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U.S. Department of Health and Human Services

Safety

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Enforcement Report for August 26, 2009

August 26, 2009 
09-34

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
1) Screened Granulated Peanuts, finely chopped peanuts packaged and distributed in 30 lb bulk cases and/or 24 lb cases. The 30 lb cases are comprised of 6 x 5lb poly bags of product placed inside a cardboard carton. The 24 lb cases are comprised of 6 x 4 lb vacuum sealed tin cans, Recall # F-802-9;

2) Peanut Butter packed in 45 lb bulk cartons (the peanut butter is inside poly bag which is inside a cardboard carton) and/or packed in 42 lb. plastic pails, Recall # F-803-9;

3) Standard Nut Topping, packaged for, and distributed exclusively to Dairy Queen, is distributed in 30 lb. bulk cases (poly bag inside cardboard cartons) or packed in 30 lb. cases comprised of 6 x 5 lb. poly bags inside a cardboard carton; or packed in 24 lb. cases comprised of 6 x 4 lb vacuum sealed tin cans, Recall # F-804-9; 

4) Peck Mix. This item is packed exclusively for Peck Food Service. This product is a chopped mixture of granulated peanuts, honey roasted peanuts, brazils, cashews and English walnuts and is a nut topping intended to be sprinkled on ice cream, Recall # F-805-9;

5) Mailender Mix. This item is one (1) of four peanut mixes which the firm provides to wholesale customers of the same name, hence the name 'Mailender' mix. This product is a mixture of granulated peanuts, almonds, cashews, filberts and brazil nuts and is a nut topping intended to be sprinkled on ice cream. The product is packed and distributed in 24 lb. cases comprised of 6 x 4 lb. vacuum sealed tin cans. Recall # F-806-9;

6) Quezel Mix. This item is one (1) of four peanut mixes which the firm provides to wholesale customers of the same name, hence the name 'Quezel' mix. This product is a mixture of split blanched peanuts, cashews, brazil nuts, and almonds and is a nut topping intended to be sprinkled on ice cream. *The firm has stated that this product contains none of the peanuts received from PCA, however the mix was processed using the same equipment which processed the other nut toppings which contained PCA peanuts). The produce was packed and distributed in 30 lb. bulk cases with the product contained in a poly bag placed inside each card board carton, Recall # F-807-9;

7) Meadows Mix. This item is one (1) of four peanut mixes which the firm provides to wholesale customers of the same name, hence the name 'Meadows' mix. This product is a mixture of chopped peanuts, brazil nuts, cashews, almonds and filberts and is a nut topping intended to be sprinkled on ice cream. The product is sold in 10 lb. cases comprised of 6 x 5 lb. poly bags inside a cardboard carton, Recall # F-808-9;

8) AAA Topping Mix, This item is a finely chopped mixture of granulated peanuts, brazil nuts, cashews and almonds. The product is a nut topping intended to be sprinkled on top of ice cream. The product is distributed as follows: 30 lb. bulk cases with product inside a poly bag inside a cardboard carton; 30 lb. cases comprised of 6 x 5 lb. poly bags inside a cardboard carton; 24 lb cases comprised of 6 x 4 lb vacuum sealed tin cans; and 12 lb. cases comprised of 12 x 1 lb vacuum sealed tin cans, F-809-9
CODE
1) The #10 tins (vacuum cans) are identified with dates on the bottom of the can ranging from15 07 through 24 07; and/or 10 08 through 27 08. The cartons are identified with dates ranging from 04/19/07 through 6/30/07 and/or 2/14/08 through 7/31/08. Bags are not dated;

2) The cartons are identified with dates ranging from 04/19/07 through 6/30/07 and/or 2/14/08 through 7/31/08. Bags are not dated;

3) The #10 tins (vacuum cans) are identified with dates on the bottom of the can ranging from 15 07 through 24 07; and/or 10 08 through 27 08. The cartons are identified with dates ranging from 04/19/07 through 6/30/07 and/or 2/14/08 through 7/31/08. Bags are not dated;

4) The #10 tins (vacuum cans) are identified with dates on the bottom of the can ranging from15 07 through 24 07; and/or 10 08 through 27 08. The cartons are identified with dates ranging from 04/19/07 through 6/30/07 and/or 2/14/08 through 7/31/08. Bags are not dated;

5) The #10 tins (vacuum cans) are identified with dates on the bottom of the can ranging from15 07 through 24 07; and/or 10 08 through 27 08. The cartons are identified with dates ranging from 04/19/07 through 6/30/07 and/or 2/14/08 through 7/31/08;

6) The cartons are identified with dates ranging from 04/19/07 through 6/30/07 and/or 2/14/08 through 7/31/08. The bags are not dated;

7)  The cartons are identified with dates ranging from 04/19/07 through 6/30/07 and/or 2/14/08 through 7/31/08. The bags are not dated;

8) The #10 tins (vacuum cans) are identified with dates on the bottom of the can ranging from 15 07 through 24 07; and/or 10 08 through 27 08. The cartons are identified with dates ranging from 04/19/07 through 6/30/07 and/or 2/14/08 through 7/31/08. The bags are not dated
RECALLING FIRM/MANUFACTURER
Hillson Nut Co., Inc., Cleveland, OH, by letter on February 3, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
199,456 pounds
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Caveman Bar Peanut and Sea Salt, 1.5 oz., individually wrapped in cellophane with adhesive backed label. Product packaged in brown paperboard box with 12- 1.5 oz bars per box, Recall # F-810-9;

2) Caveman Bar Salted Corn and Peanut, 1.5 oz., individually wrapped in cellophane with adhesive backed label which reads in part, Caveman Bar...Salted Corn & Peanut, Recall # F-811-9
CODE
None
RECALLING FIRM/MANUFACTURER
Complete Life Potential, Poulsbo, WA, by press release beginning on or about February 5, 2009 and February 13, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE
8,662 bars
DISTRIBUTION
CA, FL, WA
___________________________________
PRODUCT 
1) Traditions Meal Solutions, Meal 417, Spaghetti w/Meat sauce, peach cup, fruit punch, animal crackers, crackers, milk-1 day pack, Traditions, net wt 26.8 lbs, Recall # F-812-9;  

2) Traditions Meal Solutions, Meal 419, Special K cereal, fruit cup, apple juice, apple cinnamon bar, milk-1 day pack, Traditions, net wt 16.8 lbs. Recall # F-813-9;

3) Traditions Meal Solutions, Meal 423, tuna/mayo/relish, applesauce, fruit punch, cheddar goldfish, blueberry bar, milk-1 day pack, Traditions, net wt 21.8 lbs. Recall # F-814-9;

4) Traditions Meal Solutions, Meal 425, Chicken Noodle Soup, raisins, apple juice, crackers, oatmeal creme cookie, milk-1 day pack, Traditions, net wt 23.6 lbs, Recall # F-815-9;

5) Traditions Meal Solutions, Meal 441, Chili with Beans, raisins, tomato juice, crackers, vanilla creme cookies, milk-1 day pack, Traditions, net wt 25.4 lbs.
Recall # F-816-9;

6) Traditions Meal Solutions, Meal 442, Beef Stew, peach cup, fruit punch, crackers, vanilla creme cookie, milk-1 day pack, Traditions, net wt 27.2 lbs, Recall # F-817-9;

7) Traditions Meal Solutions, Meal 443, Lasagna, applesauce, fruit punch, crackers, chocolate creme cookie, milk-1 day pack, Traditions, net wt 27.2 lbs., Recall # F-818-9;

8) Traditions Meal Solutions, Meal 444, Beans and Franks, fruit cup, apple juice, crackers, Strawberry bar, milk-1 day pack, Traditions, net wt 28.4 lbs., Recall #  F-819-9;

9) Traditions Meal Solutions, Meal 445, Noodles & Chicken, raisins, apple juice, crackers, blueberry bar, milk-1 day pack, Traditions, net wt 23.9 lbs., Recall # F-820-9;

10) Traditions Meal Solutions, Meal 446, Scalloped Potatoes & Ham, raisins, fruit punch, crackers, Strawberry bar, milk-1 day pack, Traditions, net wt 23.9 lbs., Recall # F-821-9;

11) Traditions Meal Solutions, Meal 461, Chili with beans, peach cup, orange juice, chocolate creme cookie, unsalted crackers, milk-1 day pack, Traditions, net wt 26.8 lbs., Recall # F-822-9;

12) Traditions, The main course, Meal 451, Chili with Beans, Beef Stew, Lasagna, Noodles and Chicken, Scalloped Potatoes and Ham, apple juice, fruit punch, raisins, applesauce, fruit cup, peach cup, Oreo cookie, Teddy Grahams, Chips Ahoy cookies, vanilla creme cookie, crackers, milk 1 day pack. Net wt 5.9 Traditions, The main course, Meal 451, Chili with Beans Hormel, Beef Stew Dinty Moore, Lasagna Hormel, Noodles and Chicken, Scalloped Potatoes and Ham, apple juice, fruit punch, raisins, applesauce, fruit cup, peach cup, Oreo cookie, Teddy Grahams, Lorna Doone cookies, vanilla creme cookie, crackers, milk 1 day pack. net wt 5.9 Traditions Meal Solutions, Meal 451, Chili with Beans, Beef Stew, Lasagna, Beans and Franks, Noodles and Chicken, tomato juice, apple juice, raisins, applesauce, fruit cup, peach cup, vanilla creme cookie, Goldfish cheddar, chocolate creme cookie, apple cinnamon bar, blueberry bar, crackers, milk 1 day pack. Net wt 5.9 Traditions, The main course, Meal 451, Chili with Beans, Beef Stew, Lasagna, Noodles and Chicken, Scalloped Potatoes and Ham, apple juice, fruit punch, raisins, applesauce, fruit cup, pear cup, Oreo cookie, Teddy Grahams, Lorna Doone cookies, vanilla creme cookie, wheat crackers, crackers, milk 1 day pack. Net wt 5.9 Traditions Meal Solutions, Meal 451, Chili with Beans, Scalloped Potatoes, Lasagna, Beans and Franks, Noodles and Chicken, tomato juice, apple juice, fruit punch, raisins, applesauce, fruit cup, peach cup, vanilla creme cookie, cheddar Goldfish, chocolate creme cookie, apple cinnamon bar, blueberry bar, saltine crackers, milk 1 day pack. Net wt 5.9 Traditions Meal Solutions, Meal 451, Chili with Beans, Beef Stew, Lasagna, Noodles and Chicken, Beans and Franks, tomato juice, apple juice, fruit punch, raisins, applesauce, fruit cup, peach cup, vanilla creme cookie, Goldfish crackers, chocolate creme cookie, apple cinnamon bar, blueberry bar, saltine crackers, milk 1 day pack. Net wt 5.9 Traditions Meal Solutions, Meal 451, Scalloped Potatoes and Ham, Beef Stew, Lasagna, Beans and Franks, Noodles and Chicken, tomato juice, apple juice, fruit punch, raisins, applesauce cup, fruit cup, peach cup, vanilla creme cookie, chocolate creme cookie, lemon creme cookie, apple cinnamon bar, blueberry bar, saltine crackers, milk 1 day pack, net wt 5.5 lbs, Recall # F-823-9;

13) Traditions Meal Solutions, Meal 464, Beef Stew, raisins, low sodium V-8 juice, Melba Toast, vanilla creme cookie, crackers, milk-1 day pack, Traditions, net wt 25 lbs. Recall # F-824-9;

14) Traditions Meal Solutions, Meal 465, Lasagna, raisins, apple juice, chocolate peanut butter bar, wheat crackers, milk-1 day pack, Traditions, net wt 23.9 lbs, Recall # Recall # F-825-9;

15) Traditions Meal Solutions, Meal 466, Beans and Franks, applesauce, fruit punch, Low sodium crackers, peanut butter, strawberry bar, milk-1 day pack, Traditions, net wt 28.62 lbs, Recall # F-826-9;

16) Traditions Meal Solutions, 7-Pack, Beans and Franks, Chicken Noodle soup, Chili with Beans, Beef Stew, Lasagna, Noodles and Chicken, raisins, applesauce, fruit cup, peach cup, apple juice, tomato juice, green beans, green peas, Lorna Doone cookies, apple cinnamon bar, strawberry bar, blueberry bar, wheat crackers, saltine crackers, non fat dry milk. Net wt 8.4 lbs Traditions Meal Solutions, 7-Pack, Tuna/mayo/relish, Chicken Noodle soup, Chili with Beans, Beef Stew, Lasagna, Noodles and Chicken, Scalloped Potatoes and ham, raisins, applesauce, fruit cup, peach cup, apple juice, tomato juice, green beans, green peas, Lorna Doone cookies, apple cinnamon bar, strawberry bar, blueberry bar, wheat crackers, saltine crackers, non fat dry milk. Net wt 8.8 lbs, Recall # F-827-9;

