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U.S. Department of Health and Human Services

Safety

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Enforcement Report for September 30, 2009

September 30, 2009
09-39

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
1) a) BERGIN Fruit and Nut Company CRANBERRY HONEY NUT MIX (10-oz clamshell tub) and b) KOWALSKI'S MARKETS Cranberry Honey Nut Mix (10-oz clamshell tub) and c) BERGIN NUT COMPANY Cranberry Honey Nut Mix (16-oz bag). Sold in bulk in 1-lb, 5-lbs and 30-lbs. Item #'s - # 604157 (30-lb), # 601068 (5-lb bag), # 604159 (5-lb bag), # 604158 (1-lb bag), # 604163 (10-oz clamshell tub). Recall # F-875-9;

2) Honey Roast Peanut Splits, product code 600625, 50-lb bag. This product was distributed to one customer only, Best Maid Cookies. Recall # F-876-9   
CODE
No coding
RECALLING FIRM/MANUFACTURER
Bergin Fruit and Nut Co Inc., Falcon Heights, MN, by press release and letter dated January 30, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
MN, ND, WI
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PRODUCT 
Giulia Alfalfa Seed for sprouting in 50 lb poly bag. Item #ALFMC050, Date of Mfr. 1/06/2009. Recall # F-1114-9
CODE
Lot # 032-748
RECALLING FIRM/MANUFACTURER
Recalling Firm: Caudill Seed & Warehouse Inc., Louisville, KY, by telephone on March 12, 2009 and by letter on March 20, 2009.
Manufacturer: Mediterranea Sementi SRL, Teramo, Italy. Firm initiated recall is ongoing.
REASON
The product is contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
415/50 lb poly bags
DISTRIBUTION
CA, MI, MN, NE, OH, VA
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PRODUCT 
Roasted Peanut Crispy Cat Candy Bar. The product is a dark chocolate rice crispy base made with organic ingredients. Bar UPC 8.93048.00003.9, Carton UPC 8.93048.00004.6. Recall # F-1183-9
CODE
Lot Numbers: 0038A, 0048A, 0578A, 0588A and 1588A with expiration dates from Jan 2009 through June 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tree Huggin Treat, Inc., Ashville, NC, by letter on February 9, 2009.
Manufacturer: Noble Foods, Inc., Pointe-claire, Canada. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
157,824 individual units
DISTRIBUTION
Nationwide and Canada
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PRODUCT 
1) Southern Grove Honey Roasted Peanuts packaged in 1.75 oz plastic bag, UPC 41498-16133. Recall # F-1184-9;

2) Cumby's Snacks" Honey Roasted Peanuts, packaged in 3 oz foil pouches, UPC 42704 80081. Recall Number: F-1185-9;

3) Cumby's Snacks" Hole in One Snack Mix, packaged in 8 oz foil pouches, UPC 42704 00851. Recall # F-1186-9
CODE
Best before January 30, 2010
RECALLING FIRM/MANUFACTURER
Barcelona Nut Co., Inc., Baltimore, MD, by letter on January 29, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE
47,668 lbs
DISTRIBUTION
MA, IL
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PRODUCT 
1) Rich's Ice Cream Nutty Sundae Cone. Artificially Flavored Vanilla Lowfat Ice Cream Cone with Chocolate Coating and Peanuts, UPC 7545542000. 3 fl oz, 24 count per shipping carton. Recall # F-1187-9;

2) Rich's Ice Cream Candy Bar Avalanche UPC 7545534100. Artificially Flavored Nougat Frozen Dairy Dessert with Candy Pieces, Peanuts and Caramel Swirl 10 FL oz. Shipping carton is labeled with year of manufacture plus Julian date and time, digitally stamped on each shipping carton for example 9021 (9 indicates year 2009, 021 indicates January 21). Recall # F-1188-9
CODE
No codes
RECALLING FIRM/MANUFACTURER
Rich Ice Cream Co., West Palm Beach, FL, by telephone, email, and faxes on January 29, 2009. Firm initiated recall is complete.
REASON
The products were produced using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
21,802 cases/24 ct per case
DISTRIBUTION
Nationwide, Puerto Rico, Bahamas, Virgin Islands
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PRODUCT 
French Burnt Peanuts Here's Howe brand, 3.5 oz, UPC 73171-00529; 14 oz, UPC 73171-04464; 10 lb, UPC 73171-06513. Candy Place brand, 15 oz, UPC 30034-04182. Primrose brand, 25 lb bulk, UPC 71576-00014. Recall # F-1189-9
CODE
Expiration dates through 080309
RECALLING FIRM/MANUFACTURER
George J Howe Co., Grove City, PA, by press release and e-mail on February 4, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
10,573 cases
DISTRIBUTION
AR, DE, FL, IL, IN, MD, MI, NC, NJ, NY, OH, PA, VA, VT, and WV
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PRODUCT 
1) Best Choice Premium Candy Bar Crunch Ice Cream, 1.75 Quarts (1.66L), UPC 070038596226. Recall # F-1190-9;

2) Best Choice Ice Cream, Tin Roof Sundae, Half Gallon (1.89L), UPC 070038596172. Recall # F-1191-9;

3) LuVel, Candy Bar Sundae, Premium Ice Cream, Half Gallon (1.89L), UPC 077322147812, and Candy Bar (bulk packaging), 3 gallons. Recall # F-1192-9;

4) LuVel, Caramel Turtle Pie, Premium Ice Cream, Half Gallon (1.89L), and Turtle Pie (bulk packaging), 3 gallons. Recall # F-1193-9;

5) Hiland, Premium Ice Cream, Old Recipe, Candy Bar Crunch, 1.75 Qt., UPC 072060082685. Recall # F-1194-9
CODE
1) 1/1/08 through 1/12/10;
2) 1/1/08 through 1/27/10
3) Best by April 2, 2009;
4) 6/5/08, 10/30/08 Bulk Packaging: Best by April 2, 2009;
5) 1/1/08 though 1/29/08
RECALLING FIRM/MANUFACTURER
Turner’s Dairies, Inc., Covington, TN, by letter on February 2, 2009 and press release on February 13, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
101,517 units
DISTRIBUTION
KS, MS, TX, MO, TN
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PRODUCT 
1) Virginia Runner Peanuts packaged in 1 lb, 5 lb, 25 lb and 30 lb containers. Recall # F-1195-9;

2) Classic Mix, 1-, 5- and 25-lb sizes. Recall # F-1196-9;

3) Y2K Trail Mix, 1-, 5- and 25-lb sizes. Recall # F-1197-9;

4) Cajun Mix packaged in 1-, 5- and 25-lb containers. Recall # F-1198-9
CODE
Products with a pack date between July 15 and August 30, 2008
RECALLING FIRM/MANUFACTURER
Vending Nut Co., Inc., Fort Worth, TX, by e-mail or letter on February 6, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
8,400 lbs
DISTRIBUTION
TX
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PRODUCT 
Durhams Ellis Peanut Topping, Net Weight 5 lb (80 oz); and 3lb Peanut Topping. Recall # F-1199-9
CODE
5 lb pack, Exp. Date 3/2003 thru 3/2010; 3 lb Pack, Exp. Date 3/2003 thru 3/2010; and 8-3 lb Pack, exp. date 3/2003-3/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dollins Pecan Co, Inc., Comanche, TX, by letter on February 13, 2009 and press release on February 26, 2009. 
Manufacturer: Peanut Corporation of America (PCA), Plainview TX. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
17,310 lbs
DISTRIBUTION
OK, TX, WI
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PRODUCT 
1) Sparrow Roasted Peanut Meal 10 lbs, item #: F-541047-10, UPC: 4543897410.  Recall # F-1200-9;

