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U.S. Department of Health and Human Services

Safety

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Enforcement Report for September 23, 2009

September 23, 2009
09-38

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

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PRODUCT 
1) Kashi TLC Chewy Granola Bars, Trail Mix, 6 - 1.2 oz, net wt. 7.4 oz; UPC 1862703000. Recall # F-1089-9;

2) Kashi TLC Chewy Granola Bars, Honey Almond Flax, 6 - 1.2 oz, net wt. 7.4 oz; UPC 1862703001. Recall # F-1090-9;

3) Kashi TLC Chewy Granola Bars, Peanut Peanut Butter, 6 - 1.2 oz, net wt. 7.4 oz; UPC 1862703002. Recall # F-1091-9;

4) Kashi TLC Chewy Granola Bars, Honey Almond Flax, Trail Mix, Peanut Peanut Butter, 3 - 7.4 oz, net wt. 22.2 oz, UPC 1862723959 and 25 - 1.2 oz bars, net wt 30.9 oz, UPC 1862728409. Recall # F-1092-9;

5) Kashi GO LEAN Crunch protein and fiber cereal, honey almond flax, with a free Kashi TLC Chewy Granola Bar, Honey Almond Flax, 1.2 oz; cereal UPC 1862739683 and bar UPC 1862703001. Note: only the granola bar is under recall. The cereal is not under recall. Recall # F-1093-9;

6) Kashi TLC Chewy Cookies, Oatmeal Dark Chocolate. Kashi TLC Chewy Cookies, Oatmeal Dark Chocolate, net wt. 8.5 oz; UPC 1862762001 and 1862742593; Kashi TLC Chewy Cookies, Oatmeal Dark Chocolate, 3 - 8.5 oz boxes, net wt. 25.4 oz; UPC 1862734267. Recall # F-1094-9;

7) Kashi TLC Chewy Cookies, Oatmeal Raisin Flax, net wt. 8.5 oz; UPC 1862762003. Recall # F-1095-9  
CODE
1) All lots with a Best If Used Before date prior to September 10, 2009. An example of a code is JUN1809 CDB4, where JUN1809 stands for June 18, 2009;

2) All lots with a Best If Used Before date prior to September 10, 2009;

3) All lots with a Best If Used Before date prior to August 8, 2009;

4) All trail mix and honey almond flax bars with a Best If Used Before date prior to September 10, 2009. All peanut peanut butter bars with a Best If Used Before date prior to August 8, 2009.

5) All lots the granola bar with a Best If Used Before date prior to September 10, 2009;

6) and 7) All lots with a Best If Used Before date prior to July 30, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kashi Co, San Diego, CA, by press release and letters on February 2, 2009. 
Manufacturer: Cherrydale Manufacturing LLC, Allentown, PA. Firm initiated recall is complete.
REASON
The product was manufactured on the same line as product using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
38,973,181 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Kashi TLC Chewy Cookies, Happy Trail Mix, net wt. 8.5 oz; UPC 1862762002. Recall # F-1096-9;

2) Kashi TLC Chewy Cookies, Happy Trail Mix /Oatmeal Raisin Flax, 3- 8.5 oz boxes, net wt. 25.4 oz; UPC 1862731567. Recall # F-1097-9
CODE
All lots with a Best If Used Before date prior to July 30, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kashi Co, San Diego, CA, by press release and letters on February 2, 2009. 
Manufacturer: Biscomerica, Inc, Rialto, CA. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
16,913,446 packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Half-Gallon Central Dairy Candy Bar Whirl Ice Cream, UPC 073948-06313, 3 gallon Central Dairy Candy Bar, no UPC. Recall # F-1098-9
CODE
Lots 15108 through 01209
RECALLING FIRM/MANUFACTURER
Prairie Farms Dairy, Jefferson City, MO, by telephone and letter on February 2, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
5,379 – ½ gallon units and 23 – 3 gallon units
DISTRIBUTION
MO
___________________________________
PRODUCT 
1)  French Burnt Peanuts, sugar coated peanuts packaged under the following labels: a) Superior Candies French Burnt Peanuts, Net Wt. 3 oz. plastic film bags 12 bags per case, UPC 7 22648 98429 9; b) Felix & Oscar's French Burnt Peanuts, Net Wt. 11 oz (312.4g) clear plastic tubs, 6 tubs per case, UPC 8 36576 00212 0; c) Garden Fresh French Burnt Peanuts, Net Wt. 14 oz. (397g) clear plastic tubs, 12 per case, UPC 6 85603 57772 4. Recall # F-1099-9;

2) Boston Baked Beans, candy coated peanuts a) Stuckey's Big Bag Boston Baked Beans, Net Wt. 11 oz. (311.9g) plastic film bags, 12 bags per case, UPC 0 91976 32228 9; b) Garden Fresh Boston Baked Beans, Net Wt. 20 oz. clear plastic tubs, 12 per case, UPC 6 85603 57773 1. Recall # F-1100-9;

3) Superior Southwest Mix, Net Wt. 8 oz (227g) plastic bags, 6 bags per case; UPC 7 22648 65420 8. Recall # F-1101-9;

4) Superior Veracruz Spicy Nut Mix, Net Wt. 5.5 oz (155g) and 7.75 oz. plastic bags, 12 bags per case; UPC 7 22648 98733 7 (note: the same UPC code is on both size packages). Recall # F-1102-9;

5) International Santa Cruz Mix; 25 lb. bulk poly-lined cases; item 34009.  Recall # F-1103-9
CODE
1) a) Lot numbers: 333 7, 117 8, 218 8, 024 9; b) Lot number: 01 07 08; c) Lot numbers:  200 8, 214 8, 224 8, 228 8, 235 8, 246 8, 255 8, 280 8;
 
2) a) Lot number:  197 8; b) lot number: 235 8 07 03 08;

3) Lot numbers: 203 8, 123 8, 102 8;

4) Lot numbers: 217 8, 191 8, 011108, 01109;

5) Lot number: 07 28 08
RECALLING FIRM/MANUFACTURER
Superior Nut & Candy Dist. Co., Chicago, IL, by press release on February 15, 2009. 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
2,317 cases
DISTRIBUTION
FL, GA, IL, MD, NM, SC, WI
___________________________________
PRODUCT 
Chef Sunshine Brand Creamy Peanut Butter, Ingredients: Peanuts, Dextrose Hydrogenated Vegetable Oil and Salt. # 10 Cans - Code # 393-112, Net Wt. 6 lbs. 14 oz ; Plastic Tub - Code 070509, Net Wt 5 lb; and Plastic Tub - Code 020908, Net Wt. 10 lbs. Recall # F-1104-9
CODE
Lot numbers: 070509 and 020908
RECALLING FIRM/MANUFACTURER
Sunshine Peanut Company, Jacksonville, FL, by telephone, e-mail and letter on February 13, 2009. Firm initiated recall is complete.
REASON
The product was 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
41,000 lbs
DISTRIBUTION
VA, AL
___________________________________
PRODUCT 
1)  Graeter's brand Chocolate Bridge Mix, 12 oz size packaged in clear plastic bags, Product #F5999, UPC Code: 100006090959990 2. This product is labeled as containing the following ingredients: Milk Chocolate, pecans, cashews, almonds, peanuts, raisins, and confectioners glaze. Recall # F-1105-9;

2) Graeter's brand Milk Chocolate Covered Peanuts, 12 oz size packaged in clear plastic bags, Product #F5100, UPC Code: 1000060951000 6. Recall # F-1106-9
CODE
Product code only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Graeters Manufacturing Inc., Cincinnati, OH, by press release on February 6, 2009.  
Manufacturer: Madelaine Choc. Novelty Co. Ltd, Rockaway Beach, NY. Firm initiated recall is complete.
REASON
The product was 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
740 lbs. of chocolate peanuts and 83 lbs. of bridge mix
DISTRIBUTION
OH
___________________________________
PRODUCT 
1) CUB Foods Peanut Butter Cookies, 12 CT, Net Wt. 12 oz, UPC 41303-63070 24 CT, Net Wt. 24 oz, UPC 41303-63003. Recall # F-1108-9;

2) CUB Foods Peanut Butter Blossom, tray 9 in 36 ct, Net Wt. 22 oz, UPC 41303-63056; 18 CT, Net Wt. 11 oz, UPC 41303-67091. Recall # F-1109-9;

3) CUB Foods Iced Peanut Butter Cookies, 12 CT, 12 oz, UPC 41303-63028. Recall # F-1110-9
CODE
Sell by date through and including 01/26/09 
RECALLING FIRM/MANUFACTURER
Recalling Firm: Supervalu, Inc. Eden Prairie, MN, by press release on January 20, 2009. 
Manufacturer: Best Brands Corp., Minnetonka, MN. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
IA, MN
___________________________________
PRODUCT 
1) Trail mix: Quick Fix Trail Mix sold in 2 oz and 8 oz cellophane bags. Packages labeled in part. Recall # F-1111-9;

2) Trail Mix: Trail Fix Trail Mix sold in 2 oz and 8 oz cellophane bags. Recall # F-1112-9;

3) Trail Mix: Gourmet's Delight Trail Mix sold in 2 oz and 8 oz cellophane bags. Recall # F-1113-9
CODE
None
RECALLING FIRM/MANUFACTURER
Rock Creek Nut Co., Union, OR, by telephone on or about February 18, 2009 and by press release on March 10, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
38,030 retail packages
DISTRIBUTION
GA, HI, MN, OR, PA, WA
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PRODUCT 
Instant Non Fat Dry Milk, Vitamins A & D Added, Net Wt. 20 grams packaged in shelf stable meal kits. The meals are packaged in small white boxes that have no identifying information and consist of single-serving size food items. Recall # F-1115-9
CODE
Meals purchased prior to July 2, 2009 
RECALLING FIRM/MANUFACTURER
CPI Foods, Dallas, TX, by press release on July 2, 2009.  Firm initiated recall is ongoing.
REASON
Products were manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
15,320 packets
DISTRIBUTION
WV, TX, NC, AZ, TX NV, OK, KY
___________________________________
PRODUCT 
1) Vanilla Creme Instant Pudding; Artificially flavored; 7 packets, total net weight 5.1 oz. Also distributed under the label of Advance Health Systems. Also other private labels - Before & After Weight Loss Clinic Diet Center Diet Health & Sports Family Bariatric Fitness Bootcamp Unlimited Form You3 Inches-A-Weigh Wt Loss Ct for Women Liberty Fitness Lifestyles Wt. Control Centers Metabolic Medical Centers PROFAST Metabolic Research Centers Monarch Medical Wt Loss Center New Direction New Lifesytle Wt Loss Physicians Weight Loss Centers PhysiciansFAST Results! Weight Loss Self Center Step One Weight Loss & Wellness Sues Nu-Energy Weight Control Center The Weight Management Program Weight No More WonderSlim. ID code CLN VP01. Recall # F-1116-9;  

