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U.S. Department of Health and Human Services

Enforcement Report - Week of November 21, 2012

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Class I Food Event

Event ID63343
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmFreshPoint South Florida
CityPompano Beach
StateFL
CountryUS
Distribution PatternFL, NJ and US Virgin Islands Barbados, St. Kitts, Dutch Antilles and Aruba
 

Associated Products

Product Description***Fresh Point***Fresh Cuts***Service Salsa Mango***2 x 5lb Tray***Net Wt. 50 lb.***
Code InfoItem # 302940 - Used by date 08/04 though 08/17 or Julian production date 215 through 230
ClassificationClass I
Reason for RecallCoast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & vegetables are conducting a voluntary product recall of "KENT'S" & "KEITT'S" mangos packed at AGRICOLA DANIELLA.
Product Quantity5 cases
Recall NumberF-0699-2013
Product Description***Fresh Point***Fresh Cuts***Fruit Mango/Papaya Diced***2 x 5lb Tray***Net. Wt. 10 lb.***
Code InfoItem # 300735 - Used by date 08/04 though 08/17 or Julian production date 215 through 230
ClassificationClass I
Reason for RecallCoast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & vegetables are conducting a voluntary product recall of "KENT'S" & "KEITT'S" mangos packed at AGRICOLA DANIELLA.
Product Quantity1 case
Recall NumberF-0700-2013
Product Description***Fresh Point***Fresh Cuts***Salsa Mango and Papaya*** 2 x 5lb Tray***Net Wt. 10 lb.***
Code InfoItem # 302942- Used by date 08/04 though 08/17 or Julian production date 215 through 230
ClassificationClass I
Reason for RecallCoast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & vegetables are conducting a voluntary product recall of "KENT'S" & "KEITT'S" mangos packed at AGRICOLA DANIELLA.
Product Quantity1 case
Recall NumberF-0701-2013
Product Description***Fresh Point***Fresh Cuts***Retail Mango Sliced***6 X 8oz Cups Packages***Net Wt. 27 lb.***
Code InfoItem # 301348 - Used by date 08/04 though 08/17 or Julian production date 215 through 230
ClassificationClass I
Reason for RecallCoast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & vegetables are conducting a voluntary product recall of "KENT'S" & "KEITT'S" mangos packed at AGRICOLA DANIELLA.
Product Quantity9 cases
Recall NumberF-0702-2013
Product DescriptionFresh Mango peeled and cut into cubes, slices, or halves labeled as listed: ***Fresh Point***Fresh Cuts***Food Service Fruit Mango PLD Cubed 1/2***2 x 5lb Tray***Net Wt. 310 lb.*** ***Fresh Point***Fresh Cuts***Food Service Fruit Mango Peeled / Halved***2 X 2.5 lb Tray***Net Wt. 245 lb.*** ***Fresh Point***Fresh Cuts***Food Service Fruit Mango PLD/Sliced***2 x 5lb Tray***Net Wt. 30 lb.*** ***Fresh Point***Fresh Cuts***Food Service Fruit Mango PLD/Cubed 1***2 x 5lb Tray***Net Wt. 30 lb.
Code InfoItem # 380780, 300825, 300810, 300760 - Used by date 08/04 though 08/17 or Julian production date 215 through 230
ClassificationClass I
Reason for RecallCoast Citrus Distributors, Inc. and its divisions Coast Tropical and Olympic Fruit & vegetables are conducting a voluntary product recall of "KENT'S" & "KEITT'S" mangos packed at AGRICOLA DANIELLA.
Product Quantity85 cases
Recall NumberF-0703-2013

Class I Food Event

Event ID63443
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-12
Initial Firm Notification of Consignee or Public Email
Recalling FirmSuper Store Industries
CityTurlock
StateCA
CountryUS
Distribution PatternAlbertsons retail stores in OR, UT, WA, ID, MT and Walmart stores in WA only.
 

Associated Products

Product DescriptionIce Cream - label reads in part "*** Lovin' SCOOPFUL CHURNED LIGHT ICE CREAM *** SUPER DUPER PEANUT BUTTER CUP***
Code Infoall codes
ClassificationClass I
Reason for RecallThe firm received product from a raw material supplier which was recalled by Sunland, Inc. the raw material has the potential to be contaminated with Salmonella
Product Quantity1400 cs (6 units/cs) each unit =1.75 qt
Recall NumberF-0659-2013

Class I Food Event

Event ID63448
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAdvance Pierre N
CityWooster
StateOH
CountryUS
Distribution PatternU.S. Nationwide
 

Associated Products

Product DescriptionPierre Peanut Butter & Grape Jelly on White Bread, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 71421921205, Lot Codes: 1080123, 1080589 & 2040471, Exp dates: 5/12/12, 5/18/12 & 1/21/13; Lot Codes: 1070182, 1070188, 107018A, 1070205, 1080079, 1080590, 1080631, 2020626 & 2030538 and Lot Codes: 1070232, 1080112, 1080120, 1080576, 1090133.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0660-2013
Product DescriptionPierre Peanut Butter & Strawberry Jelly on White Bread, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 71421921212, Lot Code: 1080124, Exp date: 5/29/12.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0661-2013
Product DescriptionPierre Peanut Butter & Grape Jelly on Whole Grain, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 75999110047, Lot Codes: 1070195, 1070209 & 1090328, Exp dates: 8/14/12, 9/2/12 & 9/7/12 and Lot Codes: 1070189, 1070197, 1070206, 1070471, 1070535, 1080080, 1080125, 1080314, 1080505, 1080865, 1090039, 1090086, 1090131, 1090289, 2020162, 2020638, 2030158, 2030335 & 2030839.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0662-2013
Product DescriptionPierre Peanut Butter & Jelly Squarewich, 2.70oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 75999210051, Lot Code: 2030322, Exp. date: 12/5/12.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0663-2013
Product DescriptionPB & J Jamz, 2.80oz., Distributed by: AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 605388670137, Lot Codes: 1070172, 1070178, 1070191, 1070192, 1070193, 1070207, 1070208, 1070507, 1070630, 1080001, 1080150, 1080322, 1080728, 1080834, 1080835, 1090001, 1090127, 2020624, 2030324, 2030339, 2040147, 2040214 & 2040604, Exp. dates: 4/12/12, 4/14/12, 4/24/12, 5/2/12, 5/3/12, 5/23/12, 5/22/12, 4/13/12, 4/28/12, 4/27/12, 5/28/12, 5/21/12, 5/24/12, 5/21/12, 6/4/12, 5/25/12, 5/29/12, 1/19/13, 12/5/12, 12/8/12, 1/6/13, 1/20/13 & 1/21/13.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0664-2013
Product DescriptionPierre Jamwich Crustless Peanut Butter & Jelly Sandwich, 2.8oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 75999112805, Lot Code: 2030545, Exp. date: 1/7/13.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0665-2013
Product DescriptionPierre Peanut Butter & Strawberry Jelly on White, 8/12PK, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 75999213687, Lot Code: 1080122, Exp. date: 5/2/12.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0666-2013
Product DescriptionMarket Day, Peanut Butter & Jelly Grahamwich, 12/2.20oz., Manufactured for: Market Day, Inc., Itasca, IL 60143.
Code InfoUPC Code: 75999213748, Lot Codes: 1080571, 1080667, 1080825 & 2030374, Exp. dates: 5/14/12, 5/28/12, 6/5/12 & 12/31/12.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0667-2013
Product DescriptionPierre On The Go PB Jamwich Honey, 2.00oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 75999213393, Lot Codes: 1070174, 1070214, 1070241, 1070610, 1070658 & 1080292, Exp. dates: 4/16/12, 5/15/12, 4/18/12, 4/17/12, 4/19/12 & 5/1/12.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0668-2013
Product DescriptionPierre On The Go PB Jamwich Grape, 2.00oz, Pierre On The Go PB Jamwich Grape, 2.00oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 759992133946, Lot Codes: 1070533, 1070534, 1080053, 1080054, 1080646 & 1080855, Exp. dates: 4/22/12, 4/23/12, 5/1/12, 4/30/12, 5/17/12 & 5/21/12.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0669-2013
Product DescriptionPB & Grape Jamwich, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 75999613968, Lot Codes: 1070180, 1070181, 1070316, 1070466, 1070467, 1070468, 1070469, 1070547, 1080048, 1080305, 1080570, 1090087, 2020071 & 2020629, Exp. dates: 4/27/12, 4/26/12, 4/13/12, 5/7/12, 5/8/12, 5/20/12, 5/19/12, 4/15/12, 4/28/12, 5/28/12, 5/27/12, 6/5/12, 12/4/12 & 1/7/13.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0670-2013
Product DescriptionPB & Grape Jelly on Whole Grain Graham Wafers, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 75999200595, Lot Code: 2050305, Exp. date: 2/12/13 and Lot Codes: 1080651, 1080813, 1090278 & 2020608.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0671-2013
Product DescriptionPierre Peanut Butter Cup, 1.11oz., AdvancePierre, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 462476.
Code InfoLot Codes: 1080118, 1080295, 1090009, 2020043, 2020645, 2030820 & 2030822.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0672-2013
Product DescriptionPierre Peanut Butter & Grape Jelly Cups., 1.50oz. and 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoLot Code: 1070233 (1.50oz) and Lot Codes: 1070485, 2020046, 2030542, 2030818 & 2030819 (2.80oz).
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0673-2013
Product DescriptionPierre Peanut Butter & Straw Jam on Whole Grain, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoLot Codes: 1080731, 1090099 & 1090132.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0674-2013
Product DescriptionPeanut Butter & Jelly on Graham Wafers, 2.20oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoLot Codes: 1070218-1070220, 1070748, 1070753, 1070756, 1070799, 1070829, 1080129, 1080130, 1080132-1080135, 1080293, 1080466, 1080572, 1080573, 1080575, 1080734, 1080814-1080816, 1080905, 1080906, 1090057, 1090139, 1090222, 1090280, 1090391, 1090612, 2020057, 2020058, 2020612, 2020613, 2020615-2020618, 2030544, 2030860, 2040181, 2040183-2040186 & 2050260.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0675-2013
Product DescriptionPierre Peanut Butter & Straw. Jam on White Bread, 2.80oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoLot Codes: 107017A, 1070465 & 1080437.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0676-2013
Product DescriptionPierre Peanut Butter Jamwich & Banana on Whole Grain Bread, 2.80oz., AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoLot Code: 1070194.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0677-2013
Product DescriptionPierre On The Go Peanut Butter + Strawberry Jam, Jamwich, 2.00oz, AdvancePierre Foods, Inc., 9990 Princeton Glendale Road, Cincinnati, OH 45246.
Code InfoUPC Code: 75999213392, Lot Codes: 1070175, 1070186, 1070200, 1070659 & 1080671, Exp. dates: 4/21/12, 4/29/12, 5/16/12, 4/20/12 & 5/17/12.
ClassificationClass I
Reason for RecallProducts were manufactured with peanut butter products recalled by Sunland, Inc. found to be contaminated with Salmonella.
Product Quantity3.2 Million lbs. (total for all products)
Recall NumberF-0678-2013

Class I Food Event

Event ID63452
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSconza Candy Company, Inc.
CityOakdale
StateCA
CountryUS
Distribution PatternProduct was only sold to one customer, Chris Candies, 1557 Spring Garden Avenue Pittsburg, PA 15212
 

Associated Products

Product DescriptionOrganic Toffee Peanuts;Bulk packaging - 20 pound cases; Ingredients: Organic Peanuts, Organic Sugar, Salt.
Code InfoItem No, 600-72445 Lot No: 100401, 100402, 100514, 100624, 100907, 100908, 101112, 101115, 110413, 110614, 110718.
ClassificationClass I
Reason for RecallSconza Candy Company is recalling organic toffee peanuts that were manufactured with peanuts from Sunland which are under recall because of the possibility of Salmonella contamination.
Product Quantity35,660 pounds
Recall NumberF-0656-2013

Class I Food Event

Event ID63477
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmBucks Ice Cream
CityMilford
StateCT
CountryUS
Distribution PatternCT, NY and NJ
 

Associated Products

Product DescriptionIskream brand Peanut Butter and Jelly No Sugar Added, reduced fat, packaged in Pint (retail) an 2.5 gallon bulk cartons
Code InfoAll lot codes
ClassificationClass I
Reason for RecallIce Cream manufactured with Sunland recalled peanut butter has the potential to be contaminated with salmonella
Product Quantity592 Cases cases (8 pack-pint) and 4 /2.5 Gallon
Recall NumberF-0679-2013

Class I Food Event

Event ID63478
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmKennys Farmhouse Cheese
CityAustin
StateKY
CountryUS
Distribution PatternKY, TN, FL, IL, VA, OH
 

Associated Products

Product DescriptionKentucky Rose, blue cheese Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel Packaging could be vacuum packed bags, paper wrap, or plastic wrap
Code InfoKentucky Rose, blue cheese Lot #120531
ClassificationClass I
Reason for RecallDue to possible Listeria monocytogenes contamination
Product Quantity139.19lbs
Recall NumberF-0691-2013
Product DescriptionKentucky Blue, bleu cheese Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel Packaging could be vacuum packed bags, paper wrap, or plastic wrap
Code InfoLot 120531 Lot 120612
ClassificationClass I
Reason for RecallDue to possible Listeria monocytogenes contamination
Product Quantity77.78lbs
Recall NumberF-0692-2013
Product DescriptionAwe Brie Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel Packaging could be vacuum packed bags, paper wrap, or plastic wrap
Code InfoLot 120716 Lot 120629 Lot 120614
ClassificationClass I
Reason for RecallDue to possible Listeria monocytogenes contamination
Product Quantity71.06lbs
Recall NumberF-0693-2013
Product DescriptionTomme de Nena Sizes could be 8oz packages, 1.5lbs packages, 3.5lbs packages, 7lbs packages, or 15lb wheel Packaging could be vacuum packed bags, paper wrap, or plastic wrap
Code InfoLot 120716 Lot 120614
ClassificationClass I
Reason for RecallDue to possible Listeria monocytogenes contamination
Product Quantity63.67lbs
Recall NumberF-0694-2013

Class I Food Event

Event ID63480
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmDean Foods Company
CityDallas
StateTX
CountryUS
Distribution PatternSold by retailers in AZ, CA, CO, ID, MT, ND, NV, OR, UT, WA, and WY.
 

