A09J-02237. INTERNATIONAL UNIT SERIAL NUMBERS - A09J-02145, A09J-02204, A09J-01298, A09J-02207, A09J-02209, A09J-02223, A09J-02236, A09J-02142, A09J-02210, A09J-01829, A09J-01839, A09J-01847, A09J-01849, A09J-01860, A09J-01873, A09J-01874, A09J-01876, A09J-01897, A09J-01941, A09J-01942, A09J-01943, A09J-01948, A09J-02012, A09J-02272, A09J-02304, A09J-02348, A09J-02501, A09J-02502, A09J-02505, A09J-02510, A09J-02512, A09J-02614, A09J-02629, A09J-02630, A09J-02634, A09J-02668, A09J-02681, A09J-01878, A09J-01880, A09J-01881, A09J-02515, A09J-02545, A09J-02609, A09J-02686, A09J-01879, A09J-01918, A09J-02618, A09J-01894, A09J-02028, A09J-02282, A09J-02504, A09J-02513, A09J-02698, A09J-01883, A09J-02022, A09J-02047, A09J-02174, A09J-02178, A09J-02184, A09J-02186, A09J-02193, A09J-02356, A09J-02396, A09J-02411, A09J-02412, A09J-02414, A09J-02419, A09J-02421, A09J-02422, A09J-02423, A09J-02425, A09J-02427, A09J-02428, A09J-02429, A09J-02432, A09J-02442, A09J-02445, A09J-02446, A09J-02447, A09J-02498, A09J-02506, A09J-02560, A09J-02576, A09J-02577, A09J-02579, A09J-02580, A09J-02581, A09J-02584, A09J-02587, A09J-02598, A09J-02622, A09J-02646, A09J-02706, A09J-02709, A09J-02710, A09J-02711, A09J-02712, A09J-02713, A09J-02714, A09J-02722, A09J-02724, A09J-02735, A09J-02737, A09J-02738, A09J-02739, A09J-02748, A09J-02749, A09J-02750, A09J-02751, A09J-02752, A09J-02753, A09J-02754, A09J-02755, A09J-02756, A09J-02757, A09J-02758, A09J-02759, A09J-02760, A09J-02761, A09J-02763, A09J-02764, A09J-02766, A09J-02767, A09J-02768, A09J-02769, A09J-02770, A09J-02771, A09J-02772, A09J-02773, A09J-02774, A09J-02780, A09J-02782, A09J-02791, A09J-02795, A09J-02797, A09J-02798, A09J-02799, A09J-02800, A09J-02814, A09J-02815, A09J-02817, A09J-02818, A09J-02819, A09J-02820, A09J-02825, A09J-02848, A09J-02863, A09J-02867, A09J-02868, A09J-02869, A09J-02870, A09J-02871, A09J-02872, A09J-02873, A09J-02874, A09J-02875, A09J-02876, A09J-02878, A09J-02879, A09J-02880, A09J-02881, A09J-02882, A09J-02883, A09J-02884, A09J-02885, A09J-02886, A09J-02887, A09J-02888, A09J-02889, A09J-02890, A09J-02891, A09J-02892, A09J-02893, A09J-02894, A09J-02895, A09J-02896, A09J-02897, A09J-02898, A09J-02899, A09J-02900, A09J-02901, A09J-02902, A09J-02904, A09J-02905, A09J-02906, A09J-02907, A09J-02910, A09J-02911, A09J-02912, A09J-02914, A09J-02930, A09J-02931, A09J-02932, A09J-02934, A09J-02935, A09J-02937, A09J-02950, A09J-02951, A09J-02952, A09J-02956, A09J-02957, A09J-02959, A09J-02961, A09J-02962, A09J-02963, A09J-02964, A09J-02965, A09J-03001, A09J-03002, A09J-03003, A09J-03004, A09J-03005, A09J-03006, A09J-03007, A09J-03018, A09J-03019, A09J-03024, A09J-03026, A09J-03031, A09J-03032, A09J-03033, A09J-03034, A09J-03037, A09J-03038, A09J-03039, A09J-03040, A09J-03041, A09J-03049, A09J-03050, A09J-03051, A09J-03061, A09J-03066, A09J-00901, A09J-00902, A09J-00903, A09J-00904, A09J-00905, A09J-00906, A09J-00908, A09J-00910, A09J-00911, A09J-00912, A09J-00913, A09J-00914, A09J-00915, A09J-00917, A09J-00920, A09J-00921, A09J-00922, A09J-00925, A09J-00927, A09J-00929, A09J-00931, A09J-00932, A09J-00933, A09J-00934, A09J-00935, A09J-00936, A09J-00937, A09J-00938, A09J-00939, A09J-00941, A09J-00942, A09J-00943, A09J-00944, A09J-00945, A09J-00946, A09J-00947, A09J-00949, A09J-00950, A09J-01116, A09J-01117, A09J-01119, A09J-01120, A09J-01125, A09J-01151, A09J-01155, A09J-01156, A09J-01157, A09J-01158, A09J-01160, A09J-01163, A09J-01164, A09J-01168, A09J-01179, A09J-01180, A09J-01184, A09J-01185, A09J-01186, A09J-01187, A09J-01188, A09J-01189, A09J-01190, A09J-01191, A09J-01193, A09J-01194, A09J-01196, A09J-01197, A09J-01199, A09J-01200, A09J-01228, A09J-01233, A09J-01234, A09J-01239, A09J-01240, A09J-01241, A09J-01243, A09J-01248, A09J-01251, A09J-01252, A09J-01253, A09J-01254, A09J-01255, A09J-01257, A09J-01258, A09J-01259, A09J-01260, A09J-01261, A09J-01262, A09J-01263, A09J-01264, A09J-01265, A09J-01266, A09J-01267, A09J-01272, A09J-01273, A09J-01288, A09J-01293, A09J-01294, A09J-01295, A09J-01299, A09J-01300, A09J-01301, A09J-01302, A09J-01303, A09J-01311, A09J-01313, A09J-01316, A09J-01318, A09J-01319, A09J-01320, A09J-01321, A09J-01322, A09J-01323, A09J-01324, A09J-01325, A09J-01326, A09J-01327, A09J-01328, A09J-01332, A09J-01333, A09J-01334, A09J-01335, A09J-01336, A09J-01337, A09J-01338, A09J-01341, A09J-01342, A09J-01343, A09J-01344, A09J-01345, A09J-01346, A09J-01347, A09J-01348, A09J-01350, A09J-01352, A09J-01357, A09J-01359, A09J-01360, A09J-01361, A09J-01363, A09J-01364, A09J-01365, A09J-01366, A09J-01367, A09J-01368, A09J-01369, A09J-01370, A09J-01371, A09J-01372, A09J-01373, A09J-01374, A09J-01375, A09J-01376, A09J-01377, A09J-01378, A09J-01379, A09J-01380, A09J-01381, A09J-01382, A09J-01383, A09J-01384, A09J-01385, A09J-01386, A09J-01387, A09J-01388, A09J-01389, A09J-01390, A09J-01391, A09J-01392, A09J-01393, A09J-01394, A09J-01395, A09J-01396, A09J-01397, A09J-01398, A09J-01399, A09J-01400, A09J-01422, A09J-01430, A09J-01445, A09J-01446, A09J-01447, A09J-01448, A09J-01450, A09J-01526, A09J-01527, A09J-01528, A09J-01529, A09J-01530, A09J-01531, A09J-01532, A09J-01533, A09J-01534, A09J-01535, A09J-01536, A09J-01537, A09J-01538, A09J-01539, A09J-01540, A09J-01541, A09J-01542, A09J-01543, A09J-01544, A09J-01545, A09J-01546, A09J-01547, A09J-01548, A09J-01549, A09J-01550, A09J-01551, A09J-01552, A09J-01553, A09J-01555, A09J-01556, A09J-01558, A09J-01559, A09J-01583, A09J-01586, A09J-01595, A09J-01596, A09J-01599, A09J-01600, A09J-01602, A09J-01605, A09J-01607, A09J-01608, A09J-01609, A09J-01612, A09J-01620, A09J-01624, A09J-01628, A09J-01629, A09J-01630, A09J-01632, A09J-01633, A09J-01636, A09J-01637, A09J-01638, A09J-01639, A09J-01640, A09J-01641, A09J-01642, A09J-01646, A09J-01648, A09J-01649, A09J-01676, A09J-01677, A09J-01678, A09J-01679, A09J-01680, A09J-01681, A09J-01682, A09J-01683, A09J-01684, A09J-01685, A09J-01686, A09J-01687, A09J-01688, A09J-01690, A09J-01691, A09J-01692, A09J-01693, A09J-01694, A09J-01695, A09J-01696, A09J-01697, A09J-01702, A09J-01703, A09J-01704, A09J-01705, A09J-01706, A09J-01707, A09J-01709, A09J-01714, A09J-01716, A09J-01723, A09J-01724, A09J-01735, A09J-01737, A09J-01738, A09J-01739, A09J-01740, A09J-01741, A09J-01742, A09J-01743, A09J-01744, A09J-01745, A09J-01746, A09J-01747, A09J-01748, A09J-01750, A09J-01751, A09J-01752, A09J-01753, A09J-01756, A09J-01757, A09J-01759, A09J-01760, A09J-01763, A09J-01764, A09J-01765, A09J-01766, A09J-01767, A09J-01768, A09J-01769, A09J-01771, A09J-01774, A09J-01775, A09J-01776, A09J-01777, A09J-01778, A09J-01779, A09J-01780, A09J-01781, A09J-01782, A09J-01783, A09J-01784, A09J-01785, A09J-01786, A09J-01787, A09J-01788, A09J-01789, A09J-01790, A09J-01794, A09J-01795, A09J-01800, A09J-01801, A09J-01802, A09J-01804, A09J-01805, A09J-01806, A09J-01807, A09J-01808, A09J-01809, A09J-01810, A09J-01811, A09J-01812, A09J-01813, A09J-01814, A09J-01815, A09J-01816, A09J-01817, A09J-01818, A09J-01819, A09J-01821, A09J-01822, A09J-01823, A09J-01824, A09J-01856, A09J-01867, A09J-01882, A09J-01884, A09J-01885, A09J-01886, A09J-01887, A09J-01888, A09J-01889, A09J-01890, A09J-01892, A09J-01893, A09J-01895, A09J-01900, A09J-01905, A09J-01907, A09J-01913, A09J-01916, A09J-01917, A09J-01919, A09J-01920, A09J-01921, A09J-01922, A09J-01923, A09J-01924, A09J-01925, A09J-01951, A09J-01953, A09J-01954, A09J-01955, A09J-01957, A09J-01958, A09J-01959, A09J-01960, A09J-01961, A09J-01962, A09J-01964, A09J-01965, A09J-01966, A09J-01969, A09J-01970, A09J-01975, A09J-01977, A09J-01980, A09J-01982, A09J-01983, A09J-01984, A09J-01985, A09J-01986, A09J-01987, A09J-01988, A09J-01990, A09J-01991, A09J-01994, A09J-01995, A09J-01996, A09J-02026, A09J-02043, A09J-02044, A09J-02045, A09J-02051, A09J-02052, A09J-02055, A09J-02072, A09J-02074, A09J-02075, A09J-02081, A09J-02083, A09J-02086, A09J-02087, A09J-02088, A09J-02089, A09J-02091, A09J-02093, A09J-02096, A09J-02097, A09J-02104, A09J-02108, A09J-02110, A09J-02111, A09J-02113, A09J-02114, A09J-02116, A09J-02117, A09J-02118, A09J-02119, A09J-02122, A09J-02123, A09J-02124, A09J-02125, A09J-02127, A09J-02129, A09J-02130, A09J-02133, A09J-02179, A09J-02181, A09J-02187, A09J-02189, A09J-02190, A09J-02195, A09J-02196, A09J-02198, A09J-02212, A09J-02240, A09J-02241, A09J-02242, A09J-02243, A09J-02244, A09J-02245, A09J-02246, A09J-02247, A09J-02248, A09J-02249, A09J-02250, A09J-02253, A09J-02257, A09J-02258, A09J-02259, A09J-02260, A09J-02261, A09J-02262, A09J-02263, A09J-02264, A09J-02265, A09J-02266, A09J-02267, A09J-02270, A09J-02271, A09J-02273, A09J-02274, A09J-02275, A09J-02276, A09J-02278, A09J-02279, A09J-02280, A09J-02284, A09J-02285, A09J-02287, A09J-02289, A09J-02291, A09J-02292, A09J-02293, A09J-02294, A09J-02295, A09J-02296, A09J-02297, A09J-02298, A09J-02301, A09J-02303, A09J-02305, A09J-02308, A09J-02310, A09J-02311, A09J-02312, A09J-02313, A09J-02317, A09J-02319, A09J-02320, A09J-02321, A09J-02322, A09J-02323, A09J-02324, A09J-02325, A09J-02326, A09J-02327, A09J-02328, A09J-02329, A09J-02330, A09J-02331, A09J-02332, A09J-02333, A09J-02334, A09J-02335, A09J-02336, A09J-02337, A09J-02338, A09J-02339, A09J-02340, A09J-02341, A09J-02342, A09J-02343, A09J-02344, A09J-02345, A09J-02346, A09J-02347, A09J-02350, A09J-02352, A09J-02353, A09J-02354, A09J-02355, A09J-02358, A09J-02359, A09J-02362, A09J-02363, A09J-02364, A09J-02365, A09J-02366, A09J-02367, A09J-02370, A09J-02371, A09J-02372, A09J-02374, A09J-02376, A09J-02377, A09J-02378, A09J-02379, A09J-02381, A09J-02385, A09J-02389, A09J-02390, A09J-02391, A09J-02392, A09J-02394, A09J-02395, A09J-02397, A09J-02398, A09J-02399, A09J-02413, A09J-02415, A09J-02416, A09J-02417, A09J-02418, A09J-02424, A09J-02426, A09J-02430, A09J-02431, A09J-02433, A09J-02434, A09J-02435, A09J-02436, A09J-02437, A09J-02438, A09J-02439, A09J-02440, A09J-02441, A09J-02443, A09J-02444, A09J-02448, A09J-02449, A09J-02508, A09J-02509, A09J-02511, A09J-02557, A09J-02573, A09J-02574, A09J-02575, A09J-02578, A09J-02582, A09J-02583, A09J-02585, A09J-02586, A09J-02588, A09J-02589, A09J-02590, A09J-02591, A09J-02592, A09J-02593, A09J-02594, A09J-02595, A09J-02596, A09J-02597, A09J-02599, A09J-02621, A09J-02623, A09J-02648, A09J-02651, A09J-02652, A09J-02653, A09J-02654, A09J-02655, A09J-02656, A09J-02657, A09J-02658, A09J-02659, A09J-02660, A09J-02662, A09J-02663, A09J-02664, A09J-02665, A09J-02666, A09J-02667, A09J-02669, A09J-02670, A09J-02673, A09J-02674, A09J-02676, A09J-02677, A09J-02678, A09J-02679, A09J-02680, A09J-02682, A09J-02684, A09J-02685, A09J-02687, A09J-02688, A09J-02689, A09J-02690, A09J-02692, A09J-02694, A09J-02695, A09J-02696, A09J-02697, A09J-02699, A09J-02701, A09J-02702, A09J-02703, A09J-02704, A09J-02705, A09J-02707, A09J-02708, A09J-02715, A09J-02716, A09J-02717, A09J-02718, A09J-02719, A09J-02720, A09J-02721, A09J-02723, A09J-02725, A09J-02726, A09J-02728, A09J-02729, A09J-02730, A09J-02731, A09J-02732, A09J-02733, A09J-02734, A09J-02736, A09J-02740, A09J-02741, A09J-02742, A09J-02743, A09J-02744, A09J-02745, A09J-02746, A09J-02747, A09J-02762, A09J-02765, A09J-02776, A09J-02777, A09J-02778, A09J-02779, A09J-02781, A09J-02783, A09J-02786, A09J-02794, A09J-02796, A09J-02801, A09J-02802, A09J-02803, A09J-02804, A09J-02805, A09J-02806, A09J-02816, A09J-02839, A09J-02840, A09J-02843, A09J-02844, A09J-02845, A09J-02846, A09J-02847, A09J-02852, A09J-02854, A09J-02858, A09J-02859, A09J-02860, A09J-02861, A09J-02862, A09J-02865, A09J-02866, A09J-02877, A09J-02903, A09J-02909, A09J-02913, A09J-02915, A09J-02916, A09J-02917, A09J-02918, A09J-02919, A09J-02920, A09J-02921, A09J-02922, A09J-02923, A09J-02924, A09J-02925, A09J-02926, A09J-02927, A09J-02928, A09J-02929, A09J-02933, A09J-02936, A09J-02938, A09J-02939, A09J-02940, A09J-02941, A09J-02942, A09J-02943, A09J-02944, A09J-02945, A09J-02946, A09J-02947, A09J-02948, A09J-02949, A09J-02953, A09J-02954, A09J-02955, A09J-02958, A09J-03009, A09J-03010, A09J-03011, A09J-03012, A09J-03013, A09J-03014, A09J-

