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U.S. Department of Health and Human Services

Safety

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Enforcement Report for October 28, 2009

October 28, 2009
09-43

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS I

___________________________________
PRODUCT 
Watta Munch Pistachios packaged in: 2.25 oz, UPC 830140046053; 4.50 oz, UPC 830140066051. Recall # F-1580-9
CODE
Codes: 1681, 24028P, 13418P, 01818P Use By: Mar 2009 to Apr 2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Everson Distributing Co., Inc., Chicopee MA, by telephone, letter and press release on April 9, 2009. 
Manufacturer: Setton Pistachio of Terra Bella, Inc., Terra Bella, CA. Firm initiated recall is ongoing.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
1,708 cases/12 pack
DISTRIBUTION
NJ, NY
___________________________________
PRODUCT 
Eastern Lamejun Bakers, Pistachio Nuts California, packaged in 0.75 - 1.00 pound plastic bags, with a twist tie, of roasted, salted, in-shell pistachios; Item # 136. Recall # F-1581-9
CODE
No code
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eastern Lamejun Bakers, Belmont, MA, by press release on April 10, 2009. 
Manufacturer: Setton Pistachio of Terra Bella, Inc., Terra Bella, CA. Firm initiated recall is ongoing.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
175-200 packages
DISTRIBUTION
MA
___________________________________
PRODUCT 
1) Flanigan Farms Pistachio Nuts, Dry Roasted, Net Wt. 2 oz, UPC 74628 04528-6,
Recall # F-1582-9;

2) Flanigan Farms Pistachio Nuts, Special Shelled, 2 oz, UPC 74628 02017-7. Recall # F-1583-9
CODE
1) Sell-By Date 9-1-08 thru 3-24-10;
2) Sell-By Date 02-17-10
RECALLING FIRM/MANUFACTURER
Flanigan Farms, Inc., Culver City, CA, by e-mail, letter dated April 7, 2009 and by press release on April 10, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella, Inc., because they have the potential to be contaminated with Salmonella.

VOLUME OF PRODUCT IN COMMERCE
1,889 lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Plastic bags containing pistachios are labeled as follows: a) Energy Club Salted Pistachios (Classic Size) 2.5 oz, SKU: 0 52679 01940 0; b) Energy Club Salted Pistachios (Value Size) 4.5 oz , SKU: 0 52679 01941 8; c) Energy Club Salted Pistachios (Value Size) 4.5 oz, SKU: 0 52679 01943 2; d) Energy Club Salted Pistachios (Snack Size) Net Wt 1.25 oz, SKU: 0 52679 00940 2; e) Mucho Saber Roasted & Salted Pistachios (Classic Size) 2.5 oz, SKU: 0 52679 31940 2; f) Mucho Sabor Habanero Pistachios (Classic Size ) 2.0 oz, SKU: 0 52679 31970 9; g) Energy Club Gourmet Roasted & Salted Pistachios (Lay down Bag) 13 oz, SKU: 0 52679 17940 2; h) Energy Club Salted Pistachios (Value Size) 5.75 oz, SKU: 0 52679 71943 1; i) Energy Club Salted Pistachios (Classic Size) 4.5 oz, SKU: 0 52679 70943 2; j) Energy Club Salted Pistachios (Classic Size) 3.0 oz, SKU: 0 52679 71940 0; k)Energy Club Salted Pistachios "Pistaches salees" (Classic Size) 2.5 oz, 0 52679 51940 6. Recall # F-1584-9;

2) Plastic jars & cup containing pistachios are labeled as follows: a) Energy Club Gourmet Roasted & Salted Pistachios (Jar) Net Wt 13 oz SKU: 0 52679 25941 8; b) Energy Club Pistachios, (Jar) 13 oz Set, SKU: 0 52679 25032 3; c) Energy Club Snack 'n Drive Salted Pistachios (Cup) Net Wt 5 oz (140 g), SKU: 0 52679 07941 2. Recall # F-1585-9 
CODE
Code dates: 01/19/10 to 03/27/10
RECALLING FIRM/MANUFACTURER
Energy Club Inc, Pacoima, CA, by telephone and e-mail on March 31, 2009, letter, dated April 1, 2009 and press release on April 6, 2009. Firm initiated recall is ongoing. 
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella, Inc. because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
45, 596 lbs
DISTRIBUTION
Nationwide, Virgin Islands, Bahamas, Dominican Republic, Grand Caymay BWI, Trinidad and Canada

___________________________________
PRODUCT 
World Direct", California Pistachio Kernel Roasted Salted, UPC #208389. The product is packaged in clear plastic bags of various net weights averaging less than 1 lb per bag. Recall # F-1586-9
CODE
None
RECALLING FIRM/MANUFACTURER
Dekalb Farmers Market, Decatur, GA, by press release April 6, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Unknown
DISTRIBUTION
GA
___________________________________
PRODUCT 
Ciao Bella Gelato, Italian Ice Cream, Turkish Pistachio 3.5 single serving cups, UPC:  799512015076; 12 pack, UPC 799512020018. Recall # F-1587-9
CODE
Lot numbers: 09021, 09027, 09028, 09063, 09068, 09076, 09085, 09086
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ciao Bella Gelato Co, Inc., Irvington, NJ, by press release and letters on March 31, 2009. 
Manufacturer: Oregon Ice Cream, LLC, Eugene, OR. Firm initiated recall is ongoing.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
NY, NJ, IL, NC, AZ, CA
DISTRIBUTION
3579 cases of 12 x 3.5 oz cups; 42,948 individual units
___________________________________
PRODUCT 
Art's California Pistachios, In shell, UPC# 070762 01103, in flexible plastic tubes,  
UPC codes: Case: 3 00 70762 01103 4, Inner Pack (Carton) 1 00 70762 01103 0, Item/Consumer Unit: 0 70762 01103 3. Recall # F-1588-9
CODE
Expiration dates between May 31, 2009 and December 31, 2009, product is not coded
RECALLING FIRM/MANUFACTURER
Bezzerides Co., Benicia, CA, by telephone, e-mail, letter and press release on April 8, 2009. Firm initiated recall is ongoing.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella, Inc. because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
22,970 lbs
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Natural Pistachio Nuts labeled as follows: Eillien's 2 oz Natural Pistachio Nuts, UPC 34952-12654; Eillien's 8 oz Natural Pistachio Nuts, UPC 34952-12706; Eillien's 10oz Natural Pistachio Nuts, UPC 34952-56526; Eillien's 12oz Natural Pistachio Nuts, , UPC 34952-57112; Eillien's 12oz Natural Pistachio Trays UPC 34592-55420; Eillien's 14oz Natural Pistachio Nuts UPC 34952-13364; Eillien's 16oz Natural Pistachio Nuts UPC 34952-56092, Eillien's 22oz Natural Pistachio Nut Jars UPC 34952-56990; Eillien's 24oz Natural Pistachio Nut Jars UPC 34952-56197, Eillien's 2.5oz Natural Pistachio Nuts Item #118018, Setton's Bulk Natural pistachio Nuts Item #400465 all lots, Blain's Farm & Fleet 14oz Natural Pistachio Nut Tin UPC 34952-81873, Blain's Farm & Fleet 16oz Natural Pistachio Nuts UPC 34952-81224, Mill's Fleet Farm 16oz Natural Pistachio Nuts UPC 34952-35214, Mill's Fleet Farm 24oz Natural Pistachio Nuts UPC 34952-35847, Trig's 16oz Natural Pistachio Nuts UPC 34952-56505, Supreme Choice 9oz Natural Pistachio Nuts UPC 34952-56547, Urge 2.75oz Natural Pistachio Nuts UPC 39779-01051. Recall # F-1589-9;  