Associated Products

Product DescriptionAlbertsons Peanut Butter Cup Ice Cream, 1.5 QTS (1.42 L)(vanilla ice cream with peanut butter cup pieces, fudge and peanut butter swirls)
Code InfoUPC 41163 45891, any Best By or EXP dates ranging from 4/06/2011 to 9/25/2013, Plant Code 49-11 or 06-20.
ClassificationClass I
Reason for RecallProduct was manufactured using an ingredient that was recalled due to Salmonella contamination.
Product Quantity135,597 x 1.5 QTS
Recall NumberF-0685-2013
Product DescriptionAlbertsons Peanut Butter Chocoate Ice Cream, 1.5 QTS (1.42 L), (chocolate ice cream with a peanut butter swirl)
Code InfoUPC 41163 45903, any Best By or EXP dates ranging from 3/26/2011 to 8/03/2013, Plant Code 49-11 or 06-20.
ClassificationClass I
Reason for RecallProduct was manufactured using an ingredient that was recalled due to Salmonella contamination.
Product Quantity67,781 x 1.5 QTS
Recall NumberF-0686-2013
Product DescriptionWestern Family "Creamery Select" Premium Ice Cream Peanut Butter Cup, 1.5 QTS (1.42 L), (vanilla ice cream with peanut butter cup pieces, fudge swirl, and peanut butter ribbon)
Code InfoUPC 15400 21432, any Best By dates ranging from 9/09/2011 to 10/03/2013, Plant Code 49-11.
ClassificationClass I
Reason for RecallProduct was manufactured using an ingredient that was recalled due to Salmonella contamination.
Product Quantity82,444 x 1.5 QTS
Recall NumberF-0687-2013

Class I Food Event

Event ID63489
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmToft Dairy Inc
CitySandusky
StateOH
CountryUS
Distribution Pattern3 Distributors 211 Retailers
 

Associated Products

Product DescriptionPrime Time brand Buckeye Bites Ice Cream in a paper carton 48 oz containers and 3 gallon tubs
Code InfoLot codes between Feb 11 2012 and Mar 14 2013
ClassificationClass I
Reason for RecallProduct was manufactured using an ingredient that was recalled due to Salmonella contamination.
Product Quantity15,600-48oz cartons and 1,482 3 gallon tubs
Recall NumberF-0683-2013

Class I Food Event

Event ID63493
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Oct-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPublix Corporate Office
CityLakeland
StateFL
CountryUS
Distribution PatternProduct was distributed to Publix Distribution centers and stores in FL, AL, TN, GA, and SC.
 

Associated Products

Product DescriptionFrozen Publix Brand Premium Tempura Shrimp, 11 oz box packed 10 boxes per case.
Code InfoProduction Codes: 668/30WI, 668/01DI, 668/03DI, 668/04DI, 668/06DI, 668/08DI, 668/10DI, 668/11DI, 668/13DI, 668/15DI, 668/18DI, 668/20DI
ClassificationClass I
Reason for RecallOn 10/16/2012, Publix Super Markets, Inc. recalled their Publix Premium Tempura Shrimp because it was discovered that a dipping sauce packet was included in the box with the shrimp. The sauce contains undeclared soy.
Product Quantity2, 670 cartons
Recall NumberF-0688-2013

Class I Food Event

Event ID63582
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Oct-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmB.T. McElrath Chocolatier, Inc
CityMinneapolis
StateMN
CountryUS
Distribution PatternMN, CA, FL, WA, IL, AK, MA.
 

Associated Products

Product DescriptionPeanut Butter Pave, UPC code 693868102117 & 69386905312, in the following sizes: 1) 5 Piece Peanut Butter Pave, 63 Grams per pack, 12 Packs per case. 2) 2 Piece Peanut Butter Pave, 26 Grams per pack, 10 Packs per case. 3) Bulk Peanut Butter Pave, 415 Grams per pack.
Code InfoLot #'s 12031, 12046, 12159, 12201
ClassificationClass I
Reason for RecallThe product has the potential to be contaminated with Salmonella.
Product Quantity6500 pieces
Recall NumberF-0689-2013

Class II Biologics Event

Event ID40107
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Apr-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CitySaint Louis
StateMO
CountryUS
Distribution PatternPR, MO, PA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info11FM83788, 11GR40841
ClassificationClass II
Reason for RecallBlood products, collected from a donor who lived in the past 3 years in an area considered endemic for malaria, were distributed.
Product Quantity2 unit
Recall NumberB-0017-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info11GR40841
ClassificationClass II
Reason for RecallBlood products, collected from a donor who lived in the past 3 years in an area considered endemic for malaria, were distributed.
Product Quantity1 unit
Recall NumberB-0018-13

Class II Biologics Event

Event ID40170
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-May-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternTN, MO, IL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info011FF83187; 11KS06248
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity2 units
Recall NumberB-0011-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info011FF83187
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity1 unit
Recall NumberB-0012-13

Class II Biologics Event

Event ID41421
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Dec-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CitySaint Louis
StateMO
CountryUS
Distribution PatternPR and MO
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info11KS06480; 11KS04232; 11KS00538; 11KS08264; 11FF95935; 11KS05443, 11FF97614
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity7 units
Recall NumberB-0026-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info11KS00538
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-0027-13

Class II Biologics Event

Event ID42476
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01LG82416
ClassificationClass II
Reason for RecallBlood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-0013-13
Product DescriptionPlasma Frozen
Code Info01LG82416
ClassificationClass II
Reason for RecallBlood product, collected from a donor in whom donor suitability was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-0014-13

Class II Biologics Event

Event ID42632
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jul-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityCheyenne
StateWY
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info06CWYA9738; 06CWYA9965
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had been incarcerated, were distributed.
Product Quantity2 units
Recall NumberB-0019-13

Class II Biologics Event

Event ID44175
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jan-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmZLB Bioplasma, Inc.
CitySalt Lake City
StateUT
CountryUS
Distribution PatternGermany
 

Associated Products

Product DescriptionSource Plasma
Code Info6270545251
ClassificationClass II
Reason for RecallBlood product, collected from a donor who received a tattoo within 12 months of donation, was distributed.
Product Quantity1 unit
Recall NumberB-0020-13

Class II Biologics Event

Event ID44635
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Feb-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBioLife Plasma Services L.P.
CityLaramie
StateWY
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionSource Plasma
Code Info04LWYC8378; 04LWYC9513
ClassificationClass II
Reason for RecallBlood product, collected from a donor who received a mumps, measles , rubella (MMR) vaccination, was distributed
Product Quantity2 units
Recall NumberB-0023-13

Class II Biologics Event

Event ID46650
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Nov-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmDCI Biologicals Wilmington, Inc.
CityWilmington
StateNC
CountryUS
Distribution PatternPA & England
 

Associated Products

Product DescriptionSource Plasma
Code InfoWN0111902, WN0112085, WN0112669, WN0112932, WN0113477, WN0113681
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor with a history of high risk behavior, were distributed.
Product Quantity6 units
Recall NumberB-0016-13

Class II Biologics Event

Event ID48349
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Mar-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmCSL Plasma, Inc
CityCharleston
StateSC
CountryUS
Distribution PatternIL, NC, Switzerland & Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info0440717563, 0440713681, 0440713230, 0440712609, 0440712115, 0440710890, 0440710577, 0440709938, 0440709495. 0440708625, 0440707487, 0440706213, 0440705292, 0440705095, 0440704240, 0440703417, 0440703076, 0440702360, 0440702102, 0440701110, 0440700493, 0440700055, 0440699483, 0440698945, 0440698119, 0440685470, 0440684962, 0440684518, 0440684078, 0440683544, 0440682994, 0440682511, 0440681992, 0440681513, 0440681001, 0440680529, 0440680040, 0440679541, 0440679061, 0440678588, 0440678117, 0440677686, 0440677207, 0440676730, 0440676310, 0440675859, 0440675386, 0440674933, 0440674463, 0440673998, 0440673580, 0440673127, 0440672760, 0440672365, 0440671941, 0440671419, 0440671000, 0440670465, 0440670110, 0440669519, 0440669298, 0440668072, 0440667731, 0440665974, 0440665434, 0440664800, 0440664592, 0440663832, 0440663209, 0440662780, 0440662226, 0440661794, 0440661265, 0440660962, 0440659944, 0440657030, 0440651153, 0440649798, 0440649241, 0440648922, 0440647941, 0440647344, 0440646973, 0440646377, 0440645582, 0440645308, 0440644618, 0440644470, 0440643572, 0440643294, 0440642620, 0440642361, 0440641452, 0440640879, 0440639985, 0440639863, 0440639074, 0440637987, 0440637239, 0440637117, 0440636419, 0440636295, 0440635471, 0440634714, 0440634460, 0440633683, 0440632910, 0440632741, 0440632201, 0440631992, 0440631364, 0440631231, 0440630630, 0440630452, 0440629894, 0440629221, 0440628449, 0440627734, 0440627085, 0440626658, 0440626456, 0440626072
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity122 units
Recall NumberB-0021-13

Class II Biologics Event

Event ID49627
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jul-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternKS, TX
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02GC02139;02LC96551;02LC92860
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity3 units
Recall NumberB-0010-13

Class II Devices Event

Event ID53336
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDako North America Inc.
CityCarpinteria
StateCA
CountryUS
Distribution PatternNationwide distribution: USA including states of: AK, CA, CO, CT, DC, FL, GA, HI, IA, IL IN, KS, KY, MA, MD, MI, MN, MO, NE, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, and WA.
 

