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U.S. Department of Health and Human Services

Safety

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Enforcement Report for October 21, 2009

October 21, 2009
09-42

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
Nirav Golden Raisin; packaged in 7 oz. and 14 oz. plastic bags, 24 bags per case; 7 oz. bag - UPC 0 24433 01027 6, 14 oz. bag - UPC 0 24433 01025 2. The raisins were also packaged in bulk clear plastic bags in 2 lb, 5 lb, 10 lb and 30 lb bags, which did not have a UPC code. Recall # F-023-9    
CODE
All raisins distributed between 11/4/08 and 7/24/09
RECALLING FIRM/MANUFACTURER
Indian Groceries and Spices, Inc., Skokie, IL, by press release on June 10, 2009 and July 24, 2009. Firm initiated recall is ongoing.
REASON
The golden raisins contain undeclared sulfites.
VOLUME OF PRODUCT IN COMMERCE
12,720 lbs
DISTRIBUTION
AR, FL, IL, IA, MI, MN, MO, OH and TN
___________________________________
PRODUCT 
1) Walgreens Bridge Mix; chocolate covered mixed nuts; 3.5 oz, 4 oz., 14 oz and 15 oz bags, 12 bags per case; 3.5 oz - item 291436, UPC 0 49022 42365 7; 4 oz - item 293822, UPC 0 49022 28797 6; 14 oz - item 291435, UPC 0 49022 42366 4; 15 oz - item 293814, UPC 0 49022 28927 7. Recall # F-024-9;

2) Walgreens Chocolate Covered Peanuts, 3.5 oz, 4 oz, 13.5 oz and 15 oz, 12 bags per case; 3.5 oz - item 291440, UPC 0 49022 42361 9; 4 oz - item 293819, UPC 0 49022 28800 3; 13.5 oz - item 291439, UPC 0 49022 42362 6; 15 oz - item 293820, UPC 0 49022 28799 0. Recall # F-025-9;

3) Walgreens Caramel Nut Clusters, 3.5 oz, 4 oz, 13.5 oz, 15 oz, 12 bags per case; 3.5 oz - item 291442, UPC 0 49022 42359 6; 4 oz - item 293817, UPC 0 49022 28802 7; 13.5 oz - item 291441, UPC 0 49022 42360 2; 15 oz - item 293816, UPC 0 49022 28803 4. Recall # F-026-9;

4) Walgreens Chocolate Peanut Clusters, 3.5 oz and 4 oz, 12 bags per case; 3.5 oz - item 291443, UPC 0 49022 42358 9; 4 oz - item 293818, UPC 0 49022 28801 0. Recall # F-027-9
CODE
All products sold between January 1, 2007 and January 29, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Walgreen Co., Deerfield, IL, by e-mail on January 29, 2009.
Manufacturer: GKI Foods, Inc., Brighton, MI. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
6,943,682 lbs
DISTRIBUTION
Nationwide, including PR
___________________________________
PRODUCT 
1) Chocolate dark double dipped peanuts. Chocolate dark double dipped peanuts, 12-11 oz. packages, Every Day’s A Party, UPC 760208126192 and Chocolate dark double dipped peanuts, 12-11 oz. packages, JL Manufacturing, UPC 760208126192. Recall # F-028-9;

2) Chocolate bridge mix. Chocolate bridge mix, 12-14 oz. packages, Every Day’s A Party,  UPC 760208121128; Chocolate bridge mix, 12-18 oz. packages, Fresh Pick's Meat & Produce, UPC 760208124488; Chocolate bridge mix, 12-18 oz. packages, Harvest Fresh Market, UPC 760208124488; Chocolate bridge mix, 12-18 oz. packages, JL Manufacturing, UPC 760208124488; Chocolate bridge mix, 12-18 oz. packages, L & L Food Centers, UPC 760208124488; Chocolate bridge mix, 12-18 oz. packages, Oakridge Family Food Centers, UPC 760208124488; Chocolate bridge mix, 12-18 oz. packages, Olsen's Piggly Wiggly, UPC 760208124488; Chocolate bridge mix, 12-14 oz. packages, Plum Markets, UPC 760208121128 and Chocolate bridge mix, 12-18 oz. packages, Rodhe's IGA Marketplace,  UPC 760208124488. Recall # F-029-9;

3) Chocolate peanut clusters. Chocolate peanut clusters, 12-12 oz. packages, Fresh Pick's Meat & Produce, UPC 60208116001; Chocolate peanut clusters, 12-12 oz. packages, Harvest Fresh Market, UPC 760208116001; Chocolate peanut clusters, 12-12 oz. packages, JL Manufacturing, UPC 760208116001 and Chocolate peanut clusters, 12-12 oz. packages, Sentry Food, UPC 760208116001. Recall # F-030-9;

4) Chocolate peanuts, sugar free. Chocolate peanuts, sugar free, 12-12 oz. packages, Chuppa's Marketplace, UPC 760208123092; Chocolate peanuts, sugar free, 12-12 oz. packages, Every Day's A Party, UPC 760208123030; Chocolate peanuts, sugar free, 12-12 oz. packages, JL Manufacturing, UPC 760208123092; Chocolate peanuts, sugar free, 12-12 oz. packages, Johnny Pomodoro's,  UPC 760208123092; Chocolate peanuts, sugar free, 12-12 oz. packages, Plum Markets, UPC 760208123030; Chocolate peanuts, sugar free, 12-12 oz. packages, Rodhe's IGA Marketplace, UPC 760208123092. Recall # F-031-9
CODE
All lots with date codes from 08 01 2008 to 01 30 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Lipari Foods, Inc., Warren, MI, by telephone and letter on January 30, 2009 and by press release on February 3, 2009.
Manufacturer: GKI Foods, Inc., Brighton, MI. 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
4,644
DISTRIBUTION
IL, IN, KY, MI, OH, PA, WV and WI
___________________________________
PRODUCT 
1) Chocolate Coated Peanuts Medium, 40 lb case; a) Item #05-005-40M and b) Item #05-9005-40M (no UPC). Recall # F-1397-9;

2) Candy Bar Blend, 10 lb. case; a) Item #05-332-10 and 40 lb. cases; b) Item #05-032-40, c) Item #05-332-40 and d) Item #05-1032-40 (no UPC). Recall # F-1398-9;

3) Nutz Blend, 30 lb. case; Item #05-083-30 and Item #05-383-30 (no UPC). Recall # F-1399-9;

4) Nutty Waffle Cone Blend, 25 lb. case; Item #05-348-25 (no UPC). Recall # F-1400-9;

5) Chocolate Peanuts 605 Medium, 40 lb. case; Item #05-605-40M (no UPC), Item #05-805-40M (no UPC) and Item 05-5305-40M. Recall # F-1401-9;

6) Milk Chocolate Peanuts Medium, 40 lb case; Item #05-1005-40M (no UPC). Recall # F-1402-9;

7) Sweet & Salty Blend, 25 lb case; Item #05-1482-25 (no UPC). Recall # F-1403-9;

8) Chocolate Fudge Peanuts, 20 and 40 lb case; a) Item #05-1905-20M, item #05-1905-40M and b) item #05-1905-40S/M (no UPC). Recall # F-1404-9;

9) Fudge Coated Salted Peanuts, 20 lb case; Item #05-2805-20 (no UPC). Recall # F-1405-9;

10) Chocolate Nuts and Toffee Blend, 40 lb. case; Item #13-124-40 (no UPC). Recall # F-1406-9;

11) Sugar Free Chocolate Peanuts Med, 40 lb. case; Item #19-005-40M (no UPC). Recall # F-1407-9;

12) NSA Chocolate Coated Peanuts, 40 lb. case; Item #19-505-40M (no UPC). Recall # F-1408-9;

13) Chocolate Coated Peanuts, 40 lb case; Item #05-01905-40M (no UPC). Recall # F-1409-9;

14) Chocolate Fudge Peanuts (HOL Peanut Butter Debris), 40 lb case; Item #49-00045-40 (no UPC). Recall # F-1410-9;

15) Fudge Pretzel Peanut PB Cup, 25 lb case, Item #05-2382-25 (no UPC). Recall # F-1411-9
CODE
1) Code dates: a) 080712, 082981 and 083082, b) 081142 and 082531;
 
2) Code dates: a) 070782, 070952, 071101, 071162, 071222, 071311, 071432, 071642, 071772, 071922, 071992, 072081, 072122, 072752, 072832, 073021, 080292, 080492, 080741, 080912, 081182, 081212, 081271, 081272, 081342, 082242, 082402, 082592, 083032, 083041, 083101, 083152; b) 070462, 071002, 071242, 071311, 071571, 071711, 071772, 072011, 072312, 080741, 080781, 080792, 081342, 081402, 081502, 082422, 082472, 082522, 082621, 082972, 083172, 083252, 083362, 083522 and 083452; c)  071162, 081402, 081552, 082482, 082872, 083232 and 090052; d) 071242, 081552 and 083172;

3) Code dates: a) 080941, b) 080881;

4) Code dates: 081512 and 081572;

5) Code dates: 070951, 071232, 080812, 081142, 082522, and 080252;

6) Code dates: 070902 and 083162;

7) Code dates: 080671, 081101, 083191 and 09008;

8) Code dates: a) 071092, 071172, 071221, 071653, 072082, 080212, 080372, 081372, 081401, 081541, 082361 and 083012. b) 070722, 070741, 070742, 071092, 071172, 071212, 071222, 081141, 081142, 081292, 81301, 82461, 082462, 082661, 082812, 082821, 083082, 083312, 083401, 083402 and 083532;

9) Code dates: 071691, 080471, 080472, 080481, 080482, 080531, 080532, 080541, 080542, 080551, 080552, 080561, 080562, 080591, 080592, 080611, 080612, 080661, 080662, 080671, 080672, 080681, 080682, 080862, 080891, 080892, 080931, 080932, 080941, 080942, 080951 and 080952;

10) Code dates: 071171 and 083191;

11) Code date: 071172;

12) Code dates: 070541, 070542, 070751, 070752, 070822, 071032, 071041, 071912, 071921, 071922, 081142, 081422, 081441, 081442, 082342, 082762, 082812, 082911, 083011, 083012, 083441 and 083442;

13) Code dates: 070481, 070482, 070872, 071092, 071302, 071371, 071591, 071671, 071672, 072302, 072311, 072421, 072482, 072491, 072642, 072712, 072821, 072822, 072981, 072982, 081141, 081352, 081481, 081482, 081681, 081682, 081781, 081782, 082051, 082221, 082412, 082421, 082682, 082962, 082971, 083161, 083162, 083522, 083531 and 090122;

14) Code dates: 070722, 070741, 071653, 072002, 080302, 080712, 081972 and 081981;

15) Code date 082001
RECALLING FIRM/MANUFACTURER
Pecan Deluxe Candy Co., Dallas, TX, by letter on January 30, 2009 and press releases on February 1, 2009 and February 23, 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
33,911 cases; 876,830 lbs
DISTRIBUTION
TX
___________________________________
PRODUCT 
1) Dough-to-Go Peanut Butter Chocolate Chip cookies, 12 per case. Product code CBB-335-40. Recall # F-1412-9; 

2) Dough-to-Go Peanut Butter Peanut cookies (72 cookies per case). Product code CBB-330-20. Recall # F-1413-9;

3) Dough-to-Go peanut butter chocolate chip cookie dough portions (80 per case) and in 18-lb. pails. Product code CBR-190-20. Recall # F-1414-9;

4) Dough-to-Go peanut butter peanut cookie dough in portions (80 cookie dough portions per case and 144 portions per case) and in 18-lb. pails. Product code CBR-330-20. Recall # F-1415-9;

5) Jane Dough's mixed box (36 cookies per case, mixed box, 12 each of chocolate chip, peanut butter and oatmeal raisin), Product code FUN-001-0U. Recall # F-1416-9;

6) Jane Dough's peanut butter cookie dough (36 peanut butter cookie dough portions per case). Product code FUN-320-0O. Recall # F-1417-9;

7) Jane Dough's peanut butter cookies (24 peanut butter cookies per case). Product code CMB-PBU-30. Recall # F-1418-9;

8) Auntie Ono Peanut Butter Cookie Dough (36 portions of peanut butter cookie dough). Recall # F-1419-9
CODE
Product manufactured prior to January 23, 2009
RECALLING FIRM/MANUFACTURER
Dough-To-Go Inc., Santa Clara, CA, by telephone and e-mail on January 21, 2009 and by press release on January 23, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanut butter recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
WA, CA, NV, HI and AZ
___________________________________
PRODUCT 
1) Werner Gourmet Snacks Peanuts Con Chile Y Limon; Net Wt 8 oz with 12 packages per case. Product packaged in clear film packages with a label that reads: Just Eat it! Werner Gourmet Snacks USA Peanuts Con Chile Y Limon UPC 7 09972 80086 0. Recall # F-1420-9;

2) Werner Gourmet Snacks Cranberry Mix - Product packaged in clear film packages, Net Wt 2.5 oz or 3 oz, 7 09972 80049 5 and 6.5 oz or 7 oz, UPC 7 09972 80008 2, with 12 packages per case. The product label reads in part, Just Eat It! Werner Gourmet Snacks Cranberry Mix USA. Recall # F-1421-9;

3) Werner Gourmet Snacks Gourmet Mix. Product packaged in clear film packages, Net Wt 8 oz or 9 oz (UPC 7 09972 80004 4), with 12 per case. Label reads: Just Eat it! USA Werner Gourmet Snacks Gourmet Mix. Recall # F-1422-9;

4) Werner Gourmet Snacks Hot & Spicy Peanuts. Product packaged in clear film packages, Net Wt 8 oz with 12 packages per cases. Label reads: Just Eat It! USA Werner Gourmet Snacks HOT & SPICY Peanuts; UPC 7 09972 80011 2. Recall # F-1423-9;

5) Werner Gourmet Snacks Hot & Sweet Sportsman's Mix. Product packaged in clear film packages, Net Wt 8 oz or 9 oz (UPC 7 09972 80006 8) with 12 packages per case. Label reads: Just Eat It! Werner Gourmet Snacks USA HOT & SWEET Sportsman's Mix. Recall # F-1424-9;

6) Werner Gourmet Snacks Fancy Mixed Nuts. Product packaged in clear film packages, Net Wt 1.5 oz (UPC 7 09972 08851 8) and 4 oz or 4.75 oz (UPC 7 09972 80009 9) with 12 packages per case. Label reads: Just Eat It! USA Werner Gourmet Snacks Fancy Mixed Nuts. Recall # F-1425-9;

7) Werner Gourmet Snacks Roasted & Salted Peanuts. Products packaged in clear film packages, Net Wt 3 oz or 3.5 oz (UPC 7 09972 80052 5) and 8.5 oz or 9 oz (UPC 7 09972 80012 9), with 12 packages per case. Label reads: Just Eat It! USA Werner Gourmet Snacks Roasted & Salted Peanuts. Recall # F-1426-9;

8) Werner Gourmet Snacks Hot & Spicy Rancher's Mix. Product packaged in clear film packages, Net Wt 3 oz, UPC 7 09972 80080 8 and 7 oz, UPC 7 09972 80005 1 with 12 packages per case. Label reads: Just Eat It! USA Werner Gourmet Snacks Hot & Spicy Rancher's Mix. Recall # F-1427-9;

9) Werner Gourmet Snacks Sportsman's Mix. Product packaged in clear film packages, Net Wt 3 oz or 3.5 oz, UPC 7 09972 80071 6 and 8 oz or 9 oz, UPC 7 09972 80001 3 with 12 packages per case. Label reads: Just Eat It! USA Werner Gourmet Snacks Sportsman's Mix. Recall # F-1428-9;

10) Werner Gourmet Snacks Tropical Mix. Product packaged in clear film packages, Net Wt 3 oz or 3.5 oz, UPC 7 09972 80048 8 and 8 oz or 9 oz UPC 7 09972 80002 0 with 12 packages per case. Label reads: Just Eat It! Gourmet Werner Snacks USA Tropical Mix. Recall # F-1429-9;

11) Werner Gourmet Snacks Yogurt Mix. Product packaged in clear film packages, Net Wt 8 oz or 9 oz, UPC 7 09972 80003 7 with 12 packages per case. Label reads: Just Eat It! USA Werner Gourmet Snacks Yogurt Mix. Recall # F-1430-9;

12) Werner Gourmet Snacks Honey Roasted Peanuts. Product packaged in clear film packages, Net Wt 2.5 oz, UPC 7 09972 80057 and 6 oz, UPC 7 09972 80025 9 with 12 packages per case. Label reads: Just Eat It! USA Werner Gourmet Snacks Yogurt Mix. Recall # F-1431-9;

13) Werner Gourmet Snacks Baked Beans. Packaged in clear film, Net Wt 8 oz, UPC 7 09972 80026 6 with 12 packages per case. Label reads: Just Eat It!, USA, Werner Boston Baked Beans. Recall # F-1432-9  
CODE
1) Best by dates 3/20/2008 - 12/7/2009. Lot #s 7152 through 7334;
2), 10) Best by dates 3/20/2008 - 9/10/2009. Lot #s 7152 through 7334;
3), 4), 5), 8) Best by dates 3/20/2008 - 9/14/2009. Lot #s 7152 through 7334;
6) and 7) Best by dates 3/20/2008 - 9/22/2009. Lot #s 7152 through 7334;
9) Best by dates 3/20/2008 - 9/23/2009. Lot #s 7152 through 7334;
11) Best by dates 3/20/2008 - 9/29/2009. Lot #s 7152 through 7334;  
12) Best by dates 1/1/2008 - 9/29/2009, Lot #s 7152 through 7334;
13) Best By dates: 3/20/2008- 2/9/2009. Lot numbers: 7152 through 7334
RECALLING FIRM/MANUFACTURER
Werner Gourmet Meat Snacks, Tillamook, OR, by letters on January 29, 2009, by press release on February 1, 2009 and February 27, 2009 and by letter on February 23, 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
696,792 packages
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
1) Ass Kickin' Honey Roasted Peanuts in 1 oz. bags and 12 oz cans. Recall # F-1433-9;

2) Ass Kickin' Chipotle Honey Peanuts in 1 oz. bags and 12 oz cans. Recall # F-1434-9
CODE
AK744, AK763, AK767 and AK772
RECALLING FIRM/MANUFACTURER
Southwest Specialty Food, Inc., Goodyear, AZ, by telephone and fax on February 4, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1) 24,325/12 oz cans; 30,280/1 oz bags; 2) 12,029/12 oz cans
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Premier Nutrition 30g Protein Odyssey Triple Layer Protein Bar 2.8 oz (80g) UPC 6 43843 00160 (7), 12 count carton with UPC 6 43843 00161 4. Recall # F-1435-9;

2) Premier Nutrition 30g Protein Odyssey Triple Layer Protein Bar 2.8 oz (80g), UPC 6 43843 00101 (0), 12 count carton with UPC 6 43843 00102 7. Recall # F-1436-9
CODE
1) BEST BY: 06/12/08A through 07/25/09A;
2) BEST BY: 10/01/08A, through 10/11/09A
RECALLING FIRM/MANUFACTURER
Recalling Firm: Premier Nutrition, Carlsbad, CA, by press release and letters on April 29, 2009.
Manufacturer: Nellson Nutraceutical Inc., Irwindale, CA. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
4,300, 72-count cases
DISTRIBUTION
Nationwide, Canada, France, Israel, United Kingdom
___________________________________
PRODUCT 
1) Thai Peanut Tofu, Net Wt. 10 oz (284g), UPC 4956801028. Perishable Keep Refrigerated. Recall # F-1437-9;

2) Thai Peanut Tofu Wrap, Net Wt. 12 oz (340g), UPC 4956801034. Perishable Keep Refrigerated. Recall # F-1438-9;

3) Thai Peanut Braised Tofu, Net Wt. 8 lbs, UPC 4956804407. Perishable Keep Refrigerated. Recall # F-1439-9;

4) Savory Tofu Saute Net Wt. 10 oz (284 g), UPC 4956801038. Perishable Keep Refrigerated and Savory Tofu Saute Net Wt. 7 Lbs, UPC 4956804014. Perishable Keep Refrigerated. Recall # F-1440-9;

5) Follow Your Heart Peanut Butter Fudge Cake Net Wt. 5 oz (142g), UPC 4956803012. Perishable Keep Refrigerated. Recall # F-1441-9
CODE
Best By: MM/DD/YY. Date range of recalled products is 01/27/09 - 02/09/09
RECALLING FIRM/MANUFACTURER
Earth Island, Chatsworth, CA, by telephone and fax on/around January 28, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
263 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Karp's Peanut Butter Cookie Dough for Ice Cream, Net Wt. 18 lbs. Frozen. Reference : 58554. Recall # F-1442-9
CODE
Lot Code #81557001, Lot Code#81967001, Lot Code#72067001, Lot Code# 71627001
RECALLING FIRM/MANUFACTURER
Over the Top Food Company, East Walpole, MA, by letter dated 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
401 cases
DISTRIBUTION
GA
___________________________________
PRODUCT 
1) Ocean Spray BRAND CRAISINS Sweetened Dried Cranberries TRAIL MIX CRANBERRY, FRUIT & NUTS, 48 oz plastic bags imprinted with front and back labels, UPC: 3120029629 Non-Sams Clubs UPC: 0003120029629 Sams Clubs and in 1.75 oz plastic bags imprinted with front and back labels, label, UPC 311812. Recall # F-1443-9;

2) Ocean Spray BRAND CRAISINS SWEETENED DRIED CRANBERRIES TRAIL MIX CRANBERRY, FRUIT & NUTS in 170g plastic bags imprinted with front and back labels, the back label states: PACKAGED IN THE UNITED STATES OF AMERICA FROM IMPORTED AND LOCAL INGREDIENTS. This product differs from the US version by excluding coconut from the ingredients. Distributed exclusively in Australia. UPC: 332100001292. Recall # F-1444-9;

3) Ocean Spray BRAND/MARQUE CRAISINS Sweetened Dried Cranberries/ Canneberges seches sucrees TRAIL MIX/ MELANGE MONTAGNARD in 170g plastic bags imprinted with front and back labels. This product is only distributed in Canada. UPC 0-31200-44632-9. Recall # F-1445-9
CODE
1) Best By Dates (48 oz): MAY2509 MAY2609 JUN1909 JUN2009 JUN2209 JUN2409 JUL2009 JUL2109 JUL2209 AUG0209 Best By Dates (1.75 oz): MAY0509 MAY0609 MAY0709 MAY1109 MAY1209 MAY2809 JUN0409 JUN0509 JUN1009 JUN1209 JUN2009 JUN2109 JUN2209 JUN2309 JUN2409 JUN0909 JUN2509 JUL2909 JUL3109 AUG0209 OCT0409 OCT0609 OCT0709 OCT0909;

2) Best Before Date 14/11/09;

3) Best By Date 091109 091209 091509 091609
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ocean Spray Cranberries, Inc., Middleboro, MA, by letter on February 2, 2009 and by fax, email and telephone on February 3, 2009.
Manufacturer: Diamond Foods, Inc., Fishers, IN. 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
28,782 cases
DISTRIBUTION
Nationwide, Canada, Australia
___________________________________
PRODUCT 
Chocolate covered peanuts, packaged in Novelty "Poop", 4 oz paper bags. Product packed under the following labels: Big Sky Bear Scat, Compliments of Glacier National Park Fund Bear Poop, Duck Inn Bear Scat, Flathead Lake Monster Eggs, Glacier Park Bear Scat, Glacier Park Moose Droppings, Gunflint Lodge Moose Droppings, Gunflint Outfitters Moose Droppings, Hunley Crew Rations, Idaho Bear Scat, Minnesota Chicken Coop Poop, Montana Fish Eggs, Montana Bear Poop, Montana Bear Scat, Montana Bird Do-Do, Montana Buffalo Chips, Montana Cow Patties, Montana Deer Droppings, Montana Dino Eggs, Montana Fish Eggs, Montana Moose Droppings, Nessie's Crater Lake Monster Eggs, Oregon Bear Scat, Oregon Deer Droppings, Oregon Fish Eggs, Oregon Osprey Poop, Pagosa Springs Moose Droppings, Priest Lake Bear Scat, Priest Lake Deer Droppings, Priest Lake Moose Droppings, Smoky Mountains Bear Scat, South Dakota Cow Pies, South Dakota Prairie Dog Pebbles, Southern Oregon Lizard Eggs, Tennessee Bear Scat, Washington Chicken Coop Poop, White Fish, MT Bear Scat, Wisconsin Deer Droppings, Wyoming Bear Poop, Wyoming Buffalo Chips, Yellowstone Buffalo Chips. UPC's may be found on the following packages; Bear Scat (UPC 725901311801), Fish Eggs (UPC 725901311870), Deer Droppings, (UPC 725901311849), Osprey Poop, (UPC 725901311917), Lizard Eggs (UPC 725901311924), Monster Eggs (UPC 725901311931). Please note: Not all packages will have a UPC.  Recall # F-1446-9
CODE
Product is not coded. All potentially affected Chocolate Covered Peanut packages will have a white ingredient label with black lettering for the Ingredient and Allergy information and purple lettering for the Company information located on the bottom of each package.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Huckleberry Haven Inc., Kalispell, MO, by letter dated February 2, 2009, by telephone on February 3, 2009 and press release on February 5, 2009.
Manufacturer: GKI Foods, Inc., Brighton, MI. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
2,020 packages
DISTRIBUTION
OR, TN, MT, WA, SD, ID, SC, MN, CO, WY, NC, and WI
___________________________________
PRODUCT 
Grandpa's Oven Santa Fe Snack Mix, a spicy and savory blend of rye chips, Spanish peanuts and pretzel chips, net wt. 12 oz, UPC 7067810906. Recall # F-1447-9
CODE
All lots with Best if Used By dates of SEP1008, SEP1108, SEP1408, OCT1408, OCT2308, NOV2408, NOV2508, OCT1109, NOV2009 and DEC2009
RECALLING FIRM/MANUFACTURER
Rothbury Farms, Inc., Kentwood, MI, by press release and e-mail on February 19, 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
31,395
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Publix Premium No Sugar Added Peanut Brittle Light Ice Cream, 1/2 gallon, in paper cartons, 6 each per case. Recall # F-1448-9;
 