2) Pistachio Kernels labeled as follows: Eillien's 9 oz Nut Lover Tin with 50% Dry Roasted Pistachio Kernels UPC 34952-56883, Eillien's 8 oz Roasted & Salted Pistachio Kernels UPC 34952-56686, Blain's Farm & Fleet 10 oz Dry Roasted Pistachio Kernels UPC 34952-81792, Blain's Farm & Fleet 22 oz Deluxe Mixed Nut Jars w/25% Pistachio Kernels UPC 34952-81825, Figi's 12 oz Pistachio Kernel Tin 01202-96201 (case ct 1), Mill's Fleet Farm 10 oz Dry Roasted Pistachio Kernels UPC 034952-35811, Setton's Bulk Dry Roasted Kernels 25 # box, Item #409870 all lots, Bulk Dry Roast Pistachio Kernels 25# Box Setton Farms FMO# 0208, 2507, 2738, 3258, Bulk Mixed Nuts with Dry Roasted Pistachio Kernels 30# Box, Lot # 012309/031809/031909, R/S Bulk Pistachios Kernels 01202-96201. Recall # F-1590-9;

3) Red Pistachio Nuts labeled as follows: Eillien's 2 oz Red Pistachio Nuts UPC34952-00605; Eillien's 8 oz Red Pistachio Nuts UPC 34952-12711; Eillien's 12 oz Red Pistachio Trays UPC 34592-55430; Eillien's 2.5 oz Red Pistachio Nuts Item #118000; Setton's Bulk Red Pistachio Nuts Item #400473 all lots; Mill's Fleet Farm 16 oz Red Pistachio Nuts UPC 34952-35213. Recall # F-1591-9;

4) Eillien's 33oz Deluxe Party Tray UPC 34952-57094, Eillien's 33oz Deluxe Party Tray UPC 34952-57018, Eillien's Bulk Mixed Nuts with Pistachios 30# box all lots, Blain's Farm & Fleet 16oz Mixed Pistachio Nuts UPC 34952-81381, Blain's Farm & Fleet 33oz Deluxe Party Tray UPC 34952-56014, Mill's Fleet Farm 16oz California (mixed) Pistachio Nuts UPC 34952-35215, Figi's 15oz Nut Carousel 01240-81201 (case ct. 1) product shipped from Eillien's after 09/01/08, Figi's 26oz Nut Carousel 01240-82201 (case ct. 1), Figi's 27oz Nut Shop 01208-41410 (case ct. 1), Breaktime Sanck Mix Bulk 01200-80901, Playtime Sanck Mix 01200-79901. Recall # F-1592-9
CODE
All sell by dates prior to 01/08/10. All lot numbers of bulk cases.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Eillien's Candies, Inc., Green Bay, WI, by fax and press release on March 31, 2009. 
Manufacturer: Setton Pistachio of Terra Bella, Inc., Terra Bella, CA. Firm initiated recall is ongoing.
REASON
The products were manufactured using pistachios recalled by Setton Pistachio of Terra Bella, Inc. because they have the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
Not known
DISTRIBUTION
WI, MI, MN, IL, ND, SD, MT, WA, OR, CA, CO, NE, IA
___________________________________
PRODUCT 
1) Surefine, Pistachios, 12 oz, UPC 011161161349. Recall # F-1593-9;

2) Stop & Shop, Dry Roasted Pistachios, Net Wt, 6 oz (170g), UPC 688267081729.  Recall # F-1594-9;

3) Giant, Dry Roasted Pistachios, Net Wt 6 oz (170g), UPC 68826701729. Recall # F-1595-9;

4) First Choice, Natural Pistachios, Net Wt 32 oz (2 LB) 907g, UPC 011110831620. 
Recall # F-1596-9;

5) Harris Teeter, Salted Pistachios, Net Wt 12 oz (340 g), UPC 007203653117. Recall # F-1597-9;

6) Fresh Finds, Roasted and Salted Pistachios, Net Wt 2 oz (57g), UPC 033717702417. Recall # F-1598-9 
CODE
1) Lots: Use by dates between OCT 31 09 to APR 10 10; 

2) Lots: Sell by dates between: NOV 05 09 to APR 10 11;

3) Lots: Sell by dates between: NOV 05 09 to APR 10 11;

4) Lots: Sell by dates between: FEB 04 10 to APR 10 10

5) Use By Date: all dates;

6) Lots: Best by dates between MAR 03 10 TO APR 10 10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bremner Food Group Dothan Facility, Dothan, AL, by telephone and e-mail on April 8, 2009 and by press release on April 10, 2009.
Manufacturer: Setton Pistachio of Terra Bella, Inc., Terra Bella, CA. Firm initiated recall is ongoing.
REASON
The product was manufactured using pistachios recalled by Setton Pistachio of Terra Bella, Inc. because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
9,795 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Cascadian Farm Peanut Chip Chewy Granola Bars packaged and sold as 6/1.2 oz bars/carton, 12-cartons/case, Net Wt 7.4 oz. Not sold individually. Carton is labeled in part "Cascadian Farm ORGANIC." Individual bars sku #0 21908-40802 6, carton of 6 bars sku #0 21908-14631 7, case sku #1 0021908 14631 4. Recall # F-1599-9;

2) Cascadian Farm Sweet and Salty Mixed Nuts Chewy Granola Bar, packaged and sold as 5/1.2-oz bars/carton, Net Wt 6.2-oz. Not sold individually. Carton is labeled in part "Cascadian Farm ORGANIC." sku #'s 0 21908 50442 1 (individual bars), 0 21908 40774 6 (cartons), 1 00 21908 40774 3 (case). Recall # F-1600-9;

3) Cascadian Farm Sweet and Salty Peanut Pretzel Chewy Granola Bar, packaged and sold as 5/1.2 oz bars/carton, Net Wt. 6.2 oz. Not sold individually. Carton is labeled in part “Cascadian Farm ORGANIC,” sku #’s 0 21908-50443 8 (individual bar), 0 21908 40775 3 (carton), 1 00 21908 40775 0 (case). Recall # F-1601-9
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: General Mills, Inc., Minneapolis, MN, by press release and letter on February 13, 2009.
Manufacturer: Roskam Baking Co., Kentwood, MI. 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
119,447 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) ProFlex 15 Protein Bar, Chocolate Peanut Butter. Product is sold in a cardboard box containing ten (10) individually wrapped 1.94 oz (55 g) bars. Cardboard box label reads in part, Net Wt 19.4 oz, Product of USA, Not for Resale in Canada. Lot number located on the bottom of the product box. Bar label reads in part, Net Wt 1.94 oz, Product of USA, This Unit is Not Labeled for Individual Sale. Lot number located under the flap on the product wrapper. Recall # F-1602-9;

2)  ProFlex 20, Peanut Butter Protein Bars. Sold in a cardboard box containing ten (10) individually wrapped 2.3 oz (65 g) bars. Cardboard box label reads in part, Restores and tones lean muscle, Net Wt 23 oz, not for resale in Canada. Lot number is printed on the bottom of the product box. Box label for EU distribution reads in part, Made in the USA. Bar labeled in part, Restores and tones lean muscle with 20 grams of protein..., Net Wt 2.3 oz, Product of USA..., not for resale in Canada. Lot number is under the flap on the product wrapper. Recall # F-1603-9;