2) Sparrow Coarse Peanut Meal 10 lbs, Item #: F-541010-10, UPC: 4543898510.
Recall # F-1201-9
CODE
1) Lot #: 8284D and 8297B;
2) Lot #: 8297B and 8298D
RECALLING FIRM/MANUFACTURER
Sparrow Enterprises Ltd., East Boston MA, by e-mail on January 29, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanut meals, recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
279 cases
DISTRIBUTION
PA, NY
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PRODUCT 
10th Tee Peanut Honey Back Nine Golf Energy Bar sold as individually wrapped 50 gram bars and 12-count printed trays; wrapper: UPC 7198803004; 12 Count Tray: UPC  7198803014. Recall # F-1202-9   
CODE
Best By Dates of 5/16/2009 and 8/27/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: SCNS Sports Foods, Inc., Upland, CA, letter on March 5 and 6, 2009.
Manufacturer: Nellson Nutraceutical Inc., Irwindale, CA. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
49,104 bars
DISTRIBUTION
 Nationwide
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PRODUCT 
Deep Freeze Nut Sundae On a Stick Chocolate and Nut Coated Ice Cream Bar 5 fl. oz, UPC 8 59072 00013 1. Recall # F-1203-9
CODE
EAM. EXP.02.04.10. *** Please Note: Only packaging case receives code, individual retail units are not coded***
RECALLING FIRM/MANUFACTURER
El Monte Dairy, South El Monte, CA, by letters on March 27, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
522 cases. Each case contains 24/5 fl oz bars
DISTRIBUTION
CA
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PRODUCT 
WOW Café & Wingery Thai Peanut Dressing & Sauce, 1 U.S. Gal. (3.8L), packaged in a plastic jug. Recall # F-1204-9
CODE
Lot numbers: 3247, 1718, and 2138
RECALLING FIRM/MANUFACTURER
Wow Café & Wingery, Covington, LA, by e-mail beginning on February 4, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
572 cases
DISTRIBUTION
Nationwide
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PRODUCT 
1)  Chocolate Peanuts from the makers of Jelly Belly in 7 oz. bag Item # 24050 12 X 7oz Chocolate peanuts Case UPC 00071567983921 Unit/bag UPC -071567240505; 10 lb Chocolate peanuts Case/unit UPC - 00071567040501. Recall # F-1205-9;

2) 10 lb Choc Peanut Clusters Case/unit UPC – 00071567040556, Item number 4055, Recall # F-1206-9;

3) 10 lb Choc Peanuts-No Sugar Added Case/unit UPC - 00071567056557, Item number 5655. Recall # F-1207-9
CODE
1) 7 oz. size: Lot codes and best by dates as follows: 071029 BEST BEFORE Oct 29, 2008 071108 BEST BEFORE Nov 08, 2008 071116 BEST BEFORE Nov 16, 2008 071121 BEST BEFORE Nov 21, 2008 080304 BEST BEFORE Mar 4, 2009 080310 BEST BEFORE Mar 10, 2009 080611 BEST BEFORE Jun 11,2009 080820 BEST BEFORE Aug 20, 2009 081112 BEST BEFORE Nov 12, 2009 10-lb size: Lot numbers 071029, 071107,071130 071201, 080103, 080206, 080305, 080403, 080404,080422 080423, 080605, 080722, 080820, 080821, 080903, 080904, 081125,090128;

2) Lot codes: 081020,081105

3) Lot codes 071121 080201 080324 080401 080531
RECALLING FIRM/MANUFACTURER
Jelly Belly Candy Co., Fairfield, CA, by telephone, letter and e-mail on February 13, 2009 and press release on March 3, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
8,358 cases
DISTRIBUTION
Nationwide, Hawaii, and Saipan
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PRODUCT 
Frozen Bananas sold as: (1) World Famous Gourmet Nutty Nanner Frozen Bananas, Net Wt. 3 oz (85 gm), UPC 0 7293240444 7, packaged in a clear paper wrap, 24 individual wrapped bananas per cardboard box, 4 cardboard boxes/case; (2) Frozen Bananas, Net Wt. 3 oz, packaged in a clear paper wrap, 24 individual wrapped bananas per cardboard box , 4 cardboard boxes/case. Recall # F-1208-9
CODE
Exp. date: 01/01/2008-01/30/2010
RECALLING FIRM/MANUFACTURER
Ricketts Investment Group (dba) L & H Industries, Anaheim, CA, by telephone and e-mail on February 26, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1366 cases
DISTRIBUTION
FL, CA
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PRODUCT 
Farm Rich the appetizer company brand Breaded Vegetable Sticks, Net Wt 12 lbs (6/2 lbs bags), Product Code 62762, UPC 1 00 41322 67262 6 -- Keep Frozen -- This item is manufactured for food service operators. Recall # F-1217-9
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rich Products Corp., Buffalo, NY, by e-mail on April 6, 2009 and by press release on April 7, 2009.
Manufacturer: Rich Products Corp., Brunswick, GA. Firm initiated recall is ongoing.
REASON
The product contains undeclared eggs. The batter used to make the breaded vegetable sticks contained eggs but they were not declared on the finished product labeling.
VOLUME OF PRODUCT IN COMMERCE
67,262 cases
DISTRIBUTION
Nationwide
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PRODUCT 
1) Parker Chocó Peanut Butter Cup, Item #1442 (AF #13229) (no UPC Code); 30 pound case. Recall # F-1221-9;

2) Peanut Butter Cookies & Crème Organic Bark, Item #2348(#70056), UPC #24259 70056; 2/5 lb. bags/case. Recall # F-1222-9;

3) Parker Peanut Butter Milk Blend, Item #2310 (#105631) (no UPC Code); 30 pound case.  Recall # F-1223-9;

4) Organic Confections Sweet & Salty bark, UPC Code 718345022372, Item #2237, packaged 12-8oz units per case; UPC Code 718345022570, Item #2257, packaged 20 bars per case; UPC Code 718345022884, Item #2288, packaged 16-5oz units per box; and Item #2250 packaged in a bulk 25lb case (no UPC code). Recall # F-1224-9;

5) Parker Products Sweet & Salty Bark 8 oz Candy Island Confections. Recall # F-1225-9;

6) Parker Products Tabasco Praline Peanut, 30 lb case, Item 1636. Recall # F-1226-9;

7) Parker Products Chocolate Coated Peanuts, 30 lb case, Item #1015. Recall # F-1227-9;
 
8) Parker Products Peanut Splits, 5 lb case, Item #2233. Recall # F-1228-9;

9) Parker Products Popcorn Praline Peanut Blend, 30 lb case; Item #2340. Recall # F-1229-9;

10) Parker Products Peanut Cluster, 30 lb case, Item #2004. Recall # F-1230-9;

11) Parker Products Peanut Honey Cluster, 30 lb case, item #2202. Recall # F-1231-9;

12) Peanut Crunch, 30-pound case, Item #1949. Recall # F-1232-9
CODE
1) Lot #08311;
2) Lot #08277;
3) Lot #08213
4) All lot numbers beginning with 07 and 08;
5) Lot 09007, and all 07 and 08 lots;
6), 7) All 07 and 08 lots and Lot 09023;
9) All 07 and 08 lots and lots 09012, 09013;
8), 10) and 11) All 07 and 08 lots;
12) Code Dates: 07031, 07032, 07073, 07074, 07110, 07179, 07180, 07242, and 07243
RECALLING FIRM/MANUFACTURER
Recalling Firm: Parker Products, Inc., Fort Worth, TX, by press release on January 23, 2009 and March 3, 2009 and by telephone, e-mail and letters.
Manufacturer: Peanut Corp., of America, Lynchburg, VA. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanut butter recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
91,404.75
DISTRIBUTION
TX
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PRODUCT 
1) Peanut Butter, 6 ct 5 lb, UPC Code 26720 34123; 1 ct 50 lb, UPC 26800 34123; 10 ct. 5 lb, UPC Code 26730 34123; 500 ct. 1 oz, UPC 26295 34123; 200 3/4 oz; 200 2.25 oz, Peanut Butter, 200 1/2 oz; 200 2 oz Recall # F-1233-9;

2) Peanut Butter/Grape Jelly Combo, 200 ct. 2/12 oz, Peanut Butter/Grape Jelly Combo CSV, 200 2.12 oz; Peanut butter Grape Combo, 24 bags 12 ct. The product is packaged in a plastic pouch. Recall # F-1234-9;

3) Creamy Peanut Butter, 400 1.12 oz, 5 lb. Recall # F-1235-9;

4) Peanut Butter & Strawberry Jam Combo, 200 2.12 oz; 24 bags 12 ct. Recall # F-1236-9;

5) No Salt Peanut Butter, 1 ct. 50 lb, UPC 26802 34123; 12 ct. 16 oz, UPC 2660034123. Recall # F-1237-9;

6) Crunchy Peanut Butter, 200 2 oz. The product is packaged in a pouch. Recall # F-1238-9; 
CODE
1) Codes: 7045, 7101, 7102, 7106, 7108, 7114, 8253, 8254, 8255, 8256, 8261, 8262, 8263, 8266, 8267, 8268, 8269, 8294, 8295, 8296, 8297, 8301, 8302, 8303, 8304, 8311, 8315, 8316, 8322, 8323, 8324, 8325, 8343, 8344, 8345, 8346;

2) Codes:  8262, 8266, 8267, 8268, 8269, 8294, 8297, 8301, 8303, 8315, 8316, 8323, 8324, 8325;

3) Code 7045, 7102, 7107, 8254, 8296;