2) New Direction Cream of Chicken Soup Mix; Artificially Flavored; 7 packets - total net weight 12/8 oz; ID Code NMPCC5; Recall # F-1117-9;

3) New Direction Weight Control System - Variety Pack; Contains: 7 packets (4-1/7 oz. beverages, 1-1.7 oz hot cocoa, 1 - 1.2 oz pudding, 1-1.8 oz soup); total new weight 12.4 oz); NMPVP4 UPC 6 46049 00713 8. Recall # F-1118-9;

4) Dulce de Leche instant Caramel Pudding, Artificially Flavored; 7 packets - total net weight 5.8 oz. Packaged under the label of Advance Health Systems and other private labels: Austin Bariatric Clinic PA betterMD.net Connecticut Weight & Wellness Diet Center Diet Health & Sports Diet High Protein.com Dr.'s Maberys Optimal Weight & Wellness Ctrs Fitness Bootcamp Unlimited Form You3 Healthy Inspirations Inches-A-Weigh Wt Loss Ct for Women Liberty Fitness Lifestyles Wt. Control Centers Lindora Medical Weight Loss Clinic New Direction New Lifesytle Wt Loss Nutmeg State Weight Management NutriBest Physicians Weight Loss Centers PhysiciansFAST Quick Weight Loss Centers Results! Weight Loss Slim4life thermo Snacks The Weight Management Program Trim 360 Weight Loss Weight Loss Systems by Nashua Nutrution Weight No More WonderSlim You Food. ID Code DD01. Recall #F-1119-9;

5) Lemon Chiffon Instant Pudding, Artificially flavored; 7 packets - total net weight: 5.4 oz; Packaged under the label of Advanced Health Systems and other private labels: Bariatrics of Alabama betterMD.net Clinical Nutrition Center Diet Health & Sports Diet High Protein.com Dietary Ways Doctors Best Weight Loss Dr.'s Maberys Optimal Weight & Wellness Ctrs Family bariatric Focus 28 Inc. Health Management & Nutrition Healthy Inspirations Inches-A-Weigh Wt Loss Ct for Women Lifestyles Wt. Control Centers Lindora Medical Weight loss Centers LLC Metabolic Medical Centers PROFAST Metabolic Research Centers New Direction New Lifesytle Wt Loss Nutmeg State Weight Management NutriBest Optimum Health Formulas Physicians Weight Loss Centers PhysiciansFAST Diet Center Form You3 Liberty Fitness Quick Weight Loss Centers Results! Weight Loss Slim 4 Life St Vincent Healthcare The Leangevity Center The Weight Management Program Trim 360 Weight Loss Weight Loss Systems by Nashua Nutrution WonderSlim You Food. ID Code LP01. Recall # F-1120-9;

6) Creamy Vanilla Shake Mix, Artificially Flavored; 7 packets - Total net weight 6.3 oz; Packaged under the mane of Advanced Health Systems and other private labels: Advanced Health Systems Diet Center Doctors Best Weight Loss Form You3 Inches-A-Weigh Wt Loss Ct for Women Liberty Fitness Lindora MediSlim New Direction Physicians Weight Loss Centers PhysiciansFAST Results! Weight Loss The Leangevity Center Weight No More. ID code: CLN VS01. Recall # F-1121-9;

7) Nutrimed 420 Chocolate Artificially Flavored Nutritional Supplement; 7 packets - total net weight 6.5 oz; Code ID N+C2. Recall # F-1122-9;

8) Nutrimed 420 Strawberry Artificially Flavored Nutritional Supplement; 7 packets - total net weight 6.4 oz.; Packaged under the label of Advance Health Systems and other private labels to follow. Code N+S2. Recall # F-1123-9;

9) Nutrimed 420 Vanilla Artificially Flavored Nutritional Supplement; 7 packets - total net weight 6.6 oz.; ID Code N+V2. Recall # F-1124-9;

10) NutriMed 160 Chocolate Shake, Artificially Flavored; 7 packets - total net weight: 10.1 oz.; also packaged under the private labels of: North Star Medical St Vincent Healthcare; ID Code MN160C. Recall # F-1125-9;

11) NutriMed 160 Vanilla Shake, Artificially Flavored; 7 packets - total net weight: 10.2 oz.; also packaged under the private labels of: North Star Medical St Vincent Healthcare. ID Code NM160V. Recall # F-1126-9
CODE
1) Lot codes: R9052, R9090, R9452, R9604;

2) Lot codes: R9125, R9234, R9367, R9548, R9628, R9789;

3) Lot codes: 09012217, 09022717, 09032317, 09051217, 09061217. Note: Since the variety box contains multiple products, a date of packaging is used as the lot code (Year, month, day, and variety #);

4) Lot codes: R9147, R9306, R9540, R9545, R9735;

5) Lot codes R9093, R9212, R9315, R9316, R9492, R9495, R9677, R9683;

6) Lot code: R9048, R9199, R9205, R9388, R9480, R9664;

7) Lot codes: R9108, R9248, R9342, R9498, R9767;

8) Lot code: R9114, R9644;

9) Lot codes: R9271, R9634;

10) Lot code: R9151;

11) Lot codes: R9130, R9145
RECALLING FIRM/MANUFACTURER
Food Sciences Corp., Mount Laurel, NJ, by letter on July 10, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using an ingredient recalled by Plainview Milk Products because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
798,406 packets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Simbree Oat Almond Pistash and Simbree Oat Bites with Peanuts, Almonds and Pistachios/ Bouches d'avoine aux arachides, amandes et pistaches, 15 oz and 6 oz, sold in clear plastic canisters. Labeled in part... Ingredients: Rolled oats, wild blackberry honey, dry roasted peanuts... UPC codes are found on US and Canadian individual packages and Canadian cases only. United States and Canadian UPC codes for 15oz/426g individual packages: 8 9484800002 1, and 6oz/170g individual packages: 8 9484800006 9; Canadian only case UPC codes 15oz/170g: 8 9484800027 4, and 6 oz/170g 8 9484800024 3. Recall # F-1131-9;  

2) Simbree Almond Pistachio Energy Bites, 6 oz (170 g), sold in plastic pre-printed bags. Labeled in part, "SIMBREE energy bites Almond Pistachio... Net wt. 6 oz... INGREDIENTS: Rolled oats*, Wild blackberry honey, ground peanuts*... United States and Canadian UPC codes for 6 oz/170g individual packages: 8 9484800006 9 and Canadian case UPC codes for 6oz/170g: 8 9484800024 3. Recall # F-1132-9
CODE
The expiration dates range from 02/2009-02/2010. 
RECALLING FIRM/MANUFACTURER
Recalling Firm: Simbree, LLC, Seattle, WA, by e-mail and telephone on January 29, 2009 and by press release on January 30, 2009. 
Manufacturer: Key Lime West, Inc., Garden Grove, CA. Firm initiated recall is complete.
REASON
VOLUME OF PRODUCT IN COMMERCE
3,078 individual packages
DISTRIBUTION
AK, MT, PA, WA, and Canada
___________________________________
PRODUCT 
1) Goo Goo Cluster, Milk Chocolate, Peanuts, Caramel & Marshmallow, Net Wt. 1.75 oz (50g), single, 6 pack, 10 pack and 24 pack. UPC: 24 pack - 0 72150 001114; 10 pack - 277376; single bar - 0 7215000101 5; 6 pack - 0 72150 00102 2. Recall # F-1133-9;

2) Goo Goo Peanut Butter, Milk Chocolate, Peanuts & Peanut Butter, Net wt. 1.5oz (43g), 4 pack. UPC: 0 72150 24054 4. Recall # F-1134-9
CODE
1) Best by 070209;
2) Best by 091909
RECALLING FIRM/MANUFACTURER
Standard Functional Foods Group, Nashville, TN, by press release on February 2, 2009 and by letter on February 3, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
464,664 pieces
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Superior Nut Company Item # 7155; 6-4 lbs cans; Item #7150, 30 lb. cases- Chopped Sifted Peanuts. Recall # F-1135-9;

2) Superior Nut Company Item # 6145; 6-3.5 lbs cans- 3 to 1 Chopped Mixed Nuts. Recall # F-1136-9;

3) Superior Nut Company Item # 6180, 30# cases; Item #6185, 6/3.5 cans - Chopped Mixed Nuts 50% Peanuts. Superior Nut Company Item #6185; 6 -- 3.5 lbs cans - Chopped Mixed Nuts 50% Peanuts. Recall # F-1137-9;

4) Superior Nut Company Item # 8415; 500# - Chunky Variegate Liquid Peanut Butter. Recall # F-1138-9
CODE
All Lot #'s Ending in 07 and 08
RECALLING FIRM/MANUFACTURER
Superior Nut Co., Inc., Cambridge, MA, by telephone and follow-up letter on January 30, 2009. Firm initiated recall is ongoing.
REASON
Product was 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
76,542 lbs
DISTRIBUTION
CT, MA, ME
___________________________________
PRODUCT 
1) Rainbow Mix, Item #15161 - packed in 30 lb cardboard box w/plastic liner; Item #15164 - packed in 5 lb. clear plastic bags; and Item #15166 - packed in 1 lb clear plastic bags. Recall # F-1139-9;

2) Sesame Nut Mix, Item #15551 - packed in 25 lb cardboard box w/plastic liner; Item #15554 - packed in 5 lb. clear plastic bags; and Item #15556- packed in 1 lb clear plastic bags. Recall # F-1140-9;

3)  Student Food Mix, Item #15601 - packed in 30 lb cardboard box w/plastic liner; Item #15604 - packed in 5 lb. clear plastic bags; and Item #15606 - packed in 1 lb clear plastic bags. Recall # F-1141-9;

4) Oriental Snack Mix, Item Numbers: 15441, 15444, and 15446. The product is packed in 20 lb Cardboard boxes w/plastic liners (15441); 5 lb clear plastic bags (15444); and 1 lb. clear plastic bags (15446). Recall # F-1142-9;

5) Sweet & Salty Crunch Mix , Item Numbers: 15661, 15664, 15666, packed in 30 lb Cardboard boxes w/plastic liners (15661); 5 lb Clear plastic bags (15654); and 1 lb. Clear plastic bags (15666). Recall # F-1143-9;

6) Sweet & Spicy Crunch, Item Numbers: 15651, 15654 and 15656. Packed in 25 lb Cardboard boxes w/plastic liners (15651); 5 lb Clear plastic bags (15654); and 1 lb. Clear plastic bags (15656). Recall # F-1144-9;

7) Trail Mix, Item Numbers: 15701, 15704, and 15706. The recalled product is packed in 30 lb Cardboard boxes w/plastic liners (15701); 5 lb clear plastic bags (15704); and 1 lb. clear plastic bags (15706). Recall # F-1145-9;

