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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Class I Food Event

Event ID47202
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Feb-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmWILDCAT CREEK POPCORN
CityPAYNE
StateOH
CountryUS
Distribution PatternProduct was shipped to stores in IN & OH.
 

Associated Products

Product DescriptionWildcat Creek Farms Country Style Butter Flavored Popcorn Salt, 4.5oz glass shaker, UPC 7 28123 91010 4 & 40 oz pete container, UPC 7 28123 91009 8. 4633 Rd. 94, Payne, OH 45880
Code InfoAll product. 4.5 oz glass shaker, UPC 7 28123 91010 4 & 40 oz pete container, UPC 7 28123 91009 8
ClassificationClass I
Reason for RecallPossible undeclared allergens. Milk, eggs, yellow #5, yellow #6 and red 40.
Product Quantity564/4.5 oz glass jars & 90/40 oz pete containers
Recall NumberF-1129-2013

Class I Food Event

Event ID63311
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Sep-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmWhole Foods Market
CityAustin
StateTX
CountryUS
Distribution PatternFL and CA
 

Associated Products

Product DescriptionPeanut Butter Power Chews sold as a bulk item through Whole Foods Market self serve bins, PLU 9663
Code InfoAll product sold through the firm's self serve bins between May 1 and September 27th.
ClassificationClass I
Reason for RecallThe bulk Peanut Butter Power Chews and Treasure Trove Mix have the potential to be contaminated with Salmonella. The products were manufactured by Sunridge Farms/Falcon Trading who was supplied peanut butter by Sunland, Inc.
Product Quantity18 lbs.
Recall NumberF-1197-2013
Product DescriptionTreasure Trove Mix, sold from Whole Foods Market Bulk Bins PLU 6922
Code InfoAll product sold through the firm's self serve bins between May 1 and September 27th.
ClassificationClass I
Reason for RecallThe bulk Peanut Butter Power Chews and Treasure Trove Mix have the potential to be contaminated with Salmonella. The products were manufactured by Sunridge Farms/Falcon Trading who was supplied peanut butter by Sunland, Inc.
Product Quantity431 lbs.
Recall NumberF-1198-2013

Class I Food Event

Event ID63420
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTalenti I, LLC
CityDallas
StateTX
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionChocolate Peanut Butter Cup Gelato. The product was distributed to retail stores throughout the United States between September 2011 and September 2012 and is packaged in clear, plastic One Pint (473ml) containers with UPC code 1 86852 00094 5 printed on the back of the container and "Best By" date range of 3/21/13 through 3/26/14 printed on the bottom of the container. The firm also sold the product in a 5 QT size with UPC code 1-8685200090-7 and best by range 03/21/13 through 03/26/2014.
Code InfoThe product was distributed to retail stores throughout the United States between September 2011 and September 2012 and has UPC code 1 86852 00094 5 printed on the back of the container and "Best By" date range of 3/21/13 through 3/26/14 printed on the bottom of the container. The 5 QT size had UPC code 1-8685200090-7 and best by range 03/21/13 through 03/26/2014.
ClassificationClass I
Reason for RecallTalenti Gelato is recalling Talenti Chocolate Peanut Butter Cup Gelato. The peanut butter used in this product has the potential to be contaminated with Salmonella. Consumption of food contaminated with Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is being initiated because the peanut butter used in the product is supplied by Sunland, Inc., which has issued a national recall of some of its products.
Product Quantity66,041 cases of pint size and 837 cases of 5 qt. size
Recall NumberF-1060-2013

Class I Food Event

Event ID63456
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmHines Nut Co
CityDallas
StateTX
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionThe HINES package is a cello/poly laminated bag, predominately blue, with a yellow label stating "SALTED JUMBO VIRGINIA PEANUTS" packed as 8 oz, 10 oz, 12 oz, 16 oz and 24 oz; Hines also packages three "theme" cello/poly laminated bags that are 5.5oz each. The themes for these bags are: 1) Independence Day - red, white and blue in color with a stylized flag on the front; 2) Football Season - with a football on the front; and Hunting Season - with a camouflage motif on the front of the bag. The Dollar General Clover Valley package is a cello/poly laminated bag, predominately white with red trim and red lettering. These bags are packaged as 8 oz bags.
Code InfoThe product will have best by/expiration dates on the packaging from October 12, 2012 through August 27, 2013. The lot number information can be located on the fourth line of the Packing Information: printed in black on the package. The packing information begins with the words "BEST BUY". The recall lot numbers are as follows, located on the fourth line of the "BEST BUY" statement: S03718, S03699, S03724, S03753, S03765, S03784, S03798, S03806, S03810, S03824, S03826, S03840, S03863, S03886, S03907, S03928, S03933, S03938, S03950, S03958, S03967, S03972, S03978, S03989, S03991, S04012, S04025, S04042, S04054, S04066, S04097, S04109, S04123, S04134, S04141, S04141, S04165, S04200, S04201, S04211, S04229, S04236, and S04247.
ClassificationClass I
Reason for RecallHines Nut Company Inc. recalled its SALTED JUMBO VIRGINIA IN-SHELL PEANUTS. These peanuts were processed in the Sunland, Inc. Peanut Processing Plant and may be contaminated with Salmonella. Salmonella is an organism that can cause serious and sometimes fatal infections in young children, frail or elderly people, and those with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
Product QuantityApproximately 57,000 lbs
Recall NumberF-1194-2013

Class I Devices Event

Event ID64423
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSymbios Medical Products, LLC
CityIndianapolis
StateIN
CountryUS
Distribution PatternNationwide Distribution including PA, CA, OH, AL, FL, WV, TN, NJ, NC, TX, CO, NY, TX, MO, MS, SC, and GA.
 

Associated Products

Product DescriptionGOPump Elastometric infusion PumpKit with/ and without accesssories all containing Dual GOPump, part number 510076: One infusion pump comprising two, 150 mL elastomeric reservoirs, each of which connects to its own catheter. Liquid flow rate is labeled at 2 mL/hr per elastomer. The Symbios Disposable Infusion Pump Kit is a disposable, self-contained infusion system utilizing an inflatable elastomeric reservoir to mechanically provide percutaneous infusion of prescribed solutions at a pre-set rate for post-operative pain management
Code InfoKit Part Number 510545-BP, lot 12-100983, 12-100984, 12-101096, 12-101125 Kit Part Number 510112-BP, lot 12-101110, 12-101103 Kit: 510401-BP lot 12-101045 Kit: 510644, lot 12-101028, 12-101097, 12-101130 GOPump Dual Infusion Pump Kit All Kits contain Pump Part Number: 510076 Lot Number: 12-100601
ClassificationClass I
Reason for RecallReceived 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.
Product Quantity458
Recall NumberZ-0940-2013

Class I Food Event

Event ID64493
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPublix Super Markets, Inc.
CityLakeland
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPublix 7 inch Chocolate Cookies n Cream Cake Scale ID Number * 002-13584-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantityunknown
Recall NumberF-1145-2013
Product DescriptionPublix 7 inch Cookies Cream Layer Cake Scale ID Number * 002-16466-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1146-2013
Product DescriptionPublix 7inch W/T Iced Chocolate Layer cake Scale ID Number * 002-16467-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1147-2013
Product DescriptionPublix 7 inch Dec. Butter cream w/Filling Cake Scale ID Number * 002-19722-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1148-2013
Product DescriptionPublix 7 inch Dec. Whip Topping with filling cake Scale ID Number * 002-19734-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1149-2013
Product DescriptionPublix 7 inch Dec. Fudge iced w/filling cake Scale ID Number * 002-19748-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1150-2013
Product DescriptionPublix 7inch Dec. Cream Cheese Iced W/F cake Scale ID Number * 002-19759-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1151-2013
Product DescriptionPublix 7 inch Cream Cheese VAN DEC cake Scale ID Number * 002-92096-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1152-2013
Product DescriptionPublix 7 inch Cream Cheese CHOC DEC cake Scale ID Number * 002-92097-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1153-2013
Product DescriptionPublix 7inch Cream Cheese 1/2 & 1/2 DEC cake Scale ID Number * 002-92099-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1154-2013
Product DescriptionPublix Chocolate Ganache cake Scale ID Number * 002-94078-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1155-2013
Product DescriptionPublix Dulce de Leche Bon Bon cake Scale ID Number * 002-94003-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1156-2013
Product DescriptionPublix Chocolate Ganache Supreme cake Scale ID Number * 002-94085-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1157-2013
Product DescriptionPublix Chocolate Ganache Bon Bon cake Scale ID Number * 002-94098-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1158-2013
Product DescriptionPublix 7 inch Chocolate Ganache Grandeur cake Scale ID Number * 002-94130-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1159-2013
Product DescriptionPublix 7 inch Buttercream Choc Dec cake Scale ID Number * 002-943330-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1160-2013
Product DescriptionPublix 7 inch Raspberry Sacher Torte Scale ID Number * 002-94132-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1161-2013
Product DescriptionPublix Latte Blast cake Scale ID Number * 002-94162-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1162-2013
Product DescriptionPublix 7 inch Whipped Topping Choc Dec cake Scale ID Number * 002-94396-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1163-2013
Product DescriptionPublix 7 inch Whipped Topping 1/2 & 1/2 cake Scale ID Number * 002-94420-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1164-2013
Product DescriptionPublix 7 inch Fudge iced Choc DEC cake Scale ID Number * 002-94432-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1165-2013
Product DescriptionPublix 7inch Ice Cream Choc Dec cake Scale ID Number * 002-94468-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1166-2013
Product DescriptionPublix 7inch Ice Cream 1/2 & 1/2 DEC cake Scale ID Number * 002-94490-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1167-2013
Product DescriptionPublix 7 inch Buttercream 1/2-1/2 cake Scale ID Number * 002-94502-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1168-2013
Product DescriptionPublix W/T Blackout layer cake Scale ID Number * 002-95322-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1169-2013
Product DescriptionPublix 7inch Chocolate Shadow cake Scale ID Number * 002-95323-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code Info Recalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1170-2013
Product DescriptionPublix 7inch Checkerboard Whole cake Scale ID Number * 002-95325-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1171-2013
Product DescriptionPublix 7 inch German Chocolate Layer cake Scale ID Number * 002-95353-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1172-2013
Product DescriptionPublix Peanut Butter Fudge Fix cake Scale ID Number * 002-95628-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1173-2013
Product DescriptionPublix 7 inch Chocolate w Pistachio layer cake Scale ID Number * 002-95657-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1174-2013
Product DescriptionPublix 7 inch Ripple layer cake Scale ID Number * 002-95658-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1175-2013
Product DescriptionPublix 7 inch Chocolate with Mocha layer cake Scale ID Number * 002-95697-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code Info Recalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1176-2013
Product DescriptionPublix 7 inch Chocolate with Fudge layer cake Scale ID Number * 002-95663-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1177-2013
Product DescriptionPublix 7 inch Chocolate with Buttercream layer cake Scale ID Number * 002-95664-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1178-2013
Product DescriptionPublix 7 inch Chocolate with Cherry Buttercream layer cake Scale ID Number * 002-95767-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1179-2013
Product DescriptionPublix Chocolate with Cheesecake torte 6" whole Scale ID Number * 002-95770-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1180-2013
Product DescriptionPublix 7 inch Chocolate with Chocolate butter cream layer cake Scale ID Number * 002-95954-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1181-2013
Product DescriptionPublix 7 inch Chocolate with Mint butter cream layer cake Scale ID Number * 002-95955-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1182-2013
Product DescriptionPublix 7 inch German Chocolate cake Scale ID Number * 002-95958-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1183-2013
Product DescriptionPublix 7 inch Black Forest cake Scale ID Number * 002-95970-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1184-2013
Product DescriptionPublix Caramel Pecan Crunch cake Scale ID Number * 002-94301-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1185-2013
Product DescriptionPublix Midnight Fudge Fantasy cake Scale ID Number * 002-94254-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1186-2013
Product DescriptionPublix Peanut Butter Fudge Fix cake Scale ID Number * 002-94599-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1187-2013
Product DescriptionPublix 7 inchW/T Black Forest layer cake Scale ID Number * 002-95334-00000 *The last five digits of the scale ID number contain the unit price. For example $4.99 would have the last five digits ending 00499.
Code InfoRecalled products were distributed from November 11, 2012 through November 15, 2012.
ClassificationClass I
Reason for RecallMaplehurst Deli-Bake South Inc. the cake supplier notified Publix Super market of a contamination with Listeria Monocytogenes on 11/15/2012.
Product Quantity
Recall NumberF-1188-2013

Class I Food Event

Event ID64502
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Feb-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmSee's Candies Inc.
CitySouth San Francisco
StateCA
CountryUS
Distribution PatternSee Candies stores in CA, AZ, NM, MO, OK, NV, UT, TX.
 

Associated Products

Product DescriptionSee's Candies, Divinity with Walnuts; Net Wt. 1.7 oz, (48 gr). See's Candies, South San Francisco, CA.
Code InfoL.A.D. 102/13
ClassificationClass I
Reason for RecallOne code of 1.7 oz Divinity Easter Eggs with Walnuts may actually contain Peanut Butter Eggs.
Product Quantity2048 units
Recall NumberF-1061-2013

Class II Biologics Event

Event ID39583
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Dec-04
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIllinois
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoLG13666; LG13318
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 Units
Recall NumberB-0698-13

Class II Biologics Event

Event ID40188
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-May-05
Initial Firm Notification of Consignee or Public FAX
Recalling FirmZLB Bioplasma, Inc.
CityEvans
StateCO
CountryUS
Distribution PatternIL
 

Associated Products

Product DescriptionSource Plasma
Code Info6150025377;6150024781;6150024580;6150021661;6150021487;6150020920;6150025471
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose physical was overdue, were distributed.
Product Quantity7 units
Recall NumberB-0640-13

Class II Biologics Event

Event ID40989
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Oct-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoKW94520; KW92744; KW90445
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity3 Units
Recall NumberB-0699-13
Product DescriptionFresh Frozen Plasma
Code InfoKW88673
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity1 Unit
Recall NumberB-0700-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoKW88673
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity1 Unit
Recall NumberB-0701-13
Product DescriptionPlatelets Irradiated
Code InfoKW88673
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was in close contact with an individual diagnosed with viral hepatitis, were distributed.
Product Quantity1 Unit
Recall NumberB-0702-13

Class II Biologics Event

Event ID41049
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Oct-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info11FR07265
ClassificationClass II
Reason for RecallBlood product, which was entered negative in the computer for K, Fya and Fyb antigen when tested turned out to be positive, was distributed.
Product Quantity1 Unit
Recall NumberB-0622-13

Class II Biologics Event

Event ID41387
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Nov-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri
 

Associated Products

Product DescriptionRed Blood Cells
Code Info11KS10932
ClassificationClass II
Reason for RecallBlood product, collected from a donor in which hematocrit and hemoglobin was not adequately determined, was distributed.
Product Quantity1 Unit
Recall NumberB-0646-13

Class II Biologics Event

Event ID41895
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Apr-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityOmaha
StateNE
CountryUS
Distribution PatternNE
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info09FZ51123; 09FZ51136
ClassificationClass II
Reason for RecallBlood products, collected from donors whose arm scrubs may have been incorrectly performed, were distributed.
Product Quantity2 units
Recall NumberB-0585-13

Class II Biologics Event

Event ID41905
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Mar-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center of the Ozarks
CitySpringfield
StateMO
CountryUS
Distribution PatternMO, Austria
 

Associated Products

Product DescriptionRed Blood Cells
Code Info6690261
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-0649-13

Class II Biologics Event

Event ID41921
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiouxland Community Blood Bank
CitySioux City
StateIA
CountryUS
Distribution PatternIA, Austria
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2024507
ClassificationClass II
Reason for RecallBlood products, collected from a donor who received a MMR vaccine, were distributed.
Product Quantity1 unit
Recall NumberB-0651-13

Class II Biologics Event

Event ID42093
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Apr-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternMissouri; Saipan
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011KV10514
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 Unit
Recall NumberB-0652-13
Product DescriptionPlasma Frozen
Code Info011KV10514
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 Unit
Recall NumberB-0653-13

Class II Biologics Event

Event ID45120
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jul-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityOmaha
StateNE
CountryUS
Distribution PatternNE, PA, NJ
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info09GR11089; 09GR11095
ClassificationClass II
Reason for RecallBlood products, possibly contaminated with air, were distributed.
Product Quantity2 units
Recall NumberB-0200-13

Class II Biologics Event

Event ID50431
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Sep-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityOmaha
StateNE
CountryUS
Distribution PatternPA, CO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info009FQ38724
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving post donation information, were distributed.
Product Quantity1 unit
Recall NumberB-0733-13
Product DescriptionPlasma Frozen
Code Info009FQ38724
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving post donation information, were distributed.
Product Quantity1 unit
Recall NumberB-0734-13

Class II Biologics Event

Event ID50951
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Dec-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityCleveland
StateOH
CountryUS
Distribution PatternOhio, California.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info42 FZ34322, 42 FZ34323, 42 FZ34325, 42 FZ34328, 42 FY90934, 42 FY90942, 42 FY90943, 42 FY90947, 42 FY90954, 42 FY90990, 42 FY90993, 42 G76618, 42 G76631, 42 G76632, 42G 76644, 42 G 76646, 42 R05856, 42 R05859, 42 R 05863, 42 R05872, 42 R05877, 42 R05880, 42 K06759, 42 K06764, 42K06775, 42K06777, 42 K06781, 42 K06794, 42 FR54630, 42 S41166, 42 S41235, 42 S41239, 42 S41242, 42 S41247, 42 FG41438
ClassificationClass II
Reason for RecallBlood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed.
Product Quantity35 units
Recall NumberB-0584-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info42 FY90992, 42 FY90993, 42 R05863, 42 R05877, 42R05880, 42 S41235, 42 S41239, 42 S41247, 42 K06775, 42 K06777, 42 K06794, 42FH67049
ClassificationClass II
Reason for RecallBlood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed.
Product Quantity12 units
Recall NumberB-0586-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code Info25612, 25600,25607, 25634, 25694, 25713, 25731, 25781, 25938, 26009, 26036
ClassificationClass II
Reason for RecallBlood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed.
Product Quantity11 units
Recall NumberB-0587-13

Class II Biologics Event

Event ID52256
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-09
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityPortland
StateOR
CountryUS
Distribution PatternMedical Centers nationwide
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21KS81850; 21KS81876; 21KS81897; 21KS81923; 21KS81935; 21KS81947; 21KS82044; 21KS82070; 21KS82103; 21KS82123; 21KS82126; 21KS82133; 21KS82142; 21KS82158; 21KS82159; 21KS82162; 21KS82165; 21KS82343; 21KS82344; 21KS82485; 21KS82487; 21KY24230; 21KY24248; 21LG75833; 21LG75842; 21LG75852; 21LG75874; 21LG75890; 21LG75920; 21LG75931; 21LG75963; 21LG75981; 21LG75982; 21LK55444; 21LK55449; 21LK55473; 21LL53586; 21LL53593; 21LL53597; 21LL53612; 21LL53616; 21LL54081; 21LL54095; 21LS04243; 21LS04244.
ClassificationClass II
Reason for RecallBlood products, possibility sterility compromised and contaminated, were distributed.
Product Quantity45 units
Recall NumberB-0627-13
Product DescriptionRed Blood Cells
Code Info21KS82405; 21KS82409
ClassificationClass II
Reason for RecallBlood products, possibility sterility compromised and contaminated, were distributed.
Product Quantity2 units
Recall NumberB-0628-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info21KY24238; 21LH71621.
ClassificationClass II
Reason for RecallBlood products, possibility sterility compromised and contaminated, were distributed.
Product Quantity2 units
Recall NumberB-0629-13
Product DescriptionCryoprecipitated AHF
Code Info21KS81143; 21KS81153; 21KS81169; 21KS81174; 21KS81177; 21KS81182; 21KS81406; 21KS81409; 21KS81418; 21KS81426; 21KS81876; 21KS81897; 21KS81923; 21KS81935; 21KS82044; 21KS82103; 21KS82123; 21KS82126; 21KS82133; 21KS82318; 21KS82343; 21KS82344; 21KY24230; 21KY24234; 21KY24238; 21KY24248; 21LG74950; 21LG75874; 21LG75890; 21LG75963; 21LG75981; 21LG75982; 21LH70417; 21LH70423; 21LH70426; 21LH70436; 21LH70451; 21LH70454; 21LH70460; 21LH70462; 21LH70468; 21LH70478; 21LL51972; 21LL52214, 21LL52547; 21LL53593; 21LL53597.
ClassificationClass II
Reason for RecallBlood products, possibility sterility compromised and contaminated, were distributed.
Product Quantity47 units
Recall NumberB-0630-13
Product DescriptionPlasma Frozen
Code Info21KS82070; 21KS82165; 21KS82485; 21KS82487; 21KW70562; 21KW70564; 21KW70567; 21KW70568; 21KW70571; 21KW70579; 21KY23565; 21KY23579; 21KY23581; 21KY23590; 21KY23592; 21KY23602; 21LG75833; 21LG75852; 21LG75961; 21LH70618; 21LH70637; 21LH70642; 21LH70644; 21LL53612.
ClassificationClass II
Reason for RecallBlood products, possibility sterility compromised and contaminated, were distributed.
Product Quantity24 units
Recall NumberB-0631-13
Product DescriptionPlasma Frozen Cryoprecipitate Reduced
Code Info21KS81418; 21KS81426; 21KY24230; 21LG75006; 21LH70417; 21LH70426; 21LL51972; 21LL52533; 21LL52547.
ClassificationClass II
Reason for RecallBlood products, possibility sterility compromised and contaminated, were distributed.
Product Quantity9 units
Recall NumberB-0632-13

Class II Drugs Event

Event ID55714
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Mar-10
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmK C Pharmaceuticals Inc
CityPomona
StateCA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionEye Drops advanced relief (Dextran 70 0.1%, Polyethylene glycol 400 1%, Povidone 1%, Tetrahydrozoline HCl 0.05%) ophthalmic solution, 1/2 fl oz (15 mL) bottle, Distributed By Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37072.
Code InfoLot #: 9P367, Exp 12/12
ClassificationClass II
Reason for RecallLabeling: Label Mix-Up: Incorrect back labeling of the immediate container of eye drops (unit carton and front label are correct) which do not list three active ingredients: Dextran 70, PEG 400, and povidone.
Product Quantity31,704 bottles
Recall NumberD-192-2013

Class II Drugs Event

Event ID59001
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-May-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmA B Nutrition, Inc.
CitySpring
StateTX
CountryUS
Distribution PatternIn retail store located in TX and internet sales nationwide.
 