17) Traditions Instant Nonfat Dry Milk, 1 Pack Milk, 250/25 Grams, Recall # F-828-9
CODE
1) Ship date, invoice no.: 9/25/2008, 9405 11/4/2008, 9631 9/4/2008, 9255 9/30/2008, 9419
2) Ship date, invoice no.: 4/28/2009, 10665 2/6/2008, 8235;

3) Ship date, invoice no.: 5/15/2008, 8705 11/17/2008, 9720 2/6/2008, 8235 12/18/2008, 9917;

4) Ship date, invoice no.: 3/17/2008, 8405 2/6/2008, 8235;

5) Ship date, invoice no.: 1/25/2008, 8175 1/21/2008, 8139 7/3/2008, 8944 1/16/2008, 8057

6)  Ship date, invoice no.: 3/18/2008, 8424 1/25/2008, 8176 1/15/2008, 8125 4/30/2008, 8621 7/28/2008, 9053 4/8/2008, 8495 12/2/2008, 9824 12/8/2008, 9835 11/18/2008, 9706 5/28/2008, 8753 3/27/2008, 8457 12/1/2008, 9789 11/17/2008, 9715 12/15/2008, 9867 11/17/2008, 9716 11/17/2008, 9720 2/6/2008, 8235 12/18/2008, 9917;

7) Ship date, invoice no.: 1/25/2008, 8176 1/15/2008, 8125 1/25/2008, 8175 5/30/2008, 8767 3/17/2008, 8405 7/3/2008, 8944 4/8/2008, 8495 5/15/2008, 8687 3/26/2008, 8430 5/21/2008, 8724 5/28/2008, 8753 6/16/2008, 8841 3/27/2008, 8457;

8) Ship date, invoice no.: 3/11/2008, 8379 3/17/2008, 8405 7/3/2008, 8944 728/2008, 9053 3/12/2008, 8388 5/27/2008, 8760 6/6/2008, 8807 6/16/2008, 8841 2/6/2008, 8235 6/10/2008, 8818;

9) Ship date, invoice no.: 12/18/2008, 9918 3/18/2008, 8424 12/18/2008, 9920 12/8/2008, 9837 4/22/2009, 10638 6/5/2009, 10915 12/8/2008, 9836 7/3/2008, 8944 12/29/2008, 9969 6/4/2009, 10984 11/17/2008, 9716 11/5/2008, 9623 6/15/2009, 10967 A;

10) Ship date, invoice no.: 6/5/2009, 10915 5/19/2009, 10781 7/3/2008, 8944 5/13/2008, 8672 6/16/2008, 8841 6/15/2009, 10967 A 2/6/2008, 8235;

11) Ship date, invoice no.: 4/9/2008, 8509 1/9/2008, 8092 1/16/2008, 8112 2/6/2008, 8234 3/27/2008, 8456 4/8/2008, 8519 5/19/2009, 10795 4/9/2008, 8514 4/9/2008, 8512 4/9/2008, 8518 4/8/2008, 8515 1/9/2008, 8084;

12) Ship date, invoice no.: 2/26/2008, 8310 4/30/2009, 10685 1/10/2008, 8107 1/10/2008, 8107 8/26/2008, 9198 5/21/2008, 8727 6/3/2008, 8791 5/8/2009, 10732 6/5/2009, 10915 5/8/2009, 10734 5/13/2008, 8671 7/24/2008, 9039 4/30/2009, 10684 5/21/2008, 8731;

13) Ship date, invoice no.: 1/16/2008, 8116 10/8/2008, 9482 4/21/2009, 10631 10/8/2008, 9483 5/19/2009, 10798 4/9/2008, 8507 5/5/2009, 10710 4/28/2009, 10672 5/5/2009, 10711;

14) Ship date, invoice no.: 4/9/2008, 8509 6/25/2008, 8893 6/18/2008, 8856 6/25/2008, 8893 11/13/2008, 9687 3/27/2008, 8456 4/8/2008, 8519 6/4/2008, 8798 6/25/2008, 8895 4/21/2009, 10631 4/9/2008, 8514 4/9/2008, 8512 4/9/2008, 8518 5/19/2009, 10798 5/5/2009, 10710 5/21/2008, 8732 4/8/32008, 8515 4/15/2008, 8541 4/28/2009, 10672 5/5/2009, 10711;
 
15) Ship date, invoice no.: 1/9/2008, 8092 1/16/2008, 8112 2/6/2008, 8234 5/21/2008, 8730 3/27/2008, 8456 1/12/2009, 10068 12/4/2008, 9823 4/9/2008, 8514 4/9/2008, 8507 5/21/2008, 8732 1/9/2008, 8084;

16) Ship date, invoice no.: 5/29/2008, 8765 11/5/2008, 9624 4/9/2008, 8513 12/4/2008, 9822 3/20/2008, 8444 5/15/2008, 8691;

17) Ship dates: 01/17/2008 - 06/30/2009
RECALLING FIRM/MANUFACTURER
Valley Innovative Services, Inc, AKA Traditions, Pearl, MS, by telephone, fax and letters beginning on June 26, 2009. Firm initiated recall is ongoing.
REASON
The non-fat dried milk packet found inside the kit was 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
17,060 cases
DISTRIBUTION
VA, LA, NE, IA, GA, OH, SC, FL, MS, PA, AL, TX, KY, MO, AR, MI
___________________________________
PRODUCT 
1) Sauer's brand, Gold Medal brand, and Piggly Wiggly brand Brown Gravy Mixes, packaged in .75 oz. pouch, 4.5 oz plastic jar, 10 oz. plastic jar, and 19 oz. plastic jar, labeled in part *** UPC s: 52500 02312, 52500 00691, 52500 01507, 52500 01776, 52500 02100, and 41290 41229, Recall # F-829-9;

2) Sauer's brand Brown Gravy with Onions Mix, packaged in .75 oz pouch, labeled in part,  UPC 52500 02314, Recall # F-830-9;

3) Sauer's brand Brown Gravy with Mushrooms Mix, packaged in .75 oz. pouch, labeled in part, UPC 52500 02313, Recall # F-831-9;

4) Sauer's brand Country Style Gravy Mix , packaged in 1.31 oz. pouch, labeled in part, UPC 52500 02327, Recall # F-832-9;

5) Sauer's brand and Gold Medal brand Turkey Gravy Mix, packaged in .87 oz. pouches, labeled in part, UPC 52500 02394 and 52500 02103, Recall # F-833-9;

6) Sauer's Hollandaise Sauce Mix, packaged in 1.12 oz. pouch, labeled in part, UPC 52500 02340, Recall # F-834-9;

7) Sauer's brand Pork Gravy Mix, packaged in .87 oz. pouch, labeled in part, UPC 52500 02373, Recall # F-835-9;

8) Sauer's brand Cajun Gumbo Mix, packaged in 1.25 oz. pouch, labeled in part, UPC 52500 02364, Recall # F-836-9;

9) Sauer's brand Alfredo Sauce Mix, in 1.60 oz. pouch, labeled in part, UPC 52500 02360, Recall # F-837-9;

10) Sauer's brand Onion Gravy Mix, in 1.12 oz. pouch, labeled in part, UPC 52500 02356, Recall #F-838-9;

11) Sauer's brand Country Style Sausage Gravy Mix, packaged in 1.31 oz. pouch, UPC 52500 02331, Recall # F-839-9
CODE
1) Lot number’s: 8008R, 8066R, 8092R, 8093R, 8133R, 8141R, 8142R, 8148R, 8217R, 8273R, 8302R, 8303R, 8344R, 9070R, 9105R, 9120R, 9124R, 8007R, 8072R, 8178R, 9008R, 8178R, 8197R, 8198R, 8288R, 9078R, 9162R, 9166R, 8115R, 8129R, 8134R, 8136R, 8142R, 8184R, 8192R, 8206R, 8232R, 8252R, 8266R, 8275R, 8287R, 8301R, 8316R, 8339R, 8364R, 9012R, 9036R, 9069R, 9082R, 9105R, 9153R, 9160R, 8133R, 8339R, 9056R, 9077R, 9141R, 8262R, 9013R, 9014R, 9154R;

2) Lot Number’s: 8009R, 8043R, 8093R, 8196R, 8268R, 8358R, 9117R;

3) Lot Number’s: 8011R, 8086R, 8248R, 8289R, 8294R, 9117R;

4) Lot Number’s: 8018R, 8162R, 9119R;

5) Lot Number’s: 7339R, 7347R, 7365R, 8105R, 8106R, 8183R, 8255R, 8282R, 8295R, 8301R, 8325R, 8359R, 9166R, 8073R;

6) Lot Number’s: 8029R, 8155R;

7) Lot Number’s: 8016R, 8087R, 8176R, 8217R, 9078R;

8) Lot Number’s: 8028R, 8143R;

9) Lot Number’s: 8028R, 8029R, 8107R;

10) Lot Number’s: 8011R, 8084R, 8184R, 9056R;

11) Lot Number: 9119R
RECALLING FIRM/MANUFACTURER
C.F. Sauer Co., Inc., Richmond, VA, by press release on July 7, 2009, e-mail and telephone on July 7, 2009 and July 8, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using an ingredient recalled by Plainview Milk Products because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
81,951 cases
DISTRIBUTION
AL, NC, SC, MS, MI, OH, TN, VA, WV, KY, FL, PA
___________________________________
PRODUCT 
1) SunRidge Farms brand Tropical Golden Nuggets, UPC 086700221570, 10 lb Case, Item #: 022157, Recall # F-840-9;

2) SunRidge Farms brand Chocolate Energy Bars, UPC 086700211168, 10 lb Case, Item #: 021116, Recall # F-841-9;

3) SunRidge Farms brand Energy Nuggets, UPC 086700680643, 8 oz. Bag, 12 bags per case, Item #: 868064, Recall # F-842-9;

4) SunRidge Farms brand Naturally Preferred Honey Nut Nuggets, UPC 011100372376, 8 oz. Bag, Item #: 37237, Recall # F-843-9;

5) SunRidge Farms brand Dry Roasted Peanuts, Roasted & Salted, UPC 086700011850, 30 lb Case, Item #: 01185, Recall # F-844-9;

6) SunRidge Farms brand All Natural Honey Roasted Peanuts, UPC 086700011867, 30 lb Case, Item #: 001186, Recall # F-845-9;

7) SunRidge Farms brand Organic Supreme Fruit & Nut Mix, UPC 086700061190, 16 lb Case, Item #: 006119, Recall # F-846-9;

8) SunRidge Farms brand Miso Curry Nut Mix a) UPC 086700061879, in 16 lb Case, Item #: 006187, b) UPC 086700662403, 7.5 oz, packages packed 8 to a case, Case Item #: 866240, Recall # F-847-9
CODE
1) Lot number: 2708;
2) Lot numbers: 2948, 3108, 3388;
3) Lot number: 2490893;
4) Nov1209DD, Nov0209GB, Aug3009DB, Jly1709DA
5), 6), 7), and 8) All lot codes prior to 0300999;
RECALLING FIRM/MANUFACTURER
Recalling Firm: Falcon Trading Co., Pajaro, CA, by press release, letters, telephone, and e-mails on January 23, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE
910 cases
DISTRIBUTION
CA, PA., NC, LA
___________________________________
PRODUCT 
1) Archer Farms Banana Peanut Granola Bars 8.5 oz UPC CODE 085239 20044 5, Recall # F-848-9;

2) Archer Farms Peanut Butter Monster Bars/Bites. UPC CODE 085239 20151 0 is for the 1.76 oz bars and UPC CODE 085239 20040 7 is for the 6 count box/10.6 oz. UPC CODE 0 85239 20054 4 is for the 15 count box/9 oz, Recall # F-849-9;

3) Archer Farms Milk Chocolate Monster Bars/Bites. UPC CODE 085239 20150 3 is for the 1.76 oz bars and UPC CODE 0 85239 20039 1 is for the 6 count box/10.6 oz. UPC CODE 0 85239 20052 0 is for the 15 count box/9 oz, Recall # F-850-9;

4) Archer Farms Milk Chocolate Dipped Peanut Butter Bars/Bites. UPC CODE 0 85239 20048 3 is for the 6 count box of bars/9.52 oz, UPC CODE 0 85239 20054 4 is for the 15 count box of bites/9.52 oz, Recall # F-851-9;

5) Archer Farms Peanut Butter Dipped Peanut Butter Bites 15 count/9.52 oz. UPC CODE 0 85239 20092 6, Recall # F-852-9;

6) Archer Farms Organic Cranberry Nut Trail Mix Bars 6 count box/6.56 oz UPC CODE 0 85239 20090 2, Recall # F-853-9;

7) Archer Farms Organic Chocolate Chip Peanut Trail Mix Bars 6 count box/6.5 oz UPC CODE 0 85239 20210 4, Recall # F-854-9;

8) Market Pantry Chocolate Peanut Butter Nutrition Bars. UPC CODE 0 85239 88300 6 is for the 5 pack/8.8 oz and UPC CODE 0 85239 88305 1 is for the 1.76 oz bars, Recall # F-855-9;