3) Attain Nutrition Bars, Chocolate Peanut Butter bar. Product sold in cardboard box containing six (6) individually wrapped 1.59oz (45 g) bars. Cardboard box label reads in part, Reduces Hunger Cravings to Support Healthy Weight Loss, Net Wt 9.52 oz (270 g), Product of Canada, Not for Resale in Canada. Lot number located on the bottom of the product box. Box label for EU distribution reads in part, Product of Canada. Bar label reads in part, 1.59 OZ, Reduces Hunger Cravings to Support Healthy Weight Loss, Product of Canada, This Product Not Labeled for Individual Sale. Lot number located under the flap on the product wrapper. Recall # F-1604-9
CODE
1) Lot numbers: F7052, F7062, I7002 and I7012;

2) Lot numbers: F7082P and F7092P;

3) Boxes: 3557, 0888, 1968, 2538, 2548, 3378, 3388, and 0388. Bar Wrappers: 3557XX, 0888XX, 1968XX, 2538XX, 2548XX, 3378XX, 3388XX, and 0388XX (lot number is the first 4 digets of the 6 digit number)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Melaleuca, Inc., Idaho Falls, ID, by press release on February 13, 2009, and by letter and press release on February 20, 2009 and February 21, 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
181,622 boxes
DISTRIBUTION
Nationwide, Canada, United Kingdom, Ireland and the Netherlands

___________________________________
PRODUCT 
Crushed Peanuts. Label reads: Fresh From The Northwest, Lyfonda Farm CrushedPeanuts. Peanut pieces packaged in 5-lb units in clear, sealed plastic bags with adhesive labels. UPC code: 0 47628 50140 3. Recall # F-1605-9
CODE
No codes
RECALLING FIRM/MANUFACTURER
Lyfonda Farm, Sandy, OR, by telephone on February 4 and 5, 2009. Firm initiated recall is complete.
REASON
The product was manufacture using peanut product recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
25/5-lb bags
DISTRIBUTION
WA
___________________________________
PRODUCT 
1) Peanut Butter Passion Ice Cream in paper cartons a) 1.75 quarts and b) 48 oz. Recall # F-1700-9;

2) Light Peanut Butter Passion Ice Cream in paper cartons. 6/1.75 quarts per cases. Recall # F-1701-9
CODE
1) a) Sell By Aug 2009 49-70; b) Sell By Sep 13 2009 49-70
2) Sell By Aug 2009 49-70
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger, Co. Cincinnati, OH, by e-mail on January 19, 2009.
Manufacturer: Layton Dairy Plant, Layton, UT. 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
3,074 cases
DISTRIBUTION
AK, AZ, CO, ID, MT, NM, NV, OR, UT, WA, WY
___________________________________
PRODUCT 
1) Trader Joe's Peanut Butter Chewy Coated & Drizzled Granola Bars, 7.4-ounce, UPC 88713. Recall # F-1702-9;

2) Trader Joe's Nutty Chocolate Chewy Coated & Drizzled Granola Bars, 7.4-ounce, UPC 88721. Recall # F-1703-9;

3) Trader Joe's Sliced Green Apples With All Natural Peanut Butter, 7-ounce, UPC 92459. Recall # F-1704-9;

4) Trader Joe's Sutter's Formula Cookies, 16-ounce, UPC 00176. Recall # F-1705-9
CODE
All codes
RECALLING FIRM/MANUFACTURER
Recalling Firm: Trader Joes Co., Monrovia, CA, by e-mail on January 18, 2009 and by  press releases on January 22, 2009, January 23, 2009, February 2, 2009 and February 27, 2009 and website posting.  
Manufacturer: Lovin Oven, LLC, Azusa, CA. 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
26,602 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Nut Topping sold under the following brand names: a) Kroger, in 2.25 oz containers, UPC 000111174500. b) Ralphs, in 2.25 oz containers with a Sell by date of DEC-9-2009 and earlier. UPC 0001111071444; c) Fred Meyer: in 2.25 oz containers with a Sell by date of DEC-21-09 and earlier, UPC 0001111074507. Recall # F-1706-9
CODE
a) Sell by date of DEC-22-09 and earlier; b) Sell by date of DEC-9-2009 and earlier; c) Sell by date of DEC-21-09 and earlier
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kroger, Co. Cincinnati, OH, by e-mail on January 29, 2009 and by press release on January 30, 2009.
Manufacturer: Kenlake Foods, Murray, 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
90,058 cases/12/2.25 oz packages; 2,110 cases/72/2.25 oz packages; 6,428 cases/120/2.25 oz packages
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) LARABAR Peanut Butter Cookie snack bar, UPC code #54818-00014-7 packaged as individual bar, 54818-00064-2 packaged as 16 bar sleeve, code 93759-298-8 packaged as 6-bar pack, code 93759-0299-5 packaged as 6-bar pack, UPC case code 54818-00085-7. Recall # F-1707-9;

2) JamFrakas Peanut Butter Bliss Crisp snack bars with UPC codes 93759-00212-4 packaged as individual bars, 93759-00213-1 packaged as caddy (18-bar sleeve), and UPC Case Code 93759-00214-8. Recall # F-1708-9
CODE
All lot codes
RECALLING FIRM/MANUFACTURER
General Mills, Inc., Minneapolis, MN, by press release and telephone on January 19, 2009.  
Manufacturer: Pasta Fresca, Inc., Louisville, CO. 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
12,833 cases
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Weaver Trail's End Caramel Corn with Peanuts, net wt. 9.5 oz. The product is packaged in a metal tin and is sold for scouting fund-raising only. Recall # F-1709-9; 

2) Weaver Trail's End Gourmet Popcorn Chocolate Lover's boxes containing individual tins of Chocolatey Caramel Crunch, White Chocolatey Caramel Crunch, Chocolatey Pretzels, White Chocolatey Pretzels and Chocolatey Peanut Clusters, net wt. 88 oz. Only the 12 oz bag of Trail's End Chocolatey Peanut Clusters in the box are under recall. oduct is packaged in a metal tin and is sold for scouting fund-raising only. Recall # F-1710-9
CODE
1) Lots 102861 109 JAN 19 08 through 102861 297 JUL 23 09;

2)  Shipping box code dates of 082107, 083007, 083107, 091307, 091407, 092207, 100407, 100507, 101007, 101607, 101807, 101907, 112907, 113007, 082008, 082608, 082708, 091308, 091608, 091908, 082008, 092208, 092308, 092408, 092508, 092908, 100108, 100408, 100908, 101108, 101408, 102008, 102208, 102308, 102408, 102508, 103108, 111508, 111808 and 111908 containing Chocolatey Peanut Clusters bags with best before code dates of 031308, 040408, 040508, 052108, 053008, 053108, 061408, 062208, 070108, 071608, 071808, 071908, 082508, 082708, 082808, 082908, 083008, 090908, 091208, 091308, 091508, 091608, 091708, 091808, 091908, 092008, 092208, 092308, 092408, 092508, 093008, 100108, 100208, 100608, 100708, 100808, 100908, 101008, 101308, 101508, 101608, 102008, 102108, 102208, 102308, 102408, 102508, 102708, 102808, 102908, 103108, 110308, 110508, 110608, 111708, 111808, 111908, 112208, 112408, 112508, 112608, 042509, 051509, 051809, 051909, 052009, 052609, 052709, 061309, 061609, 061909, 062009, 062209, 062309, 062409, 062509, 062909, 070209, 070409, 070909, 071109, 071409, 072009, 072209, 072309, 072409 and 073109
RECALLING FIRM/MANUFACTURER
Weaver Popcorn Co. Inc., Van Buren, IN, by press releases on January 28, 2009 and March 13, 2009 and by letter on March 13, 2009. Firm initiated recall is complete.
REASON
The product was manufactured using peanuts recalled by Peanut Corporation of America because it has the potential to be contaminated with Salmonella.
VOLUME OF PRODUCT IN COMMERCE
14,173,793 units
DISTRIBUTION
CA, CO, FL, IN, PA, TX, WA
___________________________________
PRODUCT 
1) Readi-Bake 1.0 oz and 1.25 oz. Peanut Butter Cookie Dough and BakerSource - Classic 1.0 oz. Peanut Butter Cookie Dough. Recall # F-1711-9;