4) Code 7107, 7114, 7124, 8262, 8268, 8297, 8302, 8315, 8322, 8323, 8344, 8345;

5) Code 8253, 8347;

6) Code 7165, 7166, 7169, 8172, 8189, 8190, 8270
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boca Grande Foods/Modern Packaging, Duluth, GA, by press release on January 20, 2009 and letter on January 21, 2009.
Manufacturer: Peanut Corp. of America, Blakely, GA, Firm initiated recall is ongoing.
REASON
The products were manufactured using peanut paste recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Peanut butter from honey roasted peanuts sold via bulk bin in store. Peanuts from these bins are used in an in-store, self-serve grinder to manufacture peanut butter. The self-serve fresh ground peanut butter is packaged in 16 oz and 32 oz plastic sealed containers. Recall # F-1239-9;

2) Peanut butter made from Split, Dry Roasted, and Unsalted Peanuts. The peanuts are sold in bulk bins. Peanuts from these bins are also used in an in-store, self-serve grinder to manufacture peanut butter. The self-serve fresh ground peanut butter is packaged in 16 oz and 32 oz plastic sealed containers. Recall # F-1240-9
CODE
1) Roth Bulk Food Bin # 8612;
2) Roth Bulk Food Bin # 2033
RECALLING FIRM/MANUFACTURER
Roth’s IGA Foodliner, Inc., Salem, OR, by press release dated February 24, 2009 and March 4, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
8,634 lbs
DISTRIBUTION
OR
___________________________________
PRODUCT 
1) Thrifty Nut brand Dry Roasted Peanuts, Thrift Products Co., Grand Rapids, MI. Net wt. 5 oz., UPC 7934833903. Net wt. 12 oz, UPC 7934811905. Net wt. 32 oz. No UPC.
Recall # F-1241-9;

2) Thrifty Nut brand Granulated Honey Roasted Peanuts, net wt. 5 #, UPC 7934898868. Recall # F-1242-9;

3) Thrifty Nut brand Honey Roasted Peanuts. Thrifty Nut brand Honey Roasted Peanuts, net wt. 5 oz, UPC 7934833941 and Thrifty Nut brand Honey Roasted Peanuts, 8 oz, UPC 7934810941. Recall # F-1243-9
CODE
1) All lots with a Best if Used by date of 11/09 or earlier;
2) and 3) All lots with a Best if Used by date of 7/09 or earlier;
RECALLING FIRM/MANUFACTURER
Thrift Products Company, Inc., Kentwood, MI, by press release, telephone and/or letter on February 3, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Approx. 8,220 lbs
DISTRIBUTION
IN, MI

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS I

___________________________________
PRODUCT 
1) Propofol Injectable Emulsion 1%, 1000 mg/100 mL (10 mg/mL) in 100 mL vials, Rx only, NDC 0703-2859-01. Recall # D-1966-2009;

2) Propofol Injectable Emulsion 1%, 200 mg/20 mL (10 mg/mL) in 20 mL vials, Rx only, NDC 0703-2856-01. Recall # D-1967-2009;

3) Propofol Injectable Emulsion 1%, 500 mg/50 mL (10 mg/mL) in 50 ml vials, Rx only, NDC 0703-2858-01. Recall # D-1968-2009;

4) Propofol Injectable Emulsion 1%, 1000 mg/100 mL (10 mg/mL) in 100 mL vials, Rx only, NDC 0703-2859-01. Recall # D-1969-2009  
CODE
1) Lot # 31305429B, Exp 01/11; Lot # 31305430B, Exp 01/11;

2) Lot # 31305323B, Exp 01/11;

3) Lot # 31305431B, Exp 01/11;

4) Lot # 31305324B, Exp 01/11
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by telephone, letter and press release on July 16, 2009 and by letter on July 29, 2009.
Manufacturer: Teva Parenteral Medicines, Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Non-Sterility: contamination with endotoxins.
VOLUME OF PRODUCT IN COMMERCE
268,765 vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Concentrated Acetaminophen Drops, Bulk Pharmacy Container, Institutional Use Only, 80 mg/0.8 mL, 16 oz (473 mL) bottle, NDC 42192-504-16. Recall # D-1970-2009
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Brookstone Pharmaceuticals, LLC, Alpharetta, GA, by press release on July 13, 2009 and letter dated July 10, 2009. Firm initiated recall is ongoing.
REASON
Possible overdosing may result from product packaging and the absence of an integrated dosage delivery device.
VOLUME OF PRODUCT IN COMMERCE
6,633 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
1) Children's Tylenol Plus, Multi-Symptom Cold, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottles, Grape Flavor, Oral Suspension, Product code 3910400, UPC 300450391049. Recall # D-1952-2009;

2) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, Grape Flavor Oral Suspension. Product code 2960400, UPC 300450296047. Recall # D-1953-2009;

3) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, bubblegum Yum Flavor, Oral Suspension. Product code 4070400, UPC 300450407047. Recall # D-1954-2009;

4) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, very berry Strawberry Flavor, Oral Suspension. Product code 4930400, UPC 300450493040.Recall # D-1955-2009;

5) Concentrated Tylenol, Infants' Drops, (acetaminophen 80 mg/0.8 mL), Grape Flavor.  Packaged in the following configurations: 1/4 fl oz (7.5 mL) bottle with dropper, a) Product code 1224000, UPC 300450122407; 1/2 fl oz (15 mL) bottle with dropper, b) Product code 1221500, UPC 300450122155; 1 fl oz (30 mL) bottle with dropper, c) Product code 1220100, UPC 300450122018; 1 fl oz (30 mL) bottle with dropper, d) Product code 1221000, UPC 300450122100; (For Hospital/Government Use Only), 1/2 fl oz (15 mL) bottle, e) Product code 1221800, UPC 350580144183. Recall # D-1956-2009

6) Concentrated Tylenol, Infants' Drops, (acetaminophen 80 mg/0.8 mL), Cherry Flavor.  Packaged in the following configurations: 1/2 fl oz (15 mL) bottle with dropper, a) Product code 1861500, UPC 300450186157; 1 fl oz (30 mL) bottle with dropper, b) Product code 1863000, UPC 300450186300; (For hospital/government use only), 4 fl oz (120 mL) bottle, c) Product code 1230300, UPC 350580123034. Recall # D-1957-2009;

7) Children's Tylenol, (acetaminophen 160 mg/5 mL), 4 fl oz (120 mL) bottle, Dye Free Cherry Flavor, Oral Suspension. Product code 1660400, UPC 300450166043. Recall # D-1958-2009;

8) Children's Tylenol, (acetaminophen 160 mg/5 mL), Cherry Blast Flavor, Oral Suspension. Packaged in the following configurations: 4 fl oz (120 mL) bottle, Product code 1230400, UPC 300450123046; 1 fl oz (30 mL) bottle, Product code 1230100, UPC 300450123015. Recall # D-1959-2009;
 
9) Children's Tylenol Plus, Cough & Runny Nose, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, and Dextromethorphan HBr 5 mg), 4 fl oz (120 mL) bottle, Cherry Flavor, Oral Suspension. Product code 2490400, UPC 300450249043. Recall # D-1960-2009;

10) Children's Tylenol Plus Flu, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, Dextromethorphan HBr 5 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottle, Bubble Gum Flavor, Oral Suspension. Product code 3860400, UPC 300450386045. Recall # D-1961-2009;

11) Children's Tylenol Plus Cold, (each 5 mL contains: Acetaminophen 160 mg, Chlorpheniramine maleate 1 mg, and Phenylephrine HCl 2.5 mg), 4 fl oz (120 mL) bottle, Grape Flavor, Oral Suspension. Product code 3870400, UPC 300450387042. Recall # D-1962-2009;

12) Children's Tylenol Plus Cough & Sore Throat, (each 5 mL contains: Acetaminophen 160 mg and Dextromethorphan HBr 5 mg), 4 fl oz (120 mL) bottle, Cherry Flavor, Oral Suspension. Product code 2470400, UPC 300450247049. Recall # D-1963-2009;

13) Concentrated Tylenol Infants' Drops, (acetaminophen 80 mg/0.8 mL), 1 fl oz (30 mL) bottle with dropper, Dye-Free Cherry Flavor. Product code 1670100, UPC 300450167019. Recall # D-1964-2009;

14) Children's Tylenol Plus Cold & Allergy, (each 5 mL contains: Acetaminophen 160 mg, Diphenhydramine HCl 12.5 mg, and Phenylephrine 2.5 mg), 4 fl oz (120 mL) bottle, Bubble Gum Flavor, Oral Suspension. Product code 3900400, UPC 300450390042. Recall # D-1965-2009
CODE
1) Lot numbers: SBM041 exp 1/10, SBM067 exp 2/10, SCM037 exp 2/10, SDM027 exp 3/10, and SEM109 exp 5/10;