8) Yogurt Nut Delight, Item Numbers: 15793, 15794, and 15795, packed in 25 lb Cardboard boxes w/plastic liners (15793); 5 lb clear plastic bags (15794); and 1 lb. clear plastic bags (15795). Recall # F-1146-9:

9) Chocolate Nut Delight, Item Numbers: 15121, 15124, and 15126, packed in 30 lb Cardboard boxes w/plastic liners (15121); 5 lb clear plastic bags (15124); and 1 lb. clear plastic bags (15126). Recall # F-1147-9;  

10)  Bar & Pub Snack Mix, Item Numbers: 15061, 15064 and 15066, packed in 25 lb Cardboard boxes w/plastic liners (15061); 5 lb clear plastic bags (15064); and 1 lb. clear plastic bags (15066). Recall # F-1148-9;

11) Casino Nut Mix, Item Numbers: 15091, 15094 and 15096, packed in 20 lb Cardboard boxes w/plastic liners (15091); 5 lb clear plastic bags (15094); and 1 lb clear plastic bags (15096). Recall # F-1149-9;

12) Cherry Berry Delight Nut Mix, Item Numbers: 15133, 15134, and 15136, 20 lb Cardboard boxes w/plastic liners (15133); 5 lb clear plastic bags (15134); and 1 lb. clear plastic bags (15136). Recall # F-1150-9;
 
13) Country Club Mix, Item Numbers: 15141, 15144, and 15146, packed in 25 lb Cardboard boxes w/plastic liners (15141); 5 lb clear plastic bags (15144); and 1 lb. clear plastic bags (15146). Recall # F-1151-9;

14) Diet Trail Mix, Item Numbers: 15201, 15204, and 15206, packed in 30 lb Cardboard boxes w/plastic liners (15201); 5 lb clear plastic bags (15204); and 1 lb. clear plastic bags (150206. Recall # F-1152-9;

15) Firecracker Hot and Spicy Mix, Item Numbers: 15241, 15244, and 15246, packed in 25 lb Cardboard boxes w/plastic liners (15241); 5 lb clear plastic bags (15244); and 1 lb. clear plastic bags (15246). Recall # F-1153-9;
 
16) Nuts w/Peanuts Roasted and Salted, Item Numbers: 13431, 13434, and 13436, packed in 25 lb Cardboard boxes w/plastic liners (13431); 5 lb clear plastic bags (13434); and 1 lb. clear plastic bags (13436). Recall # F-1154-9;

17) Nutty Cheddar Mix, Item Numbers: 15431, 15434, and 15436, packed in 25 lb Cardboard boxes w/plastic liners (15431); 5 lb clear plastic bags (15434); and 1 lb clear plastic bags (15436). Recall # F-1155-9;

18) Peanut Blanched Roasted and Non-salted, Item Numbers: 13471, 13474, 13476, packed in 30 lb Cardboard boxes w/plastic liners (13471); 5 lb clear plastic bags (13474); and 1 lb clear plastic bags( 13476). Recall # F-1156-9;

19) Peanuts Blanched Roasted and Salted, Item Numbers: 13481, 13484 and 13486, packed in 30 lb Cardboard boxes w/plastic liners (13481); 5 lb clear plastic bags (13484); and 1 lb clear plastic bags (13486). Recall # F-1157-9;

20) Salted Dry Roasted Peanuts, Item Numbers: 13511, 13514, and 13516, packed in 30 lb Cardboard boxes w/plastic liners (13511); 5 lb clear plastic bags (13514); and 1 lb clear plastic bags (13516). Recall # F-1158-9;

21) Peanuts Spanish Roasted and Salted, Item Numbers: 13691, 13694, 13696, in 30 lb Cardboard boxes w/plastic liners (13691); 5 lb clear plastic bags (13694; and 1 lb clear plastic bags (13696). Recall # F-1159-9;

22) Peanut Splits Roasted and Non-Salted, Item Numbers: 13711, 13714, and 13716, packed in 30 lb Cardboard boxes w/plastic liners (13711); 5 lb clear plastic bags (13714; and 1 lb clear plastic bags (13716). Recall # F-1160-9;

23) Peanuts Granulated Roasted and Non-Salted, Item Numbers: 13551, 13554, 13556, packed in 30 lb Cardboard boxes w/plastic liners (13551); 5 lb clear plastic bags (13554; and 1 lb clear plastic bags (13556). Recall # F-1161-9;

24) Peanuts Dry Roasted Non-Salted, Item Numbers: 13501, 13504, and 13506, packed in 30 lb Cardboard boxes w/plastic liners (13501); 5 lb clear plastic bags (13504; and 1 lb clear plastic bags (13506). Recall # F-1162-9;

25) Peanuts, Honey Roasted, Item Numbers: 13591, 13594, and 13596, packed in 30 lb Cardboard boxes w/plastic liners (13591); 5 lb clear plastic bags (13594; and 1 lb clear plastic bags (13596). Recall # F-1163-9;

26) Peanuts Redskin Roasted and Non-Salted, Item Numbers: 13641, 13644, and 13646, packed in 30 lb Cardboard boxes w/plastic liners (13641); 5 lb clear plastic bags (13644; and 1 lb clear plastic bags (13646). Recall # F-1164-9;

27) Peanuts, Spanish Roasted and Non-Salted, Item Numbers: 13671, 13674, 13676, packed in 30 lb Cardboard boxes w/plastic liners (13671); 5 lb clear plastic bags (13674; and 1 lb clear plastic bags (13676). Recall # F-1165-9;

28) Double Dipped Chocolate Peanuts, Item Number: 20391. The recalled product is packed in 25 lb. cardboard box w/plastic liners. Recall # F-1166-9;
 
29) Chocolate Dipped Peanuts, Item Numbers: 20391, 20394 and 20396, packed in 25 lb Cardboard boxes w/plastic liners (20391); 5 lb clear plastic bags (20394; and 1 lb clear plastic bags (20396). Recall # F-1167-9;

30) Carob Peanuts with Sugar, Item #21151, packed in 25 lb cardboard boxes with plastic liners. Recall # F-1168-9;

31) Carob Peanuts Sweetened, Item Numbers: 21151, 21154, and 21156, packed in 25 lb Cardboard boxes w/plastic liners (21151); 5 lb clear plastic bags (21154); and 1 lb clear plastic bags (21156). Recall # F-1169-9;

32) Carob Peanuts, No Sugar Added, Item Numbers: 31131, 31134, and 31136, packed in 10 lb Cardboard boxes w/plastic liners (31131); 5 lb clear plastic bags (31134); and 1 lb clear plastic bags (31136). Recall # F-1170-9;

33) No Sugar Added Carob Peanut Clusters, Item Numbers: 31181, 31184, packed in 10 lb Cardboard boxes w/plastic liners (31181); 5 lb clear plastic bags (31184); and 1 lb. clear plastic bags (31186). Recall # F-1171-9
CODE
Lot numbers: 220 to 422
RECALLING FIRM/MANUFACTURER
Natural Foods, Inc., Toledo, OH, by letter on February 3, 2009. Firm initiated recall is ongoing.
REASON
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
163,583 lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Traditions Meal Solutions, Meal 517; main entree containing Chicken and Rice, plus peanut butter, crackers, Fruit Cup, and cookie. Recall # F-1172-9

2) Traditions Meal Solutions, Meal 525; main entree containing Chicken and Noodles, plus peanut butter, crackers, fruit cup/raisins, and cookie. Recall # F-1173-9;

3) Traditions Meal Solutions, Meal 511; main entree containing Ravioli, plus peanut butter, crackers, raisins, and cookie. Recall # F-1174-9;

4) Traditions Meal Solutions, Meal 512; main entree containing Spaghetti, plus peanut butter, crackers, raisins, and cookie. Recall # F-1175-9;

5) Traditions Meal Solutions, Meal 513; main entree containing Spaghetti w/meatballs, plus peanut butter, crackers, fruit cup, and cookie. Recall # F-1176-9

6) Traditions Meal Solutions, Meal 513; main entree containing Beefaroni, plus peanut butter, crackers, fruit cup, and apple cinnamon bar. Recall # F-1177-9;

7) Traditions Meal Solutions, Meal 513; main entree containing Beef Stew, plus peanut butter, crackers, fruit cup/peach cup/fruit punch, and granola bar/star crunch/cookie/fig bar. Recall # F-1178-9

8) Traditions Meal Solutions, Meal 515; main entree containing Lasagna, plus peanut butter, crackers, fruit cup, and granola bar/cereal bar, Recall # F-1179-9;

9) Traditions Meal Solutions, Meal 516; main entree containing Beans and Franks, plus peanut butter, crackers, fruit cup/peach cup/raisins/apple sauce, and Banana Moon Pie/granola bar/blueberry bar/fig bar/strawberry bar/cookie, Recall # F-1180-9;

10) Traditions Meal Solutions, Meal 518; main entree containing Ravioli, plus peanut butter, crackers, fruit cup/peach cup, and cookie/fig bar. Recall # F-1181-9;