Associated Products

Product DescriptionPIRACETAM COGNITION ENHANCING AGENT Dietary Supplement PHARMACEUTICAL GRADE 800 mg 240 Capsules per bottle CTD Labs Houston, TX 77090
Code InfoLot #33250311 Exp. 04/13
ClassificationClass II
Reason for RecallMarketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Product Quantity2980 bottles
Recall NumberD-194-2013
Product DescriptionPIRACETAM POWDER COGNITION ENHANCING AGENT Dietary Supplement CTD 500 grams PHARMACEUTICAL GRADECTD Labs Houston, TX 77090
Code InfoLot # 33280311 Exp. 03/13
ClassificationClass II
Reason for RecallMarketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Product Quantity509 bottles
Recall NumberD-195-2013
Product DescriptionANIRACETAM FAST ACTING NOOTROPIC Dietary Supplement PHARMACEUTICAL GRADE 750mg 60 Capsules per bottle CTD Labs Houston, TX 77090
Code InfoLot # 32000311
ClassificationClass II
Reason for RecallMarketed Without an Approved NDA/ANDA: The product is an unapproved new drug.
Product Quantity912 bottles
Recall NumberD-196-2013

Class II Devices Event

Event ID62993
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Aug-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSpine Smith Partners LP
CityAustin
StateTX
CountryUS
Distribution PatternDistributed in Texas.
 

Associated Products

Product DescriptionCynch Lordotic T-PLlF Implant. Intervertebral fusion device with bone graft, for use with supplemental fixation.
Code InfoPart Number: 0609-2809-06, Lot: 39AQ
ClassificationClass II
Reason for RecallImplants were incorrectly laser marked as 23mm instead of 28mm.
Product Quantity3 units
Recall NumberZ-0932-2013

Class II Devices Event

Event ID63551
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInstratek, Incorporated
CityHouston
StateTX
CountryUS
Distribution PatternUSA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX.
 

Associated Products

Product DescriptionEndotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
Code InfoModel number 1052; Lots M674180, MAKL170, M674200
ClassificationClass II
Reason for RecallInstratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures.
Product Quantity235
Recall NumberZ-0922-2013

Class II Biologics Event

Event ID63778
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Oct-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMississippi Blood Services Inc.
CityFlowood
StateMS
CountryUS
Distribution PatternMississippi
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW069112124448;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who reported travel to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-0679-13

Class II Biologics Event

Event ID63779
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida's Blood Centers - Lake Park
CityPalm Beach Gardens
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038112140935; W038112214027; W038112115492; W038112070188; W038112056857; W038112023793; W038112023467; W038112040729; W038111354805; W038111354804; W038111321390;
ClassificationClass II
Reason for RecallBlood products, leukoreduced more than three days after collection, were distributed.
Product Quantity11
Recall NumberB-0676-13

Class II Biologics Event

Event ID63780
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida's Blood Centers, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038111368727; W038111244184; W038111244903; W038111240489; W038111189594; W038111181167;
ClassificationClass II
Reason for RecallBlood products, leukoreduced more than three days after collection, were distributed.
Product Quantity6
Recall NumberB-0675-13

Class II Biologics Event

Event ID63789
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Oct-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmer. National Red Cross-Greater Chesapeake & Potomac Reg.
CityBaltimore
StateMD
CountryUS
Distribution PatternDistrict of Columbia; Maryland
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info53H35682;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0707-13
Product DescriptionPlasma Frozen within 24 hours (FP24)
Code Info53H35682;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-0708-13

Class II Biologics Event

Event ID63812
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Nov-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Carolinas
CityCharlotte
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW227012037073; W227012037073;
ClassificationClass II
Reason for RecallBlood products, collected from a donor whose eligibility to donate was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-0684-13

Class II Biologics Event

Event ID63830
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank Of San Bernardino And Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW125612441491;
ClassificationClass II
Reason for RecallBlood product, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1
Recall NumberB-0686-13

Class II Biologics Event

Event ID63832
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Nov-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmVirginia Blood Services
CityRichmond
StateVA
CountryUS
Distribution PatternVirginia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW087612049410;
ClassificationClass II
Reason for RecallBlood product, labeled as leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed.
Product Quantity1
Recall NumberB-0680-13

Class II Biologics Event

Event ID63849
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Oct-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMemorial Blood Centers
CitySaint Paul
StateMN
CountryUS
Distribution PatternNew Jersey; New York
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW051512125236; W051512125236;
ClassificationClass II
Reason for RecallBlood products labeled as leukoreduced which did not meet the requirements for leukoreduced products, were distributed.
Product Quantity2
Recall NumberB-0682-13

Class II Biologics Event

Event ID63860
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSt Mary's Hospital and Medical Center, Inc.
CityGrand Junction
StateCO
CountryUS
Distribution PatternColorado
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW056312004293;
ClassificationClass II
Reason for RecallBlood product, with platelet yield that did not meet the specified minimum requirement, was distributed.
Product Quantity1
Recall NumberB-0690-13

Class II Biologics Event

Event ID63885
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Nov-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityGainesville
StateFL
CountryUS
Distribution PatternAlabama; Georgia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112345094Z; W115112345094Z; W115112345094Z;
ClassificationClass II
Reason for RecallBlood products, labeled as leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed.
Product Quantity3
Recall NumberB-0683-13

Class II Biologics Event

Event ID63886
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Nov-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112376125F;
ClassificationClass II
Reason for RecallBlood product, with platelet count below the specified minimum requirement, was distributed.
Product Quantity1
Recall NumberB-0689-13

Class II Biologics Event

Event ID63887
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Oct-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers, Inc.
CityDunwoody
StateGA
CountryUS
Distribution PatternGeorgia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW115112323972Y;
ClassificationClass II
Reason for RecallBlood product, with platelet count below the specified minimum requirement, was distributed.
Product Quantity1
Recall NumberB-0688-13

Class II Biologics Event

Event ID63889
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Nov-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc - Birmingham Region
CityBirmingham
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW115112340698M;
ClassificationClass II
Reason for RecallBlood product, with platelet count below the specified minimum requirement, was distributed.
Product Quantity1
Recall NumberB-0687-13

Class II Devices Event

Event ID64015
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAbbott Medical Optics Inc (AMO)
CitySanta Ana
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including the state of OH and the countries of: Germany, Switzerland, Sweden, Italy, China, France, Singapore, UK, Croatia, Hungary, Turkey and Brazil.
 

Associated Products

Product DescriptionAMO Sensar Intraocular Lenses (IOLs), Model AR40e, Sensar Foldable IOL with OptiEdge Product Usage: These are ultraviolet-absorbing posterior chamber intraocular lenses for use after cataract extraction.
Code InfoDiopter 18.0 4760271207 4760661207 4761191207 4760281207 4760681207 4761211207 4760291207 4760701207 4761221207 4760301207 4760721207 4761231207 4760311207 4760741207 4761241207 4760321207 4760761207 4761251207 4760331207 4760781207 4761261207 4760341207 4760801207 4761271207 4760351207 4760811207 4761281207 4760361207 4760821207 4760371207 4760841207 4760381207 4760861207 4760391207 4760881207 4760401207 4760901207 4760411207 4760921207 4760421207 4760941207 4760431207 4760961207 4760441207 4760981207 4760451207 4761001207 4760461207 4761031207 4760471207 4761041207 4760481207 4761051207 4760491207 4761061207 4760501207 4761071207 4760511207 4761081207 4760531207 4761091207 4760551207 4761101207 4760571207 4761111207 4760591207 4761121207 4760601207 4761131207 4760611207 4761151207 4760621207 4761161207 4760631207 4761171207 4760641207 4761181207 Diopter 23.5 4759221207 4759821207 4760161207 4759231207 4759831207 4760171207 4759241207 4759841207 4760181207 4759251207 4759851207 4760191207 4759261207 4759861207 4760201207 4759271207 4759871207 4760211207 4759281207 4759881207 4760221207 4759291207 4759891207 4760231207 4759311207 4759901207 4760241207 4759321207 4759911207 4760251207 4759331207 4759921207 4759341207 4759931207 4759361207 4759941207 4759381207 4759951207 4759401207 4759961207 4759421207 4759971207 4759441207 4759981207 4759461207 4759991207 4759481207 4760001207 4759671207 4760011207 4759681207 4760021207 4759691207 4760031207 4759701207 4760041207 4759711207 4760051207 4759721207 4760061207 4759731207 4760071207 4759741207 4760081207 4759751207 4760091207 4759761207 4760101207 4759771207 4760111207 4759781207 4760121207 4759791207 4760131207 4759801207 4760141207 4759811207 4760151207
ClassificationClass II
Reason for RecallTwo production orders of these IOLs that contain mislabeled IOLs.
Product Quantity155 units
Recall NumberZ-0929-2013

Class II Devices Event

Event ID64159
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternUSA Nationwide Distribution including the states of AL, AR, AK, CA, FL, ID, KS, LA, MD, MA, MO, NJ, NY, OH, PA, TN, TX, and VA.
 

Associated Products

Product DescriptionLarge Combination Clamp/Large External Fixation System, Part Number 390.005 Product Usage: Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Code Info Lot Numbers 6602070, 6582333, 6581191, and 6581193
ClassificationClass II
Reason for RecallThe L1 hex nuts, used to tighten the Large Combination Clamp, were oversized and the 11 mm sockets and wrenches will not fit on the hex nuts.
Product Quantity136
Recall NumberZ-0941-2013

Class II Devices Event

Event ID64165
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Dec-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmElekta, Inc.
CityAtlanta
StateGA
CountryUS
Distribution PatternNationwide Distribution-DC, Puerto Rico and the states of AL, AK, AZ, CA, CO, CT, FL, GA, IL, IA, KY, MD, MA, MI, MN, MS, MT, NE, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VT, VA, WA, WV, and WI.
 

Associated Products

Product DescriptionElekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1 Used as part of radiation therapy treatment process.
Code Info151055, 151700, 151809, 151695, 151479, 151696, 151867, 151704, 151765, 151860, 151024, 151521, 151803, 152217, 151774, 152220, 151626, 151842, 151847, 151446, 151801, 151953, 151664, 151751, 151352, 151298, 151728, 151504, 151981, 151705, 151977, 152123, 152126, 151955, 105982, 151160, 151634, 151954, 151416, 151074, 151587, 151729, 151694, 151965, 151418, 151674, 151259, 151698, 151699, 152043, 151636, 151811, 151568, 151258, 151584, 151423, 151623, 151627, 151507, 151640, 151933, 151340, 151722, 151810, 151051, 151411, 151360, 151595, 151433, 151611, 152008, 151151, 151714, 151653, 151675, 151538, 152031, 151523, 151519, 151432, 151783, 151410, 151371, 151084, 151387, 151978, 151530, 151328, 151689, 151567, 151598, 151760, 151269, 151557, 151558, 151789, 151398, 151632, 152214, 151301, 151441, 151256, 151391, 151038, 151585, 151327, 151326, 151250, 151130, 151828, 151245, 151672, 105803, 151073, 151956, 152232, 151319, 151959, 151960, 151958, 151435, 151779, 151969, 151848, 151875, 151881, 151882, 151736, 152023, 152080, 152079, 152064, 151734, 151763, 152154, 151110, 151363, 151216, 151173, 151678, 151467, 151961, 151178, 152091, 152051, 152115, 152116, 151708, 152176, 152192, 152098, 152200, 152174, 152246, 152364, 152673, 152425, 151156, 151764, 151886, 151076, 151369, 152175, 105941
ClassificationClass II
Reason for RecallThe DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
Product Quantity164
Recall NumberZ-0931-2013

Class II Devices Event

Event ID64173
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternDistributed in the states of AL, CA, MS, MO, NJ, OR, and TN.
 

Associated Products

Product DescriptionSynthes Spine 5.2mm Titanium Click ' X Pedicle Screw Dual Core 40 mm Thread Length, Part Number 487.072. Intended to provide precise and segmental stabilization of the spine in skeletally mature patients.
Code InfoLot Number 7542279
ClassificationClass II
Reason for RecallLot number 7542279, of the 45 mm Click 'X Pedicle Screw (Part number 487.072), was incorrectly etched as "Click 'X Pedicle Screw 05.2 L40 TAN violet" although the actual length of the screw is 45 mm.
Product Quantity18
Recall NumberZ-0938-2013

Class II Devices Event

Event ID64178
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, CT, FL, GA, IL, IN, IA, KS, KY, ME, MD, MA, MN, MS,MO, NV, NH, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, UT , VA, WA, WV, WI and the countries of VENEZUELA, UNITED KINGDOM, TURKEY, THAILAND, TAIWAN, SPAIN, SAUDI ARABIA, RUSSIAN FEDERATION, PORTUGAL, POLAND, NORWAY, NIGERIA, NICARAGUA, MOROCCO, MALTA, LEBANON, KAZAKHSTAN, JAPAN, ITALY, INDONESIA, INDIA, HUNGARY, GREECE, FRANCE, EGYPT, CHINA, CANADA, BRAZIL, BELGIUM, and NEW ZEALAND.
 

Associated Products

Product DescriptionGE Healthcare Advantx, Innova2000, Innova3100, Innova4100, Innova2100IQ, Innova3100IQ, and Innova4100IQ equipped with Video Monitor Suspension model numbers 2236709, 2353620 ,2223039-2, and 2270677-2. For use in diagnostic and interventional angiographic procedures of human anatomy.
Code InfoINNOVA 41001Q 00000000609MC8 00000000605MC6 00000000535MC5 00000000225MC3 00000000226MC1 00000000463MC0 00000000223MC8 00000000377MC2 00000000816MC9 00000000841MC7 00000000469MC7 00000000228MC7 00000000830MC0 00000001258MC3 00000000937MC3 00000000485MC3 00000000376MC4 00000000807MC8 00000001078MC5 00000000821MC9 00000000125MC5 00000000123MC0 INNOVA 4100 00000000207MC1 00000000823MC5 00000000814MC4 00000000468MC9 00000000484MC6 00000000465MC5 00000000462MC2 00000000229MC5 00000000606MC4 00000000553MC8 00000000669MC2 00000000212MC1 00000000477MC0 00000000667MC6 INNOVA 31001Q 00000000647MC8 00000000723MC7 00000000620MC5 INNOVA 3100 00000001211MC2 00000000765MC8 INNOVA 21001Q 00000000693MC2 00000000663MC5 00000000661MC9 00000001336MC7 00000001367MC2 INNOVA 2000 00000000099MC2 00000000109MC9 00000000126MC3 00000000128MC9 00000000140MC4 00000000152MC9 00000000161MC0 00000000164MC4 00000000166MC9 00000000169MC3 00000000171MC9 00000000173MC5 00000000175MC0 00000000176MC8 00000000177MC6 00000000178MC4 00000000179MC2 00000000180MC0 00000000199MC0 00000000201MC4 00000000202MC2 00000000320MC2 00000000323MC6 00000000324MC4 00000000357MC4 00000000358MC2 00000000367MC3 00000000374MC9 00000000375MC6 00000000410MC1 00000000423MC4 00000000429MC1 00000000499MC4 00000000501MC7 00000000502MC5 00000000504MC1 00000000513MC2 00000000517MC3 00000000163MC6 00000000124MC8 00000000151MC1 00000000153MC7 00000000154MC5 00000000165MC1 00000000366MC5 00000000430MC9 00000000431MC7 00000000459MC8 00000000500MC9 00000000514MC0 00000000127MC1 00000000460MC6 00000000097MC6 00000000426MC7 00000000108MC1 00000000447MC3 00000000168MC5 00000000085MC1 00000000098MC4 00000000107MC3 00000000448MC1 00000000449MC9 00000125283M02 00000000701MC3 00000000655MC1 00000000691MC6 00000000752MC6 00000000646MC0 00000000537MC1 00000000538MC9 00000000482MC0 00000000578MC5 00000000657MC7 00000000539MC7 00000000486MC1 00000000540MC5 00000000607MC2 00000000809MC4 00000000480MC4 00000000744MC3 00000000692MC4 00000000621MC3 00000000622MC1 00000000645MC2 00000000751MC8 00000000736MC9 00000000737MC7 00000000838MC3 00000000644MC5 00000000654MC4 00000000614MC8 00000000615MC5 00000001171MC8 00000001077MC7 00000001079MC3 00000000603MC1 00000000721MC1 00000000575MC1 00000000134MC7 00000001212MC0 00000000694MC0 00000000689MC0 00000000231MC1 00000000579MC3 00000000901MC9 00000000704MC7 00000000643MC7 00000000466MC3 00000000518MC1 00000000664MC3 00000000227MC9 00000000221MC2 00000000519MC9 00000000733MC6 00000000487MC9 00000000612MC2 00000000488MC7 00000000822MC7 00000000817MC7 00000001173MC4 00000000653MC6 00000000580MC1 00000000665MC0 00000000839MC1 00000000833MC4 00000000616MC3 00000000648MC6 00000000521MC5 00000000768MC2 00000000618MC9 00000000481MC2 00000000551MC2 00000000576MC9 00000000522MC3 00000000574MC4 00000000604MC9 00000000688MC2 00000000861MC5 00000000815MC1 00000000577MC7 00000000810MC2 00000000875MC5 00000000598MC3 00000000860MC7 00000000690MC8 00000000552MC0 00000000542MC1 00000000766MC6 00000000734MC4 00000000844MC1 00000000872MC2 00000000840MC9 00000000877MC1 00000000162MC8 00000000593MC4 00000000583MC5 ADVANTX 00000000290MC7 00000000726MC0 00000000546MC2 00000128246M06 00000000697MC3 00000000378MC0 00000000183MC4 00000000209MC7 00000000119MC8 00000000554MC6 00000000586MC8 00000000117MC2 00000000555MC3 00000000698MC1 00000000120MC6 00000000118MC0 00000000116MC4 00000000291MC5 00000000703MC9 00000000608MC0 00000000750MC0 00000000658MC5 00000000939MC9 00000000987MC8 00000000940MC7 00000001062MC9 00000000705MC4 00000000902MC7 00000000812MC8 00000000903MC5 00000000832MC6 00000000990MC2 00000000873MC0 00000000649MC4 00000001382MC1 00000000876MC3 00000000842MC5 00000000874MC8 00000000843MC3 00000000989MC4 00000001080MC1 00000000859MC9 00000000819MC3 00000000711MC2 00000000679MC1 00000000135MC4 00000000677MC5 00000000696MC5 00000000219MC6 00000000145MC3 00000128106M02 00000000136MC2 00000000637MC9 0000000128124M 00000000592MC6 00000000638MC7 00000000635MC3 00000000509MC0 00000000150MC3 00000000130MC5 00000000198MC2 00000000149MC5 00000000191MC7 00000000732MC8 00000000695MC7 00000000557MC9 00000000591MC8 00000000101MC6 00000000681MC7 00000000122MC2 00000000220MC4 00000000214MC7 00000000121MC4 00000000731MC0 00000000906MC8 00000000678MC3 00000000729MC4 00000000684MC1 00000000683MC3 00000000636MC1 00000000685MC8 00000000686MC6 00000000730MC2 00000000927MC4 00000000929MC0 00000000926MC6 00000000954MC8 00000000928MC2 00000000160MC2 00000000215MC4 00000000147MC9 00000000137MC0 00000000146MC1 00000000143MC8 00000000148MC7
ClassificationClass II
Reason for RecallGE Healthcare has recently become aware of a potential safety issue involving a locking nut which might loosen out of the overhead Video Monitor Suspension yoke affecting Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, and Innova 4100IQ Cardiovascular X-ray imaging systems.
Product Quantity297
Recall NumberZ-0947-2013