2)  Lot numbers: SBM042 exp 2/10, SCM015 exp 2/10, SCM036 exp 2/10, and SDM034 exp 3/10;

3) Lot numbers: SBM043 exp 2/10, SBM044 exp 2/10, and SCM029 exp 2/10;   

4) Lot numbers: SBM045 exp 2/10, SCM011 exp 2/10, SCM030 exp 2/10, and SDM035 exp 3/10;

5) a) Lot numbers: SBM064 exp 2/10, SCM033 exp 3/10, and SDM020 exp 3/10; b) Lot numbers: SCM012 exp 2/10, SCM067 exp 3/10, SDM007 exp 3/10, and SDM068 exp 3/10; c) Lot numbers: SCM082 exp 3/10, SDM039 exp 3/10, and SDM040 exp 3/10; d) Lot number: SDM078 exp 3/10; e) Lot number: SCM034 exp 2/10;

6) a)  Lot numbers: SBM065 exp 2/10, SCM005 exp 2/10, SCM006 exp 2/10, and SDM032 exp 3/10; b) Lot numbers: SDM038 exp 3/10 and SDM009 exp 3/10; c) Lot number: SDM028 exp 3/10;

7) Lot numbers: SBM066 exp 2/10 and SCM068 exp 2/10;

8) Lot numbers: SBM068 exp 2/10, SCM035 exp 2/10, SCM070 exp 3/10, SCM080 exp 3/10, and SDM005 exp 3/10; Product code 1230100, Lot number: SDM064 exp 3/10;  

9) Lot numbers: SBM069 exp 2/10, SBM070 exp 2/10, SCM081 exp 3/10, and SDM006 exp 3/10;

10) Lot numbers: SCM013 exp 2/10, SCM014 exp 2/10, and SCM069 exp 3/10;

11) Lot numbers: SCM016 exp 2/10 and SFM024 exp 5/10;

12) Lot number: SCM017 exp 2/10;

13) Lot numbers: SCM083 exp 3/10, SCM084 exp 3/10, SDM008 exp 3/10;

14) Lot number: SDM033 exp 3/10  
RECALLING FIRM/MANUFACTURER
McNeil Consumer Healthcare, Div of McNeil-PPC, Inc., Fort Washington, PA, by letters dated August 21, 2009 and September 11, 2009. Firm initiated recall is ongoing.
REASON
The raw material used to manufacture the finished product may have been contaminated with B cepacia.
VOLUME OF PRODUCT IN COMMERCE
7,983,648 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Advair Diskus 100/50mcg (fluticasone propionate/salmeterol inhalation powder, 100/50mcg), Rx only, NDC 0173-0695-00. Product Order Number: 01730695009. Recall # D-1972-2009
CODE
Lot number: 9ZP7632, Expiration Date: April 2010
RECALLING FIRM/MANUFACTURER
GlaxoSmithKline, Inc., Zebulon, NC, by letter on/about August 4, 2009. Firm initiated recall is ongoing.
REASON
Defective delivery system; There is a potential for the foil strip of the inhaler to tear rather than to peel back, which can result in medication not being available to the user as they advance doses through the Diskus unit.
VOLUME OF PRODUCT IN COMMERCE
23,932 units
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
Balneol for Her, Hydrocortisone 0.25%, Anti-Itch Lotion, a) 20 count/2 gm packets (UPC #3 68220-078-10 1) and b) 3fl.oz (89 mL) bottles (UPC #368220-078-03 3). Recall # D-1971-2009  
CODE
a) Lot number 6911, b) Lot number 6889
RECALLING FIRM/MANUFACTURER
Recalling Firm: Alaven Pharmaceutical LLC, Marietta, GA, by telephone and letter on/about June 19, 2009.
Manufacturer: Span Packaging Services LLC, Greenville, SC. Firm initiated recall is ongoing.
REASON
Stability testing does not support the potency of the product throughout the product’s shelf life.
VOLUME OF PRODUCT IN COMMERCE
13,128 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Acetaminophen 500 mg Pain Reliever-Fever Reducer, packaged under the following labels: CareOne Pain Relief Extra Strength Acetaminophen Cooling Sensation Caplets, 500 mg, 100 caplets, OTC; Equaline Extra Strength Pain Relief, acetaminophen, 500 mg, 100 caplets, OTC, NDC 41163-010-78; Good Neighbor Pharmacy Extra Strength Pain Reliever Cool Ice Caplets, acetaminophen, 500 mg, 100 caplets, OTC, NDC 24385-618-78; TopCare Extra Strength Pain Relief, acetaminophen, 500 mg, 100 caplets, OTC, NDC 36800-010-78; TopCare Extra Strength Pain Relief, acetaminophen, 500 mg, 50 caplets, OTC, NDC 36800-010-71. Recall # D-1974-2009
CODE
Lot numbers: 9FE2629 and 9FE2453
RECALLING FIRM/MANUFACTURER
L. Perrigo, Co., Allegan, MI, by letter dated July 29, 2009. Firm initiated recall is ongoing.
REASON
Presence of foreign substance; Incorrect coating on tablets
VOLUME OF PRODUCT IN COMMERCE
56,520 bottles
DISTRIBUTION
IL, MN, NY, PA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
1) Fresh Frozen Plasma Recall # B-1340-09;

2) Red Blood Cells Leukocytes Reduced. Recall # B-1341-09
CODE
1) and 2) Unit: 06LT57392
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone on January 21, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Platelets Pheresis Leukocytes Reduced. Recall # B-1591-09;

2) Platelets Pheresis Leukocytes Reduced Irradiated. Recall # B-1592-09
CODE
1) Units: W1416082539912, W1416082532401, W1416082518332, W1416082515531, W1416082508352;

2) Units: W1416082547421, W1416082547422, W1416082539911, W1416082532402, W1416082518331, W1416082515532, W1416082508351, W1416082506271, W1416082506272
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on January 16, 2009.  
Manufacturer: Puget Sound Blood Center and Program, Federal Way, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
14 Units
DISTRIBUTION
WA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1593-09;
2) Fresh Frozen Plasma, Recall # B-1595-09
CODE
1) Unit: 19GH87696;
2) Units: 19LF36484; 19LW53579
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile on January 16, 2009 and by letter on March 27, 2009. 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
3 units
DISTRIBUTION
TN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1621-09
CODE
Unit: W142808308609
RECALLING FIRM/MANUFACTURER
Tri-Counties Blood Bank, Santa Barbara, CA, by letter dated July 6, 2009. 
Tri-Counties Blood Bank, San Luis Obispo, CA. Firm initiated recall is complete. 
REASON
Blood product, incorrectly labeled as to red cell antigen type, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1623-09;
2) Recovered Plasma. Recall # B-1624-09
CODE
1) and 2) W035809092879, W035808150661
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by facsimile on April 28, 2009 or by telephone on April 29, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of receiving an accidental needle stick, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA, Switzerland
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1630-09
CODE
Unit: W045209009550
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, South Bend, IN, by telephone on May 20, 2009. Firm initiated recall is complete.
REASON
Blood product, which was labeled as leukoreduced, but exceeded the acceptable limit for white blood cell count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IN
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1703-09
CODE
Unit: 54KC14605
RECALLING FIRM/MANUFACTURER
American National Red Cross, Rio Piedras PR, by telephone on May 5, 2009 and by letter on May 8, 2009,
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
PR
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1704-09;
2) Fresh Frozen Plasma. Recall # B-1705-09;  
3) Platelets. Recall # B-1706-09
CODE
1), 2), and 3) Unit: W035209092847N
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 27, 2009 and by letter dated June 23, 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
TX
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1708-09
CODE
Units: W044209514562, W044209482728
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by letter dated July 14, 2009. Firm initiated recall is complete.
REASON
Blood products, which were inappropriately distributed in single storage bags, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1709-09;
2) Cryoprecipitated AHF. Recall # B-1710-09
CODE
1) and 2) Unit: W035209081823D
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 11, 2009 and by letter dated July 16, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, TX
___________________________________
PRODUCT 
1) Cryoprecipitated AHF. Recall # B-1726-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1727-09;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1728-09;
4) Recovered Plasma. Recall # B-1729-09
CODE
1) and 3) Unit: 5555616;
2) Unit: 2295323;
4) Units: 2295323, 5555616  
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by letters on October 27, 2004 and October 31, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
ID, WA, Austria

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1390-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1391-09
CODE
1) W047009333929; W047008711829; W047008285704;
 