9) Market Pantry Chocolate Caramel Cluster Nutrition Bars. UPC CODE 0 85239 88303 7 is for the 5 pack/8.8 oz and UPC CODE 0 85239 88308 2 is for the 1.76 oz bars, Recall # F-856-9;

10) Cherrydale Farms Peanut Crunch sold in 6 oz UPC 0 53847 00200 3, Recall # F-857-9;

11) Cherrydale Farms Dark Chocolate Peanut Butter Clusters UPC 0 53847 04995 4, Recall # F-858-9;

12) Cherrydale Farms Peanut Chocolate Bars 4.9 oz, Recall # F-859-9;

13) Cherrydale Farms Trail Mix Bites 6.5 oz and Trail Mix Bars 4.9 oz, Recall # F-860-9; 

14) Peanut Caramel Clusters: under the Haddington Farms label in 4 oz boxes UPC 0 53487 00916 3 and Bartons label in 1.7 oz boxes UPC 0 53847 20467 4, Recall # F-861-9;

15) Bartons Milk Chocolate Peanut Butter Clusters 1.7 oz boxes UPC 0 53847 20468 1, Recall # F-862-9;

16) Bartons Peanut Butter Cubby Paws 3.25 oz boxes UPC 0 53847 23459 6, Recall # F-863-9;

17) Bartons Dark Chocolate Paws Peanut Butter Clusters with Peanuts 6 oz boxes UPC 0 53847 03973 3, Recall # F-864-9;

18) Disney Hannah Montan Balanced Nutrition Chocolate Peanut Bars: 22 g bars, UPC 0 53847 23496 1 English/UPC 0 53847 20610 4 French; 6 count box UPC 0 53847 20430 8 English/UPC 0 53847 20587 9 French; 18 count box UPC 0 53847 24451 9; and 24 count box containing 12 Hannah Montana bars and 12 High School Musical Apple Cinnamon bars, UPC 0 53847 23988 1, Recall # F-865-9;

19) Bartons Nut Job bars 2.22 oz bars, UPC 0 53847 23925 6 and 12 count boxes UPC 0 53847 24023 8, Recall # F-866-9;

20) Bartons Trail Mix Energy Bars/Bites. UPC 0 53847 04995 4 is for the 5 pack of bars and UPC 0 53847 04996 1 is for the 6.5 oz box of bites, Recall # F-867-9;

21) Bartons Peanut Chocolate Energy Bars in 5 count boxes UPC 0 53847 04991 6, Recall # F-868-9;

22) Bartons Assorted Chocolate Candies under "The Chocolate Shoppe" label in a) 4 oz boxes (UPC 0 53847 23519 7); b) 4.5 oz boxes (UPC 0 53847 20479 7); c) 12 oz boxes (UPC 0 53847 23518 0) and the Assorted Chocolate label in d) 1 lb 11 oz paint can (UPC 0 53847 20392 9); e) 2 lb paint can (UPC 0 53847 31042 9) and f) 1 lb 10 oz paint can (0 53847 20391 2), Recall # F-869-9
CODE
BESTBY 01SEP 2007 through BESTBY 29 OCT 2009;
RECALLING FIRM/MANUFACTURER
Cherrydale Manufacturing LLC, Allentown, PA, by telephone and press release on January 30, 2009 and by press release on February 3 and February 13, 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
3,500,000 lbs.
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) Tin Roof Sundae Ice Cream a) Hiland 1.75 qt. Square Tin Roof Sundae, UPC 72060-08712-3, b) Hiland Gal. Square Tin Roof Sundae, UPC 72060-08145, c) Best Choice Gal. Square Tin Roof Sundae, UPC 70038-59617-0,  d) Family Pak 1.75 qt. Tin Roof Sundae, UPC 72060-01518-8, e) Hiland 3-Gal. Tin Roof Sundae, no UPC, Recall # F-870-9 ;

2) Hiland Gallon Square Goo Goo Peanut Butter Ice Cream, UPC 72060-08213-5, Recall # F-871-9
CODE
1) a) Dated 1/1/08 thru 1/29/10, b) dated 1/1/08 thru 1/29/1, c) dated 1/1/08 thru 6/23/09, d) dated 1/1/08 thru 1/29/10, e) dated 1/1/08 thru 1/29/10;

2) Dated 4/3/09 and 4/16/09
RECALLING FIRM/MANUFACTURER
Hiland Dairy Inc., Springfield, MO, by telephone and e-mail and letters on February 2, 2009 and by press release on February 4, 2009 and by letters on February 5, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
373,736 units
DISTRIBUTION
MO, KS, OK, AR
___________________________________
PRODUCT 
Bucks Spumoni “La Favorita” Fancy Fresh Ice Cream Nut Roll, packaged 24- 4 oz slices of nut roll are in each box, Recall # F-872-9
CODE
Distributed between January 2007 through January 2009 (Not coded).
RECALLING FIRM/MANUFACTURER
Bucks Spumoni Co., Inc., Milford, CT, by press release on February 2, 2009 and letter on February 4, 2009. Firm initiated recall is ongoing.
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
605 boxes (24x4 oz)
DISTRIBUTION
CT
___________________________________
PRODUCT 
1) Double dipped Chocolate Peanuts. a) GFS Double-Dipped Chocolate Peanuts, net wt. 41oz.; GFS Reorder # 252584, UPC 093901252821 and b) Spartan Double-Dipped Chocolate Peanuts, net wt. 16oz., Code 944-280, UPC 8820100176, Recall # F-873-9;

2) Spartan Bridge Mix, net wt. 18oz; Item 944-322, UPC 8820100178, Recall # F-874-9
CODE
1) a) Lots P7001 through P9005; b) All lots with an expiration date on or before 11/02/09;

2) All lots with an expiration date on or before 11/02/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Krispak, Inc., Kentwood, MI, by e-mail on January 30, 2009 and February 3, 2009, and by press release on February 6, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
102,192 packages
DISTRIBUTION
FL, IL, IN, KY, MI, OH, PA, WI, TN
___________________________________
PRODUCT 
HEAVENLY CANDY COMPANY PEANUT BLISS: This candy is manufactured and sold as 10 pound bulk bags zip lock bag. The opening of the bag is closed and reinforced with tape. Bag(s), depending upon quantity ordered, are placed in cardboard boxes and shipped directly to customers by UPS. The product has neither a product code, best by date, nor any other unique identifier. Such product is only marked with the white sticker, Recall # F-877-9
CODE
None
RECALLING FIRM/MANUFACTURER
Heavenly Candy Co., Inc., Tigard, OR, by telephone between February 23, 2009 – February 15, 2009, by press release on February 14, 2009 and by e-mail on February 14, 2009 and February 15, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
3,200 lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Big on Flavor Tropical Trail Mix Mega Snax Net Wt 9 oz. UPC 8 10106 00912 4, Recall # F-878-9; 

2) Big on Flavor Texas Trail Mix Mega Snax Net wt 9 oz., UPC 8 10106 00912 4,
F-879-9;
 
3) Big on Flavor Munchy Trail Mix Mega SNAX, Net wt 5.5 oz. (154g), UPC 8 10106 009124, Recall # F-880-9;

4) Big on Flavor Pacific Sunrise Mix Mega Snax Net Wt 4.25 oz. (119g), UPC 8 10106 00912 4, Recall # F-881-9
CODE
Products with expiration date of December 2008, no lot codes
RECALLING FIRM/MANUFACTURER
DSD Services, Inc., Shiner, TX, by telephone and fax on March 5, 2009 and press release on March 6, 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
10, 692 units
DISTRIBUTION
TX, OK, MN, LA
___________________________________
PRODUCT 
Dan the Sausageman Gift Box containing a variety of packaged foods including recalled Anna's Pantry Honey Roasted Peanuts, Net Weight 1.5 oz in a clear plastic bag. Recall # F-882-9
CODE
None
RECALLING FIRM/MANUFACTURER
Dan the Sausage Man, Burien, WA, by telephone on March 9, 2009 and by press release on March 11, 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
8,766 gift boxes
DISTRIBUTION
OH, MO, NY
___________________________________
PRODUCT 
Peanut Butter. Label reads (in part): "ALL NATURAL PEANUT BUTTER
...CONTAINS: PEANUTS...ANDRONICO'S..." UPC 205115. Packaged in 1/2 pint and pint size clear, plastic tubs with lids. Product was grinded daily by the store. Brand name: Andronico's Market, Recall # F-883-9
CODE
None
RECALLING FIRM/MANUFACTURER
Recalling Firm: Andronico’s Markets, Inc., Albany, CA, by store notice on February 12, 2009 and press release on March 24, 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
1,621 lbs
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Chang Farm Brand Soy Sprouts, 10 lb bags and 12 oz plastic bags, Recall # F-884-9;

2) Chang Farm Bean Sprouts, 10 lb bags and 12 oz plastic bags, Recall # F-885-9
CODE
1) Sell by date of May 23, 2009 or May 24, 2009;
2) Use by date of May 23, 2009 or May 24, 2009
RECALLING FIRM/MANUFACTURER
Chang & Son Enterprises, Inc., Whately, MA, by visit and press release on May 28, 2009. Firm initiated recall is complete.
REASON
Sprouts may be contaminated with Listeria monocytogenes.
VOLUME OF PRODUCT IN COMMERCE
1) 103 / 12 oz bags; 64 / 10 lb bags;
2) 329 / 12 oz bags and 1028 / 10 lbs bags
DISTRIBUTION
MA, CT, NY, NJ
___________________________________
PRODUCT 
Product labeled in part: "ONE POUND TORTILLA CHIPS SOLENA INGREDIENTS: STONE GROUND CORN, SAFFLOWER OIL, WATER, SALT, TRACE OF LIME,  Net Wt. 16 oz. (453.6 g)", Recall # F-886-9
CODE
Jun 03 09
RECALLING FIRM/MANUFACTURER
Recalling Firm: La Mexicana, Inc, Seattle, WA, by visit on June 24, 2009. Firm initiated recall is ongoing.
REASON
Product may contain undeclared milk, an allergen.
VOLUME OF PRODUCT IN COMMERCE
231 cases each containing 12-16 oz bags
DISTRIBUTION
WA, OR
___________________________________
PRODUCT 
1) Lian How brand Whole White Pepper in 10 lb. boxes with plastic liners, 5 lb. jars or 5 lb. plastic bags, and Uncle Chen Brand Whole white pepper in 5 oz plastic jars, Recall # F-887-9

2) Lian How brand Ground White Pepper in 10 lb. boxes with plastic liners, 5 lb. jars or 5 lb. plastic bags, and Uncle Chen Brand Ground white pepper in 5 oz plastic jar, Recall # F-888-9;

3) Lian How brand Whole Black Pepper in 5 lb. plastic bags, 5 lb. plastic jars and 10 lb. boxes, and Uncle Chen Brand Whole black pepper in 5 oz plastic jars, F-889-9;

4) Lian How brand Ground black Pepper in 10 lb. boxes with plastic liners, 5 lb. jars or 5 lb. plastic bags, and Uncle Chen Brand Ground black pepper in 5 oz plastic jars, Recall # F-890-9;

5) Lian How brand paprika in 10 lb. boxes with plastic liners, 5 lb. jars or 5 lb. plastic bags, Recall # F-891-9;

6) Lian How brand cayenne pepper in 10 lb. boxes with plastic liners, 5 lb. jars or 5 lb. plastic bags, Recall # F-892-9;

7) Lian How brand chopped garlic in 15 lb. boxes with plastic liners, and 5 lb. jars, Recall # F-893-9;

8)  Lian How brand minced garlic in 15 lb. boxes with plastic liners, and 5 lb. jars, Recall # F-894-9;

9) Lian How brand granule garlic in 15 lb. boxes with plastic liners, and 5 lb. jars and plastic bags, Recall # F-895-9;
 

10) Lian How brand garlic powder in 15 lb. boxes with plastic liners, and 5 lb. jars and plastic bags, Recall # F-896-9;

11) Lian How brand chopped onion in 4 lb. plastic jars, Recall # F-897-9;

12) Lian How brand onion powder in 5 lb. plastic jars, Recall # F-898-9;

13) Lian How brand curry powder in 10 lb. boxes with plastic liners, 5 lb. jars or 5 lb. plastic bags, Recall # F-899-9;

14) Lian How brand mustard powder in 10 lb. boxes with plastic liners, 5 lb. jars or 5 lb. plastic bags, Recall # F-900-9;

15) Lian How brand wasabi powder in 5 lb. plastic bags and 2.2 oz foil bags and Uncle Chen Brand 2.2 oz plastic bags, Recall # F-901-9;

 

16) Lian How brand crushed chili in 30-pound boxes and 8 lb box and 3 lb. Jar, Recall # F-902-9;

17) Lian How brand Cumin powder in 5 lb. plastic jars, Recall # F-903-9;

18) Lian How brand Orange Peel powder in 5 lb. plastic jars, Recall # F-904-9;

19) Lian How brand Black Sesame Seeds in 5 lb. plastic bags, Recall # F-905-9;