Class II Devices Event

Event ID64211
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSmiths Medical ASD, Inc.
CityRockland
StateMA
CountryUS
Distribution PatternNationwide Foreign: Canada, Mexico, Santo Domingo, Panama, Equador, Chile, Portugual, Qatar, Ireland, Libiya, UAE, Great Britain, India,Germany, Italy, Oman. Belgium, Netherlands, Switzerland, Australia, Austria, Poland, Romania, Hungary, Vietnam,Egypt, Japan, Spain
 

Associated Products

Product DescriptionLevel 1 Fast Flow Fluid Warmer's without air detection Reorder Number: H-1000 100V, 115V and Level Fast Flow Fluid Warmer's without air detection 230V
Code InfoSerial Numbers: S104C00013, S104C00014, S104C00015, S104C00016, S104C00019, S104C00020, S104C00021, S104C00022, S104C00023, S104C00024, S104C00025, S104C00026, S104C00027, S104C00028, S104C00029, S104C00030, S104C00031, S104C00032, S104C00033, S104C00034, S104C00035, S104C00036, S104C00037, S104C00038, S104C00039, S104C00040, S104C00041, S104C00042, S104C00043
ClassificationClass II
Reason for RecallLevel 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed.
Product Quantity29 OUS
Recall NumberB-1051-13
Product DescriptionLevel 1 Fast Flow Fluid Warmer's without air detection Reorder Number: H-1000 100V, 115V and Level Fast Flow Fluid Warmer's without air detection 230V
Code InfoSerial Numbers: S104C00013, S104C00014, S104C00015, S104C00016, S104C00019, S104C00020, S104C00021, S104C00022, S104C00023, S104C00024, S104C00025, S104C00026, S104C00027, S104C00028, S104C00029, S104C00030, S104C00031, S104C00032, S104C00033, S104C00034, S104C00035, S104C00036, S104C00037, S104C00038, S104C00039, S104C00040, S104C00041, S104C00042, S104C00043
ClassificationClass II
Reason for RecallLevel 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed.
Product Quantity29 OUS
Recall NumberB-1051-13
Product DescriptionLevel 1 Fast Flow Fluid Warmer's with and without air detection Reorder Number: H-1200 115V and 230V
Code InfoSerial Numbers: S10000010 S10000758 S10000897 S101A00083 S103A00018 S103A00019 S103A00020 S103A00025 S103A00027 S103A00028 S103A00029 S103A00035 S103A00037 S103A00039 S103A00041 S103A00047 S103A00050 S103A00051 S103A00052 S103A00053 S103A00055 S103A00056 S103A00057 S103A00058 S103A00060 S103A00061 S103A00062 S103A00063 S103A00064 S103A00065 S103A00066 S103A00068 S103A00069 S103A00070 S103A00071 S103A00072 S103A00074 S103A00077 S103A00078 S103A00079 S103A00080 S103A00081 S103A00082 S103A00084 S103A00085 S103A00086 S103A00087 S103A00088 S103A00089 S103A00090 S103A00091 S103A00092 S103A00093 S103A00094 S103A00095 S103A00097 S103A00098 S103A00099 S103A00100 S103A00102 S103A00103 S103A00104 S103A00105 S103A00106 S103A00107 S103A00112 S103A00117 S103A00118 S103A00119 S103A00129 S103A00130 S103A00131 S103A00132 S103A00133 S103A00134 S103A00135 S103A00136 S103A00137 S103A00138 S103A00139 S103A00140 S103A00141 S103A00142 S103A00143 S103A00144 S103A00145 S103A00146 20050458 S10000851 S103B00044 S103B00093 S103B00106 S103B00116 S103B00118 S103B00121 S103B00123 S103B00130 S103B00133 S103B00134 S103B00135 S103B00136 S103B00137 S103B00138 S103B00139 S103B00140 S103B00141 S103B00142 S103B00143 S103B00144 S103B00147 S103B00148 S103B00149 S103B00150 S103B00153 S103B00155 S103B00156 S103B00163 S103B00164 S103B00165 S103B00166 S103B00167 S103B00168 S103B00169 S103B00170 S103B00171 S103B00172 S103B00173 S103B00174 S103B00175 S103B00176 S103B00177 S103B00178 S103B00179 S103B00180 S103B00181 S103B00182 S103B00183 S103B00184 S103B00185 S103B00186 S103B00187 S103B00188 S103B00189 S103B00190 S103B00191 S103B00192 S103B00193 S103B00194 S103B00195 S103B00196 S103B00197 S103B00198 S103B00199 S103B00200 S103B00201 S103B00202 S103B00203 S103B00204 S103B00205 S103B00206 S103B00207 S103B00208 S103B00209 S103B00210 S103B00211 S103B00212 S103B00213 S103B00214 S103B00215 S103B00216 S103B00217 S103B00218 S103B00219 S103B00220 S103B00221 S103B00222 S103B00223 S103B00225 S103B00226 S103B00227 S103B00228 S103B00229 S103B00230 S103B00231 S103B00232 S103B00233 S103B00234 S103B00235 S103B00236 S103B00237 S103B00238 S103B00239 S103B00240 S103B00241 S103B00242 S103B00243 S103B00244 S103B00245 S103B00246 S103B00247 S103B00248 S103B00249 S103B00250 S103B00251 S103B00252 S103B00253 S103B00254 S103B00255 S103B00256 S103B00257 S103B00258 S103B00259 S103B00260 S103B00261 S103B00262 S103B00263 S103B00264 S103B00265 S103B00266 S103B00267 S103B00268 S103B00270 S103B00271 S103B00272 S103B00273 S103B00274 S103B00275 S103B00276 S103B00277 S103B00278 S103B00279 S103B00280 S103B00281 S103B00282 S103B00283 S103B00284 S103B00286 S103B00287 S103B00288 S103B00289 S103B00290 S103B00291 S103B00292 S103B00293 S103B00294 S103B00295 S103B00296 S103B00297 S103B00298 S103B00299 S103B00300 S103B00301 S103B00302 S103B00303 S103B00304 S103B00305 S103B00306 S103B00307 S103B00308 S103B00309 S103B00310 S103B00311 S103B00312 S103B00313 S103B00314 S103B00315 S103B00316 S103B00317 S103B00318 S103B00319 S103B00320 S103B00321 S103B00322 S103B00323 S103B00324 S103B00325 S103B00326 S103B00327 S103B00328 S103B00329 S103B00330 S103B00331 S103B00332 S103B00333 S103B00334 S103B00335 S103B00336 S103B00337 S103B00338 S103B00339 S103B00340 S103B00341 S103B00342 S103B00343 S103B00346 S103B00347 S103B00348 S103B00349 S103B00350 S103B00351 S103B00352 S103B00353 S103B00354 S103B00355 S103B00356 S103B00357 S103B00358 S103B00359 S103B00360 S103B00361 S103B00362 S103B00364 S103B00365 S103B00366 S103B00367 S103B00368 S103B00369 S103B00370 S103B00371 S103B00372 S103B00373 S103B00374 S103B00375 S103B00376 S103B00377 S103B00378 S103B00379 S103B00381 S103B00382 S103B00383 S103B00385
ClassificationClass II
Reason for RecallLevel 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed.
Product Quantity331 (223 US, 108 OUS)
Recall NumberB-1052-13
Product DescriptionNormoflo Irrigation Fluid Warmer Reorder Number: H-1100 230V
Code InfoSerial Numbers: S105B00009, S105B00010, S105B00011, S105B00012, S105B00015, S105B00016, S105B00017, S105B00018, S105B00019, S105B00020, S105B00021, S105B00022, S105B00024, S105B00027, S105B00028, S105B00032, S105B00041
ClassificationClass II
Reason for RecallLevel 1 Fast Flow Fluid Warmer, with a circuit board component that may result in false over temperature alarm, was distributed.
Product Quantity17 Units -OUS
Recall NumberB-1053-13

Class II Devices Event

Event ID64231
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc.
CityMountain View
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA including WV and OH; Internationally to Australia, Austria, Bahrain, Belgium, Brazil, China (P.R.) Estonia, France, Germany, Greece, India, Indonesia, Israel, Italy, Japan, Jordan, Kuwait, Lebanon, Macedonia, Malaysia, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Qatar, Rep of Korea, Romania, Sweden, Taiwan, Thailand, Turkey, Unite Arab Emirates, United Kingdom and Venezuela.
 

Associated Products

Product DescriptionACUSON S2000 Automated Breast Volume Scanner (ABVS); Model number 10042541 Distributed by Siemens Medical Solutions USA Inc. business Unit: Ultrasound. The S2000 Automated Breast Volume Scanner (ABVS) Ultrasound System for imaging of the breast allows volumetric acquisition of the breast image.
Code InfoModel number 10042541 - AVBS module. Note: the S2000 system part number is 10041461, however only those systems that include the ABVS module, part number 10042541 are affected. Manufactured prior to 10/30/2012.
ClassificationClass II
Reason for RecallOn some ACUSON S2000 ABVS systems, the inside of the transducer pod may contain sharp edges.
Product Quantity214 affected devices
Recall NumberZ-0930-2013

Class II Drugs Event

Event ID64233
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionTerazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.
Code InfoLot # N03029, Exp 03/14
ClassificationClass II
Reason for RecallPresence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Product Quantity3,913 bottles
Recall NumberD-193-2013

Class II Devices Event

Event ID64256
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic Navigation, Inc.
CityLittleton
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide and the countries of: Canada, AUSTRIA, BELGIUM, BRAZIL, BULGARIA, CHILE, CHINA, CROATIA, CZECH REPUBLIC, DENMARK,FINLAND, FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN ,KOREA, REPUBLIC OF KUWAIT, LEBANON, LIBYAN ARAB JAMAHIRIYA, MEXICO, NETHERLANDS, New Zealand, POLAND, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, Taiwan(R.O.C.) , THAILAND, TURKEY, UNITED ARAB EMIRATES. and UNITED KINGDOM.
 

Associated Products

Product DescriptionMedtronic O-arm Imaging System Product Usage: image-intensified fluoroscopic x-ray system, mobile
Code InfoProduct Catalog Numbers: 9732719, 9732719R, 9733346, 9733346R, BI-700-00027, BI-700-00027R, BI-700-00027-GER, BI-700-00027-GERR, BI-700-00027-100, BI-700-00027-100R, BI-700-00027-120, BI-700-00027-120R, BI-700-00027-230, BI-700-00027-230R Units with serial numbers 101 through 564 and unit 580 are affected. Serial numbers 565 and higher are not affected .
ClassificationClass II
Reason for RecallPotential failure of the braking system that controls the O-arm Imaging System gantry movement in the vertical direction
Product Quantity463 units
Recall NumberZ-0926-2013

Class II Devices Event

Event ID64274
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Feb-11
Initial Firm Notification of Consignee or Public Visit
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution-USA including the states of FL, IL, IN, NJ, NC, OK, TX, and WI, and the countries of UNITED KINGDOM, TUNISIA, SERBIA, RUSSIAN FEDERATION, NORWAY, NIGERIA, LITHUANIA, LEBANON, KOREA, REPUBLIC OF KOREA, ITALY, INDONESIA, INDIA, FRANCE, FINLAND, COLOMBIA, CHINA, and BRAZIL.
 

Associated Products

Product DescriptionGE Healthcare, Innova 2100 IQ, Innova 3100 IQ, Innova 4100 IQ. Cardiovascular X-ray imaging systems. For use in generating fluoroscopic images of human anatomy.
Code InfoSERIAL NUMBER 592043BU4 592676BU1 593459BU1 593465BU8 592458BU4 592673BU8 592682BU9 593059BU9 593051BU6 593475BU7 593476BU5 592049BU1 593468BU2 593054BU0 592047BU5 592042BU6 592046BU7 592459BU2 593048BU2 593056BU5 593049BU0 593063BU1 593062BU3 593464BU1 594762BU7 593473BU2 592451BU9 593460BU9 597954BU7 592456BU8 592674BU6 593052BU4 593058BU1 590867BU8 592050BU9 593064BU9 592460BU0 592457BU6 592680BU3 592455BU0 593462BU5 592678BU7 594763BU5 593055BU7 592675BU3 592452BU7 593463BU3 594385BU7
ClassificationClass II
Reason for RecallExposed high voltage wires inside the cabinet . On a cable located in the system cabinet, two of the shrink tubings covering the 400V live cable leave an area potentially unprotected.
Product Quantity48
Recall NumberZ-0934-2013

Class II Devices Event

Event ID64287
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternWorldwide Distribution -- USA, including the states of CA, LA, MA, NY, and PA, and the countries of Canada and Switzerland.
 

Associated Products

Product DescriptionSynthes Titanium Midface Distractor, MR Conditional, Part number 487.982. For temporary stabilization and gradual lengthening of the cranial or midfacial bones.
Code InfoAll Lots
ClassificationClass II
Reason for RecallThere is the potential for the anterior footplates to not fit onto the Titanium Midface Distractor Assembly as the tab of some distractors may be oversized.
Product Quantity596
Recall NumberZ-0942-2013

Class II Devices Event

Event ID64291
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-11
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - USA (All States in continental USA including PR except RI.). Internationall to: ALGERIA, ARGENTINA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BRAZIL, BELARUS, BELGIUM, BULGARIA, BOSNIA & HERZEGOVINA, CANADA, CHILE, CHINA, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, FRENCH POLYNESIA, GEORGIA, GERMANY, GREECE, GUADELOUPE, HONDURAS, HUNGARY, INDIA, INDONESIA, IRAN, ISLAMIC REPUBLIC OF IRAN, IRAQ, ITALY, IRELAND, ISRAEL, JAPAN, JORDAN, KENYA, KOREA, KUWAIT, KAZAKHSTAN, LATVIA, LEBANON, LIBYA, LITHUANIA, LUXEMBOURG, MALAYSIA, MEXICO, MACEDONIA, MARTINIQUE, MOROCCO, NETHERLANDS, NORWAY, PAKISTAN, PERU, PHILIPPINES, REUNION, NEW ZEALAND, OMAN, POLAND, PORTUGAL, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SOUTH AFRICA, SPAIN, SUDAN, SWEDEN, SINGAPORE , SLOVAKIA, SOUTH KOREA, SWITZERLAND, SYRIA, TAIWAN, THAILAND, TURKEY, TUNISIA, UNITED ARAB EMIRATES, UNITED KINGDOM, UZBEKISTAN, VENEZUELA, URUGUAY, VIET NAAM, and YUGOSLAVIA.
 

Associated Products

Product DescriptionOptima MR450w, Discovery MR450, Discovery MR750, Signa HDx, Signa HDxt, Signa HDi, Signa Vibrant, and GE 1.5T Signa HDe MR System. The GE Signa HDx MR system is a whole body magnetic resonance scanner.
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ClassificationClass II
Reason for RecallAn error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
Product Quantity4026 (1672 US; 2354 OUS)
Recall NumberZ-0935-2013

Class II Devices Event

Event ID64306
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionCommand Instrument Broach Handle. Used in Total Hip Arthroplasty. Catalog Number: 6266-0-100
Code InfoCatalog Number: 6266-0-100 Lot Code: RD6W017, RD7L234X, RD7L234, RD7L235, RD5T305A, RD6W017J, RD6W017A, RD5T307, RD5T305T, RD5T305M, RD5T305L, RD5T306X, RD5T305, RD5T306
ClassificationClass II
Reason for RecallStryker® Orthopaedics has received reports from the field indicating handle fracture and subsequent disassociation of cam assembly subcomponents during use.
Product Quantity48 units
Recall NumberZ-0919-2013

Class II Food Event

Event ID64314
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmInventure Foods, Inc.
CityBluffton
StateIN
CountryUS
Distribution PatternAZ, KY, IL, NJ, GA, FL, MN, CA, CO, and TX.
 

Associated Products

Product DescriptionJamba Multigrain Fruit Chips( Blueberry) 5ozx12 and 1.5ozx55
Code Info 5ozx12 size: Date code: 7/13/2013 and SKU: 90013 and 90013R. 1.5ozx55 size: Date code: 7/13/2013 and 7/14/2013 and SKU: 90011 and 90012.
ClassificationClass II
Reason for RecallOn 2/6/2013 the firm received a recall notification letter from Dakota Milling informing that they are voluntarily recalled the 41440 Boulder 7 Grain Flour blends because of the potential metal contamination.
Product Quantity1252 cases
Recall NumberF-1135-2013
Product DescriptionJamba Multigrain Fruit Chips (Cranberry) 5ozx12
Code InfoDate code: 7/14/2013 and 10/21/13 SKU: 90014 and 90014R
ClassificationClass II
Reason for RecallOn 2/6/2013 the firm received a recall notification letter from Dakota Milling informing that they are voluntarily recalled the 41440 Boulder 7 Grain Flour blends because of the potential metal contamination.
Product Quantity134 cases
Recall NumberF-1136-2013

Class II Devices Event

Event ID64318
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntegra LifeSciences Corp.
CityPlainsboro
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA and the countries of Austria, Australia, Bangladesh, Belgium, Bulgaria, Brazil, Switzerland, Canada, China, Costa Rica, Czech Republic, Germany, Dominican Republic, Egypt, Emirates, Spain, Finland, France, Great Britian, Hong Kong, Hungary, Indonesia, Ireland, Israel, India, Italy, Japan, Korea (South), Kuwait, Lebanon, Sri Lanka, Latvia, Macedonia, Mexico, Malaysia, Netherlands, Philippines, Pakistan, Poland, Portugal, Qatar, Serbia, Saudi Arabia, Singapore, Slovenia, Thailand, Tunisia, Taiwan, United Arab, Viet Nam and South Africa.
 

Associated Products

Product DescriptionIntegra CUSA excel. CEM Nosecone for CUSA EXcel System. The CEM Nosecone is intended for use CUSA Excel/CUSA Excel + Ultrasonic Surgical Aspiration System, CUSA handpiece, and Covidien Force FX Electrosurgical Generator. Used in surgical procedures where combined ultrasonic dissection and electrosurgical coagulation is desired, either simultaneously or independently.
Code InfoCEM Nosecone Catalogue No. C6623 Lot numbers: 1092855, 1093129, 1100436, 1100437, 1101217, 1101328, 1103393, 1104265, 1105067, 1110311, 1110892, 1112182, 1112183, 1114112, 1114655, 1115225, 1115499, 1115500, 1120771, 1121141, 1121142, 1121383, 1121627, 1122258, 1122259, 1123049 and 1130710. CEM Nosecone, Catalogue No. C6636: 1091431, 1091679, 1091680, 1093475, 1095103, 1095416, 1095417, 1100242, 1100434, 1100435, 1101094, 1101218, 1101219, 1103104, 1103395, 1103849, 1103849, 1103850, 1103852, 1103917, 1103918, 1103922, 1104257, 1104263, 1105071, 1110475, 1110476, 1110978, 1111490, 1111493, 1112187, 1112188, 1112212, 1113179, 1113180, 1113663, 1114357, 1114358, 1114659, 1114660, 1115039, 1115502, 1115504, 1115505, 1120776, 1120777, 1121167, 1121168, 1121169, 1121565, 1121566, 1121567, 1122344, 1123051, 1123052, 1123508, 1123511 and 1124053.
ClassificationClass II
Reason for RecallThere is a potential for erosion of the CUSA EXcel tip used with the Nosecone. Specifically, the potential for tip erosion occurs when using a CUSA CEM Nosecone if the side of the tip, rather than the annulus of the tip, is in contact with the tissue. This erosion can potentially lead to tip breakage. There were no reports of a patient injury associated with these complaints.
Product QuantityUSA 6,190, EU 22,972 and ROW 288 units
Recall NumberZ-0920-2013

Class II Devices Event

Event ID64320
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDiagnostica Stago, Inc.
CityParsippany
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - USA and Canada.
 

