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U.S. Department of Health and Human Services

Safety

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Enforcement Report for June 3, 2009

June 3, 2009                                                                                        09-22

 

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________

PRODUCT

a) B. Lloyd's brand Mixed Nuts, 5 oz. box. Box has UPC 851613001287. Recall # F-253-9

b) Simply Enjoy brand Sweet & Salty Mixed Nuts in 8 oz. cans. Cans have UPC code 688267062827. Recall # F-254-9

CODE

a) BL0810042, BL0810025, BL0810033, BL0810038;

b) BL0808027, BL0808035, BL0808037, BL0809027

RECALLING FIRM/MANUFACTURER

Recalling Firm: B. Lloyd's Pecan Co aka Ross-Smith Pecan Co, Barwick, GA, by telephone and letter on February 5, 2009.

Manufacturer: Peanut Corporation of America, Blakely, GA. 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

1,080 cases

DISTRIBUTION

MA, VT

___________________________________

PRODUCT

Dynamic Duos Movie Night flavor Ice Cream in 1.5 quarts. The product is shipped in cases containing 6 units. UPC 020735112106. Recall # F-255-9

CODE

Sell by codes 10/06/09 through 1/23/10

RECALLING FIRM/MANUFACTURER

Turkey Hill Dairy Inc, Conestoga, PA, by press release on February 27, 2009. Firm initiated recall is complete.

REASON

The product is manufactured using peanuts recalled by Peanut Corporation of America (TX) because they have the potential to be contaminated with Salmonella

VOLUME OF PRODUCT IN COMMERCE

21,906 units

DISTRIBUTION

CT, DE, MA, MN, NJ, PA, and VT

___________________________________

PRODUCT

a) Celery with Peanut Butter sold as: Read Pac Cool Cuts Celery with Peanut butter 12/6.75 oz, each case consists of 12-6.75 oz. Each 3 pack single serve unit (6.75 oz) consists of Celery Sticks (1.25 oz) and All Natural Peanut Butter (1 oz) (GFF), packaged in preformed 2 cavity tray using printed RP lid stock. (CC Celery w/ Peanut Butter 12/6.75oz) (ER CC Celery w/ Peanut Butter 12/6.75oz) UPC: 077745-22415-2; Trader Joe's Celery with Peanut Butter 12/6.75 oz & 30/6.75 oz, each case consists of 12-6.75 oz & 30-6.75 oz. Each 3 pack single serve unit (6.75 oz) consists of Celery Sticks (1.25 oz) and All Natural Peanut Butter (1 oz) (GFF), packaged in preformed 2 cavity tray using printed RP lid stock. (CC Celery w/ Peanut Butter 12/6.75oz) (ER CC Celery w/ Peanut Butter 12/6.75oz & ER CC Celery w/ Peanut Butter 30/6.75oz) UPC: 0-00048-5401& 0-00048-5401; Eating Right Celery with Peanut Butter 12/6.75 oz, each case consists of 12-6.75 oz. Each 3 pack single serve unit (6.75 oz) consists of Celery Sticks (1.25 oz) and All Natural Peanut Butter (1 oz) (GFF), packaged in preformed 2 cavity tray using printed RP lid stock. (CC Celery w/ Peanut Butter 12/6.75oz) (ER CC Celery w/ Peanut Butter 12/6.75oz) UPC: 0-79893-70175-2. Recall # F-259-9

 

b) Eating Right Apples with Peanut Butter, Each case consists of 12-6.75 oz. Each 3 pack single serve unit (6.75 oz) consists of Apples (1.25oz) [Calcium Ascorbate added to maintain freshness and color] and All Natural Peanut Butter (1oz) (GFF). Packed in pre-formed 2 cavity tray using printed RP lid stock. (ER CC Apples w/Peanut Butter 12/6.75oz) UPC: 0-79893-70175-2. Recall # F-260-9

CODE

a) By Dates of 12/27/08 to 2/2/09;

b) By Dates of 12/27/08 to 2/2/09

RECALLING FIRM/MANUFACTURER

Recalling Firm: Ready Pac Foods Inc, Irwindale, CA, by telephone and letter on January 18, 2009 and by press release on January 20, 2009.  

Manufacturer: GFF Inc, City Of Industry, CA. 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

10,964 cases. Contents in each case varied between 30 units/6.75 and 12units /6.75 oz.

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

Chef Pierre Gourmet Restaurant Style Chocolate Peanut Butter Silk Pie; a frozen, food service pie; Net Wt. 34 oz. (2 lb 2 oz) 963 g; UPC 0 32100 05095 1 Case label: Chef Pierre Made By Sara Lee Bakery *** 4-10# Gourmet Silk Pies *** Chocolate Peanut Butter *** Store at 0 degrees F (-18 degrees C) or Below *** Net Wt. 8.5 lb, (3.85 kg) *** bar code 1 00 32100 05095 8. Recall # F261-9

CODE

Lot numbers: 7103, 7201, 7242, 7331, 8018, 8133, 8199, 8256 and 8305

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sara Lee Food & Beverage, Downers Grove, IL, by press release and letters dated January 30, 2009.

Manufacturer: Sara Lee Corporation, Traverse City, MI. Firm initiated recall is complete.

REASON

The product was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

36,243 cases

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

Strubs brand Norwegian Style Sliced Smoked Steel Head Salmon -- 300 grams -- Ready to eat – Made in Canada from Imported Ingredients --- Distributed in cartons containing vacuum-packed 300 gram packages bearing UPC code 0 71217 69997 4 and registration number "0609". There are 24 - 300 gram packages per carton. Recall # F-262-9

CODE

Code date of "03MA09" (production date). There is no production date on the individual packages

RECALLING FIRM/MANUFACTURER

Recalling Firm: West Side Foods, Bronx, NY, by telephone on March 23, 2009.

Manufacturer: Niagara Smoked Fish Ltd, Mississauga, Canada. Firm initiated recall is ongoing.

REASON

The imported salmon was found to be contaminated with Listeria monocytogenes based on FDA sampling and analysis.

VOLUME OF PRODUCT IN COMMERCE

13 cartons (24 - 300 gram packages per carton)

DISTRIBUTION

NY, MD

___________________________________

PRODUCT

a) Fazenda Roasted in Olive Oil Peanuts, USDA Organic, net, Wt. 8 oz. metal can, UCP 899030000445; 6 oz. olive green plastic bag, UPC 899030000636. Recall # F-263-9;

 

b) All Nuts Original Roasted and Salted peanuts, net. Wt. 8 oz. can: UPC 899030000063.  Recall # F-264-9;  

 

c) All Nuts Less Than 60% Peanuts Mixed Nuts, Net wt. 8 oz. can, UPC 899030000087. Recall # F-265-9;

 

d) Fazenda Roasted in Olive Oil Mixed Nuts, USDA ORGANIC, Net Wt. 6 oz, olive green color plastic bags, UPC 899030000650; and Net. Wt. 8 oz. can, UPC 899030000452. Recall # F-266-9

CODE

a) 8 oz. can - best by dates between 1/1/2008 and 1/1/2010; 6 oz. bag - best-by dated between 6/1/2008 and 5/1/2009;

 

b) Best by dates between 1/1/2008 and 1/1/2010;

 

c) Best by dates between 1/1/2008 and 1/1/2010;

 

d) 6 oz. bag, Best by dated between 6/1/2008 and 5/1/2009. - 8 oz. can, Best by dates between 1/1/2008 and 1/1/2010

RECALLING FIRM/MANUFACTURER

Nutsco, Inc, Camden, NJ, by press release and telephone on February 3, 2009 and by faxed and e-mailed letter 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

2,755 cases

DISTRIBUTION

NJ, DE, NY and MI

___________________________________

PRODUCT

The Cookie Machine Peanut Butter Gourmet Cookie Dough, Net Wt. 4 lb, packaged in round plastic tubs. Recall # F-267-9

CODE

All products

RECALLING FIRM/MANUFACTURER

Texas Bluebonnets Inc. dba The Cookie Machine, Arlington, TX, by telephone and letter on February 2, 2009 and by press release on February 6, 2009. Firm initiated recall is complete.