Associated Products

Product DescriptionPT Link Waterbath, Model#PT100. Lab Vision PT Module Plus provides an automated standarized alternative to labor intensive and time consuming dewaxing and epitote retrieval procedures.
Code InfoCatalog #: PT-Module
ClassificationClass II
Reason for RecallDako is recalling the PT Link Waterbath because of a possible electrical hazard. Specifically, if the heater pad under the reagent tank becomes wet, it may present an electrical shock hazard when the lid is open.
Product Quantity136 units
Recall NumberZ-0287-2013

Class II Biologics Event

Event ID54951
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jan-10
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCsl Plasma Inc
CityBoca Raton
StateFL
CountryUS
Distribution PatternIllinois, Switzerland, Germany
 

Associated Products

Product DescriptionSource Plasma
Code Info4100020301, 4100015238, 4100015014, 10GKTWNC, 10GKTQBZ, 10GKTPDP, 10GKTMVJ, 10GKTLDC, 10GKTJBF, 10GKSZZM, 10GKSSSK, 10GKSRLN, 10GKSQFD, 10GKSNXC, 10GKSNHC, 4100008642, 4100008400, 4100007605, 4100002901, 10GKTRFK, 10GKRNQY, 4100007167, 4100006935, 4100006713, 4100006485, 4100006232, 4100005974, 4100004309, 4100004145, 10GKWQHS, 10GKWJVP, 10GKWKYL, 10GKWKMV, 10GKWJZY, 10GKVFYH, 10GKTBPS, 10CCRKNT, 10CCRJFR, 10CCRHBK, 10CCRGNP, 10CCRFXW, 10CCNZPS, 10CCNYVV, 10CCNXBX, 10CCNWKB, 10CCNVFS, 10CCNTHY, 10CCNSVS, 10GKTKDC, 10GKTHJK, 10GKTGRS, 10GKTDTW, 10GKTCCB, 10GKSTWG, 10GKSSJD, 10GKSQMB, 10GKSPYJ, 10GKSNNX, 10GKSNDT, 10GKSLPP, 10GKSLDH, 10GKSJFP, 10GKSGTB, 10GKRRLR, 10GKRQRZ, 10GKRMCC, 10GKRLGP, 10GKRJWD, 10GKRGPB, 10GKVCGG, 10GKVCDW, 10GKVCDG, 10GKVCCP, 10GKVCCG, 10GKVCBY, 10GKVCBT, 10GKVBYT, 10GKVBYJ, 10GKVBXT, 10GKVBXD, 10GKVBWV, 10GKVBVL, 10GKVBVC, 10GKTLHJ, 10GKTLGY, 10GKTLGK, 10GKTLFY, 10GKTLFN, 10GKTLFJ, 10GKTLFC, 10GKTLDY, 10GKTJLX, 10GKRPDX, 10GKSWMW, 10GKSJVQ, 10GKRSWN, 10GKHSNQ, 4100006257, 4100006076, 4100005019, 4100003913, 4100003803, 10GKSYDL, 10GKSXCW, 10GKSVKP, 10GKSBVR, 10GKRJCK, 10GKRFTJ, 10GKRDBW, 10GKRCLX, 10GKQPFK, 10GKQNHS, 10GKLHFZ, 10GKLGVM, 10GKLGJB, 10GKLFZC, 10GKLFNN, 10GKLFDW, 10GKLCFM, 10GKHPWM, 10GKHMBV, 10GKHLCQ, 4100156872, 4100151758, 4100150927, 4100141878, 4100137061, 4100127585, 4100126419, 4100120439, 4100119881, 4100118519, 4100118007, 4100116970, 4100116514, 4100115441, 4100114900, 4100113815, 4100113349, 4100111916, 4100110597, 4100109862, 4100109007, 4100107967, 4100107501, 4100106084, 4100104664, 4100104291, 4100101988, 4100101449, 4100100414, 4100098679, 4100094674, 4100092636, 4100092205, 4100087219, 4100086607, 4100081023, 4100079792, 4100078847, 4100277794, 4100270271, 4100269106, 4100266590, 4100265754, 4100261616, 4100258493, 4100254860, 4100252259, 4100243551, 4100240483, 4100239427, 4100225861, 4100224644, 4100262143, 4100256311, 4100253204, 4100250514, 4100248982, 4100247971, 4100245826, 4100243716, 4100242583, 4100241044, 4100240416, 4100238766, 4100238000, 4100233565, 4100231984, 4100230944, 4100229062, 4100227937, 4100226722, 4100225148, 4100224432, 4100222519, 4100221736, 4100219984, 4100218408, 4100217636, 4100215329, 4100213387, 4100212640, 4100210907, 4100209118, 4100208375, 4100206465, 4100204467, 4100203490, 4100200989, 4100199736, 4100198859, 4100197922, 4100196096, 4100195185, 4100194296, 4100192490, 4100191646, 4100190418, 4100189227, 4100188444, 4100187217, 4100186284, 4100184961, 4100184493, 4100183070, 4100182705, 4100181083, 4100180783, 4100173360, 4100169528, 4100168563, 4100167197, 4100166737, 4100165418, 4100164993, 4100163671, 4100162976, 4100162010, 4100160973, 4100160435, 4100159186, 4100158643, 4100157442, 4100156927, 4100155318, 4100154310, 4100153322, 4100152694, 4100150514, 4100149690, 4100148262, 4100147759, 4100146482, 4100146016, 4100143921, 4100142681, 4100142116, 4100004857
ClassificationClass II
Reason for RecallBlood products, collected from deferred donors, were distributed.
Product Quantity259 units
Recall NumberB-0034-13

Class II Devices Event

Event ID62733
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY; and countries of: ARGENTINA, AUSTRALIA, BANGLADESH, BRAZIL, CALI COLOMBIA, CALLO PERU, GERMANY, GUAYQUIL ECUADOR, HONG KONG, INDIA, INDONESIA, JAPAN, LEBANON, MADRID SPAIN, MEXICO, NEW ZEALAND, SANTIAGO, SANTIAGO CHILE, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, TAIWAN, THAILAND, and UNITED ARAB EMIRATES (UAE).
 

Associated Products

Product DescriptionPerfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Infocatalog number: 16400 serial numbers: 1001-1141, 1143-1274,1333
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues.
Product Quantity274
Recall NumberZ-0280-2013
Product DescriptionPerfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Infocatalog number: 16401 serial numbers: 1001-1243, 1247-1648, 1650-1821, and 1824-3003.
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues.
Product Quantity1097
Recall NumberZ-0281-2013
Product DescriptionPerfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Infocatalog number: 16405 serial numbers: 1001-1466.
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues.
Product Quantity466
Recall NumberZ-0282-2013
Product DescriptionPerfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Infocatalog number: 16406 serial numbers: 1001-1004,1007-1055,1057-1310, 1648, 1649, 1657, 1822, and 1823.
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues.
Product Quantity312
Recall NumberZ-0283-2013
Product DescriptionPerfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Infocatalog number: 16409 serial numbers: 1001-1026
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues.
Product Quantity26
Recall NumberZ-0284-2013
Product DescriptionPerfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.
Code Infocatalog number: 16410 serial numbers:1001-1034,1036-1061,and 1602-1622.
ClassificationClass II
Reason for RecallTerumo Cardiovascular Systems (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure alarms. If the malfunction of the arterial or cardioplegia monitor occurs prior to initiating cardiopulmonary bypass, it could inconvenience the user or delay the case; the risk to the patient is dependent on the patient's status. If the failure occurs during cardiopulmonary bypass, the risk to the patient ranges from negligible to severe and is dependent on the patient's condition, the user's experience and competency and the user's knowledge of the instructions in the Operator's Manual. While the Operator's Manual for the Sarns system 8000 provides instruction on how to respond to the malfunctions, Terumo CVS is informing users of the risks associated with these malfunctions, reminding users to review the instructions in the Operator's Manual and providing an Addendum to clarify the instruction for responding to an inaccurate pressure reading or false alarm. There are no known reports of patient injury as a result of these issues.
Product Quantity81
Recall NumberZ-0285-2013

Class II Biologics Event

Event ID62797
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jul-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmMedical Information Technology, Inc.
CityWestwood
StateMA
CountryUS
Distribution PatternNationwide Canada
 

Associated Products

Product DescriptionMEDITECH Blood Bank Software - Client Server Releases 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1 and 6.12.
Code InfoClient Server Releases 5.63, 5.64, 5.65, 6.0, 6.04, 6.05, 6.06, 6.1 and 6.12.
ClassificationClass II
Reason for RecallBlood Bank Software, with a defect or glitch, was distributed.
Product Quantity9
Recall NumberB-0101-13

Class II Biologics Event

Event ID62934
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Jun-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CitySalt Lake City
StateUT
CountryUS
Distribution PatternNevada; California
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info020FT37984;
ClassificationClass II
Reason for RecallBlood products, which were not quarantined after receiving post donation information, were distributed..
Product Quantity1 unit
Recall NumberB-0050-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info020FT37984;
ClassificationClass II
Reason for RecallBlood products, which were not quarantined after receiving post donation information, were distributed.
Product Quantity1 unit
Recall NumberB-0051-13

Class II Biologics Event

Event ID63035
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmer. National Red Cross-Greater Chesapeake & Potomac Reg.
CityBaltimore
StateMD
CountryUS
Distribution PatternMaryland
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info53LP82140;
ClassificationClass II
Reason for Recall
Product Quantity1
Recall NumberB-0007-13

Class II Biologics Event

Event ID63050
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross The
CityPomona
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info06GH47154;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity1
Recall NumberB-0048-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info06GH47154;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was previously deferred, were distributed.
Product Quantity1
Recall NumberB-0049-13

Class II Biologics Event

Event ID63162
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmMedical Information Technology, Inc.
CityWestwood
StateMA
CountryUS
Distribution PatternNationwide Foreign: Canada, UK, Virgin Islands
 

Associated Products

Product DescriptionMEDITECH Blood Bank Software, Client Server Releases 5.6, 5.65, 6.0,6.05, 6.06, and 6.13.
Code InfoClient Server Releases 5.6, 5.65, 6.0, 6.05, 6.06, and 6.13
ClassificationClass II
Reason for RecallBlood Bank Software, with a defect or glitch, was distributed.
Product Quantity6
Recall NumberB-0102-13

Class II Biologics Event

Event ID63238
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Aug-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmDCI Donor Services Tissue Services Division
CityNashville
StateTN
CountryUS
Distribution PatternNew Mexico; California
 

Associated Products

Product DescriptionSkin
Code Info030539712; 030539982; 030539984; 030511381; 030511382; 030511388; 030511390; 030512003; 030513334; 030513335; 030513336; 030515326; 030515327; 030515777; 030517764; 030517766; 030517769; 030517777; 030518353; 030521200; 030521201; 030521206; 030521207; 030522051; 030522052; 030522056; 030524991; 030524994; 030525179; 030525253; 030529885; 030530134; 030532171; 030520430; 030521191; 030521194; 030533264; 030533266; 030534536; 030534875; 030539711
ClassificationClass II
Reason for RecallSkin allografts, lacking assurance of proper temperature maintenance during transportation, were distributed.
Product Quantity41
Recall NumberB-0053-13

Class II Devices Event

Event ID63275
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Jul-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Howmedica Osteonics Corp.
CityMahwah
StateNJ
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide and countries of: Canada, Chile, Sweden and United Kingdom
 