2) Readi-Bake 1.0 oz. Sugar Free PB Cookie Dough. Recall # F-1712-9
CODE
1) Use by Dates:  2/26/09; 2/5/09, 2/8/09, 2/26/09; 2/8/09, 2/26/09

2) Use by Date of 2/20/09. 3/18/09, 4/3/09
RECALLING FIRM/MANUFACTURER
Recalling Firm: Country Home Bakers, Atlanta, GA, by e-mail on February 4, 2009.
Manufacturer: Peanut Corp. of America, Blakely, GA. 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
3,507 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) Jana's Peanut Butter Cookie - Frozen. Product sold as follows: 1) 1.0 oz cookie sold in clamshell of 24 cookies with 12 clamshells/case. Case item number H60631.771 and clamshell UPC is 10089805606317; 2) 0.9 oz cookies sold in clamshells of 24 cookies with 12 clamshells /case. Case label reads in part, Classic Thaw 'N' Serve, Jana's Peanut Butter Cookie, H60631.77A, Keep frozen, Net wt 16.2 lbs, 09 oz - 12/24 count. UPC for clamshell is 10089805606317 and 3) 1.33 oz cookies in clamshells of 10 cookies with 12 clamshells/case. Case labeled in part, Classic Thaw 'N' Serve, H60693.977, Jana's Peanut Butter cookies, Keep Frozen, Net Wt. 9.98 lb, 1.33 oz - 12/10 count. The clamshell packages have a black and white label stating Peanut Butter with Peanut, a nutritional facts panel and ingredients listing. At the bottom of this panel it states. The first five digits of the code printed on the back or side of the clamshell match the first five digits of the lot numbers. These products may be further labeled by the stores in which they are sold; therefore labeling may contain the store name and/or brand name. Recall # F-1713-9;

2) Classic Bake N' Serve Jana's Peanut Butter with Peanuts cookies. Product packaged in a blue poly liner within a corrugated case. Case label reads in part, KERRY CLASSIC BAKE 'N' SERVE, H10622.94, 64 Count/2.25 oz, Keep frozen. Product manufactured using PCA peanut products. Recall # F-1714-9 
CODE
1) 1.0 oz cookie: Lot numbers and expiration dates affected include 1120758303, 5/20/2008; 1210758403, 6/9/2008; 1212758403, 6/11/2008 0102758303, July 3, 2007; 0113758402, July 14, 2007; 0127758303, July 28, 2007; 0207758303, August 8, 2007; 0216758303, August 17, 2007; 0227758403, August 28, 2007; 0228758401, August 29, 2007; 0310758303, September 8, 2007; 0316758403, September 14, 2007; 0329758303, September 27, 2007; 0330758301, September 28, 2007; 0414758303, October 13, 2007; 0505758303, November 3, 2007; 0512758303, November 10, 2007; 0525758303, November 23, 2007; 0609758303, December 8, 2007; 0616758303, December 15, 2007; 0630758303, December 29, 2007; 0714758303, January 12, 2008; 0804758403, February 2, 2008; 0810758303, February 8, 2008; 0831758303, February 29, 2008; 0907758303, March 7, 2008; 0921758302, March 21, 2008; 0921758303, March 21, 2008; 1005758303, April 4, 2008; 1026758303, April 25, 2008; and 1116758303, May 16, 2008. 2) 0.9 oz cookie: lot numbers and expiration dates affected include 0114858403, 7/14/2008, 0122858403, 7/22/2008; 0221858403, August 18, 2008; 0411858402, October 10, 2008; 0411858403, October 10, 2008; 0417858303, October 16, 2008; 0514858303, November 11, 2008; 0603858403, December 2, 2008; and 0702858403, December 31, 2008; and 3) Lot number and expiration date affected include 0131858403, 7/31/2008; 0103758301, July 4, 2007; 0228758401, August 29, 2007; 0316758403, September 14, 2007; 0609758303, December 8, 2007; 0714758303, January 12, 2008; 0728758402, January 26, 2008; 0810758303, February 8, 2008; 1114758303, May 14, 2008; 0221858303, August 21, 2008; 0415858403, October 14, 2008; 0610858403, December 19, 2008; and 0626858403, December 25, 2008;

2) Lot # and expiration dates: 0105758502, January 5, 2008; 0612758502, June 11, 2008; 1004758502, October 3, 2008; and 0314858503, March 14, 2009.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Kerry Ingredients, Beloit, WI, by telephone on February 4, 2009, e-mail on February 5, 2009, press release on February 8, 2009 and by telephone, e-mail and letter on March 6, 2009 and March 9, 2009, and press release on March 13, 2009. 
Manufacturer: Kerry Ingredients and Flavours, Tualatin, OR. 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
Dough: 556 cases; cookies: 97,860 clamshells
DISTRIBUTION
CA, WI, OR
___________________________________
PRODUCT 
HEB Creamy Creations Peanut Brittle Premium Ice Cream, Round Quart Paper Container (946 mL), UPC 4122017911. Recall # F-1715-9
CODE
All lots
RECALLING FIRM/MANUFACTURER
Recalling Firm: HE Butt Corporate Headquarters, San Antonio, TX, by e-mail on January 30, 2009 and by press release on February 5, 2009.
Manufacturer: HEB Grocery Ice Cream Plant, San Antonio, TX. 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
25,650 units
DISTRIBUTION
TX