REASON

The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

450 units

DISTRIBUTION

TX

___________________________________

PRODUCT

Baldwin County Fried Peanuts, Net Wt. 10 oz. cellophane bags, Summerdale Peanut Co. and 1-30 pound case of bulk product. Recall # F-268-9

CODE

The product is not coded.

RECALLING FIRM/MANUFACTURER

Summerdale Peanut Co., LLC, Summerdale, AL, by visit and telephone beginning January 29, 2009 and by press release 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

222 units plus 1/30 lb case PCA peanuts

DISTRIBUTION

AL

___________________________________

PRODUCT

The Popcorn Factory Thai Peanut Popcorn, Thai flavored premium popcorn mixed with cranberries and peanuts; Net Wt 32 oz. (906g) rectangular tin; item SO219TP; The Thai Peanut Popcorn was also packaged in 6 oz. plastic bags which packed into the Ultimate Gift Assortment 2 gallon round tin, item PO2260. Recall # F-269-9

CODE

Item SO219TP, lots 08287, 08289, 08331, 08341, 08344, 08345, 08358, 09002; Item PO2260, lots 08298, 08301, 08331, 08341, 08344, 08345, 08350, 08359, 09002

RECALLING FIRM/MANUFACTURER

The Popcorn Factory, Lake Forest, IL by letters on February 6, 2009. Firm initiated recall is complete.

REASON

The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

Item SO219TP - 287 tins, item PO2260 - 1337 tins

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

a) 8 Inch Peanut Butter Cake Single Layer, 16 oz. (1 lb. 0 oz.), PLU 7950, UPC 21795000000. Recall # F-270-9;

 

b) 8 Inch Caramel Apple Cinnamon Cake, Single Layer, 16 oz. (1 lb. 0 oz.), PLU 9871, UPC 21987100000. Recall # F-271-9; 

 

c) Filled and Variety Donuts - Individual, PLU9898, UPC 21989800000; these donuts are sold from self-service cases and could have been any one of the varieties: #14185 White Crème Long Johns #14189 Bavarian Crème Long Johns #14370 Lemon Bismarks #14376 Jelly Bismarks #14526 Bavarian Crème Bismarks. Recall # F-272-9;  

 

d) Regular Donuts - Individual, PLU 9896, UPC 21989600000; these donuts are sold from self-service cases and could have been any one of the varieties: #10125 French Donuts #11121 Plain Cake Donuts #11472 Sour Crème Cake Donuts #12103 Devil's Food Cake Donuts #14225 Raised Donut Rings #14550 Apple Fritters #14606 Cinnamon Rolls #14710 Twists #14810 Cinnamon Twists #16003 Cherry Cake Donuts #17003 Blueberry Cake Donuts. Recall # F-273-9;  

 

e) Mix or Match 12 CT Donuts; these donuts are packaged by the bakery associates with any combination of donuts in the box to make up the dozen, and then sold with the bakery scale label PLU 5921, UPC 21592100000. Recall # F-274-9

CODE

All products purchased prior to February 5, 2009

RECALLING FIRM/MANUFACTURER

Recalling Firm: Sears Holdings, Hoffman Estates, IL, by press release and e-mails February 5, 2009.

Manufacturer: Rich Products Corp, Buffalo, NY. 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

112 cakes, 62,011 donuts, 1,017 dozen donuts

DISTRIBUTION

AZ, CA, CO, GA, IL, IN, MI, NV, NY, NC, OH, PA, SC,TN, VA and WV

___________________________________

PRODUCT

a) Slim-Fast Optima, controls hunger for up to 4 hours; Caramel Crispy Peanut Meal-On-The-Go Bars; Sold in packages as follows: 6-1.97 oz (56g) Bars, Net Wt. 11.85 oz (336g); (Discontinued 9/2008) 12-1.97 oz (56g) Bars, Net Wt. 1.48 lb. (672 g); Individual bars - Net. Wt. 1.97 oz (56 g) 12 bars pack UPC: 0834613690; 6 bar pack UPC: 0834603790; Individual bars UPC: 0834603490. Recall # F-275-9;

 

b) Slim-Fast Meal Options; Breakfast & Lunch Bars Peanut Butter Naturally and Artificially Flavored. 8-1.2 oz (34g) Bars Net Wt. 9.6 oz (272g); UPC0834601522. Recall # F-276-9;

 

c) Slim-Fast Meal Options, Breakfast & Lunch Bars; Dutch Chocolate Naturally & Artificially Flavored; 8-1.20z (34g) Bars Net. Wt. 9.6 oz (272g); UPC: 0834601520. Recall # F-277-9

CODE

All expiration dates

RECALLING FIRM/MANUFACTURER

Recalling Firm: Unilever United States, Inc., Englewood, NJ, by press release on February 13, 2009 and by letters on February 13, 2009 and February 16, 2009 and press release on February 17, 2009.

Manufacturer: Nellson Nutraceutical, Inc., Irwindale, CA. Firm initiated recall is ongoing.

REASON

Product was manufactured using peanuts recalled by Peanut Corporation of America, Plainview, TX, because they have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

431,482 cases

DISTRIBUTION

NC, VA

___________________________________

PRODUCT

a) Peanut Caramel Patties, chocolate covered in Decorative Tins, 12 oz. (340 g), (no UPC code provided). Recall # F-278-9;

 

b) Dark Chocolate Covered Peanuts in Decorative Tins, 10 oz. (no UPC code provided). Recall # F-279-9;

 

c) Milk Chocolate Covered Peanuts in Decorative Tins, 10 oz. (283 g). No UPC code provided. Recall # F-280-9;

 

d) Dark Chocolate Nut Clusters in Decorative Tins, 9 oz. (255 g). No UPC code provided. Recall # F-281-9;

 

e) Peanut Brittle in Decorative tins, 8 oz. (227 g) UPC: 5837300109; 12 oz. (340 g) called Peanut Crunch, UPC: 5837300183; and 16 oz (454 g). No UPC provided. Recall # F-282-9;

 

f) Milk Chocolate Bridge Mix in Decorative Tins, 12 oz (340 g), no UPC code provided; 8 oz (227 g), UPC: 58373 00103. Recall # F-283-9;

 

g) Dark Chocolate Bridge Mix in Decorative Tins, 12 oz. (340 g), no UPC provided; 8 oz (227 g), UPC: 58373 00102. Recall # F-284-9;

 

h) Sugar Free and No Sugar Added Peanut Caramel Patties in Decorative Tins, all sizes. Recall # F-285-9;

 

i) Sugar Free and No Sugar Added Bridge Mix in Decorative Tins, 11 oz. (312 g) No UPC provided. Recall # F-286-9

CODE

The product is not coded. All product on the market through March 2009.

RECALLING FIRM/MANUFACTURER

Recalling Firm: Allstate Can Corp. Parsippany, NJ, by press release and letter on February 6, 2009.

Manufacturer: GKI Foods, Inc. Brighton, MI. 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

28,193 pieces (tins)

DISTRIBUTION

NJ, NY and MN

___________________________________

PRODUCT

a) Kings Naturally Mixed Nuts, non salted, 9 oz. deli cup with UPC 0738664055.

Recall # F-287-9;

 

b) Kings Cranberry Mix, 20 oz. deli cup with UPC 71930390277. Recall # F-288-9;

 

c) Kings Oriental Mix, 16 oz. deli cup with UPC 71930390277. Recall # F-289-9;

 

d) Kings Far East Spicy Mix, 6.5 oz. deli cup with UPC 71930390525. Recall # F-290-9;

 

e) Kings Trail Mix, 9.5 oz. deli cup with UPC 71930390560. Recall # F-291-9;

 

f) Kings Naturally Mixed Nuts, salted, 9 oz. deli cup with UPC 7386640054. Recall # F-292-9

CODE

a) and f) Product purchased before February 1, 2009;

b) and c) Label codes 3089, 0095;

d) Label codes 3082, 3484;

e) Label codes 3082, 0095;

RECALLING FIRM/MANUFACTURER

Recalling Firm: King Super Markets Inc., Parsippany, NJ by e-mail on February 2, 2009 and by press release on February 9, 2009.