Associated Products

Product DescriptionSpecial Orthopaedic Solution Peri-Acetabular Prosthesis V40 Femoral Extension Component Product Usage: The PAR extension piece is a component of the PAR assembly. The Peri-Acetabular Reconstruction (PAR) endoprosthesis was developed to meet the unique needs of patients who require reconstruction of large acetabular defects after a Type I and II pelvic resection.
Code InfoMultiple codes C-2051-7-004 RX00138D FEMORAL PELVIC EXTENSION C-2052-5-004 RX00146D FEMORAL PELVIC EXTENSION C-HM42-7-802 RX4278C 40MM EXT W/FEMALE V40 TAPER C-HM42-7-803 RX4278D 50MM EXT W/FEMALE V40 TAPER C-HM42-7-804 RX4278E 60MM EXT W/FEMALE V40 TAPER C-HM49-4-401 RX4944B PAR 40MM EXT W/FEMALE V40 TAPE C-HM49-4-402 RX4944C PAR 50MM EXT W/FEMALE V40 TAPE C-HM49-4-403 RX4944D PAR 60MM EXT W/FEMALE V40 TAPE C-HM49-9-202 RX4992C PAR EXTENSION C-TAPER 40MM C-HM49-9-203 RX4992D PAR EXTENSION C-TAPER 50MM C-HM49-9-204 RX4992E PAR EXTENSION C-TAPER 60MM C-HM52-1-802 RX5218C PAR FEMORAL EXT V40 TAPER 40MM C-KM10-9-400 HG102AA FEMORAL PELVIC EXTENSION C-KM26-5-204 RX2652E PAR FEM EXT V-40, 40MM C-KM26-5-205 RX2652S PAR FEM EXT V-40 50MM C-KM26-5-206 RX2652T PAR FEM EXT V-40 60MM C-KM28-1-501 RX2815B PAR FEM EXT V-40, 40MM C-KM28-1-502 RX2815C PAR FEM EXT V-40 50MM C-KM28-1-503 RX2815D PAR FEM EXT V-40 60MM C-KM28-4-201 RX2842B PAR FEM EXT V-40, 40MM C-KM28-4-202 RX2842C PAR FEM EXT V-40, 50MM C-KM28-4-203 RX2842D PAR FEM EXT V-40, 60MM C-KM28-6-901 RX2869B PAR FEM EXT V-40, 40MM C-KM28-6-902 RX2869C PAR FEM EXT V-40, 50MM C-KM28-6-903 RX2869D PAR FEM EXT V-40, 60MM C-KM28-7-801 RX2878B PAR FEM EXT V-40, 40MM C-KM28-7-802 RX2878C PAR FEM EXT V-40 50MM C-KM28-7-803 RX2878D PAR FEM EXT V-40 60MM C-KM29-6-101 KM2961B PAR FEM EXT V-40, 50MM C-KM29-6-102 RX2961C PAR FEM EXT V-40, 60MM C-KM29-9-101 RX2991B PAR FEM EXT V-40, 50MM C-KM29-9-102 RX2991C PAR FEM EXT V-40 60MM C-KM30-0-901 RX3009B PAR FEM EXT V-40, 50MM C-KM30-0-902 RX3009C PAR FEM EXT V-40, 60MM C-KM30-1-101 RX3011B PAR FEM EXT V-40, 50MM C-KM30-1-102 RX3011C PAR FEM EXT V-40 60MM C-KM32-0-801 RX3208B PAR FEM EXT V-40, 50MM C-KM32-0-802 RX3208C PAR FEM EXT V-40 60MM C-KM32-9-201 RX3292B 40MM EXT W/FEMALE V40 TAPER C-KM32-9-202 RX3292C 50MM EXT W/FEMALE V40 TAPER C-KM32-9-203 RX3292D 60MM EXT W/FEMALE V40 TAPER C-KM33-6-601 RX3366B 40MM EXT W/FEMALE V40 TAPER C-KM33-6-602 RX3366C 50MM EXT W/FEMALE V40 TAPER C-KM33-6-603 RX3366D 60MM EXT W/FEMALE V40 TAPER C-KM34-8-902 RX3489C 40MM EXT W/FEMALE V40 TAPER C-KM35-4-501 RX3545B 40MM EXT W/FEMALE V40 TAPER C-KM35-4-502 RX3545C 50MM EXT W/FEMALE V40 TAPER C-KM35-4-503 RX3545D 60MM EXT W/FEMALE V40 TAPER C-KM35-5-501 RX3555B 40MM EXT W/FEMALE V40 TAPER C-KM35-5-502 RX3555C 50MM EXT W/FEMALE V40 TAPER C-KM35-5-503 RX3555D 60MM EXT W/FEMALE V40 TAPER C-KM35-9-001 RX3590B 40MM EXT W/FEMALE V40 TAPER C-KM37-5-101 RX3751B 40MM EXT W/FEMALE V40 TAPER C-KM37-5-102 RX3751C 50MM EXT W/FEMALE V40 TAPER C-KM37-5-103 RX3751D 60MM EXT W/FEMALE V40 TAPER C-KM37-7-100 RX3771A 40MM EXT W/FEMALE V40 TAPER C-KM37-7-101 RX3771B 50MM EXT W/FEMALE V40 TAPER C-KM37-7-102 RX3771C 60MM EXT W/FEMALE V40 TAPER C-KM37-7-801 RX3778B 40MM EXT W/FEMALE V40 TAPER C-KM37-7-803 RX3778D 60MM EXT W/FEMALE V40 TAPER C-KM37-8-401 RX3784B 40MM EXT W/FEMALE V40 TAPER C-KM37-8-402 RX3784C 60MM EXT W/FEMALE V40 TAPER C-KM38-1-301 RX3813B 40MM EXT W/FEMALE V40 TAPER C-KM38-1-302 RX3813C 50MM EXT W/FEMALE V40 TAPER C-KM38-1-303 RX3813D 60MM EXT W/FEMALE V40 TAPER C-KM39-1-101 RX3911B 40MM EXT W/FEMALE V40 TAPER C-KM39-1-102 RX3911C 50MM EXT W/FEMALE V40 TAPER C-KM39-1-103 RX3911D 60MM EXT W/FEMALE V40 TAPER C-KM40-1-301 RX4013B 40MM EXT W/FEMALE V40 TAPER C-KM40-1-302 RX4013C 50MM EXT W/FEMALE V40 TAPER C-KM40-1-303 RX4013D 60MM EXT W/FEMALE V40 TAPER C-KM40-6-400 RX4064A 40MM EXT W/FEMALE V40 TAPER C-KM40-7-301 RX4073B 40MM EXT W/FEMALE V40 TAPER C-KM40-7-302 RX4073C 50MM EXT W/FEMALE V40 TAPER C-KM40-9-501 RX4095B 40MM EXT W/FEMALE V40 TAPER C-KM40-9-502 RX4095C 50MM EXT W/FEMALE V40 TAPER C-KM40-9-503 RX4095D 60MM EXT W/FEMALE V40 TAPER C-KM41-3-001 RX4130B 40MM EXT W/FEMALE V40 TAPER C-KM41-3-002 RX4130C 50MM EXT W/FEMALE V40 TAPER C-KM41-3-003 RX4130D 60MM EXT W/FEMALE V40 TAPER C-KM41-6-401 RX4164B 40MM EXT W/FEMALE V40 TAPER C-KM41-6-402 RX4164C 50MM EXT W/FEMALE V40 TAPER C-KM41-6-403 RX4164D 60MM EXT W/FEMALE V40 TAPER C-KM42-7-902 RX4279C 50MM EXT W/FEMALE V40 TAPER C-KM42-7-903 RX4279D 60MM EXT W/FEMALE V40 TAPER C-KM43-0-401 RX4304B 40MM EXT W/FEMALE V40 TAPER C-KM43-0-402 RX4304C 50MM EXT W/FEMALE V40 TAPER C-KM43-0-403 RX4304D 60MM EXT W/FEMALE V40 TAPER C-KM43-1-201 RX4312B 40MM EXT W/FEMALE V40 TAPER C-KM43-1-202 RX4312C 50MM EXT W/FEMALE V40 TAPER C-KM43-1-203 RX4312D 60MM EXT W/FEMALE V40 TAPER C-KM43-1-301 RX4313B 40MM EXT W/FEMALE V40 TAPER C-KM43-1-302 RX4313C 50MM EXT W/FEMALE V40 TAPER C-KM43-1-303 RX4313D 60MM EXT W/FEMALE V40 TAPER C-KM43-2-101 RX4321B 40MM EXT W/FEMALE V40 TAPER C-KM43-4-900 RX4349A 50MM EXT W/FEMALE C-TAPER C-KM43-4-901 RX4349B 60MM EXT W/FEMALE C-TAPER C-KM43-5-901 RX4359B 40MM EXT W/FEMALE V40 TAPER C-KM43-5-902 RX4359C 50MM EXT W/FEMALE V40 TAPER C-KM43-5-903 RX4359D 60MM EXT W/FEMALE V40 TAPER C-KM43-7-901 RX4379B 40MM EXT W/FEMALE V40 TAPER C-KM43-7-902 RX4379C 50MM EXT W/FEMALE V40 TAPER C-KM43-7-903 RX4379D 60MM EXT W/FEMALE V40 TAPER C-KM43-9-501 RX4395B 40MM EXT W/FEMALE V40 TAPER C-KM43-9-502 RX4395C 50MM EXT W/FEMALE V40 TAPER C-KM43-9-503 RX4395D 60MM EXT W/FEMALE V40 TAPER C-KM44-1-701 RX4417B 40MM EXT W/FEMALE V40 TAPER C-KM44-1-702 RX4417C 50MM EXT W/FEMALE V40 TAPER C-KM44-1-703 RX4417D 60MM EXT W/FEMALE V40 TAPER C-KM44-2-701 RX4427B 40MM EXT W/FEMALE V40 TAPER C-KM44-2-702 RX4427C 50MM EXT W/FEMALE V40 TAPER C-KM44-2-703 RX4427D 60MM EXT W/FEMALE V40 TAPER C-KM45-1-801 RX4518B 40MM EXT W/FEMALE V40 TAPER C-KM45-1-802 RX4518C 50MM EXT W/FEMALE V40 TAPER C-KM45-1-803 RX4518D 60MM EXT W/FEMALE V40 TAPER C-KM46-9-301 RX4693B 40MM EXT W/FEMALE V40 TAPER C-KM50-2-202 RX5022C PAR FEM EXT C-TAPER 40MM C-KM50-2-203 RX5022D PAR FEM EXT C-TAPER 50MM C-KM50-2-204 RX5022E PAR FEM EXT C-TAPER 60MM C-KM50-4-102 RX5041C PAR 40MM EXT W/FEMALE V40 TAPE C-KM51-6-202 RX5162C PAR 40MM EXT W/FEMALE V40 TAPE C-M052-9-402 RX5294C PAR FEM EXT V40 40MM C-M053-2-202 RX5322C PAR FEM EXTENSION C-TAPER 40MM C-M053-2-203 RX5322D PAR FEM EXTENSION C-TAPER 50MM C-M053-2-204 RX5322E PAR FEM EXTENSION C-TAPER 60MM C-M054-3-202 RX5432C PAR EXTENTION 50MM V40 TAPER C-M054-3-203 RX5432D PAR EXTENSION 60MM V40 TAPER C-M054-9-902 RX5499C PAR EXTENSION V40 TAPER 40MM C-M055-2-603 RX5526D PAR FEMORAL EXTENSION V40 TAPE C-M055-2-604 RX5526E PAR FEMORAL EXTENSION V40 TAPE C-M055-3-402 RX5534C PAR FEMORAL EXT V40 TAPER 40MM C-M055-3-403 RX5534D PAR FEMORAL EXT V40 TAPER 50MM C-M055-3-404 RX5534E PAR FEMORAL EXT V40 TAPER 60MM C-M055-9-301 RX5593B TI PAR FEMORAL EXT V40 TAPER 4 C-M056-1-102 RX5611C PAR FEMORAL EXT V40 TAPER 40MM C-M056-1-103 RX5611D PAR FEMORAL EXT V40 TAPER 50MM C-M056-1-104 RX5611E PAR FEMORAL EXT V40 TAPER 60MM C-M056-4-202 RX5642C PAR FEM EXT V40 TAPER 40MM C-M056-4-203 RX5642D PAR FEM EXT V40 TAPER 50MM C-M056-4-204 RX5642E PAR FEM EXT V40 TAPER 60MM C-M059-1-202 RX05912C PAR FEM EXT V40 TAPER 40MM C-M062-2-601 RX06226B PAR FEM EXT C-TAPER 40MM C-M062-2-602 RX06226C PAR FEM EXT C-TAPER 50MM C-M062-2-603 RX06226D PAR FEM EXT C-TAPER 60MM C-M062-3-401 RX06234B PERI-ACETABULAR PROSTHESIS FEM C-M062-3-402 RX06234C PERI-ACETABULAR PROSTHESIS FEM C-M062-3-403 RX06234D PERI-ACETABULAR PROSTHESIS FEM C-M062-5-702 RX06257C PAR EXT V40 TAPER 40MM C-M062-5-703 RX06257D PAR EXT V40 TAPER 50MM C-M062-5-704 RX06257E PAR EXT V40 TAPER 60MM C-M062-8-500 RX06285A PAR FEMORAL EXT C-TAPER 60mm C-M062-9-202 RX06292C PAR FEMORAL EXT V40 TAPER 40MM C-M062-9-203 RX06292D PAR FEMORAL EXT V40 TAPER 50MM C-M062-9-204 RX06292E PAR FEMORAL EXT V40 TAPER 60MM C-M063-6-601 RX06366B PAR FEM EXT V40 TAPER 40MM C-M063-6-602 RX06366C PAR FEM EXT V40 TAPER 50MM C-M063-8-702 RX06387C PAR FEM EXT V40 TAPER 40MM C-M064-3-102 RX06431C PAR FEM EXT V40 TAPER 40MM C-M064-3-103 RX06431D PAR FEM EXT V40 TAPER 50MM C-M064-3-104 RX06431E PAR FEM EXT V40 TAPER 60MM C-M066-2-302 RX06623C PAR FEM EXT V40 TAPER 40MM C-M066-2-303 RX06623D PAR FEM EXT V40 TAPER 50MM C-M066-2-304 RX06623E PAR FEM EXT V40 TAPER 60MM C-M066-6-003 RX06660D PAR FEM EXT V40 TAPER 50MM C-M066-6-004 RX06660E PAR FEM EXT V40 TAPER 60MM C-M066-8-602 RX06686C PAR FEM EXT V40 TAPER 50MM C-M066-9-302 RX06693C PAR FEM EXT V40 TAPER 40MM C-M066-9-303 RX06693D PAR FEM EXT V40 TAPER 50MM C-M066-9-304 RX06693E PAR FEM EXT V40 TAPER 60MM C-M067-1-002 RX06710C PAR FEM EXT V40 TAPER 40MM C-M067-1-003 RX06710D PAR FEM EXT V40 TAPER 50MM C-M067-4-402 RX06744C PAR FEMORAL EXTENSION V40 TAPE C-M067-4-403 RX06744D PAR FEMORAL EXTENSION V40 TAPE C-M067-4-404 RX06744E PAR FEMORAL EXTENSION V40 TAPE C-M067-4-702 RX06747C PAR FEMORAL EXTENSION V40 TAPE C-M067-4-703 RX06747D PAR FEMORAL EXTENSION V40 TAPE C-M067-4-704 RX06747E PAR FEMORAL EXTENSION V40 TAPE C-M067-5-105 RX06571C PAR V-40 FEMORAL EXTENSION PI C-M067-5-106 RX06751D PAR V-40 FEMORAL EXTENSION PI C-M067-5-107 RX06751E PAR V-40 FEMORAL EXTENSION PI C-M068-0-902 MHM2LD PAR V-40 FEMORAL EXTENSION PI C-M068-0-903 MHM2LE PAR V-40 FEMORAL EXTENSION PI C-M068-0-904 MHM2LH PAR V-40 FEMORAL EXTENSION PI C-M068-2-402 MHM8YD PAR V40 FEMORAL EXTENSION 40MM C-M068-2-403 MHM8YE PAR V40 FEMORAL EXTENSION 50MM C-M068-6-902 MHN77T PAR V40 TAPER EXTENSION PIECE C-M068-6-903 MHN77V PAR V40 TAPER EXTENSION PIECE C-M068-6-904 MHN77W PAR V40 TAPER EXTENSION PIECE C-M068-7-402 MHN77X PAR V40 TAPER EXTENSION PIECE C-M068-7-403 MHN77Y PAR V40 TAPER EXTENSION PIECE C-M068-7-404 MHN780 PAR V40 TAPER EXTENSION PIECE C-M068-9-902 MHNYT1 PAR V40 TAPER EXTENSION PIECE C-M068-9-903 MHNYT2 PAR V40 TAPER EXTENSION PIECE C-M068-9-904 MHNYT3 PAR V40 TAPER EXTENSION PIECE C-M069-2-802 MHPKKL PAR FEM EXT V40 TAPER 60MM C-M069-4-004 MHRH4X PAR C-TAPER EXTENSION PIECE 60 C-M069-5-102 MHRARE PAR V40 TAPER EXTENSION PIECE C-M069-5-103 MHRARH PAR V40 TAPER EXTENSION PIECE C-M069-5-104 MHRARJ PAR V40 TAPER EXTENSION PIECE C-M069-5-602 MHR3DH PAR V40 TAPER EXTENSION PIECE C-M069-5-603 MHR3E0 PAR V40 TAPER EXTENSION PIECE C-M069-5-604 MHR3DX PAR V40 TAPER EXTENSION PIECE C-M070-0-400 MHTPHK PAR V40 FEMORAL EXTENSION COMP C-M071-4-501 MJMVKP V40 FEMORAL EXTENSION COMPONEN C-M071-4-502 MJM0MW V40 FEMORAL EXTENSION COMPONEN C-M071-4-503 MJM1N5 V40 FEMORAL EXTENSION COMPONEN C-M071-8-001 MJP1N6 V40 FEMORAL EXTENSION COMPONEN C-M071-8-801 MJPVJ4 V40 FEMORAL EXTENSION COMPONEN C-M071-8-802 MJPEPK V40 FEMORAL EXTENSION COMPONEN C-M071-8-803 MJP9T9 V40 FEMORAL EXTENSION COMPONEN C-M072-0-901 MJR51TA C-TAPER FEMORAL EXTENSION COMP C-M072-0-902 MJR20A8 C-TAPER FEMORAL EXTENSION COMP C-M072-0-902 MJRVXNA C-TAPER FEMORAL EXTENSION COMP C-M072-0-903 MJRPR1A C-TAPER FEMORAL EXTENSION COMP C-M078-6-002 MLDP0A PAR EXTENSION PIECE C-TAPER 40 C-M079-0-602 MLE6V3 V40 FEMORAL EXTENSION COMPONEN KM15-3-502 RX1535B FEMORAL EXTENSION COMP 60mm KM15-3-503 RX1535C FEMORAL EXTENSION COMP 80mm KM15-3-504 RX1535D FEMORAL EXTENSION COMP 100mm KM16-9-203 RX1692D 45mm FEMORAL EXTENSION KM16-9-205 RX1692E 60mm FEMORAL EXTENSION KM19-1-302 RX1913C FEMORAL EXT 'C' TAPER - 50mm KM19-1-303 RX1913D FEMORAL EXT 'C' TAPER - 60mm KM19-1-304 RX1913E FEMORAL EXT 'C' TAPER - 80mm KM20-4-102 RX2041C PAR EXTENSION C-TAPER 40mm KM20-4-103 RX2041D PAR EXTENSION C-TAPER 50mm KM20-4-104 RX2041E PAR EXTENSION C-TAPER 60mm KM20-5-701 RX2057B PAR FEM EXTENSION - 60mm KM21-2-402 RX2124C FEM EXTENSION C-TAPER 40mm PAR KM21-2-403 RX2124D FEM EXTENSION C-TAPER 50mm PAR KM21-2-404 RX2124E FEM EXTENSION C-TAPER 60mm PAR KM21-5-302 RX2153C PAR FEMORAL EXTENSION - 40MM KM21-5-303 RX2153D PAR FEMORAL EXTENSION - 50MM KM21-5-304 RX2153E PAR FEMORAL EXTENSION - 60MM KM21-6-802 RX2168C FEM EXTENSION C-TAPER 40mm PAR KM21-6-803 RX2168D FEM EXTENSION C-TAPER 50mm PAR KM21-6-804 RX2168E FEM EXTENSION C-TAPER 60mm PAR KM21-7-702 RX2177C PAR FEM EXTENSION V40 - 40MM KM21-7-703 RX2177D PAR FEM EXTENSION V40 - 50MM KM21-7-704 RX2177E PAR FEM EXTENSION V40 - 60MM KM21-7-901 RX2179E PAR LOCKING SCREW KM21-7-902 RX2179C PAR FEMORAL EXTENSION - 40MM KM21-7-903 RX2179D PAR FEMORAL EXTENSION - 50MM KM21-9-402 RX2194C PAR FEM EXT C-TAPER 40MM KM21-9-403 RX2194D PAR FEM EXT C-TAPER 60MM KM21-9-404 RX2194E PAR FEM EXT C-TAPER 50MM KM21-9-405 RX2194F PAR FEM EXT 40MM KM21-9-406 RX2194G PAR FEM EXT 50MM KM21-9-407 RX2194H PAR FEM EXT 60MM KM22-8-702 RX2287C FEM EXTENSION C-TAPER 40mm PAR KM22-8-703 RX2287D FEM EXTENSION C-TAPER 50mm PAR KM22-8-704 RX2287E FEM EXTENSION C-TAPER 60mm PAR KM23-6-702 RX2367C PAR FEM EXT 40MM V40 KM23-6-703 RX2367D PAR FEM EXT 50MM V40 KM23-6-704 RX2367E PAR FEM EXT 60MM V40 KM23-7-403 RX2374D PAR FEM EXT 50MM V40 KM23-7-404 RX2374E PAR FEM EXT 60MM V40 KM23-7-503 RX2375D PAR FEM EXT 50MM V40 KM23-7-504 RX2375E PAR FEM EXT 60MM V40 KM23-7-902 RX2379C PAR FEM EXT 40MM V40 KM23-7-903 RX2379D PAR FEM EXT 50MM V40 KM23-7-904 RX2379E PAR FEM EXT 60MM V40 KM24-5-902 RX2459C PAR FEM EXTENSION V40 - 40MM KM24-5-903 RX2459D PAR FEM EXTENSION V40 - 50MM KM24-5-904 RX2459E PAR FEM EXTENSION V40 - 60MM KM26-0-902 RX2609C PAR FEM EXT 40MM FEM C-TAPER KM26-0-903 RX2906D PAR FEM EXT 50MM FEM C-TAPER KM26-0-904 RX2906E PAR FEM EXT 60MM FEM C-TAPER KM27-6-402 RX2764C PAR FEM EXT 40MM FEM C-TAPER KM27-6-403 RX2764D PAR FEM EXT 50MM FEM C-TAPER KM27-6-404 RX2764E PAR FEM EXT 60MM FEM C-TAPER KM28-3-700 RX3837A PAR FEM EXT - 80MM - V40 TAPER P-KM11-0-503 KM1105N6 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N9 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N7 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N11 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N31 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N51 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N11 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N41 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N81 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 KM1105N101 PAR FEMORAL EXTENSION 60MM P-KM11-0-503 X1105Q2 PAR FEMORAL EXTENSION 60MM P-KM11-0-504 KM1105D11 PAR FEMORAL EXTENSION 80MM P-KM11-0-504 KM1105D41 PAR FEMORAL EXTENSION 80MM P-KM11-0-504 KM1105D2 PAR FEMORAL EXTENSION 80MM P-KM11-0-504 KM1105D7 PAR FEMORAL EXTENSION 80MM P-KM11-0-505 KM1105E11 PAR FEMORAL EXTENSION 100MM P-KM11-0-505 KM1105E2 PAR FEMORAL EXTENSION 100MM
ClassificationClass II
Reason for RecallStryker has become aware that insufficient taper torsional strength may result when a PAR extension piece is used with a forged CoCr stem.
Product Quantity301 units
Recall NumberZ-0286-2013