2) Publix Premium Limited Edition Monkey Business Banana Ice Cream 1/2 Gallon, Paper Carton, 6 ice creams per case, Frozen. UPC 41415-29443. Recall # F-1449-9;

3) Publix Premium Peanut Butter Goo Goo Ice Cream , 1/2 Gallon, Paper Carton, 6 cartons per case, Frozen. UPC 41415 28843. Recall # F-1450-9
CODE
1) Sell by dates of October 20, 2007 to October 7, 2008;
2) Sell by dates of March 11, 2008 to September 19, 2009;
3) Sell by dates of November 24, 2007 to October 20, 2009
RECALLING FIRM/MANUFACTURER
Publix Super Markets, Lakeland, FL, by press release on January 30, 2009 and by e-mails on February 3, 2009. Firm initiated recall is complete.
REASON
The products were manufactured using peanut paste recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
560,526 ½ gallon containers
DISTRIBUTION
FL, GA, AL, SC and TN
___________________________________
PRODUCT 
1) Trail Mix. Label reads: "Champion Premium Trail Mix Nuts & Chocolate" and in smaller font "Sweet Raisins, Crunchy Nuts and Milk Chocolate Candies Net Wt 24 oz (680 g)" Product of USA, China, India, Brazil, and /or Vietnam". Packaged in plastic stand up resealable pouch. First three ingredients are raisins (raisins coated in vegetable oil (may contain one or more of the following: partially hydrogenated cottonseed/soybean, sunflower and/or canola oil)), peanuts (peanuts, peanut oil, salt), chocolate candies (milk chocolate [sugar, cocoa butter, whole milk, chocolate liquor, lactose, lecithin [added as an emulsifier], vanillin (an artificial flavor), sugar, coloring (includes yellow #5 lake, yellow #6 lake, blue #2 lake, red #40 lake, blue #1 lake, yellow #6). UPC 70044-00980. Recall # F-1451-9;

2) Trail Mix. Label reads: "Champion Premium Trail Mix White Mountain" and in smaller font "Nuts, Pineapple, Cranberries and Creamy Vanilla Candies Net Wt 24 oz (680 g)" Product of USA, Canada, and Thailand". Packaged in plastic stand up resealable pouch. First three ingredients are cranberries (cranberries, sugar, sunflower), peanuts (peanuts, peanut oil, salt), dried pineapple (pineapple, sugar, citric acid, sulfur dioxide, pineapple juice). UPC: 70044-00981. Recall # F-1452-9;

3) Trail Mix. Label reads: "Champion Premium Trao; Mix, Raisins, Nuts & Seeds" and in smaller font "Sweet Raisins, Crunchy Nuts and Seeds Net Wt 24 oz (680 g)" Product of USA, China, India, Brazil, and /or Vietnam". Packaged in plastic stand up resealable pouch. First three ingredients are raisins (raisins coated in vegetable oil (may contain one or more of the following: partially hydrogenated cottonseed/soybean, sunflower and/or canola oil)), peanuts (peanuts, peanut oil, salt), pumpkin seeds (pumpkin seeds, vegetable oil [may contain one or more of the following: partially hydrogenated cottonseed, soybean, peanut, canola, sunflower and/or safflower oil]), salt). UPC 70044-00982. Recall # F-1453-9;

4) Trail Mix. Label reads: "Southern Grove Trail Mix Nut & Chocolate" and in smaller font "Raisins, Crunchy Nuts and Milk Chocolate Candies Net Wt 10 oz (283G)" Product of USA, China, India, Brazil, and /or Vietnam". Packaged in plastic stand up resealable pouch. First three ingredients are raisins (raisins coated in vegetable oil (may contain one or more of the following: partially hydrogenated cottonseed/soybean, sunflower and/or canola oil)), peanuts (peanuts, peanut oil, salt), chocolate candies (milk chocolate (sugar, cocoa butter, whole milk, chocolate liquor, lactose, lecithin (added as an emulsifier), vanillin (an artificial flavor), sugar, coloring (includes yellow #5 lake, yellow #6 lake, blue #2 lake, red #40 lake, blue #1 lake, yellow #6). UPC 41498-17780. Recall # F-1454-9;

5) Trail Mix. Label reads: "Southern Grove Trail Mix Fruit & Nut" and in smaller font "Tropical Fruit, Berries, Raisins and Crunchy Nuts Net Wt 10 oz (283 g)" Product of USA, Canada, China, Philippines, and/or Thailand. Packaged in plastic stand up resealable pouch. First three ingredients are raisins (raisins coated in vegetable oil (may contain one or more of the following: partially hydrogenated cottonseed/soybean, sunflower and/or canola oil)), peanuts (peanuts, peanut oil, salt), dried banana chips (bananas, refined sugar, coconut oil, banana flavor). UPC 41498-17781. Recall # F-1455-9;

6) Trail Mix. Label reads: " Southern Grove Trail Mix Nut , Seed & Berry" and in smaller font "Sweet Raisins, Crunchy Nuts and Seeds Net Wt 10 oz (283 g)" Product of USA, China, India, Brazil, and /or Vietnam". Packaged in plastic stand up resealable pouch. First three ingredients are raisins (raisins coated in partially hydrogenated cottonseed/soybean oil), pumpkin seeds (pumpkin seeds, salt), sunflower seeds (sunflower seeds, safflower oil, salt). UPC 41498-17782. Recall # F-1456-9;

7) Trail Mix. Label reads: "Suthern Grove Trail Mix White Mountain" and in smaller font "Nuts, Pineapple, Cranberries and Creamy Vanilla Candies Net Wt 10 oz (238 g)" Product of USA, Canada, and Thailand. Packaged in plastic stand up resealable pouch. First three ingredients are cranberries (cranberries, sugar, sunflower oil), peanuts (peanuts, peanut oil, salt), dried pineapple (pineapple, sugar, citric acid, sulfur dioxide, pineapple juice). UPC 41498-17783. Recall # F-1457-9;

8) Trail Mix. Label reads: "bloom Trail Mix Raisins & Nuts" and in smaller font "with Raisins, Peanuts, Chocolate Candies, Almonds & Cashews NET WT. 6 OZ (170 g)" Product of USA, China, India, Brazil, and /or Vietnam". Packaged in plastic stand up resealable pouch. First three ingredients are raisins (raisins coated in vegetable oil [may contain one or more of the following: partially hydrogenated cottonseed/soybean, sunflower and/or canola oil]), peanuts (peanuts, peanut oil, salt), chocolate candies (milk chocolate [sugar, cocoa butter, whole milk, chocolate liquor, lactose, lecithin, [added as an emulsifier], vanillin [an artificial flavor], sugar, coloring, [includes yellow #5 lake, yellow #6 lake, blue #2 lake, red #40 lake, blue #1 lake, yellow #6] gum arabic, corn syrup, confectioner's glaze [carnauba wax, beeswax, shellac]). UPC 25439-92166. Recall # F-1458-9;

9) Trail Mix. Label reads: "bloom Trail Mix Fruit & Nuts" and in smaller font "with Raisins, Peanuts, Banana Chips, Dried Pineapple, Dried Cranberries, Dried Cherries, Dried Strawberries, Almonds & Walnuts Net Wt. 6 oz (170 g)" Product of USA, Canada, China, Philippines, and/or Thailand". Packaged in plastic stand up resealable pouch. First three ingredients are raisins (raisins coated in vegetable oil (may contain one or more of the following: partially hydrogenated cottonseed/soybean, sunflower and/or canola oil)), peanuts (peanuts, peanut oil, salt), dried banana chips (bananas, refined sugar, coconut oil, banana flavor). UPC 25439-92167. Recall # F-1459-9;

10) Trail Mix. Label reads: "bloom Trail Mix Winter Blend" and in smaller font "Dried Cranberries, Peanuts, Dried Pineapple, & Vanilla Chips Net Wt. 6 oz (170 g)" Product of USA, Canada, and Thailand. Packaged in plastic stand up resealable pouch. First three ingredients are cranberries (cranberries, sugar, sunflower oil), peanuts (peanuts, peanut oil, salt), dried pineapple (pineapple, sugar, citric acid, sulfur dioxide, pineapple juice). UPC 25439-92168. Trail Mix. Label reads: "Food Lion Trail Mix Winter Blend" and in smaller font "Dried Cranberries, Peanuts, Dried Pineapple, & Vanilla Chips Net Wt. 6 oz (170 g)" Product of USA, Canada, and Thailand. Packaged in plastic stand up resealable pouch. Same ingredients as Bloom. UPC 35826-06486. Recall # F-1460-9;

11) Trail Mix. Label reads: "bloom Trail Mix Nutseed Blend" and in smaller font "Raisins, Pumpkin Seeds, Sunflower Seeds, Peanuts, Almonds & Cashews" Product of USA, China, India, Brazil and/or Vietnam. Packaged in plastic stand up resealable pouch. UPC 25439-92169. Recall # F-1461-9;

12) Trail Mix. Label reads: "FOOD LION Trail Mix Raisins & Nuts" and in smaller font "with Raisins, Peanuts, Chocolate Candies, Almonds & Cashews Net wt. 6 oz (170g)" Product of USA, China, India, Brazil and/or Vietnam. Packaged in plastic stand up resealable pouch. First three ingredients are raisins (raisins coated in vegetable oil (may contain one or more of the following: partially hydrogenated cottonseed/soybean, sunflower and/or canola oil)), peanuts (peanuts, peanut oil, salt), chocolate candies (milk chocolate [sugar, cocoa butter, whole milk, chocolate liquor, lactose, lecithin (added as an emulsifier), vanillin [an artificial flavor], sugar, coloring [includes yellow #5 lake, yellow #6 lake, blue #2 lake, red #40 lake, blue #1 lake, yellow #6]. UPC 35826-06484. Recall # F-1462-9;

13) Trail Mix. Label reads: "Food Lion Trail Mix Fruit & Nuts" and in smaller font "with Raisins, Peanuts, Banana Chips, Dried Pineapple, Dried Cranberries, Dried Cherries, Dried Strawberries, Almonds & Walnuts Net Wt. 6 oz (170 g)" Product of USA, Canada, China, Philippines, and/or Thailand". Packaged in plastic stand up resealable pouch. First three ingredients are raisins (raisins coated in vegetable oil [may contain one or more of the following: partially hydrogenated cottonseed/soybean, sunflower and/or canola oil]), peanuts (peanuts, peanut oil, salt), dried banana chips (bananas, refined sugar, coconut oil, banana flavor). UPC 35826-06485. Recall # F-1463-9;

14) Trail Mix. Label reads: "Food Lion Trail Mix Nutseed Blend" and in smaller font "Raisins, Pumpkin Seeds, Sunflower Seeds, Peanuts, Almonds & Cashews Net Wt. 6 oz (170 g)" Product of USA, China, India, Brazil and/or Vietnam. Packaged in plastic stand up resealable pouch. First three ingredients are raisins (raisins coated in vegetable oil (may contain one or more of the following: partially hydrogenated cottonseed/soybean, sunflower and/or canola oil), peanuts (peanuts, peanut oil, salt), pumpkin seeds (pumpkin seeds, vegetable oil may contain one or more of the following: cottonseed, soybean, peanut, canola, sunflower and/or safflower oil, salt). UPC 35826-06487. Recall # F-1464-9;

15) Trail Mix. Label reads: "ACME Trail Mix" and in smaller font "Made with Milk Chocolate M&M's Brand Chocolate Candies Net Wt 32 oz (2 lb) 907g" Product of USA, India, Brazil, and /or Vietnam. Packaged in plastic stand up resealable pouch. First three ingredients are peanuts (peanuts roasted in peanut oil, salt), raisins (raisins coated in partially hydrogenated cottonseed/soybean oil), M&M'S plain milk chocolate candies (milk chocolate [sugar, chocolate, cocoa butter, skim milk, milkfat, lactose, soy lecithin, salt, artificial flavors], sugar, cornstarch, less than 1% of: corn syrup, gum acacia, coloring (inlcudes red 40 lake, yellow 6, yellow 5, blue 2 lake, red 40, blue 1 lake, blue 1, blue 2, yellow 5 lake, yellow 6 lake), dextrin). UPC 75090-89808. Trail Mix. Label reads: "Albertsons Trail Mix" and in smaller font "Made with Milk Chocolate M&M's Brand Chocolate Candies Net Wt 32 oz (2 lb) 907g" Product of USA, India, Brazil, and /or Vietnam. Packaged in plastic stand up resealable pouch. Same ingredients as Acme, UPC 41163-42714 Trail Mix. Label reads:"Jewel Trail Mix" and in smaller font "Made with Milk Chocoate M&M's" Net Wt 32 oz (2 lb) 907g". Product of USA, India, Brazil, and /or Vietnam.  Packaged in plastic stand up resealable pouch. Same ingredients as Acme, UPC 41280-11174 Trail Mix. Label reads: "shaw's Trail Mix" and in smaller font "Made with Milk Chocolate M&M's Brand Chocolate Candies Net Wt 32 oz (2 lb) 907g" Product of USA, India, Brazil, and /or Vietnam. Packaged in plastic stand up resealable pouch. Same Ingredients as Acme, UPC 45674-50421. Recall # F-1465-9;

16) Trail Mix. Label reads: "ACME Fruit & Nut Mix Net Wt 32 oz (2 lb) 907g" and Product of USA, China, Philippines and Thailand. Packaged in plastic stand up resealable pouch. First three ingredients are dehydrated whole strawberries (strawberries, sugar, citric acid, sulfur dioxide, artificial flavor, red 40), dehydrated pineapple tidbits (pineapple, sugar, citric acid, sulfur dioxide, pineapple juice), raisins (raisins coated with partially hydrogenated soybean/cottonseed oil). UPC 75090-89809 Trail Mix. Label reads: "Albertsons Fruit & Nut Mix Net Wt 32 oz (2 lb) 907g" Product of USA, China, Philippines and Thailand. Packaged in plastic stand up resealable pouch. Same ingredients as Acme, UPC 41163-42715 Trail Mix. Label reads: "shaw's Fruit & Nut Mix Net Wt 32 oz (2 lb) 907g" Product of USA, China, Philippines and Thailand. Packaged in plastic stand up resealable pouch. Same ingredients as Acme brand, UPC 45674-50422. Recall # F-1466-9  
CODE
1) Best Before 01 02 08 N07002 ##:##, Best Before 08 23 08 N07235 ##:##, Best Before 08 29 08 N07241 ##:##, Best Before 09 25 08 N07268 ##:##, Best Before 09 26 08 N07269 ##:##, Best Before 10 03 08 N07276 ##:##, Best Before 02 28 09 N08059 ##:##, Best Before 10 09 09 N08283 ##:##, Best Before 10 15 09 N08289 ##:##, Best Before 12 04 09 N08339 ##:##, Best Before 12 15 09 N08350 ##:##;

2) Best Before 01 03 08 N07003 ##:##, Best Before 03 08 08 N07067 ##:##, Best Before 03 27 08 N07086 ##:##, Best Before 08 22 08 N07234 ##:##, Best Before 08 30 08 N07242 ##:##, Best Before 02 27 09 N08058 ##:##, Best Before 10 06 09 N08280 ##:##, Best Before 10 25 09 N08299 ##:##, Best Before 12 05 09 N08340 ##:##;

3) Best Before 08 17 08 N07229 ##:##, Best Before 10 05 08 N07278 ##:##, Best Before 10 02 09 N08276 ##:##, Best Before 10 13 09 N08287 ##:##, Best Before 12 08 09 N08343 ##:##;

4) Best By JAN 10 2008 N07010, Best By MAR 15 2008 N07074, Best By MAR 19 2008 N07078, Best By MAR 23 2008 N07082, Best By JUN 11 2008 N07162, Best By JUN 19 2008 N07170, Best By JUL 05 2008 N07186, Best By AUG 23 2008 N07235, Best By AUG 29 2008 N07241, Best By OCT 03 2008 N07276, Best By OCT 10 2008 N07283, Best By OCT 18 2008 N07291, Best By MAR 06 2009 N08066, Best By OCT 01 2009 N08275, Best By OCT 09 2009 N08283, Best By OCT 15 2009 N08289, Best By OCT 24 2009 N08298, Best By DEC 04 2009 N08339, Best By DEC 11 2009 N08346, Best By DEC 15 2009 N08350, Best By DEC 16 2009 N08351;

5)  Best By MAR 16 2008 N07075, Best By JUN 13 2008 N07164, Best By JUL 03 2008 N07184, Best By AUG 16 2008 N07228, Best By AUG 17 2008 N07229, Best By AUG 21 2008 N07233, Best By OCT 06 2008 N07279, Best By OCT 11 2008 N07284, Best By MAR 05 2009 N08065, Best By OCT 02 2009 N08276, Best By OCT 07 2009 N08281, Best By OCT 21 2009 N08295, Best By OCT 22 2009 N08296, Best By DEC 08 2009 N08343, Best By DEC 17 2009 N08352, Best By DEC 19 2009 N08354;

6) Best By JAN 02 2008 N07002, Best By JAN 11 2008 N07011, Best By MAR 09 2008 N07068, Best By MAR 26 2008 N07085, Best By JUN 06 2008 N07157, Best By JUN 12 2008 N07163, Best By JUL 06 2008 N07187, Best By AUG 08 2008 N07220, Best By OCT 13 2008 N07286, Best By OCT 08 2009 N08282, Best By OCT 20 2009 N08294;

7)  Best By JAN 03 2008 N07003, Best By MAR 08 2008 N07067, Best By MAR 27 2008 N07086, Best By JUN 07 2008 N07158, Best By JUN 08 2008 N07159, Best By AUG 14 2008 N07226, Best By AUG 22, 2008 N07234, Best By AUG 30 2008 N07242, Best By OCT 12 2008 N07285, Best By FEB 27 2009 N08058, Best By OCT 06 2009 N08280, Best By OCT 14 2009 N08288, Best By DEC 05 2009 N08340, Best By DEC 08 2009 N08343;

8) Best Before 03 07 08 N07066 ##:##, Best Before 08 13 08 N07225 ##:##, Best Before 10 18 08 N07291 ##:##, Best Before 03 06 09 N08066 ##:##, Best Before 10 24 09 N08298 ##:##, Best Before 12 09 09 N08344 ##:##, Best Before 12 16 09 N08351 ##:##;

9) Best Before 10 27 09 NO8301 ##:##, Best Before 12 08 09 NO8343 ##:##;

10) Bloom: Best Before 08 14 08 N07226 ##:##, Best Before 02 27 09 N08058 ##:##, Best Before 12 05 09 N08340 ##:##, Best Before 12 09 09 N08344 ##:## Food Lion: Best Before 08 14 08 N07226 ##:##, Best Before 02 27 09 N08058 ##:##, Best Before 10 06 09 N08280 ##:##, Best Before 10 14 09 N08288 ##:##, Best Before 12 05 09 N08340 ##:##;

11) Best Before 10 20 09 N08294 ##:##;

12) Best Before 03 07 08 N07066 ##:##, Best Before 06 11 08 N07162 ##:##, Best Before 07 05 08 N07186 ##:##, Best Before 08 13 08 N07225 ##:##, Best Before 10 03 08 N07276 ##:##, Best Before 12 04 09 N08339 ##:##, Best Before 12 09 09 N08344 ##:##, Best Before 12 16 09 N08351 ##:##;

13) Best Before 06 13 08 N07164 ##:##, Best Before 08 16 08 N07228 ##:##, Best Before 10 05 08 N07278 ##:##, Best Before 12 08 09 N08343 ##:##, Best Before 12 17 09 N08352 ##:##, Best Before 12 19 09 N08354 ##:##;

14) Best Before 03 09 08 N07068 ##:##, Best Before 06 12 08 N07163 ##:##, Best Before 07 06 08 N07187 ##:##, Best Before 08 08 08 N07220 ##:##, Best Before 12 18 09 N08353 ##:##;

15) ACME: Sell By 12 19 07 N07170 ##:##, Sell By 01 05 08 N07186 ##:##, Sell By 03 06 08 N07249 ##:##, Sell By 02 13 09 N07225. Albertson's: Sell By 07 09 07 N07009 ##:##, Sell By 07 10 07 N07010 ##:##,; Sell By 09 23 07 N07082 ##:##, ; Sell By 12 11 07 N07162 ##:##, Sell By 02 29 08 N07241 ##:##.Sell By 03 06 08 N07249 ##:##, Sell By 04 10 08 N07283 ##:##, Sell By 04 01 09 N08275 ##:##, Sell By 04 24 09 N08298 ##:##,Sell By 05 05 09 N08310 ##:##, Sell By 06 12 09 N08347 ##:## Jewel: Sell By 02 01 08 N07213 ##:##, Sell By 02 08 08 N07220 ##:##, Sell By 02 13 08 N07225 ##:## Shaw's: Sell By 07 10 07 N07010 ##:##, Sell By 12 19 07 N07170 ##:##, Sell By 12 29 07 N07180 ##:##, Sell By 04 10 08 N07283 ##:##, Sell By 08 28 08 N08059 ##:##, Sell By 04 09 09 N08283 ##:##, Sell By 05 05 09 N08310 ##:##;

16) Acme: Sell By 09 12 07 N07071 ##:##, Sell By 12 13 07 N07164 ##:##, Sell By 03 05 08 N07248 ##:##, Sell By 04 05 08 N07278 Albertson's: Sell By 07 09 07 N07009 ##:##, Sell By 09 12 07 N07071 ##:##, Sell By 12 13 07 N07164 ##:##, Sell By 03 05 08 N07248 ##:##, Sell By 04 05 08 N07278 ##:##, Sell By 09 05 08 N07065 ##:##, Sell By 04 17 09 N08291 ##:## Shaw's: Sell By 07 09 07 N07009 ##:##, Sell By 01 07 08 N07188 ##:##, Sell By 03 05 08 N07248 ##:##, Sell By 04 11 08 N07284 ##:##, Sell By 09 05 08 N07065 ##:##, Sell By 04 07 09 N08281 ##:##, Sell By 06 19 09 N08354 ##:##
RECALLING FIRM/MANUFACTURER
National Raisin, Co., Fowler, CA, by telephone, email, fax from beginning February 14, 2009 through February 17, 2009 and by press release on February 17, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using oil roasted/salted peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
63,138 cases (1,130,712 units)
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Mixed Nuts with Peanuts. Ing. Almonds, Brazils, Cashews, Filberts, Pecans, Walnuts, Peanuts, Salted. RSTD in Canola Oil. Total Net Wt 8 oz. Hialeah Products (954) 923-3379 Packed in a facility that processes peanuts. Dairy Products, soy products, wheat. UPC 796602-00177. Recall # F-1467-9;

2)  Salted Peanuts, 8 oz. bag, UPC 796602-00143; and 10-oz. tub, UPC 796602-00884.
Recall # F-1468-9;

3) No Salt Peanuts 8 oz bag and 10 oz tub UPC 796602-00309. Recall # F-1469-9;

4) Honey Roasted Peanuts 8 oz bag UPC 796602-00241, 10 oz Tub UPC 796602-00885. Recall # F-1470-9;

5) Hot & Spicy Peanuts, 8-oz. bag (UPC 796602-00146) and 10-oz. tub (UPC 796602-01040. Recall # F-1471-9;

6) Boca Bar Mix, 6 oz. bag (UPC796602-00243) and 8 oz. tub (UPC 796602-01048).  Recall # F-1472-9;

7) Cajun Hot Mix, 6 oz. bag (UPC 796602-00138) and 7 oz. tub (UPC 796602-01049). Recall # F-1473-9;

8) Governors Mix, 6 oz. bag (UPC896602-00644) and 11 oz. tub (UPC 796602-01051). Recall # F-1474-9;

9) Hot to Trot Mix, 6 oz. bag (UPC 796602-01029) and 6 oz. tub (UPC 796602-01154). Recall # F-1475-9;

10) Las Vegas Mix, 8 oz. bag and 8 oz. tub (UPC 796602-01753).
Recall # F-1476-9;

11)  Munchie Crunchie Mix, 8 oz. bag (UPC796602-00645) and 7 oz. tub (UPC 796602-01053). Recall # F-1477-9;

12) Nacho Cheddar Mix, 6 oz. bag (UPC 796602-00421) and 6 oz. tub (UPC 796602-01054). Recall # F-1478-9;

13) Oriental Treats, 6 oz. bag (UPC 796602-00132) and 7 oz. tub (UPC 796602-01056). Recall # F-1479-9;