Manufacturer: Aurora Products, Inc., Stratford, CT. 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

6,468 pieces

DISTRIBUTION

NJ, NY

___________________________________

PRODUCT

a) Sunset Orchards brand Salted Peanuts in $0.99 size, $1.49 size and 2/$1 size; packed in plastic with UPC 085737-70006-5 for $0.99 size, UPC 085737-14906-2 for $1.49 size, and UPC 085737-21001-4 for 2/$1 size. Recall # F-293-9;

 

b) Sunset Orchards brand Trail Mix in $0.99 size and $1.99 size; packed in plastic with UPC 085737-70038-6 for $0.99 size and UPC 085737-70050-8 for $1.99 size. Recall # F-294-9;

 

c) Sunset Orchards brand Hot Cajun Mix in $0.99 size and $1.99 size; packed in plastic with UPC 085737-70031-7 for $0.99 size and UPC 085737-70053-9 for $1.99 size. Recall # F-295-9;

 

d) Sunset Orchards brand Mixed Nuts in $0.99 size; packed in plastic with UPC 085737 -70012-6. Recall # F-296-9;  

 

e) Sunset Orchards brand Hot & Spicy Peanuts in $0.99 size and 2/$1.00 size; packed in plastic; with UPC 085737-70070-1 for $0.99 size and UPC 085737-21003-8 for 2/$1.00 size. Recall # F-297-9;

 

f) Sunset Orchards brand Raisin Nut & Seed Mix, $1.99 size; packed in plastic with UPC 085737-70052-2. Recall # F-298-9;

 

g) Sunset Orchards brand Fruit & Nut Mix in $1.99 size; packed in plastic with UPC 085737-70054-6. Recall # F-299-9

CODE

All product date codes prior to 02/05/2009

RECALLING FIRM/MANUFACTURER

Zaloom Marketing Corp., South Hackensack, NJ, by letters on January 30, 2009 and press release on February 6, 2009. Firm initiated recall is complete.

REASON

The product was manufactured using peanuts recalled by Peanut Corporation of America, Blakely, GA, because they have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

250 cases x 30 lb bulk mixed into a variety of products

DISTRIBUTION

NJ and possibly adjoining states

___________________________________

PRODUCT

a) Chocolate Peanut Butter Cake is sold by individual slices through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-300-9;

 

b) Chocolate Peanut Butter Bundts are sold by individual slices through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-301-9;

 

c) Cowboy Cookies are sold by individual cookie through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-302-9;

 

d) Monster Cookies are sold by individual cookie through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-303-9;

 

e) Peanut Butter Cookies are sold by individual cookie through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-304-9;

 

f) Peanut Butter Chocolate Chip Cookies are sold by individual cookie through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-305-9;

 

g) Peanut Butter Fudge Bars are sold by individual bars through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-306-9;

 

h) Double Delicious Bars are sold by individual bars through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-307-9;

 

i) Turtle Brownies are sold by individual brownies through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-308-9;

 

j) Peanut Butter Fudge Cups are sold by individual cups through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-309-9;

 

k) Peanut Butter Fudge Pie is sold by individual slices through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-310-9;

 

l) Rice Pilaf is sold by display bowls through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-311-9;

 

m) Sesame Peanut Noodle Salad is sold by display bowls through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-312-9;

 

n) Thai Chicken Salad is sold by display bowls through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-313-9;

 

o) Turkey Thai Peanut Soup is served from a soup kettle with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-314-9;

 

p) Peanut Butter is sold by 2 oz. plastic cups through cafe display case counters with a food card identifying the name of the product. No UPC codes, or labels, exist for this product. Recall # F-315-9

CODE

a) No codes. The product was distributed 02/08/07 through 01/22/09.

b) No code information. The product was distributed 01/09/07 through 01/22/09;

c) No code information. The product was distributed 01/15/07 through 02/04/09;

d) No code information. The product was distributed 04/18/07 through 01/22/09;

e) No code information. The product was distributed 01/05/07 through 01/29/09;

f) No code information. The product was distributed01/09/07 through 02/05/09.

g) No code information. The product was distributed 02/16/07 through 12/15/08.

h) No code information. The product was distributed 01/11/07 through 01/29/09;

i) No code information. The product was distributed 08/15/07 through 11/23/09; 

j) No code information. The product was distributed 02/12/07 through 01/27/09;

k) No code information. The product was distributed 01/03/07 through 02/29/08.

l) No code information. The product was distributed on 01/26/07;

m) No code information. The product was distributed 01/08/07 through 02/04/09;

n) No code information. The product was distributed 01/04/07 through 02/03/09;

o) No code information. The product was distributed 01/25/07 through 01/08/09;

p) No code information. The product was distributed 01/01/07 through 02/05/09

RECALLING FIRM/MANUFACTURER

Allan Brothers Coffee LLC, Albany, OR, by telephone on February 5, 2009 and by press release on February 13, 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

27,411.55 (varying units)

DISTRIBUTION

OR

___________________________________

PRODUCT

Cayenne candied peanuts in milk chocolate. a) Sticker label reads: "Coco-luxe Confections County Fair Peanuts cayenne candied peanuts in milk chocolate Net Wt 3 OZ. (84g)". Packaged in clear, 3 oz plastic bag. UPC 8 55182 00193 8. b) Sticker label reads: "Coco-luxe Confections County Fair Peanuts cayenne candied peanuts in milk chocolate Net Wt. 6 oz (168 g)". Outer package is a cardboard gift box. Inner package is a clear, plastic bag containing 6 oz of product. UPC: 8 55182 00195 2. Recall # F-316-9

CODE

Undetermined

RECALLING FIRM/MANUFACTURER

Coco-luxe Confections, Sausalito, CA, by e-mail and telephone beginning February 27, 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

576 units

DISTRIBUTION

CO, CA, OR, WA

PRODUCT

Westco Nut Mix, 6/64oz cans, Item number R3408. (There were no labels available for FDA review). Recall # F-317-9

CODE

Date Codes: 355 811 18:52 DOP Jan 2009 and 355811 18:7 DOP Feb 2009

RECALLING FIRM/MANUFACTURER

Recalling Firm: I J Valdosta, Valdosta, GA, by e-mail on March 23, 2009.

Manufacturer: Westco Fruit & Nut Co., Inc. T/A Westcott, Irving, NJ. 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

134 cases

DISTRIBUTION

FL, PA, Bahamas, Guantanamo Bay, Cuba

 

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________

PRODUCT

Equate Ibuprofen Tablets, 200 mg, 100 coated Tablets, NDC 49035-604-78. Recall # D-422-2009

CODE

Lot 9BE1961

RECALLING FIRM/MANUFACTURER

L. Perrigo Co, Allegan, MI, by telephone on March 24, 2009. Firm initiated recall is complete.

REASON

Presence of Foreign Substance; metal shavings.

VOLUME OF PRODUCT IN COMMERCE

2,880 bottles

DISTRIBUTION

AR

___________________________________

PRODUCT

Furosemide Tablets, USP, 40 mg, 1000 Tablets, Rx only, 0781-1966-10. Recall # D-423-2009

CODE

Lot number: 180974, Exp 12-11

RECALLING FIRM/MANUFACTURER

Recall Firm: Sandoz, Inc, Princeton, NJ, by letter on April 10, 2009.

Manufacturer: Sandoz Inc, Broomfield, CO. Firm initiated recall is complete.

REASON

Furosemide tablets were out of specification for tablet thickness and potency.

VOLUME OF PRODUCT IN COMMERCE

5773 / 1000 tablet bottles

DISTRIBUTION

Nationwide

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced, Recall # B-0948-09

CODE

Unit: 2547704

RECALLING FIRM/MANUFACTURER

Central Kentucky Blood Center Inc. Lexington, KY, by letter dated January 21, 2009. Firm initiated recall is complete.