Class II Food Event

Event ID63287
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMcCormick & Company, Inc.
CityHunt Valley
StateMD
CountryUS
Distribution PatternProducts were shipped nationwide
 

Associated Products

Product DescriptionZatarain's New Orleans Style Beef Flavor Rice Mix, packaged in 6.8 oz boxes, 12 boxes per carton, Box UPC: 7142901001
Code InfoBEST BY JUN 09 14 H, BEST BY JUL 29 14 H, BEST BY AUG 28 14 H
ClassificationClass II
Reason for RecallFood product containing wheat was packaged into containers which do not declare wheat on the label.
Product Quantity1050 cases
Recall NumberF-0681-2013
Product DescriptionZatarain's New Orleans Style Chicken Flavor Rice Mix, Item No. Z09705, packaged in 6.3 oz boxes, 12 boxes per carton, Box UPC: 7142901001
Code InfoBEST BY JUN 10 14 H, BEST BY JUL 30 14 H, BEST BY AUG 31 14 H
ClassificationClass II
Reason for RecallFood product containing wheat was packaged into containers which do not declare wheat on the label.
Product Quantity125,556 boxes
Recall NumberF-0682-2013
Product DescriptionZatarain's Chicken/Cheddar Brocolli Mix, Item Number: 900108337, a combination pack containing, 6.3 oz boxes of New Orleans Style Chicken Flavor Rice Mix and Cheddar Broccolli Mix.
Code InfoBEST BY MAY 09 13Z, BEST BY JUN 15 13Z, BEST BY AUG 05 13Z and BEST BY AUG 08 13Z
ClassificationClass II
Reason for RecallFood product containing wheat was packaged into containers which do not declare wheat on the label.
Product Quantity320 cases
Recall NumberF-0698-2013

Class II Food Event

Event ID63317
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmRDK Corp
CityRacine
StateWI
CountryUS
Distribution PatternDistribution was made to fund-raising organizations located in AZ, IL, and WI. There was no foreign, military, or government distribution.
 