11) Traditions Meal Solutions, Meal 518; main entree containing Scalloped Potatoes and Ham, plus peanut butter, crackers, fruit cup/peach cup, and cookie/granola bar/ apple cinnamon bar/Star Crunch/cookie. Recall # F-1182-9
CODE
1) Meal 517: 09/09/2008 – 09/21/2008;
2) Meal 525: 09/12/2008 – 09/18/2008;
3) Meal 511: 09/09/2008 – 09/20/2008;
4) Meal 512: 09/09/2008 – 09/21/2008;
5) Meal 513 09/09/2008 – 09/20/2008;
6) Meal 513: 09/09/2008 – 09/20/2008;
7) Meal 513: 09/09/2008 – 09/20/2008;
8) Meal 515: 09/09/2008 – 09/18/2008;
9) Meal 516: 09/09/2008 – 09/20/2008;
10) Meal 518: 09/13/2008 – 09/22/2008;
11) Meal 524: 09/10/2008 – 09/18/2008
RECALLING FIRM/MANUFACTURER
Valley Services, Inc., Jackson, MS, by letter on February 5, 2009, and February 9, 2009 and by press release on February 6, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
27,599 cases of 24 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
BAO DING SEA FOOD brand Boiled Horse mackerel, Net Wt: 450g, UPC 6 937490 900081 -- PRODUCT OF CHINA -- POST CODE: 350214 -- The processed fish is vacuum packed in a plastic bag. Recall # F-1216-9
CODE
UPC code only
RECALLING FIRM/MANUFACTURER
Bao Ding Seafood Co., New York, NY, by press release on June 10, 2009. Firm initiated recall is complete.
REASON
The processed fish was found to be uneviscerated based on sampling and analysis by New York State Department of Agriculture & Markets
VOLUME OF PRODUCT IN COMMERCE
15 cases
DISTRIBUTION
NY
___________________________________
PRODUCT 
Nature Valley (TM) Granola Nut Clusters, Nut Lovers flavor Net Wt 3.5 oz & 5.0 oz  foil pouch; 10 - 5 oz pouches to a case and 7 - 3.5 oz per sleeve, 8 sleeves per case. Ingredients: Roasted Peanuts, Cashews, pecans, granola main ingredients. UPC 16000 28917 5.oz & 1600050661 3.5 oz size. Recall # F-1218-9
CODE
Use by date: 07MAR2010, 08MAR2010, 09MAR2010, 10MAR2010, 11MAR2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Mills, Inc., Minneapolis, MN, by press release, fax and e-mail on July 8, 2009. Firm initiated recall is ongoing.
REASON
"NUT LOVERS" flavor of Nature Valley Granola Nut Cluster may be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
141,904 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
The product is mung bean sprouts packaged in clear plastic bags in four (4) sizes as follows: 9.0 oz. bags, labeled in part: "SHANGHAI BEAN SPROUTS***Net Wt. 9 OZ ***INGREDIENTS: Mung Bean Sprouts***COUNTRY OF ORIGIN - CHINA SPROUTED, 80 oz. (5 lb) bags, labeled in part: SHANGHAI COMPANY INC. BEAN SPROUTS***Net Wt. 80 oz (5 lb) 2,268g***" 25 lb and 30 lb bulk plastic bags, unlabeled. Recall # F-1219-9
CODE
Manufacturing code and expiration dates are: "190005" with expiration date of "7-16-09" and "191005" with expiration date of "7-18-09". Only the 9 oz. and 80 oz. bags contain labeling, codes, and expiration dates. The 25 lb. and 30 lb. bulk bags have no labeling, codes, or expiration dates.
RECALLING FIRM/MANUFACTURER
Shanghai Co., Inc., Portland, OR, informed verbally and by telephone on July 13, 2009. Firm initiated recall is ongoing.
REASON
Finished product samples have tested positive for Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
10,661 lbs in various size packages
DISTRIBUTION
OR, WA
___________________________________
PRODUCT 
Chang Farm Soy Sprouts, Net wt 12 oz plastic bag, Soy Sprouts (no labeling on bag) 10 lb plastic bags. Recall # F-1220-9
CODE
USE BY 7/17/09
RECALLING FIRM/MANUFACTURER
Chang & Son Enterprises, Inc., Whatley, MA, by telephone and visit on July 15, 2009. Firm initiated recall is ongoing.
REASON
Sprouts are contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
108 x 12 x 2 oz cases and 42 x 10 lb bags
DISTRIBUTION
MA, CT, NY

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

_________________
PRODUCT 
1) Morning Star Farms Veggie Corn Dogs, net wt. 10 oz. Recall # F-1128-9;

2) Morning Star Farms Mini Veggie Corn Dogs, net wt. 10 oz. Recall # F-1129-9;

3) Morning Star Farms Meat Free Corn Dogs, net wt. 10 lb. Recall # F-1130-9
CODE
All lots beginning with SEP 23 2010 through OCT 20 2010.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kellogg USA Inc., Battle Creek, MI, by letter dated May 8, 2009. Firm initiated recall is complete.
REASON
Products are manufactured under insanitary conditions, which can lead to micro-contamination.
VOLUME OF PRODUCT IN COMMERCE
103,457 packages
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) New Whey Fruit Punch 25g and 42 g. The product is a liquid dietary supplement which is approximately 3 oz liquid and in a clear test tube like container. The product is a transparent liquid colored based on flavor. Recall # F-1209-9;
 
2) New Whey Blue Raspberry 25g and 42g. The product is a liquid dietary supplement which is approximately 3 oz liquid in a clear test tube like container. The product is a transparent liquid colored based on flavor. Recall # F-1210-9;

3) New Whey Orange 42g. The product is a liquid dietary supplement which is approximately 3 oz liquid in a clear test tube like container. The product is a transparent liquid colored based on flavor. Recall # F-1211-9;

4) New Whey Grape 42g. The product is a liquid dietary supplement which is approximately 3 oz liquid in a clear test tube like container. The product is a transparent liquid colored based on flavor. Recall # F-1212-9
CODE
1) Lot numbers: 1960, 1972, 1973, and 1932;

2) Lot numbers: 1900 and 1959; Lot numbers: 1920, 1930, 1936, and 1944;

3) Lot numbers: 1750, 1887, 1924, 1928, 1934, and 1946;

4) Lot numbers: 1925 and 1949
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ids, Oviedo FL, by telephone on or about February 4, 2009. Firm initiated recall is complete.
REASON
Product may contain a foreign object due to a potential tampering incident.
VOLUME OF PRODUCT IN COMMERCE
43,700 containers
DISTRIBUTION
FL
___________________________________
PRODUCT 
1) Hardcore Energize Bullet Blue Rage flavor. The product is a liquid dietary supplement which approximately 3 oz liquid in a clear test tube like container. The product is a transparent liquid colored based on flavor, this is a blue colored liquid for blue raspberry flavor. The product is shipped 6 or 12 vials per pack. Recall # F-1213-9;

2) Hardcore Energize Bullet Black Rush flavor. The product is a liquid dietary supplement which approximately 3 oz liquid in a clear test tube like container. The product is a transparent liquid colored based on flavor, this is a dark red colored liquid for black cherry flavor. The product is shipped 6 or 12 vials per pack. Recall # F-1214-9
CODE
1) Lot numbers: 1945, 1961, 1962, and 1794;
2) Lot number: 1963
RECALLING FIRM/MANUFACTURER
Recalling Firm: Isatori Technologies, Golden, CO, by telephone and follow-up letter on June 4, 2009. Firm initiated recall is ongoing.
REASON
Dietary Supplements may contain a foreign object due to a potential tampering incident.
VOLUME OF PRODUCT IN COMMERCE
90,696 containers
DISTRIBUTION
Canada
___________________________________
PRODUCT 
1) Milk Chocolate Reese's Peanut Butter Cups in 8 pack. The product is shipped 36 packs per case. Item number 34000-40558-000. Production codes 94J1S, 94K1F, 94K1S, 94K1T, 94M1F, 94M1S, 94M1T, 94N1F, 94N1S, and 94N1T; 2) Milk Chocolate Reese's Peanut Butter Cups Miniatures in 12 oz bags. The product is shipped 24 bags per case.
Item number 34000-44860-000. Production codes 94N2T. Recall # F-1215-9
CODE
Best Before Date June 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Hershey Co, Hershey, PA, by telephone on July 2, 2009 and July 31, 2009. Firm initiated recall is ongoing.
REASON
Product may contain sifter screen materials.
VOLUME OF PRODUCT IN COMMERCE
6,849 and 80 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Jam labeled in part: "BISCUIT MOUNTAIN JAM 8 oz/224g STRAWBERRY***Ingredients: fruit, pectin sugar, lemon juice, butter***". Recall # F-1255-9
CODE
“Mar 12 2009”
RECALLING FIRM/MANUFACTURER
Biscuit Mountain Jam, Obrien, OR, by telephone on March 16, 2009. Firm initiated recall is ongoing.
REASON
Product contains undeclared milk but butter is listed as an ingredient.
VOLUME OF PRODUCT IN COMMERCE
6 – 8 oz jars
DISTRIBUTION
OR
___________________________________
PRODUCT 
1) Spinach Ravioli 11.5 lbs 12 count bags, 12 bags per pack. Labeled as: a) Talluto's Egg Pasta Large Square Spinach Ravioli; b) Talluto's Egg Pasta Large Round Spinach Ravioli; c) Talluto's Large Round Spinach Ravioli. Recall # F-1256-9;

2) Spinach Ravioli 7.5 lbs 20 count bags, 12 bags per pack. Labeled as Talluto's Square Spinach Ravioli. Recall # F-1257-9;

3) Cheese Ravioli 11.0 lbs 12 count bags, 12 bags per pack. Labeled as Talluto's Large Square Cheese Ravioli. Recall # F-1258-9;

4) Cheese Ravioli 7.5 lbs 20 count bags, 12 bags per pack. Labeled as Talluto's Square Ravioli. Recall # F-1259-9;

5) Cheese Ravioli 13 lbs 12 count bags, 12 bags per pack. Labeled as Vola Brand Pre-Cooked Large Round Cheese Ravioli. Recall # F-1260-9;

6) Cheese Raviolini 10 lbs bags. Labeled as Luciani's Home Style Italian Cheese Raviolini. Recall # F-1261-9;

7) Butternut Squash Ravioli 12 lbs 12 count bags, 12 bags per pack. Labeled as Talluto's Authentic Italian Food Large Square Butternut Squash Ravioli. Recall # F-1262-9;

8) Asiago Cheese Ravioli 12 lb bags. Labeled as Talluto's Authentic Italian Food Large Round Asiago Cheese Ravioli. Recall # F-1263-9;

9) Pumpkin Ravioli 5.75 lb 12 count bags, 6 bags per pack. Labeled as Talluto's Large Round Pumpkin Ravioli. Recall # F-1264-9;

10) Portabello Mushroom Ravioli 5.75 lb 12 count bags, 6 bags per pack. Labeled as Talluto's Portabello Mushroom Ravioli. Recall # F-1265-9;

11) Mushroom Ravioli 7.5 lb 20 count bags, 12 bags per pack. Labeled as Talluto's Mushroom Ravioli. Recall # F-1266-9;

12) Gorgonzola Ravioli 7.5 lb 20 count bags, 12 bags per pack. Labeled as Talluto's Square Gorgonzola Ravioli. Recall # F-1267-9;

13) Lobster Ravioli 3.75 lb 20 count bags, 6 bags per pack. Labeled as Talluto's Black Lobster Ravioli; Talluto's Square lobster Ravioli. Recall # F-1268-9;

14) Lobster Ravioli 5.75 lb 12 count bags, 6 bags per pack. Labeled as Talluto's Large Round Lobster Ravioli. Recall # F-1269-9;

15) Shrimp Ravioli 5.75 lb 12 count bags, 6 bags per pack. Labeled as Talluto's Large Round Shrimp Ravioli. Recall # F-1270-9;

16) Shrimp Ravioli 7.5 lb 20 count bags, 12 bags per pack. Labeled as Talluto's Square Shrimp Ravioli. Recall # F-1271-9

17) Grilled Vegetable Ravioli 5.75 lb 12 count bags, 6 bags per pack. Labeled as Talluto's Large Round Grilled Vegetable Ravioli. Recall # F-1272-9;

18) Ricotta and Broccoli Rabe Ravioli 11 lbs 12 count bags, 12 bags per pack. Labeled as Talluto's Large Round Ricotta & Broccoli Rabe Ravioli. Recall # F-1273-9