20) Lian How brand Peppercorn powder in 5 lb. plastic jugs, Recall # F-906-9;

21) Lian How brand White Sesame Seed in 5 lb. plastic jugs, Recall # F-907-9;

22) Lian How brand Turmeric in 5 lb. plastic jugs, Recall # F-908-9;

23) Lian How brand Ginger powder in 5 lb. plastic jugs, Recall # F-909-9;

24) Lian How brand Meat Tenderizer in 10 lb. plastic jug, Recall # F-910-9;

25) Lian How brand Bay Leaves in 10 lb. box, Recall # F-911-9;

26) Lian How brand Nutmeg in 5 lb. plastic jugs, Recall # F-912-9;

27) Lian How brand Cloves in 5 lb. plastic jugs, and dried clove powder in 5 lb. plastic jugs, Recall # F-913-9;

28) Lian How brand Coriander Powder in 5 lb. plastic jugs, Recall # F-914-9;

29) Lian How brand Coriander in 3 lb plastic jug, Recall # F-915-9;

30) Lian How brand Fennel Seed in 5 lb. plastic jugs, Recall # F-916-9;

31) Lian How brand Fennel Seed Powder in 5 lb. plastic jugs, Recall # F-917-9;

32) Lian How brand Cinnamon Powder in 5 lb. plastic jugs, Recall # F-918-9;

33) Lian How brand Garlic Salt in 9 lb. plastic jugs, Recall # F-919-9;

34) Lian How brand Black Pepper Salt in 5 lb. plastic jugs, Recall # F-920-9;

35) Lian How Brand Chili Sauce in 1 gallon plastic jug, 8 oz and 16 oz. plastic jar, Recall # F-921-9;

36) Lian How Brand Hot Bean Sauce in 1 gallon plastic jug, 8 oz 16 and 32 oz. plastic jar, Recall # F-922-9;

37) Lian How Brand Bean Sauce in 1 gallon, plastic jug, 8 oz, and 16 oz. plastic jar, Recall # F-923-9;

38) Lian How Brand Hot Broad Bean Sauce (paste) in 1 gallon plastic jug, 8 oz, and 16 oz. plastic jar, Recall # F-924-9;

39) Uncle Chen Brand Hunan Red Chili Sauce in 1 gallon clear plastic Jug, Recall # F-925-9;

40) Lian How Brand Sweet Flour Sauce in 1 gallon jug, 8 oz and 16 oz plastic jar, Recall # F-926-9;

41) Uncle Chen Brand Sriracha Chili Sauce in 5 gallon white plastic tub, 28oz and 17 oz plastic bottle, Recall # F-927-9;

42) Uncle Chen Brand Garlic Sauce in 1 gallon plastic jug, 8 oz and 16 oz plastic jar, Recall # F-928-9;

43) Uncle Chen Brand Extra Hot Garlic Chili Sauce in 1 gallon plastic jug and 16 oz plastic jar, Recall # F-929-9;

44) Uncle Chen Brand Fresh Ground Chili Paste in 1 gallon plastic jug and 8 oz and 16 oz plastic jar, Recall # F-930-9;

45) Uncle Chen Brand Black Bean Garlic Sauce in 16 oz clear plastic jar, Recall # F-931-9;

46) Lian How Brand 100% Sesame Oil in 10 oz and 6 oz clear glass bottle, Recall # F-932-9;

47) Lian How Brand Chinese Style Sesame & Soybean Oil in 1 gallon, 1/2 gallon plastic bottle and 16 oz and 8 oz clear glass bottle, Recall # F-933-9;

48) Lian How Brand Jai Sun Blended Sesame & Soybean Oil in 1 gallon, 1/2 gallon plastic jug, and 16 oz and 8 oz clear plastic bottle, Recall # F-934-9;

49) Lian How Brand Mei Wei Blended Sesame & Soybean Oil in 1 gallon, 1/2 gallon plastic jug, and 16 oz and 8 oz clear plastic bottle, Recall # F-935-9;

50) Lian How Brand 100% Black Sesame Oil in 16 oz clear plastic bottle and 8 oz clear glass bottle, Recall # F-936-9;

51) Lian How Brand Sesame Oil in 1 gallon plastic jug, Recall # F-937-9;

52) Lian How Brand Chili Oil in 1 gallon plastic jug and 8 oz. clear plastic bottle, Recall # F-938-9;

53) Lian How Brand Superior Red Chili Oil in 10 oz clear glass bottle, Recall # F-939-9;

54) Lian How Brand Hot Sesame Oil in 6 oz clear glass bottle, Recall # F-940-9;

55) Uncle Chen Brand Extra Hot - Fresh Ground Chili Paste in 1 gallon and 16 oz. clear plastic jug, Recall # F-941-9;

56) Lian How brand Five-Spicys Powder in 5 lb. plastic bags, Recall # F-942-9;

57) Lian How brand Star Anise Powder in 5 lb. plastic jugs, Recall # F-943-9
CODE
All products manufactured on or prior to April 15, 2009. No lot coding.
RECALLING FIRM/MANUFACTURER
Recalling Firm: U.F. Union International Food Co., Union City, CA, by press release on March 30, and April 15, 2009. Firm initiated recall is ongoing.
REASON
Product may be contaminated with Salmonella Rissen.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
CA, WA, NV, OR, AZ, SC, TX, WI, CO, UT         
___________________________________
PRODUCT 
1) a) The Ice Cream Club and b) Gladstone Farms Ice Cream, Snickers in 3 gallon, cylindrical paper tubs. Vanilla Flavored Ice Cream with Snickers Candy Bars and Caramel Sauce, Recall # F-944-9;

2) The Ice Cream Club Brand Snickers Hard Pack Yogurt in 3 gallon cylindrical paper tubs. Frozen Yogurt Snicker's Artificial Flavor Added, Recall # F-945-9;
CODE
1) a) Lot numbers: 9044, 9012, 8504 and 8464, 8443, 8345, 8315, 8304, 8284, 8173, 8153, 8113, 8094, 8073, and 8044; b) Lot numbers: 8523, 8464, 8413, 8363, 8305, 8284, 8173, 8113, 8052, and 8044

2) Lot numbers: 9012 and 8495; Lot numbers: 8453, 8332, 8304, 8284, 8173, 8152, 8103, 8076, and 8054
RECALLING FIRM/MANUFACTURER
The Ice Cream Club, Inc., Boynton Beach, FL, by telephone on February 2, 2009, by letters on February 5, 2009 and February 25, 2009. Firm initiated recall is complete.  
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America (PCA) because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,561 tubs
DISTRIBUTION
FL, AL, VA, SC, TN, LA, GA, NC, KY, Bahamas and Caicos Islands.
___________________________________
PRODUCT 
Simply Enjoy Sweet and Salty Mixed Nuts, 8 oz can, UPC 68826706282, Recall # F-946-9
CODE
Sell By Dates: 5/22/09; 5/28/09; 6/15/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: The Stop & Shop Supermarket Co., LLC, by e-mail and press release on February 6, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
780 cases
DISTRIBUTION
ME, MA, NH, RI, CT, NY, NJ
___________________________________
PRODUCT 
1) Little Debbie Snacks, Peanut Butter Toasty Crackers, Peanut Butter, Net Wt. 1.38 oz. (39g) and 8 packages of 4 Sandwich Crackers, Net Wt 7.44 oz (210g), Recall # F-947-9;

2) Little Debbie Snacks, Peanut Butter Cheese Crackers, Peanut Butter, Net Wt. 1.38 oz. (39g) and 8 packages of 4 sandwich crackers, Net Wt. 7.44 oz (210g), Recall # F-948-9
CODE
All codes currently on the market
RECALLING FIRM/MANUFACTURER
Recalling Firm: McKee Foods Corp., Collegedale, TN, by visit, e-mails, voice mail and telephone beginning January 15, 2009. Firm initiated recall is complete.
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
295,476 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Standing Rock Commercial Meal Kits in lunch box style containers; these MRE kits contain an entree, cookies, cracker snacks, two (2) pack saltines, peanut butter, and a cutlery kit;  The peanut butter packaged in 1/2 oz, 3/4 oz., or 2 oz. single serve pouches in the kits is labeled as: Peanut Butter, Boca Grande Foods. Meals with 1/2 oz. packets had 4 packets per meal; with 3/4 oz. packets had 2 packets per meal; and with 2 oz. packets had 1 packet per meal. There is no label on the individual meal kits. They are packaged 18 per shipping case. The shipping cases are labeled as follows: a) Standing Rock Meal Kit: Spaghetti Rings & Franks, Contains the following: Spaghetti Rings & Franks entree, cookies, cracker snacks, two (2) pack saltines, peanut butter, cutlery kit; 12 Month Shelf Life - Commercial Meals; contains: 18 meal kits/case, net weight: 15 lbs per case b) Standing Rock Meal Kit: Beef Ravioli, Contains the following: Beef Ravioli entree, cookies, cracker snacks, two (2) pack saltines, peanut butter, cutlery kit; 12 Month Shelf Life - Commercial Meals; contains: 18 meal kits/case, net weight: 15 lbs per case, Recall # F-949-9;

2) Standing Rock Commercial Meal Kits in lunch box style containers; these MRE kits contain an entree, cookies, cracker snacks, two (2) pack saltines, peanut butter, and a cutlery kit; The peanut butter packaged in 1/2 oz, 3/4 oz., or 2 oz. single serve pouches in the kits is labeled as: Peanut Butter, Boca Grande Foods. Meals with 1/2 oz. packets had 4 packets per meal; with 3/4 oz. packets had 2 packets per meal; and with 2 oz. packets had 1 packet per meal. There is no label on the individual meal kits. They are packaged 18 per shipping case. The shipping cases are labeled as follows: Standing Rock Meal Kit: Noodles and Chicken, Contains the following: Noodles & Chicken entree, cookies, cracker snacks, two (2) pack saltines, peanut butter, cutlery kit; 12 Month Shelf Life - Commercial Meals; contains: 18 meal kits/case, net weight: 15 lbs per case, Recall # F-950-9;

3) Standing Rock Commercial Meal Kits in lunch box style containers; these MRE kits contain an entree, cookies, Cheez-it crackers, two (2) pack saltines, peanuts, and a cutlery kit; In some of the kits the packages of peanuts were substituted with an individually wrapped Kashi TLC Chewy Granola Bars -Peanut Peanut Butter, net wt. 1.23 oz. (35 g)., UPC 18627 03002 There is no label on the individual meal kits. They are packaged 18 per shipping case. The shipping cases are labeled as follows: a) Standing Rock Meal Kit: Lasagna, Contains the following: Lasagna entree, cookie, Cheez-it crackers, two (2) pack saltines, peanuts, cutlery kit; 12 Month Shelf Life -Commercial Meals; contains: 18 meal kits/case, net weight: 15 lbs per case b) Standing Rock Meal Kit: Corned Beef Hash, Contains the following: Corned Beef Hash entree, cookie, Cheez-it crackers, two (2) pack saltines, peanuts, cutlery kit; 12 Month Shelf Life - Commercial Meals; contains: 18 meal kits/case, net weight: 15 lbs per case c) Standing Rock Meal Kit: Scalloped Potatoes with Ham, Contains the following: Scalloped Potatoes with Ham entree, cookie, Cheez-it crackers, two (2) pack saltines, peanuts, cutlery kit; 12 Month Shelf Life - Commercial Meals; contains: 18 meal kits/case, net weight: 15 lbs per case, Recall # F-951-9
CODE
1) DOP: 092508/DOE: 092509, DOP: 092308/DOE: 092309, DOP: 092208/DOE: 092209; Beef Ravioli Meal Kit: DOP: 092508/DOE: 092509, DOP: 092308/DOE: 092309, DOP: 092208/DOE: 092209;

2) DOP: 092508/DOE: 092509, DOP: 092308/DOE: 092309, DOP: 092208/DOE: 092209;

3) a) DOP: 092008/DOE: 092009; b) Kit: DOP: 092008/DOE: 092009; c) DOP: 092008/DOE: 092009
RECALLING FIRM/MANUFACTURER
Imperial Food Service, South Elgin, IL, by telephone and fax on January19, 2009 and February 6, 2009, and by press release on February 5, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanut products recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
313,890 meals
DISTRIBUTION
TX, KY, AR
___________________________________
PRODUCT 
1) Advocare Meal Replacement Shake Net Wt 2.08 oz (59g) Chocolate Natural & Artificial Flavor. Item #12725, Recall # F-952-9;

2) Advocare Meal Replacement Shake, Net Wt 2.08 oz (59g), Berry Natural & Artificial Flavor. Item # 12726, Recall # F-953
CODE
1) Lot numbers: 0904599, 0905639, 0905659, 0904459, 0904549, 0905689, 0905729, 0905749, 0904409, 0904569, 0904539, 0904449, 0904359, 0904369, and 0904349;