Associated Products

Product DescriptionAunt Marie's Bakery Gourmet Cookie Dough, Chocolate Chunk, packaged in 3-lb. plastic tubs. Distributed by Racine Danish Kringles, Racine, WI.
Code InfoLot 12005
ClassificationClass II
Reason for RecallForeign object in cookie dough
Product Quantity1,324/3-lb. tubs
Recall NumberF-0658-2013

Class II Devices Event

Event ID63344
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTerumo Cardiovascular Systems Corporation
CityAnn Arbor
StateMI
CountryUS
Distribution PatternNationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI
 

Associated Products

Product DescriptionHX2 Temp Manage SYS 120V The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Code InfoCatalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.
ClassificationClass II
Reason for RecallBased on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up, not during a procedure. When a failure occurred at start-up, the clinicians mitigated the failure by shutting down the devices and using a back-up system as recommended in the user's manual.
Product Quantity19 units
Recall NumberZ-0278-2013
Product DescriptionTested AC Control BD, 120V, X2 The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.
Code InfoCatalog number: 817168 and serial numbers: 824POOO023, 831 P001130, 831 P001133, 831 P001136, 831 P001140, 831 POO1141 , 831 P001144, 831 P001145, 831 P001146, 831 P001149, 831 P001151, 831 P001159, 831P001161, 831P001164, and 836POOOO05.
ClassificationClass II
Reason for RecallBased on a retrospective review of quality data, AC Control boards used in the manufacture of the HX2 Temperature Management System were identified as being manufactured using the incorrect flux material. Use of the incorrect flux may contribute to premature board failure. A search of TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred during set up, not during a procedure. When a failure occurred at start-up, the clinicians mitigated the failure by shutting down the devices and using a back-up system as recommended in the user's manual.
Product Quantity15 units
Recall NumberZ-0279-2013

Class II Biologics Event

Event ID63348
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jul-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmSurgical Biologics LLC
CityKennesaw
StateGA
CountryUS
Distribution PatternLouisiana
 

Associated Products

Product DescriptionAmniotic membrane
Code Info2012838004; 2012838005; 2012838006; 2012838007; 2012838008; 2012838009; 2012838010; 2012838011; 2012838012; 2012838013; 2012838014; 2012838015; 2012838016; 2012838017; 2012838018; 2012838019; 2012838020; 2012838021;
ClassificationClass II
Reason for RecallAmniotic membrane allografts, recovered from a donor whose preprocessing tissue culture indicated growth of Group D Enterococcus, were distributed.
Product Quantity18
Recall NumberB-0194-13

Class II Food Event

Event ID63357
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican Licorice Co
CityUnion City
StateCA
CountryUS
Distribution PatternNationwide distribution.
 

Associated Products

Product DescriptionAmerican Vines band Natural Vines Black Soft Licorice Twists; All Natural Ingredients, 8 oz (226g), No Preservatives, Product is processed and packaged by American Licorice Company, Union City, CA; Displays and Pallets info: ----6 ct. Case, Item: #8483, Case UPC: 00-41364 08483-8; ----12 ct. Case, Item: #8481, Case UPC: 100-41364 08481-4; ----36/8oz Combo Floor Display (Black Only), Item: #8484, Item UPC: 041364084817, Case UPC: 100-41364 08484-5; ----18/8oz Combo Wing Display (Black Only), Item: #8485, Item UPC: 041364084817, Case UPC: 100-41364 08485-2
Code InfoAffected Date Codes: 01 04 13, 01 05 13, 01 26 13, 01 27 13, 03 02 13, 03 16 13, 04 07 13, 04 09 13, 04 19 13; Date Code is printed on white sticker located on back of package
ClassificationClass II
Reason for RecallFirm's internal sampling of the product found elevated levels of lead in the product.
Product Quantity13796 Cases
Recall NumberF-0657-2013

Class II Food Event

Event ID63419
StatusCompleted
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTaco Loco Products Inc
CityAnchorage
StateAK
CountryUS
Distribution PatternProduct distributed to retail stores in Alaska only
 

Associated Products

Product DescriptionSalmon Wrap. Two wraps per package. Net Wt 8 oz
Code InfoLot Expiration: 06/11/2012 through 11/15/2012
ClassificationClass II
Reason for RecallProduct manufactured using cooking spray which contains soy oil and soy was not declared on the label.
Product Quantity480 / 8 oz packages
Recall NumberF-0680-2013

Class II Devices Event

Event ID63445
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Dec-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmProgressive Medical Inc
CitySaint Louis
StateMO
CountryUS
Distribution PatternUSA (nationwide) including the states of CO, IN, KS, MA, MN, MO, NE, OH, SC, TN, TX, VA, and WI.
 

Associated Products

Product DescriptionProgressive Medical PMI Endoscopic Dissector with Kittner Tip (5mm x 40cm), Reorder Number: PMILK40, Product Sterile in Unopened/Undamaged pouch, Cotton Tip - X-Ray Detectable, 1 Pc/Pouch, 10 Pouches/Box, 20 boxes/case. Exclusively Distributed in the U.S. Market by: Progressive Medical, Inc., St. Louis, MO, Made in China. The product is used for pushing tissue from the incision or wound during medical procedures. Per the IFU, the indications for use are for gynecological laparoscopy, laparoscopic cholecystectomy, and other laparoscopic procedures.
Code InfoLot 1108-01
ClassificationClass II
Reason for RecallSome of the sterile packages had broken seals.
Product Quantity70 boxes
Recall NumberZ-0276-2013

Class II Devices Event

Event ID63446
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSynthes USA HQ, Inc.
CityWest Chester
StatePA
CountryUS
Distribution PatternNationwide Distribution-including the states of CA, MN, NC, and TN.
 

Associated Products

Product DescriptionSynthes External Fixation System Tube to Tube Clamp, Part Number 390.007. Intended for use to provide treatment for long bone and pelvic fractures that require external fixation. Specifically, the components can be used for: Stabilization of soft tissues and fractures; Polytrauma/multiple orthopedic trauma; Vertically stable pelvic fractures, or as treatment adjunct for vertically unstable pelvic fractures; Arthrodeses and osteotomies with soft tissue problems - failures of total joints; Neutralization of fractures stabilized with limited internal fixation; Non-unions/septic non-unions; Intra-operative reductions/stabilization tool to assist with indirect reduction; and Unilateral rectilinear bone segment transport or leg lengthening.
Code InfoPart number 390.007, Lot number 6800599
ClassificationClass II
Reason for RecallThe insert provided with the product for the specific lot number indicates that this product is MR safe. This product is MR Conditional and is etched as MR Conditional. The insert is incorrect.
Product Quantity8
Recall NumberZ-0277-2013

Class II Devices Event

Event ID63458
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmZimmer, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and Internationally to Belgium, Czech Republic, Egypt, France, Germany, Morocco, Netherlands, Romania, Saudi Arabia, Spain, Switzerland, Turkey, and UAE.
 

Associated Products

Product Description ATS 3000 Automatic Tourniquet System w/HOSES AND LOP SENSOR Intended to be used by qualified medical professionals to temporarily occlude blood flow in a patient's extremities during surgical procedures on those extremities.
Code InfoCatalog 60-3000-101-00, Serial # 3005IACJ, 3006JAEP, 3007CADR, 3007EACT, 3007EAKT, 3007GAGR, 3007HABK, 3007KAAR, 3007KAET, 3008CADE, 3008HAHC, 3008LACK, 3009AACN, 3009HABA, 3009LAEF, 3010CABH, 3010DAHG, 3010GAAC, 3010GAAJ, 3011LABL, 3011LABN, 3011LABQ, 3011LACC, 3011LACE, 3011LACF, 3011LACG, 3011LACH, 3011LACJ, 301 1LACK, 3011LACL, 3011LACM, 3011LACN, 3011LACP, 3011LACQ, 3011LACR, 3011LACS, 3011LACT, 3011LACU, 3011LACW, 3011LADA, 3011LADE, 3011LADF, 3011LADG, 3011LADH, 3011LADJ, 3011LADK, 3011LADM, 3011LADP, 3011LADQ, 3011LADR, 3011LADS, 3011LADT, 3011LADU, 3011LADW, 3011LAEA, 3011LAEB, 3011LAEC, 3011LAED, 3011LAEE, 3011LAEF, 3011LAEH, 3012AAAG, 3012AAAK, 3012AAAM, 3012AAAN, 3012AAAP, 3012AAAQ, 3012AAAR, 3012AAAS, 3012AAAT, 3012AAAU, 3012AAAW, 3012AABA, 3012AABB, 3012AABC, 3012AABE, 3012AABG, 3012AABH, 3012AABK, 3012AABL, 3012AABM, 3012AABN, 3012AABQ, 3012AABR, 3012AABS, 3012AABU, 3012AACA, 3012AACB, 3012AACC, 3012AACD, 3012AACE, 3012AACH, 3012AACJ, 3012AACM, 3012AACN, 3012AACP, 3012AACQ, 3012AACR, 3012AACS, 3012AACT, 3012AACW, 3012AADA, 3012AADB, 3012AADC, 3012AADD, 3012AADE, 3012AADF, 3012AADG, 3012BAAA, 3012BAAB, 3012BAAC, 3012BAAD, 3012BAAE, 3012BAAF, 3012BAAG, 3012BAAH, 3012BAAJ, 3012BAAK, 3012BAAL, 3012BAAM, 3012BAAN, 3012BAAP, 3012BAAQ, 3012BAAR, 3012BAAS, 3012BAAT, 3012BAAU, 3012BAAW, 3012BABA, 3012BABB, 3012BABC, 3012BABD, 3012BABE, 3012BABF, 3012BABG, 3012BABH, 3012BABJ, 3012BABK, 3012BABL, 3012BABM, 3012BABN, 3012BABP, 3012BABQ, 3012BABR, 3012BABS, 3012BABT, 3012BABU, 3012BABW, 3012BACE, 3012BACG, 3012BACH, 3012BACJ, 3012BACK, 3012BACL, 3012BACM, 3012BACN, 3012BACP, 3012BACQ, 3012BACR, 3012BACS, 3012BACT, 3012BACU, 3012BACW, 3012BADA, 3012BADB, 3012BADC, 3012BADD, 3012BADG, 3012BADH, 3012BADJ, 3012BADK, 3012BADL, 3012BADN, 3012BADP, 3012BADR, 3012BADS, 3012BADU, 3012BADW, 3012BAEA, 3012BAEB, 3012BAEC, 3012BAEH, 3012BAEJ, 3012BAEL, 3012BAEM, 3012BAEN, 3012BAEQ, 3012BAER French Catalog 60-3000 301-02 Serial # 3012 AAAE German Catalog 60-300060-301-03, Serial # 3012AAAF Spanish Catalog 60-3000-301-11, Serial # 3012AAAB, 3012AAAC, 3012AACG, 3012BACA, 3012BACB, 3012BACC, 3012BACD Dutch 60-3000-301-12, Serial # 3012AAAA, 3012AAAD, 3012EACA
ClassificationClass II
Reason for RecallZimmer is conducting a voluntary removal of some Zimmer A.T.S. 3000 tourniquets after receiving complaints of both out-of-box failures and failures during surgical procedures on some of the affected units. During failure the unit will alarm, lock into a non-operational mode, and the display screen will go blank. Based on investigation, this problem appears to be due to a counterfeit chip on the control board.
Product Quantity204
Recall NumberZ-0296-2013

Class II Food Event

Event ID63466
StatusTerminated
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Oct-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmWhole Foods Market Group Inc.
CityEverett
StateMA
CountryUS
Distribution PatternMassachusetts, Connecticut, New York and New Jersey
 

Associated Products

Product DescriptionWhole Foods Meal Shrimp Stir Fry, 16 oz plastic container, Refrigerated, Product Code 3640630222
Code InfoSell by dates: 10/8/2012 and 10/10/2012
ClassificationClass II
Reason for RecallLabel fails to declare tree nuts (almond and cashews) in the "Contains:" allergen statement.
Product Quantity164 units
Recall NumberF-0684-2013

Class II Biologics Event

Event ID63475
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmOklahoma Lions Eye Bank
CityOklahoma City
StateOK
CountryUS
Distribution PatternOklahoma; Egypt
 

Associated Products

Product DescriptionCornea
Code Info110227100, 110227200
ClassificationClass II
Reason for RecallHuman Corneas, recovered from a donor who had not been properly evaluated, were distributed.
Product Quantity2
Recall NumberB-0154-13

Class II Food Event

Event ID63508
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmParadise Tomato Kitchens Inc
CityLouisville
StateKY
CountryUS
Distribution PatternVarious states
 

Associated Products

Product DescriptionMazzio's Marinara Sauce, 6.65-lb pouch, 6 pouches per case Pouches are packed in cardboard box for shipment
Code InfoLot Numbers: 101141 101195 101253 101304
ClassificationClass II
Reason for RecallThe ingredient statement does not declare milk as the source of the butter on the label.
Product Quantity6352 cases
Recall NumberF-0690-2013

Class II Drugs Event

Event ID63511
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmNew England Compounding Center
CityFramingham
StateMA
CountryUS
Distribution PatternNationwide Japan
 

Associated Products

Product DescriptionAll Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
Code InfoAll lot codes
ClassificationClass II
Reason for RecallLack of Assurance of Sterility
Product Quantity
Recall NumberD-052-2013
Product DescriptionAll Non Sterile Products manufactured by NECC (New England Compounding Center), Framingham, MA. A complete list of products can be found on their website at www.neccrx.com
Code InfoAll lot codes
ClassificationClass II
Reason for RecallGMP Deviations
Product Quantity
Recall NumberD-053-2013

Class II Drugs Event

Event ID63585
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmeridose LLC
CityWestborough
StateMA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionAll Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
Code InfoAll lot codes within expiry
ClassificationClass II
Reason for RecallLack of assurance of sterility
Product Quantity
Recall NumberD-054-2013
Product DescriptionAll Non-Sterile Products manufactured by Ameridose LLC, Westborough, MA. A complete list of all products subject to this recall can be accessed on-line at www.ameridose.com
Code InfoAll lot codes within expiry
ClassificationClass II
Reason for RecallGMP deficiencies
Product Quantity
Recall NumberD-055-2013

Class II Devices Event

Event ID63586
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Oct-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmTrivascular, Inc
CitySanta Rosa
StateCA
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide and the countries of Belgium, Cyprus, Italy, Spain, Switzerland and Turkey. TriVascular stated that no purchased devices are in hospital inventory in Europe or the U.S.
 