14) Shock & Awe Mix, 8 oz. bag (UPC 796602-00140) and 8 oz. tub (UPC 796602-01547). Recall # F-1480-9;

15) Szechwan Mix, 6 oz bag (UPC 796602-01318) and 6 oz. tub (UPC 796602-01057). Recall # F-1481-9;

16) South Beach Mix, 8 oz. bag (UPC796602-01617) and 7 oz. tub (UPC 796602-01616). Recall # F-1482-9;

17) Hi Voltage Mix, 8 oz. bag (UPC 796602-00268) and 11 oz. tub (UPC 796602-01086). Recall # F-1483-9;

18) Celebration Mix, 8 oz. bag (UPC 796602-01273). Recall # F-1484-9;

19) Raisin Nut Mix, 8 oz. bag (UPC 796602-00257) and 11 oz. tub (UPC 796602-01091). Recall # F-1485-9;

20) Student Mix, 8 oz. bag (UPC 796602-00903). Recall # F-1486-9;

21) Sunflower Snack Mix, 8 oz. bag (UPC 796602-01925) and 9 oz. tub (UPC 796602-01924). Recall # F-1487-9;

22) Yogurt Trail Mix, 8 oz. bag (UPC 796602-01183) and 11 oz. tub (UPC 796602-01092). Recall # F-1488-9
CODE
Expiration date codes of 07-09 and earlier
RECALLING FIRM/MANUFACTURER
Hialeah Products Co., Hollywood, FL, by telephone on January 30, 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
50,400 lbs
DISTRIBUTION
Nationwide, Jamaica, West Indies, Barbados, and St. Lucia
___________________________________
PRODUCT 
1) Wilcoxson’s Nutty Royale Premium Sugar Cones. Product sold as: 1) Box of 6-2 ½ fl oz Sundae Cones, UPC 0 48154 00403 1; 2) Individual 2 ½ fl oz Sundae Cone, wrapped in paper. UPC 0 48154 00413 0. Recall # F-1489-9;

2) Wilcoxson’s Tin Roof Sundae, 3 gallon bulk container with the firms logo printed on the container. Recall # 1490-9
CODE
1) None;

2) Code 3207 and 2508 (first two numbers indicate week of the year produced, last two numbers indicate the year. 32 = 32nd week; 07 = 2007)
RECALLING FIRM/MANUFACTURER
Wilcoxson's Ice Cream Co, Inc., Livingston, MT, by press release and letter on March 19, 2009 and by telephone and visits on May 9, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because they have potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
39,303 units
DISTRIBUTION
MT, WA and WY
___________________________________
PRODUCT 
CVP Consumer Value Products Burnt Peanuts, Net Wt 5.25 oz (149g), UPC 7 61706 14007 9. Recall # F-1491-9
CODE
Best Buy of August 1, 2007 through October 31, 2009, Lot numbers 0017 through 0319
RECALLING FIRM/MANUFACTURER
Recalling Firm: Franklin Connections LP, El Paso, TX, by e-mail and letter dated February 2, 2009.
Manufacturer: Primrose Candy Co., Chicago, IL. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because they have potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
88,715 lbs
DISTRIBUTION
TX
___________________________________
PRODUCT 
1) Tiora Products Cappuccino Topping, Net Wt 22 lbs, 20/1.1 lb bags, UPC 859626001683 and 718122412686. Recall # 1492-9;

2) J Traders Cappuccino Topping, 6/2 lb bags, Item numbers: 20063 and 407484, UPC 859626001072. Recall # F-1493-9;

 3) CBC Cappuccino Toping, 12/1 lb bags, Item number: 10137, UPC 718122414888. The product is packaged in a white plastic film which is then packaged into a cardboard box. Recall # F-1494-9
CODE
No code
RECALLING FIRM/MANUFACTURER
Custom Beverage Concepts, Inc., Tallapoosa, GA, by letter on/about June 29, 2009 and July 16, 2009. Firm initiated recall is ongoing.
REASON
Products were manufactured using an ingredient recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
23,509 cases
DISTRIBUTION
FL, GA, KY, MD, VA, WI and PR
___________________________________
PRODUCT 
Curry Spice Powder in 3.5 oz plastic container with a red plastic lid. Product of Vietnam. UPC 9 8751231986 1. Recall # F-1495-9
CODE
Exp. date: 01/31/2010
RECALLING FIRM/MANUFACTURER
TV Food, LLC, San Leandro, CA, by visit on April 20, 2009. Firm initiated recall is complete.
REASON
Product may be contaminated with salmonella.
VOLUME OF PRODUCT IN COMMERCE
13 cartons (624 jars)
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) English Toffee Cappuccino Mix; packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0001, packaged under the following labels: a) Consumers Choice Gourmet Cappuccino, English Toffee, item 16590, UPC 64596 16590; b) Decadent Cappuccino English Toffee Cappuccino Mix, item 2835, UPC 100 64596 02835 7; c) Ronnoco English Toffee Cappuccino, item 00402101A, UPC 0 00 40515 90013 6; d) Royal Cup Coffee English Toffee Cappuccino, item RC #8929, UPC 1 00 74849 08929 5; e) Torke English Toffee Cappuccino, item 2256, f) Trescerro English Toffee Cappuccino, item 14623, UPC 60822486146230. Recall # F-1496-9;
 
2) Amaretto Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0006, packaged under the following labels: a) AM/PM Wild Bean Amaretto Cappuccino, item 07110, UPC 100 64596 07110 0; b) Decadent Cappuccino Almond Amaretto Cappuccino Mix, item 2842, UPC 100 64596 02842 5; c) Ronnoco Cherry Almond Cappuccino, item 00403801A, UPC 0 00 40515 90001 3; d) Royal Cup Coffee Almond Amaretto Cappuccino, item RC #8923, UPC 1 00 74849 08923 3; e) Torke Almond Amaretto Cappuccino, item 2254. Recall # F-1497-9;

3) Fat Free French Vanilla Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0007, packaged under the following labels: a) Consumers Choice Gourmet Cappuccino, Fat Free French Vanilla, item 16580, UPC 64596 16580; b) Decadent Cappuccino Fat Free French Vanilla Cappuccino Mix, item 2840, UPC 100 64596 02840 1; c) Trescerro Fat Free French Vanilla Cappuccino, item 14621, UPC 60822486146216. Recall # F-1498-9;

4) Original Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0010, packaged under the following labels: AaDecadent Cappuccino Original Cappuccino Mix, item 2848, UPC 100 64596 02848 7; b) Royal Cup Coffee Original Cappuccino, item RC #8926, UPC 1 00 74849 08926 4. Recall # F-1499-9;

5) Spicy Chai Tea Latte Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0015, packaged under the following labels: a) Decadent Cappuccino Chai Tea Latte, item 2901, UPC 100 64596 02901 9; b) Ronnoco Spicy Chai, item 00051, UPC 0 00 40515 4001. Recall # F-1500-9;

6) Vanilla Latte Frappe Mix, packaged in 1.75 lb plastic pouches/12 pouches per case, net wt. 21 lbs; B0023, UPC 0 02796 61001 2. Recall # F-1501-9;  

7) Ice Storm Beverage Mix (original frappe), trans fat free, packaged in 1.75 lb plastic pouches/12 pouches per case, net wt. 21 lbs; B0024; item 1625, UPC 0 64596 01625 8. Recall # F-1502-9;

8) Vanilla Frappe Mix, packaged in 1.75 lb plastic pouches/12 pouches per case, net wt. 21 lbs; B0026, packaged under the following labels: a) Vanilla Frappe Mix, UPC 0 02796 61001 2, b) Vanilla Ice Storm Beverage Mix, trans fat free, item 1640, UPC 0 64596 01525 1. Recall # F-1503-9;

9) Dunkin' Donuts Dunkaccino, cappuccino mix, packaged in 2 lb plastic pouches/12 pouches per case, net wt. 24 lbs; B0027, 27, item 0213, UPC 1 00 64596 00213 5. Recall # F-1504-9;

10) Dunkin' Donuts Hot Cocoa Mix, packaged in 2 lb plastic pouches/12 pouches per case, net wt. 24 lbs; B0028; item 0604, UPC 1 00 64596 00604 1. Recall # F-1505-9;

11) White Chocolate Hot Chocolate Mix, B0031, packaged under the following sizes and labels: a) Amanti Gourmet Coffee White Chocolate Hot Chocolate Beverage Mix, item T92WC, packaged in 2 lb plastic pouches/12 pouches per case, net wt. 24 lbs; b) BJ'S Swiss White Chocolate Hot Cocoa Mix, item B31, packaged in 12 oz. plastic pouches/32 pouches per case, net wt. 24 lbs; c) Costco Swiss White Chocolate Hot Cocoa Mix, item NW, packaged in 16 oz. plastic pouches/26 pouches per case, net wt. 26 lbs; d) Ronnoco White Chocolate Hot Chocolate, item 09000, UPC 0 00 40515 80002 0. Recall # F-1506-9;

12) McDonald's French Vanilla Cappuccino, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0033, item 00431-009, WSI:11953; UPC (00) 0 0411953 000431009 6. Recall # F-1507-9;

13)  McDonald's Creamy Hot Chocolate, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0034, item 00829-000, WSI:11953; UPC (00) 0 0411953 00829000 4. Recall # F-1508-9;  

14)  McDonald's Original Cappuccino, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0035, item 00594-003, WSI:11953; UPC (00) 0 0411953 00594003 2. Recall # F-1509-9;

15) Swiss Mocha Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0036, packaged under the following labels: a) Decadent Cappuccino Swiss Mocha Cappuccino Mix, item 10429, UPC 100 64596 02103 0; b) McDonald's Swiss Mocha Cappuccino, item 00429-009, WSI:19245; UPC (00) 0 041245 000429009 5; c) Royal Cup Coffee Swiss Mocha Cappuccino, item RC #8927, UPC 1 00 74849 08927 1; d) Torke Swiss Mocha Cappuccino, item 2257. Recall # F-1510-9;

16) McDonald's French Vanilla Blend Cappuccino, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0038, item 00431-012 and 00431-030, WSI:19245; UPC (00) 0 0419245 000431012 0 and UPC (00) 0 0419245 000431030 0. Recall # F-1511-9;
 
17) S'Mores Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0040, packaged under the following labels: a) Decadent Cappuccino S'Mores Cappuccino Mix, item 2838, UPC 100 64596 02838 8; b) Premium Gold S'Mores Cappuccino, item 15446, UPC 1 07 28225 15446 5. Recall # F-1512-9;

18)  Madagascar French Vanilla Cappuccino Mix, packaged in 1 lb plastic pouches/26 pouches per case, net wt. 26 lbs; B0043; item Montreaux. Recall # F-1513-9;

19) Hazelnut Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0048, packaged under the following labels: a) AM/PM Wild Bean Hazelnut Cappuccino, item 07107, UPC 100 64596 07107 0; b) Decadent Cappuccino Hazelnut Cappuccino Mix, item 21002, UPC 100 64596 02102 3; c) McDonald's Hazelnut Cappuccino, item 04735-006; d) Royal Cup Coffee Hazelnut Cappuccino, item RC #8925, UPC 1 00 74849 08925 7. Recall # F-1514-9;
I
20) Mocha Mint Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0055, packaged under the following labels: a) Decadent Cappuccino Chocolate Mint Cappuccino Mix, item 21883, UPC 100 64596 02183 2; B) Decadent Cappuccino Mocha Mint Cappuccino Mix, item 09113, UPC 100 64596 60911 5; c) Premium Gold Chocolate Candy Cane Cappuccino, item 800691, UPC 1 07 28225 00965 9; d) Torke Mocha Mint Cappuccino, item 1246. Recall # F-1515-9;

21) Decadent Oatmeal Cookie Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0056; item 02113, UPC 100 64596 02113 5. Recall # F-1516-9;

22) Milk Chocolate Mix, B0086; packaged under the following labels: a) BJ's Belgian Milk Chocolate Hot Cocoa Mix, item B87, packaged in 16 oz. plastic pouches/26 pouches per case, net wt. 26 lbs; b) Costco Belgian Milk Chocolate Hot Cocoa Mix, item NW, packaged in 16 oz. plastic pouches/26 pouches per case, net wt. 26 lbs; c) Ronnoco Milk Chocolate Hot Chocolate, item 80001, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; UPC 0 00 40515 80001 3. Recall # F-1517-9;

23) Hot Chocolate Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0089; packaged under the following labels: a) Consumers Choice Gourmet Hot Chocolate, item 23070, UPC 64596 23070; b) Decadent Supreme Hot Chocolate, item 3701, UPC 100 64596 03701 4. Recall # F-1518-9;

24) Dunkin' Donuts White Chocolate Mix, packaged in 2 lb plastic pouches/12 pouches per case, net wt. 24 lbs; B0092, item 1137, UPC 1 00 64596 01137 3. Recall # F-1519-9;

25) Madagascar French Vanilla Chocolate mix with inclusions, packaged in 50 lb. bulk boxes, B0098, item B313WIP. Recall #F-1520-9;

26) Fat Free French Vanilla Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0103, packaged under the following labels: a) Royal Cup Coffee Non Fat French Vanilla Cappuccino, item RC #8928, UPC 1 00 74849 08928 8; b) Ronnoco Non Fat French Vanilla Cappuccino, item 00600501A, UPC 0 00 40515 90014 3; c) Torke No Fat French Vanilla Cappuccino, item 2249. Recall # F-1521-9;

27) Cinnamon Bun Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0108, packaged under the following labels: a) Decadent Cinnamon Bun Cappuccino, item 2841, UPC 100 64596 02841 8; b) Ronnoco Cinnamon Roll Cappuccino, item 004404301A, UPC 0 00 40515 90011 2; c) Royal Cup Coffee Cinnamon Bun Cappuccino, item RC #8960, UPC 1 00 74849 08960 8; Recall # F-1522-9;

28) S'Mores Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0109, packaged under the following labels: a) AM/PM Wild Bean S'Mores Cappuccino, item 07117, UPC 100 64596 07117 9; b) Royal Cup Coffee S'Mores Cappuccino, item RC #8947, UPC 1 00 74849 08947 9. Recall # F-1523-9;
 
29) Caramel Steamer Supreme, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0112, UPC 00040556030. Recall # F-1524-9;
 
30) Strawberry Steamer Supreme, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0113, UPC 000405156030. Recall # F-1525-9;
 
31) AM/PM Wild Bean Fat Free French Vanilla Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0117, item 07102, UPC 100 64596 07102 5. Recall # # F-1526-9;
 
32) Consumers Choice Gourmet Cappuccino, High Caffeine French Vanilla Cappuccino Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0118, item 16250, UPC 64596 16250. Recall # F-1527-9;

33)AM/PM Wild Bean Latte Steamer Milk Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0123, item 07201, UPC 100 64596 07201 5. Recall # F-1528-9;

34) AM/PM Wild Bean Hot Chocolate Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0124, item 07301, UPC 100 64596 07301 2. Recall # F-1529-9;
 
35) Pumpkin Spice Cappuccino Mix; packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0126, packaged under the following labels: a) AM/PM Wild Bean Pumpkin Spice Cappuccino, item 07113, UPC 100 64596 07113 1; b) Consumers Choice Gourmet Cappuccino, Pumpkin Spice, item 15520, UPC 64596 15520; c) Decadent Cappuccino Pumpkin Spice Cappuccino Mix, item 2837, UPC 100 64596 02837 1; d) Ronnoco Pumpkin Spice Cappuccino, item 00402301A, UPC 0 00 40515 90023 5; e) Supreme Cappuccino, Pumpkin Spice, item 15520; f) Torke Pumpkin Spice Cappuccino, item 1248. Recall # F-1530-9;

36) Royal Dowry Chocolates Caramel Crunch Hot Chocolate Mix, packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0127, Item 19581, UPC 1 07 28225 00963 5. Recall # F-1531-9;

37) Torke Banana Nut Cappuccino Mix; packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0130, Item 0530. Recall # F-1532-9;

38) Dunkin' Donuts Milky Way Hot Cocoa Mix, packaged in 2 lb plastic pouches/12 pouches per case, net wt. 24 lbs; B0131, Item 0239, UPC 1 00 64596 00239 5. Recall # F-1533-9;

39) Irish Creme Cappuccino Mix; packaged in 2 lb plastic pouches/6 pouches per case, net wt. 12 lbs; B0009, packaged under the following labels: a) Decadent Cappuccino Irish Creme Cappuccino Mix, Item 21004, UPC 0 64596 02100 9; b) Torke English Toffee Cappuccino, item 2251; c) Trescerro English Toffee Cappuccino, item 14622, UPC 60822486146223. Recall #F-1534-9
CODE
1) a) and c) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009; b) and f) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010; d) and e) All product with a Julian date code prior to 1769 or 17609;

2) a), d) and e) All product with a Julian date code prior to 1769 or 17609; b) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010; c) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009;

3) a) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009; b) and c) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010;

4) a) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010; b) All product with a Julian date code prior to 1769 or 17609;

5) a) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010; b) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009;

6) and 7) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010;

8) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010;

9) Use By dates prior to June 25, 2010;

10) Use By dates prior to June 25, 2010;

11) a) Use By dates prior to June 25, 2010; b), c), and d) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009;

12) Use Thru dates prior to June 25, 2010;

13) Use Thru dates prior to June 25, 2010;

14) Use Thru dates prior to June 25, 2010;

15) a) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010; b) Use Thru dates prior to June 25, 2010; c) and d) All product with a Julian date code prior to 1769 or 17609;

16) Use Thru dates prior to June 25, 2010;

17) a) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010; b) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009;

18) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009;

19)  a) All product with a Julian date code prior to 1769 or 17609; b) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010; c) Use Thru dates prior to June 25, 2010; d) All product with a Julian date code prior to 1769 or 17609;

20) a) and b) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010; c) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009; d) All product with a Julian date code prior to 1769 or 17609;

21) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010;

22) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009;

23) a)All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009; b) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010;

24) Use by Dates prior to June 25, 2010;

25) Julian dates prior to 3068;

26) a) and c) All product with a Julian date code prior to 1769 or 17609; b) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009;

27) a) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010; b) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009; c) All product with a Julian date code prior to 1769 or 17609;

28) AM/PM Wild Bean and Royal Cup labels: All product with a Julian date code prior to 1769 or 17609;

29) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009;

30) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009;

31) All product with a Julian date code prior to 1769 or 17609;

32) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009;

33) All product with a Julian date code prior to 1769 or 17609;

34) All product with a Julian date code prior to 1769 or 17609;

35) Consumers Choice, Ronnoco and Supreme labels: All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009; Decadent label: All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010; AM/PM Wild Bean and Torke labels: All product with a Julian date code prior to 1769 or 17609;

36) All product with a Julian date code prior to 1769 or 17609, or a Made on Date prior to June 25, 2009;

37) All product with a Julian date code prior to 1769 or 17609;

38) Use By dates prior to June 25, 2010;

39)a) and b) All product with a Julian date code prior to 1769 or 17609, or a Use by Date prior to June 25, 2010; c) All product with a Julian date code prior to 1769 or 17609
RECALLING FIRM/MANUFACTURER
America’s Food Technologies, Inc., Tinley Park, IL, by e-mail on June 27, 2009 and follow-up letters dated June 30, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using instant non-fat dry milk being recalled by Plainview Milk Products Cooperative because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
975,817 cases
DISTRIBUTION
Nationwide and Australia
___________________________________
PRODUCT 
Valley Foods Emergency Shelf Stable Meal Kits, unit size approximately 2.3 lbs, cardboard heat-sealed, or plastic containers shipped in cases. Each case (size 23 x 191/2 x 83/4 or 22 x 21 x 9 3/4) contains 16 meal kits (size 8.5 x 9 3/4 or 8 inch hinged trays). Each meal kit includes one (1) individually packed 2 oz. packet of Famous Amos Peanut Butter Cookies. Recall # F-1535-9
CODE
The cases are identified with a Use by date of: 6/10/09, or 6/11/09. The Famous Amos Peanut Butter Cookie is identified with the code: BC02269B. The individual meal kits are not marked with a use by date.
RECALLING FIRM/MANUFACTURER
Valley Foods Inc., Youngstown, OH, by telephone and E-mail on January 15, 2009. Firm initiated recall is ongoing.
REASON
The recalling firm manufactured and distributed shelf stable meal kits which contain a cookie component. The cookies were manufactured using peanuts which were produced by Peanut Corporation of America (PCA) in Blakely, GA. Peanuts and peanut products produced by PCA have been implicated in an outbreak of salmonellosis and these products may be contaminated with Salmonella Typhimurium.
VOLUME OF PRODUCT IN COMMERCE
4,224 cases
DISTRIBUTION
PA, TN
___________________________________
PRODUCT 
Health Valley Organic Peanut Crunch Chewy Granola Bars, 6 - 1 oz individually wrapped bars per carton (6.1oz, 172g), UPC 035742154834. Recall # F-1536-9
CODE
Lot Codes 13JUN09, 14JUN09, 28JUL09
RECALLING FIRM/MANUFACTURER
Lovin Oven, LLC, Azusa, CA, by e-mail dated January 19, 2009 and press release on January 21, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Lot 13JUN09 - 2058 cases, Lot 14JUN09 - 464 cases, Lot 28JUL09 - 223.5 cases
DISTRIBUTION
Nationwide and Hong Kong, Thailand, Jordan, Philippines
___________________________________
PRODUCT 
1) Peanuts, Roasted Salted (Plastic Cup),10 oz UPC 65585200090 Peanuts, Roasted Salted , Bulk No UPC Peanuts, Roasted Salted (Mini Cup), 3 oz No UPC Labeled under: Aurora Products, Inc. Private Labels: Adams Fairacres Belmont Market C-Town Country Market Ernest Klein and Co International Supermarket Gourmet Garage Grauls Green Hills Market Harvest CO-OP Market High Land Park, Hurley Ridge Jubilee Marketplace Wild By Nature McCaffreys Quality Makes the Difference McQuades Marketplace Morton Williams Supermarkets Palmers Market Roberts Union Market Wild By Nature. Recall # F-1537-9;

2)  Peanuts, Roasted Un Salted (Plastic Cup),10 oz UPC 65585200088 Labeled under: Aurora Products, Inc. Private Labels: Adams Fairacres Belmont Market C-Town Country Market Ernest Klein and Co International Supermarket Gourmet Garage Grauls Green Hills Market Harvest CO-OP Market High Land Park, Hurley Ridge Jubilee Marketplace Wild By Nature McCaffreys Quality Makes the Difference McQuades Marketplace Morton Williams Supermarkets Palmers Market Roberts Union Market Wild By Nature Peanuts, Roasted Un Salted Bulk No UPC. Recall # F-1538-9;

3) Mixed Nuts Salted (Mini Cup) 4.5 oz No UPC Mixed Nuts Salted (Mini Cup), 5 oz Mixed Nuts, Salted, (Pouch) , 5oz UPC 65585200252 Mixed Nuts Salted (Plastic Cup), 9 oz UPC 65585200084 Mixed Nuts Salted- Family Tub, 20 oz UPC 65585200340 Mixed Nuts Salted , Bulk No UPC Labeled under: Aurora Products, Inc. Private Labels: Adams Fairacres Belmont Market Bethel Market Boiceville Market Caraluzzis Old World Market C-Town Country Market Ernest Klein and Co International Supermarket Food Emporium/ Food 2 Go Gourmet Garage Grauls Green Hills Market Harvest CO-OP Market High Land Park, Hurley Ridge Jubilee Marketplace Kings Naturals Lees Miles McCaffreys Quality Makes the Difference McQuades Marketplace Morton Williams Supermarkets Palmers Market Rice Epicurean Markets Roberts Water Stewart Market Whole Foods Wild By Nature Windfall Market. Recall # F-1539-9;

4) Mixed Nuts Un Salted (Plastic Cup) 9 oz UPC 65585200243 Mixed Nuts Un Salted, Bulk No UPC Labeled under: Aurora Products, Inc. Private Labels: Adams Fairacres Belmont Market Bethel Market Boiceville Market Caraluzzis Old World Market C-Town Country Market Ernest Klein and Co International Supermarket Food Emporium/ Food 2 Go Gourmet Garage Grauls Green Hills Market Harvest CO-OP Market High Land Park, Hurley Ridge Jubilee Marketplace McCaffreys Quality Makes the Difference McQuades Marketplace Morton Williams Supermarkets Palmers Market Water Stewart Market Wild By Nature Windfall Market. Recall # F-1540-9;

5) Cranberry Health Trail Mix (Mini Cup), 3 oz No UPC Cranberry Health Trail Mix (Pouch) 4.5oz UPC 65585200206 Cranberry Health Trail Mix (Plastic Cup) 9.25 oz UPC 65585200288 Cranberry Health Trail Mix- (Family Tub) 21 oz UPC 65585200585 Cranberry Health Trail Mix, Bulk No UPC Labeled under: Aurora Products, Inc. Private labels: Adams Fairacres Belmont Market Bethel Market Boiceville Market Caraluzzis Old World Market C-Town Country Market Ernest Klein and Co International Supermarket Food Emporium/ Food 2 Go Gourmet Garage Grauls Green Hills Market High Land Park, Hurley Ridge Jubilee Marketplace Lees Miles McCaffreys Quality Makes the Difference McQuades Marketplace Morton Williams Supermarkets Natures basket Palmers Market Rice Epicurean Markets Roberts Water Stewart Mark Wild By Nature Windfall Market Zabars. Recall # F-1541-9;