Associated Products

Product DescriptionVial Label: 1) LIATEST VWF:Ag Buffer - 5 ml Diagnostica Stago 2) LIATEST VWF:Ag Latex + 4 ml R3 Diagnostica Stago 3) LIATEST VWF:Ag Latex Diluent 4 mL Diagnostica Stago Model, catalogue, number 00518 - 58978 - 58979 Kit Label: LIATEST VWF:Ag DIAGNOSTICA STAGO S.A.S. 92600 Asnières sur Seine (France) Coagulation Assay
Code InfoLot/Unit Numbers : Combination of All STA-R®/ STA-R EVOLUTION® and lots of STA® - LIATEST® VWF: AG are involved. Lot Number Expiry date 108128 2013-03 108512 2013-04 108778 2013-07 109415 2013-10 109591 2014-01
ClassificationClass II
Reason for RecallDiagnostica Stago has confirmed that sometimes the delta OD measured can be changed leading to a lowered percentage result.
Product Quantity2901 kits
Recall NumberZ-0951-2013

Class II Devices Event

Event ID64326
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBacterin International, Inc.
CityBelgrade
StateMT
CountryUS
Distribution Pattern13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee
 

Associated Products

Product DescriptionBacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
Code Info005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211
ClassificationClass II
Reason for RecallA portion of a silicone wound drain was found to be cracked.
Product Quantity15 boxes (10/box) to 4 consignees in US and 81 boxes (10/box) to 1 foreign consignee
Recall NumberZ-0936-2013

Class II Food Event

Event ID64341
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Feb-13
Initial Firm Notification of Consignee or Public Email
Recalling FirmLYFE Kitchen Retail, Inc.
CityRichmond
StateBC
CountryCA
Distribution PatternCA and NV
 

Associated Products

Product DescriptionLYFE Kitchen, Sweet Corn Chowder with Cashew Cream, Yukon Gold Potatoes and Bell Peppers; 28 oz. 680 gr, Keep Refrigerated. UPC 855764003527 Del Monaco Specialty Products, Morgan Hill, CA
Code InfoExpiration date 3/25/13 Orange Carrot Ginger Sleeve UPC 8557640035703, product code 00350;
ClassificationClass II
Reason for RecallCostco notified firm that some containers of their LYFE Kitchen Sweet Corn Chowder were packaged in a sleeve labeled Orange Carrot Ginger Soup. Individual boxes of the corn chowder are properly labeled and product identity is visible to the consumer.
Product Quantity111 cases (each case has 12x 28 oz container).
Recall NumberF-1062-2013

Class II Devices Event

Event ID64342
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Feb-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSmith & Nephew Inc
CityMemphis
StateTN
CountryUS
Distribution PatternWorldwide Distribution - USA including NM, TN, TX, NC, CA, MI, KY, MA, NJ, OH, and HI. Internationally to Canada, United Arab Emirates, Mexico, Argentina, Japan, and Chile.
 

Associated Products

Product DescriptionINTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162380, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 80 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
Code InfoBatch Number 12KM01206
ClassificationClass II
Reason for Recall75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
Product Quantity69 units
Recall NumberZ-0943-2013
Product DescriptionINTERNAL HEX RECON SCREW, TI-6AL-4V, REF 7162375, TRIGEN (R) INTERNAL HEX CAPTURED RECON SCREW, QTY: (1), 6.4 MM, 75 MM, TITANIUM, Smith & Nephew, Inc. Orthopedic. Bone screw for intramedullary rod fixation.
Code InfoBatch Number 12JM17051
ClassificationClass II
Reason for Recall75 mm screws were packaged and labeled using an 80 mm screw outer box and label, while 80 mm screws were packaged and labeled using a 75 mm screw outer box and label.
Product Quantity90 units
Recall NumberZ-0944-2013

Class II Devices Event

Event ID64344
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSorin C.R.M., srl
CitySaluggia, VC
State
CountryIT
Distribution PatternWorldlwide Distribution - USA (Nationwide) and worldwide to Argentina, Australia, Austria, Belgium, Brazil, Canada, Cuba, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hong Kong, India, Iran, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Morocco, The Netherlands, Portugal, Russia, Saudi Arabia, Slovenia, Spain, Sweden, Switzerland, Tunisia, Ukraine, Uruguay and the United Kingdom.
 

Associated Products

Product DescriptionIsoline Implantable Defibrillation Lead, Model Isoline 2CR5, 2CR6 and 2CT6. These lead models are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening arrhythmias
Code InfoModels: 2CR5, 2CR6 and 2CT6, Distributed From 03/19/08 To 01/21/13
ClassificationClass II
Reason for RecallIsoline defibrillation leads distributed may have internal insulation breach.
Product Quantity1376 Isoline leads
Recall NumberZ-0928-2013

Class II Devices Event

Event ID64348
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInnominata Dba Genbio
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide distribution: CA, IL, MA, MD, ME, NC, ND, NJ, NY, OR, VA and WI.
 

Associated Products

Product DescriptionANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata dba GenBio for Bio-Rad. The kit is used as an aid in diagnosis of Lyme disease.
Code InfoLot #120960 (121003. 121058,121002), ; Exp./Cad/Verw/bis: 2013-09; Catalog#802-3011; 25271, 25272, 25273; Label P/N 522-0040, 522-0037, 522-0011
ClassificationClass II
Reason for RecallMultiple incidents of low-reacting assay plates.
Product Quantity195
Recall NumberZ-0927-2013

Class II Food Event

Event ID64353
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKellogg Company
CityBattle Creek
StateMI
CountryUS
Distribution PatternDistribution centers in GA, CA, PA, IL with further distribution nationwide. No Canadian or outside USA distribution.
 

Associated Products

Product DescriptionKellogg's Special K Red Berries, Crunchy Rice & Wheat Flakes with Strawberries 11.2oz; 37 oz; 22.4 ounce Twin Pack
Code Info1. 11.2 oz. pkg, UPC Code 38000 59923, Better if Used by DEC 02 2013 KNC 105 00:13 through DEC 02 2013 KNC 105 02:30 2. 37 oz Club Pkg, UPC Code 38000 20940 , Better if Used by NOV 30 2013 KNB 107 17:31 to NOV 30 2013 KNB 107 20:05 3. 22.4 oz Twin PackUPC Code 38000 78356 Better if Used by: NOV 30 2013 KNA 105 07:00 to NOV 30 2013 KNA 105 08:51 NOV 30 2013 KNB 105 15:00 to NOV 30 2013 KNB 105 17:05
ClassificationClass II
Reason for RecallA limited amount of Kellogg's Special K, Red Berries is being recalled due to possible glass fragments present in the product, likely from a single batch of one ingredient.
Product Quantity26,880 all sizes
Recall NumberF-1134-2013

Class II Devices Event

Event ID64354
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBiomet, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution - No USA distribution -Internationally to Canada, Japan, and Chile
 

Associated Products

Product DescriptionREF S313152 Straight Acetabular Inserter Handle Ringloc non-sterile Orthopedic manual surgical instrument
Code InfoCatalog Number 5313152 Lot 153880,153930, 415500, 648010
ClassificationClass II
Reason for RecallThe Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.
Product Quantity58
Recall NumberZ-0925-2013

Class II Food Event

Event ID64361
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Dec-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmEthnic International Holding Inc
CityCranbury
StateNJ
CountryUS
Distribution PatternConnecticut, Georgia, Massachussets, Maryland, New Jersey, New York, Tennessee and Virginia.
 

Associated Products

Product DescriptionAPPLE DRINK MIX. Yoruk Prens Elma Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of green apple on label.
Code InfoExpiration date 1/04/2013.
ClassificationClass II
Reason for RecallYoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis.
Product QuantityTotal of 166 Cases (20 containers per case) for all 4 flavors
Recall NumberF-1063-2013
Product DescriptionORANGE DRINK MIX. Yoruk Prens Portalcal Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of orange on label.
Code InfoExpiration date 1/04/2013.
ClassificationClass II
Reason for RecallYoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis.
Product Quantity166 total cases (20 units per case)- all 4 flavors
Recall NumberF-1064-2013
Product DescriptionPOMEGRANATE DRINK MIX. Yoruk Prens Nar Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of pomegranate on label.
Code InfoExpiration date 1/04/2013.
ClassificationClass II
Reason for RecallYoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis.
Product Quantity166 total cases all 4 flavors (20 units per case)
Recall NumberF-1065-2013
Product DescriptionCINNAMON DRINK MIX. Yoruk Prens Tarcin Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of cinnamon sticks on label.
Code InfoExpiration date 1/04/2013.
ClassificationClass II
Reason for RecallYoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis.
Product Quantity166 total cases (all 4 flavors) (20 units per case)
Recall NumberF-1066-2013
Product DescriptionROSEHIP DRINK MIX. Yoruk Prens Tarcin Kusburnu Net 400 g. USA Distributor: Ethnic Int. Holding Inc. 4 Corporate Drive, Cranbury, NJ 08512. Tel. 609-395-8513. Picture of flower on label.
Code InfoExpiration date 1/04/2013.
ClassificationClass II
Reason for RecallYoruk Prens brand drink mix flavored Apple, Orange, Pomegranate, Cinnamon and Rosehip. We were informed that these products include some colorants, which are not allowed to use in the USA as per a New York State Department of Agriculture and Markets sample analysis.
Product Quantity
Recall NumberF-1067-2013

Class II Food Event

Event ID64368
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmDakota Specialty Milling, Inc
CityFargo
StateND
CountryUS
Distribution PatternAZ, AR, CA, GA, HI, IL, IN, KS, MA, MI, MN, MO, NY, ND, OH, PA, TN, TX, VA, WA, WI.
 

Associated Products

Product Description10021 Roman Meal Premium Oat Bran Mix ( Oat Flour, Oats, Oat Bran, white Wheat Bran, Red Wheat Bran, Stabilizi...., Wheat Germ), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS.
Code Info4031205 4181205 5111205 5291205 5301205 6061205 6071205 7051205 7061205 7131205 7161205 8031205 8161205 8221205 8231205 9131205 9261205 10101205 10291205 11131205 11161205 11191205 12071205 12101205 1021305
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity3,009.5000 CWTS
Recall NumberF-1074-2013
Product Description10021 RM Honey Oat Bran Mixture - Hong Kong / Thailand (oats, oat bran, oat flour), Roman Meal Company, Tacoma, Washington, Net WT 20 KILOS.
Code InfoHong Kong 5111205 8291205 Thailand 5211205 8031205 8221205 8291205
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity507.9400 CWTS = (62.6120 Hong Kong, 445.3280 Thailand)
Recall NumberF-1075-2013
Product Description10058-T, RM Multigrain W/Calcium Mixture - Thailand (wheat bran, yellow corn flour, oats, calcium carbonate, millet flour, yellow flax, stabilized wheat germ), Roman Meal Company, Tacoma, Washington, Net WT 20 KILOS.
Code Info3291205 4241205 5221205 8061206 8271205 8301205
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity634.9170 CWTS
Recall NumberF-1076-2013
Product Description10073, Roman Meal Enhanced Healthy White Mix (sugarcane fiber, whole meal barley flour, white corn, wheat starch, oats, vitamins), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS.
Code Info4021203 4271206 5181206 6131206 6291206 7171205 8101205 8161205 8291205 9101206 9261206 10041206 10221206 11151206 12111206 12211206
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity577.5000 CWTS
Recall NumberF-1077-2013
Product Description10200, Roman Meal Barley Mix (Barley), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS.
Code Info4231205 5091205 6051205 6291205 7171205 7261205 8231205 9251205 10161205 11011205 11131205 12101205
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity535.0000 CWTS
Recall NumberF-1078-2013
Product Description10204, Roman Meal Multi Whole Grain Mix (Millet, White Wheat, Triticale, Oats, Rye, Barely, Buckwheat, Brown Rice), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS.
Code Info3211206 3221206 4181206 4191206 4261206 5091206 5211206 6111206 6211203 6291203 7261205 8101206 8271206 9111206 9211206 9241206 10241206 11051206 11211206 12121206 12201206 12211206
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1,365.0000 CWTS
Recall NumberF-1079-2013
Product Description10209, Roman Meal New 12 Grain Mix (wheat bran, sunflower, wheat germ, wheat, barley, sesame seed, Millet, yellow corn, brown flax, Triticale, Oats, Rye, buckwheat, spelt, Brown Rice, kamut flour, amaranth flour), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS.
Code Info2291203 3221203 5081203 5091203 6051203 6061203 6271203 6281203 8031203 9051203 10111203 10121203 11151203 12141203 12161203 12171203 1071303
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity3,000.5000 CWTS
Recall NumberF-1080-2013
Product Description13006, Roman Meal Twelve Grain(wheat bran, sunflower seed, stabilized wheat germ, wheat, barley, sesame seed, Millet, yellow corn, flaxseed, Triticale, Oats, Rye, rice flour, black malt, buckwheat flour, spelt, kamut flour, amaranth flour), Roman Meal Company, Tacoma, Washington, 1 Net WT 50 LBS.
Code Info3231206 3261206 5011206 5021206 7181206 7191206 7201206 8291206 8301206 10121206 10151206 11281206 11291206
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1,773.0000 CWTS
Recall NumberF-1081-2013
Product Description40048, SPECIALTY VANILLA GRANOLA (...ATS. WHEAT, SUGAR, OAT FLOUR, CANOLA OIL W/TOCOPHEROLS, BROWN SUGAR, VANILLA EXTRACT, HONEY, SI...., SALT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 40 LBS.
Code Info2241207 3261207 3271207 3281207 4171207 4181207 6061207 6071207 7101207 8241207 8251207 8271207 11091207 11101207 12051207 12061207 12141207
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity3,064.4000 CWTS
Recall NumberF-1082-2013
Product Description40120, CANADIAN OAT BASE (OATS. OAT BRAN, OAT FIBER, RYE, SUNFLOWER, OAT FLOUR, WHEAT, BARLEY), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS.
Code Info4131205 4161205 5301205 5311205 6131205 8041205 8061205 8291205 9101205 9111205 9271205 11191205 11201205 11271205 12151205 12171205
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1,615.5000 CWTS
Recall NumberF-1083-2013
Product Description40133, SARA LEE SPECIALTY 8 GRAIN BLEND 100 (SUNFLOWER, WHEAT, OATS, RYE, BARLEY, WHOLE MEAL YELLOW CORN, MILLET, TRITICALE, RYE FLOUR), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS.
Code Info3141203 3151203 5011203 5021203 6201203 6061203 6071203 7181203 7191203 8301203 8311204 9141203 9171203 9271203 9281203 10191203 10221203 11121203 11281203 12131203 1071303
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity4,265.0000 CWTS
Recall NumberF-1084-2013
Product Description40134, SARA LEE 12 WHOLE GRAIN BLEND 100 ( WHEAT, OATS, RYE, BARLEY, WHOLE GRAIN CORN, SUNFLOWER, BROWN FLAXSEED, MILLET, TRITICALE, BROWN RICE, BUCKWHEAT, WHOLE MEAL AMARANTH FLOUR, SPELT, SORGHUM) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS.
Code Info3201205 4231205 4241205 5161205 6031205 6251205 8141201 10021201 11081201 1071301
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity4,457.0000 CWTS
Recall NumberF-1085-2013
Product Description40145, SPECIALTY MULTIGRAIN BASE ( WHEAT BRAN, SUNFLOWER, WHEAT, OAT BRAN, RYE, OATS, OAT FLOUR, FLAXSEED, WHEAT GERM), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS.
Code Info3061203 3151203 4161203 5021203 5101203 6061203 6181203 7181203 8011203 8161203 9251203 10101203 11271203 11281203 12291203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1,354.0000 CWTS
Recall NumberF-1086-2013
Product Description40154, SPECIALTY SG WHOLE WHEAT BLEND ( WHOLE WHEAT FLOUR, WHEAT BRAN, WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS.
Code Info10311203 11011203 11081203 11291203 11301203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1,206.5 CWTS
Recall NumberF-1087-2013
Product Description40180, SPECIALTY 9 GRAIN BLEND 400 ( OATS, WHITE WHEAT, BARLEY, RYE, TRITICALE, SPELT, BUCKWHEAT, MILLET, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS.
Code Info4171205 6261205 6271205 7251205 7261205 8171205 11011205 11101205 11121205 11301205 12051205 12211205 1071305 1081305
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1,078.0000 CWTS
Recall NumberF-1088-2013
Product Description40450, NORTH DAKOTA MULTI 7 GRAIN BREAD MIX( WHEAT FLOUR, MALTED BARLEY FLOUR, NIACIN, IRON..., RIBOFLAVIN,FOLIC ACID, SUGAR ASCORBIC ACID, NUTRI SOY FLOUR, WHEAT..., BARLEY FLOUR, RYE FLOUR, FLAX MEAL....., OAT BRAN, ROLLED OATS, NONFAT DRY MILK, DRY YEAST), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , Net WT 15.2 OZ. CHECK LABEL
Code Info10311202
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity463.0000 CWTS
Recall NumberF-1089-2013
Product Description40632, SPECIALTY GRANNY GRAINS BLEND ( WHEAT BRAN, WHEAT, OATS , BARLEY, RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 Net WT 40 LBS.
Code Info11161203 11191203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity402.4000 CWTS
Recall NumberF-1090-2013
Product Description40730, SPECIALTY DAKOTA 12 GRAIN BLEND 200( WHEAT, OATS , BARLEY, RYE, TRICALE, MILLET, BROWN RICE, BULGUR WHEAT, YELLOW CORN, BUCKWHEAT, SPELT, AMARANTH), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS.
Code Info3281205 4171205 4181205 5041205 5291205 6221205 7241205 8171205 8301205 8311205 9041205 10011205 10021205 10241205 11211205 11261205 11291205 12281205 1041305
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1,838.5000 CWTS
Recall NumberF-1091-2013
Product Description40740, SPECIALTY 11 GRAIN BLEND ( WHEAT,RYE, TRICALE, CORN, BROWN RICE, OATS, BUCKWHEAT, PARLEY, AMARANTH, MILO, QUINOA), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS.
Code Info3011206 5181206 6271206 8021206 9171206 11011206 11301206 12131206 1021306
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity384.5000 CWTS
Recall NumberF-1092-2013
Product Description41406, MULTI GRAIN WHOLE MEAL FLOUR BLEND 100( WHITE WHEAT, TRITICALE, OATS, RYE, BARLEY, MILLET, BUCKWHEAT, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS.
Code Info2151203 3161203 3191203 4041203 4181203 4191203 5141203 6011203 6031203 7101203 8061203 8281203 9271203 10171203 11051203 11061203 11121203 11131203 12061203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity2,003.5000 CWTS
Recall NumberF-1093-2013
Product Description41410, 3 FLOUR BLEND( OATS, BARLEY, MILLET), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 Net WT 50 LBS.
Code Info1021303
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity52.5000 CWTS
Recall NumberF-1094-2013
Product Description41433, SUN CHIP 6 GRAIN BLEND( WHOLE MEAL: BROWN RICE, BUCKWHEAT AND QUINOA), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , ----LBS.
Code Info2241206 2271206 2281206 2291206 3121206 3131206 3141206 3271206 3281206 4171206 6041206 6051206 6181206 6191206 6251206 6261206 7021206 7061206 8301206 8311206 9041206 12051206 12061206 12071206 12101206 12111206
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity5,380.0000 CWTS
Recall NumberF-1095-2013
Product Description90341440, BOULDER 7 WHOLE GRAIN BLEND ( MILO: SORGHUM, MILLET, BROWN RICE, WHOLE GRAIN CORN, TEFF, AMARANTH, QUINOA) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 50. LBS.
Code Info7191203 9261203 10091203 11051203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity255.5000 CWTS
Recall NumberF-1096-2013
Product Description41511, 7 GRAIN BLEND - SOY FREE( WHEAT, WHEAT BRAN, RYE, BARLEY, TRITICALE, RICE FLOUR, OATS, CORN) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 NET WT. 50. LBS.
Code Info5251205 6221205 7241205 8041205 8201205 9051205 10171205 11081205
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity236.5000 CWTS
Recall NumberF-1097-2013
Product Description41512 and 41512-T, IBC 12 WHOLE GRAIN BLEND( WHEAT, OATS, BARLEY , RYE, TRITICALE, MILLET, BUCKWHEAT, YELLOW CORN, SORGHUM, BROWN RICE, QUINOA, AMARANTH) DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50. LBS and 1,750 LBS.
Code Info41512: 3081201 3181201 3191201 4031201 5031202 5301201 6211201 6221201 7111201 7251201 8071201 8081201 8211201 8221201 9071201 9081201 10101201 10241201 41512-T: 3081201 4021201 4031201 5301201 7101201 7241201 8211201 9071201 10301201
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity10,359.5000 ( 41512) + 3080.0000 ( 41512-T) = 13,439.5 CWTS
Recall NumberF-1098-2013
Product Description41631, BLEND DC SOFT MULTIGRAIN BLEND ( WHOLE MEAL OATS, WHOLE MEAL BARLEY. WHOLE MEAL BROWN RICE, WHOLE MEAL CORN, WHOLE FLAXSEED), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 53 NET WT. 50 LBS .
Code Info3161203 3311203 4011203 4201203 5101203 5221203 7191203 7201203 8131203 9121203 11061203 11071203 11091203 1031303
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1,146.5000 CWTS
Recall NumberF-1099-2013
Product Description41653, MIX 8 GRAIN INSTANTIZED( OATS, WHEAT, BARLEY, TRITICALE, WHITE WHEAT, RYE, AMARANTH, FLAXSEED, WHEAT GERM, YELLOW CORN), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS .
Code Info2281205 4041205 4231205 5161205 6011205 6131205 6141205 7181205 7191205 8081205 8091205 8231205 8241205 9051205 9061205 10041205 10231205 11081205 11091205 11201205 12111205 1091305
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity2,748.5000 CWTS
Recall NumberF-1100-2013
Product Description41672, SPECIALTY LIGHT WHITE BLEND 200 ( CELLULOSE FIBER, WHEAT FLOUR, SALT, CELLULOSE GUM, GUAR GUM, CALCIUM PROPIONATE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 NET WT. 50 LBS .
Code Info12171206
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity77.0 CWTS
Recall NumberF-1101-2013
Product Description41678, NICKLES 12 GRAIN BLEND ( SUNFLOWER, WHEAT, OATS, WHOLE WHEAT FLOUR, SESAME SEEDS, FLAXSEED, BARLEY, RYE, TRICALE, BROWN RICE, MILLET, YELLOW CORN, BUCKWHEAT, BULGUR WHEAT, AMARANTH, QUINOA), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS .
Code Info3191205 3201205 4131205 4261205 4271205 5291205 5301205 7021205 7031205 7301205 7311205 8161205 8171205 9061205 9071205 9101205 10151205 10161205 11091205 11101205 12051205 12061205 12071205 12281205 12291205
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity4,814.0000 CWTS
Recall NumberF-1102-2013
Product Description41681, NICKLES 9 GRAIN BLEND ( OATS, WHEAT, BARLEY, TRITICALE, WHITE WHEAT, BROWN FLAX, RYE, AMARANT, WHEAT GERM, CORN, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS .
Code Info6291205 10031205 10161205
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity836.5000 CWTS
Recall NumberF-1103-2013
Product Description41757, SPECIALTY ANCIENT GRAIN FLOUR BLEND ( SPELT, OATS KAMUT, AMARANTH, MILLET, QUINOA, TEFF), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS .
Code Info2211206 3051206 3201206 3211206 5111206 6271206 7031206 8091206 9201206 10181206 11151206 12121206 12131206 1111306
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity570.0000 CWTS
Recall NumberF-1104-2013
Product Description42203, OCTOBER GRAINS & SEEDS MIX ( OATS, GOLDEN FLAX, SUNFLOWER, SESAME SEED, WHITE WHEAT, OAT FLOUR, BARLEY, WHET BRAN, CORN, MILLET, AMARANTH), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS .
Code Info4171205 5161205 6081205 7111205 7301205 10121205 11081205 12181205 1031305
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity221.0000 CWT
Recall NumberF-1105-2013
Product Description42204, MULTIGRAIN MIX FOR P.S. BREAD ( WHITE WHEAT, OATS, BARLEY, TRICALE, BROWN FLAX, CORN, SESAME SEED, POTATO FLAKES, WHEAT, RYE, WHEAT BRAN), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS .
Code Info3011205 4111205 4271205 5041205 5071205 5211205 6151205 7061205 8081205 8131205 9121205 9131205 9251205 10311205 11131205 11291205 12141205 12151205 1021305 1031305
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity2,006.0000 CWTS
Recall NumberF-1106-2013
Product Description42207, FIBER PLUS BLEND POLY FREE ( ENRICHED WHEAT FLOUR RIBOFLAVIN, REDUCED IRON, THIAMINE MONONITRATE, NIACIN, FOLIC ACID, OAT BRAN, OAT FIBER, INULIN), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 19 NET WT. 50 LBS .
Code Info12171206
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity84.0 CWTS
Recall NumberF-1107-2013
Product Description42208, WHOLE GRAIN FLOUR BLEND( MILLET, TRITICALE, RYE, BROWN RICE, BARLEY), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS .
Code Info2141203 2281203 3021203 4171203 5101203 5231203 7081203 8061203 9101203 9121203 11021203 11291203 12221203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1,378.0000 CWTS
Recall NumberF-1108-2013
Product Description42209, QUADRUPLE WHEAT BLEND( WHITE WHEAT, SPELT, BUCKWHEAT, CALCIUM SULFATE, FERROUS SULFATE-CONTAINS WHEAT STARCH), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS .
Code Info3161203 3291203 5151203 5161203 6111203 6121203 7031203 8021203 9041203 9261203 9271203 10311203 11011203 11121203 12071203 12101203 12271203 12281203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1,397.5000 CWTS
Recall NumberF-1109-2013
Product Description42300, KASHI COARSE 7 GRAIN BLEND ( RYE, WHEAT BRAN, WHOLE WHEAT FLOUR, OATS, BARLEY, YELLOW CORN, MILLET, BROWN RICE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS .
Code Info3261203 3271203 4091203 4101203 5031203 5211203 6121203 6181203 6291203 6301204 7011203 7091203 7301203 7311203 8281203 9131203 10021203 10031203 10121203 10161203 10181203 10261203 10291203 11301203 12271203 1021303 1081303
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity5,052.0000 CWTS
Recall NumberF-1110-2013
Product Description4050100, ORGANIC WHOLE WHEAT BREAD FLOUR (ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT. 50 LBS .
Code Info3061203 3141203 3151203 4141203 4151203 4161203 5111203 5131203 5141203 6061203 6071203 7021203 7031203 7051203 7301203 8291203 9211203 9241203 10041203 10051203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity3,215.5000 CWTS
Recall NumberF-1111-2013
Product Description4060215, OAT FLOUR (OATS), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 0 NET WT. 50 LBS .
Code Info2271203 3231203 3261203 4121203 4131203 5041203 5031203 6011203 6281203 7261203 8231203 9181203 9201203 10031203 10251203 10291203 11161203 1119103 12211203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity3,127.5000
Recall NumberF-1112-2013
Product Description4060564, LIGHT RYE FLOUR (RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND, NET WT. 50 LBS .
Code Info3051203 4131203 8091203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity35.0000 CWTS
Recall NumberF-1113-2013
Product Description4060570-T, TOTE - DARK RYE FLOUR, (WHOLE RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , NET WT. 1,750 LBS
Code Info5091203 5241205 5251203 6141203 6151203 7061203 7101203 7131203 8081203 9061203 10101203 11071203 11271203 12271203 12281203 12291203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity4,621.8700 CWTS
Recall NumberF-1114-2013
Product Description4060610, SPECIALTY PASTRY FLOUR (SOFT WHITE WHOLE WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS..
Code Info3291203 5071203 5081203 7301203 8101203 10081203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity647.5000
Recall NumberF-1115-2013
Product Description4060625, WHOLE MEAL BARLEY FLOUR (BARLEY), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 0 NET WT 50 LBS..
Code Info3291203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity10.0000
Recall NumberF-1116-2013
Product Description4060685, WHOLE MEAL TRITICALE FLOUR (TRITICALE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS..
Code Info3021203 6011203 6211203 8011203 8141203 10161203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity95.5000
Recall NumberF-1117-2013
Product Description4060800, ORGANIC WHOLE HARD WHITE WHEAT FLOUR (ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS..
Code Info8091203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity328.0000
Recall NumberF-1118-2013
Product Description4060801, ORGANIC HIGH GLUTEN REFINED HARD RED SPRING WHEAT FLOUR(ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS..
Code Info12041203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity50.0000
Recall NumberF-1119-2013
Product Description4060804, ORGANIC ALL PURPOSE FLOUR(ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , 1 NET WT 50 LBS..
Code Info8311203 12151712
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1,051.8000
Recall NumberF-1120-2013
Product Description4060805, ORGANIC HARD WHOLE WHEAT PASTRY FLOUR(ORGANIC WHEAT), DAKOTA SPECIALTY MILLING, INC., FARGO, ND , NET WT 50 LBS..
Code Info8301203 12131203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity457.0000
Recall NumberF-1121-2013
Product Description4060567, MEDIUM RYE FLOUR (RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND NET WT 50 LBS..
Code Info4051203 4131203 4201203 4221203 4231203 5181203 5211203 6041203 11081203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity858.5000 CWTS
Recall NumberF-1122-2013
Product Description4060570, DARK RYE FLOUR (RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND NET WT 50 LBS..
Code Info2131203 3021203 3051203 4301203 6141203 6151203 6181203 9191203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity862.5000 CWTS
Recall NumberF-1123-2013
Product Description40735, SPECIALTY DAKOTA 12 GRAIN BLEND 100 (WHEAT, OATS, BARLEY, RYE, TRICALE, MILLET, BROWN RICE, BULGAR WHEAT, YELLOW CORN, BUCKWHEAT, SPELT, AMARANTH) DAKOTA SPECIALTY MILLING, INC., FARGO, ND NET WT 50 LBS..
Code Info3231205 4161205 4191203 4251203 4261203 6291203 7021203 9102103 11201303 1031303
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity1732.5000 CWTS
Recall NumberF-1124-2013
Product Description4060573 LOW MICRO. DARK RYE FLOUR (WHOLE RYE), DAKOTA SPECIALTY MILLING, INC., FARGO, ND, NET WT 50 LBS.
Code Info10291203 12111203
ClassificationClass II
Reason for RecallSome flour and flour blends produced at Dakota Specialty Milling have the potential to be contaminated with pliable metal wire mesh fragments from a defective flour sifter.
Product Quantity302.5000 CWTS
Recall NumberF-1125-2013