REASON

Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

KY

___________________________________

PRODUCT

a) Platelets. Recall # B-0953-09;

b) Red Blood Cells Leukocytes Reduced. Recall # B-0954-09

CODE

a) and b) Unit: 2420039

RECALLING FIRM/MANUFACTURER

Central Kentucky Blood Center Inc. Lexington, KY, by letter dated December 30, 2008. Firm initiated recall is complete.

REASON

Blood products, which were collected from a donor who had traveled to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

KY

___________________________________

PRODUCT

Source Plasma. Recall # B-0957-09

CODE

Unit: 08JM0F1914

RECALLING FIRM/MANUFACTURER

BioLife Plasma Service LP, Joplin, MO, by facsimile on December 19, 2008. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who did not receive a complete physical and screening prior to donation, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

___________________________________

PRODUCT

a) Red Blood Cells Leukocytes Reduced. Recall # B-0958-09;

b) Recovered Plasma. Recall # B-0959-09

CODE

a) and b) Unit: 6328886

RECALLING FIRM/MANUFACTURER

Florida’s Blood Centers, Inc. Orlando, FL, by letter or e-mail on November 28, 2008.

REASON

Blood products, collected from a donor who had received a tattoo within one year of donation, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

Austria and FL

___________________________________

PRODUCT

Red Blood Cells. Recall # B-0960-09

CODE

Unit: LF35747

RECALLING FIRM/MANUFACTURER

Blood Center of Iowa, Des Moines, IA, by letter dated January 27, 2009. Firm initiated recall is complete.

REASON

Blood product, collected from a donor who lived in an area considered endemic for malaria, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

IA

___________________________________

PRODUCT

Red Blood Cells. Recall # B-0961-09

CODE

Unit: 6208771

RECALLING FIRM/MANUFACTURER

HemaCare Corporation, Van Nuys, CA, by telephone on December 31, 2008 and by letter dated January 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

CA

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-0962-09

CODE

Unit: 01FC79102

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Blood Services, West Henrietta, NY, by facsimile, letter or electronic notification on December 29, 2008.

Manufacturer: American Red Cross Blood Services, Syracuse, NY. 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

NY

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-0966-09

CODE

Unit: 18GL49230

RECALLING FIRM/MANUFACTURER

American National Red Cross Great Lakes Region, Lansing, MI, by telephone or e-mail on January 23, 2009 and follow-up letters dated February 4, 2009 and March 10, 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

MI

___________________________________

PRODUCT

Platelets Pheresis Leukocytes Reduced. Recall # B-0970-09

CODE

Unit: W071208038387

RECALLING FIRM/MANUFACTURER

Medic Inc. Knoxville, TN, by letter on December 24, 2008. Firm initiated recall is complete.

REASON

Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

TN

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-0972-09

CODE

Unit: 6053029

RECALLING FIRM/MANUFACTURER

Blood Bank of Alaska, Inc. Anchorage, AK, by telephone on November 26, 2008. Firm initiated recall is complete.

REASON

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

AK

___________________________________

PRODUCT

a) Cryoprecipitated AHF. Recall # B-0974-09;

b) Red Blood Cells Leukocytes Reduced. Recall # B-0975-09

CODE

a) and b) Unit: FG53400

RECALLING FIRM/MANUFACTURER

Piedmont Blood Center, Inc. Spartanburg, SC, by telephone on June 5, 2007. Firm initiated recall is complete.

REASON

Blood products, collected from a donor taking the medication Tegison, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

SC

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-0976-09

CODE

Unit: 012GL90760

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone and electronic mail on July 5, 2006 and by follow-up letter on July 6, 2006.

Manufacturer: American Red Cross Blood Services, Asheville, NC. Firm initiated recall is complete.

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

NC

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-0978-09

CODE

Unit: FM65854

RECALLING FIRM/MANUFACTURER

Piedmont Blood Center, Inc. Spartanburg, SC, by telephone on October 31, 2007. Firm initiated recall is complete.

REASON

Blood product, which was collected from a donor who traveled to an area considered endemic for malarial, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

SC

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-0979-09

CODE

Unit: FM66109

RECALLING FIRM/MANUFACTURER

Piedmont Blood Center, Inc. Spartanburg, SC, by telephone on November 13, 2007. Firm initiated recall is complete.

REASON

Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

SC

___________________________________

PRODUCT

a) Platelets. Recall # B00980-09;

b) Red Blood Cells Leukocytes Reduced. Recall # B-0981-09

CODE

a) and b) Unit: 2531950

RECALLING FIRM/MANUFACTURER

Central Kentucky Blood Center, Inc. Lexington, KY, by letter dated February 27, 2009. Firm initiated recall is complete.

REASON

Blood products, collected from a donor who visited a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

KY

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-0982-09

CODE

Units: 2438772, 2325765

RECALLING FIRM/MANUFACTURER

Central Kentucky Blood Center, Inc. Lexington, KY, by letter dated February 26, 2009. Firm initiated recall is complete.

REASON

Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.

VOLUME OF PRODUCT IN COMMERCE

2 units

DISTRIBUTION

KY

 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________

PRODUCT

Recovered Plasma. Recall # B-0963-09

CODE

Unit: 01FC79102

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Blood Services, West Henrietta, NY, by facsimile, letter or electronic notification on December 29, 2008.

Manufacturer: American Red Cross Blood Services, Syracuse, NY. Firm initiated recall is complete.

REASON

Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

___________________________________

PRODUCT

Recovered Plasma. Recall # B-0967-09

CODE

Unit: 18GL49230

RECALLING FIRM/MANUFACTURER

American National Red Cross Great Lakes Region, Lansing, MI, by telephone or e-mail on January 23, 2009 and follow-up letters dated February 4, 2009 and March 10, 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

CA

___________________________________

PRODUCT

Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0968-09

CODE

Unit: 165510472

RECALLING FIRM/MANUFACTURER

Blood Systems Inc/dba United Blood Services, Meridian, MS, by letter on January 20, 2009. Firm initiated recall is complete.

REASON

Blood product, leukodepleted greater than five days after collection, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

MS

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-0969-09

CODE

Units: 9098894; 9098598; 9098596

RECALLING FIRM/MANUFACTURER

Florida’s Blood Centers, Inc. Orlando, FL, by letter on December 12, 2008. Firm initiated recall is complete.

REASON

Blood product, leukodepleted greater than five days after collection, was distributed.

VOLUME OF PRODUCT IN COMMERCE

3 units

DISTRIBUTION

Fl

___________________________________

PRODUCT

Red Blood Cells Leukocytes Reduced. Recall # B-0971-09

CODE

Unit: 16LQ61555

RECALLING FIRM/MANUFACTURER

American Red Cross Blood Services, Columbus, OH, by telephone on November 18, 2008 and follow-up letter on November 19, 2008. Firm initiated recall is complete.

REASON

Blood product, manufactured without additive solution, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

NJ

___________________________________

PRODUCT

Recovered Plasma. Recall # B-0973-09

CODE

Unit: FG53400

RECALLING FIRM/MANUFACTURER

Piedmont Blood Center, Inc. Spartanburg, SC, by telephone on June 5, 2007. Firm initiated recall is complete.

REASON

Blood product, collected from a donor taking the medication Tegison, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

___________________________________

PRODUCT

Recovered Plasma. Recall # B-0977-09

CODE

Unit: 012GL90760

RECALLING FIRM/MANUFACTURER

Recalling Firm: American Red Cross Carolinas Blood Services Region, Charlotte, NC, by telephone and electronic mail on July 5, 2006 and follow-up letter on July 6, 2006.

Manufacturer: American Red Cross Blood Services, Asheville, NC. Firm initiated recall is complete.

REASON

Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.

