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U.S. Department of Health and Human Services

Safety

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Enforcement Report for February 3, 2010

February 3, 2010                                                                                   10-05

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I
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PRODUCT
1) Mi Pueblito Queso Fresco Authentic Mexican Style Fresh Cheese; Net Wt 14 oz (392 g), UPC 0 24077 10025 8. Recall # F-0587-2010;

2) La Fe String Cheese Oaxaca, Oaxaca Style, Queso de Hebra Estilo Net Wt. 14 oz, UPC code 0 23545 40115 6. Recall # F-0588-2010;  

3) El Viejito Oaxaca, Queso de hebra Estilo, Net Wt. 14 oz., UPC Code 7 18122 18071 4. Recall # F-0589-2010;

4) Mi Pueblito Cotija/Anejo por Libra, vacuum packed in plastic wrap by weight. UPC Code 0 24077 10221 4. Recall # F-0590-2010;

5) Mi Pueblita Cuajada Fresca Net wt. 14 oz., UPC Code 0 24077 10216 0. Recall # F-0591-2010;

6) Mi Pueblito Queso Colombiano De Arriero, Fresh Style Cheese Net wt. 14 oz. unit, UPC Code 0 24077 10219 1. Recall # F-0592-2010;

7) Mi Pueblito Queso Molido, A Mexican Style Hard cheese 14 oz., UPC Code 0 24077 10211 3. Recall # F-0593-2010;

8) Mi Pueblito Queso Cotija de Triangulo 14 oz., UPC Code 0 24077 10220 7. Recall # F-0594-2010;

9) Mi Pueblito Queso Fresco 14 oz. pack, UPC Code 0 24077 10025 8. Recall # F-0595-2010;

10) Mi Pueblito Queso Fresco De Rancho, Fresh Style Cheese 14 oz., UPC Code 0 24077 10215 3. Recall # F-0596-2010;

11) Mi Pueblito Queso Casero, Fresh Style Cheese 14 oz., UPC Code 0 24077 10222 1. Recall # F-0597-2010;

12) Mi Pueblito Queso Oaxaca, Fresh Style Cheese 14 oz., UPC Code 0 24077 10224 5. Recall # F-0598-2010;

13) Mi Pueblito Requeson, Ricotta Style Cheese 15 oz., UPC Code 0 24077 10200 9. Recall # F-0599-2010;

14) Mi Pueblito Queso Serrano, Fresh Style Cheese 16 oz., UPC Code 0 24007 10200 0. Recall # F-0600-2010
CODE
Sell by date going back to February 1, 2009
RECALLING FIRM/MANUFACTURER
Quesos Mi Pueblito, LLC, Passaic, NJ, by press release on August 18, 2009 and August 27, 2009, and by letter through fax and regular mail on or about August 18, 2009 and September 1, 2009. Firm initiated recall is ongoing.
REASON
The State of New Jersey randomly sampled cheese and found contamination with listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
unknown
DISTRIBUTION
NJ, NY, DE, MD, CT, VA
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PRODUCT
1) Peanut Brittle #NS2358, No Sugar Added, 30 lbs. Net, SKW 501905. Recall # F-0601-2010;

2) Peanut Brittle #5596 Small Grind, Net 25 lbs., SKU # 501632. Recall # F-0602-2010;

3) Homestyle Peanut Brittle Nuggets/Coconut Oil Coating, 25 lbs. Net, SKW 501664. Recall # F-0603-2010;

4) Chocolate Peanuts, 30 lbs. Net, SKW 501015. Recall # F-0604-2010;

5) Choco Coated Peanut Splits #1004, 30 lbs. Net, SKW 501645. Recall # F-0605-2010  
CODE
1) Lots 7109 - 8350 inclusive;
2) Lots 8198 - 8330 inclusive;
3) Lots 7075 - 9012 inclusive;
4) Lots 7100 - 8057 inclusive;
5) Lots 7152 - 8364 inclusive
RECALLING FIRM/MANUFACTURER
Star Kay White, Inc., Congers, NY, by e-mail and telephone on January 30, 2009 and by press release on February 6, 2008. 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
5,749 units
DISTRIBUTION
NY, NJ, MA, PA, OH, FL, TX, UT, CA, IA, NV, MO and IN
___________________________________
PRODUCT
1) Mariegold Baking 9 Grain bread - 32 oz., UPC# 0-25202-78031. Recall # F-0606-2010; 

2) Mariegold Baking Wheat Bread - 16 oz., UPC# 0-25202-10202 and 24 oz., UPC# 0-25202-78012. Recall # F-0607-2010;

3) Mariegold Baking White Bread -16 oz., UPC# 0-25202-10201, 24 oz., UPC# 0-25202-78011 and 32 oz., UPC# 0-25202-78034. Recall # F-0608-2010
CODE
All code dates prior to April 9, 2009. The product code date can be found on the plastic tab that is used to close the bag.
RECALLING FIRM/MANUFACTURER
Unified Grocers, Los Angeles, CA, by letters, via e-mail and fax and press release and visits on April 1, 2009. Firm initiated recall is complete.
REASON
Unified Grocers initiated the recall of the Mariegold Baking bread products because they may contain undeclared milk and soy.
VOLUME OF PRODUCT IN COMMERCE
47,879 units
DISTRIBUTION
CA, NV and AZ
___________________________________
PRODUCT
1) Inshell Roasted Pistachios. Item 846 - Roasted & Salted Inshell Pistachios packaged in a 16oz clear cello bag. Item 846 FR - Roasted & Salted Inshell Pistachios (sold as a Fund Raiser) packaged in a 16oz clear cello bag. Item 848RMIC - Inshell Roasted & Salted Pistachios packaged in a 16 oz clear cello bag with a silver label with lettering "rmic" within a circle of stars. Item 90 - Trendy Snack and Coffee product contains Item 846, Roasted & Salted Inshell Pistachios in a 16oz clear cello bag. Item 95 - Magazine Rack Gift Basket product (Deluxe Snack Assortment) contains Item 846, Roasted & Salted Inshell Pistachios in a 16oz clear cello bag. Products are not labeled with a UPC or lot codes. Recall # F-0776-2010;

2) Shelled Roasted & Salted Pistachios. Item 848 Roasted & Salted Shelled Pistachios packaged in 16 oz clear cello bag. Item 222 - Imperial Mix packaged in a 16oz clear cello bag. Item 91A - Fancy Nut Tin 24oz, packaged in an octagonal sectioned liner inside a decorative gift tin. Item 92B - Blue Snowman Roasted Nuts Gift Tin, 1lb 12oz (Stack Tin) packaged in a 4 oz clear cello bag included in the gift tin. Products are not labeled with a UPC or lot codes. Recall # F-0777-2010
CODE
No lot numbers
RECALLING FIRM/MANUFACTURER
Renfroe Pecan Co., Pensacola, FL, by telephone on March 31, 2009. Firm initiated recall is complete.
REASON
Pistachios were obtained from Setton Pistachio of Terra Bella, Inc., CA which has been recalled due to possible Salmonella contamination.
VOLUME OF PRODUCT IN COMMERCE
168 lbs.
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Hickory Harvest brand Natural Pistachios, 9.5 oz., and 8.5 oz. size product packed in film bags distributed 24 bags per case, UPC Numbers: 0-36232-07682-7; and 0-36232-07683-4. 8 oz. size product packed in plastic tubs distributed 18 tubs per case, UPC #0-36232-07679-7 and 2.75 oz. size product, packed in film bags distributed 72, and/or 12 bags per case, UPC Numbers: 0-36232-07678-0; and 0-36232-07684-1. Recall # F-0778-2010;

2) I M Good brand Natural Pistachios, 1.25 oz. size product packed in film tubes distributed 72 tubes per case, UPC #7-93724-80106-9; and 2.5 oz. and 4 oz. size product distributed in film bags, distributed 12 bags per case (2.5 Oz.) and/or 45 bags per case (4 oz.), UPC Numbers: 7-93724-60671-8 and 7-93724-00706-5. Recall # F-0779-2010;

3) I M Good brand Habanero Pistachios, 1.25 oz. size and 3.75 oz. sizes, packed in film tubes distributed 72 tubes per case, UPC #7-93724-80166-3 (1.25 oz.); and/or packed film bags distributed 50 bags per case, UPC #7-93724-00666-2 (3.75 oz.). Recall # F-0780-2010;

4) I M Good brand Red Pistachios, 1.25 oz. size packed in film tubes, distributed 72 tubes per case, UPC #7-93724-80107-6. Recall # F-0781-2010;

5) I M Good brand Garlic & Onion Pistachios, 1.25 oz. size packed in film tubes distributed 72 tubes per case. Recall # F-0782-2010;

6) I M Good Brand Jumbo Red Pistachios, packed in 1.25 oz. film bags, distributed 60 bags per case. Recall # F-0783-2010;

7) I M. Good brand Jumbo Pistachios, packed in 1.25 oz. film bags, distributed 60 bags per case, UPC #7-93724-10105-3. Recall # F-0784-2010
CODE
1), 2) and 7) Best by Dates ranging from Nov 23 09 thru Feb 28 10;
3), 4), 5), 6) Best by dates: Sept 15 09 thru Feb 28 10;
RECALLING FIRM/MANUFACTURER
Ohio Hickory Harvest Brand Products, Inc., Akron, OH, by telephone on March 31, 2009 and April 1, 2009 and April 7, 2009 and by press release on April 8, 2009. Firm initiated recall is ongoing.
REASON
The recalled products were manufactured using pistachios which were recalled by Setton Pistachio of Terra Bella, CA. These pistachios were recalled from distribution because the product has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,135 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Pine River Deluxe Mixed Nuts with Peanuts, 5 oz bags (7.5lb/case), Item P160, Case Item Number 16-00728, UPC 0 25231 00728 4. Recall # F-0785-2010
CODE
Lot 39041
RECALLING FIRM/MANUFACTURER
Pine River Prepack, Inc., Newton, WI, by press release on April 1, 2009 and memorandum dated April 6, 2009. Firm initiated recall is ongoing. 
REASON
The product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella, CA, because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
754 lbs. (approx. 2,413-5 oz units)
DISTRIBUTION
AL, GA, IL, IN, MA, MI, MO, NC, OH, OK, PA, TN, VA, WI
___________________________________
PRODUCT
1) 1 lb. Sack O' Pistachios-Red and Natural, in-shell, salted pistachios in cloth or burlap bag. Item/Order numbers: 8, AB008, AG008, AC008, AR008, BR008. Recall # F-0786-2010; 

2) 1.5 lb. Sack O' Pistachios-Red and Natural, in-shell, salted pistachios in cloth or burlap bag. Item/Order numbers: 741, AG741, AR741. Recall # F-0787-2010;

3) 2 lb. Sack O' Pistachios-Red and Natural, in-shell, salted pistachios in cloth or burlap bag. Item/Order numbers: 9, AB009, AG009, AC009, AR009, BR009. Recall # F-0788-2010;

4) 1.5 oz. Bag of Red and Natural, in-shell, salted pistachios. These bags are components of Gift/Hostess Assortment-an assortment of candies, cheeses, sausages and nuts in an octagon-shaped box, and Santa's 78 Favorites or 78 Piece CMP assortment. Item/Order numbers: 1928, AB719, AC719, AJ719, 688, AB688, AC688, AG688, and AR688. Recall # F-0789-2010;
CODE
1) Lot numbers: 6933, 6995, and 7325. The lot number for this product is stamped on the ingredient label. The ingredient label is applied directly to the interior plastic bag;

2) Lot number: 6995. The lot number for this product is stamped on the ingredient label. The ingredient label is applied directly to the interior plastic bag;

3) Lot numbers: 6934, 6995, 7325. The log number for this product is stamped on the ingredient label. The ingredient label is applied directly to the interior plastic bag

4) Lot numbers 6942, 6949. The lot number for this product is stamped directly on the clear plastic bag of the pistachios.
RECALLING FIRM/MANUFACTURER
Swiss Colony, Inc., Monroe, WI, by press release on April 18, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella, because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
21,814 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Crunch Time***Pistachio nuts to share…natural, traditional pistachio nuts 888 net wt. 18.25 oz. (517g). Recall # F-0790-2010
CODE
Best By Date 02/2009 – 03/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Staples, The Office Superstore, Framingham, MA, by email on April 9, 2009.
Manufacturer: Setton Pistachio of Terra Bella, Inc., Terra Bella, CA. Firm initiated recall is complete.
REASON
Product contains pistachios from Setton Farms and may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
23,000 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Blanched Virginia Peanuts Roasted & Salted: Davis Lewis Orchards, Net Wt. 14 oz  (392g) UPC 731205353720; David Lewis Orchards, Net Wt 16 oz (448g) UPC 73120535353164; Davis Lewis Orchards, Net Wt 8 oz (224g), UPC 731205353089; Davis Lewis Orchards, 25 lb., UPC 7 3120535600; Clark's Nutrition & Natural Foods Market, Net Wt 8 oz (224g) UPC 731205353085; Clark's Nutrition & Natural Foods Market, Net Wt 14 oz (392g), UPC 731205353140; Marbella Farmers Market, Net wt 16 oz (448g) UPC 731205353164: Hadley, Net Wt 16 oz (448g) UPC 731205353164; Hadley, Net Wt 4 oz (112g), UPC 731205353041; Hadley, 2 oz., UPC 7 3120535302; Jensen's Finest Foods, Net Wt 16 oz (448 g) UPC 731205353164; Gelson's, Net Wt 14 oz (392g), UPC731205353423. Recall # F-1026-2010;

2) Bobbies Freeway Snack Trail Mix: Davis Lewis Orchards, Net Wt 7 oz (196g), UPC 731205657071; Davis Lewis Orchards, Net Wt. 15 oz (420g) UPC 731205657729; Davis Lewis Orchards, Net Wt 12 oz (336g), UPC 731205657996; Davis Lewis Orchards, 16 oz (448g), UPC 731205657163; Davis Lewis Orchards, 25 lb, UPC 73120565700; Marbella Farmers Market, Net Wt 16 oz (448g) UPC 731205657163; Bobbie's, Net Wt 10 oz (280g), UPC 731205657552; Jensen's Finest Foods, Net Wt 16   oz (448g), UPC 731205657163; Jensen's, 16 oz(448g), UPC 731205657927; Fresh to Market, 16 oz (448g), UPC 731205657927; Fresh to Market, Net Wt 16 oz (448g), UPC 731205657163; Clark's Nutrition & Natural Foods Market, Net Wt 7 oz (196g) UPC 731205657071; Kern Valley Produce, Net Wt 16 oz (448g), UPC 731205657927; Bristol Farms, 10 oz, UPC 73120565755-2. Recall # F-1027-2010;

3) Chocolate Peanut Butter Cherry Blend: Davis Lewis Orchards, Net Wt. 12 oz (336g) UPC 731205644927; Gelson's, Net Wt 16 oz (448g), UPC731205644422. Recall # F-1028-2010;

4) Gourmet Naturally Good Fruit Blend: Davis Lewis Orchards, Net Wt 16oz (448g), UPC 731205611165; Davis Lewis Orchards, Net Wt. 12 oz (392g) UPC 731205 61172; Davis Lewis Orchards, Net Wt 7 oz (196g) UPC 731205611073; Davis Lewis Orchards, 25 lb, UPC 73120561100; Marbella Farmers Market, Net Wt 16 oz (448g) UPC 731205611165; Jensen's Finest Foods, Net Wt 16 oz (448g), UPC731205611165; Fresh to Market, Net Wt 16 oz (448g) UPC 731205611165; Clark's Nutrition & Natural Foods, 14 oz, UPC 731205660149. Recall # F-1029-2010;

5) Gelson's Finest Custom Blend Eastern Delight Net Wt. 8 oz (224g) UPC 731205612421. Recall # F-1030-2010;

6) Gelson's Finest Gourmet Gelsons Finest Blend Roasted & Salted Net Wt 14 oz (392g) UPC 731205637424. Recall # F-1031-2010;

7) Gelson's Finest Gourmet Gelsons Finest Blend Roasted No Salt Net Wt 14 oz (392g) UPC 731205639428. Recall # F-1032-2010;

8) Gelson's Finest Gourmet Trip Mix Net Wt. 16 oz (448g) UPC 731205657422. Recall # F-1033-2010.