19) Crab Ravioli 5.75 lb 12 count bags, 6 bags per pack. Labeled as Talluto's Large Round Crab Ravioli. Recall # F-1274-9;

20) Crab Ravioli 3.75 lb 20 count bags, 6 bags per pack. Labeled as Talluto's Square Crab Ravioli. Recall # F-1275-9;

21) Spinach, Tomato and Cheese Ravioli 5.75 lb 12 count
bags, 6 bags per pack. Labeled as Talluto's Large Round Spinach, Sundried Tomato & Goat Cheese Ravioli. Recall # F-1276-9;

22) Spinach Crepe Manicotti 12 lb 6 count bags, 12 bags per pack. Labeled as Talluto's Spinach Crepe Manicotti. Recall # F-1277-9;

23) Crepe Manicotti 12 lb 6 count bags, 12 bags per pack. Labeled as Talluto's Crepe Manicotti (code 01-1410-07); Luciani's Home Style Italian Crepe manicotti. Recall # F-1278-9;

24) Stuffed Shells 21 lbs 12 count bags, 12 bags per pack. Labeled as Talluto's Stuffed Shells. Recall # F-1279-9

25) Stuffed Shells 10.5 lbs 96 count bags. Labeled as Vola Brand 1.75 oz Stuffed Shells. Recall # F-1280-9

26) Ricotta Cavatelli 12 lbs 12/1 lb bags per pack. Labeled as Talluto's Ricotta Cheese Cavatelli; Luciani's Home Style Italians Ricotta Cavatelli. Recall # F-1281-9;

27) Asiago Cheese Tortellini 12lbs 12/1 lb bags per pack. Labeled as Talluto's Tomato Asiago Cheese Tortellini; Talluto's Spinach Asiago Cheese Tortellini; Talluto's Asiago Cheese Tortellini; Talluto's Rainbow Asiago Cheese Tortellini. Recall # F-1282-9;

28) Asiago Cheese Tortellini 10 lb bag. Labeled as Talluto's Authentic Italian Food Asiago Cheese Tortellini. Recall # F-1283-9;

29) Cheese Tortelloni 12lbs 12/1 lb bags per pack. Labeled as Talluto's Cheese Tortelloni. Recall # F-1284-9

30) Spinach Ricotta Cheese Gnocchi 12 lbs 12/1 lb bags per pack. Labeled as Talluto's Spinach Ricotta Cheese Gnocchi. Recall # F-1285-9

31) Potato Gnocchi 12 lbs 12/1 lb bags per pack. Labeled as Talluto's Potato Gnocchi. Recall # F-1286-9;

32) Ricotta Cheese Gnocchi 12 lbs 12/1 lb bags per pack. Labeled as Talluto's Ricotta Cheese Gnocchi. Recall # F-1287-9;

33) Pasta Sheets 15 lb 15 count bags, 3 bags per pack. Labeled as Talluto's Squid Ink Pasta Sheets. Recall # F-1288-9;

34) Agnolotti 12 lbs 12/1 lb bags per pack. Labeled as Talluto's Roasted Pepper Agnolotti (code 01-2111-03); Talluto's Pesto Agnolotti. Recall # F-1289-9
CODE
1) a) Code 01-1012-02, b) code 01-1024-02, c) code 01-1025-02;
2) Code 01-1015-01;
3) Code 01-1011-02;
4) Code 10-1010-01;
5) Code 011-1016-02-2;
6) Code 03-1901-14;
7) Code 01-1039-02;
8)  Code 01-1038-02;
9) Code 01-1036-16;
10) Code 01-1028-16;
11) Code 01-1027-01;
12) Code 01-1022-01;
13) Code 01-1021-26 and code 01-1019-26;
14) Code 01-1020-16;
15) Code 01-1017-16;
16) Code 01-1014-01;
17) Code 01-1082-16;
18) Code 01-1079-02;
19) Code 01-1078-16;
20) Code 01-1077-26;
21) Code 01-1075-16;
22) Code 01-1411-07;
23) Code 01-1410-07 and code 03-1410-07;
24) Code 01-1310-02;
25) Code 011-1314-27-1;
26) Code 01-1210-03, 01-1210-R3 and code 03-1210-03;
27) Code 01-1722-03; code 01-1721-03; code 01-1720-14; code 01-1725-03;
28) Code 01-1720-14;
29) Code 01-2010-03;
30) Code 01-1112-03 and 01-1112-R3;
31) Code 01-1111-03 and 01-1111-R3;
32) Code 01-1110-03 and 01-1110-R3;
33) Code 01-1555-10;
34) Code 01-2111-03; code 01-2110-03
RECALLING FIRM/MANUFACTURER
TAIF, Inc., Folcroft, PA, by telephone on May 26, 2009. Firm initiated recall is ongoing.
REASON
Product contains an undeclared allergen, wheat, on all product labeling.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
AZ, GA, MD, NJ, NY, OH, PA, SC, and TX

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1323-09
CODE
Unit: 6529977
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, Alaska, by fax on March 20, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Alaska
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1354-09
CODE
Unit: W067309002831
RECALLING FIRM/MANUFACTURER
Coffee Memorial Blood Center, Inc., Amarillo, TX, by telephone on March 13, 2009. Firm initiated recall is complete.
REASON
Blood product, manufactured from a Whole Blood unit that was overweight, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1396-09
CODE
Unit: W036509041598
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport LA, by telephone on April 16, 2009. Firm initiated recall is complete.
REASON
Blood product, with red cell volume that did not meet specified requirements, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1417-09
CODE
Unit: W165709006989
RECALLING FIRM/MANUFACTURER
Our Lady Of The Lake Hospital Inc., Baton Rouge, LA, by telephone and facsimile on March 19, 2009. Firm initiated recall is complete.  
REASON
Blood product, which was not labeled as an autologous unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
1) Platelets, Recall # B-1473-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1474-09
CODE
1) Unit: 2410682;
2) Units: 2392222; 2410682; 2462742; 2476112
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center Inc., Lexington, KY, by letter dated March 30, 2009. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who traveled to malarial endemic areas, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
KY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1557-09
CODE
Unit: 20GZ24868
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by electronic notification on October 8, 2007 or by letter dated October 10, 2007. 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-1559-09
CODE
Unit: 55S55020
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Little Rock, AR, by telephone or electronic notification on December 14, 2007 and by facsimile on December 17, 2007.
Manufacturer: American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, 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, AR
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1561-09
CODE
Units: 55FV20494, 55Y33191
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Little Rock, AR, by facsimile or electronic notification on December 17, 2007.
Manufacturer: American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR. 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
AR, MO
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1563-09
CODE
Unit: 55S58780
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Little Rock, AR, by telephone or electronic notification on October 9, 2007 and by facsimile on October 10, 2007.
Manufacturer: American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR. 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
AR
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1564-09
CODE
Unit: 55FR63236
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Little Rock, AR, by telephone, facsimile, or electronic notification on September 14, 2007.
Manufacturer: The American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR. 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
AR
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1566-09;
2) Plasma Frozen. Recall # B-1567-09;
3) Platelets Pheresis Leukocytes Reduced. Recall # B-1568-09
CODE
1) and 2) Units: 55H12665, 55Y34603;
3) Units: 55Q27800, 55Q28542
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Little Rock, AR, by telephone on August 16, 2007, by facsimile on August 17, 2007, and by letter dated August 17, 2007.
Manufacturer: American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR. 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
6 units
DISTRIBUTION
AR, OK, TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1569-09
CODE
Unit: 55FK55406
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by facsimile or electronic notification on August 1, 2007. 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
AR
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1573-09
CODE
Unit: W115909013585
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by telephone on July 13, 2009. Firm initiated recall is complete.
REASON
Blood product, which exceeded the maximum criteria for platelet count, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1574-09;
CODE
Unit: 20KK44411
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by electronic notification on September 4, 2008 or by letter dated September 5, 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
ID, UT