6) Hikers Trail Mix (Plastic Cup) 9.5 oz UPC 65585200150 Hikers Trail Mix (Plastic Cup) Bulk No UPC Labeled under: Aurora Products, Inc. Private Labels: Adams Fairacres Belmont Market Bethel Market Boiceville Market Caraluzzis Old World Market C-Town Country Market Ernest Klein and Co International Supermarket Grauls Green Hills Market Harvest CO-OP Market High Land Park, Hurley Ridge Jubilee Marketplace Lees Miles McCaffreys Quality Makes the Difference McQuades Marketplace Morton Williams Supermarkets Palmers Market Roberts Water Stewart Market Wild By Nature Windfall Market. Recall # F-1542-9;

7) Cranberry Honey Nut with Soy (Mini Cup) 3 oz UPC 65585200538 Cranberry Honey Nut with Soy (Plastic Cup) 9.5 oz UPC 65585200395 Cranberry Honey Nut with Soy Bulk No UPC Labeled under: Aurora Products, Inc. Private Labels: Adams Fairacres Belmont Market Bethel Market Boiceville Market Caraluzzis Old World Market C-Town Country Market Ernest Klein and Co International Supermarket Grauls Green Hills Market Harvest CO-OP Market High Land Park, Hurley Ridge Jubilee Marketplace Lees Miles McCaffreys Quality Makes the Difference McQuades Marketplace Morton Williams Supermarkets Omni Foods Supermarkets Palmers Market Rice Epicurean Markets Roberts Stews Union Market Water Stewart Market Windfall Market. Recall # F-1543-9;

8) Berry Nutty Trail Mix (Plastic Cup) 10 oz UPC 65585200161 Labeled under: Aurora Products, Inc. Private label: Adams Fairacres Belmont Market Bethel Market Boiceville Market Caraluzzis Old World Market C-Town Country Market Green Hills Market Harvest CO-OP Market High Land Park, Hurley Ridge Jubilee Marketplace Lees Miles McCaffreys Quality Makes the Difference McQuades Marketplace Morton Williams Supermarkets Palmers Market Roberts Water Stewart Market. Recall # F-1544-9;

9) Raisin Nut Party Trail Mix (Plastic Cup) 11 oz UPC 65585200094 Raisin Nut Party Trail Mix Bulk No UPC Labeled under: Aurora Products, Inc. Private Label: Bethel Market Boiceville Market Caraluzzis Old World Market C-Town Country Market Ernest Klein and Co International Supermarket Gourmet Garage Grauls Green Hills Market Harvest CO-OP Market High Land Park, Hurley Ridge Jubilee Marketplace McCaffreys Quality Makes the Difference McQuades Marketplace Palmers Market Roberts. Recall # F-1545-9;

10) Caribbean Crunch Grail Mix (Plastic Cup) 17.5 oz UPC 65585200474 Caribbean Crunch Grail Mix , Bulk Labeled under: Aurora Products, Inc. Private Labels: Adams Fairacres Boiceville Market Grauls Green Hills Market Harvest CO-OP Market High Land Park, Hurley Ridge Lees Miles McCaffreys Quality Makes the Difference McQuades Marketplace Morton Williams Supermarkets Palmers Market Rice Epicurean Markets Roberts Water Stewart Market Whole Foods Wild By Nature Windfall Market. Recall # F-1546-9;

11) Organic Peanuts, Raw (Plastic Cup) 10 oz 65585200445 Labeled under: Aurora Products, Inc. Private Label: Belmont Market Bethel Market Caraluzzis Old World Market Ernest Klein and Co International Supermarket Harvest CO-OP Market High Land Park, Hurley Ridge McCaffreys Quality Makes the Difference McQuades Marketplace Morton Williams Supermarkets Palmers Market Whole Foods Wild By Nature Windfall Market. Recall # F-1547-9;

12) Organic Roasted Salted Peanuts (Plastic Cup) 10 oz UPC 65585200446 Labeled under: Aurora Products, Inc. Private Label: Boiceville Market McCaffreys Quality Makes the Difference McQuades Marketplace Morton Williams Supermarkets Gourmet Garage Grauls Green Hills Market Palmers Market Water Stewart Market Whole Foods Wild By Nature Windfall Market. Recall # F-1548-9;

13) Organic Roasted Unsalted Peanuts (Plastic Cup) 10 oz Labeled under: Aurora Products, Inc. Private Label: Caraluzzis Old World Market Ernest Klein and Co International Supermarket Gourmet Garage Grauls Green Hills Market Harvest CO-OP Market High Land Park, Hurley Ridge Jubilee Marketplace McQuades Marketplace Water Stewart Market Whole Foods Wild By Nature Windfall Market. Recall # F-1549-9
CODE
1) thru 10) Best If Used By Date Code: 10/1/2007 to 10/28/09;
11) thru 13) Best If Used By Date Code: 1/01/2007 to 4/02/09
RECALLING FIRM/MANUFACTURER
Aurora Products, Inc., Stratford, CT, by  
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
105,779 cases
DISTRIBUTION
Nationwide and Bermuda
___________________________________
PRODUCT 
1) Seasoned peanuts. Label reads (in part): "Candies Tolteca Co. Mexican Candy $1.29 CACAHUATE C/CHILE AHORA CON MAS..! Ponle Sabor a Tu Vida Net Wt. 4 oz. (113.2 g.) First three ingredients are: Peanuts, Peanut Oil, Salt. Packaged in clear cellophane bag with cardboard label. UPC code: 7 04927 50518 0. Ambient storage. Recall # F-1550-9;

2) Seasoned peanuts, Salt and Lemon Flavor. Label reads (in part): "Candies Tolteca Co. Mexican Candy $1.29 CACAHUATE C/SAL Y LIMON AHORA CON MAS..! Ponle Sabor a Tu Vida Net Wt. 4 oz. (113.2 g.) Packaged & First three ingredients are: Peanuts, Peanut Oil, Salt. Packaged in clear cellophane bag with cardboard label. UPC code: 7 04927 50517 3. Ambient storage. Recall # F-1551-9;

3) Seasoned peanuts, Chile Flavor. Label reads (in part): "Candies Tolteca Co. Mexican Candy $1.99 CACAHUATE CON CHILE Ponle Sabor a Tu Vida Net Wt. 7 oz. (198.1 g.)” First three ingredients are: Peanuts, wheat flour, sugar. Packaged in clear cellophane bag with cardboard label. UPC code: 7 04927 50525 8. Ambient storage. Recall # F-1552-9
CODE
No code
RECALLING FIRM/MANUFACTURER
Candies Tolteca, Fresno, CA, by telephone, e-mail and letters on or about February 24, 2009 and by press release on March 31, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using peanuts recalled by Peanut Corporation of America because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
494,400 units
DISTRIBUTION
CA, NV
___________________________________
PRODUCT 
Peanut Meal, Net Wt 8 oz, UPC 8 17855 64240 4 – Ingredients: U.S. NO. 1 Fancy Peanuts. Recall # F-1553-9    
CODE
No code
RECALLING FIRM/MANUFACTURER
Maeco Foods, INC., College Point, NY, by visit and telephone during March 6 – March 10, 2009 and by press release on March 31, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
NY City
___________________________________
PRODUCT 
1) Kroger & Private Selections Peanut Butter Cookies - Regular, Jumbo, Decorated, Iced, Gourmet, Mini and Sandwich cookies UPC 0001111007562, 0001111007263, 0004157358393, 0001111005409, 0001111018904, 0001111007519, 0001111007539, 0001111007504, 0001111007515, 0001111018840, 0001111005441, 0001111005485, 0001111005462, 0001111005484, and 0001111007343. Recall # F-1554-9;

2) Private Selection Peanut Chocolate Chunk Cookies UPC Codes 0001111007184, 0001111007095, 0004157358547, & 0004157359576. Recall # F-1555-9;

3) Private Selection Chocolate Trio Single-Layer and Double Layer Iced Cakes UPC Codes: Chocolate Trio Single Layer Cakes 0001111007956, 0001111007559, 0001111019385; Chocolate Trio Double Layer Cakes 0001111007561, 000111007826, 0001111007183, 0001111007184, 000111101985, & 0004157358845. Recall # F-1556-9;

4) Country Oven Peanut Butter Regular Cookie Dough 17.72 lbs in a plastic lined cardboard box UPC 0001111019930. Recall # F-1557-9;

5) Country Oven Peanut Butter Jumbo Cookie Dough 18.38 lbs in a plastic lined brown cardboard box UPC 0001111019982. Recall # F-1558-9;

6) Private Selection Peanut Chocolate Chunk Cookie Dough 18.37 lbs in a plastic lined brown cardboard box, UPC 0001111020006. Recall # F-1559-9
CODE
1) All codes;
2) All codes;
3), 4) and 5) Use by 4/14/09 and earlier;
6) Use By 7/14/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger Co., Cincinnati, OH, by press release and e-mail on January 31, 2009.
Manufacturer: Country Oven Bakery, Bowling Green, KY. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut products recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
386,860 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
6" Chocolate Peanut Butter Creme Cake. Label reads: "JUST DESSERTS Chocolate Peanut Creme THREE LAYER CAKE...Net Wt 27 oz (1.69 lbs) (765.4g). Packaged in plastic dome and base. Label consists of a sticker on the dome. Four units per case. First three ingredients are: sugar, unbleached flour (wheat flour, malted barley flour, niacin, iron, thiamin mononitrate, riboflavin, folic acid), water. UPC 13609-01518. Recall # F-1560-09
CODE
UPC code only
RECALLING FIRM/MANUFACTURER
New Desserts, Inc., Oakland, CA, by e-mail, letters and press release on March 2, 2009. Firm initiated recall is ongoing.
REASON
The product was manufactured using peanut butter recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
18,443 units
DISTRIBUTION
CA, OR, WA, CO, TN, NH, CT, IN, GA, FL

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS III

___________________________________
PRODUCT 
Drinking Water, in 1 gallon, UPC #7203636062, and 2.5 gallon UPC #7203636061 plastic bottles sold under the Harris Teeter brand name and Drinking Water in 1 gallon plastic bottles UPC #3582600576 sold under the Food Lion brand name. Recall # F-1565-9
CODE
Both brands – Lot number: PL3746, 05/04/11
RECALLING FIRM/MANUFACTURER
Alamance Foods, Inc., Burlington, NC, by telephone and e-mail on May 19, 2009. Firm initiated recall is ongoing.
REASON
Laboratory testing revealed a high total microbial plate count.
VOLUME OF PRODUCT IN COMMERCE
8,785 cases (3/1 gallon bottles per case and 2/2.5 gallon bottles per case)
DISTRIBUTION
NC

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Cyclosporine Capsules USP, 100 mg, 30 Capsules Rx Only, APOTEX CORP., NDC 60505-0134-0. Recall # D-011-2010
CODE
Lot HM4156
RECALLING FIRM/MANUFACTURER
Apotex Inc., Etobicoke Ontario, Canada, by letter on or about June 1, 2009. Firm initiated recall is ongoing.
REASON
Exceeds Impurity Specification; for unknown related compounds 12 month stability.
VOLUME OF PRODUCT IN COMMERCE
19,794
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Fexofenadine Hydrochloride Tablets, 180 mg, 500 count bottle, Rx only, NDC 55111-194-05. Recall # D-013-2010;

2) Pravastatin Sodium Tablets USP, 10 mg, 90 count bottles, NDC 55111-229-90, 500 count bottles, NDC 55111-229-05, Rx only. Recall # D-014-2010;

3) Risperidone Tablets USP, 0.25 mg, 500 count bottles, Rx only, NDC 55111-201-05. Recall # D-015-2010;

4) Citalopram Tablets USP, 40 mg, 100 count bottles, Rx only, NDC 55111-344-01. Recall # D-016-2010
CODE
1) Lot # C90833, Exp 03/11;
2) Lot # C92476, Exp 09/10;
3) Lot # C92847, Exp 04/11;
4) Lot # C90995, Exp 01/12
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Dr Reddy'S Laboratories Inc., Bridgewater, NJ, by letters on October 2, 2009.
Manufacturer: Dr. Reddy's Laboratories Ltd., Andhra Pradesh, India. Firm initiated recall is ongoing.
REASON
Superpotent (Single Ingredient) Drug, Tablet Thickness: Firm received complaints of double-sized tablets.
VOLUME OF PRODUCT IN COMMERCE
23,735 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
Claritin, (loratadine) Tablets 10 mg/ Antihistamine, 5 tablets per package, Non-Drowsy,
Item Number 80317-15; Case UPC number 100-41100-80317-4. Recall # D-008-2010
CODE
Lot number 8G16AR; Exp. Date 9/30/2011
RECALLING FIRM/MANUFACTURER
Schering Corp., Kenilworth, NJ, by letter on September 4, 2009. Firm initiated recall is ongoing.
REASON
Incorrect Expiration Date; product labeled with a 42-month expiration date (09/30/2011) instead of a 30-month expiration date (09/30/2010) on both the outer carton and individual blisters.
VOLUME OF PRODUCT IN COMMERCE
215,550 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Nicotine Transdermal System, 7 mg delivered over 24 hours, 1 patch per pouch. Recall # D-009-2010
CODE
Lot 37801, Exp 01/12
RECALLING FIRM/MANUFACTURER
AVEVA Drug Delivery Systems, Inc., Miramar, FL, by letter on September 24, 2009. Firm initiated recall is ongoing.
REASON
Subpotent (Single Ingredient) Drug: AVEVA Drug Delivery Systems Inc. is recalling their 7mg/day Nicotine Transdermal Patch. Some units in Nicotine Transdermal System 7 mg delivered over 24 hours could have low potency or myosmine and beta-nicotyrine impurities above the 0.50% limits in the application specification.
VOLUME OF PRODUCT IN COMMERCE
395,820 units
DISTRIBUTION
NY

___________________________________
PRODUCT 
Nicotine Transdermal System Patch, 14 mg delivered over 24 hours, 1 patch per pouch. Recall # D-010-2010
CODE
 Lot # 37050, Exp 06/11
RECALLING FIRM/MANUFACTURER
AVEVA Drug Delivery Systems, Inc., Miramar, FL, by letter on May 29, 2009. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: recalled due to failures encountered during routine stability testing, resulting in discolored and degraded products.
VOLUME OF PRODUCT IN COMMERCE
428,760 pouches
DISTRIBUTION
CA
___________________________________
PRODUCT 
Thyrolar 3 (liotrix tablets, USP), each tablet contains 37.5 mcg Liothyronine sodium (T3) and 150 mcg Levothyroxine sodium (T4), packaged in 100-ct. bottles, Rx only. NDC 0456-0060-01. Recall # D-012-2010
CODE
Lot #090808, Exp. August 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Forest Pharmaceuticals Inc., Earth City, MO, by letters dated July 17, 2009.
Manufacturer: Forest Pharmaceuticals Inc., Cincinnati, OH. Firm initiated recall is ongoing.
REASON
Exceed Impurity Specification for related compounds.
VOLUME OF PRODUCT IN COMMERCE
2,237/100-count bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
1) Cryoprecipitated AHF, Pooled. Recall # B-1663-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1664-09
CODE
1) Unit: 5806277;
2) Unit: 6693677
RECALLING FIRM/MANUFACTURER
Florida’s Blood Centers, Inc., Orlando, FL, by telephone and letter on April 3, 2009 and follow-up letter dated April 27, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who visited a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1665-09
CODE
Unit: 6253477
RECALLING FIRM/MANUFACTURER
South Texas Blood & Tissue Center, San Antonio, TX, by fax on March 20, 30, 2009 and April 7, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor taking the drug Evista, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1666-09
CODE
Unit: J72100 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by telephone on November 28, 2006 and by letter dated December 12, 2006. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who reported travel to a malarial endemic area, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
VA
___________________________________
PRODUCT 
Fresh Frozen Plasma. Recall # B-1667-09
CODE
Unit: 5166877
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by letter dated March 1, 2007. Firm initiated recall is complete.
REASON
Blood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
NJ
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1668-09
CODE
Unit: 003KC31742
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone and letter on January 2, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1670-09   
CODE
Unit: 03R51462
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Douglasville, GA, by e-mail on March 4, 2008, telephone on March 3, 2008 and by follow-up letter on March 10, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1671-09
CODE
Unit: 5000503
RECALLING FIRM/MANUFACTURER
Atlanta Blood Services, Atlanta, GA, by telephone on June 25, 2009 and by letter dated July 14, 2009. Firm initiated recall is complete.
REASON
Blood product, which was inappropriately distributed in a single storage bag, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1672-09
CODE
Unit: 08MMTE0619
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, L.P., Missoula, MT, by facsimile on November 7, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a physical examination prior to donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
Austria
DISTRIBUTION
1 unit
___________________________________
PRODUCT 
Source Plasma. Recall # B-1673-09   
CODE
Unit: 08FWIE9698
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Fond Du Lac, WI, by facsimile on April 24, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a physical examination prior to donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Platelets. Recall # B-1674-09;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1675-09;
3) Red Blood Cells Leukocytes Reduced. Recall # B-1676-09
CODE
1) Unit: 4661542;
2) Unit: 4654007;
3) Units: 4661542, 4648622
RECALLING FIRM/MANUFACTURER
Community Blood Bank, Inc., Rancho Mirage, CA, by facsimile on May 27, 2009 and June 9, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor with a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1677-09
CODE
Unit: 08SPAC7187
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services, LP, State College, PA, by facsimile on April 24, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who did not receive a complete physical examination, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1678-09;

2) Plasma Frozen within 24 hours (FP24). Recall # B-1679-09
CODE
1) and 2) Unit: W044608563638
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on June 8, 2009. Firm initiated recall is complete.
REASON
Blood products, which tested negative for the hepatitis C virus (HCV), but were collected from a donor who previously tested reactive for HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TX
___________________________________
PRODUCT 
Osteocel Plus Cellular Bone Matrix, 1cc Nuvasive. Recall # B-1694-09  
CODE
Lots: 091327107, 091327108, 091327009, 091327110, 091327111, 091327112, 091327105, 091327106, 091327113, 091327114, 091327115, 091327116, 091327117, 091327118, 091327103, 091327104, 091327119, 091327120, 091327121, 091327122, 091327123, 091327124, 091327125, 091327126, 091327127, 091327128, 091327129, 091327130
RECALLING FIRM/MANUFACTURER
AlloSource, Inc., Centennial, CO, by telephone on April 07, 2009. Firm initiated recall is complete.
REASON
Osteocel Plus Ceullular Bone Matrix, recovered from a donor with a positive Hepatitis B core Antibody serology result, was distributed.
VOLUME OF PRODUCT IN COMMERCE
28 lots
DISTRIBUTION
CA
___________________________________
PRODUCT 
3 Cartilage allografts, mislabeled as 1) Patella Bone with Attachments ID; 091426-001, 2) Femoral Hemi Condyle Lateral Right, ID: 091426-0902, 3) Talus, ID: 091426-003. Recall # B-1695-09
CODE
Units: 091246001, 091246002, 091246003
RECALLING FIRM/MANUFACTURER
AlloSource, Inc., Centennial, CO, by telephone on February 25, 2009, and by letter on March 6, 2009. Firm initiated recall is complete.
REASON
Tissue allografts, quarantined due to positive cultures, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
AZ, KY, TX
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1713-09    
CODE
Unit: W226909911123 Part 2
RECALLING FIRM/MANUFACTURER
Virginia Blood Service Inc, Richmond, VA, by telephone on March 19, 2009 and April 29, 2009. Firm initiated recall is complete.
REASON
Blood product, which exhibited signs of hemolysis within its segments, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
VA

___________________________________
PRODUCT 
Platelets. Recall # B-1714-09
CODE
Unit: 7220688
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by fax on November 03, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had taken aspirin prior to the donation, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
OR
___________________________________
PRODUCT 
Source Plasma. Recall # B-1716-09 
CODE
Units: 08MIND1526, 08MIND1873, 08MIND2896, 08MIND3025, 08MIND4220, 08MIND4905, 08MIND5479, 08MIND6364, 08MIND6718, 08MIND7560, 08MIND7976, 08MIND8624, 08MIND9321, 08MIND9911, 08MINE0503, 08MINE1116, 08MINE1658, 08MINE2290, 08MINE3005, 08MINE3372 and 08MINE4188
RECALLING FIRM/MANUFACTURER
BioLife Plasma Services L.P., Muncie, IN, by facsimile on November 21, 2008. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor with a history of high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
21 units
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1717-09;
2) Cryoprecipitated AHF, Pooled. Recall # B-1718-09
CODE
1) and 2) Unit: 003GP85930
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Atlanta, GA, by facsimile/electronic mail on April 18, 2007 and by letter on April 26, 2007 and June 5, 2007.
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
GA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1721-09
CODE
Unit: 003FR76355
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone on January 23, 2009, by facsimile on March 24, 2009 and May 8, 2009. Firm initiated recall is complete.
REASON
Blood product, which was not quarantined subsequent to receiving information regarding a post donation illness, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
1) Platelets. Recall # B-1722-09;
2) Fresh Frozen Plasma. Recall # B-1723-09;
3) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1724-09
CODE
1), 2), and 3) Unit: 6710750
RECALLING FIRM/MANUFACTURER
Blood Bank of Alaska, Inc., Anchorage, AK, by facsimile on December 22, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who did not speak English, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
Alaska
___________________________________
PRODUCT 
Red Blood Cells. Recall # B-1731-09
CODE
Unit: M173437
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on November 30, 2004.
Manufacturer: Puget Sound Blood Center and Program, Bellevue, WA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
WA
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1739-09
CODE
Unit: W043209004676
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by fax on July 15, 2009. Firm initiated recall is complete.
REASON
Blood product, labeled as leukoreduced, but which did not meet the criteria for leukoreduced products, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TN
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1740-09
CODE
Unit: 72J516151
RECALLING FIRM/MANUFACTURER
Lifesouth Community Blood Centers, Mobile, AL, by fax on July 02, 2009. Firm initiated recall is complete.
REASON
Blood product, with platelet count below the specified minimum requirement, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
AL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced. Recall # B-1741-09
CODE
Units: W038309040925, W038309040852 (part 1 and 2)
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Building Center, Davenport, IA, by letter dated June 29, 2009. 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
NC, IA, IL
___________________________________
PRODUCT 
Platelets Pheresis Leukocytes Reduced, Recall # B-1742-09
CODE
Unit: W044208327399
RECALLING FIRM/MANUFACTURER
San Diego Blood Bank, San Diego, CA, by telephone on November 28, 2009 and by follow-up letter dated August 06, 2009. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor who had traveled to a malarial endemic area, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1669-09
CODE
Unit: 03R51462
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Douglasville, GA, by e-mail on March 4, 2008, telephone on March 3, 2008 and by follow-up letter on March 10, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1680-09;
2) Red Blood Cells Leukocytes Reduced Irradiated. Recall # B-1681-09
CODE
1) Units: 5002281, 5002282, 5002288, 5002290, 5501408;
2) Units: 5501409, 5501410, 5501411
RECALLING FIRM/MANUFACTURER
Community Blood Bank of Erie County, Buffalo, NY, by telephone on June 18, 2009 and by facsimile on June 19, 2009. Firm initiated recall is complete.
REASON
Blood products, collected using scales that did not have complete daily QC documentation, were distributed
VOLUME OF PRODUCT IN COMMERCE
8 units
DISTRIBUTION
NY
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1715-09
CODE
Unit: 003L03982
RECALLING FIRM/MANUFACTURER
The American National Red Cross - Southern Region, Douglasville, GA, by telephone on April 16, 2008 and by letter on April 28, 2008 and May 30, 2008. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
GA
___________________________________
PRODUCT 
Recovered Plasma Cryoprecipitate Reduced. Recall # B-1719-09
CODE
Unit: 003GP85930
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Atlanta, GA, by facsimile/electronic mail on April 18, 2007 and by letter on April 26, 2007 and June 5, 2007.
Manufacturer: The American National Red Cross - Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1720-09
CODE
Unit: AQ030670
RECALLING FIRM/MANUFACTURER
Plasma Biological Services, 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
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PRODUCT 
Platelets. Recall # B-1725-09
CODE
Units: 7422757, 7422758, 7422762, 7422763, 7422765, 7422767, 7121021, 7121022, 7121024, 7121026, and 7121034
RECALLING FIRM/MANUFACTURER
Lane Memorial Blood Bank, Eugene, OR, by fax on February 4, 2005. Firm initiated recall is complete.
REASON
Blood products, which may have been exposed to unacceptable temperatures during processing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
OR