9) Blanched Virginia Peanuts Roasted No Salt: Marbella Farmers Market, Net Wt 16 oz (448g) UPC 731205364160; Clark's Nutrition & Natural Foods, Net Wt 8 oz (224g), UPC 73120535364085 and 14 oz UPC 731205364146; Davis Lewis Orchards, Net Wt 8 oz (224g), UPC 731205364085; Davis Lewis Orchards, 25 lb, UPC 73120536400; Hadley's, 16 oz, UPC 73120536416. Recall # F-1034-2010;

10) Southern Grown Spanish Peanuts Roasted & Salted: Marbella Farmers Market: Net Wt 16 oz (448g) UPC 731205356165; Hadley, Net Wt 16 oz (448g), UPC731205356165; Jensen's Finest Foods, Net Wt 16 oz (448g), UPC731205356165; Clark's Nutrition & Natural Foods Market, Net Wt 8 oz (224g) UPC731205356080 and 16 oz, UPC 731205356165; Davis Lewis Orchards, 16 oz, UPC 731205356165; Davis Lewis Orchards, 25 lb, UPC 73120535600. Recall # F-1035-2010;

11) Peanuts Honey Roasted: Marbella Farmers Market, Net Wt 16 oz (448g) UPC 731205341161; Hadley, net Wt 16 oz (448g) UPC 731205341161; Kern Valley Produce, Net Wt 16 oz (448g) UPC 731205341925; Jensen's Finest Foods, Net Wt 16 oz (448g) UPC 731205341161; David Lewis Orchards, Net Wt 16 oz (448g) UPC 731205341161 and Net Wt 16 oz (448g) UPC 731205341161; Davis Lewis Orchards, 8 oz., UPC 73120534108; Davis Lewis Orchards, 25 lb., UPC 73120534100; Clark's Nutrition & Natural Foods Market, Net Wt 8 oz (224g) UPC 731205341086. Recall # F-1036-2010;

12) Zesty! Peanuts Hot & Spicy: Marbella Farmers Market, Net Wt. 16 oz (448g) UPC 731205342168; Jensen's Finest Foods, Net Wt 16 oz (448g) UPC 731205342168; Clark's Nutrition & Natural Foods, Net Wt 16 oz (448) UPC 731205342168; Davis Lewis Orchards, Net Wt 8 oz (224g) UPC 731205342083; Hadley, Net Wt 16 oz (448g), UPC 731205342168; Kern Valley Produce, Net Wt 9 oz (252g) UPC 731205341925; Jensen's Finest Foods, Net wt 14 oz (392g) UPC 731205612148; Jensen's Custom Blend, Net Wt 9 oz (252g) UPC 731205612094; Davis Lewis Orchards, Net Wt 9 oz (252g), UPC 731205612094; Davis Lewis Orchards, 25 lb, UPC 731205 34200. Recall # F-1037-2010

13) Oriental Delight Custom Blend: Marbella Marmers Market, Net Wt. 14 oz (392) UPC 731205612148 and Wt. 9 oz (252g) UPC 731205612599; Kern Valley Produce, Net Wt 9 oz (252g), UPC 731205341925; Jensen's Finest Foods, Net wt 14 oz (392g), UPC 731205612148; Jensen's Custom Blend, Net Wt 9 oz (252g) UPC 731205612094; Davis Lewis Orchards, Net Wt 9 oz (252g) UPC 731205612094 and 73120561259, 6 oz (168g), 10 oz., UPC 73120561272, 25 lb, UPC 73120561200; and 14 oz (392g) UPC 731205612148; Clark's Nutrition & Natural Foods Market, Net Wt 6 oz (168g), UPC 731205612063 and 9 oz, UPC 731205612094; Bristol Farms, 10 oz, UPC 7 3120563755 4. Recall # F-1038-2010;

14) Justin's Athletic Mix Gourmet: Marbella Farmers Market, Net Wt 16 oz (448g) UPC 731205633167; Jensen's Finest Foods, Net Wt 16 oz (448g) UPC 731205633167; Clark's Nutrition & Natural Foods, Net Wt 7 oz (196g) UPC 731205633075; Davis Lewis Orchards, net Wt 16 oz (448g) UPC 731205633167 and 25 lb, UPC 73120563300. Recall # F-1039-2010;

15) Roasted & Salted Fruit Blend: Marbella Farmers Market, Gourmet Net Wt 16 oz (448g) UPC 731205637165; Kern Valley Produce, Net Wt 16 oz (448g) UPC 731205637929; Roasted & Salted Fruit Blend Gourmet, Net Wt 10 oz (280g) UPC 731205637554; Jensen's Finest Foods, Net Wt 16 oz (448g) UPC 731205637165; Jensen's Gourmet, Net Wt 16 oz (448g) UPC 731205637929; Davis Lewis Orchards, Net Wt 12 oz (336g) UPC 731205637998, 7 oz (196g) UPC 731205637073, 16 oz (448g) UPC 731205637165, and 25 lb, UPC UPC73120563700; Clark's Nutrition & Natural Foods Market, Net Wt 16 oz   (448g) UPC 731205637288; Fresh to Market, Net Wt 16 oz (448g) UPC 731205637165; Bristol Farms, 10 oz, UPC 7 3120563955-8. Recall # F-1040-2010;

16) Roasted No Salt Fruit Blend Gourmet: Marbella Farmers Market, Net Wt 16  oz (448g) UPC 731205639169; Kern Valley Produce, Net Wt 16 oz (448g) UPC 731205639923; Jensen's Finest Foods, Net Wt 16 oz (44g) UPC 731205639169; Jensen's Gourmet, Net Wt 16 oz (448g) UPC 731205639923; Davis Lewis Orchards, Net Wt 12 oz (336g) UPC 731205639992, and 25 lb, UPC 73120563900; Clark's Nutrition & Natural Foods Market, Net Wt 7 oz (196g) UPC 731205639077; Clark's Nutrition & Natural Foods, Net Wt 7 oz (196g) UPC 731205639077; Davis Lewis Orchards, net Wt 7 oz (196g) UPC 731205639077 and 16 oz (448g) UPC731205639169; 10 oz (280g) UPC 731205639558; Bristol Farms, 7 oz, UPC 7 3120561255-1. Recall # F-1041-2010;

17)  Delicious Fruit Nut Mix Gourmet: Marbella Farmers Market, Net Wt 16 oz (448g) UPC 731205653165; Hadley, Net Wt 5 oz (140g) UPC 731205438052, Net Wt 16 oz (448g) UPC 731205438168, and 40 oz (1120g) UPC 731205438403; 9 oz (252g) UPC 731205653554; Davis Lewis Orchards Net Wt 12 oz (336g) UPC 731205653998, 7 oz (196g) UPC 731205653073, 16 oz (448g) UPC 731205653165, and 25 lb, UPC 73129565300; Clark's Nutrition & Natural Foods, Net Wt 14 oz (392g) UPC 731205666141; Bristol Farms, 9 oz, UPC 7 3120565355-4. Recall # F-1042-2010;

18) Jimmie's Hot & Spicy Trail Mix, Marbella Farmers Market, Net Wt 16oz (448g) UPC 731205655169; Davis Lewis Orchards, Net Wt 7 oz (196g) UPC 73120565077, 16 oz, UPC 73120565516, and 25 lb, UPC 73120565500. Recall # F-1043-2010;

19) Roasted No Salt Sierra Blend Natural: Marbella Farmers Market, Natural Net Wt 16 oz (448g) UPC 731205626169; Clark's Nutrition & Natural Foods Market, Net Wt 7 oz (196g) UPC 731205639077 and 16 oz (448g) UPC 731205626169; Davis Lewis Orchards, Net Wt 16 oz (448g) UPC 731205626169. Recall # F-1044-2010;

20) Custom Blend California Blend Gourmet: Marbella Farmers Market, Net Wt 16 oz (448g) UPC 731205627166; Clark's Nutrition & Natural Foods Market, Net Wt 7 oz (196g) UPC 731205627074. Recall # F-1045-2010;

21) Double-Double Chocolate Fruit Blend: Marbella Farmers Market, Net Wt 16 oz (448g) UPC 731205628163; Jensen's Finest, Net Wt 16 oz (448g) UPC 731205628163; Clark's Nutrition & Natural Foods, Net Wt 16 oz (448g) UPC 731205628163; Davis Lewis Orchards, Net Wt 16 oz (448g) UPC 731205628163 and 25 lb, UPC 73120562800. Recall # F-1046-2010;

22) Virginia Peanuts Roasted No Salt: Hadley, Net Wt 16oz (448g) UPC 731205364160; Clark's Nutrition & Natural Foods, Net Wt 14 oz (392g) UPC 731205364146. Recall # F-1047-2010;

23) Virginia Peanuts Roasted & Salt: Hadley, Net Wt 2 oz (51g), UPC 731205353027. Recall # F-1048-2010;

24) Roasted No Salt Traditional Trail Mix: Hadley, Net Wt 5 oz (140g) UPC 731205436058; Net Wt 16 oz (448g) UPC 731205436164; Net Wt 40 oz (1120g) UPC 731205436409; Clark's Nutrition & Natural Foods, Net Wt 16 oz (448g) UPC 731205663164. Recall # F-1049-2010;

25) Roasted and Salted Traditional Trail Mix: Hadley, Net Wt 4 oz (112g) UPC 731205437048, UPC 731205437048; Net Wt 40 oz (1120g) UPC 731205437406; Net Wt 16 oz (448g) UPC 731205437161. Recall # F-1050-2010;

26) Custom Blend American Oriental Mix: Hadley, Net Wt 2 oz (56g) UPC 731205440024, 4oz (112g), 12 oz (336g) UPC 731205440123. Recall # F-1051-2010;

27) Hadley Aztec Trail Mix Net Wt 16 oz (448g), UPC 731205442165 and 40 oz (1120g), UPC 731205442400. Recall # F-1052-2010;

28) Hadley Dozen Delight Custom Blend 16 oz (448g), UPC 731205445166, 40 oz (1120g), UPC 731205445401, and 5 oz, UPC 73120543805. Recall # F-1053-2010;

29) Hadley Spicy Morongo Mix Net Wt 4 oz (112g) UPC 731205446040, Net Wt 7 oz (196g) UPC 731205446071, 12 oz (336g) UPC, 731205446125, and 2 oz, UPC 73120544602, 25 lb, UPC73120544625. Recall # F-1054-2010;

30) Hadley Milk Chocolate Peanut Clusters Net Wt 10 oz (280g) UPC 731205813101. Recall # F-1055-2010;

31) The Best of Hadley Snack Sampler Net Wt 32 oz (896g) UPC 731205140320. Recall # F-1056-2010;

32) Raw Liberty Fruit Blend: Kern Valley Produce, Net Wt 16 oz (448g) UPC 731205624929; Clark's Nutrition & Natural Foods Market, Net Wt 14 oz (352g) UPC 731205624141. Recall # F-1057-2010;

33) Clark's Nutrition & Natural Foods Market Natural Trail Mix Roasted No Salt Net Wt. 16 oz (448g) UPC 731205663164. Recall # F-1058-2010;

34) Clark's Nutrition & Natural Foods Market Natural Freeway Snack Trail Mix Net Wt 16 oz (448g) UPC 731205669166. Recall # F-1059-2010;   

35) Davis Lewis Orchards Roasted & Salted Travelers Treat Net Wt 7 oz (196g) UPC 731205625070; Net Wt 16 oz (448g) UPC 731205625162. Recall # F-1060-2010;

36) Hadley's Fruit Orchard brand Spicy Party Mix, 12 oz, UPC 73120543912. Recall # F-1061-2010;

37) Hadley's Fruit Orchard brand Tropical Isle Mix, 16 oz, UPC73120542916.  Recall # F-1062-2010;

38) Hadley's Fruit Orchard brand #374 Snacking Crate, 52 oz, UPC 73120513752. Recall # F-1063-2010; 

39) Hadley's Fruit Orchard brand Party Sampler #748, 36 oz, UPC 73120514524.  Recall # F-1064-2010;

40) Hadley's Fruit Orchard brand Peanut Butter Stock Roasted, 25 lb bulk, UPC 73120529300. Recall # F-1065-2010; 

41) Hadley's Fruit Orchard brand Peanut Butter Stock Honey Roasted, 25 lb. bulk. Recall # F-1066-2010
CODE
Pull by dates between 01/01/2008 and 12/31/2009
RECALLING FIRM/MANUFACTURER
International Commodity Distributors, Inc., Garden Grove, CA, by letter on February 4, 2009 and by press release on February 23, 2009. Firm initiated recall is complete.
REASON
Expanded recall. 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
213,052
DISTRIBUTION
Nationwide
___________________________________

PRODUCT
1) Mike-sells Caramel Corn with peanuts in 8.75 oz (248 g) clear plastic tubs with white lid. There are 12 tubs packaged in a brown cardboard cases with a white sticker with product name and lot code. UPC code 7110410429. Recall # F-1168-2010;

2) Caramel Corn sold under the following brand names: a) Better Made Caramel Corn in an 8 oz (227 g) clear plastic tub with white lid . There are 12 tubs packed in a brown cardboard case with white sticker label with product name and lot code. UPC code 4163300708; b) Seyfert Dan-Dee Troyer Farms Caramel Corn in an 8 oz clear plastic tub with a white lid. There are 12 tubs packed in brown cardboard boxes with a white sticker label with product name and lot code. UPC code 7017500154; c) Jays Naturally low fat Caramel Corn in an 8 oz (227 g) clear plastic tub with white lid. There are 12 tubs packed in a brown cardboard box with a white sticker label with the product name and lot number. UPC code 4120001502. Recall # F-1169-2010;

3) Copper Kettle Caramel Corn with Real butter in an 8 oz clear and brown plastic package. There are 15 bags packed in a brown cardboard case with a white sticker label with the product name and lot code. UPC code 6047831231. Recall # F-1170-2010;

4) Copper Kettle Caramel Puffs with real butter in 6.5 oz clear and brown plastic bag. There are 15 bags packaged in a brown cardboard case with a white sticker label containing the product name and lot code. UPC code 6047831232. Recall # F-1171-2010;

5) Mike-sells oven baked puffcorn delites caramel in a 7 oz (198 g) clear and brown plastic bag. There are 15 bags packed in a brown cardboard case with a white sticker label attached with the product name and lot code. UPC code 7110410215. Recall # F-1172-2010;

6) Caramel Corn in a 25 # bulk clear plastic bag. Bag is contained in a brown cardboard box. There is a white sticker including product name and nutritional ingredient information affixed to the box. UPC code 6047877451. Recall # F-1173-2010
CODE
1), 3), 4), 5) The cases have lot code numbers 15209 to 33509. The bags have lot codes with the first three digits 152- 335. The product has use by dates from 11/28/09 through 5/30/10;

2) a) and b) The cases have lot code numbers 15209 to 33509. The tubs have lot codes with the first three digits 152 - 335. The product has use by dates from 11/28/09 through 5/30/10; c) The cases have lot code numbers 21309 to 33509. The tubs have lot codes with the first three digits 213- 335. The product has use by dates from 11/29/09 through 3/31/10;

6) The boxes have lot code numbers 15209 to 33509
RECALLING FIRM/MANUFACTURER
Snax In Pax, Topeka, IN, by telephone and letters and press release on December 3, 2009. Firm initiated recall is ongoing.
REASON
Products contain milk which is not declared on the product label. The product lists butter as an ingredient but does not list milk as the source of the butter as required by FALCPA
VOLUME OF PRODUCT IN COMMERCE
306,000/ 8 oz tubs; 39/ 25 lb bags; 159,030/ 6 to 7 oz bags
DISTRIBUTION
IA, IN, MI, MS, OH, PA, WI
___________________________________
PRODUCT
Baltic Shore [in Russian] brand Herring Salted, 1300 grams (1.3 kg or 2.86 lbs.) packaged in a round, plastic container, UPC 4 607010 730598. The product is labeled mainly in Russian, plus with a white sticker labeled in English. Recall # F-1202-2010
CODE
Code numbers 24.08.09 and 13.07.09
RECALLING FIRM/MANUFACTURER
Recalling Firm: TGF Production LLC, Brooklyn, NY, by press release on October 15, 2009.
Manufacturer: Market Plus o., LTD., Petersburg, Russia. New York initiated recall is complete.
REASON
The imported processed fish was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets. This product poses a potential health risk as it may be contaminated with Clostridium botulinum spores, which can cause botulism, a serious and potentially fatal food-borne illness.
VOLUME OF PRODUCT IN COMMERCE
38 cases (4 x 1300 g containers per case)
DISTRIBUTION
NY, NC, AZ, MN, MO
___________________________________
PRODUCT
PISTACHIOS INSHELL ROASTED AND SALTED in clear plastic bags. Net wt. 16 oz (1 lb) 454 g. Recall # F-1211-2010
CODE
No lot codes
RECALLING FIRM/MANUFACTURER
Janzen Farms, Dayton, OR, ay telephone beginning on April 10, 2009 and by telephone and press release on April 17, 2009. Firm initiated recall is ongoing.
REASON
Products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
56 – 1 lb packages
DISTRIBUTION
OR, WA
___________________________________
PRODUCT
Natural Pistachios Roasted & Salted or R&S Natural Pistachios, packaged in 12-oz (340.5g) and 5 lbs net containers. UPC Code for the 12-oz size is 078264075126. Recall # F-1212-2010
CODE
Lot numbers: 2698, 2948, and 3048
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hines Nut Co., Dallas, TX, by press release on April 13, 2009. 
Manufacturer: Setton Pistachio of Terra Bella, Inc., Terra Bella, CA. Firm initiated recall is ongoing.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
6,950 lbs
DISTRIBUTION
TX, GA, NC
___________________________________
PRODUCT
1) Natural Roasted and Salted Pistachios aka Roasted and Salted Pista in Shell; in-shell roasted salted pistachios packaged in 1 lb. plastic bags; item 573166. Recall # F-1213-2010;