Associated Products

Product DescriptionTriVascular brand Fill Polymer Kit, Endovascular Graft, Aneurysm Treatment System, European Model Number: TVFP14-B, (in European distributor inventory only); PRODUCT Usage: The TriVascular Ovation Abdominal Stent Graft System is indicated in subjects diagnosed with an aneurysm in the abdominal aorta having vascular morphology suitable for endovascular repair, including: (1) Adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories, (2) Non-aneurysmal proximal aortic neck: - with a length of at least 7 mm proximal to the aneurysm, - with an inner wall diameter of no less than 16 mm and no greater than 30 mm, and - with an aortic angle of d 60 degrees if proximal neck is e 10 mm and d 45 degrees if proximal neck is < 10 mm, (3) Non-aneurysmal distal iliac landing zone: - with a length of at least 10 mm, - with an inner wall diameter of no less than 8 mm and no greater than 20 mm
Code InfoThe following lot numbers are in distributor inventory in Europe: FF121211-04, FF010912-01, FF013112-01, FF020912-01, FF022212-03, FF022912-01, FF040412-01, FF051012-01
ClassificationClass II
Reason for RecallSelected lots of the Fill Polymer Kit (European Model Number: TVFP14- B) in European distributor inventory only that potentially contain leaking stopcocks due to possible cracks in the stopcock component. TriVascular indicated that these Fill Polymer Kits are for use with the Ovation or Ovation Prime Abdominal Stent Graft Systems that may display leaks upon initiation of mix but prior to use in the patient.
Product Quantity41 units
Recall NumberZ-0288-2013

Class II Biologics Event

Event ID63601
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOne Lambda Inc
CityCanoga Park
StateCA
CountryUS
Distribution PatternDomestic and international consignees. US Sates nationwide, Canada, Saudi Arabia, UK, France, Germany, Italy, Russia, Sweden, Portugal and Spain, Turkey, Brazil, China, Chile, Japan, and Malaysia.
 

Associated Products

Product DescriptionProduct Name: LABType® HD Class II DRB1 Typing Test Product Number: RSSOH2B1/RSSOH2B1X Lot Number: 07B Expiration Date: 03/2014 Product Insert Number: RSSO_LTYP_PI_EN Rev 21
Code InfoLot Number: 07B Expiration Date: 03/2014 Product Insert Number: RSSO_LTYP_PI_EN Rev 21
ClassificationClass II
Reason for RecallHLA typing assay, associated with incorrect typing results, was distributed.
Product Quantity1
Recall NumberB-0340-13

Class II Devices Event

Event ID63603
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGulf South Medical Supply Inc
CityJacksonville
StateFL
CountryUS
Distribution PatternNationwide distribution: USA including states of: DE, KY, LA, MD, NJ, NY, PA, TX, VA, and WV.
 

Associated Products

Product DescriptionSelect Medical Products Vinyl Powder-Free Exam Gloves, Medium Model # 6370 and Large Model # 6371, 100 per box; 10 boxes per case. Usage: Patient Examination.
Code InfoLot # (for both sizes) 030212BU216995995 Medium gloves are Model # 6370, Product # 802634 Large gloves are Model # 6371, Product # 80635.
ClassificationClass II
Reason for RecallGulf South Medical Supply recalled their Select Medium and Large size Vinyl Exam Gloves because they were inadvertently shipped prior to U.S. Customs clearing them for sale.
Product Quantity275 cases and 17 boxes
Recall NumberZ-0295-2013

Class II Devices Event

Event ID63660
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMOOG Medical Devices Group
CitySalt Lake City
StateUT
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) including the countries of Canada and Lithuania.
 

Associated Products

Product DescriptionEnteraLite Infinity Enteral Feeding Pump identified with the following list numbers: INFKIT2 and INFORNG. The device is used with disposable PVC administration tubing sets to provide a means for the volumetric delivery of fluids used in enteral applications. The EnteraLite Infinity enteral feeding pump with disposable PVC administration tubing sets and user accessories provide a means for the volumetric delivery of fluids used in enteral applications.
Code InfoINFKIT2 with serial numbers: 506249031, 506264096, 506272024, 506335006, 506335145, 506336089, 506336096, 506362083, 506362086, 507018037, 507018060, 507067220, 507085140, 507087018, 507087140, 507095089, 507095171, 507121102, 507122050, 507122066, 507123149, 507123163, 507144016, 507144057, 507144215, 507144220, 507144221, 507144226, 507151002, 507155019, 507155021, 507155094, 507155127, 507155156, 507155159, 507156065, 507157048, 507157124, 507164009, 507173005, 507173019, 507173063, 507179123, 507180064, 507186018, 507186098, 507186176, 507197012, 507197024, 507197036, 507201013, 507201038, 507205054, 507206064, 507212012, 507212013, 507214065, 507214098, 507214162, 507215041, 507218016, 507219057, 507219087, 507219103, 507220106, 507221098, 507227116, 507229033, 507229039, 507229060, 507232030, 507236063, 507236203, 507236303, 507239056, 507241089, 507242130, 507242201, 507247049, 507248031, 507248087, 507248095, 507249131, 507250175, 507255025, 507257123, 507257129, 507261065, 507264041, 507264127, 507268121, 507268351, 507268374, 507269084, 507270096, 507270106, 507271157, 507275046, 507276154, 507278013, 507281028, 507281055, 507283119, 507284158, 507285186, 507289004, 507289120, 507289157, 507289165, 507291090, 507291168, 507291232, 507292108, 507292179, 507292339, 507295099, 507306069, 507311133, 507313050, 507313057, 507313059, 507313084, 507325044, 507330149, 507337080, 507337082, 507337085, 507339076, 507339095, 507344149, 507345001, 507345103, 507347150, 507348077, 507351090, 507353065, 507353120, 508018015, 508018090, 508030083, 508037024, 508037097, 508039099, 508039101, 508058001, 508058159, 508058160, 508066002, 508066030, 508066097, 508066123, 508066152, 508066153, 508066268, 508067033, 508067069, 508067092, 508067117, 508067166, 508067229, 508067231, 508070062, 508070228, 508071060, 508071132, 508071257, 508072146, 508072151, 508077022, 508099062, 508100033, 508112135, 508112159, 508114018, 508114111, 508116029, 508126038, 508131043, 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511076144, 511076145, 511076146, 511076147, 511076148, 511076149, 511076150, 511076151, 511076152, 511076153, 511076154, 511076155, 511076156, 511076157, 511076158, 511076159, 511076160, 511076161, 511076162, 511076163, 511076164, 511076165, 511076166, 511076167, 511076168, 511076169, 511076170, 511076171, 511076172, 511076173, 511076174, 511076175, 511076176, 511076177, 511076178, 511076179, 511076180, 511077001, 511077002, 511077003, 511077004, 511077005, 511077006, 511077007, 511077008, 511077009, 511077010, 511077011, 511077012, 511077013, 511077014, 511077015, 511077016, 511077017, 511077018, 511077019, 511077020, 511077022, 511077023, 511077024, 511077025, 511077026, 511077027, 511077028, 511077029, 511077030, 511077031, 511077032, 511077033, 511077034, 511077035, 511077036, 511077037, 511077038, 511077039, 511077040, 511077041, 511077042, 511077043, 511077044, 511077045, 511077046, 511077047, 511077048, 511077049, 511077050, 511077051, 511077052, 511077053, 511077054, 511077055, 511077056, 511077057, 511077058, 511077059, 511077060, 511077061, 511077062, 511077063, 511077064, 511077065, 511077066, 511077067, 511077068, 511077069, 511077070, 511077071, 511077072, 511077073, 511077074, 511077075, 511077076, 511077077, 511077078, 511077079, 511077080, 511077081, 511077082, 511077083, 511077084, 511077085, 511077086, 511077087, 511077088, 511077089, 511077090, 511077091, 511077092, 511077093, 511077094, 511077095, 511077096, 511077097, 511077098, 511077099, 511077100, 511077101, 511077102, 511077103, 511077104, 511077105, 511077106, 511077107, 511077108, 511077109, 511077110, 511077111, 511077112, 511077113, 511077114, 511077115, 511077116, 511077117, 511077118, 511077119, 511077120, 511077121, 511077122, 511077123, 511089001, 511089002, 511089003, 511089004, 511089005, 511089006, 511089007, 511089008, 511089009, 511089010, 511089011, 511089012, 511089013, 511089014, 511089015, 511089016, 511089017, 511089018, 511089019, 511089020, 511089021, 511089022, 511089023, 511089024, 511089025, 511089026, 511089027, 511089028, 511089029, 511089030, 511089031, 511089032, 511089033, 511089034, 511089035, 511089036, 511089037, 511089038, 511089040, 511089041, 511089042, 511089043, 511089044, 511089045, 511089046, 511089047, 511089048, 511089049, 511089050, 511089051, 511089052, 511089053, 511089054, 511089055, 511089056, 511089057, 511089058, 511089059, 511089060, 511089061, 511089062, 511089063, 511089064, 511089065, 511089066, 511089067, 511089068, 511089069, 511089070, 511089071, 511089072, 511089073, 511089074, 511089075, 511089076, 511089077, 511089078, 511089079, 511089080, 511089081, 511089082, 511089083, 511089084, 511089085, 511089086, 511089087, 511089088, 511089089, 511089090, 511089091, 511089092, 511089093, 511089094, 511089095, 511089096, 511089097, 511089098, 511089099, 511089100, 511089101, 511089102, 511089103, 511089104, 511089105, 511089106, 511089107, 511089108, 511089109, 511089110, 511089111, 511089112, 511089113, 511089115, 511089116, 511089117, 511089118, 511089119, 511089120, 511089121, 511089122, 511089123, 511089124, 511089125, 511089126, 511089127, 511089128, 511089129, 511089130, 511089131, 511089132, 511089133, 511089134, 511089135, 511089136, 511089137, 511089138, 511089139, 511089140, 511089141, 511089142, 511089143, 511089144, 511089145, 511089146, 511089147, 511089148, 511089149, 511089150, 511089151, 511089152, 511089153, 511089154, 511089155, 511089156, 511089157, 511089158, 511089159, 511089160, 511089161, 511089162, 511089163, 511089164, 511089165, 511089166, 511089167, 511089168, 511089169, 511089170, 511089171, 511089172, 511089173, 511089174, 511097001, 511097002, 511097003, 511097004, 511097006, 511097007, 511097008, 511097009, 511097010, 511097011, 511097012, 511097013, 511097014, 511097015, 511097016, 511097017, 511097018, 511097019, 511097020, 511097021, 511097022, 511097023, 511097024, 511097025, 511097026, 511097027, 511097028, 511097029, 511097030, 511097031, 511097032, 511097033, 511097034, 511097035, 511097036, 511097037, 511097038, 511097039, 511097040, 511097041, 511097042, 511097043, 511097044, 511097045, 511097046, 511097047, 511097048, 511097049, 511097050, 511097051, 511097052, 511097053, 511097054, 511097055, 511097056, 511097057, 511097058, 511097059, 511097060, 511097061, 511097062, 511097063, 511097064, 511097065, 511097066, 511097067, 511097068, 511097069, 511097070, 511097071, 511097072, 511097073, 511097074, 511097075, 511097076, 511097077, 511097078, 511097079, 511097080, 511097081, 511097083, 511097084, 511097085, 511097086, 511097087, 511097088, 511097089, 511097090, 511097091, 511097092, 511097093, 511097094, 511097095, 511097096, 511097097, 511097098, 511097099, 511097100, 511097101, 511097102, 511097103, 511097104, 511097105, 511097106, 511097107, 511097108, 511097109, 511097110, 511097111, 511097112, 511097113, 511097114, 511097115, 511097116, 511097117, 511097118, 511097119, 511097120, 511097121, 511097122, 511097123, 511097124, 511097125, 511097126, 511097127, 511097128, 511097129, 511103001, 511103002, 511103003, 511103004, 511103005, 511103006, 511103007, 511103008, 511103009, 511103010, 511103011, 511103012, 511103013, 511103014, 511103015, 511103016, 511103017, 511103018, 511103019, 511103020, 511103021, 511103022, 511103023, 511103024, 511103025, 511103026, 511103027, 511103028, 511103029, 511103030, 511103031, 511103032, 511103033, 511103034, 511103035, 511103036, 511103037, 511103038, 511103039, 511103040, 511103041, 511103042, 511103043, 511103044, 511103045, 511103046, 511103047, 511103048, 511103049, 511103050, 511103051, 511103052, 511103053, 511103054, 511103055, 511103056, 511103057, 511103058, 511103059, 511103060. INFORNG with serial numbers: 608164025, 609065045, 610036056, 610216015, 610216042, 610244002, 610244003, 610244004, 610244005, 610244006, 610244007, 610244008, 610244009, 610244011, 610244012, 610244013, 610244014, 610244015, 610244016, 610244017, 610244018, 610244019, 610244020, 610244021, 610244022, 610244023, 610244024, 610244025, 610244026, 610244027, 610244028, 610244029, 610244030, 610244031, 610244032, 610244033, 610244034, 610244035, 610244036, 610244037, 610244038, 610244039, 610244040, 610244041, 610244042, 610244043, 610244044, 610244045, 610244046, 610244047, 610244048, 610244049, 610244050, 610244051, 610244052, 610244053, 610244054, 610321001, 610321002, 610321003, 610321004, 610321005, 610321006, 610321007, 610321008, 610321009, 610321010, 610321011, 610321012, 610321013, 610321014, 610321015, 610321016, 610321017, 610321018, 610321019, 610321020, 610321021, 610321022, 610321023, 610321024, 610321025, 610321026, 610321027, 610321028, 610321029, 610321030, 610321031, 610321034, 610321035, 610321036, 610321037, 610321038, 610321039, 610321040, 610321041, 610321042, 610321043, 610321044, 610321045, 610321046, 610321047, 610321048, 610321049, 610321050, 610321051, 610321052, 610321053, 610321054, 610321055, 610321056, 610321057, 610321058, 610321059, 610321060, 610321061, 610321062, 610321063, 610321064, 610336001, 610336002, 610336003, 610336004, 610336005, 610336006, 610336007, 610336008, 610336009, 610336010, 610336011, 610336012, 610336013, 610336014, 610336015, 610336016, 610336017, 610336018, 610336019, 610336020, 610336021, 610336022, 610336023, 610336024, 610336025, 610336026, 610336027, 610336028, 610336029, 610336030, 610336031, 610336032, 610336033, 610336034, 610336035, 610336036, 610336037, 610336038, 610336039, 610336040, 610336041, 610336042, 610336043, 610336044, 610336045, 610336046, 610336047, 610336048, 610336049, 610336050, 610336051, 610336052, 610336053, 610336054, 610336055, 610336056, 610336057, 610336058, 610336059, 610336060, 610354001, 610354002, 610354003, 610354004, 610354005, 610354006, 610354007, 610354008, 610354009, 610354010, 610354011, 610354012, 610354013, 610354014, 610354015, 610354016, 610354017, 610354018, 610354019, 610354020, 610354021, 610354022, 610354023, 610354024, 610354025, 610354026, 610354027, 610354028, 610354029, 610354030, 610354031, 610354032, 610354033, 610354034, 610354035, 610354036, 610354037, 610354038, 610354039, 610354040, 610354041, 610354042, 610354043, 610354044, 610354045, 611054001, 611054002, 611054003, 611054004, 611054005, 611054006, 611054007, 611054008, 611054009, 611054010, 611054011, 611054012, 611054013, 611054014, 611054015, 611054016, 611054017, 611054018, 611054019, 611054020, 611054021, 611054022, 611054023, 611054024, 611054025, 611054026, 611054027, 611054028, 611054029, 611054030, 611054031, 611054032, 611054033, 611054034, 611054035, 611054036, 611054037, 611054038, 611054039, 611054040, 611054041, 611054042, 611054043, 611054044, 611054045, 611054046, 611054047, 611054048, 611054049, 611054050, 611054051, 611054052, 611054053, 611081001, 611081002, 611081003, 611081004, 611081005, 611081006, 611081007, 611081008, 611081009, 611081010, 611081011, 611081012, 611081013, 611081014, 611081015, 611081016, 611081017, 611081018, 611081019, 611081020, 611081021, 611081022, 611081023, 611081024, 611081025, 611081026, 611081027, 611081028, 611081029, 611081030, 611081031, 611081032, 611081033, 611081034, 611081035, 611081036, 611081037, 611081038, 611081039, 611081040, 611081041, 611081042, 611081043, 611081044, 611081045, 611081046, 611081047, 611081048, 611081049.
ClassificationClass II
Reason for RecallMOOG Medical Devices Group is conducting a voluntary for a limited set of serial numbers of the EnteraLite Infinity and Infinity Orange Small Volume Enteral Feeding Pumps because certain diodes on the PCB assembly may result in insufficient voltage to a portion of the pump resulting in an error 13 message and shutting the pump down entirely.
Product Quantity8,736
Recall NumberZ-0294-2013