RECALLS AND FIELD CORRECTIONS:  FOODS - CLASS II

___________________________________
PRODUCT 
Seasource Detox Spa Foaming Sea Salt Scrub, comes in a 6.8 fluid oz white tube and is identified with a lot number on the crimping at the top of the tube. Recall # F-1561-9
CODE
Lot: Z628
RECALLING FIRM/MANUFACTURER
Recalling Firm: Arbonne International, Irvine, CA, by e-mail and letter on September 1, 2009.
Manufacturer: Corwood Labs Inc., Hauppauge, NY. Firm initiated recall is ongoing.
REASON
Routine testing discovered the presence of Pseudomonas aeruginosa bacteria.
VOLUME OF PRODUCT IN COMMERCE
20,318
DISTRIBUTION
Nationwide, Canada, Australia, United Kingdom
__________________________________
PRODUCT 
Breaded Natural Cheese Curds, Code #13229. Keep Frozen. Net Case Weight - 30 lbs, 80 servings. Recall # F-1562-9
CODE
7/17/09, 7/24/09, 8/7/09, 8/14/09
RECALLING FIRM/MANUFACTURER
Golden County Foods Inc - Appetizer Division, Plover, WI, by telephone and letter on August 19, 2009. Firm initiated recall is ongoing.
REASON
Cheese curds may potentially contain up to four stainless steel machine bolts.
VOLUME OF PRODUCT IN COMMERCE
7348 cases
DISTRIBUTION
AZ, CO, IA, KY, MI, MN, MO, NE, ND, TX, WI
___________________________________
PRODUCT 
Big Gus Original Recipe Tartar Sauce, UPC Code: #14758 3000. The product is packed in one (1) gallon size plastic jars. The jars are distributed in cases and each case contains four (4) one gallon jars. The product label states: 'Keep Refrigerated.' Recall # F-1563-9
CODE
All codes manufactured on June 13, 2009
RECALLING FIRM/MANUFACTURER
Big Gus Onion Rings, Inc., Cleveland, OH, by letters on June 18, 2009. Firm initiated recall is ongoing.
REASON
Tartar sauce contains undeclared color, FD&C Yellow #5.
VOLUME OF PRODUCT IN COMMERCE
5 cases
DISTRIBUTION
OH
___________________________________
PRODUCT 
Bumble Bee Chicken BBQ Chicken in Barbeque Sauce with Crackers NET WT 3.5 oz (99g) with UPC Code 8660070310. The crackers in question are individually wrapped in a foil package and placed with a 2.9oz can of Chicken in Barbecue Sauce in a plastic tray. Recall # F-1564-9  
CODE
All kits shipped from March 2007 until February 5, 2009
RECALLING FIRM/MANUFACTURER
Recalling Firm: Bumblebee Foods, LLC, San Diego, CA, by letter on February 5, 2009.
Manufacturer: The Suter Co., Inc., Sycamore, IL. Firm initiated recall is complete.
REASON
The crackers contain undeclared milk.
VOLUME OF PRODUCT IN COMMERCE
25,909 cases
DISTRIBUTION
MD, MS, NC, NY, OH, PA, TX, VA
___________________________________
PRODUCT 
1) Gnocchi. Labeled as Stangelli's Italian Foods Gnocchi Potato Dumpling 1lb 10oz. Recall # F-1566-9;

2) Stuffed Shells. Labeled as Stangelli's Italian Foods 8 Stuffed Shells 22 oz. Recall # F-1567-9;

3) Manicotti. Labeled as Stangelli's Italian Foods 7 Manicotti 1lb 5 oz. Recall # F-1568-9;

4) Pepperoni Balls. Labeled as Stangelli's Italian Foods Frozen Pepperoni Balls (Deep Fried Dough Containing Pepperoni) 10 oz. Recall # F-1569-9;

5) Cheese and Pepperoni Balls. Labeled as Stangelli's Italian Foods Cheese & Pepperoni Balls 10oz. Recall # F-1570-9;

6) Cookie Dough. Labeled as Stanganelli's Scoop & Bake Cookie Dough 3 lb tubs available in the following flavors: chocolate chip, peanut butter, oatmeal raisin, sugar, chocolate peanut butter chip, white chocolate macadamia, and chocolate chunk pecan.  Product is sold exclusively for fundraisers. Recall # F-1571-9
CODE
Product is not coded. Shipping boxes are stamped with manufacturing date.
RECALLING FIRM/MANUFACTURER
Spagel Brothers, Erie, PA, by visit and telephone beginning June 1, 2009. Firm initiated recall is complete
REASON
Products contain undeclared wheat.
VOLUME OF PRODUCT IN COMMERCE
12,610 bags and 8,021 tubs
DISTRIBUTION
NY, PA
___________________________________
PRODUCT 
1) Jalapeno Jelly. Recall # F-1572-9;
2) Jalapeno Orange Jelly. Recall # F-1573-9;
3) Cactus Jelly. Recall # F-1574-9;
4) Red Chile Jelly. Recall # F-1575-9;
5) Pomegranate Candy. Recall # F-1576-9;
6) Orange Candy. Recall # F-1577-9;
7) Lemon Candy. Recall # F-1578-9;
8) Jalapeno Candy. Recall # F-1579-9
CODE
All codes /production dates
RECALLING FIRM/MANUFACTURER
Cactus Candy Co., Phoenix, AZ, by letter on July 23, 2009. Firm initiated recall is ongoing.
REASON
Products contain undeclared color, FD&C Yellow #5 and Blue #1.
VOLUME OF PRODUCT IN COMMERCE

DISTRIBUTION
AZ, NM, FL, CA

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS II

___________________________________
PRODUCT 
Temodar (temozolomide) capsules, 5 mg, 5-count bottles, Rx only; NDC 0085-3004-02. Recall # D-021-2010
CODE
Lot # 7HLO009, Exp 09/10
RECALLING FIRM/MANUFACTURER
Schering-Plough Products, LLC, Las Piedras, PR, by letter on October 9, 2009. Firm initiated recall is ongoing.
REASON
Impurities/Degradation Products: This product is being recalled because of an out of specification (OOS) stability result obtained for moisture and total degradation products.
VOLUME OF PRODUCT IN COMMERCE
13,141 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
1) M.V.I. ADULT (Multi-Vitamin Infusion), 10 mL UNIT VIAL, 10 Unit Vials of 10 mL each to be used as a single dose per carton, Rx only; NDC 61703-422-81. Recall # D-022-2010;

2) M.V.I.-12 (Multi-Vitamin Infusion Without Vitamin K), 10 mL UNIT VIAL, 10 Unit Vials of 10 mL each to be used as a single dose per carton, Rx only; NDC 61703-423-81. Recall # D-023-2010
CODE
1) Lot # 8132A, 8133A, Exp 09/09; Lot # 8134A, Exp 10/09; Lot # 8135A, 8136A, 8139A, exp 11/09; Lot # 8140A, 8141A, 8142A, 8143A, Exp 12/09; Lot # 8144A, 8145A, Exp 01/10; Lot # 8146A, 8148A, 8149A, Exp 02/10; Lot # 8150A, 8151A, 9013A, Exp 03/10; Lot # 9014A, 9015A, 9018A, Exp 04/10; Lot # 9019A, 9020A, 9021A, Exp 05/10; Lot # 9022A, 9023A, Exp 06/10;

2) Lot # 8130A, 8131A, 8137A, Exp 10/09; Lot # 8138A, 8147A, Exp 01/10; Lot # 9016A, 9017A, Exp 04/10
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hospira Inc., Lake Forest, IL, by letters on September 10, 2009.  
Manufacturer: AstraZeneca LP, Westborough, MA. Firm initiated recall is ongoing.
REASON
Subpotent (Multiple Ingredient Drug): The discolored top chamber solution does not meet the visual appearance specification. This discoloration potentially impacts the potency of the Biotin and Folic Acid contained in the top chamber.
VOLUME OF PRODUCT IN COMMERCE
1,862,420 vials
DISTRIBUTION
Nationwide

___________________________________
PRODUCT 
OPANA ER (Oxymorphone Hydrochloride) Extended-Release Tablets, 10 mg, 100 count bottles, Rx Only; NDC 63481-674-70. Recall # D-024-2010
CODE
Lot 401445NV
RECALLING FIRM/MANUFACTURER
Recalling Firm: Endo Pharmaceutical, Inc., Westbury, NY, by  
Manufacturer: Novartis Consumer Health, Lincoln, NB. Firm initiated recall is ongoing.
REASON
Mislabeled; Bottles labeled as 10 mg tablets actually contain 5 mg tablets.
VOLUME OF PRODUCT IN COMMERCE
8,170 bottles
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS:  DRUGS - CLASS III