2) Raw Pistachio Kernels aka Raw Green Pista Shells; raw pistachio kernels sold in 8 oz and 1 lb plastic bags. Recall # F-1214-2010
CODE
All pistachios sold between September 29, 2008 and March 31, 2009.
RECALLING FIRM/MANUFACTURER
Kamdar Plaza, Chicago, IL, by web posting, press release and by letter on April 15, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using pistachios that have been recalled by Setton Pistachio of Terra Bella because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
4,946 lbs
DISTRIBUTION
IL
___________________________________
PRODUCT
WHITE LOTUS PASTE & 2 YOLKS MOONCAKE, NET WT: 22.5 oz. (640 G), UPC 6 932494 910890 --- Product of China --- Ingredients: Lotus Seed, Sugar Refined Peanut Oil, Flour, Water --- Translation of Chinese writing revealed that egg yolks are declared in Chinese as an ingredient but not in English. The product was packaged in a flexible plastic tray packed inside a metal tin. Recall # F-1215-2010
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Domega, NY International Co Ltd, Brooklyn, NY, by press release and letters dated October 19, 2009.
Manufacturer: Kuizhou Foreign Trade Co., Ltd., Jiangmen City, China. New York initiated recall is complete.  
REASON
The product contained undeclared eggs based on sampling and analysis by New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
561 cases (16 x 640 g packages per case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Potato Salad, Keep refrigerated NET WT. 16 oz. (1 Lb), Archer Farms, UPC 8523940228, INGREDIENTS: Potatoes, Mayonnaise,  Contains Egg. Recall # F-1216-2010
CODE
Expiration date 10/04/2009
RECALLING FIRM/MANUFACTURER
Garden-Fresh Foods, Inc., Milwaukee, WI, by e-mail, and telephone on September 14, 2009 and by press release on September 16, 2009. Firm initiated recall is complete.
REASON
Archer Farms 16 oz. Potato Salad may contain Sour Cream that is not listed as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
390 containers
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Organicgirl Berries & Balsamic Salad Mix in 5.75 oz. clamshell, 6 per carton, gluten-free sweet & tangy balsamic dressing with baby baby spring mix, crunchy toasts and sweet wild blueberries & cranberries (walnuts undeclared), UPC 895203-001332. Recall # F-1217-2010
CODE
Lot number: 31B073830, with Use-By-Date of December 16, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Organic Girl, Salinas, CA, by e-mail, telephone and press release on December 10, 2009.
Manufacturer: NewStar Fresh Foods, LLC, Salinas, CA. Firm initiated recall is ongoing.
REASON
Product contains undeclared walnuts.
VOLUME OF PRODUCT IN COMMERCE
120 cases
DISTRIBUTION
FL, CA and TX
___________________________________
PRODUCT
1) Jalapeno Cheese Bread and Hamburger Buns. Recall # F-1218-2010;
2) White Bread, Rolls and Hamburger Buns. Recall # F-1219-2010;
3) White Bread with Sesame seed and Egg Wash Hamburger Buns. Recall # F-1220-2010; 
4) Sourdo Bread. Recall # F-1221-2010; 
5) White Sourdo Cranberry Pecan Loaf. Recall # F-1222-2010
CODE
All products distributed from 11/18/2009 to 12/17/2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Jon, Inc., Dallas, TX, by telephone on December 16, 2009.
Manufacturer: Signature Baking Co., Dallas, TX. Firm initiated recall is ongoing.
REASON
Products have undeclared allergens, eggs, cheese, and/or pecans.
VOLUME OF PRODUCT IN COMMERCE
5,114 units
DISTRIBUTION
TX
___________________________________
PRODUCT
1) Honey Roasted Peanut Roca Buttercrunch Toffee labeled in part Brown and Haley Honey Roasted Peanut Roca Buttercrunch Toffee. Product is packaged as: 1) "3 Pieces" package, Net Wt 1.2 oz, UPC 041770-06170 packed in a paper box, (12 count caddy), UPC 41770-06179 2; 2) 4.6 oz Round Canister, UPC 0 41770-05440 4; 3) 5.8 oz Stand-up Bag, UPC 0 41770-06150 1; 4) 5.8 oz Holiday Stand-up Bag, UPC 0 41770-56140 7; 5) 7.3 oz Stand-up Bag, with 25% More Free, UPC 0 41770-06270 6; 6) 8.8 oz Oval Tin, UPC 0 41770-03040 8; 7) 16.3 oz Round Canister, UPC 0 41770-05450 3; 8) 32 oz Stand-up Bag, UPC 0 41770-05470 1; 9) 1000 PC (piece) Honey Roasted Peanut Roca case: pieces individually sealed in orange plastic film, Case UPC # 20233, MFG UPC # 41770; 10) 12 LB Honey Roasted Peanut ROCA Flow Wrap case: pieces individually sealed in orange plastic film, Case UPC # 20231, MFG UPC # 41770; 11) 12 LB Honey Roasted Peanut Roca case: pieces individually wrapped in orange foil, Case UPC # 20232, MFG UPC # 41770; 12) 2 LB HR (Honey Roasted) Peanut ROCA Bag - Mishapes: heat-sealed plastic bag, UPC 041770-19130 7; 13) 0.82 oz Box: pieces individually wrapped in orange plastic film, no UPC codes; 14) 0.41 oz. Box: pieces individually wrapped in orange plastic film, no UPC codes; The following are only sold in Brown and Haley outlet stores: 15) 5 oz tray containing 12 pieces, individually wrapped in orange foil in a heat-sealed clear plastic overwrap, no UPC; 16) HRP (Honey Roasted Peanut) ROCA Boo Boos: 1 lb clear round plastic container, UPC 041770-19010 2 and labeled in part, BROWN & HALEY. The following is only sold in China; 17) 300 g Gift Box, UPC 0 41770-01080 6 and labeled in part, BROWN & HALEY. Recall # F-1242-2010;

2) Brown and Haley Dark Chocolate Peanut Delights, 16 oz clear round plastic container, UPC 0 41770-39200 1. Product is only sold at Brown & Haley outlet stores. Recall # F-1243-2010;

3) Brown & Haley ROCA Buttercrunch Assorted Flavors, 560g gift box, UPC 0 41770-03280 8 and labeled in part, ROCA Buttercrunch in 4 Flavors... AUSTRALIA. Product sold only in Hong Kong, China and Australia. Recall # F-1244-2010
CODE
1) Date code: 1) A07A712, N01N812, O12O712, O28O712, R20R812, S11S712, W25W812, Y02Y712; 2) E03E615; 3) H27H715, H29H615, L05L615, O15O715, O26O715, O29O725, O300715, W23W815, O300715; 4) L09L825, L22L815, O29O725, W25W815, Y12Y825; 5) A01A715, H27H715, H27H725, H27H735, O05O815, &15&715, &18&725; 6) E25E715, R07R825, W25W825, Y14Y815; 7) B16B815, B29B815, E04E715, E12E715, E12E815, L26L715, W24W815, W25W815, Y02Y725, ; 8) B04B715, B29B815, H17H715, L30L815, E02E815, N20N615, O05O815, O27O715, W17W715, &12&715; 9) W29W813, W30W823, N01N813, N21N713, &18&713, H18H713; 10) N/A; 11) A20A817; 12) S20S715, B25B825; 13) N/A; 14) N/A; 15)  N/A; 16) W21W625; 17) H19H715, L21L715, L21L725, L26L620, S08S715, Y02Y715, Y02Y725, Y02Y745. (A07A712: A - Alpha character for estimated ship month; 07 - production day; A - Alpha character for production month; 7 - production year; 1 - shift that produced product; 2 - production line.);

2) Date code: E18E718 (E18E718: E - Alpha character for estimated ship month; 18 - production day; E - Alpha character for production month; 7 - production year; 1 - shift that produced product; 8 - production line.);

3) Date Code: A26A810, A09A840, E30E810, S28S710, Y30Y710. (A26A810: A - Alpha character for estimated ship month; 26 - production day; A - Alpha character for production month; 8 - production year; 1 - shift that produced product; 0 - production line.)
RECALLING FIRM/MANUFACTURER
Brown & Haley, Inc., Tacoma, WA, by press release, telephone, e-mail and letters on February 27, 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
712,883 packages, tins, bags, canisters or boxes
DISTRIBUTION
Nationwide, Canada, China, Hong Kong, Kuwait, Germany, Vietnam, United Kingdom, Japan and Belgium.

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II
___________________________________
PRODUCT
Hannaford 64 oz Eggnog Pasteurized, UPC 41268 11109. Recall # F-1068-2010
CODE
Made on November 9 and November 12 with exp. date of Nov. 30 and Dec. 3
RECALLING FIRM/MANUFACTURER
H. P. Hood and Sons, Portland, ME, by Web posting on November 18, 2009. Firm initiated recall is ongoing.
REASON
The product contains undeclared colors, FD&C Yellow #5, FD&C Yellow #6, and FD&C Red #40.
VOLUME OF PRODUCT IN COMMERCE
594 cases (5,346 units)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Dip N Stix cheddar cheese flavored pretzels in 2 oz and 8 oz clear plastic bags. There are 24 bags of the 8 oz size packed in a brown cardboard box. There are 36 bags of the 2 oz size packed in a brown cardboard box. Plastic bag has black label with gold and red print affixed. There is no UPC code. Recall # F-1069-2010
CODE
Best by dates prior to 2/29/10
RECALLING FIRM/MANUFACTURER
American Gourmet Of Snack Co., Essexville, MI, by telephone on December 8, 2009. Firm initiated recall is ongoing.
REASON
The product contains undeclared color, FD&C Yellow # 5.
VOLUME OF PRODUCT IN COMMERCE
612 2 oz bags; 420 8 oz bags
DISTRIBUTION
MI and NE
___________________________________
PRODUCT
1) Pumpkin pretzels in 14 oz clear plastic bags with orange stripes and brown label, and in bulk 12.5 pound box. UPC code for the 14 oz is 44823 10226. Recall # F-1070-2010;

2) Autumn almonds in a 2 oz clear plastic bag with a leaf design. UPC code is 44823 02171. Recall # F-1071-2010;

3) Pumpkin malted milk balls in 20 lb bulk container with a white label. UPC code is 44823 02144. Recall # F-1072-2010;

4) Pumpkin crunch in 8 oz and 16 oz clear plastic bags with pumpkin designs on the bag. There is an oval shaped label on the front of the bag. UPC code is 44823 06188 and 4482300618. Recall # F-1073-2010;

5) Pumpkin heads in a clear plastic bag with pumpkin design. There is a brown oval label on the front of the bag. UPC code is 44823 06180. Recall # F-1074-2010
CODE
No lot codes
RECALLING FIRM/MANUFACTURER
The South Bend Chocolate Co., Inc., South Bend, IN, by letter dated November 4, 2009. Firm initiated recall is ongoing.
REASON
The products contain undeclared color, FD&C Yellow # 5.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) #00709 - GORP HIKER MIX - this is a bulk product. ING: SALTED SUNFLOWER SEEDS, RAISINS, SALTED PEANUTS, RST SOYBEANS, CHOC DROPS, CHOC DROPS WITH PEANUT 238028 25 lb. Recall # F-1174-2010;

2) #00713 - ORIENTAL PARTY MIX - this is a bulk product. ING: SPANISH PEANUTS, SUNFLOWER SEEDS, GREEN PEAS, SOYBEANS, PUMPKIN SEEDS, SALTED SESAME STICKS, NOSHIEs oriental rice, GREEN CHILI BIT 139015 15 lb. Recall # F-1175-2010;

3) #00718 - DIET DELITE MIX - this is a bulk product. ING: CURRANTS, ROASTED NO SALT CASHEW PIECES, NO SALT SUNFLOWER SEEDS, NO SALT PEPITAS, RAW ALMONDS, SELECT RAISINS 248010 25 lb. Recall # F-1176-2010;

4) #00720 - CAJUN HOT & STUFF - this is a bulk product. ING: HOT CORN STICKS, RST RED SKIN PEANUTS, CORN NUTS, RST/SLT CASHEW PIECES, NOSHIES, PEANUT CRUNCHIES, RST/SLT SUNFLOWER SEEDS, CHEDDAR WHALE CRACKERS, CAJUN SEASONING, SALT, CORN CHIPS, FLAX., MINI PRETZEL BALLS 139005 17 lb. Recall # F-1177-2010;

5) #00721 - BAGEL PRETZEL WORCHESTER MIX - this is a bulk product. ING: GARLIC BAGEL CHIPS, PRETZEL STICKS & TWISTS, RST/SLT SPANISH PNUTS, SOUR CREAM/ONION & DILL. SALSA: BOWLBY BITS. SOURCREAM & ONION and RST PEPPER W/CHEESE: SESAME STICKS. CHEDDAR WHALE CRACKERS. RST/SLT XL PEANUTS. 218023 10 lb. Recall # F-1178-2010;

6) #00728 - SESAME SNACK MIX - this is a bulk product. ING: CHEDDAR SESAME STICKS, SLT SESAME STICKS, RST/SLT SUNFLOWER SEEDS, RST/SLT XL PEANUTS, RST/SLT CASHEW PIECES, RST/SLT SOYBEANS, HONEY&ONION SESAME STICKS, CHEDDAR CORN STICKS, CaJun Rice cheese sticks 139029 18 lb. Recall # F-1179-2010;

7) #00733 - BAGEL NUT & PRETZEL MIX - this is a bulk product. ING: Fried Green Peas, Garlic bagel chiPs, rst/slt sPanish Peanuts, XL Rst/Slt Peanuts, Cajun Rice with see weed cheese sticks, sesame sticks, mini Pretzels, cheddar cheese thins 139005 11 lb. Recall # F-1180-2010;

8) #00734 - WEAVER DYNO MIX - this is a bulk product. ING: Raw Almonds with Skin, Turkish Apricots, diced PaPaYas, PineaPPles, sweetened banana chiPs, brazil nuts, diced dates, no salt Peanuts, dark raisins, English walnut halves, 248011 25lb.
Recall # F-1181-201;

9) #00736 - HAWAIIAN SUPREME - this is a bulk product. ING: APRICOTS, PAPAYA, SWEET BANANA CHIPS, RAISINS, PINEAPPLES, ALMONDS, CASHEWS, PEANUT OIL, SUGAR, SULPHUR DIOXIDE 238006 25 lb. Recall # F-1182-2010;

10) #00740 - FANCY FRUIT MIX - this is a bulk product. ING: PRUNES, NECTARINES, APRICOTS, PEACHES, PEARS, APPLE RINGS 238005 25 lb. Recall # F-1183-2010;

11) #00741- BERRY & NUT MIX - this is a bulk product. ING: CRASINS, GOLDEN RAISONS, CHERRY FLAVORED CRANBERRIES, PECAN TOPPERS, DICED APPLES, SELECT ALMONDS, BLUEBERRY FLAVORED CRANBERRIES, DICED APRICOT BITS 139007 25 lb. Recall # F-1184-2010;

12) #00742 - TROPICAL FRUIT MIX - this is a bulk product. ING: RAISINS, PAPAYA, PINEAPPLES, ALMONDS, RAW COCONUT, NO SALT PEANUTS, DICED DATES, RAW CASHEW PIECES, APRICOTS, SULPHUR DIOXIDE 228023 20 lb. Recall # F-1185-2010;

13) #00746 - WEAVERS HEALTH MIX - this is a bulk product. ING: NO SALT PEANUTS, RAW ALMOND W/SKIN, PUMPKIN SEEDS, RAW SUNFLOWER SEEDS, ENGLISH WALNUT HALVES & PIECES, DARK RAISINS, BRAZIL NUTS, DICED DATES, SULPHUR DIOXIDE 228020 25 lb. Recall # F-1186-2010;

14) #00756 - DELUXE NUT MIX W/PEANUTS RST/SLT - this is a bulk product. ING: BLANCH FILBERTS, BRAZIL NUTS, PEANUTS, ALMONDS, CASHEW BUTTS, PECAN HALVES, NUTS RST IN PEANUT OIL 248019 25 lb. Recall # F-1187-2010;

15) #00760- NUTS & BOLTS MIX - this is a bulk product. ING: SALTED DELUXE NUT MIX (FILBERTS, ALMONDS WITH SKIN, ALMONDS BLANCHED, CASHEWS, MAMMOTH PECAN HALVES, BRAZIL NUTS), SALTED SESAME STICKS, CAJUN RICE CHEESE STICKS, NOSHIES, SALTED MACADAMIA NUTS, CHILI BITS 149011 15lb. Recall # F-1188-2010;

16) #00762 - DELUXE NUT MIX R/S - this is a bulk product. ING: ALMONDS W/SKIN, ALMONDS BLANCHED, CASHEWS, FILBERTS, MAMMOTH PECAN HALVES, BRAZIL NUTS, NUTS RST IN PEANUT OIL 139027 25 lb. Recall # F-1189-2010;

17) #00770 - DELUXE NUT MIX N/S - this is a bulk product. ING: Cashews, mammoth Pecan halves, brazil nuts, blanched roasted almonds, almonds with skin, blanched roasted filberts, nuts roasted in Peanut oil 238028 25 lb. Recall # F-1190-2010;

18) #00782 - WASABI ORIENTAL MIX - this is bulk product. ING: Green mustard coated horse bean, Fava Bean Rst/Slt Noshies, Cajun rice cheddar stick w/seedweed, Yellow wasabi Peanut crunchies, Green wasabi Peanut crunchies Nat. with sesame Peanut crunchies, Wasabi fried Green Pea, Pretzel Balls 149020 15 lb. Recall # F-1191-2010;

19) #00802 - RAZZ MA TAZZ MIX - this is a bulk product. ING: CRASINS, HONEY RST PEANUTS, ULTIMATE WHITE CHOCOLATE CHIPS, MILK CHOCOLATE COVERED RAISINS, HONEY SESAME STICKS, ROASTED NO SALT CASHEW PIECES 139007 25 lb. Recall # F-1192-2010;

20) #00845 - FRUIT MEDLEY MIX - this is a bulk product. ING: DARK & GOLDEN RAISINS, DICED: PAPAYA, APRICOTS, PEACHES, and APPLE RINGS 228015 25 lb. Recall # F-1193-2010;

21) #01105 - YOGURT BRIDGE MIX - this is a bulk product. ING: Yogurt covered: Pretzels, Raisins, Almonds, Peanuts, Malt Balls, Cherry Yogurt covered Pretzels 138003 22 lb. Recall # F-1194-2010;

22) #03487 - CHOCOLATE BRIDGE MIX - this is bulk product. ING: Double dipped Peanuts, malt balls, choc raisins, choc almonds, choc caramels, choc stars, dark choc nonpareils’. Contains milk, wheat, and soy. May contain traces of Peanuts, tree nuts & eggs 149020 25 lb. Recall # F-1195-2010;

23) #00712 - NUTS & BITS MIX - this is a bulk product. ING: CHOCO BUTTONS ASST, CHOCOLATE STARS, SALTED PECAN BOWLBY BITS, NO SALT PEANUTS, SESAME STICKS, CHEDDAR CHEESE STICKS, HONEY ROASTED PEANUTS, PRETZEL BALLS 139013 20 lb. Recall # F-1196-2010;

24) #00710 - NUTTY FRUIT MEDLEY - this is a bulk product. ING: SWEET BANANA CHIPS, DICED PAPAYA, ROASTED SUNFLOWER SEEDS, PINEAPPLE, ROASTED CASHEW PIECES, DATES, ALMONDS, DICED APRICOTS, RAISINS 248003 25 lb. F-1197-2010;

25) #00738 - CUSTOM Z SNACK MIX - this is a bulk product. ING: Jumbo XL roasted salted Peanuts, Oriental Noshie Rice, Cajun Corn Sticks, Fried Green Wasabi Peas, cheddar corn sticks, chili bite 246018 15 lb. Recall # F-1198-2010;