___________________________________
PRODUCT 
Source Plasma, Recall # B-1576-09
CODE
Units: LC0505611, LC0506096, LC0506359, LC0560135, LC0560418, LC0560916, LC0561191, LC0561901, LC0562333, LC0562762, LC0563323, LC0564360, LC0564761, LC0565435, LC0567888, LC0569767, LC0570584, LC0570846, LC0571483, LC0571821, LC0572369, LC0572749, LC0573631, LC0573823, LC0575374, LC0575630, LC0576129, LC0576632, LC0577137, LC0577734, LC0583642, LC0584003, LC0584429, LC0584905, LC0585544, LC0586009, LC0586446, LC0587499, LC0587975, LC0588793, LC0589084, LC0589788, LC0590038, LC0590707, LC0591286, LC0591808, LC0592097, LC0592587, LC0592973, LC0593460, LC0593902, LC0594324, LC0594789, LC0595229, LC0596166, LC0596714, LC0596924, LC0597957, LC0598638, LC0598947, LC0599724, LC0600041, LC0600624, LC0601680, LC0602155, LC0603538, LC0610470, LC0610735, LC0611605, LC0612236
RECALLING FIRM/MANUFACTURER
Las Cruces Biologicals LLC, Las Cruces, NM, by e-mail on April 9, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received tattoos within one year of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
70 units
DISTRIBUTION
CA, FL, United Kingdom
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1577-09
CODE
Unit: 020Z29477
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by letter dated May 18, 2007 or by electronic notification on May 18, 2007. 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
ID
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1579-09
CODE
Unit: W141608617151
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated March 23, 2009 and by telephone and electronic notification on July 28, 2009.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. 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
WA
___________________________________
PRODUCT 
Red Blood Cells, Recall # B-1580-09
CODE
Unit: W141608160419
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter dated April 14, 2009.
Manufacturer: Puget Sound Blood Center and Program, Everett, WA. 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
WA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1581-09
CODE
Units: 08FINE8902, 08FINE0461
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Fort Wayne, IN, by facsimile on April 13, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from donors who did not receive a complete physical examination, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Fresh Frozen Plasma. Recall # B-1584-09;
2) Red Blood Cells. Recall # B-1585-09
CODE
1) and 2) Unit: W120609200816
RECALLING FIRM/MANUFACTURER
Michigan Community Blood Centers, Saginaw, MI, by facsimile on April 17, 2009. Firm initiated recall is complete.
REASON
Blood products, which were quarantined subsequent to receiving information regarding a post donation illness, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
1) Red Blood Cells, Recall # B-1604-09;
2) Platelets Pooled, Recall # B-1605-09;
3) Fresh Frozen Plasma, Recall # B-1606-09
CODE
1), 2), and 3) Unit: K177471
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on February 6, 2009. 
Manufacturer: Puget Sound Blood Center and Program, Federal Way, WA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
WA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1625-09;
2) Plasma Frozen within 24 hours (FP24). Recall # B-1626-09
CODE
1) and 2) Units: 7000204, 7000306
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Buffalo, NY, by facsimile on March 31, 2009 and by telephone on April 1, 2009. 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
4 units
DISTRIBUTION
NY, NJ
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1627-09
CODE
Unit: 7026432
RECALLING FIRM/MANUFACTURER
Community Blood Center of the Ozarks, Springfield, MO, by letter dated May 26, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MO
___________________________________
PRODUCT 
1) Red Blood Cells. Recall # B-1628-09;
2) Fresh Frozen Plasma. Recall # B-1629-09
CODE
1) and 2) Unit: 1684649
RECALLING FIRM/MANUFACTURER
Blood Bank of Hawaii, Honolulu, Hawaii, by facsimile on June 9, 2009 and by letter dated June 16, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported taking the medication Avodart, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Hawaii
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1631-09
CODE
Unit: W036509066264
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Baton Rouge, LA, by telephone on June 16, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor with a history of high risk behavior, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1632-09;
2) Plasma Frozen. Recall # B-1633-09
CODE
1) and 2) Unit: 003FJ09579
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by telephone and by letter on July 29, 2008. Follow-up letters were sent on September 3, 2008 and October 21, 2008.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA 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
GA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1634-09
CODE
Unit: 019LW55493
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by letter and electronic mail on March 21, 2007. 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
TN
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1636-09;
2) Cryoprecipitated AHF. Recall # B-1637-09
CODE
1) and 2) Unit: 003GP84061
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by e-mail and telephone on February 22, 2008 and follow-up letters on February 25, 2008 and March 28, 2008.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA,  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
AL, CA, GA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1639-09;
2) Cryoprecipitated AHF. Recall # B-1640-09;
3) Plasma Cryoprecipitated Reduced. Recall # B-1641-09
CODE
1), 2), and 3) Unit: 003GV29370
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Douglasville, GA, by fax and telephone on August 28, 2007 and follow-up letter on August 30, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA, Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA, SC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1643-09
CODE
Units: 003FH30819; 003FG57064
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by facsimile, electronic mail and letter on October 17, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. 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
GA
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1644-09
CODE
Unit: 041GM69446
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by telephone on October 1, 2007 and by letter on October 10, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood product, which did not meet the acceptable product specifications for release, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
1) Plasma Frozen, Recall # B-1648-09;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1649-09
CODE
1) and 2) Unit: 003G39643
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Atlanta, GA, by facsimile and telephone on April 23, 2007 and follow-up letter on April 24, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. 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
GA
___________________________________
PRODUCT 
1) Cryoprecipitated AHF. Recall # B-1650-09;
2) Red Blood Cells. Recall # B-1652-09  
CODE
1) and 2) Unit: 03FJ04848
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Atlanta, GA, by telephone, letter, and e-mail on June 12, 2007 and follow-up letters dated July 16, 2007 and July 25, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. 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
GA, CA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Source Plasma, Recall # B-1150-09
CODE
Units: LU0036320, LU0036654, LU0037428, LU0037731
RECALLING FIRM/MANUFACTURER
DCI Biologicals Lubbock, LLC, Lubbock, TX, by fax on June 8, 2007. 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
4 units
DISTRIBUTION
England and NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1410-09
CODE
Units: 6686031, 6686032, 6686034
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc. Orlando, FL, by telephone on January 2, 2009 and by letter dated January 7, 2009. Firm initiated recall is complete.
REASON
Blood products, manufactured from units of Whole Blood that were stored at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
1) Platelets. Recall # B-1432-09;
2) Platelets Pheresis Leukocytes Reduced. Recall # B-1433-09
CODE
1) Units: 9650208, 9650217, 9650225;
2) Units: 9650209 (2 units), 9650210
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on September 21, 2007. Firm initiated recall is complete.
REASON
Blood products, which were stored at an unacceptable temperature, were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1475-09
CODE
Unit: W0363095337350
RECALLING FIRM/MANUFACTURER
BloodCenter of Wisconsin, Inc, Milwaukee, WI, by facsimile on February 22, 2009. Firm initiated recall is complete.
REASON
Blood product, prepared without the appropriate amount of additive (ADSOL), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WI
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1480-09
CODE
Unit: 2565424
RECALLING FIRM/MANUFACTURER
Central Kentucky Blood Center, Inc, Lexington, KY, by letter on March 4, 2009. Firm initiated recall is complete.
REASON
Blood product, which was labeled with an incorrect expiration date, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
KY
___________________________________
PRODUCT 
1) Fresh Frozen Plasma. Recall # B-1520-09;
2) Plasma Cryoprecipitated Reduced. Recall # B-1521-09;
3) Cryoprecipitated AHF. Recall # B-1522-09;
4) Pediatric Fresh Frozen Plasma. Recall # B1523-09
CODE
1) Units: W084608003040, W084508001811, W084508001814, W084508001817, W084908004779, W084908004780, W085008003052, W085008003054, W085008003056, W085108001084, W085108001085, W085108001091, W085508003345, W085508003346, W085508003347, W085508003353, W085608003038, W085608003039, W085608003045, W085608003046, W087008003085, W085309000039, W08509000040, W085309000041, W085309000043, W085309000044, W085309000045, W085309000046, W085809000147, W085809000148, W085809000149, W085809000152, W085809000154, W085809000155, W085809000159, W085809000163, W085809000164, W085809000165, W085809000166, W086708002061, W086708002062, W086708002068, W086708002069, W086708002072, W085909000122, W085909000125, W085909000126, W085909000128, W084909000001, W085309000056, W085309000068, W086208006982, W084408002407, W085008003053, W085108001086, W085809000151, W086708002064, W085909000129, W085909000134, W085309000060, W085909000070, W086009000156, W086208006489, W086208006590, W084408002409, W084408002411, W084508001815, W085008003055, W085108001092, W085508003348, W085608003040, W085608003043, W087008003081, W087008003084, W086608005957, W086608005958, W086608005959, W086708002066, W086708002071, W086308006174, W086308006180, W085909000120, W085909000121, W085909000123, W085909000131, W085909000135, W085909000136, W085309000054, W085309000057, W085309000066;

2) and 3) Unit: W085508003352;

4) W08490909000005 (Parts A, B, C, D, E, and F)
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on January 9, 2009. Firm initiated recall is complete.
REASON
Blood products, which may have been stored at unacceptable temperatures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
98 units
DISTRIBUTION
PA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1556-09
CODE
Unit: 20GZ24868
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by electronic notification on October 8, 2007 or by letter dated October 10, 2007. 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-1558-09
CODE
Unit: 55S55020
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Little Rock, AR, by telephone or electronic notification on December 14, 2007 and by facsimile on December 17, 2007.
Manufacturer: American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, 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-1560-09
CODE
Units: 55FV20494, 55Y33191
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Little Rock, AR, by facsimile or electronic notification on December 17, 2007.
Manufacturer: American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, 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-1562-09
CODE
Unit: 55S58780
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Little Rock, AR, by telephone or electronic notification on October 9, 2007 and by facsimile on October 10, 2007.
Manufacturer: American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, 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-1565-09
CODE
Unit: 55FR63236
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Little Rock, AR, by telephone, facsimile or electronic notification on September 14, 2007.
Manufacturer: American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, 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-1570-09
CODE
Unit: 55FK55406
RECALLING FIRM/MANUFACTURER
American National Red Cross, Greater Ozark-Arkansas Region, Little Rock, AR, by facsimile or electronic notification on August 1, 2007. 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-1572-09
CODE
Unit: W041209047970
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Albuquerque, NM, by telephone and facsimile on July 8, 2009. Firm initiated recall is complete.
REASON
Blood product, which was manufactured without the entire quantity of additive solution, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
UT
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1575-09
CODE
Unit: 20KK44411
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by electronic notification on September 4, 2008 or by letter dated September 5, 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
ID, UT
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1578-09
CODE
Unit: 020Z29477
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Salt Lake City, UT, by letter dated May 18, 2007 or by electronic notification on May 18, 2007. 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 
Fresh Frozen Plasma (Apheresis), Recall # B-1582-09
CODE
Units: W084309000288; W084309000295; W084309000425
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on March 24, 2009 and March 25, 2009. Firm Initiated recall is complete.
REASON
Blood products, collected using expired needles and additive solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
PA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1583-09
CODE
Units: 08DILD7042, 08DILD7786, 08DILD8355, 08DILE1121, 08DILE2278, 08DILE2823, 08DILE3589, 08DILE4317, 08DILE5707, 08DILE6269, 08DILE7046, 08DILE7662, 08DILE8510, 08DILE9005, 08DILE9817, 08DILF0410, 08DILF1627, 08DILF2593, 08DILF3882, 08DILF4376, 08DILG3070, 09DILA2614, 09DILA3156, 09DILA4612, 09DILA5072
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Dekalb, IL, by facsimile on February 24, 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
25 units
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1635-09
CODE
Unit: 019LW55493
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by letter and electronic mail on March 21, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Plasma Cryoprecipitated Reduced. Recall # B-1638-09
CODE
Unit: 003GP84061
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by e-mail and telephone on February 22, 2008 and follow-up letters on February 25, 2008 and March 28, 2008.
Manufacture: The American National Red Cross – Southern Region, Douglasville, GA. 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
AL, CA, GA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1642-09
CODE
Units: 003FH30819; 003FG57064
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by facsimile, electronic mail and letter on October 17, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. 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
CA 
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1645-09
CODE
Units: 003FM36475 Part 1; 03FM36475 Part 2
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by fax on January 29, 2008 and letter on February 7, 2008.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood products, which failed to meet the minimum specifications for red blood cell percent recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT 
Red Blood Cells Washed. Recall # B-1646-09
CODE
Units: 003E62107; 003FW99642; 003FS26803; 003GF39264
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by telephone on September 27, 2007 and October 3, 2007 and follow-up letters on October 5, 2007 and October 11, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood products, which were washed with an incorrect wash solution, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
GA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1647-09
CODE
Unit: AQ030465
RECALLING FIRM/MANUFACTURER
Recalling Firm: Plasma Biological Services, Inc., Memphis, TN, by facsimile on September 20, 2007.
Manufacturer: Plasma Biological Services, Asheville, NC. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Plasma Cryoprecipitated Reduced. Recall # B-1651-09
CODE
Unit: 03FJ04848
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Atlanta, GA, by telephone, letter, and e-mail on June 12, 2007 and follow-up letters dated July 16, 2007 and July 25, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. 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
GA, CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
Twin-Pass Dual Access Catheter, REF 5200, sterilized with Ethylene Oxide, RX Only, Non-Pyrogenic. The TWIN-PASS catheters are intended to be used in conjunction with steerable guidewires in order to access discrete regions of the coronary and peripheral arterial vasculature, to facilitate placement and exchange of guidewires and other interventional devices, for use during two guidewire procedures and to subselectively infuse/deliver diagnostic or therapeutic agents. Recall # Z-1712-2009
CODE
Lot Numbers: 540787, 540909, 541079, 541304, 541342, 541881, 541992, 542111, 542253, 542302, 542693, 542875, 542962, 542994, 543173, 543304, 543508, 543590, 543591, 543698, 543775, 543922, 544188, 544315, 544597 and 544831
RECALLING FIRM/MANUFACTURER
Vascular Solutions, Inc., Maple Grove, MN, by letter dated July 6, 2009. Firm initiated recall is ongoing. 
REASON
Three occurrences of Twin-Pass catheters containing a piece of PTFE beading material in the OTW lumen have been reported to Vascular Solutions. The PTFE beading material is a processing aide used during hydrophilic coating. The beading is to be removed followed by a visual inspection prior to packaging.
VOLUME OF PRODUCT IN COMMERCE
5,885 units
DISTRIBUTION
Nationwide and countries of Canada, Spain, Greece, Ireland, Norway, Switzerland, England, Turkey Israel, Germany, Austria, Taiwan, Finland, Sweden, France, Ireland and Portugal
___________________________________
PRODUCT 
1) CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3604, O.D. Size: 36mm, Neck Length: -3.5mm, Taper: SLT, Sterile R, 1 each, Rx only, The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients. Recall # Z-1715-2009;
 