03015, A09J-03016, A09J-03017, A09J-03020, A09J-03021, A09J-03022, A09J-03023, A09J-03025, A09J-03027, A09J-03030, A09J-03035, A09J-03042, A09J-03048, A09J-03055, A09J-03056, A09J-03070, A09J-00940, A09J-01115, A09J-01174, A09J-01175, A09J-01256, A09J-01421, A09J-01434, A09J-01613, A09J-01614, A09J-01615, A09J-01616, A09J-01617, A09J-01621, A09J-01622, A09J-01623, A09J-01625, A09J-01626, A09J-01627, A09J-01643, A09J-01644, A09J-01645, A09J-01647, A09J-01650, A09J-01711, A09J-01712, A09J-01713, A09J-01715, A09J-01718, A09J-01719, A09J-01726, A09J-01731, A09J-01758, A09J-01761, A09J-01762, A09J-01770, A09J-01772, A09J-01773, A09J-01791, A09J-01792, A09J-01799, A09J-01852, A09J-01853, A09J-01854, A09J-01855, A09J-01857, A09J-01858, A09J-01861, A09J-01863, A09J-01864, A09J-01866, A09J-01968, A09J-01971, A09J-01972, A09J-01978, A09J-01979, A09J-01981, A09J-01997, A09J-01998, A09J-01999, A09J-02000, A09J-02007, A09J-02014, A09J-02015, A09J-02016, A09J-02024, A09J-02031, A09J-02032, A09J-02048, A09J-02053, A09J-02054, A09J-02090, A09J-02092, A09J-02095, A09J-02101, A09J-02103, A09J-02105, A09J-02106, A09J-02107, A09J-02109, A09J-02112, A09J-02115, A09J-02120, A09J-02121, A09J-02126, A09J-02128, A09J-02131, A09J-02132, A09J-02134, A09J-02135, A09J-02136, A09J-02141, A09J-02143, A09J-02144, A09J-02215, A09J-02216, A09J-02220, A09J-02231, A09J-02232, A09J-02233, A09J-02234, A09J-02277, A09J-02302, A09J-02306, A09J-02307, A09J-02315, A09J-02316, A09J-02318, A09J-02357, A09J-02368, A09J-02369, A09J-02700, A09J-01304, A09J-01340, A09J-01896, A09J-01928, A09J-02168, A09J-02518, A09J-02527, A09J-02541, A09J-01926, A09J-01803, A09J-01832, A09J-01833, A09J-01841, A09J-01929, A09J-01932, A09J-02037, A09J-02157, A09J-02281, A09J-02300, A09J-02519, A09J-02522, A09J-02523, A09J-02525, A09J-02528, A09J-02612, A09J-02349, A09J-01869, A09J-01875, A09J-02029, A09J-02050, A09J-02649, A09J-01898, A09J-02507, A09J-02524, A09J-02526, A09J-01820, A09J-01834, A09J-01843, A09J-01927, A09J-02154, A09J-02155, A09J-02158, A09J-02160, A09J-02166, A09J-02516, A09J-02517, A09J-02520, A09J-02529, A09J-02548, A09J-02620, A09J-02671, A09J-02672, A09J-02683, A09J-01842, A09J-01899, A09J-01967, A09J-02167, A09J-02283, and A09J-02530;

3) Serial number A09J-02205;

4) Domestic unit Serial Numbers: A09J-02644, A09J-02180, A09J-02643, A09J-02499, A09J-02169, A09J-02175, A09J-02554, A09J-02645, A09J-01891, A09J-02382, A09J-01903, A09J-02361, A09J-02380, A09J-02033, A09J-02409, A09J-01904, A09J-02351, A09J-02384, A09J-02675, A09J-02625, A09J-02628, A09J-01901, A09J-02360, A09J-02485, A09J-02631, A09J-02642, A09J-02641, A09J-02383, A09J-02647, A09J-02693, A09J-02269, and A09J-02552., A09J-02493, and A09J-01974
RECALLING FIRM/MANUFACTURER
Philips Medical Systems, Seattle, WA, by telephone and e-mail on November 2, 2009 and by letters on November 9, 2009. Firm initiated recall is ongoing.
REASON
Potential for failure of a capacitor during use which would prevent the AED from delivering effective defibrillation therapy when indicated.