26) #03489 - SUGAR FREE BRIDGE MIX - this is a bulk product. ING: choc maltitol Peanuts, choc maltitol malt balls, choc maltitol raisins, choc maltitol almonds. Shares equipment with Peanuts, tree nuts, wheat, milk, eggs & soy. 149020 12 lb. Recall # F-1199-2010
CODE
Product shipped prior to 2/25/09 - all codes up to an including 149025
RECALLING FIRM/MANUFACTURER
Weaver Nut Co., Ephrata, PA, by e-mail, telephone and letter dated February 25, 2009. Firm initiated recall is ongoing.
REASON
Products failed to list allergens as the source of ingredients as required by FALCPA.
VOLUME OF PRODUCT IN COMMERCE
2,868 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Wegmans brand Organic Butter Flavor Microwave Popcorn packed in 10.5 oz (298 g) boxes. Each box contains 3 x 3.5 oz. bags. The product is packed in shipping cases and each case contains 12 boxes per case. UPC # 077890853917.  The labeling states: Certified organic by OAI USDA ORGANIC. The recalled product is identified with the following Descriptions; Item Numbers; and `Description: MICROPOPWEGBTR3PACK12PERCASE; Item No: POPMICWEGBUT3; and Description: MICROPOPWEGBTR3PACK12PERCASE; Item No.: POPMICWEGBUT3. Recall # F-1200-2010
CODE
Lot No.: WEGB3-05/27/09; Expiration Date: 5/27/09;
Lot No.: WEGB3-06/05/09; Expiration Date: 6/5/09
RECALLING FIRM/MANUFACTURER
Caudill Seed & Warehouse, Inc., Louisville, KY, by press release and letter on March 18, 2009. Firm initiated recall is ongoing.
REASON
Product failed to list milk as the source of butter as required by FALCPA.
VOLUME OF PRODUCT IN COMMERCE
358 cases
DISTRIBUTION
NY, NJ, MD, VA and PA
___________________________________
PRODUCT
Mezzetta brand Gourmet Deli, Sweet & Hot Pepper Rings in 12 fl. Oz. packages. UPC: 0 73214 00365 5. Recall # F-1201-2010
CODE
Lots: 1MBQ051894, Best By May 2012; 1MBQ072491, Best By Jul 2012
RECALLING FIRM/MANUFACTURER
G. L. Mezzetta, Inc., American Canyon, CA, by letters on October 7, 2009. Firm initiated recall is ongoing.
REASON
Product contains undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
604 cases (6 jars/case)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) NEW" SHULA'S APPLE CRUMBLE TARTS, Crust: Cake flour, 6x powder sugar, whole eggs, European Butter Blend (Butter & Oleo), Vanilla. Filling:: Apples, sour cream, granulated sugar, fresh whole eggs, flour, vanilla, salt. Topping: Butter, Oleo Margarine, Walnuts, Flour, Brown Sugar, White Sugar, Cinnamon, Salt. Weight: 8 oz/each - 27 per case. Recall # F-1245-2010;

2) SHULA'S CHEESECAKE Cream cheese, sugar whole eggs, egg yolks, heavy cream, evaporated milk, cake flour, vanilla, lemon extract, graham cracker crumbs. Weight: 64 oz. Recall # F-1246-2010;

3) Shulas Key Lime Pie Ingredients: Sweetened Condensed milk, key lime juice, egg yolks, sugar, graham cracker crumbs, butter, vegetable margarine. Recall # F-1247-2010;

4) ULTIMATE MOLTEN LAVA CAKE Bitter Sweet Chocolate (sugar, cocoa liquor, lecithin (an emulsifier), pure vanilla, fresh eggs, butter, sugar, vegetable oleo, flour, heavy cream, 22-24% dutch cocoa, pure vanilla, artificial vanilla, and coffee extract. Weight: 7oz/ea 36/case. Recall F-1248-2010
CODE
All codes products
RECALLING FIRM/MANUFACTURER
Dr. Desserts, Inc., Hialeah, FL, by letter on June 4, 2009. Firm initiated recall is ongoing.
REASON
Products contain undeclared wheat, soy lecithin, and soy oil.
VOLUME OF PRODUCT IN COMMERCE
130 cases
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III
___________________________________
PRODUCT
Cool River Bebidas Naturales xxx West Indian Cherry Fruit Acerola16% Juice; Ingredients Agua Tratada Rayo Ultra Violeta "Treated Water Ultra Violet Light, granulated sugar, preservative, cherry fruit concentrate. Recall # F-1067-2010
CODE
990-10/2 10/5 10/9 10/13 10/16 10/23/09 lot 009 10/30 11/2 11/3 11/5 11/16 11/19 11/10 11/13 11/23 12/3/09 Puerto Rico only
RECALLING FIRM/MANUFACTURER
San Mar Manufacturing Corp., Catano, PR, by telephone on December 9, 2009. Firm initiated recall is ongoing.
REASON
The product contains undeclared color, FD&C Red # 40.
VOLUME OF PRODUCT IN COMMERCE
384 units
DISTRIBUTION
PR
___________________________________
PRODUCT
1) Slow Cooker Suppers Wicked Good Chili Dry Mix, Net Wt 14 oz. Recall # F-1234-2010;
2) Slow Cooker Suppers Mim’s Creamy Tuna & Pea Dry Mix, Net Wt 7 oz. Recall # F-1235-2010;
3) Slow Cooker Suppers Paulie’s White Chili Dry Mix, Net Wt 14 oz. Recall # F-1236-2010;
4) Slow Cooker Suppers Joseph’s Shepherd Stew Dry Mix, Net Wt 7 oz. Recall # F-1237-2010;
5) Slow Cooker Suppers Creamy Chunky Chicken Dry Mix, Net Wt 6 oz. Recall # F-1238-2010;
6) Slow Cooker Suppers Aunt Betty’s Beef Veggie Dry Mix, Net Wt 7 oz. Recall # F-1239-2010
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rand Hill, Inc., Dexter, ME, by telephone and follow-up letter on August 9, 2009.
Manufacturer: Slow Cooker Suppers, Dexter, ME. Firm initiated recall is complete.
REASON
The product claims to contain low sodium content and does not comply with labeling requirements.
VOLUME OF PRODUCT IN COMMERCE
90 cases
DISTRIBUTION
AL, CA, FL, GA, IN, MA, ME, OH, OR, VA, WI

  RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III
___________________________________
PRODUCT
Antibacterial Washcloths (Benzalkonium chloride) 0.115%, 25-count cloths per can. UPC 50428-16554. Made in China. Recall # D-328-2010
CODE
Lot number (on bottom of plastic can): 09234A, 09236C, 09237B, 09238C
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rockline Industries, Sheboygan, WI, by e-mail and telephone on December 7, 2009.
Manufacturer: Soshio Wet Tissue Co., Ltd., ShunDe, FoShan, China. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: Rockline Industries is recalling antibacterial washcloths, 25-count, sold exclusively at CVS Pharmacy because it is subpotent and does not have an expiration date.
VOLUME OF PRODUCT IN COMMERCE
97,485 cans
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II 
___________________________________
PRODUCT
Source Plasma, Recall # B-0260-10
CODE
GA1031662, GA1032306
RECALLING FIRM/MANUFACTURER
DCI Biologicals LLC, Gallup, NM, by e-mail on December 29, 2006 and June 16, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a piercing within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
UK
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0267-10
CODE
Units: 09KE17603, 09KE17604
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Omaha, NE, by telephone on March 3, 2009 and by letter dated April 7, 2009. Firm initiated recall is complete.
REASON
Blood products, for which quality control testing was not completed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NE
___________________________________
PRODUCT
Whole Blood. Recall # B-0351-10
CODE
Unit: W227709051512
RECALLING FIRM/MANUFACTURER
Mid-South Regional Blood Center, Memphis, TN, by telephone on July 6, 2009. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as to product type, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0400-10;
2) Platelets Pooled Leukocytes Reduced. Recall # B-0401-10
CODE
1) Unit: W120609041789
2) Unit: W120609181282
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Grand Rapids, MI, by fax on August 5, 2009 and September 3, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0403-10
CODE
Units: W126907701199 and W126908701764
RECALLING FIRM/MANUFACTURER
Recalling Firm: Southeastern Community Blood Center, Tallahassee, FL, by electronic mail on July 20, 2009. 
Manufacturer: Southeastern Community Blood Center, Panama City, FL. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 unit2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0404-10
CODE
Units: W044209454951 and W044208320741
RECALLING FIRM/MANUFACTURER
Recalling Firm: San Diego Blood Bank, San Diego, CA, by letter on August 5, 2009.
Manufacturer: San Diego Blood Bank, El Cajon, CA. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria, California
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0405-10
CODE
Unit: 003E72705
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA. by telephone on October 18, 2007 and by follow-up letter on October 23, 2007.
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0407-10
CODE
Unit: 03GM75612
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Douglasville, GA, by electronic notification and facsimile on July 1, 2008 and by letter on July 2, 2008. 
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA. 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
GA 
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0409-10
CODE
Units: 03FM23833 and 03FV94386
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by facsimile, letter and electronic mail on June 27, 2008 and follow-up letter on August 5, 2008.
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA. 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
GA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced, Recall # B-0411-10;
2) Fresh Frozen Plasma. Recall # B-0412-10
CODE
1) and 2) Unit: 03LS46835
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Douglasville, GA, by telephone on January 14, 2008 and letter on January 22, 2008.
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA. 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
GA
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0413-10;
2) Platelets. Recall # B-0414-10
CODE
1) and 2) Unit: W035209093706X
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone and facsimile on April 30, 2009 and by letter May 28, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor who had traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________

PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0415-10
CODE
Unit: W117009155896
RECALLING FIRM/MANUFACTURER
Blood Center Of The Pacific, San Francisco, CA, by letter and telephone on June 9, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells. Recall # B-0416-10
CODE
Unit: 2023128
RECALLING FIRM/MANUFACTURER
Southeastern Community Blood Center, Tallahassee, FL, by letter on July 22, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0417-10
CODE
Unit: W035209010774H
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by letter dated July 8, 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
TX
___________________________________
PRODUCT
1) Platelets. Recall # B-0418-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0419-10
CODE
1) and 2) Unit: W035209097326U
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by facsimile and telephone on April 30, 2009 and by letter on May 28, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0436-10
CODE
Unit: W036209499762
RECALLING FIRM/MANUFACTURER
Belle Bonfils Memorial Blood Center, Denver, CO, by email on June 8, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Switzerland
___________________________________
PRODUCT
Source Plasma. Recall # B-0437-10
CODE
Units: 2020104975, 2020104541, 2020103575, 2020101875, 2020101648, 2020100356, 2020100070, 2020098455, 2020098220, 2020096154, 2020094534, 2020094226, 2020087700, 2020087493, 2020086297
RECALLING FIRM/MANUFACTURER
PlasmaCare Inc. Hampton, Hampton, VA, by facsimile on January 16, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0438-10
CODE
Unit: 009FQ41804
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Omaha, NE, by telephone on July 31, 2009. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined after receiving post donation information concerning an illness following donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NE
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-0439-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0440-10
CODE
1) and 2) Unit: 20KV29581
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by telephone on April 1, 2009 and by facsimile on April 6, 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
GA, CA
___________________________________
PRODUCT
Source Plasma. Recall # B-0441-10
CODE
Units: 09JMSA2295, 09JMSA1870, 09JMSA1625, 09JMSA1235, 08JMSD5468, 08JMSD5352, 08JMSD4641
RECALLING FIRM/MANUFACTURER
BioLife Plasma Service, LP, Van Nuys, CA, by e-mail on July 1, 2009 and July 7, 2009. Firm initiated recall is complete.
REASON
Blood products, which were not quarantined after receiving post donation information regarding receipt of a piercing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
CA
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0442-10
CODE
Unit: W117009187149
RECALLING FIRM/MANUFACTURER
Blood Centers of the Pacific - Irwin Center, San Francisco, CA, by telephone on September 14, 2009 and by letter dated September 14, 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
1) Fresh Frozen Plasma. Recall # B-0443-10;
2) Red Blood Cells. Recall # B-0444-10;
3) Cryoprecipitated AHF. Recall # B-0446-10
CODE
1) Unit: 18Q22532;
2) and 3) Unit: 18S23673
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on June 10, 2009 and by letters dated June 17, 2009, August 17, 2009, and August 18, 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
GA, MN, MI
___________________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0447-10
CODE
Units: 06GC49213, 06LQ87513
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone or electronic notification on June 5, 2009 and by letters dated June 5, 2009 and July 6, 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
Red Blood Cells Leukocytes Reduced. Recall # B-0449-10
CODE
Unit: 06LL40977
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by facsimile on May 29, 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 Leukocytes Reduced. Recall # B-0450-10
CODE
Unit: 06LL40402
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone or electronic notification on June 5, 2009 and by letters dated June 5, 2009 and July 6, 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
1) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-0452-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0453-10
CODE
1) Unit: 01W62980;
2) Units: 01W62986, 01Q28369, 01W62966
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, West Henrietta, NY, by facsimile on June 12, 2009. Firm initiated recall is complete.
REASON
Blood products, collected in a manner that may have compromised the sterility of the units, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
NY
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0471-10;
2) Platelets. Recall # B-0472-10
CODE
1) and 2) Unit: W0352091725011
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on July 21, 2009 and by letter dated August 17, 2009.Firm initiated recall is complete.
REASON
Blood products, collected from a donor who resided in an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
__________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall B-0473-10
CODE
Recall # 72L014496
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Dunwoody, GA, by facsimile on July 4, 2009. Firm initiated recall is complete.
REASON
Blood product, with a low platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Fresh Frozen Plasma. Recall # B-0474-10
CODE
Unit: W035209183748I
RECALLING FIRM/MANUFACTURER
Carter BloodCare, Bedford, TX, by telephone on August 6, 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
Platelets Pheresis Leukocytes. Recall # B-0485-10
CODE
Unit: 9729176 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Florida's Blood Centers, Inc., Orlando, FL, by telephone on February 17, 2007. Firm initiated recall is complete.
REASON
Blood products, with platelet count below the specified minimum requirement, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0486-10
CODE
Unit: 72H32107-3
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on October 17, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Platelets Pheresis Leukocytes Reduced. Recall # B-0488-10
CODE
Unit: 72H90171-3
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on October 08, 2008. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT
Source Plasma. Recall # B-0489-10
CODE
Units: 4530079495, 4530130105, 4530071610, 4530130000, 4530087388, 4530128359
RECALLING FIRM/MANUFACTURER
CSL Plasma Services, Inc., Melrose Park, IL, by letter on September 23, 2009. Firm initiated recall is complete.
REASON
Source Plasma, collected from ineligible donors, was distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
Germany
___________________________________
PRODUCT
1) Plasma Frozen within 24 hours (FP24). Recall # B-0599-10;
2) Red Blood Cells Leukocytes Reduced. Recall # B-0600-10
CODE
1) and 2) Unit: 49LJ68440
RECALLING FIRM/MANUFACTURER
American National Red Cross SW Region – HT, Tulsa, OK, by telephone on September 23, 2009 and follow-up letters dated September 24, 2009 and October 23, 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
2 units
DISTRIBUTION
TX, OK
___________________________________
PRODUCT
1) Red Blood Cells Leukocytes Reduced. Recall # B-0601-10;
2) Cryoprecipitated AHF, Pooled. Recall # B-0602-10
CODE
1) and 2) Unit: 6313907
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on September 16, 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
2 units
DISTRIBUTION
FL, TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III 
___________________________________
PRODUCT
Source Plasma. Recall # B-0308-10
CODE
Unit: 384055508
RECALLING FIRM/MANUFACTURER
Talecris Plasma Resources Inc., Phoenix City, AL, by facsimile on February 29, 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
NC
___________________________________
PRODUCT
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-0339-10
CODE
Unit: W142809116699
RECALLING FIRM/MANUFACTURER
Recalling Firm: Tri-Counties Blood Bank dba UBS- Central Coast, Santa Barbara, CA, by telephone on July 13, 2009.
Manufacturer: Tri-Counties Blood Bank, San Luis Obispo, CA. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably low red cell recovery rate, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT
Plasma Frozen. Recall # B-0406-10
CODE
Unit: 003E72705
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA. by telephone on October 18, 2007 and by follow-up letter on October 23, 2007.
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0408-10
CODE
Unit: 03GM75612
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Douglasville, GA, by electronic notification and facsimile on July 1, 2008 and by letter on July 2, 2008.
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA. 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-0410-10
CODE
Units: 03FM23833 and 03FV94386
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by facsimile, letter and electronic mail on June 27, 2008 and follow-up letter on August 5, 2008.
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA. 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
Recovered Plasma. Recall # B-0445-10
CODE
Units: 18Q22532, 18S23673
RECALLING FIRM/MANUFACTURER
American National Red Cross Great Lakes Region, Lansing, MI, by telephone on June 10, 2009 and by letters dated June 17, 2009, August 17, 2009, and August 18, 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
GA, MN, MI
___________________________________
PRODUCT
Recovered Plasma. Recall # B-0448-10
CODE
Units: 06GC49213, 06LQ87513
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone or electronic notification on June 5, 2009 and by letters dated June 5, 2009 and July 6, 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
Recovered Plasma. Recall # B-0451-10
CODE
Unit: 06LL40402
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Pomona, CA, by telephone or electronic notification on June 5, 2009 and by letters dated June 5, 2009 and July 6, 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
Recovered Plasma. Recall # B-0603-10
CODE
Unit: 6313907
RECALLING FIRM/MANUFACTURER
South Texas Blood and Tissue Center, San Antonio, TX, by fax on September 16, 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
FL, TX

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I
___________________________________
PRODUCT
1) Centurion Healthcare Products Preemie Packs, 50, sterile; code no. LM110. Aspiration tray containing Portex uncuffed pediatric sized tracheal tubes. Recall # Z-0105-2010;