VOLUME OF PRODUCT IN COMMERCE

1 unit

DISTRIBUTION

CA

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________

PRODUCT

GE Healthcare ApexPro Telemetry System for mobile patient physiological monitoring. Recall # Z-1227-2009

CODE

Serial numbers: RT908119042GA RT908119043GA RT908119044GA RT908119046GA RT908119049GA RT908119068GA RT908119045GA RT908119050GA RT908119036GA RT908119037GA RT908119079GA RT908119035GA RT908119069GA RT908119083GA RT908119085GA RT908119059GA RT908119060GA RT908119062GA RT908119063GA RT908119065GA RT908119067GA RT908119080GA RT908119086GA RT908119087GA RT908119070GA RT908119071GA RT908119072GA RT908119073GA RT908119074GA RT908119076GA RT908119077GA RT908119078GA RT908119107GA RT908119108GA RT908119109GA RT908119110GA RT908119111GA RT908119112GA RT908119113GA RT908119114GA RT908119115GA RT908119116GA RT908119117GA RT908119118GA RT908119119GA RT908119120GA RT908119121GA RT908119123GA RT908119129GA RT908119124GA RT908119125GA RT908119081GA RT908129144GA RT908129145GA RT908119096GA RT908119097GA RT908119098GA RT908119099GA RT908119127GA RT908119126GA RT908139213GA RT908139214GA RT908139215GA RT908139216GA RT908139217GA RT908139218GA RT908139219GA RT908139220GA RT908139221GA RT908139222GA RT908119039GA RT908119052GA RT908119053GA RT908119054GA RT908119057GA RT908119058GA RT908119088GA RT908119089GA RT908119090GA RT908119101GA RT908119102GA RT908119103GA RT908119104GA RT908119106GA RT908139169GA RT908139171GA RT908139172GA RT908139173GA RT908139174GA RT908139175GA RT908139176GA RT908139177GA RT908139178GA RT908139179GA RT908139181GA RT908139182GA RT908139183GA RT908139184GA RT908139185GA RT908139186GA RT908139187GA RT908139188GA RT908139190GA RT908139191GA RT908139192GA RT908139193GA RT908139194GA RT908139195GA RT908139196GA RT908139197GA RT908139198GA RT908139199GA RT908139200GA RT908139202GA RT908139203GA RT908139204GA RT908139205GA RT908139206GA RT908139207GA RT908139209GA RT908139211GA RT908139212GA RT908119128GA RT908139223GA RT908139225GA RT908139226GA RT908139227GA RT908139228GA RT908139231GA RT908139232GA RT908139233GA RT908139234GA RT908139236GA RT908139237GA RT908139238GA RT908139239GA RT908139240GA RT908139241GA RT908139242GA RT908139243GA RT908139244GA RT908139245GA RT908139246GA RT908139247GA RT908139248GA RT908139249GA RT908139250GA RT908139251GA RT908139252GA RT908139253GA RT908139254GA RT908139255GA RT908139256GA RT908139257GA RT908139291GA RT908139293GA RT908139294GA RT908139295GA RT908139303GA RT908139305GA RT908139306GA RT908139307GA RT908139262GA RT908139264GA RT908139265GA RT908139267GA RT908139268GA RT908139269GA RT908139270GA RT908139271GA RT908139272GA RT908139273GA RT908139274GA RT908139275GA RT908139258GA RT908139276GA RT908139277GA RT908139278GA RT908139279GA RT908139280GA RT908139281GA RT908139314GA RT908139315GA RT908139316GA RT908139317GA RT908139318GA RT908139319GA RT908139259GA RT908139301GA RT908139261GA RT908139260GA RT908139302GA RT908139292GA RT908139296GA RT908139297GA RT908139298GA RT908139310GA RT908139311GA RT908139312GA RT908139313GA RT908139299GA RT908139300GA RT908139282GA RT908139283GA RT908139284GA RT908139285GA RT908139290GA RT908119066GA RT908119075GA RT908119082GA RT908139208GA RT908139230GA RT908139304GA RT908119105GA RT908139180GA RT908139289GA RT908119084GA RT908119122GA RT908139170GA RT908179333GA RT908179334GA RT908179335GA RT908179355GA RT908179363GA RT908179364GA RT908179356GA RT908179358GA RT908179359GA RT908179360GA RT908179361GA RT908179362GA RT908179366GA RT908179367GA RT908179369GA RT908179370GA RT908179395GA RT908179396GA RT908179390GA RT908179399GA RT908179400GA RT908179350GA RT908179354GA RT908179336GA RT908179338GA RT908179339GA RT908179340GA RT908179341GA RT908179398GA RT908179365GA RT908179344GA RT908179346GA RT908179347GA RT908179348GA RT908179351GA RT908179352GA RT908179353GA RT908179324GA RT908179325GA RT908179326GA RT908179327GA RT908179328GA RT908179331GA RT908179332GA RT908179342GA RT908179343GA RT908119051GA RT908119094GA RT908179322GA RT908179323GA RT908179330GA RT908179373GA RT908179374GA RT908179375GA RT908179376GA RT908179378GA RT908179379GA RT908179381GA RT908179382GA RT908179384GA RT908179385GA RT908179386GA RT908179387GA RT908179388GA RT908179389GA RT908179391GA RT908179394GA RT908139189GA RT908139235GA RT908139308GA RT908139309GA and RT908251349GA

RECALLING FIRM/MANUFACTURER

Recalling Firm: GE Healthcare, Wauwatosa, WI, by letter dated February 12, 2009.

Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.

REASON

Intermittent or continuous loss of patient monitoring.

VOLUME OF PRODUCT IN COMMERCE

291 units

DISTRIBUTION

Nationwide and Canada

___________________________________

PRODUCT

MEDRAD Sterile Disposable Syringe Kit, catalog number DSK 130-Q, Angiographic Syringe for delivery of contrast media. Recall # Z-1228-2009

CODE

Lot number: 72372

RECALLING FIRM/MANUFACTURER

Medrad, Inc., Indianola, PA, by letter on January 29, 2009. Firm initiated recall is complete.

REASON

Possible compromised sterility due to holes in styrene tray.

VOLUME OF PRODUCT IN COMMERCE

2,958 kits

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

a) Synthes InSitu Bender Cutter Kit Wide Sterile Catalog number 530.521S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. Recall # Z-1248-2009;

 

b) Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. Recall # Z-1249-2009

CODE

a) Lot number: TM00322 exp 4/13/11;

b) Lot number: TM00324 exp 4/8/10

RECALLING FIRM/MANUFACTURER

Recalling Firm: Synthes Spine, West Chester, PA, by telephone on December 19, 2008 and by letter on December 22, 2008.

Manufacturer: Synthes USA, Monument, CO. Firm initiated recall is ongoing.

REASON

The bender is heating prior to activation of the power button, requiring disassembly to stop heating.

VOLUME OF PRODUCT IN COMMERCE

66 units

DISTRIBUTION

Nationwide

___________________________________

PRODUCT

Gendex CB-500, 3D Dental Imaging Systems, Model Number G1-15-1-0. Recall # Z-1265-2009

CODE

Serial Numbers: NU010261, NU010340, NU010224, NU010286, NU010265, NU010267, NU010282, NU010283, NU010284, NU010287, NU010288, NU010289, NU010292, NU010293, NU010294, NU010299, NU010303, NU010310, NU010315, NU010316, NU010317, NU010326, NU010290, and NU010291

RECALLING FIRM/MANUFACTURER

Imaging Sciences International, LLC, Hatfield, PA, by letter dated January 7, 2009. Firm initiated recall is ongoing.