2) W047009194219; W047009334118; W047009334872; W047009194643; W047009269357; W047008545387; W047009164706; W047008291737; W047008572879; W047008099613
RECALLING FIRM/MANUFACTURER
New York Blood Center, Inc., Long Island, NY, by letter dated May 28, 2009. Firm initiated recall is complete.
REASON
Blood products, processed from overweight units of Whole Blood, were distributed.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
NJ, NY
___________________________________
PRODUCT 
Prevnar Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM 197 Protein), FOR PEDIATRIC USE ONLY, Disposable Syringe, One Dose (0.5mL) IM NDC 0005-1970-49 (single dose 0.5mL pre-filled syringe), RX only, CONTAINS NO PRESERVATIVE, and carton labeled NDC 0005-1970-50 Wyeth, FOR PEDIATRIC USE ONLY, Pneumococcal 7-valent Conjugate Vaccine (Diphtheria CRM 197 Protein), Prevnar, FOR INTRAMUSCULAR USE ONLY, RX only,10 One Dose (0.5mL)Disposable Syringes and One carton contains 10 single dose (0.5mL) pre-filled syringes. This is shipped 45 cartons of 10 x 1(0.5mL) single dose pre-filled syringes per shipper. Recall # B-1571-09
CODE
Lot D50002
RECALLING FIRM/MANUFACTURER
Recalling Firm: Wyeth Pharmaceuticals, Inc., Philadelphia, PA, by letter dated July 10, 2009.
Manufacturer: Wyeth Pharmaceuticals, Inc., Pearl River, NY. Firm initiated recall is ongoing.
REASON
Prevnar Pneumococcal 7-valent Conjugate Vaccine, single dose pre-filled syringes not intended for commercial use, was distributed. 
VOLUME OF PRODUCT IN COMMERCE
96,280 doses
DISTRIBUTION
Nationwide, North Mariana Islands, Guam and US Virgin Islands
___________________________________
PRODUCT
Recovered Plasma. Recall # B-1594-09
CODE
Unit: 19GH87696
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services Tennessee Valley Region, Nashville, TN, by facsimile on January 16, 2009 and by letter on March 27, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1622-09
CODE
Unit: W035809106252
RECALLING FIRM/MANUFACTURER
BloodSource, Inc., Mather, CA, by telephone and facsimile on April 20, 2009. Firm initiated recall is complete.
REASON
Blood product, manufactured without the entire quantity of additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Leukocytes. Recall # B-1707-09
CODE
Unit: W035209092847N
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on May 27, 2009 and by letter dated June 23, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1711-09
CODE
Unit: W035209081823D
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on June 11, 2009 and by letter dated July 16, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria, TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1730-09
CODE
Units: 20GZ16275, 20GZ16277, 20GZ16278, 20GZ16286, 20GZ16285, 20GZ16287, 20GZ16292, 20GZ16300, 20GZ16281, 20GZ16309, 20GZ16276, 20GZ16279, 20GZ16298, 20GZ16307, 20GZ16274, 20GZ16282, 20GZ16284, 20GZ16295, 20GZ16302, 20GZ16303, 20GZ16306, 20GZ16293, 20GZ16294, 20GZ16304, 20GZ16305
RECALLING FIRM/MANUFACTURER
Recalling Firm: American National Red Cross, Boise, ID, by telephone on June 18, 2008. 
Manufacturer: American National Red Cross, Great Falls, MT. Firm initiated recall is complete.
REASON
Blood products, collected during equipment validation but which did not pass the required QC testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
25 units
DISTRIBUTION
MT

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
DePuy P.F.C. Sigma Knee System, Non-Porous Cruciate Retaining Femoral Component, 73 mm M/L 69 mm A/P, 5 left, sterile; REF 96-0005. The device is used for total or unicompartmental knee arthroplasty and is intended to provide increased patient mobility and reduced pain by replacing the damaged knee joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. The device is used as a Orthopedic knee implant. Recall # Z-1686-2009
CODE
Lot Numbers: 2833275, 2833276, 2833277, 2833278, 2833279, 2835157, 2835908, 2835909, 2837020, 2838165, 2839666, 2839667, 2839668, 2839670, 2839671, 2839672, 2839675, 2840479, 2840480, 2841253, 2842526, 2842527, 2842528, 2842930, 2843263, 2843265, 2843267, 2843268, 2843270, 2844381, 2844383, 2844386, 2844796, 2844799, 2844800, 2845530, 2845534, 2846326, 2846330, 2846332, 2852392, 2852394, 2855015, 2855016, 2857271, 2857272, 2857881, 2857882, 2857884, 2857885, 2858572, 2858573, 2858574, 2858576, 2858577, 2859195, 2859197, 2859198, 2859199, 2859915, 2859916, 2859917, 2859920, 2860448, 2860449, 2860452, 2860455, 2860456, 2861519, 2861520, 2861699, 2862589, 2862591, 2863841, 2863843, 2864833, 2864834, 2864835, 2864837, 2864839, 2866038, 2868313, 2868314, 2869119, 2869120, 2869121, 2869122, 2869123, 2871182, 2871183, 2871835, 2871836, 2874434, 2874435, 2874436, 2876307, 2876309, 2876311, 2876314, 2881638, 2885685, 2885689, 2886278, 2886968 and 2886974
RECALLING FIRM/MANUFACTURER
Recalling Firm: Depuy Orthopedics, Inc., Warsaw, IN, by email on May 7, 2009, and by letter dated May 7, 2009, and May 29, 2009.
Manufacturer DePuy (Ireland) Ltd., Co. Cork, Ireland. Firm initiated recall is ongoing.
REASON
There may be a crack on the lateral side of the condyle in the posterior chamber region.  
VOLUME OF PRODUCT IN COMMERCE
260 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) GE Healthcare Signa Ovation 0.35T, Model Numbers: a) Ovation 1-3 (2276937), b) Ovation 4 (2377062-2, 2377062-5, 2377062-8, or 5118172), and c) Ovation 5 (5148725). The 0.35T Signa Ovation with Excite Magnetic Resonance system is an open, whole body scanner designed to support improved higher resolution imaging and shorter scan times. The 0.35T Signa Ovation with Excite Magnetic Resonance system is indicated for use as a diagnostic imaging device to produce transverse, sagittal, coronal and oblique images of the internal structures and organs of the body including, but not limited to, the musculoskeletal, vascular, cardiac, and neuron systems. Recall # Z-1722-2009;