Class II Devices Event

Event ID64376
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionSiemens Somatom CT's equipped with software syngo CT2010A, syngo CT2010B, syngo CT2011A and CT2012B. Computed tomography x-ray system.
Code InfoModel numbers - 7740769, 8098027, 10430603, and 10590000.
ClassificationClass II
Reason for RecallSporadic hang-up malfunctions concerning 3D reconstructions during activated "Preview Image" functionality.
Product Quantity896
Recall NumberZ-0948-2013

Class II Devices Event

Event ID64401
StatusOngoing
Product TypeDevices
Voluntary/Mandated
Recall Initiation Date20-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - Nationwide Distribution including the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV and WY.
 

Associated Products

Product DescriptionBrilliance 6, 10, 16, 40, 64, Big Bore and the iCT, iCT SP, Ingenuity CT and MX8000 Dual v. EXP are Computed Tomography X-Ray Systems. These devices are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code InfoSystem Code #728256, Serial #: 3001,3016,3019,3020,3025,3026,3030,3057,3058,3060,3071,3073,3074,3076,3080,3090,3095,3108,3114,3119,3124,3138,3151,3155,3167,3168,3174,3178,3186,3187,3192,3193,3196,3208,3210,3212,3213,3214,3218,3226,3245,3257,3264,3267,3269,3273,3274,3275,3281,3284,3289,3291,3296,3304,3306,3309,3313,3317,3327,3331,3336,3337,3339,3340,3341,3342,3344,3345,3346,3347,3348,3349,3350,3351,3352,3354,3355,3356,3357,3358,3359,3360,3361,3362,3363,3364,3365,3366,3367,3368,3369,3370,3371,3372,3373,3374,3375,3376,3377,3378,3379,3380,3381,3382,3383,3384,3385,3386,3387,3388,3389,3390,3391,3392,3393,3394,3395,3396,3397,3398,3399,3400,3402,3403,3404,3405,3406,3408,3409,3410,3411,3412,3413,3414,3415,3416,3417,3418,3419,3420,3421,3422,3423,3424,3425,3426,3427,3428,3429,3430,3431,3432,3433,3434,3435,3436,3437,3438,3439,3440,3441,3443,3444,3445,3447,3449,3450,3451,3452,3453,3454,3455,3456,3457,3458,3459,3460,3461,3462,3463,3464,3465,3466,3467,3468,3469,3470,3471,3472,3473,3474,3475,3476,3477,3478,3479,3480,3481,3482,3483,3484,3485,3486,3487,3488,3489,3490,3491,3492,3493,3494,3495,3496,3497,3498,3499,3500,3501,3502,3503,3504,3505,3506,3507,3508,3509,3510,3511,3512,3513,3514,3515,3516,3517,3518,3519,3520,3521,3522,3523,3524,3525,3526,3527,3528,3529,3530,3531,3532,3533,3534,3535,3536,3537,3538,3539,3540,3541,3542,3543,3544,3545,3546,3547,3548,3549,3550,3551,3552,3553,3554,3555,3556,3557,3558,3559,3560,3561,3562,3563,3564,3565,3566,3567,3568,3569,3570,3571,3572,3573,3574,3575,3576,3577,3578,3579,3580,3581,3582,3583,3584,3585,3586,3587,3588,3589,3590,3591,3592,3593,3594,3595,3596,3597,3598,3599,3600,3601,3602,3603,3604,3605,3606,3607,3608,3609,3610,3611,3612,3613,3614,3615,3616,3617,3618,3619,3620,3621,3622,3623,3624,3625,3626,3627,3628,3629,3630,3631,3632,3633,3634,3635,3636,3637,3638,3639,3640,3641,3642,3643,3644,3645,3646,3647,3648,3649,3650,3651,3652,3653,3654,3655,3656,3657,3658,3659,3660,3661,3663,3664,3665,3666,3667,3668,3669,3670,3671,3672,3673,3674,3675,3676,3677,3678,3679,3680,3681,3682,3683,3684,3685,3686,3687,3688,3689,3690,3691,3692,3693,3694,3695,3696,3697,3698,3699,3700,3701,3702,3703,3704,3705,3706,3707,3708,3709,3710,3711,3712,3713,3714,3715,3716,3717,3718,3719,3720,3721,3722,6039,6040,30003,30004,30006,30007,30008,30009,30012,30013,30015,30016,30021,30026,30028,30029,30030,30031,30036,30037,30038,30039,30046,30047,30050,30053,30054,30057,30060,30062,30065,30066,30072,30073,30075,30078,30079,30082,30083,30089,30090,30094,30100,30101,30103,30105,30109,30110,30111,30117,30118,30120,30122,30124,30125,30126,30128,30129,30130,30131 System Code #728251, Serial #: 3008,3098,4006,4007,4010,4011,4012,4016,4023,4031,4039,4050,4058,4061,4062,4063,4064,4065,4066,4067,40004,40005,40006,40007,40008,40009,40010,40011,40012,40014,40015,40016,40017,40018,40021,40025,40028,40030,40032 System Code #728246, Serial #: 3012,3013,3015,3017,3023,3027,3031,3043,3070,3072,3160,3185,3189,3191,3224,3295,3448,4018,4019,4024,4025,4043,4051,5001,5005,5006,5007,5013,5014,5016,5019,5022,5023,5024,5025,5028,5029,5032,5034,5036,5038,5046,5051,5052,5053,5055,5058,5059,5061,5063,5064,5069,5070,5074,5075,5077,5083,5086,5097,5102,5105,5106,5107,5108,5110,5111,5112,5113,5115,5116,5117,5119,5122,5123,5124,5125,5127,5130,5136,5137,5138,5139,5141,5143,5150,5151,5156,5158,5161,5169,5174,5179,5183,5184,5187,5188,5190,5195,5198,5202,5207,5211,5215,5217,5218,5220,5221,5224,5226,5228,5229,5230,5234,5249,5250,5252,5254,5265,5270,5274,5278,5282,5283,5285,5286,5287,5290,5291,5295,5296,5299,5309,5313,5315,5316,5317,5318,5319,5323,5328,5329,5331,5334,5343,5364,5365,5366,5367,5370,5371,5372,5375,5376,5377,5378,5379,5380,5381,5382,5383,5384,5385,5386,5387,5388,5389,5391,5392,5393,5394,5396,5397,5398,5399,5400,5401,5402,5403,5404,5405,5406,5407,5408,5409,5410,5411,5412,5414,5415,5416,5417,5418,5419,5420,5421,5422,5423,5424,5425,5426,5427,5428,5429,5432,5433,5434,5435,5437,5438,5439,5441,5442,5443,5444,5446,5447,5448,5449,5450,5451,5453,5457,5458,5459,5460,5461,5462,5463,5464,5466,5468,5471,5473,5474,5477,5478,5479,5480,5481,5482,5484,5485,5486,5487,5488,5489,5490,5491,5492,5493,5494,5496,5497,5498,5501,5502,5503,5504,5505,5506,5507,5508,5509,5510,5511,5513,5514,5515,5516,5517,5518,5519,5520,5522,5523,5524,5525,5526,5528,5530,5531,5532,5533,5534,5535,5536,5537,5538,5539,5540,5541,5542,5543,5544,5545,5546,5547,5548,5549,5550,5551,5552,5553,5554,5555,5556,5557,5558,5559,5560,5561,5562,5563,5564,5565,5566,5567,5568,5569,5570,5571,5572,5573,5574,5575,5576,5577,5578,5579,5580,5581,5582,5583,5584,5585,5586,5587,5588,5589,5590,5591,5592,5593,5594,5595,5596,5597,5598,5599,5600,5601,5602,5603,5604,5605,5606,5607,5608,5609,5610,5611,5612,5613,5614,5615,5616,5617,5618,5619,5620,5621,5622,5623,5624,5625,5626,5627,5628,5629,5630,5631,5632,5633,5634,5635,5636,5637,5638,5639,5640,5641,5642,5643,5644,5645,5646,5647,5648,5649,5650,5651,5653,5654,5655,5656,5657,5658,5659,5660,5661,5662,5663,5664,5665, 5666,5667,5668,5669,5670,5671,5672,5673,5674,5675,5676,5677,5678,5679,5680,5681,5682,5683,5684,5685,5686,5687,5688,5689,5690,5691,5692,5693,5694,5695,5696,5697,5698,5699,5700,5701,5702,5703,5704,5705,5706,5707,5708,5709,5710,5711,5712,5713,5714,5715,5716,5717,5718,5719,5720,5721,5722,5723,5724,5727,5728,5729,5730,5731,5732,5733,5734,5735,5736,5737,5738,5739,5740,5741,5742,5743,5744,5745,5746,5747,5748,5749,5750,5751,5752,5753,5754,5755,5756,5757,5758,5759,5760,5761,5762,5763,5764,5765,5766,5767,5768,5769,5770,5771,5772,5773,5774,5775,5776,5777,5778,5779,5780,5781,5782,5783,5784,5785,5786,5787,5788,5789,5790,5791,5792,5793,5794,5795,5796,5797,5798,5799,5800,5801,5802,5803,5804,5805,5806,5807,5808,5809,5810,5811,5812,5813,5814,5815,5816,5817,5818,5819,5820,5821,5822,5823,5824,5825,5826,5827,5828,5829,5830,5831,5832,5833,5834,5835,5836,5837,5838,5839,5840,5841,5842,5843,5844,5845,5846,5847,5848,5849,5850,5851,5852,5853,5854,5855,5856,5857,5858,5859,5860,5861,5862,5863,5864,5865,5866,5867,5868,5869,5870,5871,5872,5873,5874,5875,5876,5877,5878,5879,5880,5881,5882,5883,5884,5885,5886,5887,5888,5889,5890,5891,5892,5893,5894,5895,5896,5897,5898,5899,5900,5901,5902,5903,5904,5905,5906,5908,5909,5910,5911,5912,5913,5914,5915,5916,5917,5918,5919,5920,5921,5922,5923,5924,5925,5926,5927,5928,5929,5930,5931,5932,5933,5934,5935,5936,5937,5938,5939,5940,5941,5942,5943,5944,5945,5946,5947,5948,5949,5950,5951,5952,5953,5954,5955,5956,5957,5958,5959,5960,5961,5962,5963,5964,5965,5966,5967,5968,5969,5970,5971,5972,5973,5974,5975,5976,5977,5978,5979,5980,5981,5982,5983,5984,5985,5986,5987,5988,5989,5990,5991,5992,5993,5994,5995,5996,5997,5998,5999,6000,6001,6002,6003,6004,6005,6006,6008,6009,6010,6011,6012,6013,6014,6015,6016,6017,6018,6020,6021,6022,6023,6024,6025,6026,6027,6028,6029,6030,6031,6032,6033,6034,6035,6036,6037,6038,6039,6040,6041,6042,6043,6044,6045,6046,6047,6048,6049,6050,6051,6052,6053,6054,6055,6056,6057,6058,6059,6060,6061,6062,6063,6064,6065,6066,6067,6068,6069,6070,6071,6072,6073,6074,6075,6076,6077,6078,6079,6080,6081,6082,6083,6084, 6085,6086,6087,6088,6089,6090,6091,6092,6093,6094,6095,6096,6097,6098,6099,6100,6101,6102,6103,6104,6105,6106,6107,6108,6109,6110,6111,6112,6113,6114,6115,6116,6117,6118,6119,6120,6121,6122,6123,6124,6125,6126,6127,6128,6129,6130,6131,6132,6133,6134,6135,6136,6137,6138,6139,6140,6141,6142,6143,6144,6145,6146,6147,6148,6149,6150,6151,6152,6153,6154,6155,6156,6157,6158,6159,6160,6162,6163,6165,6166,6167,6168,6169,6170,6171,6172,6173,6174,6175,6176,6177,6178,6179,6180,6181,6182,6183,6184,6185,6186,6187,6188,6189,6190,6191,6192,6193,6194,6195,6196,6197,6198,6199,6200,6201,6202,6203,6204,6205,6206,6207,6208,6209,6210,6211,6212,6213,6214,6215,6216,6217,6218,6219,6220,6221,6222,6223,6224,6225,6226,6227,6228,6229,6230,6231,6232,6233,6234,6235,6236,6237,6238,6239,6240,6241,6242,6243,6244,6245,6246,6247,6248,6249,6250,6251,6252,6253,6254,6255,6256,6257,6258,6259,6260,6261,6263,6264,6265,6266,6267,6270,6271,6272,6273,6274,6275,6276,6277,6278,6279,6280,6281,6282,6283,6284,6285,6286,6287,6288,6289,6290,6291,6292,6293,6294,6295,6296,6297,6298,6299,6300,6301,6302,6303,6304,6305,6306,6307,6308,6309,6310,6311,6312,6313,6314,6315,6316,6317,6318,6319,6320,6321,6322,6323,6324,6325,6326,6327,6328,6329,6330,6331,6332,6333,6334,6335,6336,6337,6338,6340,6341,6342,6343,6344,6345,6346,6347,6348,6349,6350,6351,6352,6353,6354,6355,6356,6357,6358,6359,6360,6361,6362,6363,6364,6365,6366,6367,6368,6369,6370,6371,6372,6373,6374,6375,6376,6377,6378,6379,6380,6382,6383,6384,6385,6386,6387,6388,6389,6392,6393,6394,6395,6397,6398,6399,6400,6401,6402,6403,6404,6405,6406,6407,6408,6409,6410,6411,6412,6413,6414,6415,6416,6417,6418,6419,6420,6421,6422,6423,6424,6425,6426,6427,6428,6429,6430,6431,6432,6433,6434,6435,6436,6437,6438,6439,6440,6441,6442,6443,6444,6445,6446,6447,6448,6449,6450,6451,6452,6453,6454,6455,6456,6457,6458,6459,6460,6461,6462,6463,6464,6465,6466,6467,6468,6469,6470,6471,6472,6473,6474,6475,6476,6477,6478,6479,6480,6481,6482,6483,6484,6485,6486,6487,6488,6489,6490,6491,6492,6493,6494,6495,6496,6497,6498,6499,6500,6501,6502,6503,6504,6505,6506,6507,6508, 6509,30019,30041,30044,30067,30069,30070,30071,30097,30119,40002,40022,40027,40035,50002,50003,50004,50009,50010,50011,50013,50014,50015,50018,50022,50023,50029,50031,50032,50033,50035,50036,50041,50042,50044,50045,50046,50049,50050,50051,50052,50055,50058,50059,50061,50062,50063,50064,50065,50066,50068,50069,50070,50073,50074,50078,50080,50081,50082,50083,50084,50086,50087,50089,50090,50091,50092,50093,50094,50095,50097,50098,50099,50101,50102,50103,50106,50109,50110,50114,50122,50124,50125,50126,50128,50129,50131,50132,50133,50134,50135,50136,50137,50138,50140,50141,50142,50153,50154,50155,50156,50157,50158,50159,50160,50161,50162,50163,50164,50165,50166,50167,50168,50169,50170,50171,50172,50173,50175,50176,50177,50178,50179,50180,50181,50182,50183,60015,60020 System Code #728240, Serial #: 5003,5043,5175,5251,5284,5373,5374,5390,5395,5413,5430,5431,5436,5440,5445,5454,5455,5456,5465,5467,5469,5470,5472,5475,5476,5483,5495,5499,5500,5512,5521,5527,5822,6006,6009,6010,6011,6013,6021,6024,6026,6027,6028,6029,6030,6031,6032,6033,6034,6035,6036,6041,6045,6046,6047,6048,6049,6054,6055,6057,6058,6059,6060,6064,6066,6067,6069,6070,6071,6072,6075,6080,6081,6082,6083,6085,6089,6090,6095,6096,6099,6100,6101,6102,6103,6104,6105,6106,6112,6113,6115,6117,6119,6121,6123,6127,6129,6130,6131,6133,6134,6136,6137,6138,6139,6141,6144,6146,6148,6150,6154,6155,6156,6157,6159,6160,60002,60005,60009,60011,60012,60014,60018,60021,60022,60025,60027,60029 System Code #728235, Serial #: 9031,9036,9039,9061,9085,9088,9094,9097,9103,9104,9114,9116,9125,9129,9130,9132,9144,9146,9147,9149,9152,9153,9156,9157,9164,9167,9168,9169,9170,9174,9178,9181,9183,9186,9188,9189,9190,9191,9200,9203,9211,9212,9220,9233,9260,9265,9272,29008,29010,29011,29012,29015,29017,29019,29020,29023,29024,29028,29030,29033,29042,29043,29046,29048,29051,29055,29059,29060,29061,29062,29065,29067,29070,29071,29072,29075,29077,29078,29080,29084,29085,29086,29087,29088,29089,29090,29091,29092,29093,29094,29095,29096,29097,29098,29099,29100,29101,29102,29103,29104,29105,29106,29107,29108,29109,29111,29112,29113,29114,29116,29117,29118,29119,29120,29121,29122,29123,29124,29125,29126,29127,29128,29129,29130,29131,29132,29134,29135,29136,29137,29138,29139,29140,29141,29142,29143,29144,29145,29146,29147,29148,29149,29150,29151,29152,29153,90034,90043,90046,90048,90051,90053,90056,90058,90059,90064,90065,90069,90071,90075,90076,90083,90095,90101,90103,90108,90110,90111,90121,90122,90125,90126,90128,90130,90134,90144,90145,90146,90148,90149,90153,90155,90164,90166,90171,90172,90173,90176,90178,90179,90181,90184,90186,90187,90189,90191,90192,90195,90196,90197,90200,90204,90206,90213,90214,90221,90223,90224,90225,90226,90227,90228,90229,90230,90231,90232,90233,90234,90235,90236,90237 