2) CONSERVE, TOTAL A-CLASS HEAD W/BFH TECH., REF 38AM-3635, O.D. Size: 36mm, Neck Length: +3.5mm, Taper: SLT, Sterile R, 1 each, Rx only. The CONSERVE Total Femoral Head is indicated for use in total hip arthroplasty for reduction of relief of pain and/or improved hip function in skeletally mature patients. Recall # Z-1716-2009
CODE
1) Lot Number: 029798201;
2) Lot Number: 029798202
RECALLING FIRM/MANUFACTURER
Wright Medical Technology Inc., Arlington, TN, by letter dated May 14, 2009. Firm initiated recall is ongoing. 
REASON
Incorrect packaging, swapped sizes.
VOLUME OF PRODUCT IN COMMERCE
29 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
Foot Lok Cusion, Part Number MTAFS01, reusable nonsterile (20.3 x 42 x 25.4cm) cushion. Recall # Z-1721-2009
CODE
Lot Numbers: M055260, M042340, M024020, M022010 and M006980
RECALLING FIRM/MANUFACTURER
Med Tec Inc., Orange City, IA, by letter dated March 6, 2009 and by e-mail or telephone beginning March 16, 2009 and April 20, 2009. Firm initiated recall is ongoing.
REASON
The silkscreened indexing scale was reversed.
VOLUME OF PRODUCT IN COMMERCE
231 units
DISTRIBUTION
Nationwide, Czech Republic, Colombia, Thailand, Morocco, Brazil, the United Kingdom, India, Costa Rica, The Netherlands, Russia, Spain, Israel, Taiwan, Mexico, Turkey, Korea, Australia, Malaysia, Italy and Japan
___________________________________
PRODUCT 
Bausch & Lomb, Boston Conditioning Solution, Original Formula, For Rigid Gas Permeable Contact Lenses, 1 fl. oz. (30 ml), Item Number: 7474G. Recall # Z-1735-2009
CODE
Lot Number: GA7060; Expires January 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bausch & Lomb Inc, Rochester, NY, by letter on dated June 26, 2009.
Manufacturer: Bausch & Lomb Inc., Greenville, SC.  Firm initiated recall is ongoing.
REASON
The product failed to meet one of the shelf life specifications at the end of the expiry period.
VOLUME OF PRODUCT IN COMMERCE
56,000 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Stryker PainPump catheter and split introducer needle, sterile; REF 500-23. Recall # Z-1736-2009;

2) Stryker ExFen 2.5" extended fenestration catheter set for PainPump, sterile; REF 500-25. Recall # Z-1737-2009;

3) Stryker ExFen 5.0" extended fenestration catheter set for PainPump, sterile; REF 500-50. Recall # Z-1738-2009;

4) Stryker PainPump base kit, 120 mL infusion kit, sterile; REF 500-100. Recall # Z-1739-2009;

5) Stryker PainPump, 5-day infusion kit, 120 mL infusion kit (0.83 mL/hr), sterile; REF 500-110. Recall # Z-1740-2009;

6) Stryker PainPump, 2-day infusion kit, 120 mL infusion kit (2.08 mL/hr), sterile; REF 500-120. Recall # Z-1741-2009;

7) Stryker PainPump, 2-day infusion kit with ExFen 2.5", 120 mL infusion kit (2.08 mL/hr), sterile; REF 500-120-25. Recall # Z-1742-2009;

8)  Stryker PainPump, 2-day infusion kit with ExFen 5.0", 120 mL infusion kit (2.08 mL/hr), sterile, Stryker Instruments, Kalamazoo, MI; REF 500-120-50. Recall # Z-1743-2009;

9) Stryker PainPump, 1-day infusion kit, 120 mL infusion kit (4.16 mL/hr), sterile; REF 500-140. Recall # Z-1744-2009;

10) Stryker PainPump, two site infusion kit with ExFen 2.5", 120 mL infusion kit, sterile; REF 500-166-25. Recall # Z-1745-2009;

11) Stryker PainPump, two site infusion kit with ExFen 5.0", 120 mL infusion kit, sterile; REF 500-166-50. Recall # Z-1746-2009;

12) Stryker PainPump, two site infusion set, sterile; REF 500-200. Recall # Z-1747-2009;

13) Stryker PainPump, two site infusion set, sterile; REF 500-250. Recall # Z-1748-2009;

14) Stryker PainPump, 270 mL base infusion kit, sterile; REF 0501-100-000. Recall # Z-1749-2009;

15) Stryker PainPump, 270 mL infusion kit (2.08 mL/hr), sterile; REF 0501-120-000. Recall # Z-1750-2009;

16) Stryker PainPump, 270 mL infusion kit (4.16 mL/hr), sterile; REF 0501-140-000. Recall # Z-1751-2009;

17) Stryker PainPump, 270 mL infusion kit (4.16 mL/hr) with ExFen 2.5", sterile; REF 0501-140-025. Recall # Z-1752-2009;

18) Stryker PainPump, 270 mL infusion kit (2.08 cc/hr) with ExFen 5.0", sterile; REF 501-140-50. Recall # Z-1753-2009;

19) Stryker PainPump, 270 mL two site infusion kit with ExFen 2.5", sterile; REF 0501-416-025. Recall # Z-1754-2009;

20) Stryker PainPump, 270 mL two site infusion kit with ExFen 5.0", sterile; REF 0501-416-050. Recall # Z-1755-2009;

21) Stryker PainPump2, 250 mL pre-set PainPump with luer lock tubing set, 2.5 inch ExFen and standard catheter, sterile; REF 521-125. Recall # Z-1756-2009;
 
22) Stryker PainPump2, 250 mL pre-set PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile; REF 521-155. Recall # Z-1757-2009;

23) Stryker PainPump ExFen, sterile; REF 525-10. Recall # Z-1758-2009;
 
24) Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile; REF 525-25. Recall # Z-1759-2009;

25) Stryker PainPump2, 250 mL PainPump with 5.0 inch ExFen 2-site catheter set, sterile; REF 525-50. Recall # Z-1760-2009;
 
26) Stryker PainPump2, 250 mL PainPump with luer lock tubing set, 2.5 inch ExFen and standard catheter, sterile; REF 525-125. Recall # Z-1761-2009;

27) Stryker PainPump2, 250 mL PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile; REF 525-155. Recall # Z-1763-2009;

28) Stryker PainPump2, 250 mL PainPump with 2.5 inch ExFen catheter and luer lock tubing set, sterile; a) REF 525-156, b) REF 525-157 and c) REF 525-158. Recall # Z-1763-2009;

29) Stryker PainPump2, 2-site tube set with standard catheter, sterile; REF 525-200-2. Recall # Z-1764-2009;

30) Stryker PainPump2, 2-site tube set with 2.5" ExFens, sterile; REF 525-200-25. Recall # Z-1765-2009;

31) Stryker PainPump2, 2-site tube set with 5.0" ExFen, sterile; REF 525-200-50. Recall # Z-1766-2009;

32) Stryker PainPump2 ExFen 2.5, 2.5" extended fenestration catheter set for PainPump2, sterile; REF 525-250. Recall # Z-1767-2009;

33) Stryker PainPump2 ExFen 2.5, 2.5" catheter set for PainPump2, sterile; REF 525-251. Recall # Z-1768-2009;

34) Stryker PainPump2 ExFen 5, 5" extended fenestration catheter set for PainPump2, sterile; REF 525-500. Recall # Z-1769-2009;

35) Stryker PainPump2 ExFen 5, 5" catheter set for PainPump2, sterile; REF 525-501. Recall # Z-1770-2009;

36) Stryker standard catheter set for PainPump2 and AutoFuser PainPump, sterile, Stryker Instruments, Kalamazoo, MI; REF 0537-001-000. Recall # Z-1771-2009:

37) Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-005-000. Recall # Z-1772-2009;

38) Stryker 10.0 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-010-000. Recall # Z-1773-2009;

39) Stryker 2.5 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-025-000. Recall # Z-1774-2009;

40) Stryker 5.0 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-205-000. Recall # Z-1775-2009;
 
41) Stryker dual 10.0 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-210-000. Recall # Z-1776-2009;
 
42) Stryker dual 2.5 catheter set for PainPump2 and AutoFuser PainPump, sterile; REF 0537-225-000. Recall Z-1777-2009;

43) Stryker PainPump2, 400 mL PainPump with 2.5 inch ExFen 2-site catheter set, sterile; REF 540-25. Recall # Z-1778-2009;

44) Stryker PainPump2, 400 mL PainPump with 5.0 inch ExFen 2-site catheter set, sterile; REF 540-50. Recall # Z-1779-2009;
 
45) Stryker PainPump2, 400 mL PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile; REF 540-155. Recall # Z-1780-2009;

46) Stryker PainPump2, 400 mL pre-set PainPump with luer lock tubing set, 5.0 inch ExFen and standard catheter, sterile; REF 541-155. Recall # Z-1781-2009;
 
47) Stryker PainPump, standard antimicrobial silver catheter kit, sterile; REF 0555-001-000. Recall # Z-1782-2009;
 
48) Stryker PainPump ExFen, 2.5 in. antimicrobial silver ExFen catheter kit, sterile; REF 0555-002-000. Recall # Z-1783-2009;

49) Stryker PainPump ExFen, 5.0 in. antimicrobial silver ExFen catheter kit, sterile; REF 0555-005-000. Recall # Z-1784-2009;
 