VOLUME OF PRODUCT IN COMMERCE
1,856 units
DISTRIBUTION
Nationwide and Internationally

___________________________________
PRODUCT 
Shutter HX SP5, a component of the Leica Point Scanning Confocal Microscope Models TCS SP5 and TCS SP5 X. Material No: 1531160006 Spare Part No: 15000904000093; Laboratory instrument. Recall # Z-1221-2010
CODE
Shutter HX SP5
RECALLING FIRM/MANUFACTURER
Recalling Firm: Leica Microsystems, Inc., Bannockburn, IL, by letter on November 12, 2009. 
Manufacturer: Leica Microsystems GmbH, Mannheim, Germany. Firm initiated recall is complete.
REASON
A manufacturing defect was identified that could potentially result in the laser shutter not closing as intended which could result in the shutter not completely closing disrupting the laser beam safely.
VOLUME OF PRODUCT IN COMMERCE
15 microscopes and 8 spare part shutters
DISTRIBUTION
Nationwide, Sweden, Japan, Hong Kong, Italy, the Netherlands, Singapore, UK, and Spain
___________________________________
PRODUCT 
Vertier Surgical Table, Catalog numbers 0788100000, 0788100000S, 0788100001, and 0788100001S. Recall # Z-1238-2010
CODE
All lots
RECALLING FIRM/MANUFACTURER
Stryker Communications Corp., Flower Mound, TX, by letter on November 13, 2009.
Manufacturer: Merivaara Corp., Lahti, Finland. Firm initiated recall is ongoing.
REASON
In certain positions, product is susceptible to fluid intrusions which could possibly result in short circuit or unsolicited movement.  
VOLUME OF PRODUCT IN COMMERCE
206 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Biomet Microfixation, Patient Distractor Driver 10.87cm, (4.28")(L), Radel, Stainless Steel, Non-Sterile Product. Part Number SP-1918. Recall # Z-1319-2010
CODE
Lot numbers: 459660, 478770, 530640
RECALLING FIRM/MANUFACTURER
Biomet Microfixation, Inc., Jacksonville, FL, by letter, fax or e-mail on May 15, 2010. Firm initiated recall is ongoing.
REASON
The patient Distractor Driver, used in Osteotomy procedures, may not ratchet and advance the distraction device as intended. If the distraction device does not advance, bone consolidation may occur and a second surgery may be necessary.
VOLUME OF PRODUCT IN COMMERCE
73 units
DISTRIBUTION
Nationwide, Japan, Finland, Africa
___________________________________
PRODUCT 
Mini Max Torque 2.6 mm diameter Drill Bit, Model #HCS-072-26 & 3.8 mm Countersink, Model # HCS-070-38. Used to drill or cut bone prior to implantation of screws. Recall #  Z-1430-2010
CODE
Lot NG808, Lot NG861, & Lot 1048031
RECALLING FIRM/MANUFACTURER
Recalling Firm: Orthohelix Surgical Designs Inc., Medina, OH, by letters on September 3, 2009.  
Manufacturer: NG Instruments, Inc., Warsaw, IN. Firm initiated recall is ongoing.
REASON
The epoxy is flaking off the drill bits and countersinks.
VOLUME OF PRODUCT IN COMMERCE
HCS-072-26=63 pcs & HCS-070-38 = 11 pcs
DISTRIBUTION
CO, OH, PA, SD, TX, VA

RECALLS AND FIELD CORRECTIONS:  VETERINARY - CLASS II
___________________________________
PRODUCT 
1) Purina Strategy - Professional Formula GX (F) NS - , For Horses at Maintenance, Stallions, Breeding Mares, Foals and Performance Horses. Net Wt 50 lbs. Recall # V-063-2010;

2) Purina Layena Sunfresh Recipe Pellet NS -, Complete Feed For Laying Chickens, Net Wt 50 lbs. Recall # V-064-2010
CODE
1) 0MAR24NST1A1, 0MAR24NST2A1
2) 0MAR24NST2A1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Land O Lakes Purina LLC, Shoreview, MN, by telephone, press release and letter on April 16, 2010.
Manufacturer: Purina Mills LLC/dba Land O'Lakes Purina Feed LLC (66071), Nashville, TN. Firm initiated recall is ongoing.
REASON
Product may contain metal fragments.
VOLUME OF PRODUCT IN COMMERCE
2353 units
DISTRIBUTION
TN, KY, VA, MS, AL, IN, MO, and AR

END OF ENFORCEMENT REPORT FOR MAY 12, 2010

#