2) Signa Openspeed 0.7T MR Systems, Model Numbers: Openspeed 3 (2138300-30), Openspeed 4 (2377062-5), Openspeed 5 (2377062-5, 2377062-30). Recall # Z-1723-2009 
CODE
1) Model number: 2276937; Serial Numbers: 00000869965YM4, 00000801207YM2, 00000813952YM9, 00000952559YM3, 00000236062MR6, 00000869966YM2, 00000801206YM4, 00000813945YM3, 00000813950YM3, 00000869958YM9, 00000952561YM9, 00000813958YM6, 00000919518YM1, 00000813944YM6, 00000837353YM2, 00000813960YM2, 00000837350YM8, 00000264247MR1, 00000897708YM4, 00000897716YM7, 00000919512YM4, 00000919526YM4, 00000026540VE5, 00000919509YM0, 00000813959YM4, 00000801204YM9, 00000813947YM9, 00000952560YM1, 00000952565YM0, 00000897711YM8, 00000897717YM5, 00000919515YM7, 00000952552YM8, 00000813951YM1, 00000897701YM9, 00000869949YM8, 00000837359YM9, 00000919519YM9, 00000813946YM1, 00000869956YM3, 00000897706YM8, 00000952563YM5, 00000869947YM2, 00000801199YM1, 00000801193YM4, 00000837362YM3, 00000952548YM6, 00000952549YM4, 00000837360YM7, 00000952547YM8, 00000837346YM6, 00000869952YM2, 00000869954YM8, 00000919514YMO, 00000919524YM9, 00000837358YM1, 00000919521YM5, 00000869962YM1, 00000919513YM2, 00000897705YM0, 00000952555YM1, 00000813943YM8, 00000869961YM3, 00000813956YM0, 00000801203YM1, 00000801208YM0, 00000801209YM8, 00000813948YM7, 00000813953YM7, 00000813954YM5, 00000837347YM4, 00000837351YM6, 00000837352YM4, 00000837354YM0, 00000837357YM3, 00000837361YM5, 00000837363YM1, 00000837364YM9, 00000837365YM6, 00000869950YM6, 00000869951YM4, 00000869953YM0, 00000869955YM5, 00000869957YM1, 00000869960YM5, 00000869963YM9, 00000897698YM7, 00000897699YM5, 00000897700YM1, 00000897702YM7, 00000897703YM5, 00000897704YM3, 00000897707YM6, 00000897715YM9, 00000919507YM4, 00000919510YM8, 00000919516YM5, 00000919517YM3, 00000919520YM7, 00000919523YM1, 00000952550YM2, 00000952553YM6, 00000952557YM7, 00000952558YM5, 00000952562YM7, 00000952566YM8, 00000952554YM4, 00000919511YM6, 00000869948YM0, 00000897714YM2, 00000813957YM8, 00000813955YM2, 00000897712YM6, 00000813949YM5; Model number: 5118172; Serial Numbers; 00000000564YR5, 00000000565YR2, 00000000563YR7, 00000000561YR1; Model number: 2377062-2; Serial Number: 00000963007YM0; Model number: 2377062-5; Serial Numbers: 00000000120YR6, 00000000123YR0, 00000000132YR1, 00000000124YR8, 00000000137YR0, 00000000130YR5, 00000000134YR7, 00000000138YR8, 00000962592YM2, 00000000146YR1, 00000000117YR2, 00000000116YR4, 00000000118YR0, 00000943610YM6, 00000000152YR9, 00000000140YR4, 00000000110YR7, 00000000135YR4, 00000000106YR5, 00000000129YR7, 00000000141YR2, 00000000125YR5, 00000000142YR0, 00000000113YR1, 00000000150YR3, 00000000105YR7, 00000000131YR3, 00000000139YR6, 00000000155YR2, 00000000108YR1, 00000000143YR8, 00000000101YR6, 00000000109YR9, 00000000153YR7, 00000951021YM5, 00000000119YR8, 00000000136YR2, 00000000128YR9, 00000000100YR8, 00000000112YR3, 00000000121YR4, 00000000154YR5; Model Number: 2377062-8; Serial Numbers: 00000000776YR5, 00000000792YR2, 00000000793YR0, 00000000801YR1, 00000000803YR7, 00000000829YR2, 00000000836YR7, 00000000758YR3, 00000000765YR8, 00000000755YR9, 00000000756YR7, 00000000774YR0, 00000000784YR9, 00000000785YR6, 00000000798YR9, 00000000827YR6, 00000000816YR9, 00000000779YR9, 00000000828YR4, 00000000789YR8, 00000000838YR3, 00000000773YR2, 00000000788YR0, 00000000796YR3, 00000000763YR3, 00000000766YR6, 00000000767YR4, 00000000787YR2, 00000000790YR6, 00000000800YR3, 00000000834YR2, 00000000840YR9, 00000000830YR0, 00000000832YR6, 00000000786YR4, 00000000764YR1, 00000000775YR7, 00000000818YR5, 00000000768YR2, 00000000757YR5, 00000000760YR9, 00000000762YR5, 00000000783YR1, 00000000809YR4, 00000000782YR3, 00000000812YR8, 00000000826YR8, 00000000835YR9, 00000000770YR8, 00000000771YR6, 00000000825YR0, 00000000759YR1, 00000000821YR9, 00000000841YR7, 00000000831YR8, 00000000808YR6, 00000000823YR5, 00000000824YR3, 00000000772YR4, 00000000810YR2, 00000000837YR5, 00000000769YR0, 00000000815YR1, 00000000833YR4, 00000000804YR5, 00000000778YR1, 00000000780YR7, 00000000795YR5, 00000000799YR7, 00000000805YR2, 00000000807YR8, 00000000819YR3, 00000000839YR1, 00000000811YR0, 00000000761YR7, 00000000777YR3, 00000000781YR5, 00000000791YR4, 00000000797YR1, 00000000794YR8; and Model Number: 5148725; Serial Numbers: 00000154413HM9, 00000176551HM0, 00000139846HM0, 00000192389HM5, 00000177143HM5, 00000193109HM6, 00000148905HM3, 00000147526HM8, 00000138166HM4, 00000000SPI275,   00000188489HM9, 00000167482HM9, 00000169104HM7, 00000171692HM7, 00000157419HM3, 00000266430MR8, 00000155516HM8, 00000155515HM0, 00000160809HM0, 00000175023HM1, 00000150718HM5, 00000162563HM1, 00000164072HM1, 00000165772HM5, 00000172421HM0, 00000172816HM1, 00000172869HM0, 00000173908HM5, 00000177792HM9, 00000178519HM5, 00000179361HM1, 00000180127HM3, 00000180746HM0, 00000182071HM1, 00000182249HM3, 00000182597HM5, 00000183130HM4, 00000187365HM2, 00000188810HM6, 00000189105HM0, 00000191017HM3, 00000191154HM4, 00000196647HM2, 00000200577HM5, 00000265078MR6, 00000157418HM5, 00000174348HM3, 00000189943HM4, 00000181736HM0, 00000146891HM7, 00000158641HM1, 00000147906HM2, 00000169833HM1, 00000170940HM1, 00000190359HM0, 00000191544HM6, 00000193220HM1, 00000193936HM2, 00000195772HM9, 00000144797HM8, 00000150152HM7, 00000170109HM3, 00000181735HM2, 00000197645HM5, 00000168323HM4 and 00000181517HM4;