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
Datex-Ohmeda S/5 Device Interfacing Solution, N-DISVENT 02. The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx 01 with N-DISVENT 02, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is intended for use by qualified medical personnel only. Recall # Z-1558-2009
CODE
Parent Serial Number: 6309715 6309716 6309717 6309718 6309719 6439662 6439663 6373962 6373963 6260564 6341724 6341725 6397037* 6397038* 6399507 6478114 6478115 6478116 6260575 6260576 6260577 6260578 6260579 6260580 6260581 6260582 6260583 6260584 6260585 6260586 6260587 6195535 6195539 6195540 6195541 6195542 6195543 6195544 6195545 6195546 6195547 6195548 6195549 6195550 6229242 6238630 6238679 6260591 6260596 6260597 6260598 6260599 6260600 6279857 6279858 6279859 6279928 6279937 6279938 6279939 6279940 6279941 6279942 6306020 6309692 6309693 6309694 6341753 6341754 6341755 6341756 6385971 6388639 6395704 6395705 6395706 6395707 6397073 6428643 6438603 6438622 6438623 6438624 6438625 6438630 6438631 6444995 6451312 6451313 6451314 6465232 6465236 6465237 6468815 6483711 6175623 6175624 6175625 6175626 6175627 6175628 6175629 6175630 6175631 6175632 6175633 6175651 6175652 6175653 6175654 6175655 6175663 6175664 6195528 6195536 6195537 6229265 6229266 6229267 6238701 6260558 6272984 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6378340 6378341 6378342 6378343 6378344 6383541 6383542 6383543 6383544 6383545 6383546 6383547 6383548 6383549 6383550 6395710 6395711 6395712 6395713 6395714 6395715 6395716 6395717 6395718 6395719 6397020 6397021 6397022 6397023 6397024 6397025 6397026 6397027 6397028 6397029 6397030 6397031 6397032 6397033 6397034 6408236 6408237 6408238 6408239 6408240 6408241 6408242 6408243 6408244 6408245 6408246 6408247 6408248 6408249 6408250 6408251 6408252 6408253 6408254 6408255 6408256 6408257 6408258 6408259 6408260 6418033 6418034 6418035 6418036 6418037 6418038 6418039 6418040 6418041 6418042 6418043 6418044 6418045 6418046 6418047 6418048 6418049 6418050 6418051 6418052 6426570 6426571 6426572 6426573 6426574 6426575 6426576 6426577 6426578 6426579 6426580 6426581 6426582 6426583 6426584 6426585 6426586 6426587 6426588 6426589 6426590 6426591 6426592 6426593 6426594 6426595 6426596 6426597 6426598 6426599 6426600 6426601 6426602 6426603 6426604 6428661 6431868 6431869 6431870 6431871 6431885 6431886 6431887 6434422 6434423 6434425 6434426 6434427 6434428 6434429 6439642 6439643 6439644 6439645 6439646 6444956 6444957 6444958 6444959 6444960 6444961 6444962 6444963 6444964 6444965 6444966 6444967 6444968 6444990 6444991 6444992 6444993 6444994 6449950 6449951 6449952 6449953 6449954 6449955 6449956 6449957 6449958 6449959 6449960 6451305 6451306 6451307 6451308 6452211 6452212 6452213 6452214 6452215 6452216 6452217 6452218 6452219 6452220 6452221 6452222 6452223 6452224 6452225 6452226 6452227 6452228 6452229 6452230 6452231 6452232 6452233 6452234 6452235 6454952 6454953 6454954 6454955 6454956 6454957 6454958 6454959 6454960 6454961 6459580 6459581 6459582 6459583 6459584 6459585 6459586 6459587 6459588 6459589 6459590 6459591 6459592 6459593 6459594 6461140 6461141 6461142 6461143 6461144 6461145 6461146 6461147 6461148 6461149 6461150 6461151 6461152 6461153 6461154 6462982 6462983 6462984 6462985 6462986 6462987 6462988 6462989 6462990 6462991 6462992 6462993 6462994 6462995 6462996 6465212 6465213 6465214 6465215 6465216 6465217 6465218 6465219 6465220 6465221 6465222 6465223 6465224 6465225 6465226 6465240 6465241 6465242 6465243 6465244 6465245 6465246 6465247 6465248 6465249 6465250 6465251 6465252 6465253 6465254 6467644 6467645 6467646 6467647 6467648 6467649 6467650 6467651 6467652 6467653 6483720 6483721 6483722 6483723 6483724 6483725 6483726 6483727 6486766 6486767 6486768 6486769 6486770 6486771 6486772 6391517 6324489 6324490 6324491 6324492 6324493 6324494 6324495 6324496 6324497 6324498 6324499 6324500 6324501 6324516 6324517 6330737 6330738 6330739 6330740 6330741 6330742 6330743 6330744 6379896 6379897 6379898 6379899 6379900 6379901 6379902 6379903 6379904 6379905 6426607 6426608 6426609 6427396 6427397 6427398 6427399 6427400 6427401 6427402 6434424 6438606 6438607 6438608 6439639 6439640 6439641 6439654 6439655 6439656 6443544 6443547 6443548 6443549 6443550 6444973 6444974 6444975 6444976 6444977 6444978 6444979 6444980 6444981 6444982 6459578 6459579 6467636 6467637* 6472354 6472355 6478108 6478109 6478110 6478111 6478112 6479463 6479464 6486764 and 6486765
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter on or about April 9, 2009.
Manufacturer: GE Healthcare Finland Oy, Helsinki, Finland. Firm initiated recall is ongoing.
REASON
GE Healthcare has recently become aware of an issue in the calculations associated with Datex-Ohmeda S/5 Device Interfacing Solution N-DISVENT-02 interfaced between certain Datex-Ohmeda patient monitors (Datex-Ohmeda S/5 Anesthesia Monitor (AM), Datex-Ohmeda S/5 Critical Care Monitor (CCM), Datex-Ohmeda S/5 Compact Anesthesia Monitor (CAM), Datex-Ohmeda S/5 Compact Critical Care Monitor (CCCM)) and the Datex-Ohmeda Anesthesia Machine or Ventilator Advance, Aisys or Engstrom Carestation.
VOLUME OF PRODUCT IN COMMERCE
2,638 units
DISTRIBUTION
Nationwide, Internationally