2) Centurion Healthcare Products, Full Term Meconium Packs, 50, sterile; code no. LM115. Recall # Z-0106-2010
CODE
1) Lots: 901087, 903267, 907307, 910297, 901218, 908258, 2009020990 and 2009022390;
2 Lots: 01297, 07097, 09107, 12037, 06028, 2008091501, 2008120801, 2009033001 and 2009062201
RECALLING FIRM/MANUFACTURER
Recalling Firm: Centurion Medical Products, Howell, MI, by e-mail on September 22, 2009 and by letter dated September 23, 2009.
Manufacturers: Centurion Medical Products, Howell, MI, and Smiths Medical, Hythe, Kent, United Kingdom. Firm initiated recall is complete.
REASON
The manufacturer of the pediatric tracheal tubes used in these kits recalled them because they were manufactured with an internal diameter smaller than indicated in the label, which could result in an inability to remove secretions and cause partial or complete obstruction of the airway.
VOLUME OF PRODUCT IN COMMERCE
1,400 units
DISTRIBUTION
IL
___________________________________
PRODUCT
1) Mikro 12-24 Centrifuge with 2050 Rotor TYP #2070 and TYP 2070-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. Recall Z-0612-2010;

2) Haematokrit 24 Centrifuge with 2050 Rotor TYP #2075 and TYP #2075-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. Recall # Z-0613-2010;

3) Mikro 20 Centrifuge with 2076 Rotor TYP #2004 and TYP #2004-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. Recall # Z-0614-2010;

4) Haematokrit 20 Centrifuge with 2050 Rotor TYP #2014-01 and TYP#201424-01. Used for the purpose of determining the hematocrit count of a patient sample by way of applying centrifugal force in a manner that separates red blood cells and allows the proportion of red cell mass to plasma to be measured. Recall # Z-0615-2010
CODE
1) Units with plastic motor housing. TYP #2070 and TYP 2070-01;
2) Units with plastic motor housing. TYP #2075 and TYP #2075-01;
3) Units with plastic motor housing. TYP #2004 and TYP #2004-01;
4) Units with plastic motor housing. TYP #2014-01 and TYP#201424-01
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hettich Instruments Management I, Beverly, MA, by email on November 21, 2009, and by letter dated November 23, 2009. 
Manufacturer: Andreas Hettich Gmbh & Co. Kg, Tuttlingen, Germany. Firm initiated recall is ongoing.
REASON
Centrifuge Rotor Failure: may crack, break, and explode outside the centrifuge.
VOLUME OF PRODUCT IN COMMERCE
46 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
1) Exel Huber Needles (Right angle and Straight Models with Catalog Numbers: a) 26901CE, 26902CE, 26903CE, 26904CE, 26905CE, 26906CE, 26907CE, 26908CE, 26909CE, 26910CE, 26911CE, 26921CE, 26922CE, 26923CE, 26924CE, 26925CE, 26926CE, 26927CE, 26928CE, and 26929CE). Recall # Z-0638-2010;

2) Exel Safety Huber Infusion Sets (20G and 22G sizes with Catalog Numbers 37854S, 37855S. 37858S). Recall # Z-0639-2010;

3) Exel Huber Infusion Set, Catalog Numbers 26940R, 26941R, 26944R, 26945R, 26946R, 26948R, 26949R, 26950R, 27940R, 27941R, 27944R, 27945R, 27946R, 27948R, 27949R, 27950R, 26954R, 26955R, 26958R, 26959R, 27954R, 27955R, 27958R, 27959R. Recall # Z-0640-2010
CODE
1) Catalog 26921CE  Lots: 08D25 08F23 08H27; Catalog 26922;  Lots: 07C20 07E22 07E26 07F05 07G03 07H06 07I03 07K12 07L14 08A18 08C10 08F09 08F25 08G01 08G14 08H18 08I17 08J02 08J22 08K19 08K27 08L01 09A13 09A27 09B23 09C30 09D27 09E01 09F05 09F19 09G16 09G29;  Catalog 26942CE  Lots: 08B09 08B23 08E26 09F22 09G15; Catalog 26925CE  Lots: 09F09; Catalog 26923CE  Lots: 07H09 07I17 07J16 07K16 08D01 08E12 08F11 08G02 08H02 08H21 08I02 08I23 08J06 08K04 08L03 09A17 09A23 09B02 09C10 09D01 09F10; Catalog 26901CE  Lots: 07L21 08D16 08H11 09A09 09C02 09D07 09E13 09F01 09GO7; Catalog 26902CE  Lots: 08F18 08K24 09F05; Catalog 26904CE  Lots: 07D24 07H02 07H11 08F13 08F20 09B10 09C06 09D13 09E15; Catalog 26906CE  Lots: 08H11 09E16; Catalog 26906CE  Lots: 07I22 07K21 08B18 08C17 08D21 08E15 09B12 09C05 09D10 09D27 09E27 09F26 09G09; Catalog 26907CE  Lots: 07C27 07J13 08I19 09A07 09D29 09E12 09E26; Catalog 26909CE  Lots: 07F08 07G25;

2) Catalog 37854S Lot 09G31; Catalog 37855S Lot 09G31, Catalog 37858S Lot 09G31;

3) Catalog 27959R Lots: 07F25 08B04 08C29 08E23 08K26 09A10; Catalog 27959R Lots: 07A19 07D25 09G21; Catalog 27955R Lots: 07F18 07H23 07K26 08G14 08D10 08E22 08H05 08H23 09G21; Catalog 27954R Lots: 08E09 08E21 08J22 09B23 09C28; Catalog 27949R Lots: 07C20 07F26 07H03 07I 20 07I21 07K22 08B26 08E12 08G17 08K25 08L19 09D03 09F16 09G22 09H12; Catalog 27948R Lots: 07I13 07J09 08G08 08I09; Catalog 27950R Lots: 08D23 08E01 09D01; Catalog 27945R Lots: 07A09 07A25 07F19 07G10 07J23 07K13 07L03 08A26 08B01 08B25 08E02 08F16 08H05 08J06 08J21 08K28 08L10 08L17 08L25 09A17 09C23 09C24 09D01 09D29 09E29 09F09 09F17 09G23; Catalog 27944R Lots: 07A08 07B10 07B13 07B24 07F08 07F15 07G17 07H03 07H10 07J09 07L17 08A11 08C12 08C28 08D08 08F04 08H21 08I22 08K06 08K14 09A17 09A29 09B11 09B17 09D17 09G17; Catalog 27946R Lots: 07A18 07C30 08D11 09D29 09F16 09G24 09H17; Catalog 27941R Lots: 07I12 09B12 09C09 09F17 09H17; Catalog 27940R Lots: 07I11 07L17 08I12 09D17
RECALLING FIRM/MANUFACTURER
Recalling Firm: Exelint International Co., Culver City CA, by letter on December 25, 2009.
Manufacturer: Nissho Insurance Services Co., Ltd., Osaka-shi, Japan. Firm initiated recall is ongoing.
REASON
Non-coring needles that, when inserted into an implanted port, were shown to core the silicone ports septum. Coring of port's septum may lead to: decreased effectiveness of port, infection, necrosis, swelling, and embolization, which may result in pulmonary embolism, limb ischemia, stroke, local extravasation of medication such as chemotherapy or other caustic material; may lead to local tissue necrosis, granulomas, failure to deliver therapy, need for additional surgery to replace implanted ports, and/or death. Coring tests demonstrate that the Exel Huber Needles core 60-74%.
VOLUME OF PRODUCT IN COMMERCE
1,699,760
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT
Edwards Lifesciences "Aquarius" System; Model Numbers: GEF08200, GEF09500, GEF09600, GEF09700, and GEF09800, using Software version 6.00.04. The Aquarius monitors the fluid going into and coming out of the patient. Recall # Z-0653-2010
CODE
All units/serial numbers.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Edwards Lifesciences, LLC, Irvine, CA, by letter dated March 19, 2009. 
Manufacturer: NIKKISO Medical Systems GMBH, Hannover, Germany. Firm initiated recall is ongoing.
REASON
Reports of clinically significant fluid imbalance. When a certain level of fluid imbalance is detected, the Aquarius will trigger an alarm. However, users are able to override this alarm and continue therapy. By repeatedly overriding the balance alarm without solving the issue (closed clamp, kinked line, etc.), it is possible to remove too much fluid from or replace too much fluid to the patient. In extreme cases, this could result in hypovolemia or hypervolemia, other serious injury or death. Edwards will be providing a software upgrade that is intended to prevent the user from bypassing the fluid balance alarm more than five times in a 20-minute period.
VOLUME OF PRODUCT IN COMMERCE
2,272 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Canada, Canary Islands, China, Colombia, Czech Republic, France, Germany, Greece, India, Indonesia, Ireland, Israel, Italy, Lebanon, Malaysia, Netherlands, New Zealand, Poland, Romania, Russia, Saudi Arabia, Slovak Republic, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad and Tobago, Tunisia, United Arab Emirates and United Kingdom

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II
___________________________________
PRODUCT
1) GE OEC 9900 Elite ESP, to produce mobile fluoroscopic images of human anatomy. Recall # Z-0004-2010;

2) GE OEC 9900 Elite GSP Fluoroscopes To produce mobile fluoroscopic images of human anatomy. Recall # Z-0005-2010
CODE
All associated serial numbers
RECALLING FIRM/MANUFACTURER
GE Healthcare, Salt Lake City, UT, by letter beginning October 5, 2009. Firm initiated recall is ongoing.
REASON
A software defect - may result in a false indication and warning on the OEC 9900 Workstation and C-arm display that the X-Ray tube Anode is over-heated. This will also cause the displayed air kerma rate and cumulative air kerma to be inaccurate.
VOLUME OF PRODUCT IN COMMERCE
1,395 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 42 degrees, sterile, REF 4342-112-13. Shoulder replacement surgery. Recall # Z-0177-2010;

2) Zimmer Trabecular Metal Shoulder, humeral stem, 12 mm stem diameter, 130 mm stem length, 48 degrees, sterile, REF 4348-112-13. Shoulder replacement surgery. Recall # Z-0178-2010
CODE
1) Lot 61159758;
2) Lot 60947164
RECALLING FIRM/MANUFACTURER
Zimmer, Inc., Warsaw, IN, by e-mail on September 19, 2009 and letter dated September 29, 2009. Firm initiated recall is complete.
REASON
Some of the devices may possess a taper which will not mate with the humeral head, as intended.
VOLUME OF PRODUCT IN COMMERCE
24 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
Richard Wolf Hulka Clip; for single patient use only; a sterile tubal occluding device; 2 clips per procedure tray/pouch, 10 pouches per shipping carton; item 4986.90. Indicated for use for female sterilization (permanent contraception) by occluding the fallopian tubes. Recall # Z-0272-2010
CODE
Lot number: 1391, expiry date 02.2010
RECALLING FIRM/MANUFACTURER
Richard Wolf Medical Instruments, Corp., Vernon Hills, IL, by letters dated October 16, 2009. Firm initiated recall is ongoing.
REASON
The sterile pouch seal may fail to remain intact during handling rendering the Hulka clip non-sterile.
VOLUME OF PRODUCT IN COMMERCE
150 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Imager" II Angiographic Catheters, Sterilized with ethylene oxide gas, Made in Ireland, Unit 7,8 & 9 Material Number (Outer Carton Label of 5pk) /Material Number (Inner-Pouch Label for each Single Catheter)/ Catalog Number /Material Description: M001314001 M001314000 31-400 IMAGER II/5/ST/65/038 BX5; M001314021 M001314020 31-402 IMAGER II/5/ST/65/035 BX 5; M001314071 M001314070 31-407 IMAGER II/5/BERN/40/035 BX 5; M001314081 M001314080 31-408 IMAGER II/5/BERN/40/038 BX5; M001314091 M001314090 31-409 IMAGER II/5/BERN/65/035 BX 5; M001314101 M001314100 31-410 IMAGER II/5/BERN/65/038 BX5; M001314301 M001314300 31-430 IMAGER II/5/SIM1/65/038 BX5; M001314521 M001314520 31-452 IMAGER II/5/CHGB/65/038 BX5; M001314561 M001314560 31-456 IMAGER II/5/CHG2.5/65/038 BX5; M001314571 M001314570 31-457 IMAGER II/5/CHG2.5/65/035 BX 5; M001314581 M001314580 31-458 IMAGER II/5/CONTRA 2/65/038 BX5; M001314591 M001314590 31-459 IMAGER II/5/CONTRA 2/65/035 BX 5; M001314611 M001314610 31-461 IMAGER II/5/DUCK/65/035 BX 5; M001314661 M001314660 31-466 IMAGER II/5/C2/65/038 BX5; M001314671 M001314670 31-467 IMAGER II/5/C2/65/035 BX 5; M001314681 M001314680 31-468 IMAGER II/5/C2+2 SIDE HOLES/65/038 BX5; M001314691 M001314690 31-469 IMAGER II/5/C2+2 SIDE HOLES/65/035 BX 5; M001314751 M001314750 31-475 IMAGER II/5/TRAIN/65/038 BX5; M001314761 M001314760 31-476 IMAGER II/5/MIK/65/038 BX5; M001314791 M001314790 31-479 IMAGER II/5/HK1.0/65/035 BX 5; M001314801 M001314800 31-480 IMAGER II/5/SHK0.8/65/038 BX5; M001314811 M001314810 31-481 IMAGER II/5/SHK0.8/65/035 BX 5; M001314821 M001314820 31-482 IMAGER II/5/SHK1.0/65/038 BX5; M001314851 M001314850 31-485 IMAGER II/5/RC1/65/035 BX 5; M001314861 M001314860 31-486 IMAGER II/5/RC2/65/038 BX5; M001314881 M001314880 31-488 IMAGER II/5/RDC/65/038 BX5; M001314891 M001314890 31-489 IMAGER II/5/RDC/65/035 BX 5 and M001314911 M001314910 31-49I IMAGER II/5/RDC+2 SIDEHOLES/65/035 BX 5: M001315001 M001315000 31-500 IMAGER II/4/TENNIS RACQUET/65/035 BX5; M001315031 M001315030 31-503 IMAGER II/5/TENNIS RACQUET/65/035 BX5; M001315061 M001315060 31-506 IMAGER II/5/TENNIS RACQUET/65/038 BX5; M001315091 M001315090 31-509 IMAGER II/4/PIGTAIL/65/035 BX5; M001315101 M001315100 31-510 IMAGER II/4/STRAIGHT/65/035 BX5; M001315131 M001315130 31-513 IMAGER II/5/PIGTAIL/65/038 BX5; M001315161 M001315160 31-516 IMAGER II/5/STAIGHT/65/038 BX5; M001315191 M001315190 31-519 IMAGER II/5/PIGTAIL/65/035 BX5; M001315201 M001315200 31-520 IMAGER II/5/STRAIGHT/65/035 BX5; M001315251 M001315250 31-525 IMAGER /4/CONTRALATERAL/65/035 BX5; M001315281 M001315280 31-528IMAGER II/5/CONTRALATERAL/65/035 BX5; M001315311 M001315310 31-531 IMAGER II/5/CONTRALATERAL/65/038 BX5; M001316021 M001316020 31-602 MODEL-IMAGER II/ 4/ ST/65/035; M001316071 M001316070 31-607 MODEL-IMAGER II/ 4/ BERN/40/035; M001316091 M001316090 31-609 MODEL-IMAGER II/ 4/ BERN/65/035; M001316311 M001316310 31-631 MODEL-IMAGER II/ 4/ SIM1/65/035; M001316531 M001316530 31-653 MODEL-IMAGER II/ 4/ CHGB/65/035; M001316551 M001316550 31-655 MODEL-IMAGER II/ 4/ CHGC/65/035; M001316581 M001316580 31-658 MODEL-IMAGER II/ 4/ CONTRA 2/65/035; M001316691 M001316690 31-669 MODEL-IMAGER II/4/C2+2 SIDE HOLES/65/035 and M001316851 M001316850 31-685 MODEL-IMAGER II/ 4/ RC1/65/035. Imager" II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters. These catheters are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90 cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy. Recall # Z-0336-2010;

2) Imager" II Urology Torque Catheter, Sterilized with ethylene oxide gas, Unit 7,8 & 9. Product Description and Material/UPN/Catalog Number Imager" II Catheters C2, 5Fr, 65cm M0064003010 (inner pouch) M0064003011 (outer box); Imager" II Catheters Straight, 5Fr, 65cm M0064003020 (inner pouch) M0064003021 (outer box) and Imager" II Catheters Bern, 5Fr, 65cm M0064003030 (inner pouch) M0064003031 (outer box) The Imager II Urology Torque Catheter is single lumen, torqueable catheter that is offered with one of a variety of tip configurations, each uniquely designed to facilitate access to the urinary tract. This device is made of a bio-compatible polymer reinforced with a stainless steal braided wire with one hole at the distal tip and a luer lock hub is attached to the proximal end. The catheter may be used with a guidewire up to .038 in. diameter. Recall # Z-0337-2010
CODE
1) Lot/Batch 57139 57392 57709 57248 57533 57258 57263 57612 57242 57243 57510 57530 57531 57173 57296 57297 57381 57534 57535 57238 57389 57697 57383 57130 57265 57245 57214 57266 57298 57784 57120 57617 57621 57128 57708 57244 57783 57382 57119 57695 57698 57133 57696 57580 57247 57135 57123 57782 57134 57268 57388 57369 57124 57600 57419 57278 57283 57699 57233 57414 57415 57225 57528 57409 57410 57282 57587 57403 57404 57583 57044 57045 57046 57090 57275 57581 57582 57588 57279 57586 57706 57375 57215 57602 57603 57608 57578 57579 57376 57526 57527 57577 and 57378;

2) Lot/Batch No. 57271 57616 57269 and 57613
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove, MN, by letters on October 29, 2009.
Manufacturer: TFX Engineering LTD., Teleflex Medical, Limerick, Ireland. Firm initiated recall is ongoing.
REASON
The sterile barrier in the packaging (pouch) that contains the catheter may be breached. The breach of sterility could lead to a contamination of the device with subsequent transfer of infectious agents to the patient.
VOLUME OF PRODUCT IN COMMERCE
8,500 boxes (5/box)
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) Infinia with Hawkeye 1, model numbers: H2508PW, H2508PY, H3000WN, H3000WR, H3000WW, H3000WY, H3000WZ, H3000YM, and H3000YS. Generating head and whole body CT images of human subjects. Recall # Z-0494-2010;