REASON

Faulty calibration

VOLUME OF PRODUCT IN COMMERCE

24 units

DISTRIBUTION

FL, OH, PA and countries of Canada, Germany, England, Italy and Switzerland

___________________________________

PRODUCT

1) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087301, .035/150cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1267-2009;

 

2) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087302, .035/180cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1268-2009;

 

3) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087303, .035/300 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1269-2009;

 

4) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087304, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1270-2009;

 

5) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087305, .035/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1271-2009;

 

6) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087306, .035/300 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1272-2009;

 

7) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087308, .035/180 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1273-2009;

 

8) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087309, .035/300 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1274-2009;

 

9) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087311, .035/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1275-2009;

 

10) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087312, .035/300 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1276-2009;

 

11) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087313, .038/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1277-2009;

 

12) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087314, .038/180 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1278-2009;

 

13) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087315, .038/300 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1279-2009;

 

14) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087316, .038/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1280-2009;

 

15) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087317, .038/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1281-2009;

 

16) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087326, .032/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Recall # Z-1282-2009;

 

17) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387301, .035/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1283-2009;

 

18) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387302, .035/180 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1284-2009;

 

19) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387303, .035/300 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1285-2009;

 

20) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387304, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1286-2009;

 

21) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387305, .035/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1287-2009;

 

22) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387306, .035/300 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1288-2009;

 

23) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387307, .035/150 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1289-2009;

 

24) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387308, .035/180 cm, still/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1290-2009;

 

25) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387309, .035/300 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1291-2009;

 

26) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387310, .035/150 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1292-2009;

 

27) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387311, .035/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1293-2009;

 

28) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387312, .035/300 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1294-2009;

 

29) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387313, .038/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1295-2009;

 

30) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387314, .038/180 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1296-2009;

 

31) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387316, .038/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1297-2009;

 

32) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387318, .038/300 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1298-2009;

 

33) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387319, .038/150 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1299-2009;

 

34) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387320, .038/180 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1300-2009;

 

35) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387321, .038/300 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1301-2009;

 

36) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387322, .038/150 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1302-2009;

 

37) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387323, .038/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1303-2009;

 

38) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387325, .032/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1304-2009;

 

39) Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387326, .032/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1305-2009;

 

40) Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1306-2009;

 

41) Hydrophilic Guidewire, Catalog Number: VM18352, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Recall # Z-1307-2009

CODE

All lot codes

RECALLING FIRM/MANUFACTURER

Argon Medical Devices, Inc., Athens, TX, by letter dated February 26, 2009. Firm initiated recall is ongoing.

REASON

Hydrophilic guidewires have the potential to demonstrate degradation of the Pebax cladding.

VOLUME OF PRODUCT IN COMMERCE

42,645 units

DISTRIBUTION

Nationwide and countries of Germany, Thailand, Turkey and the Netherlands

___________________________________

PRODUCT

Lactosorb Pectus Stabilizer, model number: 01-3805. LactoSorb Pectus Stabilizer is a surgical implant intended to aid in the treatment of Pectus Excavatum deformities. The LactoSorb Pectus Stabilizer provides the surgeon with a means to secure the Pectus Support Bar to the chest wall. The Pectus Support Bar is used to reposition bony structures (sternum, breastbone) by applying internal force outwardly eliminating the funnel shaped deformity. Recall # Z-1323-2009

CODE

All lots

RECALLING FIRM/MANUFACTURER

Biomet Microfixation, Inc., Jacksonville, FL, by letter or email on March 20, 2009. Firm initiated recall is ongoing.

REASON

This recall is based on the occurrence of known adverse effects identified in the device instructions for use. Bending, fracture, loosening, rubbing and migration of the devices can occur as a result of excessive activity, trauma or load bearing. Implantation of foreign materials can result in an inflammatory response or allergic reaction.

VOLUME OF PRODUCT IN COMMERCE

2,117 units

DISTRIBUTION

Nationwide and countries of Argentina, Austria, Belgium, Chile, Colombia, Czech Republic, Denmark, Estonia, Finland, France, Germany, Guatemala, Israel, Italy, Lativa, Netherlands, South Africa, Spain, Sweden, Turkey, United Arab Emirates, United Kingdom and Venezuela

___________________________________

PRODUCT

Square Nut MR Safe, Catalog Number 03.311.060. The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure components together or as a means of bone distraction/compression. Each side of the Square Nut is etched with a number, 1-2-3-4, which can be referenced during distraction/compression. Distraction of bone typically occurs a rate of 1mm/day. The patient may be instructed to turn the nuts 1/4 turn four times per day, accomplishing 0.25mm per 1/4 turn. The etched numbers offer reference points to the surgeon who instructs the patient on distraction technique. Recall # Z-1324-2009

CODE

Lot Numbers: UR76230, US89403, US94671, US97826, 5674035, US90907, US94396 and US97022

RECALLING FIRM/MANUFACTURER

Synthes Spine, West Chester, PA, by letter dated February 6, 2009 and email on February 09, 2009.

Manufacturer: Synthes USA, Monument, CO. Firm initiated recall is ongoing. Firm initiated recall is ongoing.

REASON

Numbers are etched incorrectly on the product.

VOLUME OF PRODUCT IN COMMERCE

1,137 units

DISTRIBUTION

Nationwide and Switzerland

___________________________________

PRODUCT

ARCHITECT Reaction Vessel, 2000 units per carton; for in vitro diagnostic use with the ARCHITECT i System; list 7C15-01. The ARCHITECT Reaction Vessels are disposable containers in which the Chemiluminescent Microparticle Immunoassay (CMIA) reaction takes place for sample analysis. Recall # Z-1392-2009

CODE

Lot Numbers: 68446P100, 69061P100, 69283P100, 68487P100, 69063P100, 69284P100, 68488P100, 69082P100, 69340P100, 68489P100, 69176P100, 69341P100, 68491P100, 69177P100, 69342P100, 68492P100, 69178P100, 69353P100, 68511P100, 69179P100, 69433P100, 68513P100, 69180P100, 69434P100, 68515P100, 69205P100, 69435P100, 68516P100, 69206P100, 69436P100, 68553P100, 69207P100, 69438P100, 69006P100, 69208P100, 69439P100, 69007P100, 69209P100, 69521P100, 69008P100, 69266P100, 69522P100, 69009P100, 69267P100, 69523P100, 69010P100, 69280P100, 69526P100, 69058P100, 69281P100, 69527P100, 69060P100, 69282P100 and 69660P100, 68306P100, 68389P100, 68390P100, 68391P100, 68392P100, 68393P100, 69684P100, 73657P100, 73742P100, 74114P100, 74115P100, 74117P100, 74235P100, 74277P100 and 74283P100

RECALLING FIRM/MANUFACTURER

Abbott Laboratories, Abbott Park, IL, by telephone and letter dated February 26, 2009. Firm initiated recall is ongoing.

REASON

Abbott has had an increase in complaints due to the receipt of error code 1006 (unable to process test, background read failure), error code 1007 (unable to process test, activated read failure) and incorrect results when using these lots of ARCHITECT Reaction Vessels.

VOLUME OF PRODUCT IN COMMERCE

27,163 cartons

DISTRIBUTION

Nationwide including Puerto Rico, and internationally to Canada, Mexico, Guatemala, Costa Rica, Venezuela, Colombia, Chile, Argentina, Dominican Republic, Honduras, Nicaragua, Germany, Japan, Hong Kong, Taiwan, Thailand, South Korea, Uruguay, Austria, Bahrain, Belarus, Belgium, Bosnia & Herzegovina, Croatia, Czech Republic, Denmark, Estonia, Finland, France, Greece, Hungary, India, Indonesia, Ireland, Italy, Jamaica, Kuwait, Luxembourg, Malaysia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom, Zimbabwe and Australia

___________________________________

PRODUCT

Cell-Dyn Ruby Hematology Analyzer with System Software Version 2.0ML, List Number 08H67-01. Product is a multi-parameter automated hematology analyzer designed for in vitro diagnostic use in clinical laboratories. The instrument has two modes of operation: autoloader that aspirates samples from closed collection tubes, and open tube mode that aspirates samples from open collection tubes. Recall # Z-1398-2009