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PRODUCT 
GE Healthcare CIC Pro Clinical Information Center Central Station (CIC Pro version 5.1, MP100 Hardware). The CIC Pro" clinical Information Center central station is intended to collect information from a network and display this date. This data includes physiological, patient dermographic and/or other non-medical information. Recall # Z-1600-2009
CODE
Serial Numbers: SDY09050521GA SDY08400072GA SDY09030450GA SDY09030451GA SDY09020430GA SDY09030443GA SDY09010397GA SDY09020426GA SDY09010400GA SDY09050487GA SDY08510300GA SDY09010389GA SDY09010391GA SDY09030460GA SDY09020427GA SDY08520371GA SDY09010382GA SDY09010383GA SDY09020403GA SDY09020419GA SDY09030462GA SDY09050474GA SDY09020412GA SDY08520366GA SDY09010388GA SDY09030435GA SDY08410079GA SDY08420083GA SDY09020416GA SDY09010384GA SDY08520367GA SDY09030459GA SDY08400067GA SDY09030437GA SDY09030442GA SDY09030448GA SDY09030453GA SDY09020408GA SDY09020409GA SDY09020423GA SDY09030433GA SDY09010385GA SDY08490149GA SDY08500162GA SDY08500181GA SDY08500214GA SDY08500215GA SDY08500239GA SDY08510243GA SDY08510249GA SDY08510257GA SDY08490120GA SDY08490130GA SDY08500175GA SDY08500224GA SDY08490100GA SDY08500194GA SDY08490102GA SDY08510258GA SDY08510260GA SDY08510263GA SDY08510267GA SDY08520323GA SDY08500184GA SDY08500192GA SDY08500200GA SDY09020422GA SDY08510293GA SDY08480089GA SDY09030434GA SDY09030445GA SDY08480091GA SDY08490139GA SDY08510318GA SDY08490098GA SDY08490103GA SDY08490109GA SDY08490111GA SDY08490116GA SDY08490124GA SDY08490125GA SDY08490131GA SDY08490142GA SDY08500160GA SDY08500161GA SDY08500164GA SDY08500165GA SDY08500166GA SDY08500167GA SDY08500168GA SDY08500176GA SDY08500180GA SDY08500195GA SDY08500197GA SDY08510259GA SDY09010381GA SDY09010402GA SDY09020425GA SDY08520333GA SDY08520359GA SDY08520361GA SDY08520374GA SDY09010399GA SDY09020405GA SDY09020415GA SDY09020406GA SDY08500204GA SDY08500222GA SDY08500223GA SDY08510285GA SDY08510287GA SDY08510292GA SDY08520322GA SDY09030440GA SDY08500238GA SDY08520349GA SDY08520356GA SDY08520363GA SDY08520364GA SDY08520365GA SDY08520372GA SDY09020421GA SDY09030444GA SDY09030449GA SDY08400059GA SDY08400069GA SDY08520320GA SDY08520321GA SDY08520326GA SDY08520350GA SDY08520358GA SDY08520362GA SDY08520376GA SDY09030446GA SDY09030452GA SDY08510261GA SDY08510270GA SDY08520352GA SDY08490121GA SDY08490128GA SDY08490133GA SDY08500159GA SDY08500174GA SDY08520331GA SDY08490101GA SDY08490119GA SDY08490127GA SDY08490132GA SDY08490137GA SDY08500152GA SDY08510262GA SDY08510269GA SDY09030465GA SDY08510290GA SDY08510299GA SDY08520327GA SDY08520328GA SDY08520346GA SDY08520377GA SDY09020424GA SDY08500171GA SDY08500172GA SDY08500189GA SDY08500196GA SDY08500241GA SDY08510248GA SDY08510253GA SDY08500203GA SDY08500208GA SDY08480090GA SDY08490136GA SDY08490145GA SDY08490147GA SDY09010378GA SDY08510280GA SDY08520345GA SDY08500186GA SDY08490108GA SDY08490150GA SDY08500210GA SDY08500217GA SDY08500225GA SDY08500236GA SDY08510247GA SDY08510254GA SDY08510255GA SDY09050483GA SDY08500179GA SDY08520375GA SDY08500242GA SDY08480086GA SDY08480087GA SDY08490092GA SDY08490105GA SDY08490110GA SDY08490112GA SDY08490113GA SDY08490146GA SDY08500191GA SDY09010394GA SDY09030461GA SDY08480084GA SDY08480088GA SDY08490096GA SDY08490122GA SDY08500240GA SDY09030439GA SDY08510265GA SDY09020407GA SDY09020414GA SDY08500153GA SDY08510284GA SDY08520341GA SDY08520343GA SDY08490099GA SDY08490104GA SDY08490107GA SDY08490115GA SDY09030457GA SDY08500213GA SDY09030431GA SDY09030441GA SDY08490097GA SDY08490118GA SDY09010392GA SDY09010396GA SDY09010401GA SDY08510317GA SDY08520324GA SDY08520329GA SDY08520336GA SDY08520351GA SDY08520360GA SDY08500237GA SDY08510245GA SDY08510266GA SDY08510275GA SDY08510276GA SDY08510278GA SDY08510279GA SDY08510283GA SDY08510294GA SDY08510298GA SDY08520373GA SDY09030454GA SDY09030464GA SDY09030466GA SDY09050471GA SDY09050473GA SDY09050480GA SDY08490126GA SDY08500235GA SDY08510256GA SDY08510268GA SDY08510244GA SDY08510246GA SDY08510251GA SDY08510274GA SDY08510277GA SDY08510281GA SDY08510288GA SDY08510289GA SDY08510291GA SDY08510295GA SDY08510301GA SDY08510306GA SDY08510308GA SDY08510309GA SDY08510310GA SDY08510315GA SDY08490123GA SDY08520357GA SDY08500202GA SDY08500205GA SDY08510271GA SDY08510272GA SDY08500206GA SDY08500207GA SDY08500209GA SDY08500211GA SDY08500221GA SDY08500228GA SDY08500229GA SDY08500231GA SDY08490114GA SDY08490151GA SDY08500218GA SDY08500226GA SDY08500227GA SDY08500232GA SDY09010380GA SDY09050475GA SDY09050488GA SDY09050496GA SDY08490141GA SDY08500154GA SDY08500157GA SDY08500193GA SDY08500198GA SDY08500201GA SDY08510264GA SDY08510302GA SDY08500187GA SDY08490148GA SDY08510250GA SDY08510303GA SDY08510307GA SDY08510311GA SDY08520319GA SDY08520330GA SDY08520332GA SDY08520344GA SDY08520369GA SDY09050469GA SDY08490135GA SDY08490138GA SDY08490144GA SDY08500155GA SDY08500177GA SDY08500178GA SDY08500188GA SDY08500190GA SDY08510314GA SDY08520370GA SDY09010387GA SDY09020429GA SDY09030432GA SDY09030447GA SDY09030455GA SDY09050472GA SDY08490106GA SDY08490134GA SDY08490143GA SDY08500169GA SDY08500182GA SDY08500220GA SDY08500234GA SDY08490129GA SDY08510304GA SDY08500199GA SDY08500233GA SDY09020411GA SDY08500212GA SDY08500216GA SDY09050482GA SDY08520337GA SDY09050495GA SDY08500183GA SDY08500185GA SDY08510252GA SEE09040062GA and SDY08500219GA
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems Information Technology, Wauwatosa, WI, by letter dated February 24, 2009.
Manufacturer: General Electric Medical Systems Information Technology, Milwaukee, WI. Firm initiated recall is ongoing.
REASON
GE Healthcare has become aware of a potential issue associated with the failure to restart CARESCAPE CIC Pro v5.1 on the MP100 hardware. This issue may impact patient safety.
VOLUME OF PRODUCT IN COMMERCE
352 units
DISTRIBUTION
Nationwide, Austria, Australia, Canada, Czech Republic, Germany, Egypt, Spain, France, Great Britain, Italy, Poland and Sweden
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PRODUCT 
Clinac with Version 7.x Software. Model Numbers: H14, H27 and H29. Part of the Trilogy Radiotherapy Delivery System for radiation therapy intended to delivery megavoltage x-ray treatments for conventional radiotherapy and stereotactic radiosurgery and radiotherapy. Recall # Z-1729-2009
CODE
Code numbers: H140001 H140136 H140221 H140719 H140759 H140011 H140137 H140222 H140720 H140760 H140018 H140138 H140223 H140721 H140761 H140020 H140139 H140224 H140722 H140762 H140025 H140140 H140225 H140723 H140763 H140026 H140141 H140226 H140724 H140764 H140027 H140142 H140227 H140725 H140765 H140031 H140143 H140228 H140726 H140766 H140043 H140144 H140229 H140727 H140767 H140045 H140145 H140230 H140728 H140768 H140046 H140146 H140231 H140729 H140769 H140047 H140147 H140232 H140730 H140770 H140058 H140148 H140233 H140731 H140771 H140062 H140149 H140234 H140732 H140772 H140067 H140150 H140235 H140733 H140773 H140070 H140151 H140236 H140734 H140774 H140071 H140152 H140237 H140735 H140775 H140073 H140153 H140238 H140736 H140776 H140076 H140154 H140239 H140737 H140777 H140077 H140201 H140240 H140739 H140778 H140088 H140202 H140700 H140740 H140779 H140090 H140203 H140701 H140741 H140780 H140092 H140204 H140702 H140742 H140781 H140096 H140205 H140703 H140743 H140782 H140097 H140206 H140704 H140744 H140783 H140098 H140207 H140705 H140745 H140784 H140101 H140208 H140706 H140746 H140785 H140109 H140209 H140707 H140747 H140786 H140111 H140210 H140708 H140748 H140787 H140114 H140211 H140709 H140749 H140788 H140115 H140212 H140710 H140750 H140789 H140117 H140213 H140711 H140751 H140790 H140119 H140214 H140712 H140752 H140791 H140121 H140215 H140713 H140753 H140792 H140124 H140216 H140714 H140754 H140793 H140125 H140217 H140715 H140755 H140794 H140133 H140218 H140716 H140756 H140795 H140134 H140219 H140717 H140757 H140796 H140135 H140220 H140718 H140758 H140797 H272394 H272859 H273049 H273132 H273179 H272397 H272860 H273053 H273133 H273180 H272401 H272862 H273055 H273134 H273181 H272405 H272866 H273056 H273135 H273182 H272407 H272868 H273063 H273136 H273183 H272410 H272872 H273064 H273137 H273184 H272418 H272873 H273065 H273138 H273185 H272421 H272875 H273066 H273139 H273186 H272422 H272885 H273072 H273140 H273187 H272425 H272889 H273077 H273141 H273188 H272426 H272893 H273080 H273142 H273189 H272427 H272905 H273082 H273143 H273190 H272428 H272908 H273083 H273144 H273191 H272434 H272909 H273084 H273145 H273192 H272454 H272922 H273092 H273146 H273193 H272456 H272926 H273101 H273147 H273194 H272458 H272932 H273102 H273148 H273195 H272466 H272938 H273103 H273149 H273196 H272469 H272946 H273104 H273150 H273197 H272470 H272956 H273105 H273151 H273198 H272473 H272960 H273106 H273152 H273199 H272479 H272964 H273107 H273153 H273200 H272480 H272971 H273108 H273155 H273201 H272488 H272973 H273109 H273156 H273202 H272492 H272978 H273110 H273157 H273203 H272494 H272981 H273111 H273158 H273204 H272497 H272982 H273112 H273159 H273205 H272500 H272985 H273113 H273160 H273206 H272801 H272986 H273114 H273162 H273208 H272803 H272987 H273115 H273163 H273209 H272811 H272990 H273116 H273164 H273210 H272816 H272996 H273117 H273165 H273528 H272822 H272999 H273118 H273166 H273547 H272824 H273004 H273119 H273167 H273578 H272825 H273011 H273120 H273168 H273711 H272826 H273016 H273121 H273169 H273929 H272828 H273026 H273122 H273170 H290201 H272834 H273027 H273123 H273171 H290222 H272837 H273030 H273124 H273172 H290224 H272841 H273031 H273125 H273173 H290241 H272842 H273036 H273126 H273174 H290243 H272846 H273039 H273127 H273175 H290249 H272848 H273040 H273128 H273176 H290262 H272854 H273042 H273130 H273177 H290263 H272857 H273048 H273131 H273178 H290274 H291176 H291221 H291266 H293333 H293379 H291177 H291222 H291267 H293334 H293380 H291178 H291223 H291268 H293335 H293381 H291179 H291224 H291269 H293336 H293382 H291180 H291225 H291270 H293337 H293383 H291181 H291226 H291271 H293339 H293384 H291182 H291227 H291272 H293340 H293385 H291183 H291228 H291273 H293341 H293386 H291184 H291229 H292366 H293342 H293387 H291185 H291230 H292832 H293343 H293388 H291186 H291231 H293009 H293344 H293389 H291187 H291232 H293207 H293345 H293390 H291188 H291233 H293300 H293346 H293391 H291189 H291234 H293301 H293347 H293392 H291190 H291235 H293302 H293348 H293393 H291191 H291236 H293303 H293349 H293394 H291192 H291237 H293304 H293350 H293395 H291193 H291238 H293305 H293351 H293396 H291194 H291239 H293306 H293352 H293397 H291195 H291240 H293307 H293353 H293398 H291196 H291241 H293308 H293354 H293399 H291197 H291242 H293309 H293355 H293401 H291198 H291243 H293310 H293356 H293402 H291199 H291244 H293311 H293357 H293403 H291200 H291245 H293312 H293358 H293404 H291201 H291246 H293313 H293359 H293405 H291202 H291247 H293314 H293360 H293406 H291203 H291248 H293315 H293361 H293407 H291204 H291249 H293316 H293362 H293408 H291205 H291250 H293317 H293363 H293409 H291206 H291251 H293318 H293364 H293410 H291207 H291252 H293319 H293365 H293411 H291208 H291253 H293320 H293366 H293412 H291209 H291254 H293321 H293367 H293413 H291210 H291255 H293322 H293368 H293414 H291211 H291256 H293323 H293369 H293415 H291212 H291257 H293324 H293370 H293416 H291213 H291258 H293325 H293371 H293417 H291214 H291259 H293326 H293372 H293418 H291215 H291260 H293327 H293373 H293419 H291216 H291261 H293328 H293374 H293420 H291217 H291262 H293329 H293375 H293421 H291218 H291263 H293330 H293376 H293422 H291219 H291264 H293331 H293377 H293423 H291220 H291265 H293332 H293378 H293424 H293655 H293702 H293750 H293798 H293846 H293656 H293703 H293751 H293799 H293847 H293657 H293704 H293752 H293800 H293848 H293658 H293705 H293753 H293801 H293849 H293659 H293706 H293754 H293802 H293850 H293660 H293707 H293755 H293803 H293851 H293661 H293708 H293756 H293804 H293852 H293662 H293709 H293758 H293805 H293853 H293663 H293710 H293759 H293806 H293854 H293664 H293712 H293760 H293807 H293855 H293665 H293713 H293761 H293808 H293856 H293666 H293714 H293762 H293809 H293857 H293667 H293715 H293763 H293812 H293858 H293668 H293716 H293764 H293813 H293859 H293669 H293717 H293765 H293814 H293860 H293670 H293718 H293767 H293815 H293861 H293671 H293719 H293769 H293816 H293862 H293672 H293720 H293770 H293817 H293863 H293673 H293721 H293771 H293818 H293864 H293674 H293723 H293772 H293819 H293865 H293675 H293724 H293773 H293820 H293866 H293676 H293725 H293774 H293821 H293867 H293678 H293726 H293775 H293822 H293868 H293679 H293727 H293776 H293823 H293869 H293681 H293728 H293777 H293824 H293870 H293682 H293729 H293778 H293825 H293871 H293683 H293730 H293779 H293826 H293872 H293684 H293732 H293780 H293827 H293873 H293685 H293733 H293781 H293828 H293874 H293686 H293734 H293782 H293829 H293875 H293687 H293735 H293783 H293830 H293876 H293688 H293736 H293784 H293831 H293877 H293689 H293737 H293785 H293832 H293878 H293690 H293738 H293786 H293834 H293879 H293691 H293739 H293787 H293835 H293880 H293692 H293740 H293788 H293836 H293881 H293693 H293741 H293789 H293837 H293882 H293694 H293742 H293790 H293838 H293883 H293695 H293743 H293791 H293839 H293884 H293696 H293744 H293792 H293840 H293885 H293697 H293745 H293793 H293841 H293886 H293698 H293746 H293794 H293842 H293887 H293699 H293747 H293795 H293843 H293888 H293700 H293748 H293796 H293844 H293889 H293701 H293749 H293797 H293845 H293890 H294134 H294186 H294240 H294299 H294135 H294187 H294241 H294301 H294136 H294188 H294242 H294302 H294137 H294189 H294243 H294303 H294138 H294190 H294244 H294304 H294140 H294191 H294245 H294306 H294142 H294192 H294246 H294307 H294143 H294193 H294247 H294308 H294144 H294194 H294252 H294309 H294145 H294195 H294254 H294312 H294146 H294196 H294256 H294314 H294148 H294197 H294257 H294316 H294149 H294198 H294258 H294317 H294150 H294199 H294261 H294318 H294151 H294200 H294262 H294320 H294152 H294201 H294263 H294321 H294154 H294202 H294264 H294322 H294155 H294203 H294266 H294323 H294156 H294204 H294267 H294324 H294157 H294205 H294269 H294325 H294158 H294207 H294270 H294326 H294159 H294208 H294271 H294327 H294161 H294209 H294272 H294328 H294162 H294210 H294273 H294330 H294163 H294214 H294275 H294331 H294164 H294216 H294276 H294332 H294165 H294217 H294277 H294333 H294166 H294218 H294278 H294334 H294167 H294219 H294279 H294336 H294168 H294220 H294280 H294337 H294169 H294221 H294281 H294338 H294170 H294222 H294282 H294340 H294172 H294223 H294283 H294341 H294173 H294224 H294285 H294342 H294174 H294225 H294286 H294343 H294175 H294226 H294287 H294348 H294176 H294227 H294288 H294350 H294177 H294228 H294289 H294353 H294178 H294230 H294290 H294354 H294179 H294232 H294293 H294355 H294180 H294234 H294294 H294358 H294181 H294235 H294295 H294360 H294182 H294236 H294296 H294361 H294184 H294237 H294297 H294363 H294185 H294239 H294298 H294364
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter dated May 29, 2009. Firm initiated recall is ongoing.
REASON
Unexpected Movement: if the stereotactic motion disable function is turned on, the couch can be moved via float mode unexpectedly.
VOLUME OF PRODUCT IN COMMERCE
1,933 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, The Varis RV function is designed to assist the operator of a radiation therapy device in providing accurate treatment setups for each patient by monitoring set up parameters and preventing the radiation therapy device from commencing irradiation while any parameter is out of conformance with the treatment plan. Additional applications provide various data management and library functions. Recall # Z-1809-2009
CODE
Code numbers: H140001 H140136 H140221 H140719 H140759 H140798 H271041 H271626 H271951 H272197 H140011 H140137 H140222 H140720 H140760 H140799 H271066 H271662 H271961 H272202 H140018 H140138 H140223 H140721 H140761 H140800 H271157 H271664 H271964 H272209 H140020 H140139 H140224 H140722 H140762 H140801 H271159 H271681 H271966 H272219 H140025 H140140 H140225 H140723 H140763 H140802 H271167 H271693 H271973 H272220 H140026 H140141 H140226 H140724 H140764 H140804 H271169 H271711 H271974 H272223 H140027 H140142 H140227 H140725 H140765 H140805 H271190 H271720 H271975 H272231 H140031 H140143 H140228 H140726 H140766 H140806 H271194 H271724 H271976 H272236 H140043 H140144 H140229 H140727 H140767 H140807 H271242 H271762 H271993 H272237 H140045 H140145 H140230 H140728 H140768 H140808 H271258 H271780 H271994 H272238 H140046 H140146 H140231 H140729 H140769 H140809 H271265 H271783 H272000 H272259 H140047 H140147 H140232 H140730 H140770 H140810 H271308 H271785 H272009 H272271 H140058 H140148 H140233 H140731 H140771 H140811 H271334 H271797 H272023 H272277 H140062 H140149 H140234 H140732 H140772 H140812 H271362 H271802 H272029 H272283 H140067 H140150 H140235 H140733 H140773 H140813 H271370 H271825 H272033 H272291 H140070 H140151 H140236 H140734 H140774 H140814 H271385 H271831 H272035 H272299 H140071 H140152 H140237 H140735 H140775 H140815 H271393 H271833 H272043 H272301 H140073 H140153 H140238 H140736 H140776 H140817 H271400 H271835 H272045 H272302 H140076 H140154 H140239 H140737 H140777 H140819 H271407 H271838 H272049 H272306 H140077 H140201 H140240 H140739 H140778 H140820 H271413 H271856 H272052 H272307 H140088 H140202 H140700 H140740 H140779 H140821 H271425 H271858 H272062 H272309 H140090 H140203 H140701 H140741 H140780 H140822 H271438 H271860 H272069 H272310 H140092 H140204 H140702 H140742 H140781 H140824 H271439 H271862 H272078 H272311 H140096 H140205 H140703 H140743 H140782 H140825 H271452 H271870 H272086 H272325 H140097 H140206 H140704 H140744 H140783 H140826 H271497 H271872 H272089 H272326 H140098 H140207 H140705 H140745 H140784 H140827 H271502 H271879 H272111 H272327 H140101 H140208 H140706 H140746 H140785 H140828 H271507 H271881 H272129 H272328 H140109 H140209 H140707 H140747 H140786 H140830 H271515 H271893 H272134 H272329 H140111 H140210 H140708 H140748 H140787 H140831 H271519 H271895 H272137 H272333 H140114 H140211 H140709 H140749 H140788 H140832 H271523 H271896 H272143 H272345 H140115 H140212 H140710 H140750 H140789 H140833 H271531 H271900 H272157 H272346 H140117 H140213 H140711 H140751 H140790 H140834 H271559 H271903 H272159 H272354 H140119 H140214 H140712 H140752 H140791 H140835 H271582 H271906 H272162 H272355 H140121 H140215 H140713 H140753 H140792 H140836 H271587 H271918 H272172 H272359 H140124 H140216 H140714 H140754 H140793 H140837 H271588 H271921 H272174 H272362 H140125 H140217 H140715 H140755 H140794 H140838 H271593 H271926 H272178 H272365 H140133 H140218 H140716 H140756 H140795 H270788 H271594 H271935 H272187 H272370 H140134 H140219 H140717 H140757 H140796 H270794 H271607 H271941 H272188 H272372 H140135 H140220 H140718 H140758 H140797 H270862 H271624 H271942 H272195 H272388 H272394 H272859 H273049 H273132 H273179 H290278 H290557 H291040 H291085 H291131 H272397 H272860 H273053 H273133 H273180 H290282 H290558 H291041 H291086 H291132 H272401 H272862 H273055 H273134 H273181 H290287 H290559 H291042 H291087 H291133 H272405 H272866 H273056 H273135 H273182 H290304 H290560 H291043 H291088 H291134 H272407 H272868 H273063 H273136 H273183 H290308 H290561 H291044 H291089 H291135 H272410 H272872 H273064 H273137 H273184 H290313 H290600 H291045 H291090 H291136 H272418 H272873 H273065 H273138 H273185 H290326 H291001 H291046 H291091 H291137 H272421 H272875 H273066 H273139 H273186 H290341 H291002 H291047 H291092 H291138 H272422 H272885 H273072 H273140 H273187 H290352 H291003 H291048 H291093 H291139 H272425 H272889 H273077 H273141 H273188 H290371 H291004 H291049 H291094 H291140 H272426 H272893 H273080 H273142 H273189 H290372 H291005 H291050 H291095 H291141 H272427 H272905 H273082 H273143 H273190 H290376 H291006 H291051 H291096 H291142 H272428 H272908 H273083 H273144 H273191 H290379 H291007 H291052 H291097 H291143 H272434 H272909 H273084 H273145 H273192 H290386 H291008 H291053 H291098 H291144 H272454 H272922 H273092 H273146 H273193 H290392 H291009 H291054 H291099 H291145 H272456 H272926 H273101 H273147 H273194 H290397 H291010 H291055 H291100 H291146 H272458 H272932 H273102 H273148 H273195 H290399 H291011 H291056 H291101 H291147 H272466 H272938 H273103 H273149 H273196 H290400 H291012 H291057 H291102 H291148 H272469 H272946 H273104 H273150 H273197 H290405 H291013 H291058 H291103 H291149 H272470 H272956 H273105 H273151 H273198 H290423 H291014 H291059 H291104 H291150 H272473 H272960 H273106 H273152 H273199 H290503 H291015 H291060 H291105 H291151 H272479 H272964 H273107 H273153 H273200 H290504 H291016 H291061 H291106 H291152 H272480 H272971 H273108 H273155 H273201 H290505 H291017 H291062 H291107 H291153 H272488 H272973 H273109 H273156 H273202 H290508 H291018 H291063 H291108 H291154 H272492 H272978 H273110 H273157 H273203 H290509 H291019 H291064 H291109 H291155 H272494 H272981 H273111 H273158 H273204 H290510 H291020 H291065 H291111 H291156 H272497 H272982 H273112 H273159 H273205 H290511 H291021 H291066 H291112 H291157 H272500 H272985 H273113 H273160 H273206 H290512 H291022 H291067 H291113 H291158 H272801 H272986 H273114 H273162 H273208 H290517 H291023 H291068 H291114 H291159 H272803 H272987 H273115 H273163 H273209 H290519 H291024 H291069 H291115 H291160 H272811 H272990 H273116 H273164 H273210 H290520 H291025 H291070 H291116 H291161 H272816 H272996 H273117 H273165 H273528 H290530 H291026 H291071 H291117 H291162 H272822 H272999 H273118 H273166 H273547 H290533 H291027 H291072 H291118 H291163 H272824 H273004 H273119 H273167 H273578 H290540 H291028 H291073 H291119 H291164 H272825 H273011 H273120 H273168 H273711 H290541 H291029 H291074 H291120 H291165 H272826 H273016 H273121 H273169 H273929 H290547 H291030 H291075 H291121 H291166 H272828 H273026 H273122 H273170 H290201 H290548 H291031 H291076 H291122 H291167 H272834 H273027 H273123 H273171 H290222 H290549 H291032 H291077 H291123 H291168 H272837 H273030 H273124 H273172 H290224 H290550 H291033 H291078 H291124 H291169 H272841 H273031 H273125 H273173 H290241 H290551 H291034 H291079 H291125 H291170 H272842 H273036 H273126 H273174 H290243 H290552 H291035 H291080 H291126 H291171 H272846 H273039 H273127 H273175 H290249 H290553 H291036 H291081 H291127 H291172 H272848 H273040 H273128 H273176 H290262 H290554 H291037 H291082 H291128 H291173 H272854 H273042 H273130 H273177 H290263 H290555 H291038 H291083 H291129 H291174 H272857 H273048 H273131 H273178 H290274 H290556 H291039 H291084 H291130 H291175 H291176 H291221 H291266 H293333 H293379 H293425 H293470 H293515 H293563 H293610 H291177 H291222 H291267 H293334 H293380 H293426 H293471 H293516 H293564 H293611 H291178 H291223 H291268 H293335 H293381 H293427 H293472 H293517 H293565 H293612 H291179 H291224 H291269 H293336 H293382 H293428 H293473 H293518 H293566 H293613 H291180 H291225 H291270 H293337 H293383 H293429 H293474 H293519 H293567 H293614 H291181 H291226 H291271 H293339 H293384 H293430 H293475 H293520 H293568 H293615 H291182 H291227 H291272 H293340 H293385 H293431 H293476 H293521 H293569 H293616 H291183 H291228 H291273 H293341 H293386 H293432 H293477 H293522 H293570 H293617 H291184 H291229 H292366 H293342 H293387 H293433 H293478 H293523 H293571 H293618 H291185 H291230 H292832 H293343 H293388 H293434 H293479 H293524 H293572 H293619 H291186 H291231 H293009 H293344 H293389 H293435 H293480 H293525 H293573 H293620 H291187 H291232 H293207 H293345 H293390 H293436 H293481 H293527 H293574 H293621 H291188 H291233 H293300 H293346 H293391 H293437 H293482 H293529 H293575 H293622 H291189 H291234 H293301 H293347 H293392 H293438 H293483 H293530 H293576 H293623 H291190 H291235 H293302 H293348 H293393 H293439 H293484 H293531 H293577 H293624 H291191 H291236 H293303 H293349 H293394 H293440 H293485 H293532 H293578 H293625 H291192 H291237 H293304 H293350 H293395 H293441 H293486 H293533 H293579 H293626 H291193 H291238 H293305 H293351 H293396 H293442 H293487 H293534 H293581 H293627 H291194 H291239 H293306 H293352 H293397 H293443 H293488 H293535 H293583 H293628 H291195 H291240 H293307 H293353 H293398 H293444 H293489 H293536 H293584 H293629 H291196 H291241 H293308 H293354 H293399 H293445 H293490 H293537 H293585 H293630 H291197 H291242 H293309 H293355 H293401 H293446 H293491 H293538 H293586 H293631 H291198 H291243 H293310 H293356 H293402 H293447 H293492 H293539 H293587 H293632 H291199 H291244 H293311 H293357 H293403 H293448 H293493 H293540 H293588 H293633 H291200 H291245 H293312 H293358 H293404 H293449 H293494 H293541 H293589 H293634 H291201 H291246 H293313 H293359 H293405 H293450 H293495 H293542 H293590 H293635 H291202 H291247 H293314 H293360 H293406 H293451 H293496 H293543 H293591 H293636 H291203 H291248 H293315 H293361 H293407 H293452 H293497 H293544 H293592 H293637 H291204 H291249 H293316 H293362 H293408 H293453 H293498 H293545 H293593 H293638 H291205 H291250 H293317 H293363 H293409 H293454 H293499 H293546 H293594 H293639 H291206 H291251 H293318 H293364 H293410 H293455 H293500 H293548 H293595 H293640 H291207 H291252 H293319 H293365 H293411 H293456 H293501 H293549 H293596 H293641 H291208 H291253 H293320 H293366 H293412 H293457 H293502 H293550 H293597 H293642 H291209 H291254 H293321 H293367 H293413 H293458 H293503 H293551 H293598 H293643 H291210 H291255 H293322 H293368 H293414 H293459 H293504 H293552 H293599 H293644 H291211 H291256 H293323 H293369 H293415 H293460 H293505 H293553 H293600 H293645 H291212 H291257 H293324 H293370 H293416 H293461 H293506 H293554 H293601 H293646 H291213 H291258 H293325 H293371 H293417 H293462 H293507 H293555 H293602 H293647 H291214 H291259 H293326 H293372 H293418 H293463 H293508 H293556 H293603 H293648 H291215 H291260 H293327 H293373 H293419 H293464 H293509 H293557 H293604 H293649 H291216 H291261 H293328 H293374 H293420 H293465 H293510 H293558 H293605 H293650 H291217 H291262 H293329 H293375 H293421 H293466 H293511 H293559 H293606 H293651 H291218 H291263 H293330 H293376 H293422 H293467 H293512 H293560 H293607 H293652 H291219 H291264 H293331 H293377 H293423 H293468 H293513 H293561 H293608 H293653 H291220 H291265 H293332 H293378 H293424 H293469 H293514 H293562 H293609 H293654 H293655 H293702 H293750 H293798 H293846 H293891 H293941 H293989 H294037 H294085 H293656 H293703 H293751 H293799 H293847 H293892 H293942 H293990 H294038 H294086 H293657 H293704 H293752 H293800 H293848 H293893 H293943 H293991 H294039 H294088 H293658 H293705 H293753 H293801 H293849 H293894 H293944 H293992 H294040 H294089 H293659 H293706 H293754 H293802 H293850 H293895 H293946 H293993 H294041 H294090 H293660 H293707 H293755 H293803 H293851 H293896 H293947 H293994 H294042 H294091 H293661 H293708 H293756 H293804 H293852 H293897 H293948 H293995 H294043 H294092 H293662 H293709 H293758 H293805 H293853 H293898 H293949 H293996 H294044 H294093 H293663 H293710 H293759 H293806 H293854 H293899 H293950 H293997 H294045 H294095 H293664 H293712 H293760 H293807 H293855 H293900 H293951 H293998 H294046 H294097 H293665 H293713 H293761 H293808 H293856 H293901 H293952 H293999 H294047 H294098 H293666 H293714 H293762 H293809 H293857 H293902 H293953 H294000 H294048 H294099 H293667 H293715 H293763 H293812 H293858 H293903 H293954 H294001 H294049 H294100 H293668 H293716 H293764 H293813 H293859 H293904 H293955 H294002 H294050 H294101 H293669 H293717 H293765 H293814 H293860 H293905 H293956 H294003 H294051 H294102 H293670 H293718 H293767 H293815 H293861 H293907 H293957 H294004 H294052 H294103 H293671 H293719 H293769 H293816 H293862 H293908 H293958 H294005 H294053 H294104 H293672 H293720 H293770 H293817 H293863 H293909 H293959 H294006 H294054 H294105 H293673 H293721 H293771 H293818 H293864 H293910 H293960 H294007 H294055 H294106 H293674 H293723 H293772 H293819 H293865 H293911 H293962 H294008 H294056 H294107 H293675 H293724 H293773 H293820 H293866 H293912 H293963 H294009 H294058 H294108 H293676 H293725 H293774 H293821 H293867 H293913 H293964 H294010 H294059 H294109 H293678 H293726 H293775 H293822 H293868 H293914 H293965 H294011 H294060 H294110 H293679 H293727 H293776 H293823 H293869 H293915 H293966 H294012 H294061 H294111 H293681 H293728 H293777 H293824 H293870 H293916 H293967 H294013 H294062 H294112 H293682 H293729 H293778 H293825 H293871 H293917 H293968 H294016 H294063 H294113 H293683 H293730 H293779 H293826 H293872 H293918 H293969 H294017 H294064 H294114 H293684 H293732 H293780 H293827 H293873 H293919 H293970 H294018 H294065 H294116 H293685 H293733 H293781 H293828 H293874 H293920 H293971 H294020 H294067 H294117 H293686 H293734 H293782 H293829 H293875 H293921 H293972 H294021 H294068 H294118 H293687 H293735 H293783 H293830 H293876 H293922 H293974 H294022 H294069 H294119 H293688 H293736 H293784 H293831 H293877 H293923 H293975 H294023 H294070 H294120 H293689 H293737 H293785 H293832 H293878 H293924 H293976 H294024 H294071 H294121 H293690 H293738 H293786 H293834 H293879 H293925 H293977 H294025 H294072 H294122 H293691 H293739 H293787 H293835 H293880 H293926 H293978 H294026 H294073 H294123 H293692 H293740 H293788 H293836 H293881 H293928 H293979 H294027 H294074 H294124 H293693 H293741 H293789 H293837 H293882 H293929 H293980 H294028 H294075 H294125 H293694 H293742 H293790 H293838 H293883 H293930 H293981 H294029 H294076 H294126 H293695 H293743 H293791 H293839 H293884 H293931 H293982 H294030 H294077 H294127 H293696 H293744 H293792 H293840 H293885 H293932 H293983 H294031 H294078 H294128 H293697 H293745 H293793 H293841 H293886 H293933 H293984 H294032 H294079 H294129 H293698 H293746 H293794 H293842 H293887 H293934 H293985 H294033 H294080 H294130 H293699 H293747 H293795 H293843 H293888 H293935 H293986 H294034 H294081 H294131 H293700 H293748 H293796 H293844 H293889 H293936 H293987 H294035 H294082 H294132 H293701 H293749 H293797 H293845 H293890 H293938 H293988 H294036 H294083 H294133 H294134 H294186 H294240 H294299 H294366 H294168 H294217 H294273 H294327 H294298 H294135 H294187 H294241 H294301 H294372 H294169 H294218 H294275 H294328 H294361 H294136 H294188 H294242 H294302 H294373 H294170 H294219 H294276 H294330 H294363 H294137 H294189 H294243 H294303 H294376 H294172 H294220 H294277 H294331 H294364 H294138 H294190 H294244 H294304 H294377 H294173 H294221 H294278 H294332 H294140 H294191 H294245 H294306 H294378 H294174 H294222 H294279 H294333 H294142 H294192 H294246 H294307 H294380 H294175 H294223 H294280 H294334 H294143 H294193 H294247 H294308 H294381 H294176 H294224 H294281 H294336 H294144 H294194 H294252 H294309 H294382 H294177 H294225 H294282 H294337 H294145 H294195 H294254 H294312 H294384 H294178 H294226 H294283 H294338 H294146 H294196 H294256 H294314 H294386 H294179 H294227 H294285 H294340 H294148 H294197 H294257 H294316 H294389 H294180 H294228 H294286 H294341 H294149 H294198 H294258 H294317 H294392 H294181 H294230 H294287 H294342 H294150 H294199 H294261 H294318 H294159 H294182 H294232 H294288 H294343 H294151 H294200 H294262 H294320 H294161 H294184 H294234 H294289 H294348 H294152 H294201 H294263 H294321 H294162 H294185 H294235 H294290 H294350 H294154 H294202 H294264 H294322 H294163 H294208 H294236 H294293 H294353 H294155 H294203 H294266 H294323 H294164 H294209 H294237 H294294 H294354 H294156 H294204 H294267 H294324 H294165 H294210 H294239 H294295 H294355 H294157 H294205 H294269 H294325 H294166 H294214 H294271 H294296 H294358 H294158 H294207 H294270 H294326 H294167 H294216 H294272 H294297, & H294360 
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter dated May 8, 2009. Firm initiated recall is ongoing.
REASON
Potential mistreatment-- due to software issues, retired plans may be used and treated repeatedly.
VOLUME OF PRODUCT IN COMMERCE
1,587 units
DISTRIBUTION
Nationwide and Internationally
___________________________________
PRODUCT 
Pyxis Anesthesia System 3500, The Pyxis Anesthesia Station 3500 is a medication dispensing product that provides medication and inventory management for the anesthesiologist at the point of care within the operating room. The system tracks and stores controlled substances, medications and supplies for anesthesia providers and automates verification of patient usage records, documents waste, manages inventory levels and tracks utilization. Recall # Z-1883-2009
CODE
Serial Numbers: 710170646, 710170647, 710172138, 710172139, 710172227, 710172228, 710172716, 710172717, 710172883, 710172884, 710173038, 8000030317, 8000100629, 8000119658, 8000120032, 8000120033, 8000120034, 8000120036, 8000120037, 8000120038, 8000120040, 8000120042, 8000120945, 8000120946, 12838303, 12838304, 12838305, 12838306, 12838307, 12838308, 12838309, 12838311, 12838312, 12838313, 12838314, 12838315, 12780360, 12780361, 12780362, 12810275, 12810277, 12810278, 12810280, 12810282, 12810284, 12810286, 12810288, 12847974, 12847975, 12847976, 12847977, 12852780, 12852781, 12852782, 12852783, 12853714, 12853715, 12853716, 12847978, 12813196, 12835697, 12835698, 12858993, 12720368, 12720369, 12720371, 12753364, 12753365, 12753366, 12753368, 12753369, 12753370, 12753371, 12753372, 12753374, 12753727, 12753728, 12753729, 12753730, 12753732, 12753733, 12753734, 12813195, 12813197, 12804383, 12804384, 12804385, 12804386, 12804387, 12804388, 12804389, 12804390, 12804391, 12804392, 12862538, 12862541, 12862543, 12862544, 12862546, 12862547, 12862548, 12862549, 12862550, 12862551, 12862552, 12862553, 12862554, 12862555, 12862556, 12862557, 12862558, 12862559, 12862560, 12862561, 12862562, 12862563, 12862564, 12876732, 12655533, 12655534, 12655536, 12655537, 12655538, 12655539, 12655540, 12874928, 12867424, 12867425, 12867426, 12867427, 12867428, 12867430, 12867431, 12867433, 12867434, 12838367, 12853706, 12853707, 12853708, 12888255, 12720368, 12720369, 12720371, 12592245, 12874930, 12795130, 12795131, 12795132, 12795133, 12795134, 12795135, 12795136, 12795137, 12795138, 12843701, 12843702, 12843703, 12843753, 12843754, 12843755, 12843756, 12843757, 12843758, 12843759, 12843760, 12783138, 12783139, 12783140, 12874932, 12563061, 12563062, 12563063, 12563064, 12856793, 12874371, 12874372, 12874373, 12874374, 12874375, 12874376, 12874377, 12874378, 12874379, 12874380, 12874381, 12874382, 12874383, 12874384, 12819556, 12819557, 12819558, 12819559, 12819560, 12819561, 12786488, 12786489, 12786490, 12843768, 12843770, 12843771, 12843772, 12868966, 12868972, 12870869, 12870870, 12870871, 12870872, 12870873, 12870874, 12870875, 12870876, 12870877, 12870878, 12870879, 12807345, 12871437, 12872230, 12811867, 12811868, 12843749, 12843750, 12810158, 12834022, 12511905, 12511906, 12511907, 12511908, 12511909, 12514284, 12515162, 12515163, 12515164, 12515165, 12515166, 12515167, 12515168, 12515169, 12517084, 12517085, 12517086, 12517087, 12517088, 12517089, 12517090, 12517091, 12517092, 12549935, 12549937, 12549939, 12549942, 12549944, 12549946, 12552472, 12552473, 12552474, 12552475, 12552476, 12552477, 12759450, 12587758, 12587763, 12587765, 12587771, 12595383, 12595386, 12595389, 12595392, 12596725, 12600728, 12600729, 12600730, 12600731, 12600732, 12600734, 12600736, 12600737, 12600741, 12814051, 12814052, 12814053, 12814054, 12814055, 12814056, 12814057, 12814058, 12534219, 12534220, 12534222, 12534225, 12534229, 12816644, 12816645, 12816646, 12827011, 12827012, 12827013, 12827014, 12827015, 12827016, 12827017, 12827018, 12827019, 12827021, 12827023, 12827024, 12827025, 12827026, 12827027, 12827028, 12847184, 12847185, 12847186, 12847187, 12847188, 12847189, 12847190, 12847191, 12847192, 12847193, 12847194, 12795140, 12838351, 12838352, 12546145, 12806536, 12587761, 12587762, 12592236, 12592239, 12592246, 12595384, 12595385, 12595398, 12596715, 12596721, 12808661, 12808663, 12808664, 12808665, 12808666, 12808667, 12752926, 12752927, 12752928, 12752930, 12753353, 12753354, 12753355, 12753356, 12753357, 12753358, 12753359, 12753360, 12753361, 12753362, 12753363, 12852784, 12852785, 12854988, 12854989, 12854990, 12854991, 12854992, 12854993, 12854994, 12854995, 12854996, 12854997, 12854998, 12763732, 12763737, 12787545, 12787546, 12787547, 12787548, 12787550, 12787551, 12792520, 12793260, 12793261, 12847182, 12847183, 12822094, 12822095, 12822096, 12601449, 12795866, 12795867, 12795868, 12795869, 12795870, 12795871, 12795872, 12795873, 12795874, 12795875, 12795876, 12803181, 12835700, 12835701, 12835702, 12835703, 12835704, 12835705, 12835706, 12835707, 12835708, 12835709, 12835710, 12835711, 12835712, 12556158, 12556159, 12556160, 12556161, 12556162, 12556163, 12556164, 12556165, 12556166, 12556167, 12556168, 12559460, 12559461, 12753735, 12753736, 12754540, 12754544, 12754545, 12754547, 12754551, 12754552, 12754554, 12822757, 12822758, 12822759, 12822760, 12822763, 12822769, 12822770, 12822771, 12822772, 12822773, 12822775, 12822776, 12822777, 12822778, 12822779, 12822780, 12823498, 12823499, 12823500, 12823502, 12823503, 12823504, 12823505, 12823506, 12823507, 12823508, 12823509, 12875428, 12834957, 12834958, 12834959, 12834960, 12834961, 12834962, 12822053, 12822054, 12822055, 12822056, 12804393, 12833156, 12833157, 12833158, 12833159, 12834025, 12834026, 12847967, 12847968, 12847969, 12579903, 12579904, 12579905, 12579907, 12579911, 12579912, 12579913, 12579914, 12579915, 12579921, 12579922, 12579923, 12579924, 12579925, 12585045, 12585046, 12585047, 12585048, 12585049, 12585050, 12585051, 12585052, 12585053, 12585054, 12585058, 12585060, 12585061, 12597965, 12619056, 12638091, 12638092, 12638093, 12662280, 12810152, 12810153, 12810154, 12811742, 12811743, 12811744, 12811745, 12876733, 12601175, 12601176, 12526773, 12526774, 12526775, 12786259, 12786260, 12786261, 12786262, 12786264, 12786265, 12786266, 12786267, 12786268, 12786269, 12786270, 12786271, 12592234, 12592241, 12592242, 12860198, 12863837, 12863838, 12863839, 12863840, 12583173, 12583173, 12583174, 12583175, 12872243, 12872244, 12872245, 12872246, 12872248, 12872249, 12872250, 12872252, 12872253, 12872255, 12872256, 12872257, 12872258, 12873760, 12761945, 12761946, 12761947, 12761948, 12761949, 12761950, 12761951, 12763244, 12763244, 12765330, 12765337, 12765338, 12765339, 12791937, 12850276, 12850277, 12850278, 12850279, 12850280, 12850282, 12850283, 12851321, 12851326, 12851328, 12851329, 12851330, 12851331, 12851334, 12851347, 12851348, 12853709, 12853710, 12853711, 12853712, 12853713, 12782360, 12782361, 12791938, 12850275, 12850276, 12850277, 12850278, 12850279, 12850280, 12850282, 12850283, 12568466, 12580045, 12582587, 12582589, 12833067, 12833068, 12559458, 12559459, 12858992, 12858994, 12858996, 12858999, 12859005, 12859007, 12859008, 12859009, 12859010, 12859012, 12859013, 12861135, 12843747, 12853836, 12838368, 12838369, 12816647, 12816648, 12817410, 12817411, 12817412, 12817413, 12817414, 12817415, 12873755, 12858995, 12858997, 12858998, 12859000 12859001, 12859002, 12859003, 12847970, 12847971, 12847972, 12857866, 12857868, 12857869 12857870, 12860199, 12860201, 12860203, 12860204, 12860205, 12860206, 12860207, 12860209, 12860211, 12860213, 12860214, 12860215, 12873042, 12873043, 12873044, 12873045, 12791875, 12791876, 12791877, 12791878, 12791879, 12791880, 12791881, 12791882, 12791883, 12791884, 12791885, 12811001, 12811002, 12811003, 12811004, 12811005, 12811006, 12811007, 12811008, 12811009, 12811011, 12851320, 12851322, 12851323, 12851325, 12851327, 12822768, 12830021, 12830022, 12830023, 12830024, 12830025, 12830026, 12830027, 12830028, 12830029, 12830030, 12833044, 12846390, 12846391, 12846392, 12846393, 12846394, 12846395, 12846396, 12846397, 12846398, 12846400, 12846401, 12847966, 12798023, 12798024, 12798025, 12798026, 12798027, 12806530, 12806531, 12806532, 12806533, 12806534, 12806535, 12797279, 12874316, 12874385, 12874386, 12874387, 12874315, 12806524, 12809423, 12809424, 12809425, 12809426, 12809427, 12809428, 12809429, 12809430, 12809431, 12838342, 12838343, 12838344, 12838345, 12843761, 12874931, 12818210, 12559462, 12600996, 12600997, 12600998, 12600999, 12601000, 12807994, 12807995, 12807996, 12807997, 12807998, 12807999, 12808000, 12808001, 12601447, 12803177, 12803178, 12803179, 12803180, 12803852, 12806525, 12806526, 12806527, 12806528, 12813190, 12813191, 12813192, 12813193, 12815783, 12815784, 12815785, 12815786, 12815787, 12815788, 12815789, 12815790, 12815791, 12815792, 12873037, 12873038, 12873039, 12873040, 12848975, 12848976, 12848977, 12848978, 12848979, 12848980, 12848981, 12848982, 12848983, 12848984, 12848985, 12848986, 12838316, 12838317, 12838318, 12838319, 12820596, 12820597, 12820598, 12820599, 12820600, 12820601, 12820602, 12820603, 12820604, 12820605, 12820606, 12820607, 12820608, 12820609, 12820610, 12820611, 12820612, 12820613, 12820614, 12820615, 12820616, 12820617, 12820618, 12820619, 12820620, 12820621, 12820622, 12820623, 12820624, 12820625, 12820626, 12870867, 12822092, 12822093, 12830896, 12830897, 12830898, 12830899, 12830900, 12830901, 12830902, 12830903, 12830904, 12830905, 12830906, 12830907, 12830908, 12830909, 12830910, 12830911, 12830912, 12833042, 12833043, 12838346, 12803853, 12803854, 12803855, 12803856, 12803857, 12803858, 12803859, 12874925, 12874926, 12874927, 12822767, 12829260, 12829266, 12829267, 12829268, 12829269, 12829270, 12829271, 12829272, 12833045, 12773706, 12773707, 12583172, 12600993, 12600994, 12600995, 12838347, 12838348, 12838349, 12838350, 12556216, 12556217, 12556218, 12556219, 12556220, 12556221, 12556222 12556223, 12556224, 12556225, 12556226, 12556227, 12789734, 12789735, 12856569, 12856570, 12856572, 12856573, 12587764, 12592240, 12592243, 12592244, 12592247, 12592248, 12600738, 12601006, 12601174, 8000120039, 8000120041, 8000121851, 8000121852, 8000121853, 8000121854, 8000121855, 8000121856, 8000121857, 8000121858, 8000121859, 8000121860, 8000121861, 8000121862, 8000121863, 8000121864, 12600727, 12600740, 12601002, 12601004, 12601511, 12794398, 12794399, 12794400, 12794401, 12794402, 12818805, 12818806, 12818807, 12818808, 12818809, 12834965, 12834966, 12541280, 12541281, 12541282, 12541283, 12541284, 12541285, 12851337, 12851338, 12851339, 12851340, 12851341, 12851342, 12851344, 12851345, 12851346, 12488428, 12488431, 12488433, 12488435, 12538087, 12870868, 12795859, 12834012, 12834013, 12834014, 12834015, 12834016, 12834017, 12834018, 12834019, 12834020, 12834021, 12834023, 12834024, 12850288, 12850289, 12850290, 12850291, 12850292, 12850293, 12850294, 12850295, 12850296, 12850297, 12850298, 12850299, 12850300, 12850301, 12850302, 12818798, 12818799, 12818803, 12818804, 12773619, 12773621, 12773622, 12773623, 12773624, 12773625, 12773626, 12868968, 12868969, 12868970, 12868971, 8000118955, 8000118956, 8000118957, 8000118958, 8000118959, 8000118960, 8000118961, 8000118962, 8000118963, 8000118964, 8000118965, 8000118966, 8000118967, 8000118968, 8000118969, 12857851, 12857852, 12857853, 12857851, 12857852, 12857853, 12833160, 12836437, 12836438, 12836439, 12836440, 12836441, 12836442, 12836443, 12856571, 12872247, 12873756, 12873757, 12873758, 12873759, 12873761, 12873762, 12873763, 12873765, 12587284, 12587285, 12589063, 12589067, 12589069, 12589071, 12589072, 12589074, 12589075, 12589076, 12589077, 12589078, 12589079, 12709624, 12709626, 12811013, 12811015, 12797278, 12871438, 12871440, 12871441, 12871442, 12871443, 12871444, 12784008, 12784009, 12784010, 12784011, 12811869, 12752918, 12752919, 12752920, 12752921, 12752922, 12752924, 12752925, 12568468, 12574027, 12582585, 12594132, 12591366, 12591367, 12594129, 12594130, 12594131, 12601172, 12601173, 12601308, 12601309, 12601451, 12798042, 12798043, 12798044, 12798045, 12798046, 12798047, 12798049, 12798050, 12798051, 12798053, 12802151, 12813194, 12774791, 12774792, 12602063, 12583172, 12600993, 12600994, 12600995, 12786263, 12786272, 12843776, 12843777, 12843779, 12843780, 12847973, 12840507, 12840508, 12840509, 12840510, 12840511, 12840512, 12840513, 12840514, 12833046, 12798894 12798895, 12798896, 12798897, 12798898, 12798899, 12810275, 12810277, 12810278, 12810280, 12810282, 12810284, 12810286, 12810288 and 12856794.
RECALLING FIRM/MANUFACTURER
Cardinal Health Manufacturing, LLC, San Diego, CA, by letter on December 17, 2008. Firm initiated recall is ongoing.
REASON
Cardinal Health has sent out a Safety Alert Notification to inform its customers that the SR2b Software for the Pyxis Anesthesia System 3500 (PAS 3500) has received several customer reports of system "non-responsiveness" (lock ups) during the use of the product since its release in September 2008.
VOLUME OF PRODUCT IN COMMERCE
250 units
DISTRIBUTION
Nationwide and Germany
___________________________________
PRODUCT 
Stryker Trio Connector Hex Socket for Torque Wrench 3.5MM Not Sterile: Catalog number 48906075. The Trio 3.5MM Hex Socket is a reusable instrument, sterilized prior to use, used with the Trio Torque Wrench to facilitate final tightening of Trio connectors and 3.5MM Hex Screw Assembly. This Trio 3.5MM Hex Socket is used with the Trio implant system for posterior noncervical pedical and non pedical fixation of the spine. Recall # Z-1886-2009
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ, by letters on July 1, 2009.
Manufacturer: Stryker Spine, Cestas, Aquitane, France. Firm initiated recall is ongoing.
REASON
The Trio 3.5MM Hex socket has been reported to break under high stresses.
VOLUME OF PRODUCT IN COMMERCE
143 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Edwards LifeSciences, Percutaneous Sheath Introducer Set, Rx only, For single use only. Indicated for use in patients requiring access of the venous system or to facilitate catheter insertion. a) Model Number: 1350BF85, b) Model Number: 1351BF7, c) Model Number: 1351BF85H, d) Model Number: 1450BF85, e) Model Number: 1451BF6, f) Model Number: 1451BF8, g) Model Number: 1452BF85H, h) Model Number: 1550BF6C, i) Model Number: 1550BF7C, j) Model Number: 1550BF8, k) Model Number: 1550BF85, l) Model Number: 1551BF85H, m) Model Number: 1650BF85, n) Model Number: 1651BF85, o) Model Number: 1652BF85H, p) Model Number: S310740C, and q) Model Number: S5507BF85. Recall # Z-1913-2009   
CODE
a) Lot Numbers: 58501071, 58516969, 58545402, 58568606, 58584153, 58606248, 58624009, 58648809, 58503807, 58532828, 58549292, 58573256, 58594977, 58611630, 58626772, 58652695, 58511627, 58536781, 58552776, 58576340, 58598946, 58611631, 58630984, 58653740, 58516967, 58536782, 58559223, 58577684, 58602066, 58618047, 58636148, 58653741, 58516968, 58541155, 58559224, 58577685, 58606247, 5864008 and 58645016; b) Lot Numbers: 58530069, 58545403, 58598947 and 58657088; c) Lot Numbers: 58526054, 58532992, 58534647, 58552777, 58559225, 58576341, 58594979, 58594980, 58598948, 58602067, 58624011, 58630985, 58636149, 58648810 and 58657097; d) Lot Numbers: 58511628, 58516970, 58577686, 58589282, 58598949, 58615054, 58624015, 58635275 and 58664034; e) Lot Numbers: 58506614, 58526055, 58562341, 58577589, 58594981, 58615056, 58621700, 58635275, 58657143 and 58664035; f) Lot Numbers: 58511629, 58514509, 58514513, 58530070, 58532829, 58541156, 58549294, 58556099, 58564225, 58568607, 58573257, 58584154, 58602069, 58606249, 58610319, 58615059, 58621701, 58648811, 58652696, 58660278 and 58685275; g) Lot Numbers: 58503809, 58549295, 58576343, 58611633, 58630986 and 586652697; h) Lot Numbers: 58499574, 58501074, 58530071, 58532830, 58562343, 58602070, 58626774 and 58652698; i) Lot Numbers: 58564227, 58577700 and 58657145; j) Lot Numbers: 58499575, 58526057, 58549298, 58560116, 58564228 and 58573260; k) Lot Numbers: 58501075, 58530072, 58534652, 58536809, 58577701, 58598950, 58618048 and 58657146; l) Lot Numbers: 58615062, 58630987 and 58652699; m) Lot Numbers: 58545404, 58564229, 58584155, 58589283, 58618049, 58645018 and 58660284; n) Lot Numbers: 58499633, 58501080, 58511630, 58541157, 58556100, 58559226, 58584156, 58602071, 58615072, 58621702, 58645019 and 58652700; o) Lot Numbers: 58511631, 58549300, 58606253 and 58648812; p) Lot Number: 58550203; and q) Lot Numbers: 58496258, 58535112, 58604814 and 58644423
RECALLING FIRM/MANUFACTURER
Recalling Firm: Edwards Lifesciences, LLC, Irvine, CA, by letters dated May 11, 2009.
Manufacturer: Edwards Lifesciences Technology SARL, Anasco, PR. Firm initiated recall is ongoing.
REASON
Edwards LifeSciences LLC received several complaints, in which the blue connector of the introducer assembly has broken (fracture/separation) after several hours of use.
VOLUME OF PRODUCT IN COMMERCE
67,357 units
DISTRIBUTION
Nationwide, Austria, Canada, Switzerland, Czech, Republic, Germany, Denmark, Algeria, Estonia, Egypt, Spain, Finland, France, Great Britain, Hungary, Iceland, Ireland, Italy, Kuwait, Lithuania, Luxembourg, Latvia, Netherlands, Norway, Poland, Portugal, Romania, Russia, Sweden, Slovak republic, Tunisia, Turkey, Aruba, Hong Kong, Malaysia and Singapore
___________________________________
PRODUCT 
AMPLILINK Software, version 3.1.0 to 3.2.2 with COBAS AmpliPrep. Catalog number 03563383001, catalog number 04855094001, catalog number 04807197001, catalog number 04862392001, catalog number 05093236001, and catalog number 05201357001. Automated sample preparation for nucleic acid analysis on either the COBAS TaqMan or COBAS TaqMan 48. COBAS AmpliPrep/COBAS TaqMan is capable of tuning HBV, HCV, and HIV tests. Recall # Z-1928-2009
CODE
Version 3.1.0, Version 3.1.1, Version 3.1.2, Version 3.2.0, Version 3.2.1, and Version 3.2.2.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche Molecular Systems, Inc., Somerville, NJ, by letters on June 2, 2009.
Manufacturer: Roche Instrument Center AG, Rotkreuz, Switzerland. Firm initiated recall is ongoing.
REASON
Software bug: A unique series of events involving the COBAS AmpliPrep instrument running AMPLILINK software version 3.2.2 that results in specimens being amplified and detected with the wrong parameters. The error can occur on either COBAS AmpliPrep/COBAS TaqMan 48, COBAS AmpliPrep/COBAS TaqMan (docked) or cobas s 201 system (docked) running Amplilink Software versions 3.1 or 3.2 series up to and including 3.2.2.
VOLUME OF PRODUCT IN COMMERCE
282 units
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
FreeStyle Lite Blood Glucose Test Strips, CSP, 50's US, Checkpoint, FS Lite, for use with FreeStyle Lite Blood Glucose Meters and FreeStyle Freedom Lite Blood Glucose Meters, Part Number 70822-02. The product is used for testing outside the body (in vitro) diagnostic use, in the home and in professional settings to monitor blood glucose levels. Recall # Z-1936-2009 
CODE
Lot number 0822524, expiration date 2010/08
RECALLING FIRM/MANUFACTURER
Abbott Diabetes Care, Inc., Alameda, CA, by letter dated June 10, 2009. Firm initiated recall is ongoing
REASON
Low results: Freestyle Lite Blood Glucose Test strip may generate low blood glucose readings when tested with the control solution from lot 0822524 with Freestyle Freedom Lite and Freestyle Lite Blood Glucose Meters.
VOLUME OF PRODUCT IN COMMERCE
9,252 vials
DISTRIBUTION
AL, AZ, CA, FL, GA, IL, IN, MD, NJ, NY, OH, PA, RI, SC, TN, TX and WI
___________________________________
PRODUCT 
Maxilift Patient Lift, Non-AC Powered; a patient lift with a four point tilting frame, adjustable chassis, and optional electronic scale, to move patients in a hospital/nursing home situation; Model numbers 21102406, 21200001, 21200006, 21000-01, 210024-06, 211010-06, 211024-06, 211026, 212000-06, 212000-06R, 212000-6, 212024-06, 212026, 212624, 218100-01, KGA0200, KMA0520, KMA1003-04, KMA1004, KMA1005, KMA1006, KMA1040, KMA1501-06, KMA1513-06, KMA211024, KMA82124-24, KMB2351, KMB4800-06, KMB4900-06, KMB5501-12US, KRA0300, KRA0310, KRA1000, KRA1500-12, KRA2100, KRA3000-12, MA0500, MA0510, MA1010, MA1020, MA1100, MA1500, Maxi Pillar, Maxilift, Maxipillar, MAXIPILLER, MB0500R, MB0510, and MB0610. The patient lift is intended to move and transport patients/residents under the direct supervision of trained staff. Recall # Z-1945-2009
CODE
All models and all serial numbers of Maxilifts manufactured prior to January 1, 1997.
RECALLING FIRM/MANUFACTURER
Recalling Firm: ArjoHuntleigh, Addison, IL, by letter on April 27, 2009.  
Manufacturer: Arjo Med. AB, Gloucester, United Kingdom. Firm initiated recall is ongoing.
REASON
The roll pin on certain configurations of the Maxilift hanger bar could break due to a combination of severe corrosion and fatigue. Breakage of the roll pin would lead to the detachment of the hanger bar from the jib of the lifter.
VOLUME OF PRODUCT IN COMMERCE
8,015 lifts
DISTRIBUTION
Nationwide and Mexico
___________________________________
PRODUCT 
BARD Simpulse" SOLO System with Soft Splash Shield Tip Product Code: 0067590. The Simpulse SOLO Suction/Irrigator is designed to provide controlled powered irrigation during open orthopedic and general surgical procedures and for the cleansing of burns or wounds. Appropriate fluids for use include fluids with specific gravity less than 1. The pulsatile action of the pump helps to remove blood, tissue debris and foreign matter from the operative or wound site. When connected to a suction source, the device can be used to aspirate fluids from the operative or wound site. Recall # Z-1948-2009
CODE
Lot Number: JUSHF083
RECALLING FIRM/MANUFACTURER
Recalling Firm: Davol, Inc., Sub. C. R. Bard, Inc., Warwick, RI, by letter dated July 30, 2009.
Manufacturer: Davol Surgical Innovations S.A. de C.V., Chihuahua, Mexico. Firm initiated recall is ongoing.
REASON
Product sterility may be compromised due to lack of package integrity.
VOLUME OF PRODUCT IN COMMERCE
1,440 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
MDI Hybrid Implant, O-Ball abutment, sizes 2.9mm x 13mm and 2.9mm x 15mm, endosseous dental implant. The product is used as a endosseous dental implant. a) product code MII-OB13; b) product code MII-OB15. Recall # Z-1997-2009  
CODE
a) Lot numbers: 3503092-43 and 3503093-19; b) Lot number: 352092-56
RECALLING FIRM/MANUFACTURER
IMTEC Corp., Ardmore, OK, by letter dated July 7, 2009. Firm initiated recall is ongoing.
REASON
Size printed on product packaging does not match size of enclosed product.
VOLUME OF PRODUCT IN COMMERCE
605 units
DISTRIBUTION
Nationwide, Azerbaijan, Guatemala, Turkey, and Germany
___________________________________
PRODUCT 
1) Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F, NON STERILE, REF 000256. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support. Recall # Z-2017-2009;

2) Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.2cm, NON STERILE, REF 000292. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support. Recall # Z-2018-2009;

3) Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000282. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support. Recall # Z-2019-2009;

4) Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 2.4cm, NON STERILE, REF 000283. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support. Recall # Z-2020-2009;

5) Bard * Button Device Continuous Feeding Tube with 90 degree Adaptor, 18F x 1.7cm, NON STERILE, REF 000284. The device is designed for use with the BARD Button Replacement Gastrostomy Device and used for enteral feeding in patients requiring long-term nutritional support. Recall # Z-2021-2009
CODE
1) Lot Numbers: HUSA1412, HUSD0045, HUSD0046, HUSD0047, HUSD0048, HUSD0049, HUSD0050, HUSD0052 and HUSD0351;

2) Lot numbers: HUSD1971, HUSD0126 and HUSD1972;

3) Lot Numbers: HUSD1960 and HUSD1959;

4) Lot numbers: HUSD0118, HUSD1610 and HUSD0116;

5) Lot Numbers: HUSD1611, HUSD1963, HUSD0119, HUSD0120 and HUSD1962
RECALLING FIRM/MANUFACTURER
C R Bard Inc., Salt Lake City, UT, by letter January 20, 2009. Firm initiated recall is ongoing.
REASON
Possible restriction/occlusion in adaptors/tube accessories causing difficulty to infuse during routine feeding treatment.
VOLUME OF PRODUCT IN COMMERCE
13,337 units
DISTRIBUTION
Nationwide, Canada, Austria, Australia, Belgium, Finland, France, Germany, Great Britain, Holland, Italy, Norway, Spain, Sweden and Switzerland, Japan, and Latin America
___________________________________
PRODUCT 
Integra NeuroSciences a) Ventrix Ventricular Tunneling Pressure Monitoring Kit NL950-V and b) Integra NeuroSciences Ventrix Ventricular Tunneling Pressure Monitoring Kit with Ventricular Drainage System NL950-VC. This intracranial pressure (ICP) catheter is indicated for use on patients that require continuous invasive intracranial pressure monitoring and/or cerebrospinal drainage. Access is achieved through a tunneled technique using the included trocar. Recall # Z-2053-2009
CODE
a) Lot Numbers: 30500R130474, exp. 8/31/2011; 30500R134098, exp. 10/31/2011; 30500R139222, exp. 11/30/2011; 30500R143588, exp. 1/31/2012; 30500R146383, exp. 1/31/2012; 30500R147342, exp. 2/29/2012; and 30500R147899, exp. 2/29/2012; b) Lot Numbers: 138999, exp. 9/30/2011; and 142754, exp. 12/31/2011
RECALLING FIRM/MANUFACTURER
Integra Neuro Sciences, San Diego, CA, letter dated March 23, 2009. Firm initiated recall is ongoing.
REASON
Due to a dimensional error, the diameter of the stylet provided with the device may be too large to insert into the lumen of the catheter tip.
VOLUME OF PRODUCT IN COMMERCE
274 Kits
DISTRIBUTION
AR, CA, OH, TX, CT, NY, LA, FL, NY, IL, VA, Belgium and Malaysia
___________________________________
PRODUCT 
1) Nerve Block Tray, Disposable, Convenience Kit, Reorder Number DYNJTS0382B. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2079-2009;

2) Universal Block Tray, Disposable, Convenience Tray, Reorder Number CUS1407-06. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2080-2009;

3) Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1234. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2081-2009;

4) Single Shot Epidural Tray, Disposable Convenience Kit, Reorder Number CUS1474-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2082-2009;

5) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number 10-2378. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2083-2009;

6) Hand Drill - Sterile, Disposable, Convenience Kit, Reorder Number INS030. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2084-2009;

7) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS511-08. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2085-2009;

8) Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1736-02. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2086-2009;

9) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1729-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2087-2009;

10) Block Tray, Disposable, Convenience Kit, Reorder Number CUS835. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2088-2009;

11) Biopsy Tray (BMTX-1039), Disposable, Convenience Kit, Reorder Number CUS1189. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2089-2009;

12) Nerve Block Tray, Disposable, Convenience Kit, Reorder Number CUS1044-02. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2090-2009;

13) Tuohy Needle, 20G X 3.5", Removable Wing, Plastic Hub, Metal Stylet, Calibrations (10BX), Disposable, Convenience Kit, Reorder Number PITRW2035. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2091-2009;

14) Custom Procedure Tray, Disposable, Convenience Kit, Reorder Number CUS015-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2092-2009;

15) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1453. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2093-2009;

16) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1427. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2094-2009;

17) Nerve Block Tray, Disposable, Convenience Kit, Reorder Number 10-2527. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2095-2009;

18) Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS651. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2096-2009;

19) Extension Set Pack, Disposable, Convenience Kit, Reorder Number CUS994. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2097-2009;

20) CHIBA Spinal 22G X 3.50, Plastic Hub, Metal Stylet, Disposable, Convenience Kit, Reorder Number PICH2235. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2098-2009;

21) Epidural Catheter Pack with Stylet, Disposable, Convenience Kit, Reorder Number CA20CES. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2099-2009;

22) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1722-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2100-2009;

23) Universal Painpak, Disposable, Convenience Kit, Reorder Number SS3278. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2101-2009;

24) South Texas Pain Tray, Disposable, Convenience Kit, Reorder Number CUS1308-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2102-2009;

25) Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1619. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2103-2009;

26) Universal Block Tray, Disposable, Convenience Kit, Reorder Number CUS1756. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2104-2009;

27) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS1593-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2105-2009;

28) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number SS1719. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2106-2009;

29) Complete Single Shot Tray, Disposable, Convenience Kit, Reorder Number CUS042. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2107-2009;