2) Infinia with Hawkeye 4, model numbers: H3000WC and H3000WD. Generating head and whole body CT images of human subjects. Recall # Z-0495-2010;

3) Millenium VG with Hawkeye/Discovery VH with Hawkeye, model number: BR321000008. Generating head and whole body CT images of human subjects. Recall #Z-0496-2010
CODE
All serial numbers associated with the above model numbers.
RECALLING FIRM/MANUFACTURER
GE Medical Systems, LLC, Waukesha, WI, by letter February 2010. Firm initiated recall is ongoing.
REASON
Failure to provide the complete User Manual information.
VOLUME OF PRODUCT IN COMMERCE
343 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
1) Ellex Motorized Safety Filter, Zeiss; Model number 6339585. Intended for photocoagulation. Recall # Z-0577-2010;

2) Motorized Safety Filter, Wild; Model number 6339590. Intended for photocoagulation. Recall # Z-0578-2010
CODE
Solitaire LP4532 photocoagulator
RECALLING FIRM/MANUFACTURER
Ellex Medical Pty LTD, Adelaide, Australia, by letter February 11, 2009. Firm initiated recall is ongoing.
REASON
Potential for two screws important in the design of the safety filter to come loose.
VOLUME OF PRODUCT IN COMMERCE
200 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
SoftLase Pro Dental Lasers Intended use: Dentistry. Recall # Z-0587-2010
CODE
All
RECALLING FIRM/MANUFACTURER
Zap Lasers LLC, Pleasant Hill, CA, by letter December 30, 2009. Firm initiated recall is ongoing.
REASON
The SoftLase Lasers are in need of compliance upgrades due to lack of a remote interlock connector, an emission delay, user guide labels and locations, and calibration procedures and schedule.
VOLUME OF PRODUCT IN COMMERCE
1,375 units
DISTRIBUTION
Internationally
___________________________________
PRODUCT
1) iDXA, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD. Recall # Z-0600-2010; 

2) Prodigy 1-8 series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2, 13.0, & 13.1. The systems provide an estimate of BMD. Recall # Z-0601-2010;

3) DPX-NT series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2, 13.0, & 13.1. The systems provide an estimate of BMD. Recall # Z-0602-2010;

4) DPX-MD series, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2, 13.0, & 13.1. The systems provide an estimate of BMD. Recall # Z-0603-2010;

5) DPX-Bravo/Duo, GE Lunar DEXA bone densitometers operating with enCORE software versions 12.0, 12.1, 12.2,13.0, & 13.1. The systems provide an estimate of BMD. Recall # Z-0604-2010
CODE
1) Software versions 12.0, 12.1, 12.2, 13.0, & 13.1;
RECALLING FIRM/MANUFACTURER
GE Healthcare, Wauwatosa, WI, by letter on November 2, 2009. Firm initiated recall is ongoing.
REASON
Failure to properly pre-indicate the technique factors to be used during a patient scan.
VOLUME OF PRODUCT IN COMMERCE
1,764 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT
GE Healthcare MAC 800 RESTING ECG ANALYSIS SYSTEM. The MAC 800 is a portable EGG acquisition, analysis and recording system. The MAC 800 is intended to acquire, analyze, display and record information from adult and pediatric populations. Pediatric population is defined as patients between the ages of 0 and 15 years. The MAC 800 is intended to be used by trained operators in a hospital or medical professional's facility environment to record EGG signals from surface electrodes. The basic system shall provide 2 modes of operation: (I) Resting EGG mode and (2) Arrhythmia mode. The basic systems shall print 3, 6-leads of EGG. The device shall be upgradeable to provide software options such as 12-lead ECG measurement and interpretive analysis. Recall # Recall # Z-0645-2010
CODE
Serial number / Lot name of the target item: SDS08350002SA SDS08350003SA SDS08350008SA SDS08350017SA SDS08350018SA SDS08360012SA SDS08360014SA SDS08360015SA SDS08360016SA SDS09060040SA SDS09070065SA SDS09090075SA SDS09090076SA SDS09090077SA SDS09090078SA SDS09090079SA SDS09090080SA SDS09090082SA SDS09090083SA SDS09090084SA SDS09090085SA SDS09090086SA SDS09090087SA SDS08340005WA SDS08340021WA SDS08340008WA SDS08340011WA SDS08340018WA SDS08500136WA SDS08500137WA SDS08500138WA SDS08500139WA SDS08500140WA SDS08500141WA SDS09020164WA SDS09020165WA SDS09020166WA SDS09020167WA SDS09020181WA SDS09030199WA SDS09030210WA SDS09030215WA SDS09030218WA SDS09030219WA SDS09070223WA SDS09120318WA SDS08340014WA SDS09030183WA SDS09030185WA SDS09030186WA SDS09030191WA SDS09030192WA SDS09090297WA SDS09100298WA SDS09100299WA SDS09230533WA SDS08480129WA SDS09030200WA SDS09030207WA SDS09030211WA SDS09030212WA SDS09030214WA SDS09070220WA SDS09120319WA SDS09120320WA SDS09120321WA SDS09120327WA SDS09120330WA SDS09140336WA SDS09140337WA SDS09200449WA SDS09230531WA SDS09230538WA SDS08340013WA SDS09190434WA SDS09200444WA SDS09200450WA SDS09040023SA SDS09140333WA SDS08430032WA SDS09140350WA SDS09160386WA SDS09210471WA SDS09210472WA SDS09220497WA SDS09220501WA SDS09220502WA SDS09220503WA SDS09220504WA SDS09220506WA SDS09220507WA SDS09220508WA SDS08340019WA SDS09220509WA SDS09220512WA SDS08480127WA SDS09200446WA SDS09200447WA SDS09200448WA SDS09220511WA SDS09220513WA SDS09220514WA SDS09220515WA SDS09220516WA SDS09220517WA SDS09220518WA SDS09140335WA SDS08450062WA SDS09120331WA SDS08340015WA SDS09200452WA SDS09230520WA SDS09230521WA SDS09230522WA SDS08340007WA SDS09070221WA SDS09070226WA SDS09140338WA SDS09140339WA SDS09140340WA SDS09140341WA SDS09140342WA SDS09140343WA SDS09140344WA SDS09140345WA SDS09140346WA SDS09140347WA SDS09140348WA SDS09140349WA SDS09140351WA SDS09140352WA SDS09150353WA SDS09150354WA SDS09150355WA SDS09150356WA SDS09150357WA SDS09150358WA SDS09150359WA SDS09150360WA SDS09150361WA SDS09150362WA SDS09150363WA SDS09150364WA SDS09150365WA SDS09150366WA SDS09150367WA SDS09150368WA SDS09150369WA SDS09150370WA SDS09150371WA SDS09150372WA SDS09160378WA SDS09160379WA SDS09160380WA SDS09160381WA SDS09160382WA SDS09160383WA SDS09160384WA SDS09160385WA SDS09160387WA SDS09160388WA SDS09160389WA SDS09160390WA SDS09160391WA SDS09160392WA SDS09160393WA SDS09160394WA SDS09160395WA SDS09160396WA SDS09160397WA SDS09160398WA SDS09160399WA SDS09160400WA SDS09160401WA SDS09160402WA SDS09160403WA SDS09160404WA SDS09160405WA SDS09160406WA SDS09160407WA SDS09160408WA SDS09160409WA SDS09160410WA SDS09160411WA SDS09160412WA SDS09220473WA SDS09220474WA SDS09220475WA SDS09220476WA SDS09220477WA SDS09220478WA SDS09220479WA SDS09220480WA SDS09220482WA SDS09220483WA SDS09220484WA SDS09220485WA SDS09220486WA SDS09220487WA SDS09220488WA SDS09220489WA SDS09220490WA SDS09220491WA SDS09220492WA SDS09220493WA SDS09220494WA SDS09220495WA SDS09220496WA SDS09220498WA SDS09220499WA SDS09220500WA SDS09220505WA SDS08470118WA SDS08470121WA SDS08470123WA SDS08470124WA SDS08480130WA SDS08480131WA SDS08480132WA SDS08500133WA SDS08500134WA SDS08500135WA SDS08500142WA SDS08500143WA SDS08500144WA SDS08500145WA SDS08500146WA SDS08500147WA SDS08500148WA SDS08500149WA SDS08500150WA SDS08500151WA SDS08500152WA SDS08500153WA SDS08500154WA SDS08500155WA SDS08500156WA SDS08500157WA SDS09020169WA SDS09020174WA SDS09020180WA SDS09030195WA SDS09030198WA SDS09030204WA SDS09030216WA SDS09030217WA SDS09040022SA SDS09040024SA SDS09040025SA SDS09040026SA SDS09070224WA SDS09120322WA SDS09120323WA SDS09120324WA SDS09120325WA SDS09120326WA SDS09120328WA SDS09120329WA SDS09230524WA SDS09230525WA SDS09230529WA SDS09230530WA SDS09030201WA SDS09030197WA SDS09080249WA SDS09080254WA SDS09080255WA SDS08340020WA SDS09030187WA SDS09030190WA SDS09200453WA SDS09200454WA SDS09200455WA SDS09200456WA SDS09200457WA SDS09200458WA SDS09200459WA SDS09200460WA SDS09200461WA SDS09200462WA SDS09210463WA SDS09210464WA SDS09210465WA SDS09210466WA SDS09210467WA SDS09210468WA SDS09210469WA SDS09210470WA SDS09160374WA SDS09120332WA SDS09230526WA SDS08470119WA SDS08470120WA SDS08470122WA SDS08480126WA SDS08500158WA SDS08500159WA SDS08500161WA SDS08500162WA SDS09020163WA SDS09020170WA SDS09020171WA SDS09020172WA SDS09020173WA SDS09020175WA SDS09020176WA SDS09020177WA SDS09020182WA SDS09030184WA SDS09030188WA SDS09030193WA SDS09030213WA SDS09230527WA SDS09230534WA SDS09230535WA SDS09230536WA SDS09230539WA SDS08340009WA SDS08340010WA SDS08340025WA SDS08340026WA SDS08480125WA SDS08430034WA SDS08430035WA SDS08430036WA SDS08340022WA SDS08340023WA SDS08340024WA SDS08340027WA SDS08480128WA SDS09030196WA SDS09030202WA SDS09030203WA SDS09030205WA SDS09030208WA SDS09030209WA SDS09070222WA SDS09070225WA SDS09220510WA SDS08340012WA SDS09140334WA SDS09020168WA SDS08430033WA SDS08430037WA SDS08430038WA SDS08430039WA SDS08440040WA SDS08440041WA SDS08440042WA SDS08440043WA SDS08440044WA SDS08440045WA SDS08440046WA SDS08440047WA SDS08440048WA SDS08440049WA SDS08440050WA SDS08440051WA SDS08440052WA SDS08440053WA SDS08440054WA SDS08440055WA SDS08440056WA SDS08440057WA SDS08440058WA SDS08440059WA SDS08440060WA SDS08440061WA SDS08450063WA SDS08450064WA SDS08450065WA SDS08450066WA SDS08450067WA SDS08450068WA SDS08450069WA SDS08450070WA SDS08450071WA SDS08450073WA SDS08450074WA SDS08450075WA SDS08460076WA SDS08460077WA SDS08460078WA SDS08460079WA SDS08460080WA SDS08460081WA SDS08460082WA SDS08460083WA SDS08460084WA SDS08460085WA SDS08460086WA SDS08460087WA SDS08460088WA SDS08460089WA SDS08460090WA SDS08460091WA SDS08460092WA SDS08470093WA SDS08470094WA SDS08470095WA SDS08470096WA SDS08470097WA SDS08470098WA SDS08470099WA SDS08470114WA SDS08470115WA SDS09020178WA SDS09070241WA SDS09070242WA SDS09080256WA SDS09080257WA SDS09080258WA SDS09080259WA SDS09080260WA SDS09080261WA SDS09080262WA SDS09080263WA SDS09080264WA SDS09080265WA SDS09080266WA SDS09080267WA SDS09080268WA SDS09080269WA SDS09080270WA SDS09080271WA SDS09080272WA SDS09090273WA SDS09090275WA SDS09090276WA SDS09090278WA SDS09090279WA SDS09090280WA SDS09090281WA SDS09090282WA SDS09090296WA SDS09110312WA SDS09110317WA SDS09180415WA SDS09180416WA SDS09180417WA SDS09180425WA SDS09180429WA SDS09180430WA SDS09240568WA SDS09240569WA SDS09240570WA SDS09240571WA SDS09240572WA SDS09240573WA SDS09240574WA SDS09180423WA SDS09180424WA SDS08470116WA SDS08470117WA SDS09160373WA SDS08470100WA SDS08470101WA SDS08470102WA SDS08470103WA SDS08470104WA SDS08470105WA SDS08470106WA SDS08470107WA SDS08470108WA SDS08470109WA SDS08470110WA SDS08470111WA SDS08470112WA SDS08470113WA SDS09020179WA SDS09070228WA SDS09070229WA SDS09070230WA SDS09070233WA SDS09070234WA SDS09070235WA SDS09070237WA SDS09070238WA SDS09070239WA SDS09070240WA SDS09070243WA SDS09070244WA SDS09070245WA SDS09070246WA SDS09070247WA SDS09080248WA SDS09080250WA SDS09080251WA SDS09080252WA SDS09080253WA SDS09070231WA SDS09070232WA SDS09090274WA SDS09090277WA SDS09090283WA SDS09090284WA SDS09090285WA SDS09090286WA SDS09090287WA SDS09160375WA SDS09160376WA SDS09160377WA SDS09180413WA SDS09180414WA SDS09180418WA SDS09180419WA SDS09180420WA SDS09180421WA SDS09180422WA SDS09180426WA SDS09180427WA SDS09180428WA SDS09190435WA SDS09190436WA SDS09190437WA SDS09200438WA SDS09200439WA SDS09200440WA SDS09200441WA SDS09200442WA SDS09200443WA SDS09200451WA SDS09230546WA SDS09230547WA SDS09240575WA SDS09240576WA SDS09240577WA SDS09250587WA SDS08340003WA SDS08340004WA SDS08340006WA SDS09090288WA SDS09090289WA SDS09090290WA SDS09090291WA SDS09090292WA SDS09090293WA SDS09090294WA SDS09090295WA SDS09100300WA SDS09100301WA SDS09100302WA SDS09100303WA SDS08450072WA SDS09100304WA SDS09100305WA SDS09100306WA SDS09100307WA SDS09110308WA SDS09110309WA SDS09110310WA SDS09110311WA SDS09110313WA SDS09110314WA SDS09180431WA SDS09180432WA SDS09190433WA SDS08340016WA SDS08340017WA SDS09230548WA SDS09230549WA SDS09230550WA SDS09030194WA SDS08500160WA SDS09030206WA SDS09200445WA and SDS09070227WA
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, letter dated December 10, 2009. 
Manufacturer: GE Medical Systems China Co., Ltd., Wuxi, China. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of an issue with MAC800 laser printouts. When more than one ECG report in the file manager is batch printed in laser print, the potential exists for an incorrect patient identification or name to be displayed on the print out. Misidentification of patient data potentially contributing to delayed or incorrect treatment is then possible.
VOLUME OF PRODUCT IN COMMERCE
567 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT
1) AC Power Cords, 110V. Power Cord #4100079 used with a) Kinair IV Model 22600, b) Kinair IV 60601 Model 216050, c) Triadyne Proventa Model 406000, d) Therapulse ATP/II Models 227800 and 227080.S, e) Kinair Medsurg Model 201001W, and f) Kinair Medsurg Pulse Model 40900. Recall # Z-0662-2010;

2) AC Power Cords, 110V. Power Cord #4102204 used with a) Tricell 60601 Model 212857, b) First Step Select Model 215200, and c) Plexipulse Model 205835. Recall # Z-0663-2010;

3) AC Power Cords, 110V. Power Cord #M4268840 used with a) First Step All-In-One Canadian French Models 227500-09 and 227500, b) First Step All-In-One English Model 227500, c) Therakair Visio Models M8259978 and M6257763 pump only, and d) Proficare - Canada Model M8259988. Recall # Z-0664-2010; 

4) AC Power Cords, 110V. Power Cord #340225 used with a) Activac Model 340000, and b) ActiVAC (Canadian) Model 340013. Recall # Z-0665-2010;

5) AC Power Cords, 110V. Power Cord #M4268882 used with a) InfoVAC Model M825999, b) InvoVac Canadian Model M8260027, and c) Vac ATS Model 8259968. Recall # Z-0666-2010;

6) AC Power Cords, 110V. Power Cord M426884 used with VAC ATS Canadian Model M8259994. Recall # Z-0667-2010
CODE
1) Device serial numbers: a) KAPK00523 - KAPK00691; b) KAUK00001 - KAUK00134; c) TDDK0001 - TDDK00367; d) TPNK00001 - TPNK00177; e) KAS01524, KASK01004 - KASK02930; and f) KATK00001 - KATK00655;

2) Device Serial Numbers Affected: a) Serial Numbers FSUK00011-FSUK01400; b) Serial Numbers FWSK00001-FSWK02393; and c) Serial Numbers PPGK00001-PPGK00226;

3) Serial Numbers: a) FTGK00001-FTGK00106; b) FTCK00001-FTCK00624; c) Therakair Visio Canadian 800 Wids; Therakair Visio Canadian 900 Wids; Airworks Sure Std. 110V-Canada; Airworks Sure 80CM Wide, 110V - Canada; Product Assy-Provicare Std. 110V-Canada; and Product Assy-Proficare 80CM wide, 110V-Canada.