System Code #728231, Serial #: 4001,4003,4016,4021,9009,9037,9038,9041,9044,9045,9048,9049,9052,9056,9059,9062,9066,9069,9074,9075,9077,9080,9087,9089,9092,9105,9108,9118,9120,9137,9142,9143,9160,9162,9166,9175,9195,9197,9201,9202,9205,9206,9208,9214,9216,9217,9501,9502,9503,9514,9522,9526,9533,9538,9540,9541,9543,9544,9547,9552,9553,9554,9556,9561,9564,9566,9568,9569,9570,9575,9577,9578,9580,9584,9585,9586,9588,9590,9592,9596,9599,9607,9612,9615,9617,9620,9625,9627,9628,9630,9640,9641,9650,9654,9659,9663,9664,9670,9672,9675,9676,9678,9684,9688,9690,9694,9695,9696,9697,9703,9706,9709,9712,9713,9714,9718,9729,9731,9735,9736,9737,9738,9740,9747,9750,9751,9758,9761,9765,9766,9767,9772,9774,9777,9780,9782,9787,9788,9792,9794,9795,9797,9805,9807,9808,9811,9812,9813,9818,9820,9822,9824,9828,9830,9833,9834,9835,9837,9838,9840,9841,9843,9846,9848,9857,9866,9870,9871,9873,9874,9877,9882,9883,9902,9909,9916,9924,9933,9939,9956,9957,9958,9959,9960,9961,9962,9963,9964,9965,9966,9967,9968,9969,9970,9971,9972,9973,9974,9975,9976,9977,9978,9979,9980,9981,9982,9983,9984,9985,9986,9987,9988,9989,9990,9991,9992,9993,9994,9995,9996,9997,9998,9999,10000,10001,10002,10003,10004,10005,10006,10007,10008,10009,10010,10011,10012,10013,10014,10015,10016,10017,10018,10019,10020,10021,10022,10023,10024,10025,10026,10027,10028,10029,10030,10031,10032,10033,10034,10035,10036,10037,10038,10039,10040,10041,10042,10043,10044,10045,10046,10047,10048,10049,10050,10051,10052,10053,10054,10056,10057,10058,10059,10060,10061,10062,10063,10064,10065,10066,10067,10068,10069,10070,10071,10072,10073,10074,10075,10076,10077,10078,10079,10080,10081,10082,10083,10084,10085,10086,10087,10088,10089,10090,10091,10092,10093,10094,10095,10096,10097,10098,10099,10100,10101,10102,10103,10104,10105,10106,10107,10108,10109,10110,10111,10112,10113,10114,10115,10116,10117,10118,10119,10120,10121,10122,10123,10124,10125,10126,10127,10128,10129,10130,10131,10132,10133,10134,10135,10136,10137,10138,10139,10140,10141,10142,10143,10144,10145,10146,10147,10148,10149,10150,10151,10152,10153,10154,10155,10156,10157,10158,10159,10160,10161,10162,10163,10164,10165,10166,10167,10168,10169,10170,10171,10172,10173,10174,10175,10176,10177,10178,10179,10180,10181,10182,10183,10184,10185,10186,10187,10188,10189,10190,10191,10192,10193,10194,10195,10196,10197,10198,10199,10200,10201,10202,10203,10204,10205,10206,10207,10208,10209,10210,10211,10212,10213,10214,10215,10216,10217,10218,10219,10220,10221,10222,10223,10224,10225,10226,10227,10228,10229,10230,10231,10232,10233,10234,10235,10236,10237,10238,10239,10241,10242,10243,10244,10245,10247,10248,10249,10250,10251,10252,10253,10254,10255,10256,10257,10258,10259,10260,10261,10262,10263,10264,10265,10266,10267,10268,10269,10270,10271,10272,10273,10274,10275,10276,10277,10278,10279,10280,10281,10282,10283,10284,10285,10286,10287,10288,10289,10290,10291,10292,10293,10294,10295,10296,10297,10298,10299,10300,10301,10302,10303,10304,10305,10306,10307,10308,10309,10310,10311,10312,10313,10314,10315,10316,10317,10318,10319,10320,10321,10322,10323,10324,10325,10326,10327,10328,10330,10331,10332,10333,10334,10335,10336,10337,10338,10339,10340,10341,10342,10343,10344,10345,10346,10347,10348,10349,10350,10351,10352,10353,10354,10355,10356,10357,10358,10359,10360,10361,10362,10363,10364,10365,10366,10367,10368,10369,10370,10371,10372,10373,10374,10375,10376,10377,10378,10379,10380,10381,10382,10383,10384,10385,10386,10387,10388,10389,10390,10391,10392,10393,10394,10395,10396,10397,10398,10399,10400,10401,10402,10403,10404,10405,10406,10407,10408,10409,10410,10411,10412,10413,10414,10415,10416,10417,10418,10419,10420,10421,10422,10423,10424,10425,10426,10427,10428,10429,10430,10431,10432,10433,10434,10435,10436,10437,10438,10439,10440,10441,10442,10443,10444,10445,10446,10447,10448,10449,10450,10451,10452,10453,10454,10455,10456,10458,10459,10460,10461,10462,10463,10464,10465,10466,10467,10468,10469,10470,10471,10472,10473,10474,10475,10476,10477,10478,10479,10480,10481,10482,10483,10484,10485,10486,10487,10488,10489,10490,10491,10492,10493,10494,10495,10496,10497,10498,10499,10500,10501,10502,10503,10504,10505,10506,10507,10508,10510,10511,10513,10514,10515,10516,10517,10518,10519,10520,10521,10522,10523,10524,10525,10526,10527,10528,10529,10530,10531,10532,10533,10534,10535,10536,10537,10538,10539,10540,10541,10542,10543,10544,10545,10546,10547,10548,10549,10550,10551,10552,10553,10554,10555,10556,10557,10558,10559,10560,10561,10562,10563,10564,10565,10566,10567,10568,10569,10570,10571,10572,10573,10574,10575,10576,10577,10578,10579,10581,10582,10583,10584,10585,10586,10587,10588,10589,10590,10591,10592,10593,10594,10595,10596,10597,10598,10599,10600,10601,10602,10603,10604,10605,10606,10607,10608,10609,10610,10611,10612,10613,10614,10615,10616,10617,10618,10619,10620,10621,10622,10623,10624,10625,10626,10627,10628,10629,10630,10631,10632,10633,10634,10635,10636,10637,10638,10639,29016,29027,29035,29037,29044,29045,29049,29057,29066,64015,64045,64051,90029,90036,90037,900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System Code # 728243, Serial #: 7006,7008,7014,7016,7019,7025,7026,7027,7029,7030,7031,7033,7039,7042,7043,7047,7049,7050,7054,7071,7073,7076,7078,7081,7084,7086,7087,7088,7093,7095,7098,7099,7101,7102,7103,7110,7113,7114,7115,7117,7122,7124,7125,7127,7128,7130,7132,7133,7134,7136,7138,7140,7141,7142,7144,7147,7150,7151,7152,7153,7154,7156,7157,7158,7159,7160,7161,7162,7163,7164,7165,7166,7167,7168,7169,7170,7171,7173,7174,7175,7177,7178,7179,7181,7183,7184,7185,7186,7187,7188,7189,7191,7192,7193,7194,7195,7196,7197,7198,7199,7201,7202,7203,7204,7205,7206,7207,7208,7209,7210,7211,7212,7213,7214,7215,7216,7217,7218,7219,7220,7221,7222,7223,7224,7225,7226,7227,7228,7229,7230,7231,7232,7233,7234,7235,7236,7237,7238,7239,7240,7241,7242,7243,7245,7246,7247,7248,7249,7250,7251,7253,7254,7255,7256,7257,7258,7259,7260,7261,7262,7263,7264,7265,7266,7267,7269,7270,7272,7273,7274,7275,7276,7277,7278,7279,7280,7281,7282,7283,7284,7285,7286,7287,7288,7289,7290,7291,7292,7293,7294,7295,7296,7297,7299,7300,7302,7303,7304,7305,7306,7307,7308,7309,7310,7311,7312,7313,7314,7315,7316,7319,7320,7321,7322,7323,7324,7325,7326,7327,7328,7329,7330,7331,7332,7333,7334,7335,7336,7337,7338,7339,7340,7341,7342,7343,7344,7345,7346,7347,7348,7349,7350,7351,7352,7353,7354,7355,7356,7357,7358,7359,7360,7361,7362,7363,7364,7365,7366,7367,7368,7369,7370,7371,7372,7373,7374,7376,7377,7378,7379,7381,7382,7385,7387,7388,7389,7391,7392,7393,7394,7395,7397,7398,7399,7400,7401,7403,7404,7405,7406,7409,7410,7411,7412,7413,7414,7415,7416,7417,7418,7419,7420,7421,7422,7423,7424,7425,7426,7428,7429,7431,7432,7433,7434,7435,7436,7437,7438,7440,7441,7442,7443,7444,7445,7446,7447,7448,7449,7450,7451,7454,7455,7456,7457,7459,7460,7461,7462,7463,7464,7465,7466,7467,7468,7469,7470,7471,7472,7473,7474,7475,7476,7477,7478,7479,7480,7481,7482,7483,7484,7485,7487,7488,7489,7490,7491,7492,7493,7494,7495,7496,7497,7498,7499,7500,7501,7502,7503,7504,7505,7506,7507,7508,7509,7511,7512,7513,7515,7516,7517,7518,7519,7521,7522,7523,7524,7525,7526,7527,7528,7529,7530,7531,7532,7533,7534,7535,7536,7537,7538,7539,7540,7541,7542, 7544,7545,7546,7547,7548,7549,7550,7551,7552,7553,7554,7555,7556,7557,7558,7559,7560,7561,7562,7563,7564,7565,7566,7567,7568,7569,7570,7572,7573,7574,7575,7576,7577,7578,7579,7580,7581,7582,7583,7584,7585,7586,7587,7588,7589,7590,7591,7592,7593,7595,7596,7597,7598,7599,7601,7602,7603,7604,7605,7606,7607,7608,7609,7610,7611,7612,7613,7614,7615,7616,7617,7618,7620,7622,7623,7624,7625,7626,7627,7628,7629,7630,7631,7632,7633,7634,7635,7637,7638,7639,7640,7641,7642,7643,7644,7645,7646,7647,7648,7649,7650,7652,7655,7656,7657,7658,7659,7661,7662,7663,7665,7666,7667,7671,7672,7673,7674,7675,7677,7678,7679,7680,7681,7682,7684,7685,7686,7687,7689,7690,7691,7692,7693,7695,7696,7698,7699,7700,7701,7702,7703,7704,7705,7706,7707,7709 System Code #728244, Serial #: 7052,7155,7172,7176,7180,7182,7190,7200,7244,7252,7268,7271,7301,7318,7375,7380,7383,7384,7386,7390,7396,7402,7407,7408,7427,7430,7439,7452,7453,7458,7486,7510,7514,7520,7543,7571,7600,7619,7621,7636,7651,7653,7654,7660,7664,7668,7669,7670,7676,7683,7688,7694,7697,7708,7710 System Code #728244, Serial #: 7052,7155,7172,7176,7180,7182,7190,7200,7244,7252,7268,7271,7301,7318,7375,7380,7383,7384,7386,7390,7396,7402,7407,7408,7427,7430,7439,7452,7453,7458,7486,7510,7514,7520,7543,7571,7600,7619,7621,7636,7651,7653,7654,7660,7664,7668,7669,7670,7676,7683,7688,7694,7697,7708,7710 System Code # 728306, Serial #: 100019,100020,100021,100022,100023,100024,100025,100028,100031,100032,100037,100038,100039,100040,100042,100043,100044,100045,100046,100047,100048,100049,100050,100051,100052,100053,100054,100055,100056,100057,100058,100059,100060,100061,100062,100063,100064,100065,100066,100067,100068,100069,100070,100071,100072,100073,100074,100077,100078,100079,100081,100082,100083,100084,100085,100086,100087,100088,100089,100090,100091,100092,100093,100094,100095,100096,100097,100098,100099,100100,100101,100102,100103,100104,100105,100106,100107,100108,100109,100110,100111,100112,100113,100114,100115,100116,100117,100118,100119,100120,100121,100122,100123,100124,100125,100126,100127,100128,100129,100130,100131,100132,100133,100134,100135,100136,100137,100138,100139,100140,100141,100142,100143,100144,100145,100146,100147,100148,100149,100150,100151,100152,100153,100154,100155,100157,100158,100159,100160,100161,100162,100163,100164,100165,100166,100167,100168,100169,100170,100171,100172,100173,100174,100175,100176,100177,100178,100179,100180,100181,100182,100183,100184,100185,100186,100187,100188,100189,100190,100191,100192,100193,100194,100195,100196,100197,100198,100199,100200,100201,100202,100203,100204,100205,100206,100207,100208,100209,100210,100211,100212,100213,100214,100215,100216,100217,100218,100219,100220,100221,100222,100223,100224,100225,100226,100227,100228,100229,100230,100231,100232,100233,100234,100235,100236,100238,100240,100241,100242,100243,100244,100245,100246,100247,100248,100249,100250,100251,100252,100253,100254,100255,100256,100257,100258,100259,100260,100261,100262,100263,100264,100265,100266,100267,100268,100269,100270,100271,100272,100273,100274,100275,100276,100277,100278,100279,100280,100281,100282,100283,100284,100285,100286,100287,100288,100289,100290,100291,100292,100293,100294,100295,100296,100297,100298,100299,100300,100301,100302,100303,100304,100305,100306,100307,100308,100309 System Code #728311, Serial #: 200003,200004,200005,200006,200007,200008,200009,200010,200012,200013,200014,200015,200016,200017,200018,200019,200020,200021,200022,200023,200024,200025,200026,200027,200028,200029,200030,200031,200032,200033,200034,200035,200036,200037,200038,200039,200040,200041,200042,200043,200044,200045,200046,200047,200048,200049,200050,200051,200052,200053,200054,200055,200056,200057,200058,200059,200060,200061,200062,200063,200064,200065,200066,200067,200068,200069,200070,200071,200073,200074,200075,200076,200077,200078,200079,200080,200081,200082,200083,200084,200085,200086,200087,200088,200089,200090,200091,200092,200093 System Code #728231, Serial #: 310001, 310002, 310003 System Code #728130, Serial #: 8020,8022,8039,8060,8065,8067,8079,8089,8100,8105,8121,8144,8153,8169,8189,8205,8209,8211,8214,8249,8251,8252,8253,8397,8399,20302,80001,80007,80011,80015,80020
ClassificationClass II
Reason for RecallPhilips Healthcare received reports from the field stating the patient table on a system had an unexpected downward movement while a patient was on the table. Philips has determined the cause was a malfunction of the vertical brake.
Product Quantity4797 Units
Recall NumberZ-0945-2013

Class II Food Event

Event ID64402
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Feb-13
Initial Firm Notification of Consignee or Public Other
Recalling FirmFrito-Lay, Inc
CityPlano
StateTX
CountryUS
Distribution PatternNationwide through grocery outlets, foodservice, and vending customers.
 