30) Single Shot Epidural Tray, Disposable, Convenience Kit, Reorder Number CUS185-01. Kits contain syringes, drugs, sponges, drapes and other products supplied by outside manufacturers / vendors to aid in certain medical / surgical procedures. Recall # Z-2108-2009
CODE
1) Lot number S0904563; 
2) Lot number S0905505; 
3) Lot number S0905532 
4) Lot number W0905157;
5) Lot number W0905203;
6) Lot number W0905239;
7) Lot number W0906011;
8) Lot number S0905510;
9) Lot number S0905540;
10) Lot number S0905512;
11) Lot number W0905025;
12) Lot number W0905032;
13) Lot number W0905067;
14) Lot number W0905077;
15) Lot number W0905156;
16) Lot number W0905158;
17) Lot number W0905217;
18) Lot number W0905224;
19) Lot number W0905235;
20) Lot number W0905242;
21) Lot number W0905244;
22) Lot number W0905251;
23) Lot number W0905257;
24) Lot number W0905284;
25) Lot number W0905291;
26) Lot number W0905298;
27) Lot number W0905313;
28) Lot number W0906019;
29) Lot number W0905061;
30) Lot number W0905021
RECALLING FIRM/MANUFACTURER
Integra Life Sciences Corp., Salt Lake City, UT, by telephone on July 09, 2009 and letter on July 13, 2009. Firm initiated recall is ongoing.
REASON
Lack of packaging seal integrity on various pain management kits may compromise sterility of contents.
VOLUME OF PRODUCT IN COMMERCE
3,594 trays
DISTRIBUTION
Nationwide, Belgium and Japan.
___________________________________
PRODUCT 
Biphasic LIFEPAK 15 Monitor/Defibrillator. The LIFEPAK 15 is a battery operated monitor with an external portable defibrillator used by healthcare providers in EMS, hospital and clinic settings. It operates in a manual or semi-automatic defibrillation mode and is offered with optional monitoring functions including Non-Invasive Blood Pressure (NIBP). When clinically indicated the LIFEPAK 15 allows the operator to deliver a brief, high energy, external shock through the chest to a patient's heart. Recall # Z-2110-2009
CODE
Serial numbers are various and non-contiguous: Domestic Device SN, 37937856, 37937866, 37963295, 37963300, 37963302, 37963322, 37963323, 37963328, 37924152, 37968424, 37968429, 37968715, 37968716, 37968717, 37968718, 37968721, 37968722, 37968724, 37923203, 37923213, 37964622, 37976542, 37976544, 37976545, 37976551, 37923162, 37923205, 37923208, 37923100, 37870245, 37924157, 37937888, 37923079, 37923153, 37923078, 37924153, 37963927, 37964561, 37928794, 37933262, 37930942, 37930944, 37930946, 37930964, 37930966, 37930977, 37930986, 37930988, 37930989, 37930990, 37930993, 37933240, 37933241, 37933244, 37937843, 37937846, 37937847, 37937848, 37937849, 37937850, 37937854, 37937855, 37937862, 37937870, 37937871, 37937873, 37937885, 37937886, 37937887, 37937891, 37937892, 37963929, 37964567, 37964592, 37963324, 37964615, 37964559, 37964585, 37964610, 37963935, 37968422, 37963932, 37964557, 37964569, 37964628, 37963931, 37964621, 37964630, 37968425, 37933257, 37963928, 37963325, 37963930, 37964591, 37964596, 37964587, 37964554, 37964609, 37964560, 37963926, 37964564, 37964626, 37964618, 37964600, 37964601, 37964607, 37963329, 37964594, 37963923, 37963327, 37963292, 37964613, 37964608, 37964575, 37964589, 37964623, 37964565, 37964588, 37964617, 37964599, 37964614, 37968427, 37928964, 37933267, 37930962, 37930968, 37930987, 37931003, 37933246, 37933249, 37933250, 37937842, 37937852, 37937864, 37937865, 37937867, 37937872, 37937874, 37937881, 37937883, 37937889, 37937890, 37937894, 37937896, 37964552, 37937851, , International Consignees Device SN, 37937845, 37937869, 37937884, 37937893, 37937895, 37963250, 37968304, 37445046, 37799902, 37799911, 37799913, 37799914, 37799915, 37800767, 37800768, 37800769, 37800771, 37803641, 37803642, 37803643, 37803644, 37803645, 37803646, 37803647, 37803648, 37803650, 37803651, 37804604, 37804605, 37804606, 37804607, 37804615, 37805136, 37805137, 37805138, 37805139, 37805140, 37805141, 37805142, 37805143, 37805144, 37805145, 37805146, 37805147, 37805148, 37805149, 37805150, 37805151, 37805152, 37805153, 37805154, 37805155, 37805156, 37805157, 37805158, 37805159, 37805160, 37805161, 37805162, 37805163, 37805164, 37805165, 37805166, 37805167, 37805168, 37805169, 37805170, 37805171, 37805172, 37805173, 37805174, 37805182, 37805183, 37805184, 37805185, 37805186, 37805187, 37805188, 37805189, 37805190, 37805191, 37805192, 37805193, 37805194, 37805195, 37805196, 37805197, 37805198, 37805199, 37805200, 37805201, 37805202, 37808586, 37808587, 37808588, 37808589, 37808590, 37808591, 37808592, 37808593, 37808594, 37808595, 37808596, 37808597, 37808598, 37808599, 37808600, 37810775, 37810776, 37810777, 37810778, 37810779, 37810780, 37810781, 37810782, 37810783, 37810784, 37810785, 37810786, 37810787, 37810788, 37810789, 37810819, 37810820, 37810821, 37810823, 37869808, 37869810, 37869811, 37869812, 37869814, 37869816, 37869817, 37869818, 37869820, 37869821, 37869822, 37869823, 37869824, 37869827, 37869828, 37869829, 37870210, 37870211, 37870213, 37870214, 37870215, 37870216, 37870217, 37870218, 37870219, 37870220, 37870221, 37870222, 37870223, 37870224, 37870225, 37870226, 37870228, 37870229, 37870236, 37870246, 37870247, 37870249, 37870250, 37870251, 37870252, 37870254, 37870255, 37870256, 37870258, 37870259, 37870260, 37900520, 37900602, 37900603, 37900604, 37900605, 37900607, 37900608, 37900610, 37900611, 37900612, 37900615, 37900616, 37900617, 37900618, 37900621, 37900622, 37900623, 37900624, 37900625, 37900626, 37900628, 37900629, 37900630, 37900631, 37900632, 37900633, 37923087, 37923112, 37923125, 37923155, 37923156, 37923201, 37923202, 37923204, 37923206, 37923210, 37923211, 37923214, 37924154, 37924156, 37924160, 37924163, 37924165, 37928454, 37928456, 37928457, 37928458, 37928459, 37928460, 37928461, 37928462, 37928463, 37928790, 37928791, 37928792, 37928793, 37928958, 37928967, 37933252, 37933253, 37933254, 37933259, 37933260, 37933261, 37933263, 37933264, 37933265, 37933266, 37933268, 37933269, 37933270, 37928968, 37930948, 37930960, 37930970, 37930976, 37930983, 37930984, 37930991, 37930994, 37930995, 37930997, 37930999, 37931000, 37931001, 37931005, 37933237, 37933238, 37933242, 37933245, 37933247, 37933248, 37933275, 37933276, 37933277, 37933280, 37937844, 37963303, 37968306, 37869809, 37869815, 37869825, 37869826, 37870212, 37923207, 37924155, 37924164, 37928455, 37928960, 37928961, 37933256, 37930940, 37930953, 37930972, 37930974, 37930979, 37930982, 37930992, 37930996, 37931004, 37933243, 37933251, 37933271, 37933273, 37933278, and 37933279
RECALLING FIRM/MANUFACTURER
Physio Control, Inc., Redmond, WA, by letter dated August 2009. Firm initiated recall is ongoing.
REASON
Some LIFEPAK 15 Monitor/Defibrillators have a Non-Invasive Blood Pressure (NIBP) module that was supplied by CAS Medical Systems, who is recalling the modules. The NIBP modules may be susceptible to sudden changes in cuff pressure. Sudden changes in cuff pressure may possibly be caused by bumping or squeezing the cuff. In some instances this may result in a screen display reading of "XXX" instead of a valid NlBP reading. If this happens, the NlBP function will be disabled until the device power is cycled off and back on. This issue does not impact delivery of defibrillation therapy or any other functions of the LIFEPAK 15 monitor/defibrillator.
VOLUME OF PRODUCT IN COMMERCE
445 devices
DISTRIBUTION
Nationwide, Australia, Germany and Netherland          
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PRODUCT 
Varian Medical Systems, Eclipse Proton Convolution Superposition DCF, version 8.6.15, Model H48, radiation therapy treatment planning system. Recall # Z-2231-2009
CODE
Code number H484023, version 8.6.15
RECALLING FIRM/MANUFACTURER
Varian Medical Systems Oncology Systems, Palo Alto, CA, by letter on July 17, 2009. Firm initiated recall is ongoing.
REASON
Software Issue/Mistreatment Potential -- Due to software issues, dose distribution may be incorrect and unintended radiation doses may be delivered.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
TX
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PRODUCT 
Oridion Medical Capnostream20 capnograph pulse oximeter monitor and monitor with printer. Part Number Part Description CS08651, Capnostream20 with Nellcor pulse oximetry module CS08653 Capnostream20 with Masimo pulse oximetry module CS08657 Capnostream20 with Nellcor pulse oximetry module and printer CS08659 Capnostream20 with Masimo pulse oximetry module and printer. Recall # Z-2232-2009
CODE
Software version V 3.0 and earlier
RECALLING FIRM/MANUFACTURER
Oridion Medical 1987 Ltd., Jerusalem, Israel, by letter on June 25, 2009. Firm initiated recall is ongoing.
REASON
1) The monitor’s ability to withstand electrostatic discharge (ESD) to exposed metal connectors on the back of the monitor which may cause the monitor’s display to freeze. 2) The unit generates electromagnetic radiation above the limits set by applicable standards for medical devices.
VOLUME OF PRODUCT IN COMMERCE
326 units
DISTRIBUTION
Nationwide
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PRODUCT 
1) Action Products, Inc., Bol-X-II, 30x30x0.5cm, item number 32052, packaged 10/carton. Polymer pad used during radiation therapy. Recall # Z-2236-2009;

2) Action Products, Inc., Bol-X-II, 30x30x1.0cm, item number 32102, packaged 10/carton. Polymer pad used during radiation therapy. Recall # Z-2237-2009
CODE
1) I1PSX-0000;  
2) I1PIT-0000
RECALLING FIRM/MANUFACTURER
Action Products, Inc., Hagerstown, MD, by telephone and e-mail on June 26, 2009. Firm initiated recall is complete.
REASON
Medical device intended for use by healthcare practitioners was incorrectly labeled. 1.0 cm thick pad was labeled as 0.5 cm thickness, and vice versa.
VOLUME OF PRODUCT IN COMMERCE
20 pieces
DISTRIBUTION
Nationwide
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PRODUCT 
SYNCHRON Systems Salicylate (SALY) Reagent; Part Number: 378194. SALY reagent, when used in conjunction with SUNCHRON LX System(s), UniCel DxC 600/800 Systems(s), SYNCHRON CX Systems(s) and SYNCHRON Systems Salicylate Calibrator, is intended for the quantitative determination of Salicylate concentration in human serum of plasma. Recall # Z-2238-2009
CODE
Lot Numbers: M705222 and M706238
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter, Inc., Brea, CA, by letter dated October 22, 2007.
Manufacturer: Beckman Coulter, Inc., Carlsbad, CA. Firm initiated recall is ongoing.
REASON
The Salicylate Reagent lots listed here may fail calibration and/or fail to maintain linearity at the upper end of analytical range.
VOLUME OF PRODUCT IN COMMERCE
7,842 units
DISTRIBUTION
Nationwide and Canada
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PRODUCT 
1) GE, Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. Innova 2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. Recall # Z-2240-2009;

2) Innova 3100/3100IQ GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System. (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Recall # Z-2241-2009;

3) Innova 4100/4100IQ GE Innova 4100 / 4100 IQ. (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector). The Innova systems are indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. They are also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures. They are intended to replace fluoroscopic images obtained through image intensifier technology. Those devices are not intended for mammography applications. Recall # Z-2242-2009 
CODE
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2) 00000423793BU9 00000424103BU0 00000427535BU0 00000429845BU1 00000430039BU8 and 00000410867BU6;

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and 00000428165BU5
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Medical Systems, LLC, Waukesha, WI, by letter dated June 25, 2009.  
Manufacturer: GE Medical Systems SCS, Buc Cedex, France. Firm initiated recall is ongoing.  
REASON
GE Healthcare has recently become aware of a potential power supply failure with the Innova 2000, 3100 and 4100 systems that may impact patient safety. A potential power supply failure inside the GE equipment cabinet could occur with no advance warning and thereby prevent x-ray generation and image processing. Should this occur, the system cannot be restarted.
VOLUME OF PRODUCT IN COMMERCE
508 units
DISTRIBUTION
Nationwide and Internationally
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PRODUCT 
TomoTherapy Hi-Art System, Version 3.X . The TomoTherapy HI-ART System® is intended to be used as an integrated system for the planning and delivery of intensity modulated radiation therapy (IMRT). The HI-ART System provides precise delivery of radiation to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. Recall # Z-2243-2009
CODE
Serial Numbers: 110001 110040 110078 110118 110159 110197 110238 110002 110041 110079 110119 110160 110198 110239 110003 110042 110081 110120 110161 110199 110240 110004 110043 110082 110122 110162 110200 110241 110005 110044 110083 110123 110164 110201 110242 110006 110045 110084 110125 110165 110202 110243 110007 110046 110085 110126 110166 110203 110244 110008 110047 110086 110127 110167 110204 110245 110009 110048 110087 110128 110168 110205 110246 110012 110049 110088 110129 110169 110206 110247 110013 110050 110089 110130 110170 110207 110248 110014 110051 110090 110131 110171 110208 110249 110015 110052 110091 110132 110172 110209 110250 110016 110053 110092 110133 110173 110210 110251 110017 110054 110093 110134 110174 110211 110252 110018 110055 110094 110135 110175 110212 110253 110019 110056 110095 110136 110176 110213 110254 110020 110057 110096 110137 110177 110214 110255 110021 110058 110097 110138 110178 110215 110256 110022 110059 110098 110139 110179 110216 110257 110023 110060 110100 110140 110180 110217 110258 110024 110061 110101 110141 110181 110218 110259 110025 110062 110103 110142 110182 110219 110260 110026 110063 110104 110143 110183 110220 110262 110027 110064 110105 110144 110184 110221 110263 110028 110065 110106 110145 110185 110222 110264 110029 110066 110107 110146 110186 110223 110265 110030 110067 110108 110149 110187 110224 110266 110031 110068 110109 110150 110188 110225 110267 110032 110069 110110 110151 110189 110227 110268 110033 110071 110111 110152 110190 110228 110269 110034 110072 110112 110153 110191 110230 110272 110035 110073 110113 110154 110192 110233 110275 110036 110074 110114 110155 110193 110234 110276 110037 110075 110115 110156 110194 110235 110277 110038 110076 110116 110157 110195 110236 110280 110039 110077 110117 110158 110196 110237 and 110283
RECALLING FIRM/MANUFACTURER
TomoTherapy Incorporated, Madison, WI, by letter dated August 10, 2009. Firm initiated recall is ongoing.
REASON
TomoTherapy received one customer report indicating that after starting a patient procedure from the Status Console, the radiation on light and the audible indicator on the Status Console came on as expected, however the Operator Station (OS) did not display the dose rate and the procedure time, or the couch position updates. Within a few minutes, the customer pressed the Stop button on the Status Console and the radiation indicators on the Status Console shut off. After rebooting the system, the procedure that had just been attempted was marked scheduled, indicating it had not yet been initiated. This issue affects all TomoTherapy Hi-Art systems.
VOLUME OF PRODUCT IN COMMERCE
259 units
DISTRIBUTION
Nationwide, Belgium Canada Switzerland China Germany Spain France England Hong Kong India Italy Japan Korea Netherlands Poland Saudi Arabia Sweden Singapore Turkey and Taiwan
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PRODUCT 
1) AccuSure, U-100, 31Gauge, 1/2cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7001-21, packaged 10 syringes per package, 10 packages per carton. Recall # Z-2247-2009;

2) AccuSure, U-100, 31Gauge, 1cc Insulin Syringe, 5/16" (8mm), Short Needle, NDC 0603-7002-21, packaged 10 syringes per package, 10 packages per carton . Recall # Z-2248-2009
CODE
1) Lot 6JCB1;
2) Lot 7CPT1
RECALLING FIRM/MANUFACTURER
Recalling Firm: Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals, Huntsville, AL, by press release and letter on August 21, 2009.
Manufacturer: Hosuk Co. Ltd., Chungbuk, Republic Of (South) Korea. Firm initiated recall is ongoing.
REASON
Needles separate from the barrels of the syringes.
VOLUME OF PRODUCT IN COMMERCE
53,860 boxes
DISTRIBUTION
Nationwide
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PRODUCT 
BrainLab Radiotherapy Treatment Planning Software; Catalog number 20610 - Radiosurgery 3.0 Catalog number 20620 - Radiosurgery 3.5 and Catalog number 20630 - Circular ARC SRS/SRT Planning. The software is intended for use in stereotactic, conformal, computer planned, LINAC based radiation treatment of cranial, head and neck, and extracranial lesions. It is intended to be used by experienced and trained health professionals. Recall # Z-2251-2009
CODE
All versions of BrainSCAN or iPlan RT Dose software used with BrainLAB conical collimators.
RECALLING FIRM/MANUFACTURER
Brainlab AG, Muenchen, Germany, by letter dated August 12, 2009. Firm initiated recall is ongoing.
REASON
Failure to conduct important safety checks when using the BrainLab radiotherapy treatment planning software in combination with BrainLab conical collimators could result in unintended radiation outside the conical shaped field, which may lead to serious injury of the patient.
VOLUME OF PRODUCT IN COMMERCE
216 units
DISTRIBUTION
Nationwide

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PRODUCT 
Flexiflo Quantum Enteral Pump Model # 50596, 50598 and 59322. The Flexiflo Quantum enteral pump is a medical device that is used to deliver enteral nutrition products to tube-fed patients. The pumps are generally used in hospitals, nursing homes, health care institutions and home care. Recall # Z-2252-2009
CODE
Pump Serial Numbers: 1000016; 1000026; 1000030; 1000031; 1000048; 1000152; 1000154; 1000350; 1000384; 1000429; 1000506; 1000523; 1000528; 1000548; 1000569; 1000609; 1000635; 1000679; 1000751; 1000870; 1000889; 1001007; 1001102; 1001107; 1001167; 1001306; 1001329; 1001372; 1001391; 1001442; 1001654; 1001693; 1001743; 1001851; 1001865; 1001893; 1001916; 1001918; 1002027; 1002028; 1002074; 1002095; 1002110; 1002117; 1002125; 1002136; 1002142; 1002143; 1002193; 1002209; 1002227; 1002292; 1002294; 1002297; 1002313; 1002315; 1002342; 1002352; 1002376; 1002420; 1002463; 1002487; 1002489; 1002641; 1002674; 1002734; 1002790; 1002823; 1002841; 1002864; 1002898; 1002951; 1002959; 1003016; 1003018; 1003059; 1003109; 1003127; 1003128; 1003176; 1003212; 1003220; 1003263; 1003317; 1003366; 1003415; 1003422; 1003465; 1003524; 1003562; 1003585; 1003617; 1003663; 1003668; 1003682; 1003701; 1003715; 1003719; 1003747; 1003759; 1003772; 1003823; 1003917; 1003935; 1003952; 1003968; 1003971; 1004140; 1004143; 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1053081; 1053087; 1053106; 1053119; ; 053128; 1053143; 1053150; 1053212; 1053241; 1053290; 1053297; 1053310; 1053377; 1053378; 1053420; 1053431; 1053432; 1053440; 1053489; 1053499; 1053508; 1053515; 1053516; 1053520; 1053537; 1053539; 1053581; 1053588; 1053596; 1053679; 1053699; 1053728; 1053738; 1053749; 1053750; 1053759; 1053760; 1053822; 1053861; 1053894; 1053897; 1054008; 1054014; 1054025; 1054032; 1054059; 1054063; 1054081; 1054086; 1054094; 1054115; 1054178; 1054205; 1054223; 1054237; 1054252; 1054271; 1054277; 1054278; 1054330; 1054335; 1054354; 1054363; 1054379; 1054387; 1054438; 1054447; 1054464; 1054474; 1054498; 1054508; 1055015; 1055017; 1055027; 1055032; 1055035; 1055043; 1055048; 1055052; 1055078; 1055090; 1055093; 1055132; 1055144; 1055159; 1055175; 1055193; 1055202; 1055210; 1055229; 1055243; 1055254; 1055264; 1055266; 1055287; 1055303; 1055315; 1055328; 1055353; 1055366; 1055395; 1055397; 1055413; 1055417; 1055422; 1055428; 1055439; 1055474; 1055491; 1055518; 1055519; 1055523; 1055530; 1055579; 1055640; 1055694; 1055719; 1055742; 1055748; 1055750; 1055774; 1055775; 1055779; 1055835; 1055867; 1055906; 1055916; 1055943; 1055949; 1055960; 1055964; 1056145; 1056153; 1056164; 1056181; 1056222; 1056244; 1056253; 1056272; 1056349; 1056363; 1056369; 1056374; 1056375; 1056453; 1056485; 1056503; 1056536; 1056573; 1056584; 1056609; 1056610; 1056620; 1056642; 1056653; 1056688; 1056742; 1056765; 1056772; 1056784; 1056848; 1056849; 1056853; 1056876; 1056880; 1056883; 1056888; 1056921; 1056927; 1056951; 1056975; 1057008; 1057048; 1057158; 1057192; 1057215; 1057221; 1057235; 1057257; 1057260; 1057262; 1057270; 1057279; 1057295; 1057296; 1057314; 1057395; 1057423; 1057425; 1057429; 1057430; 1057432; 1057434; 1057453; 1057459; 1057492; 1057501; 1057518; 1057542; 1057544; 1057564; 1057569; 1057617; 1057628; 1057632; 1057653; 1057654; 1057699; 1057705; 1057711; 1057728; 1057745; 1057755; 1057761; 1057765; 1057770; 1057794; 1057808; 1057851; 1057852; 1057893; 1057933; 1057955; 1057991; 1058007; 1058024; 1058043; 1058060; 1058071; 1058076; 1058133; 1058135; 1058165; 1058179; 1058180; 1058186; 1058214; 1058238; 1058272; 1058286; 1058293; 1058296; 1058301; 1058308; 1058321; 1058324; 1058337; 1058382; 1058386; 1058427; 1058508; 1058533; 1058578; 1058597; 1058609; 1058616; 1058664; 1058670; 1058672; 1058678; 1058692; 1058729; 1058786; 1058808; 1058809; 1058821; 1058839; 1058846; 1058871; 1058888; 1058911; 1058918; 1058968; 1058975; 1059002; 1059003; 1059004; 1059008; 1059034; 1059100; 1059112; 1059140; 1059150; 1059153; 1059154; 1059184; 1059234; 1059237; 1059244; 1059248; 1059276; 1059278; 1059289; 1059314; 1059322; 1059330; 1059369; 1059380; 1059388; 1059399; 1059428; 1059446; 1059447; 1059465; 1059478; 1059491; 1059504; 1059520; 1059522; 1059523; 1059550; 1059593; 1059607; 1059614; 1059651; 1059667; 1059671; 1059675; 1059709; 1059832; 1060235; 1060319; 1060366; 1060472; 1060494; 1060496; 1060632; 1060649; 1060866; 1060877; 1060892; 1060898; 1060944; 1061011; 1061104; 1061199; 1061265; 1061348; 1061418; 1061421; 1061611; 1061673; 1061768; 1062095; 1062219; 1062399; 1062405; 1062454 and 1063000-1067802
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Nutrition, Abbott Laboratories, Columbus, OH, by letter dated September 4, 2009.
Manufacturer: Hospira Inc., Morgan Hill, CA, Firm initiated recall is ongoing.
REASON
The firm initiated this voluntary recall because some of its Flexiflo Quantum Enteral Pumps have a 110-volt AC power cord plug that may crack or fail. This potential power cord plug failure may cause electrical shock and/or a delay in feeding that could represent a potential health and safety risk.
VOLUME OF PRODUCT IN COMMERCE
5,173 pumps
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
VEST 6.6 or earlier software for use with Neuro Kinetics products. The device is used for vestibular testing. Recall # Z-2253-2009
CODE
Software versions 6.6 or earlier
RECALLING FIRM/MANUFACTURER
Neuro Kinetics, Pittsburgh, PA, by letter on August 10, 2009. Firm initiated recall is ongoing.
REASON
Marketed without a 510k or PMA submission to include the normative data display.
VOLUME OF PRODUCT IN COMMERCE
72 units
DISTRIBUTION
Nationwide, Korea, United Kingdom and Spain

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

__________________________________
PRODUCT 
ConvaTec, Engenex Tunnel Dressing, for use with Engenex Negative Pressure Wound Therapy, (1 x 15 cm) Rx only, Latex Free; Sterile Health Industry Bar Code: H984BWS4464509A. Packaged in boxes of 15 units per box. Product Order # 44650. Recall # Z-1814-2009
CODE
Lot number 0902102
RECALLING FIRM/MANUFACTURER
Recalling Firm: ConvaTec, Skillman, NJ, by letters on July 13, 2009.
Manufacturer: Boehringer Wound Systems LLC, Norristown, PA. Firm initiated recall is ongoing.
REASON
Labeling: the actual manufacturing date (2/2009) and actual expiration date (2/2011) are switched.
VOLUME OF PRODUCT IN COMMERCE
764 tunnel dressing
DISTRIBUTION
Nationwide, UK and France

END OF ENFORCEMENT REPORT FOR OCTOBER 21, 2009

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