2) Model Number: 2138300-30; Serial Numbers: 00000203387MR6, 00000208208MR9, 00000216409MR3, 00000229302MR5, 00000229306MR6, 00000230309MR7, 00000231588MR5, 00000237930MR3, 00000239847MR7, 00000241694MR9, 00000247255MR3, 00000253103MR6, 00000189633MR1, 00000192104MR8, 00000193652MR5, 00000194218MR4, 00000194219MR2, 00000194950MR2, 00000196364MR4, 00000197334MR6, 00000198709MR8, 00000199443MR3, 00000201708MR5, 00000201709MR3, 00000201710MR1, 00000201901MR6, 00000202223MR4, 00000203386MR8, 00000204837MR9, 00000204838MR7, 00000204839MR5, 00000206438MR4, 00000206439MR2, 00000207493MR8, 00000207494MR6, 00000208209MR7, 00000208210MR5, 00000209712MR9, 00000209713MR7, 00000212511MR0, 00000212513MR6, 00000212514MR4, 00000212515MR1, 00000215366MR6, 00000216405MR1, 00000216406MR9, 00000216407MR7, 00000216409MR3, 00000217198MR1, 00000217201MR3, 00000221250MR4, 00000221251MR2, 00000221253MR8, 00000221254MR6, 00000222950MR8, 00000225273MR2, 00000225274MR0, 00000225942MR2, 00000226318MR4, 00000228022MR0, 00000228023MR8, 00000228024MR6, 00000228773MR8, 00000229303MR3, 00000229304MR1, 00000229305MR8, 00000230308MR9, 00000230312MR1, 00000231591MR9, 00000231592MR7, 00000232328MR5, 00000233644MR4, 00000233646MR9, 00000234832MR4, 00000234833MR2, 00000234834MR0, 00000237051MR8, 00000237052MR6, 00000237053MR4, 00000237926MR1, 00000237927MR9, 00000237928MR7, 00000237929MR5, 00000239480MR7, 00000239482MR3, 00000239483MR1, 00000239484MR9, 00000239845MR1, 00000239846MR9, 00000241126MR2, 00000241127MR0, 00000241693MR1, 00000241695MR6, 00000243405MR8, 00000244231MR7, 00000244232MR5, 00000247252MR0, 00000247253MR8, 00000247254MR6, 00000247256MR1, 00000250184MR9, 00000250185MR6, 00000250186MR4, 00000250187MR2, 00000253039MR2, 00000253102MR8, Unknown; Model Number: 2377062-5; Serial Numbers: 00000000100YR8, 00000000119YR8, 00000000129YR7, 00000000102YR4, 00000000103YR2, 00000000105YR7, 00000000106YR5, 00000000108YR1, 00000000109YR9, 00000000111YR5, 00000000113YR1, 00000000118YR0, 00000000120YR6, 00000000122YR2, 00000000124YR8, 00000000127YR1, 00000000128YR9, 00000000131YR3, 00000000132YR1, 00000000133YR9, 00000000134YR7, 00000000135YR4, 00000000136YR2, 00000000137YR0, 00000000142YR0, 00000000144YR6, 00000000146YR1, 00000000149YR5, 00000000150YR3, 00000000151YR1, 00000000152YR9, 00000000155YR2, 00000943610YM6, 00000951021YM5, 00000962592YM2; Model Number: 2377062-30 Serial Numbers: 00000003047YR8, 00000003011YR4, 00000003022YR1, 00000003023YR9, 00000003024YR7, 00000003025YR4, 00000003026YR2, 00000003027YR0, 00000003028YR8, 00000003029YR6, 00000003030YR4, 00000003031YR2, 00000003033YR8, 00000003034YR6, 00000003035YR3, 00000003036YR1, 00000003039YR5, 00000003041YR1, 00000003042YR9, 00000003043YR7 and 00000003044YR5
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated October 23, 2008 and a second letter dated March 5, 2009. 
Manufacturer: Yokogawa Medical Systems, Ltd., Tokyo, Japan. Firm initiated recall is ongoing.
REASON
GE Healthcare has identified a potential pinch point hazard on Ovation MR Scanner when using CTL Array XL Body Flex and Opened Body coil. A patient's hand may be pinched between the magnet bore ceiling cover and the CTL Array, XL Body Flex, or Open Body coil if the patient puts his/her hand on the top of the coil. Two injuries and four complaints filed. 2/20/09: Recall being expanded to include the OpenSpeed Systems.
VOLUME OF PRODUCT IN COMMERCE
308 units
DISTRIBUTION
Nationwide and China, Cyprus, Argentina, Brazil Egypt, Denmark, Federal Republic OF Germany, Federal Republic of France, Get 7 D China, Greece, Hungary, Italy, Ivory Coast, Japan, Korea, Kuwait, Malawi, Mexico, Oman, Panama, Philippines, Russian Federation, Saudi Arabia, Spain , Switzerland, Turkey, Ukraine, United Arab Emeritus, United Kingdom and Venezuela
___________________________________
PRODUCT 
ACIST Automated Manifold Kit, REF Model BT2000, SKU # 014613, Sterile R, Made in Mexico. The automated manifold kit is comprised of an injection manifold, a pressure transducer cartridge, a check valve, tubing (low, high and peristaltic pump), and a saline spike. This kit is designed for exclusive use with the ACIST CMS2000, E2000 Voyager and CVi models of Angiographic Contrast Delivery Systems. This kit is for single use. Recall # Z-1872-2009
CODE
Lot numbers: 2968J 3088N 3168H 3178H 2968K 3088P 3168J 3308U 2968L 3088T 3168K 3468W
RECALLING FIRM/MANUFACTURER
Recalling Firm: Acist Medical Systems, Eden Prairie, MN,  
Manufacturer: NPA de Mexico S.A. de C.V., Tijuana, Mexico. Firm initiated recall is ongoing.
REASON
ACIST Medical Systems initiated a recall due to an increase in the incidence of field reports related to a bulge on the side and/or leaks in the bond of the 2.5 high-pressure tubing of BT2000 kits during a procedure which can result in unsatisfactory performance of the ACIST BT2000 Automated Manifold Kit.
VOLUME OF PRODUCT IN COMMERCE
62,280
DISTRIBUTION
Nationwide, Canada and Hong Kong
___________________________________
PRODUCT 
ArthroWand Saber 30 with Integrated Cable wand, Catalog number AC4330-01. Recall # Z-1900-2009
CODE
Lot numbers 4T011660-A, 4T01670-A, 4T01670-B, 4T02460-A, 4T02670-A, 4T02980-A, 4T02980-B, 4T03160-A, 4T04480-A, 4T04480B, 4T04860-A, 4T04980-A, 4T04980-B, 4T06680-A, 4T06680-B, 4T06770-A, 4T07360-A, 4T07460-A, 4T07880-A, 4T08580-A, 4T09270-A, 4T09370-A, 4T09370-B, 4T09370-C, 4T09380-A, 4T09460-A, 4T09580-A, 4T09880-A, 4T10980-A, 4T12260-A, 4T12680-A, 4T12970-A, 4T13380-A, 4T13960-A, 4T13960-B, 4T14980-A, 4T14980-B, 4T15680-A, 4T16360-A, 4T17670-A, 4T17770-A, 4T18760-A, 4T18760-B, 4T18860-A, 4T19770-A, 4T20260-A, 4T20570-A, 4T20660-A, 4T21050-A, 4T22960-A, 4T22960-B, 4T22970-A, 4T24270-A, 4T24270-B, 4T24960-A, 4T25650-A, 4T26970-A, 4T27160-A, 4T27750-A, 4T28260-A, 4T28260-B, 4T29350-A, 4T30270-A, 4T30370-A, 4T32050-A, 4T32060-A, 4T32770-A, 4T33260-A, 4T34150-A, and 4T34960-A
RECALLING FIRM/MANUFACTURER
ArthroCare Corp., Sunnyvale, CA, by letter on August 5, 2008. Firm initiated recall is ongoing.
REASON
Potential Sterility Loss-- Due to wearing or puncture in the Tyvek lid, the product may lose sterility.
VOLUME OF PRODUCT IN COMMERCE
23,443 units
DISTRIBUTION
Nationwide and countries of Netherlands, Slovak Republic, Ireland, Spain, Switzerland, Singapore, Russian Federation, Greece, Japan, Saudi Arabia, India, Slovenia, Israel, South Africa, South Korea, Poland, Thailand, Jordan, Belgium, Finland, Portugal, Cyprus, Italy, UAE, Kuwait, China, Bahrain, Denmark, Norway, Sweden, Australia, Germany, Austria, UK, New Zealand, Mexico and Canada
___________________________________
PRODUCT 
1) Clinitron CII Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure. Recall # Z-1902-2009;

2) Clinitron Up-Lift" Air Fluidized Therapy Units. Intended to prevent and/or treat pressure ulcer development and wound deterioration in patients who have a significant risk of developing these problems and who generally also have one or more of the following conditions: immobility, poor nutrition, diminished level of consciousness, reduced subcutaneous tissue or multi-system failure. Recall # Z-1903-2009
CODE
All serial numbers.
RECALLING FIRM/MANUFACTURER
Hill-Rom Manufacturing, Inc., Charleston, SC, by letter dated February 2, 2009. Firm initiated recall is ongoing.
REASON
Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.
VOLUME OF PRODUCT IN COMMERCE
625 units
DISTRIBUTION
Nationwide, Abu Dhabi, Brazil, Canada, Chile, Columbia, Mexico, Newfoundland, Puerto Rico, Saudi Arabia, Singapore, Taiwan, Turkey and Venezuela
___________________________________
PRODUCT 
a) Specimen Gate Laboratory, Product Code: 5002-0180, Software Version: 1.2 and 1.3. The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results. Recall # Z-1905-2009;

b) Specimen Gate Lab - MSMS Data Suite, Product Code: 5002-0310. The intended use of the product is data management in prenatal and neonatal screening laboratories designed to allow viewing and management of assay results. Recall # Z-1906-2009
CODE
Software Versions: 1.2 and 1.3
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perkin Elmer, Waltham MA, by fax on January 15, 2009. 
Manufacturer: PerkinElmer Life and Analytical Sciences, Wallac, OY, Turku, Finland. Firm initiated recall is ongoing.
REASON
If Result Codes are used and if they are manually edited, they are correct unless the laboratory specifically uses the View Assay button in the Specimen History screen to open another assay, and then returns back to the original assay.
VOLUME OF PRODUCT IN COMMERCE
39 units
DISTRIBUTION
Nationwide and Canada
___________________________
PRODUCT 
BHM Combi Sling, 100% Polyester Shell/100% Polyester Strap; soft polyester net fabric sling for ceiling and floor patient lifts; made in China. Part 626002: Combi Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part 626002M: Combi Mesh Deluxe - Medium, capacity 68-113 kg, 150-250 lbs; Part 626002C Combi Sling Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626002C-M Combi Sling Mesh Deluxe Small, capacity 20-68 kg, 45-150 lbs; Part 626003: Combi Deluxe - Large, capacity 113-272 kg, 250-600 lbs; Part 626003M: Combi Mesh Deluxe - Large, capacity 113-272 kg, 250-600 lbs; and Part 626003X: Combi Oversize Heavy Duty, capacity 113-272 kg, 250-600 lbs. Between 2004 and 2006, the Combi Slings were labeled as BHM Medical Inc. (800) 868-0441, 100% Polyester Shell/100% Nylon Strap, made in Canada. Prior to 2004, the slings were labeled Medi-Man, 100% Polyester Shell, made in Canada. The accessory is intended to be used with patient lift for the transfer of patient in hospitals, nursing homes, or other health care facilities by trained caregivers. Recall # Z-1990-2009
CODE
All lots released prior to 2/1/09.
RECALLING FIRM/MANUFACTURER
B.H.M. Medical, Inc., Magog, Canada, by letters dated April 15, 2009. Firm initiated recall is ongoing.
REASON
Premature failure of the stitching at the junction of the shoulder strap and sling body of the BHM/Medi-Man Combi Sling used with patient lifts.
VOLUME OF PRODUCT IN COMMERCE
1,396 slings
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Empty M9 aluminum oxygen cylinders packaged in shipping containers (1 per container) labeled as: Product #0022-57P, Desc: CYL 02 ALUM 240 LITER, Catalog #31-10-2012. Recall # Z-2031-2009;

2) Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-44P, CYL 02 ALUM 400 LITER, Catalog #31-10-0014. Recall # Z-2032-2009;
 
3) Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-58 P, Desc CYL 02 ALUM 400 LITER, Catalog #31-10-2014. Recall # Z-2033-2009;

4) Empty Jumbo D aluminum oxygen cylinders, 72 cylinders per skid labeled as: Product #0022-96D, Desc: CYL 02, JUMBO D, A VLV, 72/SKID, Catalog #31-10-0117. Recall # Z-2034-2009;

5) Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #0022-96P, Desc CYL 02, JUMBO D, W/TYPE B POST, Catalog #31-10-2017. Recall # Z-2035-2009;

6) Empty Jumbo D aluminum oxygen cylinders packaged in shipping containers labeled as: Product 0022-96, Desc CYL 02 ASSY., 637.2 LITER, Catalog #31-10-0017. Recall # Z-2036-2009;

7) Empty D aluminum oxygen cylinders packaged in shipping containers labeled as: Product #65261-E, Desc D PORTABLE W STRAIGHT POS, Catalog #65261-E. Recall # Z-2037-2009;

8) First Responder Kit containing a 240-liter aluminum oxygen cylinder with individually packaged regulator, cannula, and bag mask resuscitator, all packaged in a shipping container labeled as: Product #L903, Desc FIRST RESPONDER KIT, Catalog #L903. Recall # Z-2038-2009
CODE
InterMed 08-05-3B and InterMed 09-01-1B located on the post valve
RECALLING FIRM/MANUFACTURER
Allied Healthcare Products, Inc., St. Louis, MO, by letters dated May 15, 2009, June 1, 2009 and June 17, 2009. Firm initiated recall is ongoing.
REASON
Medical valves do not meet quality specifications which may cause the valve to fail and result in uncontrolled release of oxygen when the valve is in the open position.
VOLUME OF PRODUCT IN COMMERCE
359 cylinders
DISTRIBUTION
Nationwide and Singapore
___________________________________
PRODUCT 
Leckey 4-Point Pelvic Harness Belts, catalog 081326990. Sold as a component of the following chairs: a) Leckey Contour Advance Seat, Size 1, catalog 081117209; b) Leckey Contour Advance Seat, Size 2, catalog 081117217; c) Leckey Squiggles Saddle Seat, catalog 081326941; d) Leckey Early Sitting System, catalog 081395193. Recall # Z-2040-2009
CODE
All belts supplied on the affected seating systems between September 2007 and December 2008.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Patterson Medical Holdings, Inc., Bolingbrook, IL, by letters dated April 17, 2009.
Manufacturer: James Leckey Design, Ltd., Northern Ireland, Belfast, United Kingdom. Firm initiated recall is ongoing.
REASON
The plastic buckles on the hip belts of the 4-Point Pelvic Harness may break.
VOLUME OF PRODUCT IN COMMERCE
226 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) EUB-6500/HI VISION 6500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC5, Software Versions: V01-03, V01-05, V02-04, V03-02, V04-02, V04-03, V04-04, V05-03, V05-05A, V05-07A and V05-30A. Recall # Z-2054-2009;

2) EUB-9500/HI VISION 8500 Diagnostic Ultrasound Scanners, DICOM Option EZU-FC6, Software Versions: V11-01, V11-03, V12-03 and V12-04A. Recall # Z-2055-2009
CODE
1) Serial Numbers: 17094308, 17094309, 17150307, 17350302, 17094305, 17869402, 18435403, 18435404, 17492302, and 17204305;

2) Serial Numbers: 17084306, 17084308, 19921303, 17268307, 17268309, and 18190406
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hitachi Medical Systems America Inc., Twinsburg, OH, by letter on May 12, 2008.
Manufacturer: Hitachi Medical Corp., Tokyo, Japan. Firm initiated recall is complete.
REASON
The firm's parent company discovered a DICOM UID (Universal Identifier) code mix-up which can occur due to a software error. This error can cause the images from two (2) different patient scans to become intermingled and consequently, labeled incorrectly.
VOLUME OF PRODUCT IN COMMERCE
16 units
DISTRIBUTION
AR, CA, TX

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

___________________________________
PRODUCT 
Fort Dodge Vetisulid Injection, Sodium Sulfachlorpyridazine Injection, 21.5% (215 mg per mL), packaged in a 250-ml. multiple-dose vial, For Use in Calves Only, NADA 33-318. Recall # V-274-2009
CODE
Lot #7040655, Exp. April, 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Fort Dodge Laboratories, Inc., Fort Dodge, IA, by letters dated April 28, 2009.
Manufacturer: TEVA Animal Health Inc., Saint Joseph, MO. Firm initiated recall is ongoing.
REASON
The product failed stability (low)
VOLUME OF PRODUCT IN COMMERCE
9,023/250-ml. vials
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) NUTRO NATURAL CHOICE COMPLETE CARE, Kitten Food, 4 lbs (UPC 079105 20607 5) and 8 lbs (UPC 079105 20608 2), 9.2 lbs (Bonus Bag) (UPC 079105 20695 2), 20 lbs (UPC 079105 20609 9), 1.5 oz (sample bag -no UPC). Recall # V-275-2009;

2) NUTRO NATURAL CHOICE COMPLETE CARE, Adult (cat) Food, 4 lbs (UPC 079105 20610 5) and 8 lbs (UPC 079105 20611 2), 9.2 lbs (Bonus Bag) (UPC 079105 20694 5), 20 lbs (UPC 079105 20612 9), 1.5 oz (sample bag -no UPC). Recall # V-276-2009;

3) NUTRO NATURAL CHOICE COMPLETE CARE, Adult (cat) Food, Oceanfish Flavor, 4 lbs (UPC 079105 20622 8) and 8 lbs (UPC 079105 20623 5), 9.2 lbs (Bonus Bag) (UPC 079105 20698 3), 20 lbs (UPC 079105 20624 2). Recall # V-277-2009;

4) NUTRO MAX Cat Adult, Roasted Chicken Flavor, 3 lbs (UPC 079105 10228 5) and 6 lbs (UPC 079105 10229 2), 16 lbs (UPC 079105 10230 8), 1.5 oz (sample bag -no UPC). Recall # V-278-2009;

5) NUTRO MAX Cat Indoor Adult, Roasted Chicken Flavor, 3 lbs (UPC 079105 10243 8) and 6 lbs (UPC 079105 10244 5), 16 lbs (UPC 079105 10245 2), 1.5 oz (sample bag -no UPC). Recall # V-279-2009;

6) NUTRO MAX Cat Indoor Adult, Salmon Flavor, 3 lbs (UPC 079105 10246 9) and 6 lbs (UPC 079105 10247 6), 16 lbs (UPC 079105 10248 3). Recall # V-280-2009;

7) NUTRO MAX Cat Indoor Weight Control, 3 lbs (UPC 079105 102496 0) and 6 lbs (UPC 079105 10250 6), 16 lbs (UPC 079105 10251 3). Recall # V-281-2009;

8) Nutro Complete Care Choice Adult Chicken Formula, cat food, NET/NETTO 3 kg, 7.5 kg, and 15 kg. Recall # V-282-2009;

9) Nutro Complete Care Choice Kitten, rich in Chicken, kitten food, NET/NETTO 7.5 kg. Recall # V-283-2009;

10) Nutro Complete Care Choice Adult with Salmon, cat food, NET/NETTO 1 kg, 3 kg, 7.5 kg, and 15 kg. Recall # V-284-2009
CODE
"Best if used by "dates May 12, 2010 - August 22, 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: MARS Petcare US, Inc., Franklin, TN, by e-mail, telephone, and press release on May 21, 2009. 
Manufacturer: 1) Nutro Inc., Lebanon, TN., and 2) Nutro Products, Inc., Victorville, CA.  Firm initiated recall is ongoing.
REASON
Product was found to contain excessive Zinc and below specification Potassium.
VOLUME OF PRODUCT IN COMMERCE
365,344 units
DISTRIBUTION
Nationwide and Canada, Mexico, Japan, Korea, Thailand, Malaysia, Singapore, Indonesia, New Zealand, and Israel

END OF ENFORCEMENT REPORT FOR SEPTEMBER 30, 2009

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