2) Lot numbers: 0906339, 1105159, 0905129, 0905089, 0904169, and 0904209
RECALLING FIRM/MANUFACTURER
Progressive Laboratories, Inc., Irving, TX, by telephone on July 1, 2009. Firm initiated recall is ongoing.
REASON
The product was 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
286,969 packets
DISTRIBUTION
TX
___________________________________
PRODUCT 
20/20 LifeStyles Peanut Toffee Crunch bar sold as: 1) 2 oz. individual plastic wrapped bar, UPC 78571 00019; and 2) 12 - 2 oz count boxes. There are 12 boxes per case, Recall # F-954-9
CODE
Bar code: BEST BY12FEB09; BEST BY 15MAY09; and BEST BY 26SEP09. Case code: 12-Feb-08; 15-May-08 and 26-Sep-08
RECALLING FIRM/MANUFACTURER
Pro Sports Club, Bellevue, WA, by telephone on February 20, 2009 and by press release and letter dated February 27, 2009. Firm initiated recall is ongoing.
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
149,900 bars
DISTRIBUTION
Via internet

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Maxipime (cefepime hydrochloride, USP) for Injection, for IV use after constitution. 1 Box-10 vials; NDC 51479-055-10; ADD-Vantage Vials; Rx only. Each vial equivalence 2 grams cefepime. Product of United Kingdom, Recall # D-1892-2009
CODE
Lot numbers: 029542, 029543, Exp. Feb. 2012
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bristol-Myers Squibb Co., New Brunswick, NJ, by letters on July 8, 2009 and July 10, 2009.
Manufacturer: Patheon UK Limited, Covingham, Swindon, United Kingdom. Firm initiated recall is ongoing.
REASON
Lack of Assurance of Sterility - vial caps.
VOLUME OF PRODUCT IN COMMERCE
50,440 vials
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
Ciprofloxacin Injection, USP, 400 mg, 40 mL single dose vial, Rx only, NDC 0409-4778-86, Recall # D-1893-2009
CODE
Lot number: 74-473-DK
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira, Inc., Lake Forest, IL, by letter on/about June 24, 2009.
Manufacturer: Hospira, Inc., Rocky Mount, NC. Firm initiated recall is ongoing.
REASON
Discoloration
VOLUME OF PRODUCT IN COMMERCE
21,375 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Listerine Antiseptic Mouthwash Freshburst Flavor, ADA accepted American Dental Association, 95 ml (3.2 fl oz). Item number 42895; UPC on bottles 003-12547-42895-8, UPC on cases 503-12547-42895-3. Item number 93581; UPC on bottles 003-12547-42895-8 UPC on cases 103-12547-93581-1, Recall # D-1894-2009
CODE
All lot numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Personal Products Co., Skillman, NJ, by letters on July 7, 2009 and July 15, 2009.
Manufacturer: McNeil PPC, Inc., Lititz, PA. Firm initiated recall is ongoing.
REASON
Subpotent; Methyl Salicylate at 12 months
VOLUME OF PRODUCT IN COMMERCE
2,006,784 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Source Plasma, Recall B-1004-09
CODE
Unit: 08HMNC6009
RECALLING FIRM/MANUFACTURER
Biolife Plasma Services, LP, Moorhead, MN, by fax on February 24, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who had not had an annual physical performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

___________________________________
PRODUCT 
Recovered Plasma, Recall # B-1229-09
CODE
Unit: GX001790
RECALLING FIRM/MANUFACTURER
Interstate Blood Bank Inc, Memphis, TN, by telephone and e-mail on May 10, 2006 and follow up letter on May 17, 2006. Firm initiated recall is complete.
REASON
Blood product, released prior to completion of viral marker testing which subsequently tested HCV NAT positive, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1278-09
CODE
Unit: W165709007388X
RECALLING FIRM/MANUFACTURER
Our Lady Of The Lake Hospital, Inc., Baton Rouge, LA, by telephone and Fax on March 16, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
LA
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced, Recall # B-1383-09
CODE
Units: W087908605479 Part 1 and Part 2
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Lancaster County Medical Society, Lincoln, NB, by facsimile on March 10, 2009 and April 13, 2009. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for syphilis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated, Recall # B-1384-09
CODE
Unit: W042209023254A
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Las Vegas, NV, by telephone and facsimile on April 14, 2009. Firm initiated recall is complete.
REASON
Blood product, which was incorrectly labeled as CMV negative, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NV
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1403-09
CODE
Unit: 72K759877
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on May 15, 2009. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1404-09
CODE
Unit: W091009158458
RECALLING FIRM/MANUFACTURER
Oklahoma Blood Institute – Sylvan N Goldman Center, Oklahoma City, OK, by telephone on May 1, 2009 and by facsimile on May 8, 2009. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OK
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1405-09
CODE
Unit: 72K754673
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Huntsville, AL, by facsimile on May 9, 2009. Firm initiated recall is complete.
REASON
Blood product, which did not meet acceptable product specifications, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Source Plasma, Recall # B-1445-09
CODE
Unit: 07DILB0676
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Dekalb, IL, by facsimile on January 26, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Source Plasma, Recall # B-1446-09
CODE
Unit: 08LWIB2283
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Onalaska, WI, by facsimile on January 27, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1481-09
CODE
Unit: W288609001264
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lifesource, Glenview, IL, by telephone and fax on March 24, 2009.
Manufacturer: Lifesource Westmont, Westmont, IL. Firm initiated recall is complete.
REASON
Blood product, collected without the required QC being performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
IL
___________________________________
PRODUCT 
Platelets Pheresis, Recall # B-1482-09
CODE
Unit: 6372254 (split product)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated November 25, 2008. Firm initiated recall is complete.
REASON
Blood products labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1483-09
CODE
Units: 9924355 (split product)
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by letter dated August 1, 2008. Firm initiated recall is complete.
REASON
Blood products labeled leukoreduced without the assurance that it met the criteria for a leukoreduced product, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced, Recall # B-1484-09;
2) Fresh Frozen Plasma, Recall # B-1485-09;
3) Red Blood Cells, Recall # B-1486-09
CODE
1) Units: 7436543, 7434469;
2) Units: 7436543, 7434469, 7427482;
3) Unit: 7427482
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by letters dated April 10, 2009 and April 13, 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
6 units
DISTRIBUTION
TN, OR

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Source Plasma, Recall # B-1131-09
CODE
Unit: AQ030470
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, Asheville, NC, by facsimile on September 28, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1279-09
CODE
Unit: W115909080515
RECALLING FIRM/MANUFACTURER
Central California Blood Center, Fresno, CA, by e-mail on March 13, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose body temperature was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Plasma Frozen, Recall # B-1285-09
CODE
Units: 13FC97939, 13FC97945,13FK61798, 13FK61803, 13FR04269, 13FR04277, 13FW68098,13FW68108, 13GE74823, 13GE74833, 13GT39523,13GT39530, 13GV99790, 13GY38386, 13GY38388
RECALLING FIRM/MANUFACTURER
American Red Cross Southeastern Michigan Region, Detroit, MI, by telephone on December 2, 2008 and by follow-up letter dated December 16, 2008. Firm initiated recall is complete.
REASON
Blood products, processed from Whole Blood more than 8 hours after collection, were distributed.
VOLUME OF PRODUCT IN COMMERCE
15 units
DISTRIBUTION
MI
___________________________________
PRODUCT 
Source Plasma, Recall # B-1362-09
CODE
Unit: AQ030505
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by fax on October 2, 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
NC
___________________________________
PRODUCT 
Fresh Frozen Plasma (Apheresis), Recall # B-1400-09
CODE
Unit: W066509422149
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by fax on March 23, 2009. Firm initiated recall is complete.
REASON
Blood product, not quarantined after information was received concerning post-donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AK
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1406-09
CODE
Unit: 2557182
RECALLING FIRM/MANUFACTURER
Central Texas Regional Blood & Tissue Center, Austin, TX, by facsimile on March 10, 2009 and by telephone on June 18, 2009. Firm initiated recall is complete.
REASON
Blood product, intended for autologous transfusion, which tested repeat reactive for HBsAg but not labeled with "BIOHAZARD" label, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Source Plasma, Recall # B-1418-09
CODE
Unit: AQ030642
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1420-09
CODE
Unit: AQ030461
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1421-09
CODE
Unit: AQ030635
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on September 20, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1422-09
CODE
Unit: AQ030623
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1423-09
CODE
Unit: AQ030747
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on September 28, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1424-09
CODE
Unit: AQ030703
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1425-09
CODE
Unit: AQ030473
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1426-09
CODE
Unit: AQ030385
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1427-09
CODE
Unit: AQ030656
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1428-09
CODE
Unit: AQ030485
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on September 28, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1430-09
CODE
Unit: AQ030419
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on September 28, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1431-09
CODE
Unit: AQ030659
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on September 28, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1457-09
CODE
Unit: AQ030603
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1458-09
CODE
Unit: AQ030487
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on September 20, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1459-09
CODE
Unit: AQ030724
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1460-09
CODE
Unit: AQ030509
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1461-09
CODE
Unit: AQ030758
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Source Plasma, Recall # B-1462-09
CODE
Unit: AQ030498
RECALLING FIRM/MANUFACTURER
Plasma Biological Service, Inc., Asheville, NC, by facsimile on October 2, 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
NC
___________________________________
PRODUCT 
Fresh Frozen Plasma, Recall # B-1502-09
CODE
Unit: 72J381878
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on December 30, 2008.
Manufacturer: LifeSouth Community Blood Centers, Inc., Huntsville, AL. Firm initiated recall is complete.
REASON
Blood product, processed fro Whole Blood more than 8 hours after collection, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS I

___________________________________
PRODUCT 
1) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) with software version 4 and above, Recall # Z-1790-2009;

2) The Alaris PC Unit, Model Numbers 8000 and 8015 (formerly Medley PC Unit) software version 8 and above when used with the Alaris PCA Module (Model 8120). The Alaris PC Unit is the central programming and power supply component for the Alaris System modules, Recall # Z-1791-2009;

3) The Alaris PC Unit, Model 8015 (manufactured or serviced between April 2008 and January 2009). The Alaris PC Unit is the central programming and power supply component for the Alaris System modules, Recall # Z-1792-2009;

4) Alaris Pump Module, Model 8100, Recall # Z-1793-2009;

5) Alaris System Inter-Unit Interface (IUI) Connectors. The Modules include the following: Alaris PC Unit, Model Numbers 8000 and 8015; Alaris Pump Module, Model 8100; Alaris Patient-Controlled Analgesia (PCA), Model 8120; Alaris Syringe Module, Model 8110; Alaris SpO2 Module, Model 8210 and 8220 and Alaris EtCO2 Module, Model 8300, Recall # Z-1794-2009
CODE
1) Software version 4 and above;
2) Software version 8 and above when used with the Alaris PCA Module (Model 8120);
3), 4), and 5) Model #’s only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Cardinal Health 303 dba Cardinal Health, San Diego, CA, by letters on June 12, 2009.
Manufacturer: Cardinal Health Manufacturing LLC, San Diego, CA. Firm initiated recall is ongoing.
REASON
There is a potential risk for medication not being delivered when IV tubing sets are occluded in the Alaris Pump module. This can occur if IV sets are set up in the infusion pumps but not used for an extended period of time. If users fail to clear the occlusion, then the occluded tubing may cause medication not to be delivered. A delay of medication may result in serious injury and/or death, and may necessitate medical intervention to prevent serious injury and/or death.
VOLUME OF PRODUCT IN COMMERCE
500,000 units
DISTRIBUTION
Nationwide, Germany, England, Canada, Netherlands, Malaysia, Singapore, Australia, and New Zealand

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
1) Roche ACCU-CHEK Softclix Lancing Device, Models 3144844001 (10 lancets) and 3583031002 (17 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1590-2009;

2) Roche ACCU-Chek Active Meter Kit; REF 03184501001 includes the Roche ACCU-CHEK Softclix Lancing Device, Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1591-2009;

3) Roche ACCU-Chek Voicemate Meter; REF 12030802001 includes the Roche ACCU-CHEK Softclix Lancing Device, Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1592-2009;

4) Roche ACCU-Chek Aviva Meter Kit; REF 04893247001 includes the Roche ACCU-CHEK Softclix Lancing Device, Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1593-2009;

5) Roche Coaguchex XS Systems for Patient Self-Testing; REF 04837738001 includes the Roche ACCU-CHEK Softclix Lancing Device, Model 3144844001 (10 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1594-2009;

 6) Roche ACCU-CHEK Compact Plus Meter Kit; REFS 03149137001, 05177294001 and 05079241001 include the Roche ACCU-CHEK Softclix Lancing Device, Model 3583031002 (17 lancets). The device is used to prick the finger and to obtain a drop of blood in preparation for diabetes/insulin level testing, Recall # Z-1595-2009
CODE
1) Lot numbers: M25C2, M25C5, M25C7, N32A5 and M32B5; lots M25C9, M25D2, M27D6, M32A8 and M32B3;