___________________________________
PRODUCT 
Fentanyl Transdermal System 75 mcg/hr, 5 systems per box, Rx only; NDC 0093-6902-19. Recall # D-017-2010
CODE
Lot number 37649 exp 9/2010
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter dated August 18, 2009.
Manufacturer: AVEVA Drug Delivery Systems, Inc., Miramar, FL. Firm initiated recall is ongoing.
REASON
Incorrect NDC bar code label on the outer carton; bar code is indicated for the 100 mcg/hr strength instead of the 75 mcg/hr strength. The immediate package label is correct.
VOLUME OF PRODUCT IN COMMERCE
31,968 cartons
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
SUSPENDOL-S Compounding Vehicle, NDC 0574-0307-16, Net Contents 473 mL (one pint). Recall # Recall # D-018-2010
CODE
Lot number on bottle 8485024. The bottle label omits the first three digits "200" from the lot number. SAP Lot Number 2008485024.
RECALLING FIRM/MANUFACTURER
Paddock Laboratories, Inc., Minneapolis, MN, by letter dated August 21, 2009. Firm initiated recall is ongoing.
REASON
Presence of Foreign Substance; due to the presence of a food grade lubricant, (Super Lube, Multipurpose Synthetic Lubricant with Syncolon) was found.
VOLUME OF PRODUCT IN COMMERCE
766 bottles
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
ALLOPURINOL Tablets, USP, 100 mg, 30 Tablets, Rx only; NDC16714-142-01. Recall # D-019-2010
CODE
Lot No. 61008, EXP 10/10
RECALLING FIRM/MANUFACTURER
Rx PAK, Memphis, TN, by e-mail on September 18, 2009 followed by a letter dated September 22, 2009. Firm initiated recall is ongoing.
REASON
Labeling: Correct Labeled Product Mispack; 100 mg bottles packed in shipping boxes labeled as 300 mg.
VOLUME OF PRODUCT IN COMMERCE
41 cases of 12 units
DISTRIBUTION
Nationwide
___________________________________
PRODUCT 
Desmopressin Acetate Injection 4 mcg/ml, Each mL provides: Desmopressin acetate 4 mcg, Chlorobutanol 5 mg, Sodium chloride 9 mg, For IV or SC use 1 mL Preserved Vial, Rx only; NDC (single vials) 0703-5051-01; NDC (package of 10 vials) 0703-5051-03. Recall # D-020-2010
CODE
Lot numbers 31305212B exp 12/2010; 31306384B exp 3/2011; 31306687B exp 3/2011
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals USA, Inc., Sellersville, PA, by letter dated September 18, 2009.
Manufacturer: Teva Parenteral Medicines Inc., Irvine, CA. Firm initiated recall is ongoing.
REASON
Failed pH Specification; 6 month stability.
VOLUME OF PRODUCT IN COMMERCE
156,080 vials
DISTRIBUTION
Nationwide

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced, Recall # B-1456-09
CODE
Units: 206635460, 208469162, 208469294, 208472611
RECALLING FIRM/MANUFACTURER
Blood Systems Inc., Baton Rouge, LA, by letters dated September 28, 2007, January 3, 2008 and March 25, 2008. Firm initiated recall is complete.
REASON
Blood products, which were incorrectly tested for red blood cell antigens, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
LA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1732-09
CODE
Unit: GI58827
RECALLING FIRM/MANUFACTURER
Recalling Firm: Puget Sound Blood Center and Program, Seattle, WA, by letter on November 8, 2004.
Manufacturer: Puget Sound Blood Center and Program, Olympia, WA. 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
Austria
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1734-09;
2) Fresh Frozen Plasma. Recall # B-1735-09
CODE
1) and 2) Unit: 19LW54232
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, Tennessee Valley Region, Nashville, TN, by fax and letter on June 26, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
TN
___________________________________
PRODUCT 
1) Platelets Pheresis Leukocytes Reduced Irradiated; Recall # B-1736-09;

2) Platelets Pheresis Leukocytes Reduced. Recall # B-1737-09
CODE
1) Unit: W038309048380 ( part 1 and 2);
2) Unit: W038309048380
RECALLING FIRM/MANUFACTURER
Mississippi Valley Regional Blood Center, Davenport, IA, by telephone and fax on July 6, 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
IA, IL
___________________________________
PRODUCT 
Platelets Pooled Leukocytes Reduced. Recall # B-1738-09
CODE
Unit: 72Z272279
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by fax on June 17, 2009. Firm initiated recall is complete.
REASON
Blood product, with an unacceptably high platelet yield, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
FL
___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1748-09
CODE
Units: W036508101075, W036508101076, W036508101078, W036508101079, W036508101080
RECALLING FIRM/MANUFACTURER
LifeShare Blood Centers, Shreveport, LA, by facsimile on December 31, 2008. Firm initiated recall is complete.
REASON
Blood products, which were tested for hematocrit using a device that failed daily quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units
DISTRIBUTION
LA, AR
___________________________________
PRODUCT 
1) Platelets Leukocytes Reduced. Recall # B-1750-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1752-09
CODE
1) and 2) Unit: 22KE64381
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on April 9, 2009 and by letters dated April 10, 2009 and June 23, 2009.  Firm initiated recall is complete.
REASON
Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
PA
___________________________________
PRODUCT 
Source Plasma. Recall # B-1753-09
CODE
Units: 3900049585, 3900049380
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Petersburg, VA, by letter on April 9, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________
PRODUCT 
Source Plasma. Recall # B-1754-09

CODE
Units: 3880050687, 3880056039
RECALLING FIRM/MANUFACTURER
International BioResources, LLC, Aurora, IL, by letter on April 13, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units
DISTRIBUTION
Austria
___________________________________

PRODUCT 
Source Plasma. Recall # B-1755-09
CODE
Unit: TQ045947
RECALLING FIRM/MANUFACTURER
IBBI dba Knoxville Plasma Corp., Knoxville, TN, by facsimile on May 19, 2009. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was previously deferred, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 Unit
DISTRIBUTION
NC
___________________________________
PRODUCT 
1) Source Leukocytes. Recall # B-1756-09;
2) Red Blood Cells Leukocytes Reduced. Recall # B-1757-09; 
3) Plasma Frozen within 24 hours (FP24). Recall # B-1758-09;
4) Platelets. Recall # B-1759-09 
CODE
1) W044608427914;
2), 3) and 4) W044608427914, W044608639232
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on April 1, 2009, April 3, 2009 and April 6, and by telephone on July 14, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
7 units
DISTRIBUTION
TX, CA, NJ
___________________________________
PRODUCT 
1) Red Blood Cells Leukocytes Reduced. Recall # B-1760-09; 
2) Liquid Plasma. Recall # B-1761-9
CODE
1) and 2) Units: W044608623287, W044609213820
RECALLING FIRM/MANUFACTURER
Gulf Coast Regional Blood Center, Houston, TX, by facsimile on May 6, 2009, May 11, 2009, and May 14, 2009. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who was previously deferred, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units
DISTRIBUTION
TX, NJ

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1762-09
CODE
Unit: 004KK50641
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by telephone on June 4, 2009, by e-mail and letter dated June 9, 2009.
Manufacturer: ARC Manchester, NH, Manchester, NH. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
MA

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

___________________________________
PRODUCT 
Red Blood Cells Leukocytes Reduced. Recall # B-1733-09
CODE
Units: 003LS45894, 003LS45901, 003LS45905
RECALLING FIRM/MANUFACTURER
Recalling Firm: The American National Red Cross, Douglasville, GA, by telephone on September 24, 2007 and with follow-up letter on September 28, 2007.
Manufacturer: The American National Red Cross – Southern Region, Douglasville, GA. Firm initiated recall is complete.
REASON
Blood products, collected using a machine for which the monthly quality control testing was not performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units
DISTRIBUTION
GA
___________________________________
PRODUCT 
1) Repliform, Tissue Regeneration Matrix; 5 x 10 cm, .9-1.6 (mm); Order number 820245. Recall # Recall # B-1743-09;