CODE

Serial Numbers: 34868BG 34047BG 34116BG 34756BG 34012BG 34286BG 34595BG 34596BG 34597BG 34741BG 34920BG 34921BG 34922BG 34150BG 34429BG 34479BG 34518BG 34551BG 34552BG 34846BG 34526BG 34872BG 34873BG 34122BG 34657BG 34087BG 34163BG 34300BG 34537BG 34689BG 34691BG 34692BG 34283BG 34735BG 34111BG 34346BG 34416BG 34767BG 34963BG 34964BG 34965BG 34966BG 34969BG 34973BG 34974BG 34975BG 34976BG 34979BG 34001BG 34003BG 34004BG 34005BG 34010BG 34082BG 34091BG 34098BG 34110BG 34132BG 34191BG 34199BG 34227BG 34229BG 34231BG 34243BG 34324BG 34333BG 34336BG 34337BG 34434BG 34462BG 34503BG 34504BG 34507BG 34535BG 34568BG 34713BG 34733BG 34742BG 34760BG 34761BG RD009 34282BG 34021BG 34138BG 34140BG 34171BG 34384BG 34490BG 34506BG 34529BG 34668BG 34670BG 34736BG 34739BG 34870BG 34887BG 34893BG 34862BG 34863BG 34864BG 34880BG 34886BG 34860BG 34916BG 34917BG 34563BG 34565BG 34698BG 34080BG 34175BG 34247BG 34453BG 34188BG 34832BG 34833BG 34079BG 34123BG 34125BG 34448BG 34942BG 34737BG 34861BG 34907BG 34865BG 34866BG 34867BG 24525BG 34242BG 34261BG 34262BG 34263BG 34265BG 34267BG 34348BG 34353BG 34413BG 34415BG 34722BG 34101BG 34948BG 34310BG 34850BG 34851BG 34852BG 34853BG 34854BG 34855BG 34856BG 34857BG 34858BG 34859BG 34869BG 34871BG 34875BG 34889BG 34892BG 34894BG 34895BG 34896BG 34897BG 34915BG 34918BG 34919BG 34923BG 34924BG 34925BG 34926BG 34927BG 34928BG 34929BG 34930BG 34931BG 34941BG 34943BG 34944BG 34945BG 34946BG 34947BG 34957BG 34073BG 34075BG 34085BG 34088BG 34106BG 34131BG 34135BG 34143BG 34144BG 34146BG 34156BG 34159BG 34161BG 34165BG 34183BG 34192BG 34193BG 34196BG 34200BG 34202BG 34205BG 34206BG 34207BG 34208BG 34255BG 34256BG 34259BG 34299BG 34319BG 34343BG 34379BG 34380BG 34381BG 34383BG 34392BG 34401BG 34403BG 34407BG 34411BG 34423BG 34427BG 34428BG 34430BG 34443BG 34446BG 34447BG 34450BG 34458BG 34461BG 34486BG 34489BG 34513BG 34517BG 34519BG 34520BG 34521BG 34547BG 34549BG 34553BG 34555BG 34556BG 34573BG 34574BG 34575BG 34582BG 34588BG 34601BG 34602BG 34605BG 34612BG 34613BG 34616BG 34626BG 34630BG 34632BG 34654BG 34677BG 34678BG 34681BG 34683BG 34696BG 34699BG 34708BG 34747BG 34749BG 34757BG 34764BG 34772BG 34775BG 34776BG 34777BG 34779BG 34796BG 34797BG 34798BG 34803BG 34810BG 34811BG 34812BG 34814BG 34817BG 34819BG 34820BG and 34847BG

RECALLING FIRM/MANUFACTURER

Abbott Laboratories, Santa Clara, CA, by letter dated February 12, 2009. Firm initiated recall is ongoing.

REASON

Burn Risk-- when power is cycled to the instrument, there is a possibility that the Mixer Motor Assembly may reach 100 degrees Celsius (212 degrees Fahrenheit). If the customer touches the motor, burns may occur.

VOLUME OF PRODUCT IN COMMERCE

324 instruments

DISTRIBUTION

Nationwide and countries of Argentina, Canada, Columbia, Germany, Jamaica, Japan, Mexico, Puerto Rico, Singapore, South Korea and Venezuela

___________________________________

PRODUCT

a) Immulite 2000 and b) Immulite 2500 digital Fluidics PC Board, Part Number 450116-0002. Performs chemiluminescent immunoassays using serum, plasma, and/or urine for in vitro diagnostic testing. Recall # Z-1399-2009

CODE

a) Serial Numbers M5080 to M5137; and b) Serial Numbers F0778 to F0818

RECALLING FIRM/MANUFACTURER

Siemens Medical Solutions Diagnostics, Flanders, NJ, by letter dated January 2009. Firm initiated recall is ongoing.

REASON

Design Flaw: The redesign of the Digital Fluidics PCB used in IMMULITE 2000 and IMMULITE 2500 is missing a jumper.

VOLUME OF PRODUCT IN COMMERCE

295 Digital Fluidica PCB's, (88 in Immulite 2000 and 2500 machines, 207 as spare parts).

DISTRIBUTION

MA, NY, PA, MD, GA, FL, OH, IN, MI, IL, MO, LA, UT, AZ and CA and countries of Canada, Czech Republic, Germany, Poland, Hungary, Belgium, Russia, Republic of South Africa, Greece, Israel, Turkey, Spain, Portugal, Denmark, France, Great Britain, India, China, South Korea and Mexico

___________________________________

PRODUCT

Panorama Patient Monitoring Network with ambulatory telepacks, and software version 8.5.5, 8.5.6, 8.6.1 or 8.7. Datascope Patient Monitoring Intended for use in a fixed location, in the healthcare facility setting, as a central viewing station. Recall # Z-1401-2009

CODE

Software version 8.5.5, 8.5.6, 8.6.1, or 8.7

RECALLING FIRM/MANUFACTURER

Mindray DS USA, Inc., dba Datascope Patient Monitoring, Mahwah NJ, by letters, dated March 27, 2009. Firm initiated recall is ongoing.

REASON

Software Anomaly: Software anomaly can occur when the Panorama is attempting to play an audio file, either a physiological or technical alarm sound, at which time the system software may cause the system to freeze due to an interaction in the alarm system.

VOLUME OF PRODUCT IN COMMERCE

294 affected sites

DISTRIBUTION

Nationwide and Australia

___________________________________

PRODUCT

a) Alcon 25 GA Total Plus Pak, Catalog/Item #8065750220; for use with ACCURUS Vitrectomy System. Recall # Z-1412-2009;

 

b) Alcon Vitrectomy 25 GA Custom Pak, Catalog/Item #: a) 10240-03, b) 11077-03, c) 11187-02 and d) 13305-01. Recall # Z-1413-2009

CODE

a) Lot # 9013991X, 9014291X and 9014509X;

 

b) a) Lot #899513H; b) Lot #892675H; c) Lot # 894213H and d) Lot # 892670H

RECALLING FIRM/MANUFACTURER

Recalling Firm: Alcon Laboratories, Inc., Fort Worth, TX, by letter on April 29, 2009.

Manufacturer: Alcon Manufacturing LTD, Sinking Spring PA. Firm initiated recall is ongoing.

REASON

Specific lots of Alcon 25 GA Trocar Blades do not conform to finished product specifications in that oxidation can occur on some of the blades.

VOLUME OF PRODUCT IN COMMERCE

3,582 surgical packs

DISTRIBUTION

Nationwide and Canada

___________________________________

PRODUCT

Kimberly-Clark, Synthetic Powder Free Vinyl Exam Gloves, Small, Medium and Large, 100 gloves per box, Non-Sterile, For Medical Use, Catalogue Numbers: 55031, 55032, and 55033. Recall # Z-1414-2009

CODE

Lot # SG8326661

RECALLING FIRM/MANUFACTURER

Recalling Firm: Kimberly Clark Corp., Roswell, GA, by letter on/about April 30, 2009.

Manufacturer: Shijiazhuang Hongxiang Plastic Products Co., Ltd., Lu Quan City, Hebei, China. Firm initiated recall is ongoing.

REASON

The product may contain defects /holes reducing the product’s effectiveness as a barrier.

VOLUME OF PRODUCT IN COMMERCE

920 cases/10 boxes per case

DISTRIBUTION

Nationwide

 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

___________________________________

PRODUCT

a) Medtronic Mosaic Porcine Bioprostheses with Cinch, Heart Valve; Model 305; Catalog #s 305C21AA, 305C2701, 305C2301, 305C2501, and 305C2901; Sterile LC; Rx only; Indicated for the replacement of malfunctioning native or aortic and mitral heart valves. Recall # Z-1225-2009;

 

b) Hancock II Bioprostheses with Cinch, Heart Valve, Model # T505 & T510; Catalog #s T505C2501, T505C2101, T505U25ID , T505C2301, T505C2301, T505C2501, T505C2101, T510C29ID, T510C25ID, and T510C27ID; Sterile LC; Rx only; Indicated for the replacement of malfunctioning native or aortic and mitral heart valves. Recall # Z-1226-2009

CODE

a) Lot Serial Number 21A06D2415, 27A05F7021, 23A06W1410, 25A04V1591, and 29A07F0075;

 

b) Lot Serial # 25A07L4976, 21A08D0985, 25A06H1684, 23A07T1262, 23A08B5266, 25A08F0564, 21A07R2878, 29M07V3883, 25M07T4827, and 27M07V0682

RECALLING FIRM/MANUFACTURER

Recalling Firm: Medtronic Inc. Minneapolis, MN, by letter dated January 26, 2009.