2) Lot numbers: 116099, 116109, 116122, 116135, 116145, 116146, 116155, 116167, 116185, 116190, 116192, 116205, 116209, 116215, 116229, 116230 and 116237; lot numbers M25C2, M25C5, M25C7, N32A5 and M32B5;

3) Lot 550594A; lot numbers: M25C2, M25C5, M25C7, N32A5 and M32B5;

4) Lot numbers: 122136, 122137, 122143, 122155, 122179, 122187, 122196, 122198, 122213, 122224 and 122236; Lot numbers: M25C2, M25C5, M25C7, N32A5 and M32B5;

5) Lot numbers: 117200, 117202, 117203, 117204, 117205, 117208, 117209, 117213, 117216, 117219, 117220, 117222, 117227, 117228, 117229, 117231, 117233, 117235, 117237, 117238, 117240 and 117241; Lot numbers: M25C2, M25C5, M25C7, N32A5 and M32B5;

6) Lot numbers: 116137, 116148, 116151, 116157, 116180, 116194, 116199, 116216, 116224 and 116234; lot numbers: 116142, 116158 and 116204; lot numbers: 116134, 116141, 116149, 116164, 116170, 116171, 116188, 116191, 116202, 116207, 116212, 116217, 116221, 116231 and 116236; lot numbers: M25C9, M25D2, M27D6, M32A8 and M32B3
RECALLING FIRM/MANUFACTURER
Roche Diagnostics Corp., Indianapolis IN, by letter dated May 13, 2009, and by press release on May 18, 2009. Firm initiated recall is ongoing.
REASON
The lancet cap may be missing, which could result in an unintended lancet stick to the user.
VOLUME OF PRODUCT IN COMMERCE
449,533 packages of lancets
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Exogen 4000+ Ultrasound Bone Healing System, SAFHS, Part Numbers: a) 71034100 and b) 71034101, Rx only, The device is used for the non-invasive treatment of established non-unions excluding skull and vertebra, Recall # Z-1695-2009;

2) Exogen Express Bone Healing System, SAFHS, Part Numbers: a) 71034200 and b) 71034140, Rx only. These are distributed internationally only. The device is used for the non-invasive treatment of established nonunions excluding skull and vertebra, Recall # Z-1696-2009
CODE

1) a) Serial numbers: 0408017751, 0408017752, 0408017753, 0408017754, 0408017755, 0408017756, 0408017757, 0408017758, 0408017760, 0408017763, 0408017764, 0408017765, 0408017766, 0408017767, 0408017768, 0408017769, 0408017770, 0408017771, 0408017772, 0408017773, 0408017774, 0408017775, 0408017776, 0408017777, 0408017778, 0408017780, 0408017781, 0408017782, 0408017783, 0408017784, 0408017785, 0408017786, 0408017787, 0408017788, 0408017789, 0408017790, 0408017791, 0408017792, 0408017793, 0408017794, 0408017795, 0408017797, 0408017798, 0408017799, 0408017800, 0408017801, 0408017802, 0408017803, 0408017804, 0408017805, 0408017806, 0408017807, 0408017808, 0408017809, 0408017810, 0408017811, 0408017812, 0408017813, 0408017814, 0408017815, 0408017816, 0408017817, 0408017818, 0408017819, 0408017820, 0408017821, 0408017822, 0408017823, 0408017824, 0408017825, 0408017826, 0408017827, 0408017828, 0408017829, 0408017830, 0408017831, 0408017832, 0408017833, 0408017834, 0408017835, 0408017836, 0408017837, 0408017838, 0408017839, 0408017840, 0408017841, 0408017842, 0408017843, 0408017844, 0408017846, 0408017847, 0408017848, 0408017849, 0408017850, 0408017851, 0408017852, 0408017854, 0408017855, 0408017856, 0408017857, 0408017858, 0408017859, 0408017860, 0408017862, 0408017863, 0408017864, 0408017865, 0408017866, 0408017867, 0408017868, 0408017869, 0408017870, 0408017871, 0408017872, 0408017873, 0408017874, 0408017875, 0408017877, 0408017878, 0408017879, 0408017880, 0408017881, 0408017882, 0408017883, 0408017884, 0408017885, 0408017886, 0408017888, 0408017889, 0408017890, 0408017891, 0408017892, 0408017893, 0408017894, 0408017895, 0408017896, 0408017897, 0408017898, 0408017899, 0408017900, 0408017901, 0408017902, 0408017903, 0408017904, 0408017905, 0408017906, 0408017907, 0408017908, 0408017910, 0408017911, 0408017912, 0408017913, 0408017914, 0408017915, 0408017916, 0408017917, 0408017918, 0408017919, 0408017920, 0408017921, 0408017922, 0408017923, 0408017924, 0408017925, 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RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew Inc., Memphis, TN, by letters dated June 5, 2009 and June 8, 2009. 
Manufacturer: Morgan Electro Ceramics, Bedford, OH. Firm initiated recall is ongoing.
REASON
Problems with transducer may result in a reduced ultrasound output.
VOLUME OF PRODUCT IN COMMERCE
5,030 units
DISTRIBUTION
Nationwide, Switzerland, Canada, Malaysia, Japan, and UK
___________________________________
PRODUCT 
Capless Li Pedicle Screw System, Diameters - 4.75mm, 5.5mm, 6.5mm, 7.5mm, 8.25mm, Lengths 30mm-55mm, labeled non-sterile. The Capless LI Pedicle Screw System is indicated for the treatment of sever spondylolisthesis of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft, Recall # Z-1694-2009
CODE
Product Numbers: 71088, 71692, 71708, 71750, 71761, 71781, 71807, 71849, 71881, 71090, 71693, 71709, 71751, 71762, 71787, 71808, 71850, 71882, 71092, 71694, 71710, 71752, 71763, 71789, 71809, 71851, 71885, 71682, 71695, 71711, 71753, 71764, 71791, 71810, 71857, 71886, 71686, 71696, 71712, 71755, 71765, 71793, 71811, 71858, 71889, 71687, 71698, 71716, 71756, 71766, 71795, 71813, 71859, 71893, 71688, 71700, 71746, 71757, 71767, 71797, 71814, 71873, 71894, 71689, 71701, 71747, 71758, 71768, 71799, 71815, 71874, 71896, 71690, 71705, 71748, 71759, 71769, 71801, 71816, 71877, 71897, 71691, 71707, 71749, 71760, 71780, 71806, 71817, 71878, 71899, 71900, 71937, 71957, 73417, 73427, 73440, 73453, 73470, 74073, 71903, 71939, 72184, 73418, 73428, 73441, 73454, 73471, 74097, 71904, 71940, 72419, 73419, 73429, 73445, 73455, 73472, 74098, 71907, 71943, 73409, 73420, 73430, 73446, 73456, 73760, 74099, 71908, 71944, 73411, 73421, 73431, 73447, 73464, 73761, 74100, 71911, 71947, 73412, 73422, 73433, 73448, 73465, 73762, 74101, 71912, 71948, 73413, 73423, 73435, 73449, 73466, 73763, 74102, 71915, 71952, 73414, 73424, 73437, 73450, 73467, 73886, 74103, 71916, 71953, 73415, 73425, 73438, 73451, 73468, 74047, 74104, 71936, 71956, 73416, 73426, 73439, 73452, 73469, 74072, 74105, 74107, 74125, 74143, 74293, 74305, 75280, 75297, 75307, 75317, 74108, 74127, 74144, 74294, 74306, 75282, 75299, 75308, 75318, 74109, 74129, 74285, 74295, 74307, 75283, 75300, 75309, 75319, 74110, 74131, 74286, 74296, 74432, 75284, 75301, 75310, 75320, 74111, 74132, 74287, 74299, 74987, 75285, 75302, 75311, 75321, 74112, 74134, 74288, 74300, 74991, 75287, 75303, 75312, 75322, 74116, 74135, 74289, 74301, 75248, 75289, 75304, 75313, 75323, 74119, 74137, 74290, 74302, 75273, 75291, 75305, 75314, 75324, 74121, 74139, 74291, 74303, 75276, 75293, 75305, 75315, 75333, 74123, 74141, 74292, 74304, 75278, 75295, 75306, 75316, 75334, 75335, 75355, 75376, 76369, 76536, 76593, 76602, 76613, 76639, 75336, 75358, 75377, 76370, 76537, 76593, 76603, 76614, 76640, 75337, 75360, 75379, 76372, 76538, 76594, 76605, 76615, 76642, 75338, 75362, 75382, 76374, 76540, 76595, 76606, 76616, 76737, 75344, 75364, 75384, 76375, 76542, 76596, 76607, 76618, 77253, 75346, 75365, 75386, 76376, 76588, 76597, 76608, 76619, 77260, 75346, 75367, 75588, 76377, 76589, 76598, 76609, 76621, 77261, 75350, 75370, 75798, 76406, 76590, 76599, 76610, 76629, 77262, 75351, 75372, 75802, 76407, 76591, 76600, 76611, 76630, 77263, 75353, 75375, 76139, 76534, 76592, 76601, 76612, 76638, 77264, 77265, 77811, 77852, 79382, 77266, 77815, 78174, 77267, 77817, 78175, 77270, 77820, 78176, 77322, 77823, 78518, 77647, 77851 and 79040
RECALLING FIRM/MANUFACTURER
X Spine Systems Inc., Miamisburg, OH, by letters, telephone and e-mails in March 2009. Firm initiated recall is ongoing.
REASON
A defect cause was discovered following a customer complaint pertaining to a post operative dissociation of the Capless Li Screw construct. The screw assembly is made up of three parts; a cup which locks onto a 5.5mm rod, a yoke that cradles the rod during fusion, and a screw that attached to the vertebra. The screw ball on the screw was manufactured out of tolerance (undersized).
VOLUME OF PRODUCT IN COMMERCE
9,613 units
DISTRIBUTION
AZ, CA, CO, FL, ID, IN, MO, MS, NV, OK, TN, TX, UT, WY and countries of Spain, South Africa and the United Kingdom
___________________________________
PRODUCT 
Foot Choice Therapeutic Foot Massager, Model Number YS-322. The device is a heated foot massager intended for over the counter use, Recall # Z-1697-2009
CODE
No Lot Code. All massagers manufactured and shipped between 11/04/2005 – 06/29/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Suarez Corporation Industries, Canton, OH, by letter on August 9 –August 14, 2006.
Manufacturer: Yas Healthy Fitness Co., Ltd., Taoyuan City, Taiwan. Firm initiated recall is ongoing.
REASON
Complaints of product causing burns to consumers.
VOLUME OF PRODUCT IN COMMERCE
71,512 units
DISTRIBUTION
Nationwide and Canada
___________________________________
PRODUCT 
1) SJM Peel Away Introducer, REF 405116, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d 0,38" (.965 mm), contents 5, 2011-08, Sterile EO, Rx only. Intended for use for the introduction of catheters into a vessel, Recall # Z-1713-2009;