2) GraftJacket, Regenerative Tissue Matrix; 5 x 10 cm, Non-Meshed, Standard, .89-1.40 (mm) Order number 702050. Recall # B-1744-09;

3) GraftJacket Maxforce-Extreme, Regenerative Tissue Matrix; 4x7 cm, 1.80-2.51 (mm) Reorder number: 702029. Recall # B-1745-09;

4) GraftJacket Regenerative Tissue Matrix Maximum Force, 5 x 5, 1.40 - 1.91 (mm) Reorder number: 702029. Recall # B-1746-09
CODE
1) Lot number B27803, sublots 20 and 21;

2) Lot number B28250, sublot numbers: 17 and 18 Lot number B28520, sublot number 13;

3) Lot number B28520, sublot numbers: 9, 10 Lot number B28892, sublot number 28;

4) Lot number: B28750, sublots: 42, 43; Lot number: B28892, sublot # 33
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeCell Corp., Somerville, NJ, by telephone and e-mail on March 11, 2009.
Manufacturer: New England Organ Bank, Newton, MA. Firm initiated recall is complete.
REASON
Human Skin, recovered from donors with incomplete donor eligibility assessments, were distributed.
VOLUME OF PRODUCT IN COMMERCE
11 units
DISTRIBUTION
MA, TN
___________________________________
PRODUCT 
Human Corneas. Recall # B-1747-09
CODE
Units: SA20080231, SA20080232
RECALLING FIRM/MANUFACTURER
San Antonio Eye Bank, San Antonio, TX, by telephone on February 5, 2008. Firm initiated recall is complete.
REASON
Human corneas, recovered from an ineligible donor, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 corneas
DISTRIBUTION
TX, FL
___________________________________
PRODUCT 
Red Blood Cells (Apheresis) Leukocytes Reduced. Recall # B-1749-09
CODE
Unit: W035809081385
RECALLING FIRM/MANUFACTURER
BloodSource, Inc, Mather, CA, by telephone and facsimile on April 7, 2009. Firm initiated recall is complete.
REASON
Blood product, which did not meet the requirement for red cell recovery, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1751-09
CODE
Unit: 22KE64381
RECALLING FIRM/MANUFACTURER
American National Red Cross, Penn Jersey Region, Philadelphia, PA, by facsimile on April 9, 2009 and by letters dated April 10, 2009 and June 23, 2009.  Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA, PA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1763-09
CODE
Unit: 004KK50641
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by telephone on June 4, 2009, by e-mail and letter dated June 9, 2009.
Manufacturer: ARC Manchester, NH, Manchester, NH. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA
___________________________________
PRODUCT 
Recovered Plasma. Recall # B-1763-09
CODE
Unit: 004KK50641
RECALLING FIRM/MANUFACTURER
Recalling Firm: ARC Blood Services, New England Region, Dedham, MA, by telephone on June 4, 2009, by e-mail and letter dated June 9, 2009.
Manufacturer: ARC Manchester, NH, Manchester, NH. Firm initiated recall is complete.
REASON
Blood product, collected from a donor for whom donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit
DISTRIBUTION
CA

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

___________________________________
PRODUCT 
ARTISTE MV Systems (Part Number 8139789), equipped with a syngo RT Therapist (Part Number 8162815) or RT Therapist Assist system (Part Number 8162807), with Software version NET VA10A for RTT4.1.122 or RTT 4.1.125. Medical charged-particle radiation therapy system. Recall # Z-1888-2009
CODE
All products with Part Number 8139789
RECALLING FIRM/MANUFACTURER
Siemens Medical Solutions USA, Inc., Concord, CA, by letter on April 9, 2009. Firm initiated recall is ongoing.
REASON
Unexpected treatment plan alteration—Software issue may result in unintended modifications to treatment.
VOLUME OF PRODUCT IN COMMERCE
53 units
DISTRIBUTION
MA, UT, OH, NJ, NE, FL, OH, MI, PA, Germany, Poland, the UK, Ireland, Italy, France, South Korea, and Belgium
___________________________________
PRODUCT 
EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrated System is an in vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluids. Part Number: 1000046623. Recall # Z-1991-2009
CODE
None
RECALLING FIRM/MANUFACTURER
Siemens Healthcare Diagnostics, Inc., Newark, DE, by letter dated July 2009. Firm initiated recall is ongoing.
REASON
Incorrect results may be transmitted to LIS.
VOLUME OF PRODUCT IN COMMERCE
359 units
DISTRIBUTION
Nationwide, Australia, Austria, Belgium, Canada, France, Germany, Italy, Japan, Malaysia, Netherlands, Portugal, Slovenia, Spain and Switzerland
___________________________________
PRODUCT 
1) Posey Key Lock Belt Catalog # 1334. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2254-2009;

2) Posey Fifth Point Restraint, Locking Catalog # 2219L. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2255-2009;

3) Posey Connecting Strap/Belt, Cotton, 36" Catalog #232036. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2256-2009;

4) Posey Connecting Strap/Belt, Cotton, 48" Catalog # 232048. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2257-2009;

5) Posey Connecting Strap/Belt, Cotton, 60" Catalog # 232060. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2258-2009;

6) Posey Connecting Strap/Belt, Cotton, 72" Catalog # 232072. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2259-2009;

7) Posey Connecting Strap/Belt, Polypropylene, 18" Catalog # 235018. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2260-2009;

8) Posey Connecting Strap/Belt, Polypropylene, 24" Catalog # 235024. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2261-2009;

9) Posey Connecting Strap/Belt, Polypropylene, 36" Catalog # 235036. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2262-2009;

10) Posey Connecting Strap/Belt, Polypropylene, 48" Catalog # 235048. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2263-2009;

11) Posey Connecting Strap/Belt, Polypropylene, 60" Catalog # 235060. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2264-2009;

12) Posey Connecting Strap/Belt, Polypropylene, 72" Catalog # 235072. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2265-2009;

13) Posey Locking Twice-As Tough Cuffs, Wrists (lock on strap) Catalog # 2792. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2266-2009;

14) Posey Locking Twice-As Tough Cuffs, Ankles (lock on strap) Catalog # 2793. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2267-2009;

15) Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed), Catalog # 2794. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2268-2009;

16) Posey Connected Twice-As Tough Cuffs, Ankles (for use on bed) Catalog # 2795. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2269-2009;

17) Posey Locking Twice-As Tough Cuffs, Wrists (lock on cuff & strap) (2798). Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2270-2009;

18) Posey Locking Twice-As Tough Cuffs, Ankles (lock on cuff and strap), Catalog # 2799. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2271-2009;

19) Posey Locking Twice-As Tough Ambulatory Belt, Catalog # 2800. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2272-2009;

20) Special Order, Posey Connected Twice-As Tough Cuffs, Wrists (for use on bed) Catalog # S27947. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall #: Z-2273-2009;

21) Special Order, Posey Connected Twice-As-Tough Cuffs, Ankle (for use on the bed) , Catalog # S27957. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2274-2009;