4) Serial Numbers: a) VDZR00001-VDZR26649; and VCQK00001 - VCQK19781; b) (VDRK00001 - VDRK00085; VEPR00001 - VEPR01050; and VFSR00150 - VFSR01790;

5) Serial Numbers: a) VERR00001-10301; VFTR00121-VFTR00178; VCOK00001-VCOK44429; VCPL05419; VCQK09226-VCQK09303; VOCK08493; VOCK09154; VOCK09898; and VOCK09899; b) VFFR0001-VFFR00835; VDQK00001 - VDQK00075; c) VCDE01057-VCDE17172;

6) No serial number, export only
RECALLING FIRM/MANUFACTURER
Recalling Firm: KCI USA, Inc., San Antonio, TX, by letter dated November 4, 2009.
Manufacturer: Electri-Cord Manufacturing Co., Westfield, PA. Firm initiated recall is ongoing.
REASON
Power cords may crack and fail inside plug with potential for fire hazard.
VOLUME OF PRODUCT IN COMMERCE
791 units
DISTRIBUTION
Nationwide and Canada

___________________________________
PRODUCT
1) Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 1.2um Filter, Pressure limited check valve 111 in V7412F. Product code 352425. Recall # Z-0670-2010;

2) Outlook Pump IV Set w/Universal Spike, 2 Injection sites, 0.2um Filter, Pressure limited check valve 122 in V7415F. Product code 352428. Z-0671-2010;

3) Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um Filter, Pressure limited check valve 122 in SS3169F. Product Code 352429. Recall # Z-0672-2010

4) Outlook Pump IV Set w/Universal Spike, 2 Safesite Inj sites, 0.2um Filter, Pressure limited check valve 122 in NF3169F. Product code 352430. Recall # Z-0673-2010;

5) Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj sites, 0.2um Filter, Pressure limited check valve 119 in US3169F. Product code 352442. Recall # Z-0674-2010;

6) Outlook Pump Add On Set with Ultrasite Injection Site Spin Lock Connector 88 in US3110. Product Code 352458. Z-0675-2010;

7) Outlook Pump IV Set w/Universal Spike, Injection Site 0.2um Filter Spin Lock Connector 115 in V7416F. Product Code 352461. Recall # Z-0676-2010;

8) Outlook Pump IV Set w/Universal Spike, Ultrasite Injection Site 0.2um Filter Ultrablock Tubing 119 in UV3169F. Product Code 352472. Recall # Z-0677-2010;

9) Outlook Pump IV Set w/Universal Spike, 3 Ultrasite Inj Sites B/C Valve & Pressure Limited Check Valve 136 in US1500HP. Product Code 352520. Recall # Z-0678-2010;

10) Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M. Product Code 375038. Recall # Z-0679-2010;

11) Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Ultrasite Inj Sites, Check Valve 120 in US3116M. Product Code 375040. Recall # Z-0680-2010; 

12) Outlook Pump Set w/150 ml Burette w/Ultrasite Inj Site & 15um Filter, 2 Safesite Inj Sites, Check Valve 120 in SS3115M. Product Code 375043. Recall # Z-0681-2010; 

13) Outlook Pump Set w/150 ml Burette w/15um Filter & Inj Site, Check Valve, 2 Inj Sites, 120 in V7421M. Product Code 375118. Recall # Z-0682-2010;

14) Outlook Pump Set w/150 ml Burette w/15um Filter & Safeline Inj Site, Check Valve, 2 Safeline Inj Sites, 120 in NF3115M. Product Code 375122. Recall # Z-0683-2010;

15) Outlook Pump Set w/150 ml Burette w/15um Filter & Ultrasite Inj Site, B/C Valve, 2 Ultrasite Inj Sites, 120 in US3121M. Product Code 375150. Recall # Z-0684-2010;

16) Outlook Pump Set w/Universal Spike, 3 Ultrasite Inj Sites, Spin Lock Con & Pressure, Limited Check Valve, 134 in US3140. Product Code 375196. Recall # Z-0685-2010;

17) Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, B/C Valve and Pressure Limited Check Valve, 124 in US1502HP. Product Code 470018. Recall # Z-0686-2010;

18) Outlook Pump IV Set with Universal Spike and Spin Lock Connector 133 in 1500HP. Product Code 470019. Recall # Z-0687-2010;

19) Outlook Pump IV Set w/Universal Spike, Supor Membrane 1.2um Filter, Spin Lock Connector 123 in 1500FHP. Product Code 470020. Recall # Z-0688-2010;

20) Outlook Pump IV Set w/Universal Spike & Spin Lock Connector 118 in V1500HP. Product Code 470025. Recall # Z-0689-2010;

21) Outlook Pump IV Set w/Universal Spike, 1 Safeline & 3 Ultrasite Inj Sites, Check Valve, B/C Valve 119 in US1500XHP. Product Code 470026. Recall # Z-0690-2010;

22) Outlook Pump IV Set w/Universal Spike Check Valve, 4 Ultrasite Inj Sites, 3 B/C Valves, Spin Lock Connector 140 in US1504HP. Product Code 470042. Recall # Z-0691-2010;

23) Outlook Pump IV Set w/Universal Spike Pressure Limited Check Valve, 2 B/C Valves, 3 Ultrasite Inj Sites, 137 in US1505HP. Product Code 470043. Recall # Z-0692-2010;

24) Outlook Pump IV Set w/Universal Spike, Back Check Valve, Ultrasite Inj Site, Spin Lock Connector, 128 in US1506HP. Product Code 470046. Recall # Z-0693-2010;

25) Outlook Pump IV Set w/Universal Spike, Ultrasite Inj Site, 1.2um Filter, Spin Lock Connector, 120 in US3112F. Product Code 474001. Recall # Z-0694-2010;

26) Outlook Pump IV Set w/Universal Spike, Check Valve, 3 Safeline Inj Sites, B/C Valve, 3 N/C Valves Stopcock, 118 in NF1500M3HP. Product Code 490021. Recall # Z-0695-2010;

27) Outlook Pump IV Set w/Universal Spike, Check Valve, 3 Ultrasite Inj Sites, B/C Valve, 2 N/C Valves Stopcock, 116 in US1500M2HP. Product Code 490022. Recall # Z-0696-2010;

28) Outlook Pump IV Set w/Universal Spike, Check Valve, 4 Safeline Inj Sites, B/C Valve, 3 N/C Valves Stopcock, 138 in NF1501M3HP. Product Code 490049. Recall # Z-0697-2010;

29) Outlook Pump IV Set w/Universal Spike, Check Valve, 5 Ultrasite Inj Sites, Ultraport HF Stopcock, 148 in US1500UPHP. Product Code 490071. Recall # Z-0698-2010;

30) 15 Drop Universal IV Admin Set w Outlook Cassette Ultrasites and Ultraport Stopcock 132 in US1501UPHP. Product Code 490074. Recall # Z-0699-2010;

31) Outlook Pump IV Set w/Universal Spike, Pressure limited check Valve, Spin Lock Connector, 3 Safeline Inj Sites, 120 in. Product Code NF3106. Recall # Z-0700-2010;

32) Safeline Y Type Blood Set for Outlook Pump w/Safeline Inj Site, 170um Blood Filter, Spin lock Connector 138 in. Product Code NF3120. Recall # Z-0701-2010;

33) Outlook Pump IV Set w/Universal Spike, 2 Safeline Injection Sites, Spin Lock Connector 120 in. Product Code NF3130. Recall # Z-0702-2010;

34) Outlook Pump IV Set w/Universal Spike, 3 Safeline Inj Sites, Spin Lock Conn & Pressure Limited Check Valve 134 in. Product Code NF3140. Recall # Z-0703-2010;

35) Outlook Pump IV Set with Universal Spike, Check Valve, 3 Safeline Inj Sites, B/C Valve, Spin Lock Connector 122 in. Product Code NF3140-10. Recall # Z-0704-2010;

36) Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connector 132 in. Product Code SS3120. Recall # Z-0705-2010;

37) Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Safsite Inj Sites, Spin Lock Connector 134 in. Product Code SS3140. Recall # Z-0706-2010;

38) Safesite Y Type Blood Set for Outlook Pump w/Safesite Inj Site 170um Blood Filter, Spin Lock Connector 132 in. Product Code US3120. Recall # Z-0707-2010;

39) Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Ultrasite Injection Sites, 129 in. Product Code US3130. Recall # Z-0708-2010;

40) Outlook Pump IV Set w/Universal Spike, 2 Ultrasite Inj Sites, Spin Lock Con & Pressure Limited Check Valve, 127 in. Product Code US3180. Recall # Z-0709-2010;

41) Outlook Pump Add On Set with Injection Site & Spin Lock Connector, 90 in. Product Code V7400. Recall # Z-0710-2010;

42) Outlook Pump Syringe Add On Set w/Microbore Tubing, Injection Site, Spin Lock Connector, 88 in. Product Code V7401. Recall # Z-0711-2010;

43) Outlook Pump Add On Set for Epidural Administration w/Microbore tubing & Sliding Spin Lock Connector, 88 in. Product Code V7402. Recall # Z-0712-2010;  

44) Outlook Pump IV Set w/Universal Spike, Injection Site & Spin Lock Connector, 132 in. Product Code V7405. Recall # Z-0713-2010;

45) Outlook Pump IV Set with Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin Lock Connector, 132 in. Product Code V7410. Recall # Z-0714-2010;

46) Outlook Pump IV Set w/Universal Spike, Pressure Limited Check Valve, 3 Inj Sites, Spin Lock Connector, 132 in. Product Code V7413. Recall # Z-0715-2010;

47) Outlook Pump Nitroglycerin Set w/Universal Spike & Spin Lock Connector, 135 in. Product Code V7450. Z-0716-2010;

48) Outlook Pump IV Set for Epidural Admin w/Universal Spike, Microbore Tubing, Spin Lock Connector, 126 in. Product Code V7453. Recall # Z-0717-2010;

49) Outlook Pump Y Type Blood Set with 170um Blood Filter, Injection Site, Spin Lock Connector, 131 in. Product Code V7490.  Recall # Z-0718-2010
CODE
1) Lot number 61040398 exp 4/30/2012;

2) Lot number 61026150 exp 3/31/2012;  

3) Lot number 61071402 exp 7/31/2012;

4) Lot numbers: 61047676 exp 3/31/2012 and 61048440 exp 5/31/2012;

5) Lot numbers: 61031831 exp 2/28/2012, 61031834 exp 3/31/2012, 61047683 exp 4/30/2012, 61047686 exp 5/31/2012, 61057493 exp 6/30/2012, 61057494 exp 6/30/2012, and 61057499 exp 7/31/2012;

6) Lot number 61040782 exp 3/31/2012;

7) Lot numbers: 61040800 exp 4/30/2012 and 61048455 exp 5/31/2012;

8) Lot numbers: 61048462 exp 5/31/2012 and 61070208 exp 6/30/2012;

9)  Lot numbers: 61040846 exp 2/28/2012, 61049083 exp 2/28/2012, 61049085 exp 3/31/2012, 61049087 exp 3/31/2012, 61049088 exp 4/30/2012, 61049089 exp 5/31/2012, 61055279 exp 5/31/2012, 61059457 exp 6/30/2012, and 61059463 exp 7/31/2012;

10) Lot numbers: 61030733 exp3/31/2012, 61030734 exp 4/30/2012, 61047279 exp 4/30/2012, and 61053708 exp 5/31/2012;

11)  Lot numbers: 61047182 exp 3/31/2012, 61051500 exp 3/31/2012, 61054977 exp 4/30/2012, 61059179 exp 4/30/2012, 61059180 exp 5/31/2012, 61062501 exp 5/31/2012, 61062503 exp 6/30/2012, 61067088 exp 7/31/2012, and 61073558 exp 7/31/2012;

12) Lot numbers: 61057476 exp 5/31/2012 and 61070194 exp 6/30/2012;

13) Lot numbers: 61041089 exp 2/28/2012, 61051535 exp 5/31/2012, and 61068967 exp 7/31/2012;

14) Lot number 61062522 exp 5/31/2012;

15) Lot numbers: 61030891 exp 3/31/2012, 61033511 exp 3/31/2012, 61057278 exp 5/31/2012, 61063529 exp 6/30/2012, and 61070195 exp 6/30/2012;

16) Lot numbers: 61044265 exp 2/28/2012, 61044267 exp 2/28/2012, 61044278 exp 2/28/2012, 61044279 exp 2/28/2012, 61044280 exp 2/28/2012, 61044281 exp 2/28/2012, 61044282 exp 2/28/2012, 61044283 exp 2/28/2012, 61044285 exp 3/31/2012, 61049092 exp 3/31/2012, 61049093 exp 3/31/2012, 61049095 exp 3/31/2012, 61049097 exp 3/31/2012, 61049108 exp 3/31/2012, 61049109 exp 3/31/2012, 61049110 exp 3/31/2012, 61049111 exp 3/31/2012, 61049113 exp 3/31/2012, 61049119 exp 3/31/2012, 61049123 exp 3/31/2012, 61049124 exp 3/31/2012, 61049125 exp 3/31/2012, 61049126 exp 4/30/2012, 61049127 exp 4/30/2012, 61049130 exp 4/30/2012, 61049131 exp 4/30/2012, 61049132 exp 4/30/2012, 61049133 exp 4/30/2012, 61049135 exp 4/30/2012, 61049137 exp 4/30/2012, 61049139 exp 4/30/2012, 61049140 exp 4/30/2012, 61049141 exp 4/30/2012, 61049143 exp 4/30/2012, 61049144 exp 4/30/2012, 61051044 exp 4/30/2012, 61051045 exp 4/30/2012, 61051046 exp 4/30/2012, 61051047 exp 5/31/2012,61051048 exp 5/31/2012, 61051049 exp 5/31/2012, 61051051 exp 5/31/2012, 61051053 exp 5/31/2012, 61051054 exp 5/31/2012, 61051055 exp 5/31/2012, 61051056 exp 5/31/2012, 61055284 exp 5/31/2012, 61055293 exp 5/31/2012, 61055294 exp 5/31/2012, 61055295 exp 5/31/2012, 61055296 exp 5/31/2012, 61057005 exp 5/31/2012, 61057006 exp 5/31/2012, 61057008 exp 6/30/2012, 61057009 exp 6/30/2012, 61057010 exp 6/30/2012, 61059668 exp 6/30/2012, 61059670 exp 6/30/2012, 61059671 exp 6/30/2012, 61059672 exp 6/30/2012, 61059673 exp 6/30/2012, 61060068 exp 6/30/2012, 61060069 exp 6/30/2012, 61060070 exp 6/30/2012, 61060071 exp 6/30/2012, 61060072 exp 6/30/2012, 61060075 exp 7/31/2012, 61060076 exp 7/31/2012, 61060077 exp 7/31/2012, 61060078 exp 7/31/2012, 61062981 exp 7/31/2012, 61062982 exp 7/31/2012, 61062983 exp 7/31/2012, 61062984 exp 7/31/2012, 61062985 exp 7/31/2012, 61062986 exp 7/31/2012, and 61062987 exp 7/31/2012;

17) Lot numbers: 61048470 exp 2/28/2012, 61048471 exp 3/31/2012, 61048472 exp 4/30/2012;

18) Lot numbers 61051934 exp 3/31/2012, 61051935 exp 5/31/2012, and 61062152 exp 7/31/2012;

19) Lot numbers: 61062153 exp 5/31/2012 and 61062154 exp 6/30/2012;

20) Lot numbers: 61048403 exp 3/31/2012, 61070242 exp 6/30/2012, 61077026 exp 7/31/2012, 00VL060441 exp 3/31/2012, 00VL060442 exp 3/31/2012, 00VL060443 exp 3/31/2012, and 00VL060444 exp 3/31/2012;

21) Lot numbers: 61048410 exp 3/31/2012, 61048411 exp 4/30/2012, and 61060357 exp 6/30/2012;

22) Lot numbers: 61057030 exp 4/30/2012, 61057031 exp 4/30/2012, 61057693 exp 5/31/2012, 61060762 exp 5/31/2012, and 61060767 exp 6/30/2012;

23) Lot numbers: 61048425 exp 3/31/2012, 61048427 exp 5/31/2012, 61069538 exp 6/30/2012, and 61071924 exp 7/31/2012;

24) Lot number 61061319 exp 5/31/2012;

25) Lot numbers: 61055314 exp 4/30/2012, 61060763 exp 5/31/2012, 61063024 exp 7/31/2012;

26) Lot number 61026445 exp 5/31/2012;
27) Lot number 61040224 exp 5/31/2012;
28) Lot number 61051588 exp 5/31/2012;  

29) Lot number 61062938 exp 6/30/2012;

30) Lot numbers: 61048435 exp 3/31/2012 and 61059281 exp 5/31/2012;

31) Lot number 61020609 exp 3/31/2009;

32) Lot numbers: 61040779 exp 3/31/2012, 61049780 exp 3/31/2012, 61049782 exp 5/31/2012, 61049783 exp 5/51/2012, and 61062116 exp 7/31/2012;

33) Lot numbers: 61061736 exp 4/30/2012 and 61063963 exp 6/30/2012;

34) Lot numbers: 61040801 exp 2/28/2012, 61040802 exp 2/28/2012, 61040803 exp 2/28/2012, 61040804 exp 3/30/2012, 61040805 exp 3/30/2012, 61040806 exp 3/30/2012, 61044303 exp 3/30/2012, 61044304 exp 4/30/2012, 61049787 exp 4/30/2012, 61049790 exp 4/30/2012, 61049793 exp 4/30/2012, 61049794 exp 4/30/2012, 61049795 exp 5/31/2012, 61049796 exp 5/31/2012, 61049797 exp 5/31/2012, 61049798 exp 5/31/2012, 61049799 exp 5/31/2012, 61049800 exp 5/31/2012, 61049801 exp 5/31/2012, 61057015 exp 6/30/2012, 61057016 exp 6/30/2012, 61057017 exp 6/30/2012, 61057018 exp 6/30/2012, 61057019 exp 6/30/2012, 61057200 exp 6/30/2012, 61057201 exp 7/30/2012, 61072172 exp 7/30/2012, 61072173 exp 7/30/2012, 61072174 exp 7/30/2012, and 61072175 exp 7/30/2012;

35) Lot numbers: 61040811 exp 3/31/2012, 61047472 exp 6/30/2012, 61073459 exp 7/31/2012, 61075200 exp 7/31/2012, and 61079446 exp 7/31/2012;

36) Lot numbers 61050615 exp 3/31/2012 and 61053216 exp 4/30/2012;

37) Lot numbers: 61033501 exp 4/30/2012, 61033502 exp 6/30/2012, 61067405 exp 7/30/2012, and 61067406 exp 7/31/2012;