Manufacturer: The Heart Valve Division Medtronic Cardiovascular Surgery, Santa Ana, CA. Firm initiated recall is ongoing.

REASON

Medtronic identified several heart valves (Mosaic Porcine Bioprosthesis with Cinch & Hancock II Bioprosthesis with Cinch) that were inadvertently distributed after exposure to temperatures exceeding the 77 F (25 C) maximum storage temperature published on the labeling. The product is being retrieved as they do not meet the handling requirements.

VOLUME OF PRODUCT IN COMMERCE

15 units

DISTRIBUTION

Nationwide

  ___________________________________

PRODUCT

HemoSense INRatio2 Prothrombin Time Monitor. The INRatio2 PT Monitoring System is used for the quantitative measurement of Prothrombin Time (PT) in fresh, capillary whole blood. Recall # Z-1256-2009

CODE

Product Numbers: 0200431 and 0200432

RECALLING FIRM/MANUFACTURER

HemoSense Inc San Jose, CA, by letter dated December 19, 2008. Firm initiated recall is ongoing.

REASON

INRadio Monitors that were manufactured with a specific EEPROM memory chip fail during use. The monitors report an error code and do not report a test result.

VOLUME OF PRODUCT IN COMMERCE

921 units

DISTRIBUTION

Nationwide, Germany, Spain and Australia

___________________________________

PRODUCT

Access Myoglobin Reagents Kits, Part Number: 973243. The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in human serum and plasma using the Access Immunoassay Systems. Recall # Z-1396-2009

CODE

All lot numbers

RECALLING FIRM/MANUFACTURER

Beckman Coulter Inc. Brea, CA, by letter on October 8, 2007. Firm initiated recall is complete.

REASON

Beckman Coulter initiated the field action as a result of recent internal testing following the CLSI EP-5A - Evaluation of Precision Performance of Clinical Chemistry Devices protocol, it was determined that the total imprecision for the Access Myoglobin Reagent is greater than or equal to 10% across the expected physiological range rather than the stated claim less than 8%. Based on internal test data, this change should not have significant effect to risk classification of patients with acute coronary syndrome.

VOLUME OF PRODUCT IN COMMERCE

20,727 Kits

DISTRIBUTION

Nationwide and Canada

___________________________________

PRODUCT

a) Surgidyne S-Vac round fluted channel silicone drain, 1/8" trocar, 10 FR, round, full fluted, 28 cm length, 4 channel, contains 10, sterile; REF 332187. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing. Recall # Z-1404-2009;

 

b) Surgidyne S-Vac round fluted channel silicone drain kit, 10 FR, round, full fluted, 4 channel, 28 cm length, 1/8" trocar, contains 10, sterile, 100cc S-Vac silicone bulb evacuator; REF 332263. The device is a sterile, portable closed system designed to evacuate post-operative wound drainage and promote healing. Recall # Z-1405-2009;

CODE

a) Lot Number 2014-02-13;

b) Lot Number: 2014-03-07 and 2014-03-06

RECALLING FIRM/MANUFACTURER

Aspen Surgical Products, Inc, Caledonia, MI, by letter dated April 13, 2009. Firm initiated recall is ongoing.

REASON

An adaptor, which may be required when connecting the drain to an external device, was not included in the package.

VOLUME OF PRODUCT IN COMMERCE

90 units (9 cases)

DISTRIBUTION

CA, FL, GA, MA and MO

 

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

___________________________________

PRODUCT

a) Carrot Cake Dog Treats are sold under 3 different labels. (1) Three large dog cookie treats in the shape of bones packaged in a blue, silver and clear cellophane bag that reads "Filled With Fun - Carrot Cake Alaska Canine Cookies, UPC 6 37231 00221 5". (2) Forty five medium sized dog cookie treats in the shape of bones Net Wt 15 oz (425 grams) packaged in a white, maroon, teal, and brown colored paper bag that reads "ALASKA CANINE COOKIES Husk E. Dog Alaskan "WOOF" PACK Alaska Canine Cookies TM Inc., UPC 6 37231 00221 5". (3) Twelve medium sized dog cookie treats in the shape of bones Net Wt. 5 oz (140 grams) packed in a clear, maroon, teal, and brown colored cellophane bag that reads "YOU LUCKY DOG ALASKA CANINE COOKIES INC POLAR POOCH POUCH ALASKA CANINE COOKIES TN, INC., UPC 6 37231 00203 1". Recall # V-181-2009;

 

b) Power dog treats are sold under 2 different labels. (1) Three large dog cookie treats in the shape of bones packaged in a red, silver and clear cellophane bag that reads "Filled With Fun-Power Bone Alaska Canine Cookies Inc., UPC 6 37231 00220 8"; (2) Forty five medium sized dog cookie treats in the shape of bones Net Wt 15 oz (425 grams) packaged in a white, maroon, teal, and brown colored paper bag that reads "Alaska  Canine Cookies Husk E. Dog Alaskan "WOOF" Pack Alaska Canine Cookies TM, UPC 6 37231 00200 0". Recall # V-182-2009;

 

c) Peanut Butter dog treats are sold under 2 different labels. (1) Three large dog cookie treats in the shape of bones packaged in a gold and clear cellophane bag that reads "Filled With Fun - Peanut Butter Alaska Canine Cookies, Inc., UPC 6 37231 00210 9"; (2) Forty five medium sized dog cookie treats in the shape of bones Net Wt 15 oz (425 grams) packaged in a white, maroon, teal, and brown colored paper bag that reads "Alaska  Canine Cookies Husk E. Dog Alaskan "WOOF" Pack Alaska Canine Cookies Inc., UPC 6 37231 00200 0". Recall # V-183-2009;

 

d) White Carob Coated Peanut Butter Lollipup dog treats are packed in a clear plastic bag that reads "Alaska Canine Cookies TM Made in Alaska Husk E. Dog Net wt. 1 ounce, UPC 6 37231 00202 6". Recall # V-184-2009

CODE

None

RECALLING FIRM/MANUFACTURER

Alaska Wild Berry Products Inc. Anchorage, AK, by telephone on March 3, 2009. Firm initiated recall is ongoing.  

REASON

The product was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

1038 Pieces

DISTRIBUTION

AK, MN

___________________________________

PRODUCT

Dog Treats: Bark Bars Peanut Butter Crunch, 12 oz box, UPC 725999001103. Bark Bars Brownie Delight, 12 oz box, UPC 725999003107. Bark Bars Peanut Butter 2.5 lb Plastic Container, UPC 725999005064. Bark Bars Peanut Butter Bars Jumbo 20 Ct Tray, UPC 725999000168. Bark Bars Carbo & Peanut Butter 2.5 lb Plastic Container, UPC 725999005071. Bark Bars Milk & Cookies 4 oz carton, UPC 725999333808. Bark Bars Animal Snackers 3.5 oz box, UPC 725999512098. Bark Bars Peanut Butter 6 oz Smiles, UPC 725999530009. Bark Bars Assortment 100 Count Peanut Butter/Carbo, UPC 72599952590. Recall # V-185-2009

CODE

All codes

RECALLING FIRM/MANUFACTURER

Recalling Firm: R & R Distributors, Jacksonville FL, by letter on April 20, 2009. 

Manufacturer: American Health Kennels Inc. Pompano Beach, FL. Firm initiated recall is ongoing.

REASON

The products were manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE

Unknown

DISTRIBUTION

Nationwide

 

END OF ENFORCEMENT REPORT FOR JUNE 3, 2009

 

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