2) SJM Peel Away Introducer, REF 405153, Length 14 cm, 7F (2.33 mm), Max Guidewire o.d 0,38" (.965 mm), contents 5, 2011-08, Sterile EO, Rx only. Intended for use for the introduction of catheters into a vessel, Recall # Z-1714-2009
CODE
1) Lot Number: 2694227;
2) Lot Number: 2694252
RECALLING FIRM/MANUFACTURER
St. Jude Medical, Minnetonka, MN, by letter in June 2009. Firm initiated recall is ongoing.
REASON
Isolated lots could contain some items that have been mislabeled with the incorrect French size of the outer box label. Some 9F products have been labeled as 7F and vice versa. Only the outer box label is affected by this error, the labels on the individual product pouches correctly identify the product. St Jude Medical has not received any reports of injures resulting from this mislabeling to date.
VOLUME OF PRODUCT IN COMMERCE
400 units
DISTRIBUTION
Nationwide and Belgium
___________________________________
PRODUCT 
M-19 (Iridium 192): Brachytherapy source, Recall # Z-1717-2009
CODE
OSI A011, OSI A010, and OSI A015
RECALLING FIRM/MANUFACTURER
Source Production & Equipment, Inc., St Rose, LA, by telephone and letter in March 2008. Firm initiated recall is complete.
REASON
Radioactive source broke during use.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
AdvantageSim MD versions 7.4 through 7.6, Model 5160092. AdvantageSim MD is used to prepare geometric and anatomical data relating to a proposed external beam radiotherapy treatment prior to dosimetry planning, Recall # Z-1718-2009  
CODE
Serial Numbers: 00000118329GE2, 00000142883GE8, 00000142882GE0, 00000111103GE8, 00000051589GE0, 00000108666GE9, 00000127664GE1, 00000068379GE7, 00000073497GE0, 00000142884GE6, 00000051586GE6, 00000113886GE6, 00000080150GE6, 00000124934GE1, 00000073489GE7, 00000098605GE9, 00000106869GE1, 00000090499GE5, 00000090489GE6, 00000076519GE8, 00000080672GE9, 00000080481GE5, 00000134781GE4, 00000134782GE2, 00000132360GE9, 00000134789GE7, 00000069359GE8, 00000069362GE2, 00000138883GE4, 00000051665GE8, 00000051666GE6, 00000100844GE0, 00000061315GE8, 00000090495GE3, 00000076526GE3, 00000051583GE3, 00000051584GE1, 00000052631GE9, 00000109919GE1, 00000114863GE4, 00000109867GE2, 00000081296GE6, 00000108668GE5, 00000142879GE6, 00000068377GE1, 00000142878GE8, 00000138880GE0, 00000140659GE4, 00000112963GE4, 00000069347GE3, 00000134783GE0, 00000138888GE3, 00000118327GE6, 00000121720GE7, 00000109866GE4, 00000090496GE1, 00000081289GE1, 00000073483GE0, 00000106871GE7, 00000076518GE0, 00000068372GE2, 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000000S8336002, 000000S8336001, 00000031581AW2, 00000054166AW4, 00000051675GE7, 00000051676GE5, 00000054217AW5, 00000063727GE2, 00000063886GE6, 00000066231GE2, 00000069348GE1, 00000073484GE8, 00000073488GE9, 00000073493GE9, 00000073494GE7, 00000076528GE9, 00000079708GE4, 00000080478GE1, 00000080673GE7, 00000081292GE5, 00000082786GE5, 00000085512GE2, 00000090483GE9, 00000090485GE4, 00000090491GE2, 00000096088GE0, 00000098602GE6, 00000100848GE1, 00000106867GE5, 00000111710GE0, 00000114862GE6, 00000123787GE4, 00000124936GE6, 00000124942GE4, 00000124943GE2, 00000127010GE7, 00000127012GE3, 00000127663GE3, 00000127665GE8, 00000132364GE1, 00000132366GE6, 00000140658GE6, 00000144922GE2, 00000144924GE8, 00000144926GE3, 00000144929GE7, 00000144930GE5, 00000144931GE3, 00000144932GE1, 00000144933GE9, 00000144935GE4, 00000144936GE2, 00000145022GE0, 00000145023GE8, 00000145026GE1, 000000V8109002, 00000100847GE3, 000000J7254002, 000000V8023001, 000000X8063002, 00000053667AW2, 00000054179AW7, 00000054181AW3, 00000054182AW1, 00000054186AW2, 000000K8211001, 000000S7318001, 00000054178AW9, 000000G7346002, 000000N7271005, 000000P8354001, 000000Q8340002, 000000U8203001, 000000AC833301, 000000Q8148001, 00000031571AW3, 00000054189AW6, 00000054247AW2, 000000B8348001, 000000D7222001, 000000F8227002, 000000F8227003, 000000J8135002, 000000P8059001, 000000S8259001, 000000T8266001, 000000U8332003, 00000144928GE9, 00000054202AW7, 00000054205AW0, 000000H9005001, 00000054209AW2, 000000D8015001, 000000D8015002, 000000D8015003, 000000D8015004, 000000L7235003, 000000P8323001, 000000Q7351006, 000000Q8140003, 000000W7360002, 00000031562AW2, 00000031563AW0, 00000031564AW8, 00000031567AW1, 00000031568AW9, 00000031573AW9, 00000031574AW7, 00000031575AW4, 00000053664AW9, 00000054150AW8, 00000054183AW9, 000000C7253001, 000000C7253002, 000000C7324001, 000000C8234001, 000000H8235001, 000000H8298001, 000000J7254004, 000000K8217001, 000000K8220001, 000000K8295001, 000000K8295002, 000000K8295003, 000000L7269005, 000000N7271004, 000000N7313001, 000000N8301001, 000000N8350001, 000000P8059002, 000000P8059003, 000000P8059004, 000000Q7351001, 000000Q7351002, 000000Q7351003, 000000Q8140001, 000000S8207001, 000000T8309001, 000000U8060002, 000000U8203004, 000000U8332001, 000000V8023002, 000000W7360003, 000000W7360004, 000000X8063003, 000000Y7169002, 000000Y7169003, 000000ZB733801, 00000053656AW5, 00000053658AW1, 00000053659AW9, 00000053663AW1, 00000054157AW3, 00000054163AW1, 00000054206AW8, 000000B7310002, 000000B7310003, 000000L7235006, 000000L7269003, 00000053654AW0, 00000054193AW8, 00000053665AW6, 00000053668AW0, 00000053669AW8, 00000053673AW0, 00000054156AW5, 000000C8242002, 000000N8311001, 00000031595AW2, 00000031596AW0, 000000D7166001, 000000N7271003, 000000Q8148003, 000000U8332002, 000000Y7169005, 00000054199AW5, 00000054203AW5, 00000054207AW6, 00000054208AW4, 00000054225AW8, 00000121723GE1, 00000140663GE6, 00000140664GE4, 000000G8256001, 000000K8295005, 000000T8309002, 00000054196AW1, 00000080485GE6, 00000080486GE4, 00000080671GE1, 00000100835GE8 and 00000053651AW6
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated March 11, 2009.
Manufacturer: GE Medical Systems, SCSBuc Cedex, France. Firm initiated recall is ongoing.
REASON
It was reported by a customer site that when using Advantage Sim MD on Advantage Workstation, the series could be incorrectly labeled in image view when multiple series of an exam are loaded simultaneously in Advantage Sim MD and if their series dates are different. A mismatch of series label for structure sets may lead to under-treatment of a tumor due to too small coverage of volume treated.
VOLUME OF PRODUCT IN COMMERCE
687 units
DISTRIBUTION
Nationwide, Austria, Belgium, Brazil, Canada, Chile, China, Czech Republic, Denmark, Egypt, Finland, France, Germany, Hong Kong, India, Ireland, Israel, Italy, Japan, Korea, Malaysia, Netherlands, Poland, Portugal, Russian Federation, Saudi Arabia, Singapore, Spain, Sweden, Switzerland, Taiwan, Tokelau, Turkey, United Arab Emirates and the United Kingdom
___________________________________
PRODUCT 
GE Healthcare MUSE Cardiology Information Systems vs. 7.0, 7.0.1, 7.0.2, 7.1, 7.1.1. The MUSE Cardiology Information System is intended to store, access and manage cardiovascular information on adult and pediatric patients, Recall # Z-1719-2009
CODE
Serial Numbers: SBP08365245GA, SBP08365257GA, SBP08124375GA, SBP07041811GA, SBP08164446GA, SBP08104129GA, SBP08104136GA, SBP08164458GA, SBP08385418GA, SBP07282702GA, SBP08124399GA, SBP07373018GA, SBP08194531GA, SBP08335087GA, SBP08335073GA, SBP07011728GA, SBP08164445GA, SBP07021744GA, SBP08365297GA, SBP05480036GA, SBP08335083GA, SBP08365284GA, SBP08365278GA, SBP08365282GA, SBP07423241GA, SBP08174469GA, SBP08194513GA, SBP08144422GA, SBP07463469GA, SBP07423262GA, SBP08365246GA, SBP06160272GA, SBP07463493GA, SBP07232542GA, SBP07182278GA, SBP07212445GA, SBP08124336GA, SBP08164453GA, SBP08144435GA, SBP08335106GA, SBP06300799GA, SBP08063821GA, SBP08023779GA, SBP08194514GA, SBP08335034GA, SBP07282642GA, SBP08294905GA, SBP08365260GA, SBP08114216GA, SBP07021746GA, SBP07232570GA, SBP08335088GA, SBP07081983GA, SBP08294892GA, SBP08104175GA, SBP08375355GA, SBP08184482GA, SBP08194534GA, SBP08244758GA, SBP08335108GA, SBP08114264GA, SBP08093988GA, SBP08335092GA, SBP07192318GA, SBP08375335GA, SBP07282681GA, SBP08335022GA, SBP08124374GA, SBP08104156GA, SBP07453378GA, SBP08194517GA, SBP08104154GA, SBP08204580GA, SBP08124395GA, SBP07282685GA, SBP08023778GA, SBP08335105GA, SBP08294899GA, SBP08355141GA, SBP07021745GA, SBP07082001GA, SBP08365244GA, SBP08365281GA, SBP08194523GA, SBP08224698GA, SBP08335090GA, SBP08355175GA, SBP08204613GA, SBP06330859GA, SBP08365270GA, SBP08053807GA, SBP08124365GA, SBP08365286GA, SBP08375351GA, SBP06441264GA, SBP08335107GA, SBP07061929GA, SBP08214644GA, SBP08114259GA, SBP08355167GA, SBP08194509GA, SBP08214646GA, SBP08124353GA, SBP07513715GA, SBP07021767GA, SBP08124385GA, SBP06330842GA, SBP08194506GA, SBP07252604GA, SBP07142196GA, SBP07312784GA, SBP08124383GA, SBP08385400GA, SBP08244734GA, SBP06451324GA, SBP08214658GA, SBP08335086GA, SBP08284827GA, SBP08124403GA, SBP06391110GA, SBP07182284GA, SBP08224699GA, SBP08244733GA, SBP08365202GA, SBP08124337GA, SBP08104105GA, SBP08104181GA, SBP07373052GA, SBP08184489GA, SBP08104149GA, SBP07503683GA, SBP08335109GA, SBP08335074GA, SBP08335091GA, SBP08104152GA, SBP08335030GA, SBP07413185GA, SBP08164463GA, SBP07373060GA, SBP08365276GA, SBP06280656GA, SBP08224701GA, SBP08114274GA, SBP08194535GA, SBP08405478GA, SBP08405471GA, SBP08385457GA, SBP08385462GA, SBP08385464GA, SBP08385446GA, SBP08385444GA, SBP08385443GA, SBP08385448GA, SBP08415533GA, SBP08415532GA, SBP08425546GA, SBP08425544GA, SBP08415499GA, SBP08425541GA, SBP08425555GA, SBP08425554GA, SBP08415496GA, SBP08415497GA, SBP08425553GA, SBP08415489GA, SBP08425550GA, SBP08415523GA, SBP08425569GA, SBP08415517GA, SBP08415515GA, SBP08415494GA, SBP08445598GA, SBP08425568GA, SBP08425570GA, SBP08425582GA, SBP08425567GA, SBP08445593GA, SBP08445611GA, SBP08455627GA, SBP08445608GA, SBP08455619GA, SBP08455643GA, SBP08475675GA, SBP08455634GA, SBP08475668GA, SBP08475663GA, SBP08475654GA, SBP08485711GA, SBP08475649GA, SBP08495730GA, SBP08475651GA, SBP08495752GA, SBP08495771GA, SBP08495750GA, SBP08505773GA, SBP08515836GA, SBP08505781GA, SBP08515840GA, SBP08515903GA, SBP08515900GA, SBP08495761GA, SBP08495756GA, SBP08515918GA, SBP08515925GA, SBP08515914GA, SBP08525975GA, SBP08525957GA, SBP08515948GA, SBP08525955GA, SBP09026018GA, SBP09026022GA, SBP08525963GA, SBP09026013GA, SBP08515947GA, SBP09036051GA, SBP08385461GA, SBP06521691GA, SBP05480037GA, SBP06140217GA / SBP08204594GA, SBP06160267GA, SBP06190362GA / SBP08204588GA, SBP07122132GA, SBP07403106GA, SBP07473532GA, SBP08094018GA, SBP06200394GA, 717933, 9011933, M2BV0021F, SBP06511552GA, SBP08294857GA, SBP08294933GA, SBR06120044GA, SBY07130180GA, SBY07360211GA, SBP06511555GA, SBP06340971GA, SBP06491460GA, C48R0044F, SBP07102027GA, SBP07122115GA, SBP07192300GA, SBP07122128GA, SBP06090174GA, SAC04380008GA, SAE05180093GA, SBP06371047GA, SBP07232538GA, SBP08194511GA, SBX06380017GA, SBX07220024GA, SBX08100045GA, SBY06230110GA, SBY06240113GA, SBY06470152GA, SBY06480154GA, SBY06490158GA, SBY07360210GA, SBP06230509GA, SBP06140216GA, SBP06190256GA, SBP06190332GA, SBP06210438GA, SBP07081986GA, SBP07122122GA, SBP07453464GA, SBP07483550GA, SBP07493604GA, SBP08104135GA, SBP08124342GA, SBP08365289GA, SBP08385409GA, SBP08475667GA, SBP08415529GA, SBP09026011GA, SBP06491456GA, SBP06491457GA, SBP06491464GA, SBP07282663GA, SBP07373044GA, SBP08375385GA, SBP08324972GA, SBP08335006GA, SBP08204620GA, SBP08415520GA, SBP06290743GA, SBP06501500GA, SBP08324976GA, SBP06180301GA, SBP06220456GA, SBP07041771GA, SBP07122125GA, SBP07413195GA, SBP08023771GA, SBP08104147GA, SBP08104150GA, SBP08485713GA, SBP06080168GA, SBP06371065GA, SBP06330868GA, SBP06451322GA, SBP06441295GA, SBP06160260GA, SBP07122130GA, SBP07061863GA, SBP07362961GA, SBP07423228GA, SBR07421143GA, SBP07403113GA, SBP08124390GA, SBP08093975GA, SBP08094067GA, SBP06090177GA, SAD05473249GA, SBP07092015GA, SBP08294935GA, SBY08260270GA, SBY07220206GA, SBP08415527GA, SBP06431234GA, SBP07332848GA, SBP08485718GA, SBX08150047GA and SBP08144418GA
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Wauwatosa, WI, by letter dated October 13, 2008.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of an issue resulting from a workflow situation related to the automated labeling of patient data in the MUSE Cardiology Information System. When a prior record has been confirmed with an invalid (default) patient identifier (PID), MUSE will accept future records with the same default PID as correct. If subsequent records don not contain a name, MUSE will pre-populate the Name field with the same name associated with the initially confirmed record. This will lead to incorrect information contained in stored and printed records.