Associated Products

Product DescriptionSunchips 6 Grain Medley Creamy Roasted Garlic, Net WT. 9 oz. (255.1 g), UPC 2840000690
Code InfoAll lot codes with expiration dates prior to May 21, 2013 are impacted.
ClassificationClass II
Reason for RecallThe products were manufacturing using flour supplied by Dakota Specialty Milling and have the potential to contain metal.
Product Quantity13, 812 cases
Recall NumberF-1137-2013
Product DescriptionSunchips 6 Grain Medley Parmesan & Herb, Net Wts. 9 oz (255.1 g) UPC 2840003963 and 1 3/8 oz (38.9 g) UPC 2840000892
Code InfoAll lot codes with expiration dates prior to May 21, 2013 are impacted.
ClassificationClass II
Reason for RecallThe products were manufacturing using flour supplied by Dakota Specialty Milling and have the potential to contain metal.
Product Quantity33,819 cases
Recall NumberF-1138-2013

Class II Food Event

Event ID64408
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMondelez Global Llc
CityEast Hanover
StateNJ
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionCase UPC: 144000031944 Carton: Nabisco belVita Chocolate Variety Net Wt. 8.8 oz UPC 0 44000 03194 7 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA Inner Pouch: Nabisco belVita Chocolate Variety Net Wt. 1.76 oz UPC 0 44000 03192 3 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA 14.08 oz Please note there are mixed shippers, shipper labels are not available: Mixed belVita Shipper UPC 0044000032784 which contains a 14.08 oz 2 pc product- waiting for label for this size. 9618 cases distributed.
Code Info21 Jan 13 through 29 Sep 13
ClassificationClass II
Reason for RecallbelVita breakfast biscuit may contain fragments of flexible metal mesh caused by a faulty screen at a third-party flour supplier.
Product Quantity460,917 cases (6 boxes in each case with 5 pouches that contain 4 cookies)
Recall NumberF-1068-2013
Product DescriptionCarton: Nabisco belVita Apple Cinnamon Net Wt. 8.8 oz UPC 0 44000 02824 1 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA Inner Pouch: Nabisco belVita Apple Cinnamon Net Wt. 1.76 oz UPC 0 44000 02825 1 Distributed by Kraft Foods Global, Inc. Northfield, IL 60093-2753 USA Shipper: Mixed "Better For You" Shipper UPC 00044000034023 which also contains product not subject to the recall 590 cases distributed
Code Info8 Jan 12 through 2 Sep 13
ClassificationClass II
Reason for RecallMondelez Global LLC is conducting a voluntary recall of belVita Breakfast Biscuit Apple Cinnamon and Chocolate Varieties due to the possible presence of fragments of flexible metal mesh caused by a faulty screen at third party flour supplier.
Product Quantity551,180 boxes (each case contains 6 boxes, with 5 pouches and 4 cookies in each)
Recall NumberF-1069-2013

Class II Drugs Event

Event ID64416
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHumco Holding Group, Inc
CityTexarkana
StateTX
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMercuroclear Antiseptic Anesthetic First Aid Helps prevent infection and relieves pain and itching of minor cuts, scrapes, burns and insect bites. Active Ingredients Benzalkonium chloride 0.13% - First Aid antiseptic, Lidocaine hydrochloride 2.5% - External analgesic, Sold under the following brands: a) Good Neighbor Pharmacy, NDC 24385-593-46; b) Quality Choice, NDC 63868-0488-02; c) Select Brand NDC 15127-885-59; d) Premier Value; e) CVS Pharmacy; f) Rite Aid Pharmacy; g) Top Care; h) HEB; and i) Humco.
Code Infoa) Good Neighbor, Item Number 163792006: Lot #s: 534204, 538468, 540540; b) Quality Choice, Item Number 163792066: Lot #s: 538835, 539431; c) Select Brands, Item Number 163792067: Lot #: 540529; d) Premier Value, Item Number 163792079: Lot #s: 534545 and 535307; e) CVS, Item Number 163791091 (1 oz.): Lot #s 533472, 534055, 534256, 534546, 534995, 535249, 535318, 535683, 536302, 537285, 538138, 538189, 538439, 538672; and Item Number 163792091 (2 oz.): Lot #s: 538408, 540530, 540542, 540712; f) Rite Aid, Item Number 163792088: Lot #s: 533471, 534067, 534337, 534548, 535512, 535876, 536526, 537076, 537284, 538229, 538469, 538864, 539475, 540714, 541285, 541304, 541415, 541672; g) Top Care, Item Number 163792101: Lot #: 535070, 535681, 537323, 537376, and 537587; h) H.E.B, Item Number 163793800: Lot #s: 534442, 534701, 534981, 535332, 535403, 536300; and i) HUMCO, Item Number 163792001, 163792015 (2 oz.): Lot #s 534612, 534767, 535402, 535845, 536899, 537335, 537586, 538219, 538470, 538865, 539691, 539803, 539845, 541193 and 533470, 533554, 534032, 534057, 534158, 534399, 534547, 534686, 535069, 535246, 535317, 535682, 535874, 536247, 536301, 536900, 537075, 537283, 537588, 537722, 537960, 538190, 538191, 538289, 538410, 538671, 538673, 539640, 539692, 540143, 540144, 540176, 540539, 540713, 540820, 540851, 541101, 541146, 541195, 541611, 541673; and Item Number 163793001 (3 oz.): Lot #s: 534165, 534748, 535404, 537751, 539387, 540029, 540296, 540711.
ClassificationClass II
Reason for RecallMicrobial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.
Product Quantity1,269,846 bottles
Recall NumberD-197-2013

Class II Devices Event

Event ID64421
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGenesys Orthopedic Systems, LLC
CityAustin
StateTX
CountryUS
Distribution PatternUSA Nationwide Distribution including the states of: CA and TX.
 

Associated Products

Product Description3.75mm x 12mm Fixed Cervical Screws. Components of the Genesys Spine Anterior Cervical Plate System Product Usage: is intended for anterior screw fixation to the cervical spine.
Code InfoPart Number: GCSF37512 and Lot Number: 0243
ClassificationClass II
Reason for RecallManufacturing residue may be present on the cervical screws. Use of this product may result in patient infection, delayed fusion or non-fusion (pseudarthrosis), inflammatory response, or revision surgery.
Product Quantity9 cervical screws
Recall NumberZ-0921-2013

Class II Devices Event

Event ID64436
StatusOngoing
Product TypeDevices
Voluntary/Mandated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Medical Systems (Cleveland) Inc
CityCleveland
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including AR, AZ, IN, KS, LA, MA, MN, MS, MT, NJ, NY, NY, OH, OR, PA, TN, TX, VT, WV, WY, and worldwide including the contries of Australia, Belgium, China, France, Germany, Israel, Japan, Norway, Sweeden, and Switzerland.
 

Associated Products

Product DescriptionBrilliance 64 and Ingenuity Computed Tomography X-Ray Systems The Brilliance 64 and Ingenuity CT are whole body Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
Code InfoBrilliance 64: 728231 & Ingenuity CT: 728326, 728323. System Code # 728231, Serial #: 9654, 91003, 95130, 95157, 95504 System Code # 728326, Serial #: 32000,300003,300004,300005,300010,300011,300012,300014,300015,300018,300027,300041,300053,300059,300066,300070,300071,300073,300074,300078,300079,300080,300082,300084,300086,300091,300095,300101,300102,300112,300127,300128,300129,300131,300132,310064 System Code # 728323, Serial #: 320033
ClassificationClass II
Reason for RecallThis field change order is being released to update software and customer release notes to the affected installed base.
Product Quantity42 Units
Recall NumberZ-0950-2013

Class II Food Event

Event ID64438
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmThe King Arthur Flour Company, Inc.
CityNorwich
StateVT
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionKing Arthur Unbleached All-Purpose Flour, 5-lb. bag UPC 0-71012-01050-9
Code InfoBest Used By/ Lot Code 12/26/2013 L12A26B; 12/26/2013 L12A26C; 12/27/2013 L12A27A; 01/18/2014 A13A18A; 01/18/2014 A13A18B; 01/21/2014 A13A21A; 01/22/2014 A13A22B; 01/30/2014 A13A30A; 01/31/2014 A13A31A.
ClassificationClass II
Reason for RecallForeign material
Product Quantity40,240/5 Lb
Recall NumberF-1195-2013
Product DescriptionKing Arthur Unbleached Bread Flour, 5-lb. bag UPC 0-71012-04105-3
Code InfoBest Used By/ ot Code 12/26/2013 L12A26A; 12/26/2013 L12A26B; 01/03/2014 A13A03A; 01/03/2014 A13A03B; 01/16/2014 A13A16B; 01/17/2014 A13A17A; 01/23/2014 A13A23A; 01/28/2014 A13A28A; 01/31/2014 A13A31A.
ClassificationClass II
Reason for RecallForeign material
Product Quantity63272/5 Lb
Recall NumberF-1196-2013

Class II Devices Event

Event ID64447
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDraeger Medical, Inc.
CityTelford
StatePA
CountryUS
Distribution PatternDistributed in the states of CA, IL, and MA.
 

Associated Products

Product DescriptionDraeger Infinity Acute Care System (IACS) Monitoring Solution. Catalog Number MS20783 (Infinity MCable-Dual Hemo) Physiological patient monitoring system.
Code InfoCatalog Number MS20783 (Infinity MCable-Dual Hemo)
ClassificationClass II
Reason for RecallThe displayed value for the invasive blood pressure measurement of the IACS was different than the actual patient values. Liquid ingress in the cable connection may cause inaccurate measurements. This can happen if the Dual Hemo MCable is used in a non-vertical position, a vertical position but upside down, or laying it on the floor or on the patient bed.
Product Quantity260
Recall NumberZ-0939-2013

Class II Devices Event

Event ID64458
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVygon Corporation
CityMontgomeryville
StatePA
CountryUS
Distribution PatternProduct was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
 

Associated Products

Product DescriptionChurchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.
Code InfoLots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.
ClassificationClass II
Reason for RecallProduct was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
Product Quantity210
Recall NumberZ-0937-2013

Class II Devices Event

Event ID64477
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jul-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmKeystone Dental Inc
CityBurlington
StateMA
CountryUS
Distribution PatternNationwide Distribution including CA, IN, MA, MD, MN, MI, , NH, NY, NC, PA, and WI.
 

Associated Products

Product DescriptionGenesis Straight Esthetic 4.0 mm 1mm Cuff Abutment Part Number: G71200 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
Code InfoLot Number: 2376 Exp Date: 09/2013
ClassificationClass II
Reason for RecallMislabeled: Genesis Straight Esthetic 5.0mm Contour ,3mm cuff labeled as Genesis Straight Esthetic 4.0 mm, 1 mm cuff abutment,
Product Quantity35 units
Recall NumberZ-0923-2013
Product DescriptionGenesis Straight Esthetic 5.0 mm 3. mm Cuff Abutment Part Number: G71205 Genesis implant for single stage or two stage surgical procedures all types of of bone in partially or fully edentulous mandibles and maxillae.
Code InfoLot Number: 2385 Exp Date: 09/2013
ClassificationClass II
Reason for RecallMislabeled: Genesis Straight Esthetic 4.0mm Contour ,1mm cuff labeled as Genesis Straight Esthetic 5.0 mm, 3mm cuff abutment
Product Quantity22 units
Recall NumberZ-0924-2013

Class II Devices Event

Event ID64479
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNatus Neurology Incorporated
CityMiddleton
StateWI
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including the states of CA, FL, LA, MD, MS, MO, NJ, NY, PA, TX and the country of AUSTRALIA. BAHRAIN BRAZIL CANADA Country DENMARK EGYPT GERMANY HONG KONG INDIA INDONESIA IRELAND ITALY JAPAN KOREA KUWAIT MALAYSIA MEXICO NETHERLANDS ROMANIA RUSSIA SINGAPORE SPAIN SWITZERLAND TAIWAN THAILAND TURKEY UNITED KINGDOM URUGUAY VIET NAM
 

Associated Products

Product DescriptionNicolet EEG Wireless Amplifier 32/64 Channel. Catalog/Part Numbers : 515-015400 for the 32 channel amplifier and 515-015500 for the 64 channel amplifier. Product Usage: The Nicolet Wireless EEG Amplifier is intended to be used as a front end amplifier to acquire, store, and transmit electrophysiological signals in a wired or wireless mode for the Nicolet Neurodiagnostic system.
Code InfoC110318004 C110318027 C110815014 C110815025 C110519011 C110318029 C110318010 C110318028 C110318030 C110318019 C110318006 C110318013 C110519022 C110519021 C110323024 C110323039 C110323037 C110323034 C110519003 C110323011 C110323007 C110815003 C110323040 C110815030 C110815015 C110517040 C110815026 C110519031 C110519030 C110513015 C110519035 C110318009 C110815020 C110519023 C110519023 C110815001 C110519010 C110519017 C110318018 61855 C110519002 C110323006 38249 C110815007 C110323036 C110519007 C110519012 C110519027 C110318008 C110318016 C110318026 C110318027 C110519008 C110519009 C110815023 C110815013 C110519034 C110519029 C110323050 C110118018 C110519043 C110815027 C110519005 C110519026 C110579013 C110519045 C110519015 C110201021 C110318001 C110519050 C110323002 C110519014 C110519033 C110318012 C110519038 C110519042 C110318023 C110519020 RG100512M C110519046 C110519037 C110519019 C110519007 C110318016 C110318002 C110815016 C110815012 RC110125M C110323018 C110815024 A4312 & A4314 C110318014 C110318011 C110318015 34902 C110815011 C110309001 C110519002 A42A0 C110318025 C110519036 C110519028 C110519024 C110519013 C110318005
ClassificationClass II
Reason for RecallNatus Neurology Incorporated is recalling the Nicolet EEG Wireless Amplifier which may overheat and become uncomfortable to touch around the area of the on/off button. The overheating may result in discomfort ranging from too hot up to the potential for a burn.
Product Quantity114 (31 USA; 83 OUS)
Recall NumberZ-0946-2013

Class II Food Event

Event ID64483
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmKoda Farms Inc
CitySouth Dos Palos
StateCA
CountryUS
Distribution PatternNY, MD, CA, HI, WA,
 

Associated Products

Product DescriptionMochiko Blue Star Sweet Rice Flour, Net Wt 50 lb. or packaged in 1 lb bags. Koda Farms Milling, Inc. South Dos Palos, CA. 93665
Code InfoLot numbers F307, F308, F309, F311, F314, F315, F317, F322, F323. 50 Lb bag UPC 0 74823-00023-3; 1 lb gab UPC-0-74823-00021-9.
ClassificationClass II
Reason for RecallKoda Farms received a report from a customer that a hard yellow material was found in dough made with rice flour from Koda Farms. This is an expansion of the recall of two lots of rice flour that commenced on February 15, 2013 to include additional lots after a report of the same material found in an earlier lot of rice flour.
Product Quantity357x 50 lb bags; 119172 x 1 lb bags.
Recall NumberF-1139-2013

Class II Food Event

Event ID64498
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Nov-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmWhole Foods Market
CityAustin
StateTX
CountryUS
Distribution PatternAL, DC, GA, MD, NC, NJ, PA, SC, TN, and VA.
 

Associated Products

Product Description365 Organic Orzo, 16oz, 20 carton/case
Code InfoUPC Code: 0 99482 43112 9; Lot Code: Lot 142251
ClassificationClass II
Reason for RecallThis product (one specific lot code) was being held at the manufacturers' request in distribution centers upon receiving. The vendor had an initial positive result for egg protein in one of their regularly scheduled tests, but it occurred after the product had shipped. The manufacturer tested again when they received a second positive result. At this time the manufacturer authorized Whole Foods Market and distribution centers to destroy the product on hand. Whole Foods Market learned from the distribution centers that two distribution centers had released the product by mistake, sending it from their York, Pa. and Atlanta, Ga. Distribution Centers to Whole Foods Market stores on Sunday November 18th,2012.
Product Quantity56 cases (1120 cartons)
Recall NumberF-1144-2013

Class II Food Event

Event ID64503
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFood For Life Baking Company Inc.
CityCorona
StateCA
CountryUS
Distribution PatternUS states and Canada.
 

Associated Products

Product DescriptionEzekiel 4:9 Sprouted Grain Cereal- Original, 16 oz. Packaging label reads in part:"***Food FOR Life*** Ezekiel 4:9 SPROUTED WHOLE GRAIN CEREAL ORIGINAL NET WT. 16 OZ (454g)***MANUFACTURED BY: FOOD FOR LIFE BAKING COMPANY, INC. P.O. BOX 1434 CORONA, CA 92878-1434***".
Code InfoUPC 07347200255 1 LOT numbers: M3232, M3313, M3512, M3565 Best by dates: NOV. 21, 2013 NOV. 30, 2013 DEC. 19, 2013 DEC. 27, 2013
ClassificationClass II
Reason for RecallThe firm is recalling Ezekiel 4:9 Sprouted Grain Cereal because the product may be mislabeled and may contain an undeclared allergen - almond.
Product Quantity1787 cases
Recall NumberF-1141-2013
Product DescriptionEzekiel 4:9 Sprouted Grain Cereal- Golden Flax, 16 oz. Packaging label reads in part:" Food FOR Life***EZEKIEL 4:9 SPROUTED WHOLE GRAIN CEREAL GOLDEN FLAX***NET WT. 16 OZ(454g)***MANUFACTURED BY: FOOD FOR LIFE BAKING COMPANY, INC. P.O. BOX 1434 CORONA, CA 92878-1434***".
Code InfoUPC 07347200256 8 LOT numbers: M3253, M3309, M3414, M3439, M3523, N0068, N0165 Best by dates: NOV. 24, 2013 DEC. 5, 2013 DEC. 11, 2013 DEC. 18, 2013 DEC. 21, 2013 JAN. 14, 2014 JAN. 15, 2014
ClassificationClass II
Reason for RecallThe firm is recalling Ezekiel 4:9 Sprouted Grain Cereal because the product may be mislabeled and may contain an undeclared allergen - almond.
Product Quantity6245 cases
Recall NumberF-1142-2013
Product DescriptionEzekiel 4:9 Sprouted Grain Cereal- Cinnamon Raison, 16 oz. Packaging label reads in part:" Food FOR Life***EZEKIEL 4:9 SPROUTED WHOLE GRAIN CEREAL Cinnamon Raison***NET WT. 16 OZ(454g)***MANUFACTURED BY: FOOD FOR LIFE BAKING COMPANY, INC. P.O. BOX 1434 CORONA, CA 92878-1434***".
Code InfoUPC 07347200257 2 LOT numbers: M3232, M3313, M3328, M3425, M3512, M3527, M3537, N0045, N0132 Best by dates: JAN. 21, 2014 JAN. 30, 2014 FEB. 6, 2014 FEB. 13, 2014 FEB. 23, 2014 FEB. 25, 2014 FEB. 26,2014 MAR. 9, 2014 MAR. 15, 2014
ClassificationClass II
Reason for RecallThe firm is recalling Ezekiel 4:9 Sprouted Grain Cereal because the product may be mislabeled and may contain an undeclared allergen - almond.
Product Quantity7337 cases
Recall NumberF-1143-2013

Class II Drugs Event

Event ID64541
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmRX South LLC DBA RX3 Pharmacy
CityChester
StateVA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionMedi-bolic Booster Injectable (methionine 8.3 mg/mL, choline chloride 16.6 mg/mL, inositol 16.6 mg/mL, cyanocobalamin USP [Vit B12] 0.33 mg/mL, chromium chloride 2.6 mg/mL), 30 mL multi-dose vials, Rx3 Compounding Pharmacy, 12230 Ironbridge Rd., Suite C, Chester, VA 23831.
Code InfoLot #: 10292012:56, Exp 01/27/13 and 10302012:77, Exp 01/28/13
ClassificationClass II
Reason for RecallCGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.
Product Quantity126 vials
Recall NumberD-191-2013

Class II Food Event

Event ID64555
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmRiggio Dist Co
CityDetriot
StateMI
CountryUS
Distribution PatternDistributor and retail stores in Illinois and Michgan
 

Associated Products

Product DescriptionGlory Foods Mixed Greens, Verduras Mixtas 16 oz
Code InfoLot 171853 UPC 3639320605 Use By 3/5/13
ClassificationClass II
Reason for RecallProduct has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Routine testing by the Michigan Department of Agriculture revealed the presence of Listeria Monocytogenes in a single 16 ounce package of "Mixed Blend" Greens.
Product Quantity2200 bags
Recall NumberF-1140-2013

Class II Devices Event

Event ID64580
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHill-Rom, Inc.
CityBatesville
StateIN
CountryUS
Distribution PatternUSA Nationwide Distribution including the state of Canada
 

Associated Products

Product DescriptionTotalCare SpO2RT2 bed. Product Usage: Bed, flotation therapy, powered bed may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare SpO2RT® 2 Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Code Info S/N between N230AM1358 & O023AM3687.
ClassificationClass II
Reason for RecallIn certain situations a software problem with the TotalCare SpO2RT® 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed and tested, and will be released within thirty (30) days.
Product Quantity309
Recall NumberZ-0949-2013

Class II Food Event

Event ID64597
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBay Valley Foods LLC/ TreeHouse Foods, Inc
CityOak Brook
StateIL
CountryUS
Distribution PatternCA, FL, GA, IL, IN, KY, LA, MD, MI, MS, NY,NC, OH, OK, PA, TN, TX, UT, VA, WA, WI.
 