22) Posey Swedish Belt, Catalog #1337. Intended for medical purposes to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others. Recall # Z-2275-2009
CODE
All products manufactured between February 2009 and April 2009
RECALLING FIRM/MANUFACTURER
J. T. Posey, Co., Arcadia, CA, by letter dated May 14, 2009. Firm initiated recall is ongoing.
REASON
Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.
VOLUME OF PRODUCT IN COMMERCE
3,136 units
DISTRIBUTION
Nationwide, Canada, France, Belgium and the Netherlands
___________________________________
PRODUCT 
Centricity Enterprise Archive (EA) versions 3.0 to 3.0.7 software. The software delivers a scalable and flexible DICOM storage solution for Cardiology and Radiology images. Recall # Z-2316-2009
CODE
Software versions 3.0, 3.0.1, 3.0.2, 3.0.3, 3.0.4, 3.0.5, 3.0.6 and 3.0.7
RECALLING FIRM/MANUFACTURER
GE Healthcare Integrated IT Solution, Barrington, IL, by letters dated August 7, 2009. Firm initiated recall is ongoing. 
REASON
Software error: There is potential safety issue with Centricity Enterprise Archive (EA) 3.0.x software where study split operations are not correctly replicated to a secondary 'shadow' archive.
VOLUME OF PRODUCT IN COMMERCE
212 units
DISTRIBUTION
Nationwide, Belgium, Canada, Cayman Islands, China, Denmark, France, Germany, Great Britain, Hong Kong, India, Israel, Italy, Korea, Malaysia, Malta, Mexico, New Zealand, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan and Turkey
___________________________________
PRODUCT 
1) DCL (Diagnostic Chemicals Limited) Creatine Enzyme Reagent (R2) Catalog Number: 265-30. In-vitro diagnostic device used for the quantitative measurement of creatine in serum, plasma and urine. Recall # Z-2326-2009;

2) DCL (Diagnostic Chemicals Limited) Creatine Start Reagent (R1) Catalog Number: 265-OP. Recall # Z-2327-2009
CODE
1)  Lot Numbers: 31895 Exp. March 09, 32120 Exp March 09, 32689 Exp March 09 and 32383 Exp May 09;

2) Lot number: 32565 Exp March 09
RECALLING FIRM/MANUFACTURER
Diagnostic Chemicals, Ltd., Charlottetown Prince Edward Island, Canada, by letter dated February 12, 2009. Firm initiated recall is ongoing.
REASON
Labeled with extended expiration date (24 months instead of 18 months)
VOLUME OF PRODUCT IN COMMERCE
107 kits
DISTRIBUTION
Nationwide, Canada and Korea

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

___________________________________
PRODUCT 
Tibial Tray, component of Ortho Development Balanced Knee System, Nonporous, Sterile R, Size 3, REF 162-1300. The Balanced Knee System is indicated in the salvage of previously failed surgical attempts where femoral bone loss does not require the use of augments or stem extensions and where collateral ligaments may be relied upon for medial/lateral stability. Recall # Z-1993-2009
CODE
Lot Number: 0054891
RECALLING FIRM/MANUFACTURER
Ortho Development Corp., Draper, UT, by e-mail on May 29, 3009 and June 5, 2009. Firm initiated recall is ongoing.
REASON
Erroneous lot number on 3 of 28 units of Balanced Knee System. Three units from Lot Number 0055245 were mixed in with the recalled Lot Number 0054891.
VOLUME OF PRODUCT IN COMMERCE
13 units
DISTRIBUTION
FL, TX and Japan
___________________________________
PRODUCT 
300 Microliter CO-RE Tips for use with Microlab STAR. Product is a disposable product used with Microlab STAR series Instruments, which are microtiter diluting and dispensing devices. Part Number 235950 (case containing 11,520 tips), and Part Number 235902 (case containing 5,760 tips). Recall # Z-1999-2009
CODE
Lot Number 2950441 and Lot Number 2950461
RECALLING FIRM/MANUFACTURER
Hamilton, Co., Reno, NV, by letter and e-mail on April 10, 2009. Firm initiated recall is ongoing.
REASON
Product Defect-- some tips from the mold cavity 28 are too short and do not always aspirate or dispense liquid correctly.
VOLUME OF PRODUCT IN COMMERCE
47 cases
DISTRIBUTION
DE, NJ, PA, MA, CA, New Zealand and Japan
___________________________________
PRODUCT 
Acuvue Advance for Astigmatism Diagnostic Product. Expected Primary Package Label: Lot B0077KM 3.75D 1.7cyl. 180 Axis Exp. 2014/07. Actual Primary Package Label: Lot B007NV5 7.50D 1.75cyl. 20 Axis Exp. 2014/12. Product was provided to Eye Care professionals to use as diagnostic replenishment. Product used by Eye Care professionals in the fitting process. Recall # Z-2012-2009
CODE
B007NV51 and B0077KM1
RECALLING FIRM/MANUFACTURER
Vistakon, Jacksonville, FL, by telephone from April 7, 2009 to April 27, 2009. Firm initiated recall is complete.
REASON
Vistakon is recalling Acuvue Advance for Astigmatism Diagnostic product for mislabeling.
VOLUME OF PRODUCT IN COMMERCE
73 units
DISTRIBUTION
Nationwide,
___________________________________
PRODUCT 
AxSYM System Tubing Decontamination Solution; 500 mL bottle; List Number 07B05-09. To be used only for cleaning and inhibition of fouling bacteria in the tubing system of the in vitro immunoassay analyzer. This product does not disinfect or sterilize the tubing system. Recall # Z-2317-2009
CODE
Lot Number: 211974, expiration date 9/30/09.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Abbott Park, IL, by letters dated February 18, 2009.
Manufacturer: Minntech Corp., Plymouth, MN. Firm initiated recall is ongoing.
REASON
Bottle labels from lot 211974, AxSYM System Tubing Decontamination Solution (List Number 7B05-09), were found to be missing the following information: lot number, date of manufacture, and expiration date.
VOLUME OF PRODUCT IN COMMERCE
1,965 kits
DISTRIBUTION
Nationwide, Argentina, Brazil, Canada, Chile, Columbia, Germany, Hong Kong, Japan, Mexico, Peru, South Korea, Thailand and Trinidad & Tobago
___________________________________
PRODUCT 
ARCHITECT i System Assay CD ROM - US, list 6E58-22, Version 22.01, and ARCHITECT i System Assay CD-ROM - WW (excluding US), list 6E59-23, Version 23.0, containing the ARCHITECT LH assay file; Product List Number: 6E58 (US) and 6E59 (WW) Versions 23 and lower. The Architect LH assay is a Chemiluminescent Microparticle Immunoassay for the quantitative determination of human luteinizing hormone (LH) in human serum or plasma. Recall # Z-2325-2009   
CODE
All serial numbers
RECALLING FIRM/MANUFACTURER
Abbott Laboratories, Abbott Park, IL, by letter dated April 24, 2009. Firm initiated recall is ongoing.
REASON
There continues to be an elevated level of complaint activity for calibration error code 1227, when using ARCHITECT LH reagent lots (6C25-22 or 6C25-27) due to the use of assay disk versions that do not contain the updated ARCHITECT LH assay file contained on ARCHITECT i System Assay CD ROM versions 24 and higher (US LN 6E58, WW LN 6E59).
VOLUME OF PRODUCT IN COMMERCE
1,037 CD-ROMs - U.S., 4,676 CD-ROMs - WW
DISTRIBUTION
Nationwide, Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatemala, Hong Kong, Japan, Mexico, New Zealand, Peru, Singapore, South Korea, Taiwan, Thailand, Uruguay and Venezuela

END OF ENFORCEMENT REPORT FOR OCTOBER 28, 2009

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