38) Lot numbers:61044311 exp 2/28/2012, 61044313 exp 2/28/2012, 61047621 exp 3/31/2012, 61047623 exp 3/31/2012, 61049811 exp 3/31/2012, 61049812 exp 3/31/2012, 61049813 exp 3/31/2012, 61049815 exp 3/31/2012, 61049816 exp 4/30/2012, 61019817 exp 4/30/2012, 61051105 exp 4/30/2012, 61052697 exp 5/31/2012, 61057011 exp 5/31/2012, 61057012 exp 5/31/2012, 61057014 exp 5/31/2012, 61057256 exp 6/30/2012, 61061750 exp 6/30/2012, 61061751 exp 6/30/2012, 61061752 exp 7/31/2012, and 61061753 exp 7/31/2012;

39) Lot numbers: 61040943 exp 2/28/2012, 61040944 exp 2/28/2012, 61044231 exp 2/28/2012, 61044235 exp 2/28/2012, 61044237 exp 2/28/2012, 61044239 exp 2/28/2012, 61044240 exp 2/28/2012, 61044241 exp 2/28/2012, 61044242 exp 2/28/2012, 61044243 exp 2/28/2012, 61044244 exp 2/28/2012, 61044245 exp 2/28/2012, 61044246 exp 2/28/2012, 61044248 exp 2/28/2012, 61044249 exp 2/28/2012, 61044250 exp 2/28/2012, 61044251 exp 2/28/2012, 61044254 exp 2/28/2012, 61044297 exp 3/31/2012, 61044298 exp 3/31/2012, 61044299 exp 3/31/2012, 61049823 exp 3/31/2012, 61049824 exp 3/31/2012, 61049825 exp 3/31/2012, 61049826 exp 3/31/2012, 61049827 exp 3/31/2012, 61049828 exp 3/31/2012, 61049829 exp 3/31/2012, 61049830 exp 3/31/2012, 61049831 exp 3/31/2012, 61049832 exp 3/31/2012, 61049833 exp 3/31/2012, 61049835 exp 3/31/2012, 61049836 exp 3/31/2012, 61049837 exp 3/31/2012, 61049838 exp 3/31/2012, 61049839 exp 3/31/2012, 61049840 exp 3/31/2012, 61049842 exp 3/31/2012, 61049844 exp 3/31/2012, 61049845 exp 3/31/2012, 61049846 exp 3/31/2012, 61049847 exp 3/31/2012, 61049848 exp 3/31/2012, 61049849 exp 3/31/2012, 61049850 exp 3/31/2012, 61049853 exp 4/30/2012, 61049854 exp 4/30/2012, 61049855 exp 4/30/2012, 61049856 exp 4/30/2012, 61049857 exp 4/30/2012, 61049858 exp 4/30/2012, 61049859 exp 4/30/2012, 61049862 exp 4/30/2012, 61049863 exp 4/30/2012, 61049864 exp 4/30/2012, 61049865 exp 4/30/2012, 61049866 exp 4/30/2012, 61049867 exp 4/30/2012, 61049868 exp 4/30/2012, 61049869 exp 4/30/2012, 61049870 exp 4/30/2012, 61049871 exp 4/30/2012, 61049873 exp 4/30/2012, 61049874 exp 4/30/2012, 61049875 exp 4/30/2012, 61049876 exp 4/30/2012, 61049877 exp 4/30/2012, 61049879 exp 4/30/2012, 61049880 exp 4/30/2012, 61049881 exp 4/30/2012, 61049882 exp 4/30/2012, 61049883 exp 4/30/2012, 61049884 exp 4/30/2012, 61049885 exp 4/30/2012, 61049886 exp 4/30/2012, 61056985 exp 4/30/2012, 61056986 exp 4/30/2012, 61056987 exp 4/30/2012, 61056989 exp 5/31/2012, 61056990 exp 5/31/2012, 61056991 exp 5/31/2012, 61056992 exp 5/31/2012, 61056993 exp 5/31/2012, 61056994 exp 5/31/2012, 61056995 exp 5/31/2012, 61056996 exp 5/31/2012, 61056997 exp 5/31/2012, 61056998 exp 5/31/2012, 61056999 exp 5/31/2012, 61057000 exp 5/31/2012, 61057001 exp 5/31/2012, 61057412 exp 5/31/2012, 61057413 exp 5/31/2012, 61057414 exp 5/31/2012, 61057415 exp 5/31/2012, 61057416 exp 5/31/2012, 61057417 exp 5/31/2012, 61057418 exp 5/31/2012, 61057419 exp 5/31/2012, 61062537 exp 5/31/2012, 61062538 exp 5/31/2012, 61062539 exp 5/31/2012, 61062540 exp 5/31/2012, 61062541 exp 5/31/2012, 61062542 exp 5/31/2012, 61062543 exp 5/31/2012, 61062544 exp 5/31/2012, 61062545 exp 5/31/2012, 61062546 exp 5/31/2012, 61062547 exp 5/31/2012, 61062548 exp 5/31/2012, 61062549 exp 5/31/2012, 61062550 exp 5/31/2012, 61062551 exp 5/31/2012, 61062553 exp 5/31/2012, 61062554 exp 5/31/2012, 61062555 exp 5/31/2012, 61062556 exp 5/31/2012, 61062557 exp 6/30/2012, 61062558 exp 6/30/2012, 61062559 exp 6/30/2012, 61062560 exp 6/30/2012, 61062561 exp 6/30/2012, 61062562 exp 6/30/2012, 61062563 exp 6/30/2012, 61062564 exp 6/30/2012, 61062565 exp 6/30/2012, 61062566 exp 6/30/2012, 61062567 exp 6/30/2012, 61062568 exp 6/30/2012, 61062569 exp 6/30/2012, 61062570 exp 6/30/2012, 61062571 exp 6/30/2012, 61062573 exp 6/30/2012, 61062575 exp 6/30/2012, 61062576 exp 6/30/2012, 61062579 exp 6/30/2012, 61062581 exp 6/30/2012, 61062582 exp 6/30/2012, 61062587 exp 6/30/2012, 61062588 exp 6/30/2012, 61062589 exp 6/30/2012, 61062590 exp 6/30/2012, 61062591 exp 6/30/2012, 61062592 exp 6/30/2012, 61062593 exp 7/31/2012, 61062594 exp 7/31/2012, 61066526 exp 7/31/2012, 61066527 exp 7/31/2012, 61066528 exp 7/31/2012, 61066529 exp 7/31/2012, 61066530 exp 7/31/2012, 61066531 exp 7/31/2012, 61066532 exp 7/31/2012, 61066533 exp 7/31/2012, 61066534 exp 7/31/2012, 61066535 exp 7/31/2012, 61066536 exp 7/31/2012, 61066537 exp 7/31/2012, 61066538 exp 7/31/2012, 61066539 exp 7/31/2012, 61066540 exp 7/31/2012, 61066541 exp 7/31/2012, 61066542 exp 7/31/2012, 61066543 exp 7/31/2012, 61066914 exp 7/31/2012, 61066917 exp 7/31/2012, 61066918 exp 7/31/2012, 61066921 exp 7/31/2012, 61066924 exp 7/31/2012, 61066926 exp 7/31/2012, 61066927 exp 7/31/2012, 61066929 exp 7/31/2012, 61068262 exp 7/31/2012, 00VL044293 exp 3/31/2012, 00VL044294 exp 3/31/2012, 00VL044295 exp 3/31/2012, and 00VL044296 exp 3/31/2012;

40) Lot numbers 61049890 exp 4/30/2012 and 61065789 exp 7/31/2012;

41) Lot numbers: 61049891 exp 3/31/2012, 61049892 exp 4/30/2012, and 61057424 exp 5/31/2012;

42) Lot number 61049893 exp 4/30/2012;

43) Lot number 61034231 exp 5/31/2012;

44) Lot number 61034234 exp 2/28/2012;

45) Lot numbers: 61040883 exp 3/31/2012, 61040884 exp 3/31/2012, 61049913 exp 4/30/2012, 61049921 exp 5/31/2012, 61049922 exp 6/30/2012, 61062697 exp 6/30/2012, 61067409 exp 6/30/2012, and 61072164 exp 7/31/2012;

46) Lot numbers: 61034251 exp 2/28/2012 and 61062727 exp 6/30/2012;

47) Lot numbers: 61041162 exp 2/28/2012, 61051425 exp 3/31/2012, 61057269 exp 4/30/2012, 61057270 exp 5/31/2012, and 61062967 exp 7/31/2012;

48) Lot numbers: 61034264 exp 3/31/2012, 61055331 exp 5/31/2012, and 61061757 exp 7/31/2012;

49) Lot numbers: 61040889 exp 3/31/2012, 61040890 exp 3/31/2012, 61049971 exp 4/30/2012, 61049978 exp 5/31/2012, 61057472 exp 5/31/2012, 61067441 exp 6/30/2012, 61067532 exp 7/31/2012, and 61072167 exp 7/31/2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown, PA, by letters on November 30, 2009 and December 1, 2009.
Manufacturer: B. Braun Medical Inc., Santo Domingo, Dominican Republic. Firm initiated recall is ongoing.
REASON
System error 9 alarms. A System Error 9 alarm indicates a potential pressure loss in the pump cassette delivery chamber (chamber closest to the patient). This alarm is generated during the pumps initiation sequence and will not allow the set to be utilized. This requires a new set to be obtained, thus creating a potential for delay in therapy.
VOLUME OF PRODUCT IN COMMERCE
5,435,249 units
DISTRIBUTION
Nationwide, Afghanistan, Canada and LU
___________________________________
PRODUCT
1) Stryker CBCII ConstaVac Blood conservation system, sterile, REF 225-28E. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0719-2010;

2) Stryker CBCII collection only pkg/6, sterile, REF 225-28-S20. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0720-2010;

3) Stryker CBC Blood Conservation Kit with Quick Disconnect Blood Bag, sterile, REF 225-28-85. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0721-2010;

4) Stryker CBCII 1/8in. Double Trocar with quick disconnect , sterile, REF225-28-85S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0722-2010;

5) Stryker CBCII with Quick Disconnect, 3/16 in. Double Trocar and Reinfusion Labels, sterile, REF 225-28-85S4. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0723-2010;

6) Stryker CBCII with Quick Disconnect and 3/16 in. Double Trocar, sterile, REF 225-28-S5. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0724-2010;

7)  Stryker CBCII Blood Conservation Kit w/ 1/8 in. (3.2mm) Round PVC Drain and Curved Trocar, sterile; REF 225-28-514. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0725-2010;

8) Stryker CBCII Blood Conservation Kit w/ 1/4 in. (6.4mm) Round PVC Drain and Curved Trocar, sterile, REF 225-28-516. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0726-2010;

9) Stryker CBCII Blood Conservation Kit w 3/16in. (4.8mm) round PVC Drain and Curved Trocar, sterile, REF 225-28-526. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0727-2010;

10) Stryker CBCII Double Trocar Kit with 1/8 in. (3.2mm) Drain, sterile, REF 225-28-614. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0728-2010;

11) Stryker CBCII Double Trocar Kit with 1/4in. (6.4mm) Drain, sterile, REF 225-28-616. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0729-2010;

12) Stryker CBCII Double Trocar Kit with 3/16in. (4.8mm) Drain, sterile, REF 225-28-626. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0730-2010;

13) Stryker CBCII Double Trocar/Double Pouch Kit with 3/16in. (4.8mm) Drain, sterile, REF 225-28-626S1. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0731-2010;

14) Stryker CBCII ConstaVac Blood Conservagtion System w/ Quick Disconnect and 1/8in. (3.2mm) PVC Drain, sterile, REF 225-28-914. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0732-2010;

15) Stryker CBCII ConstaVac Blood Conservation System with Quick Disconnect and 1/4in. (6.4mm) PVC Drain, sterile, REF 225-28-916. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0733-2010;

16) Stryker CBCII ConstaVac Blood Conservation System w/Quick Disconnect and 3/16in. (4.8mm) PVC Drain, sterile, REF 225-28-926. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0734-2010;

17) Stryker CBCII ConstaVac Blood Collection Only System with 1/8in. (3.2mm) PVC Drains and Double 1/8in. (3.2mm) Trocar, sterile, REF 225-29. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0735-2010;

18) Stryker CBCII ConstaVAc Blood Conservatin Kit 1/8in. (3.2mm) PVC, sterile, REF 225-414. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0736-2010;

19) Stryker CBCII ConstaVac Blood Conservation Kit 1/8in. (3.2mm) PVC w/o Fat Retention Valve, sterile, REF 225-414S2. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0737-2010;

20) Stryker CBCII ConstaVac Blood Conservaion Kit 1/8in. (3.2mm) PVC, sterile, REF 225-414-W. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0738-2010;

21) Stryker CBCII ConstaVac Blood Conservation Kit 1/4in. (6.4mm) PVC, sterile, REF 225-416. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0739-2010;

22) REF 225-426. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0740-2010;

23) Stryker CBCII with 3/16 in. Silicone Drain, sterile, REF 0225-028-S16. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0741-2010;

24) Stryker CBCII Collection only pkg/6 with 1/8 in Trocar, sterile, REF 0225-028-S21. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0742-2010;

25) Stryker CBC ConstaVac Blood Conservation Kit 3/16in. (4.8mm) PVC, sterile, REF 225-426-W. Blood recovery system used post-operatively to collect, filter and allow for reinfusion of autologous blood. Recall # Z-0743-2010
CODE
1) Serial numbers 07303012 through 09173032;
2) Serial numbers 07355012 through 08353012;
3) Serial numbers 07303012 through 09183012;
4) Serial numbers 07306012 through 09163012;
5) Serial numbers 07362012 through 09187012;
6) Serial numbers 08128012 through 09129012;
7) Serial numbers 07303012 through 09104012;
8) Serial numbers 07323012 through 09149012;
9) Serial numbers 07310012 through 09113012;
10) Serial numbers 07311012 through 09183022;
11) Serial numbers 07316012 through 09114012;
12) Serial number 07311012 through 09176012;
13) Serial number 07362012 through 09183012;
14) Serial numbers 07305012 through 09187012;
15) Serial numbers 07310012 through 09159012;
16) Serial numbers 07305012 through 09174012;
17) Serial number 07356012 through 09169012;
18) Serial numbers 07305012 through 09177012;
19) Serial number 07361012 through 09105012;
20) Serial numbers 07318022 through 09189012;
21) Serial number 07305012 through 09168012;
22) Serial number 07304012 through 09178012;
23) Serial number 07317012 through 09192012;
24) Serial numbers 08016012 through 09115012;
25) Serial numbers 07318012 through 09189012;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Medical Div. of Stryker Corp., Portage, MI, by letter dated November 12, 2009.
Manufacturer: Stryker Puerto Rico, LTD, Arroyo, PR. Firm initiated recall is ongoing.
REASON
The product may not be sterile due to package not being intact.
VOLUME OF PRODUCT IN COMMERCE
79,617 units
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II
___________________________________
PRODUCT
1) Scour-Ease plus Concentrate, Type B Medicated Feed. A calf supplement to be mixed with dry non-medicated milk replacer powder to make a complete medicated Type C milk replacer ration for dairy and beef replacement calves. Medicated with the highest approved levels of Neomycin and Oxytetracycline. Active Drug Ingredients: Neomycin Sulfate ...10g/lb.; Oxytetracycline (from Oxytetracycline Dihydrate)...10g/lb., equivalent to Oxytetracycline Hydrochloride. Packaged in 2 different sized packages: 1) Net Wt 40 lb. (18.14kg), UPC 95668-93914; 2) Net Wt 5.55 lb. (2.52 kg), UPC 95668-94256. Recall # V-017-2010;

2) Sav-A-Caf Scours & Pneumonia Treatment, Medicated Calf Milk Replacer. Scours & Pneumonia Treatment is a nutritionally complete medicated milk replacer to be fed to pre-weaned herd replacement calves continuously for 7 to 14 days in place of normal calf milk replacer. Active Drug Ingredients: Neomycin Sulfate...1.25 g/lb., Oxytetracycline...1.25 g/lb. (from Oxytetracycline Dihydrate) equivalent to Oxytetracycline Hydrochloride. Net Weight 6 lbs., (2.72 kg). UPC 16368-53028.  Recall # V-018-2010;

3) SROC 20-20 AM NT 1600 Medicated. Milk Replacer to be fed to heard replacement calves. Active Drug Ingredient(s): Neomycin Base (from Neomycin Sulfate). 1600g/ton; Oxytetracycline.....1600g/ton. Net Weight 50 lb., (22.68 kg).
Recall # V-019-2010
CODE
1) 00-9391 ScourEase+ AH919AZ 00-9391 ScourEase+ AH920CZ;
2) 01-7530 Scr & Pneum Trt AJ923CZ, AK913AZ, AM907AZ, AM908AZ;
3) 01-2060 SROC AG927
RECALLING FIRM/MANUFACTURER
Milk Products, LLC., Chilton, WI, by telephone, e-mail and letter on December 11, 2009 and by letter dated December 16, 2009.
REASON
This recall has been initiated due to the use of Type A medication past its expiration date.
VOLUME OF PRODUCT IN COMMERCE
13, 847 lbs.
DISTRIBUTION
AL, AR, IA, ID, KS, KY, MN, MO, NE, PA, TX, WI
___________________________________
PRODUCT
Herman Prefresh Complete Pel 2 tons. Order number: 456285 02, Product number: 324TH, Delivery date: 11/18/2009. Recall # V-020-2010
CODE
No lot or serial numbers
RECALLING FIRM/MANUFACTURER
Kalmbach Feeds Inc., Upper Sandusky, OH, by telephone on November 18, 2009. Firm initiated recall is ongoing.
REASON
The recalling firm mistakenly shipped a single load of medicated swine feed containing carbadox to a dairy farm and labeled the feed as the complete dairy feed which was to have been delivered.
VOLUME OF PRODUCT IN COMMERCE
4,060 lbs.
DISTRIBUTION
OH

END OF ENFORCEMENT REPORT FOR FEBRUARY 3, 2010

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