Associated Products

Product Description55613210946 Western Family, Easy Sides, Herb & Butter Pene, Net WT 5.5 oz (156 g), UPC "0 15400 12655 7", Proudly Distributed by Western Family Foods, Inc., P.O. Box 4057, Portland OR, 97208
Code Info77A03192, 77A04262, 77B08042, 77B09252.
ClassificationClass II
Reason for RecallBay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement.
Product Quantity1102 cases (12 cartons per case)
Recall NumberF-1189-2013
Product Description556132100582 Meijer, Angel Hair Pasta with Herbs Angel Hair Pasta with Creamy Herb Sauce Mix , Net WT 4.8 oz ( 136g), UPC 7 19283 73636 95, Dist. by Meijer Distribution Inc., Grand Rapids, MI 49544.
Code Info77A02032, 77A02222, 77A03092, 77A07192.
ClassificationClass II
Reason for RecallBay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement.
Product Quantity2867 cases (12 cartons per case)
Recall NumberF-1190-2013
Product Description55613130643 Our Specialty Linguini & Parmesan, Linguini pasta with naturally flavored Parmesan & Romano Cheese Sauce Mix, Net WT 5.8 oz ( 164g), UPC 0 55049 00602 5, Distributed by S.T. Specialty Foods, Inc, Brooklyn Park, MN 55455.
Code InfoBatch 77A02072, 77A04232, 77A04242, 77A04252, 77A07222, 77A08072, 77A09172, 77A09262, 77A09272, 77A09282, 77A10161, 77A10162.
ClassificationClass II
Reason for RecallBay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement.
Product Quantity390,096 cases (12 cartons per case)
Recall NumberF-1191-2013
Product Description55613205218 Pasta on the Side,  Angel Hair Pasta with Herbs, Net WT 4.8 oz ( 136g), UPC 0 51933 08275 5, Distributed by Save- A- Lot Food Stores LTD, Earth City, MO 63045.
Code Info77A01023, 77A01173, 77A02022, 77A02053, 77A02102, 77A02162, 77A03142, 77A03282, 77A04182, 77A06062, 77A06232, 77A07072, 77A07182, 77A08132, 77A08202, 77A09132, 77A09222, 77A09242, 77A10052, 77A10082, 77A10312, 77A11012.
ClassificationClass II
Reason for RecallBay Valley Foods is voluntarily recalling approximately 430,227 cases of boxed pasta mix products manufactured by its subsidiary STP Specialty Foods, Inc. because the labeling did not include soy lecithin in the ingredient statement.
Product Quantity35028 cases (12 cartons per case)
Recall NumberF-1192-2013

Class III Food Event

Event ID34820
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmG.L. Food Wholesale Inc
CityCity Of Industry
StateCA
CountryUS
Distribution PatternCA, TX, IL, NV, OR, AZ, MO, NM, WA
 

Associated Products

Product DescriptionTausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___"
Code InfoBB Sept 21, 2013 BB Nov 26, 2013 BB Nov 27, 2013 BB Nov 20, 2013 BB Feb 29, 2013
ClassificationClass III
Reason for RecallGL Food Wholesale is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.
Product Quantity350 cases
Recall NumberF-1200-2013

Class III Food Event

Event ID34821
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGolden Dharma International Corp
CityRowland Heights
StateCA
CountryUS
Distribution PatternCalifornia, New Jersey
 

Associated Products

Product DescriptionTausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___"
Code InfoBB Apr 26, 2013 BB May 24, 2013
ClassificationClass III
Reason for RecallGolden Dharma International is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.
Product Quantity910 cartons
Recall NumberF-1131-2013

Class III Food Event

Event ID35761
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMandalay Trading Corporation
CityCity of Industry
StateCA
CountryUS
Distribution PatternCA, NV, NM, WA, GA, NJ,
 

Associated Products

Product DescriptionTausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___"
Code InfoBB Mar 16, 2014 BB Mar 17, 2014 BB Mar 20, 2014 BB Aug 14, 2014 BB Sept 11, 2014 BB Sept 12, 2014
ClassificationClass III
Reason for RecallMandalay Trading is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.
Product Quantity530 cartons
Recall NumberF-1199-2013

Class III Food Event

Event ID35779
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWalong Marketing, Inc.
CityBuena Park
StateCA
CountryUS
Distribution Patternnationwide
 

Associated Products

Product DescriptionTausi Brand Salted Black Beans, 180g (6.34oz), 100 cans/carton This product is in a two piece can with a single seam. This 6.34 oz can is wrapped with a label containing, red, yellow, and black text labeled in part "Tausi Brand Salted Black Beans***Distributed by: V8 Commercial Co, Inc. San Juan, Metro Manila Produc of the Phillipines***Ingredients: Black Beans, water, Iodized salt, sugar and caramel Net wt. 180g(6.34oz)**BB:___"
Code Infoall lots
ClassificationClass III
Reason for RecallWalong is recalling Tausi Brand Salted Black Beans because it may have the potential for pathogen growth and toxin formation due to Clostridium botulinum or other spoilage organisms.
Product Quantity650 cartons
Recall NumberF-1132-2013

Class III Biologics Event

Event ID41155
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Aug-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternIowa
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoLT79278
ClassificationClass III
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed.
Product Quantity1 Unit
Recall NumberB-0703-13

Class III Biologics Event

Event ID42114
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Apr-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSiouxland Community Blood Bank
CitySioux City
StateIA
CountryUS
Distribution PatternNC, FL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info2046257(Part A); 2046257(Part B)
ClassificationClass III
Reason for RecallBlood products, collected from a donor without a documented result for body temperature, were distributed.
Product Quantity2 units
Recall NumberB-0654-13

Class III Biologics Event

Event ID48909
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross
CityPortland
StateOR
CountryUS
Distribution PatternOregon.
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info21KS76848; 21KS76854; 21KS76857
ClassificationClass III
Reason for RecallBlood products, lacking assurance of having been maintained at an acceptable temperature during shipping or storage, were distributed.
Product Quantity3 Components
Recall NumberB-0190-13

Class III Biologics Event

Event ID54963
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Apr-10
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCSL Plasma, Inc.
CityBoca Raton
StateFL
CountryUS
Distribution PatternIllinois.
 

Associated Products

Product DescriptionSource Plasma
Code Info79691994, 79688918, 79681117, 79669337, 79665902, 79652131, 79643740, 79638296, 79632287, 79626439, 79620741, 79612906, 79605069, 79601085, 79594257, 79587846, 79577717, 79565332, 79556729, 79552424, 79545914, 79533102, 79525572, 79520171, 79512305, 79507509, 79499057, 79493970, 79466837, 51575007, 51560096, 51555603, 51547356, 51542252, 51532291, 51528041, 51518271, 51513498, 51505011, 51500313, 51490287, 51485825, 51462581, 51457266, 51446741, 51441777.
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor with a history of high risk behaviors, were distributed.
Product Quantity46 units
Recall NumberB-0705-13

Class III Biologics Event

Event ID58946
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Apr-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionSource Plasma
Code Info3630073785;3630073518;3630072890;3630072647;3630072205;3630071839;3630071293;3630071007;3630070559;3630070320;3630069898;3630069481;3630069198;3630068539;3630068130;3630067782;3630067388;3630067044;3630066659;3630066336;3630065972;3630065728;3630065190;3630065072;3630064636;3630064397;3630063950;3630063687;3630063267;3630062408;630062257;3630061843;3630061630;3630061193;3630060947;3630059940;3630058945;3630058778;3630056492;3630054774;3630054529;3630054303;3630053267;3630052995;3630052699;3630052510;3630049755;3630049615;3630049412;3630049164;3630049011;3630048782;3630048674;3630048440;3630048288;3630047925;3630047765;3630047517;3630047636;3630047017;3630046878
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity61 units
Recall NumberB-0412-13

Class III Biologics Event

Event ID61380
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jan-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityCheyenne
StateWY
CountryUS
Distribution PatternCalifornia, Austria
 

Associated Products

Product DescriptionSource Plasma
Code Info11CWYD2770; 11CWYD2350; 11CWYC4816; 11CWYC4486; 11CWYC3904; 11CWYC3580; 11CWYC3052; 11CWYC2727; 11CWYC1908; 11CWYC1363; 11CWYC1017; 11CWYC0112; 11CWYB9556; 11CWYB9227; 11CWYB8692; 11CWYB7810; 11CWYB8359; 11CWYC2252; 09CWYA7624; 09CWYA8110; 09CWYA8874; 09CWYA9397; 09CWYB0181; 09CWYB0702; 09CWYB1521; 09CWYB2032; 09CWYB2858; 09CWYB3354; 09CWYC0658; 09CWYC1200; 09CWYC2126; 09CWYC2665; 09CWY3564; 09CWY4102; 09CWYC4978; 09CWYD3431; 09CWYD4255; 10CWY5744; 10CWYD6006; 10CWYD6456; 10CWYD6716; 11CWYA8273; 11CWYA8597; 11CWYA9130; 11CWYA9455; 11CWYB0013; 11CWYB0319; 11CWYB08113; 11CWYB1113; 11CWYB1698; 11CWYB2620; 11CWYB2959; 09CWYA4921; 09CWYA5431; 09CWYC5493; 09CWYC6358; 09CWYC6852; 09CWYC7476; 09CWYC8002; 09CWYC9034; 09CWYC9340; 09CWYD0187; 09CWYD0696; 09CWYD1533; 09CWYD2130; 09CWYD2883; 09CWYD5831; 09CWYD6643; 09CWYD7938; 09CWYD8390; 09CWYD9188; 09CWYE0484; 09CWYE0991; 09CWYE1861; 09CWYE3011; 09CWYE3488; 09CWYE4252; 09CWYE4762; 09CWYE5558; 09CWYE6013; 09CWYE6581; 09CWYE7041; 09CWYE9040; 09CWYE9501; 09CWYF0303; 09CWYF0777; 09CWYF2024; 09CWYF3719; 09CWYF4214; 09CWYF5840; 09CWYF6293; 09CWYF7066; 09CWYF7538; 09CWYF8331; 09CWYF8821; 09CWYG0329; 09CWYG1670; 09CWYG1998; 09CWYG2760; 09CWYG3243; 10CWYA0513; 10CWYA0975; 10CWYA1643; 10CWYA2128; 10CWYA2839; 10CWYA3357; 10CWYA4080; 10CWYA6281; 10CWYA6671; 10CWYA7286; 10CWYA8301; 10CWYA8704; 10CWYB1419; 10CWYB1814; 10CWYB2396; 10CWYB2797; 10CWYB3474; 10CWYB3851; 10CWYB4483; 10CWYB4874; 10CWYB5507; 10CWYB5868; 10CWYB6471; 10CWYB6845; 10CWYB7465; 10CWYB7831; 10CWYB8376; 10CWYB8714; 10CWYB9616; 10CWYC0114; 10CWYC0450; 10CWYC0980; 10CWYC1303; 10CWYC2809; 10CWYC3301; 10CWYC3620; 10CWYC4126; 10CWYC4447; 10CWYC4954; 10CWYC5423; 10CWYC5730; 10CWYC6154; 10CWYC6455; 10CWYC6894; 10CWYC8322; 10CWYC8602; 10CWYC8985; 10CWYC9271; 10CWYC9672; 10CWYD0594; 10CWYD0945; 10CWYD1218; 10CWYD1629; 10CWYD1889; 10CWYD2329; 10CWYD2602; 10CWYD3040; 10CWYD3312; 10CWYD3688; 10CWYD3959; 10CWYD4373; 10CWYD5066; 10CWYD5311; 10CWYD7172; 10CWYD7444; 10CWYD7934; 10CWYD8200; 10CWYE0775; 10CWYE1104; 10CWYE1612; 10CWY2161; 11CWYA0319; 11CWYA0642; 11CWYA1424; 11CWYA1931; 11CWYA2250; 11CWYA2819; 11CWYA3155; 11CWYA3649; 11CWYA3954; 11CWYA5205; 11CWYA5495; 11CWYA5941; 11CWYA6227; 11CWYA6687; 11CWYA6972; 11CWYA7434; 11CWYA7750; 11CWYB3569; 11CWYB3922; 11CWYB4495; 11CWYB5456; 11CWYB5815; 11CWYB7439; 11CWYB7810; 11CWYB8359; 11CWYB8592; 11CWYB9227; 11CWYB9556; 11CWYC0112; 11CWYC1017; 11CWYC1363; 11CWYC1908; 11CWYC2252; 11CWYC2727; 11CWYC3052; 11CWYC3580; 11CWYC3904; 11CWYC4486; 11CWYC4816; 11CWYD2350; 11CWYD2770; 11CWYD3451; 11CWYD3863; 11CWYD4518; 11CWYD4907; 11CWYD5539; 11CWYD5919; 11CWYD6541; 11CWYD6921; 11CWYD7625; 11CWYD8019; 11CWYD8692; 11CWYD9091; 11CWYD9796; 11CWYE0230; 11CWYE0959; 11CWYE1739; 11CWYE2332; 11CWYE3085; 11CWYE3502; 11CWYE5524; 11CWYE6761; 11CWYE7153; 11CWYE7803; 11CWYE8199
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity236 units
Recall NumberB-0706-13

Class III Biologics Event

Event ID63835
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Sep-12
Initial Firm Notification of Consignee or Public Other
Recalling FirmMemorial Blood Centers
CitySaint Paul
StateMN
CountryUS
Distribution PatternMichigan
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW051512089599;
ClassificationClass III
Reason for RecallBlood product, collected in an expired collection bag, was distributed.
Product Quantity1
Recall NumberB-0685-13

Class III Biologics Event

Event ID63836
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Oct-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmHCSC-Blood Center
CityBethlehem
StatePA
CountryUS
Distribution PatternPennsylvania
 

Associated Products

Product DescriptionRed Blood Cells Washed
Code InfoW050912080799; W050912079977;
ClassificationClass III
Reason for RecallBlood Products, washed with 1.6% sodium chloride during deglycerolization, were distributed.
Product Quantity2
Recall NumberB-0677-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated Washed
Code InfoW050912082047; W050912079718; W050912067108;
ClassificationClass III
Reason for RecallBlood Products, washed with 1.6% sodium chloride during deglycerolization, were distributed.
Product Quantity3
Recall NumberB-0678-13

Class III Biologics Event

Event ID63888
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Oct-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmLifeSouth Community Blood Centers Inc
CityHuntsville
StateAL
CountryUS
Distribution PatternAlabama
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW1151123080944;
ClassificationClass III
Reason for RecallBlood product, collected from a donor who reported post donation illness, was distributed.
Product Quantity1
Recall NumberB-0691-13

Class III Drugs Event

Event ID64041
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jan-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAstraZeneca LP
CityWestborough
StateMA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionPULMICORT RESPULES 0.25 mg/2 ml Budesonide Inhalation Suspension (30 ampules/carton) NDC: 0186-1988-04
Code InfoLot/Exp date: AH0054 Exp 5/14; AK0125 Exp 7/14
ClassificationClass III
Reason for RecallDoes Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Product Quantity28,476 cartons
Recall NumberD-198-2013
Product DescriptionPULMICORT RESPULES 0.5 mg/2 ml (30 ampules/carton) Budesonide Inhalation Suspension NDC: 0186-1989-04
Code InfoLot/Exp Date: YP0035 11/13; YP0140 12/13; YP0136 12/13; AB0077 2/14; AH0133 5/14
ClassificationClass III
Reason for RecallDoes Not Meet Monograph: Budesonide may be slightly above or below the specification range.
Product Quantity64675 cartons
Recall NumberD-199-2013

Class III Devices Event

Event ID64063
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Dec-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Healthcare Diagnostics, Inc.
CityNewark
StateDE
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionSiemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test intended to quantitatively measure Total Iron Binding Capacity in human serum.
Code InfoSiemens Material Number (SMN) 10444944, Catalog number DF84 -- lot numbers BA3016, EXP 2013-01-16; EC3045, EXP 2013-02-14; EA3073, EXP 2013-03-14; DC3102, EXP 2013-04-12; FC3122, EXP 2013-05-02; EA3157, EXP 2013-06-06; BB3184, EXP 2013-07-03; EC3219, EXP 2013-08-07; EC3220, EXP 2013-08-08; GA3248, 2013-09-05; and FB3290, EXP 2013-10-17
ClassificationClass III
Reason for RecallThe analytical sensitivity claim of 6 ug/dL (1.1 umol/L) in the Instructions for Use (IFU) is no longer valid. Siemens is conducting a voluntary corrective action for Dimension Total Iron Binding Capacity (IBCT) to modify the analytical sensitivity claim to 36 ug/dL (6.44 umol/L).
Product Quantity19, 503 cartons
Recall NumberZ-0933-2013

Class III Food Event

Event ID64156
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmJMT Trading Company, Inc.
CitySouth San Francisco
StateCA
CountryUS
Distribution PatternCA Bay area and one location in HI.
 

Associated Products

Product DescriptionTausi Salted Black Beans, 180 gram (6.34 oz.) can. Ingredient: Black Beans, Water, Iodized salt, sugar and caramel. Distributed by V8 Commercial Co., Inc., San Juan, Metro Manila. Product of the Philippines. UPC 97399 00109
Code InfoBB:FEB.15, 2013; BB:APR.26, 2013; BB:FEB 15, 2014; BB: APR.11,2013.
ClassificationClass III
Reason for RecallReports were received of swollen cans of Tausi Salted Black Beans imported from the Philippines.
Product Quantity270 Cartons (100 cans per carton) have been imported since May 2011.
Recall NumberF-1130-2013

Class III Drugs Event

Event ID64266
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFresenius Kabi USA LLC (FK USA)
CitySchaumburg
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionCALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10
Code InfoLot 6004889, Expiration Date 10/2014
ClassificationClass III
Reason for RecallLabeling: Missing label
Product Quantity155,900 vials domestically
Recall NumberD-200-2013

Class III Food Event

Event ID64281
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmPhil-Am Trading, Inc.
CityJersey City
StateNJ
CountryUS
Distribution Pattern74 customers mainly located in NJ, NY and Pennsylvania.
 

Associated Products

Product DescriptionTausi Brand Salted Black Beans. Net Weight 180g (6.34 oz). Distributed by: V8 Commercial Co., Inc. San Juan, Metro Manila. Product of the Philippines.
Code InfoUPC 897399001097; Best by: BB Sep 21 2010.
ClassificationClass III
Reason for RecallThis recall has been initiated due to suspected but, as of the writing of this letter (1/17/2013), unconfirmed Clostridium botulinum (C. botulinum) contamination.
Product Quantity247 Cartons (100 cans per carton).
Recall NumberF-1133-2013

Class III Food Event

Event ID64295
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFarmers Cooperative Creamery
CityMcMinnville
StateOR
CountryUS
Distribution PatternProduct was directly distributed in California, Oregon, and Washington.
 

Associated Products

Product DescriptionSalted Print Butter, Rose Valley brand. Product is packaged in 1 lb. unit package, 36 units per case. The UPC is 0 32395 09322 0. The product is labeled in parts: "***ROSE VALLEY***SWEET CREAM BUTTER***NET WT. 16OZ***MFD. BY FARMERS CO-OPERATIVE CREAMERY***McMINNVILLE***ORE***97128***AA GRADE***KEEP REFRIGERATED***INGREDIENTS: CREAM (MILK), SALT***".
Code InfoCH 024-13. Expiration 10/30/13
ClassificationClass III
Reason for RecallSalted Print Butter, Rose Valley brand, is recalled. The Appendix N procedure was not followed and the firm used the milk to process into butter without the confirmation negative antibiotic test result.
Product Quantity9,900 lbs (or 275 cases, 36 lb. per case)
Recall NumberF-1193-2013

Class III Biologics Event

Event ID64387
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmImmucor Inc
CityNorcross
StateGA
CountryUS
Distribution PatternNationwide, Canada, Columbia, England, Germany, Japan, Norway, Peru, South Africa, and South Korea.
 

Associated Products

Product DescriptionWB corQC 4.5 mL vials
Code InfoLots 236154, 236154A, Exp. Date 2013-02-07
ClassificationClass III
Reason for RecallImmucor WB corQC, associated with complaints of hemolysis, was distributed.
Product Quantity2
Recall NumberB-1096-13

Mixed Classification Food Event

Event ID63733
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Nov-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBakery Cash & Carry Inc.
CityPonce
StatePR
CountryUS
Distribution PatternPuerto Rico only
 

Associated Products

Product DescriptionRaspberry Flavor
Code Infono code
ClassificationClass III
Reason for RecallThe firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Red #40 and Blue #1
Product Quantity240 units
Recall NumberF-1070-2013
Product DescriptionButter Flavor
Code Infono code
ClassificationClass II
Reason for RecallThe firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Yellow#5, Yellow #6 and Red #40
Product Quantity
Recall NumberF-1071-2013
Product DescriptionButter Cream
Code Infono code
ClassificationClass II
Reason for RecallThe firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: The ingredient partially hydrogenated vegetable oil contains soybean oil as a sub-ingredient.
Product Quantity3,360 units
Recall NumberF-1072-2013
Product DescriptionBrandy flavor
Code Infono code
ClassificationClass II
Reason for RecallThe firm re-packs the bulk product for retail sale without labeling, just the name of the product handwritten. Therefore, the label does not declare allergens: FD&C Red #40, Yellow#5, Yellow #6, Blue#1 and Sulfites.
Product Quantity3,360 units
Recall NumberF-1073-2013
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