50) Stryker PainPump ExFen, 10.0 in. antimicrobial silver ExFen catheter kit, sterile; REF 0555-010-000. Recall # Z-1785-2009;

51) Stryker PainPump ExFen, 2.5 in. dual site antimicrobial silver ExFen catheter, sterile; REF 0555-202-000. Recall # Z-1786-2009;

52) Stryker PainPump ExFen, 5.0 in. dual site antimicrobial silver ExFen catheter, sterile; REF 0555-205-000. Recall # Z-1787-2009;

53) Stryker PainPump ExFen, 10.0 in. dual site antimicrobial silver ExFen catheter, sterile; REF 0555-210-000. Recall # Z-1788-2009
CODE
1) Lot Numbers: 2006040602 through 2009022603;

2) Lot Numbers: 2007121703 through 2008111201;

3) Lot Numbers: 2008011401 through 2008091101;

4) Lot Numbers: 2007012901 through 2009030501;

5) Lot Numbers: 2006020702 through 2009010801;

6) Lot Numbers: 2007011504 through 2009021803;

7) Lot Numbers: 2007121701 through 2009021802;

8) Lot Numbers: 2007120405 through 2008121003;

9) Lot Numbers: 2006020602 through 2009010802;

10) Lot Numbers: 2007111901 through 2009010601;

11) Lot Numbers: 2008011404 through 2009012201;

12) Lot Numbers: 2007011503 through 2009030201;

13) Lot Numbers: 2007020701 through 2008120303;

14) Lot Numbers: 2007021501 through 2009050602;

15) Lot Numbers: 2006041001 through 2008100601;

16) Lot Numbers: 2006020601 through 2008102806;

17) Lot Numbers: 2007111902 through 2009021701;

18) Lot Numbers: 2007120402 through 2009011201;

19) Lot Numbers: 2007121904 through 2008121103.

20) Lot Numbers: 2008010201 through 2009031201.

21) Lot Numbers: 0703102 through 09082012 and 6059385645 through 7005524356;
 
22) Lot Numbers: 07158012 through 09125012;

23) Lot Numbers: 2008011002 through 2008092501;

24) Lot Numbers: 08058012 through 09106012;

25) Lot Numbers: 08044012 through 09126012;

26) Lot Numbers: 07033022 through 09125012 and 6027371259 through 7009524359;

27) Lot Numbers: 07142012 through 09104012;

28) a) Lot Numbers: 08113012 through 08365012; b) Lots Numbers: 08127012 through 09092012 and c) Lot Numbers: 08049012 through 09082012;

29) Lot Numbers: 2007022004 through 2009032301;

30)  Lot Number: 2008050802 through 2009020902;

31) Lot Numbers: 2008021901 through 2009032302;

32) Lot Numbers: 2008011003 through 2008012804;

33) Lot Number: 2008032503 through 2009040703;

34) Lot Numbers: 2008011004 through 2008120302;

35) Lot Numbers: 2008032504 through 2009022401;

36) Lot Numbers: 8141755419 through 9127935243;

37) Lot Numbers: 8136753340 through 9131936639.

38) Lot Numbers: 8136753340 through 8233798286;

39) Lot Numbers: 8136753340 through 9131936638;

40) Lot Numbers: 8142756107 through 8315838097;

41) Lot Numbers: 8143756121 through 9121931331;
 
42) Lot Numbers: 8143756122 through 9036886015;

43) Lot Numbers: 08092012 through 09090012;

44) Lot Numbers: 08050012 through 09113012;

45) Lot Numbers: 07054012 through 09077012 and 6033374026 through 7017529998

46) Lot Numbers: 07052012 through 09023012 and 06037376027 through 7011527382;

47) Lot Numbers: 2008052603 through 2008090102;

48) Lot Numbers: 2008052702 through 2008090103;

49) Lot Numbers: 2008052702 through 2008062502;

50) Lots 2008052801 through 2008090502;

51) Lot Numbers: 2008062602 through 2008062602;

52) Lot Numbers: 2008062603 through 2008090405;

53) Lot Numbers: 2008062601 through 2008062601
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Instruments Div. of Stryker Corp., Kalamazoo, MI, by letter dated June 16, 2009.
Manufacturer: Medisize Ireland Ltd, Donegal, Ireland. Firm initiated recall is ongoing.
REASON
The catheter may break when removed from the body, or the catheter may have kinks or be occluded such that the patient will not receive the intended quantity of medication.
VOLUME OF PRODUCT IN COMMERCE
44,091 units
DISTRIBUTION
Nationwide, Argentina, Australia, Brazil, Canada, England, France, Germany, Hong Kong, Italy, Japan, Latin America, Malaysia, Mexico, Netherlands, New Zealand, Singapore, South Africa, Spain, Sweden, Switzerland and Taiwan
___________________________________
PRODUCT 
1) Medtronic INTREPID Spinal System SPACER, 32X23, 8 DEG, Size: 10MM, Part Number: REF 7961810; 12MM, REF 7961812; 14MM, REF 7961814; 16MM, REF 7961816; 18MM, REF 7961818; 20MM, REF 7961820; Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1796-2009;

2) Medtronic INTREPID Spinal System SPACER, 32X23, 12 DEG, Size: 10MM, Part Number: REF 7961210; 12MM, REF 7961212; 14MM, REF 7961214; 16MM, REF 7961216; 18MM, REF 7961218; 20MM, REF 7961220; Rx only, STERILE R The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1797-2009;

3) Medtronic INTREPID Spinal System SPACER M 37X27, 8 DEG, Size 10MM, Part Number: REF 7962810; 12MM, REF 7962812; 14MM, REF 7962814; 16MM, REF 7962816; 18MM, REF 7962818; 20MM, REF 7962820; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1798-2009;

4) Medtronic INTREPID Spinal System SPACER M 37X27, 12 DEG, Size: 10MM, Part Number: REF 7962210; 12MM, REF 7962212; 14MM, REF 7962214; 16MM, REF 7962216; 18MM, REF 7962218; 20MM, REF 7962220; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1799-2009;

5) Medtronic INTREPID Spinal System SPACER L 42X30, 8 DEG, Size: 10MM: Part Number: REF 7963810; 12MM, REF 7963812; 14MM, REF 7963814; 16MM, REF 7963816; 18MM, REF 7963818; 20MM, REF 7963820; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1800-2009;

6) Medtronic INTREPID Spinal System SPACER L 42X30, 12 DEG, Size: 10MM, Part Number: REF 7963210; 12MM, REF 7963212, 14MM, REF 7963214; 16MM, REF 7963216; 18MM, REF 7963218; 20MM, REF 7963220; USA, Rx only, STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1801-2009;

7) Medtronic INTREPID Spinal System Coverplate, size: Small, Part Number: REF 7961330; medium, REF 7962330; large, REF 7963330; STERILE R. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1802-2009;

8) Medtronic SOFAMOR DANEK INTREPID SPINAL SYSTEM, 5.5MM TAPERED SCREW, Length: 20MM, , Part Number: REF 7960020; 25MM, REF 7960025, 30MM, REF 7960030; and 35MM, REF 7960035; QTY: 1 EA, NON-STERILE, Rx only, MATL: TITANIUM ALLOY, Manufactured at: Warsaw, Indiana USA. The INTREPID Spinal System is indicated for use with autogenous bone graft in patients with degenerative disc disease. Recall # Z-1803-2009
CODE
All Lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Medtronic Sofamor Danek USA Inc., Memphis, TN, by telephone starting February 6, 2009 and letter dated April 2009.
Manufacturer: Medtronic Sofamor Danek Deggendorf GmbH, Bavaria, Germany. Firm initiated recall is ongoing.
REASON
The firm received complaints regarding the use of the product in patients with poor bone quality, translational instability, difficulty implanting the cover plate and case of cover plate detachment.
VOLUME OF PRODUCT IN COMMERCE
8028 units
DISTRIBUTION
Nationwide, Australia, Germany, The Netherlands, and South Africa
___________________________________
PRODUCT 
1) Stryker Reflex Hybrid Level Anterior Cervical Plate; Non Sterile. All Product with the following Catalog Number/Description: 48650112, Reflex Hybrid one-level plate, size 12mm; 48650114m size 14 mm; 48650116, 16 mm; 48650118, size 18mm; 48650120, size 20 mm; 48650122, size 22 mm. 48650224, Reflex Hybrid Two-Level Plate, size 24 mm; 48650226, size 26 mm; 48650228, size 28 mm; 48650230, size 30 mm; 48650232, size 32 mm; 48650234, size 34 mm; 48650237, size 37 mm; 48650240, size 40 mm; 48650243, size 43 mm; 48650246, size 46 mm. 48650339, Reflex Hybrid Three-Level Plate, Size 39 mm; 48650342, size 42mm; 48650345, size 45 mm; 48650348, size 48 mm; 48650351, size 51 mm; 48650354, size 54 mm; 48650357, size 57 mm; 48650360, size 60 mm; 48650363, size 63 mm; 48650366, size 66 mm; 48650369, size 69 mm. 48650460, Reflex Hybrid four-Level Plate, size 60 mm; 48650464, size 64 mm; 48650468, size 68 mm; 48650472, size 72 mm; 48650476, size 76 mm; 48650489, size 80 mm; 48650484, size 84 mm. Recall # Z-1958-2009;

2) Stryker Reflex Hybrid variable self-drilling screw. Non Sterile. All Product with the following Catalog Number/ Description: 48664010, Variable Angle Bone Screw Self Drilling, Diameter 4.0 x 10 mm; 48664012, diameter 4.0 x 12 mm; 48604014, diameter 4.0 x 14 mm; 48664016, diameter 4.0 x 16 mm; 48664018, diameter 4.0 x 18 mm. Recall # Z-1959-2009;

3) Stryker Reflex Hybrid Variable Self-Tapping Screw. Non Sterile. All Product with the following Catalog Number/Description: 48684012, Variable Angle Bone Screw, diameter 4.0 x 10 mm; 48684012, diameter 4.0 x 12 mm; 48684014, diameter 4.0 x 14 mm; 48684018, diameter 4.0 x 18 mm; 48684020, diameter 4.0 x 20 mm; 48684512, diameter 4.5 x 12 mm; 48684516, diameter 4.5 x 14 mm; 48684516, diameter 4.5 x 16 mm; 48684518, diameter 4.5 x 18 mm; 48684520, diameter 4.5 x 20 mm. Recall # Z-1960-2009
CODE
All Products with the listed Catalog Numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by letter dated June 14, 2006. 
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is complete.
REASON
Design Flaw: The design did not prevent over angulation of the screws when the recommended instrument, All in One Guide, was not used.
VOLUME OF PRODUCT IN COMMERCE
38,987 plates, 109,572 screws
DISTRIBUTION
Nationwide

END OF ENFORCEMENT REPORT FOR SEPTEMBER 23, 2009

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