VOLUME OF PRODUCT IN COMMERCE
327 units
DISTRIBUTION
Nationwide, United Kingdom, Taiwan, Sweden, Spain, South Africa, Singapore, Saudi Arabia, Qatar, New Zealand,  Netherlands, Kuwait, Republic of Korea, Jordan, Italy, Japan, Ireland, France, Germany, Finland, Estonia, Denmark, Canada, Belgium, Austria, and Australia
___________________________________
PRODUCT 
GE Healthcare, CT Perfusion 4 on Advantage Workstation, CT and PET/CT consoles. Image analysis software package that allows the user to produce image data and to generate information with regard to changes in image intensity over time supporting CT Perfusion images, Recall # Z-1720-2009
CODE
Serial Numbers: 00000152741GE5, 00000152737GE3, 00000134590GE9, 00000119522GE1, 00000119523GE9, 00000146655GE6, 00000146668GE9, 00000146669GE7, 00000119519GE7, 00000145765GE4, 00000152738GE1, 00000121182GE0, 00000122793GE3, 00000119517GE1, 00000139086GE3, 00000141801GE1, 00000141802GE9, 00000141803GE7, 00000141804GE5, 00000141805GE2, 00000119521GE3, 00000118133GE8, 00000118134GE6, 00000118135GE3, 00000121180GE4, 00000141807GE8, 00000119516GE3, 00000123926GE8, 00000123931GE8, 00000122794GE1, 00000127524GE7, 00000127525GE4, 00000129247GE3, 00000134588GE3, 00000123927GE6, 00000123929GE2, 00000119520GE5, 00000122797GE4, 00000122795GE8, 00000123930GE0, 00000127522GE1, 00000127523GE9, 00000129243GE2, 00000127520GE5, 00000127521GE3, 00000127526GE2, 00000139088GE9, 00000129246GE5, 00000145645GE8, 00000141808GE6, 00000141811GE0, 00000151783GE8, 100995344, 00000145642GE5, 00000145647GE4, 00000118132GE0, 00000122799GE0, 00000122800GE6, 00000123928GE4, 00000127519GE7, 00000152735GE7, 00000129244GE0, 00000129245GE7, 00000129248GE1, 00000129249GE9, 00000129250GE7, 00000129251GE5, 00000134584GE2, 00000134585GE9, 00000134586GE7, 00000134587GE5, 00000145649GE0, 00000152742GE3, 00000122798GE2, 100995241, 100995217, 100995259, 80521349, 100995302, 100995275, 100995276, 100995431, 100995326, 100995412, 100995322, 80515302, 80515303, 80523248, 100995352, 100995298, 100995359, 100995306, 100995268, 100995354, 0CC08041501002, 0CC08041501003, 100995225, 80528332, 80521354, 100995279, 100995280, 100995281, 100995282, 100995283, 100995297, 100995305, 100995308, 100995288, 100995340, 100995355, 100995361, 100995385, 100995356, 100995450, 100995227, 80528736, 0CC08041501009, 80528724, 100995242, 100995351, 100995211, 100995212, 100995383, 80527216, 80527225, 80515730, 80528335, 80515721, 80521344, 80528730, 80528741, 80521352, 80521350, 80523251, 80521348, 100995222, 80515722, 100995339, 00000134592GE5, 00000134591GE7, 80505225, 80505229, 0CC08041501005, 80528328, 80528336, 80529188, 80521353, 100995224, 100995218, 100995221, 100995360, 100995240, 100995266, 100995267, 100995274, 80528329, 80528327, 00000121178GE8, 00000141809GE4, 00000152739GE9, 00000155218GE1, 00000121179GE6, 0CC08041501008, 100995239, 100995294, 100995327, 80528734, 100995366, 80515727, 80528322, 80521355, 100995278, 100995328, 100995331, 100995396, 100995411, 100995420, 00000146658GE0, 80528723, 80528324, 80505223, 80505226, 80505228, 100995220, 80528325, 0CC08041501007, 80527223, 80515296, 80528731, 80527219, 100995408, 0CC08041501010, 80528733, 80528735, 80528732, 80529189, 80521356, 100995311, 100995364, 100995219, 100995271, 100995292, 100995338, 100995334, 100995336, 100995286, 100995350, 100995379, 100995317, 100995318, 100995413, 100995449, 100995375, 80523250, 80515297, 80521351, 80528326, 0CC08041501004, 100995205, 80521343, 0CC08041501001, 100995270, 80505230, 80527218, 100995265, 100995300, 100995400, 100995426, 100995433, 80527224, 100995330, 100995341, 100995378, 100995291, 80528323, 0CC08041501006, 80505227, 100995377, 100995295, 100995272, 100995312, 100995368, 100995284, 100995349, 100995245, 80528330, 100995289, 100995255, 100995256, 100995374, 100995406, 100995319, 100995415, 100995409, 100995401, 100995332, 100995325, 100995419, 100995405, 100995407, 100995427, 100995429, 100995417, 80523253, 80528333, 00000145766GE2, 00000145644GE1, 80515298, 100995260, 0CC08040101001, 100995249, 100995388, 100995425, 100995229, 80523247, 100995209, 80528337, 100995296, 80515724, 80528339, 80505231, 80528739, 80515723, 80528340, 80515725, 80529195, 100995244, 80523249, 80515728, 80515729, 100995348, 100995370, 100995410, 100995376, 80529190, 80529191, 80529192, 80515726, 80529186, 80523246, 80528338, 80527222, 80529194, 80529193, 80528725, 80521346, 80528331, 80528334, 80528321, 80521347, 100995250, 100995251, 100995252, 100995254, 100995342, 000005189396-2, 100995223, 80523252, 100995215, 100995236, 100995231, 100995233, 100995232, 100995234, 100995237, 100995230, 100995235, 100995247, 100995304, 100995269, 100995273, 100995258, 100995285, 100995337, 100995287, 100995246, 100995314, 100995264, 100995387, 100995343, 100995365, 100995390, 100995392, 100995394, 100995391, 100995393, 100995384, 100995329, 100995404, 100995395, 100995402, 80528740, 80528737, 80527217, 80527221, 80528726, 80528727, 80528728, 100995316, 100995345, 100995353, 100995367, 80505224, 80505232, 100995207, 00000146661GE4, 00000144815GE8, 00000146660GE6, 00000146662GE2, 100995418, 100995441, 100995416, 00000146664GE8, 00000146666GE3, 00000146665GE5, 00000146659GE8, 100995238, 80529187, 100995208, 80523254, 100995214, 100995213, 100995206, 80515301, 80515305, 80527220, 100995253, 80523255, 100995210, 80515299, 80515304, 100995226, 100995257, 100995323, 100995228, 100995248, 100995262, 100995362, 100995301, 100995307, 100995309, 100995310, 100995299, 100995346, 100995403, 100995373, 100995363, 100995389, 100995422, 100995380, 100995381, 100995434, 00000145763GE9, 00000134589GE1, 00000121181GE2, 00000119518GE9, 00000151784GE6, 00000134583GE4, 00000141810GE2, 00000145641GE7, 00000145640GE9, 00000145768GE8, 00000145764GE7, 00000145767GE0, 00000151782GE0, 00000139087GE1, 00000145643GE3, 00000151780GE4, 00000151781GE2, 00000152740GE7, 00000152736GE5, 00000145646GE6, 00000145648GE2, 100995263, 100995243, 100995261, 100995421, 100995436, 100995435, 100995423, 100995424, 00000118131GE2, 00000141806GE0 and 00000118136GE1
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated October 23, 2009.
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France. Firm initiated recall is ongoing.
REASON
GE Healthcare has recently become aware of the need to adjust default settings associated with the use of CT Perfusion 4 on the Advantage Workstation, ST and PET/CT consoles that may impact patient safety. The default parameter settings in CT Perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (ISD) greater than 2 seconds of Volume Shuttle date. This can result in reduced conspicuity of subtle perfusion defects due to increased noise in these types of data sets.
VOLUME OF PRODUCT IN COMMERCE
444 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
GE Healthcare, Drapes and Sterile Covers PART NUMBER DESCRIPTION 00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL 00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500 00-900352-02 STRL, BAG, DRAIN WITH METAL TABS 00-900493-03 COVER DISPOSABLE X-RAY TUBE 00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY) 00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST 00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL 00-900885-01-OEC STRL, BAG, DRAIN, URO2600 00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76 00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600 00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL 00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600 00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL 00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600 00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER- C,9600/7700 00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600 00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600 00-901392-01 STRL, COVER, KEYBOARD, 66,68 00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL 00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK 00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800 00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL 00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600 00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800 00-901831-02 STRL, COVER, FLUOROTRAK MONITOR, DISPOSABLE BOX 10 PER PKG 00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25 00-901917-01 STRL, DRAPE, C-ARM, 6800 00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH 00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800 00-902752-01 STRL, RUI COVERS 25 COVERS 00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS 00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS 00-902776-01 STRL, DRAPE, VASCULAR 00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600 00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900 1003135 STRL, BAG, FLAT PANEL E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX Sterile EO. The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field, Recall # Z-1730-2009
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated August 15, 2008.
Manufacturer: Contour Fabricators, Inc., Fenton, MI. Firm initiated recall is ongoing.
REASON
GE Healthcare has found that the sterile products may have sterile seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state.
VOLUME OF PRODUCT IN COMMERCE
137,689 units
DISTRIBUTION
Nationwide, Canada, Australia, Bahamas, China, Hong Kong, Italy, Japan, Korea, Mexico, Malaysia, Singapore, and El Salvador
___________________________________
PRODUCT 
Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clinical Chemistry System with the heterogeneous immunoassay module is an in vitro diagnostic test intended to quantitatively measure cardiac troponin-I levels in human serum and heparinized plasma to aid in the diagnosis of myocardial infarction and in the risk of stratification of patients with acute coronary syndromes with respect to their relative risk of mortality, Recall # Z-1731-2009
CODE
Lot Number: FB9037. Expires February 6, 2009
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter on April 8, 2008. Firm initiated recall is complete.
REASON
Possibility of falsely elevated results
VOLUME OF PRODUCT IN COMMERCE
4,574 cartons
DISTRIBUTION
Nationwide, Bahamas, Belgium, Czech Republic, France, Germany, Italy, Poland, Portugal, Saudi Arabia, Spain, South Korea, and Slovakia
___________________________________
PRODUCT 
CellTracks AutoPrep System for in vitro diagnostic use, software version 2.2 or greater, Recall # Z-1734-2009
CODE
CellTracks AutoPrep: 9451, Waste Bottle CT4256
RECALLING FIRM/MANUFACTURER
Veridex, LLC, Raritan, NJ, by letter dated March 12, 2009. Firm initiated recall is ongoing.
REASON
Bottle degradation: Investigation has determined that degradation may occur in the plastic waste bottle of the CellTracks AutoPrep System.
VOLUME OF PRODUCT IN COMMERCE
196 instruments
DISTRIBUTION
Nationwide and Internationally

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS III

___________________________________
PRODUCT 
Pilgrim’s Pride Breeder – Lay with Aureomycin (CTC) Chicken Feed, Recall # V-255-2009
CODE
All feeds pulled from Bin number 40 and Bin number 45, distributed from November 30, 2008 to December 2, 2008.
RECALLING FIRM/MANUFACTURER
Pilgrim’s Pride Corp., Tenaha, TX, by letters on December 3, 2008. Firm initiated recall is complete.
REASON
Product with Chlortetracycline Aureomycin (CTC) Chicken Feed labeled as containing Tylosin.
VOLUME OF PRODUCT IN COMMERCE
630,000 pounds
DISTRIBUTION
TX
___________________________________
PRODUCT 
Bulk Whole Barley, Recall # V-256-2009
CODE
No code or lot number.
RECALLING FIRM/MANUFACTURER
Mars Petcare US, Clinton, OK, by telephone on May 21, 2009. Firm initiated recall is complete.
REASON
Product may have contained prohibited materials without cautionary statement on the label.
VOLUME OF PRODUCT IN COMMERCE
208,820 pounds
DISTRIBUTION
TX

END OF ENFORCEMENT REPORT FOR AUGUST 26, 2009

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