Class III Biologics Event

Event ID38917
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Jun-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityFarmington
StateCT
CountryUS
Distribution PatternConnecticut
 

Associated Products

Product DescriptionHelixate FS Antihemophilic Factor (Recombinant), Formulated with Sucrose
Code InfoLot Nos: 27N1162, 27N10V1, 27N11J1, 27N1501, 27N1511
ClassificationClass III
Reason for RecallAntihemophilic Factor (Recombinant), lacking assurance of proper temperature maintenance during storage, was distributed.
Product Quantity5
Recall NumberB-0193-13

Class III Biologics Event

Event ID42051
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Apr-06
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionPlatelets
Code Info01KH97931
ClassificationClass III
Reason for RecallBlood product, which did not meet acceptable product specifications, was distributed. .
Product Quantity1 unit
Recall NumberB-0015-13

Class III Biologics Event

Event ID48857
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternKansas
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045008026209
ClassificationClass III
Reason for RecallBlood product, for which the additive solution was not added during manufacturing, was distributed.
Product Quantity1 unit
Recall NumberB-0009-13

Class III Biologics Event

Event ID50653
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Nov-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityFarmington
StateCT
CountryUS
Distribution PatternCT, NY
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code Info033FL15312 (pool ID: 12845)
ClassificationClass III
Reason for RecallBlood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity1 unit
Recall NumberB-0028-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info033FL15336, 033FL15339, 033GL92944, 033GL92945, 033GL92950
ClassificationClass III
Reason for RecallBlood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity5 units
Recall NumberB-0029-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info033FL15292, 033FL15296, 033FL15300, 033FL15301, 033FL15311, 033FL15318, 033FL15319, 033FL15336, 033FN15653, 033FN15659, 033FN15673, 033FN15677, 033FN15679, 033GL92930, 033GL92931, 033GL92933, 033GL92935, 033GL92944
ClassificationClass III
Reason for RecallBlood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity18 units
Recall NumberB-0030-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info033FP67241, 033FP67243, 033FP67244
ClassificationClass III
Reason for RecallBlood products, which were incorrectly tested for human T-lymphotropic virus (HTLV), were distributed.
Product Quantity3 units
Recall NumberB-0031-13

Class III Drugs Event

Event ID62940
StatusCompleted
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmStat Rx USA
CityGainesville
StateGA
CountryUS
Distribution PatternFL, PA, and VA.
 

Associated Products

Product DescriptionTobramycin Ophthalmic Oint., 0.3%, 5ml bottle, (Generic for: Tobrex), Rx only, Sterile, Mfg By Akorn, Inc., Lake Forest, IL 60045, NDC 16590-224-05,
Code InfoLot 06JN1265 Exp 3/14 and 06JN1266 Exp 4/14
ClassificationClass III
Reason for RecallLabeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
Product Quantity22 units
Recall NumberD-050-2013

Class III Biologics Event

Event ID63036
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jul-12
Initial Firm Notification of Consignee or Public FAX
Recalling FirmThe American National Red Cross - Southern Region
CityDouglasville
StateGA
CountryUS
Distribution PatternGeorgia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info003FC73672; 003FC73672(2); 003FC73672(3);
ClassificationClass III
Reason for RecallBlood products, which were exposed to unacceptable temperature during storage, were distributed.
Product Quantity3 units
Recall NumberB-0082-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info003FC73673; 003FC73673(2); 003FC73691; 003FC73691(2); 003FC73692; 003FC73692(2); 003FC73692(3); 003FC73693; 003FC73693(2); 003FC73693(3);
ClassificationClass III
Reason for RecallBlood products, which were exposed to unacceptable temperature during storage, were distributed.
Product Quantity10 units
Recall NumberB-0083-13

Class III Biologics Event

Event ID63300
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Aug-11
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmOne Lambda Inc
CityCanoga Park
StateCA
CountryUS
Distribution PatternUS, Canada, Saudi Arabia, Brazil, China, Japan, Mexico, New Zealand, Puerto Rico, Singapore, Taiwan, and Thailand.
 

Associated Products

Product DescriptionLABScreen® Product  LABScreen® Single Antigen HLA Class II Antibody Detection Test -GROUP 1 Product Number: LS2A01 510(K) Number : BK 030069 Product Code : MZI PMA Number : N/A Preamendment : No
Code InfoProduct Number: LS2A01 Lot Numbers : 003 - 008 Expiration Date: Lot 003 11/2007 Lot 004 09/2008 Lot 005 10/2009 Lot 006 05/2010 Lot 007 04/2012 Lot 008 04/2013 Product Insert Number: LS_LSCN-PI-EN-00, Rev. 17
ClassificationClass III
Reason for RecallLABScreen HLA Class II Antibody Detection Test, associated with false reactions with the DP20 antigen, was distributed.
Product Quantity6
Recall NumberB-0091-13

Class III Biologics Event

Event ID63301
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Centers of Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFL
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW036812496391
ClassificationClass III
Reason for RecallBlood product, collected from a donor whose arm inspection prior to collection was not performed, was distributed.
Product Quantity1
Recall NumberB-0047-13

Class III Biologics Event

Event ID63332
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida Lions Eye Bank, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternFlorida; Dominican Republic
 

Associated Products

Product DescriptionCornea
Code Info1106057COS; 1101093CODG1; 1101093CODG2; 1101093COSG1; 1101093COSG2; 1103009COD; 1103009COSG1; 1103009COSG2; 1103042CODG1; 1103042CODG2; 1103042COS; 1104100COD; 1104100COS; 1105042COD; 1105042COSGW; 1105052COD; 1105052COS; 1106005COD; 1106005COS; 1106057COD; 1107047COD; 1107047COS; 1109010COD; 1109010COS; 1110020CODG1; 1110020CODG2; 1110020COSG1; 1110020COSG2; 1203082COD; 1203082COS; 1204060COD; 1204060COS; 1206025COD; 1206025COS; 1105073-COD; 05073COS
ClassificationClass III
Reason for RecallHuman Corneas, recovered from donors whose donor eligibility was not determined by using appropriate FDA-licensed, approved, or cleared donor screening tests, in accordance with the manufacturer's instructions, to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or diseases, were distributed.
Product Quantity36
Recall NumberB-0196-13

Class III Drugs Event

Event ID63428
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmITW Dymon
CityOlathe
StateKS
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLemon Hand Sanitizing Wipes [n-alkyl dimethyl benzyl ammonium chloride (0.1%) and n-alkyl dimethyl ethyl benzyl ammonium chloride (0.1%)], labeled as a) Genuine Joe Cleaning Supplies, Lemon Scent, Anti-microbial Hand Sanitizing Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured for S.P. Richards Co., 6300 Highlands Pkwy., Smyma, GA 30082, UPC 0 35255 10477 7; b) Pro Chem Lemon Aid, Hand Sanitizing Wipes, 85-count premoistened wipes per bucket, 6 buckets per case, An exclusive product of: Pro Chem, Inc., 1475 Bluegrass Lakes Parkway, Alpharetta, GA 30004; c) Scrubs, Lemon Hand Sanitizer Wipes, 120-count premoistened wipes per bucket, 6 buckets per case, Manufactured in the U.S.A. by ITW Dymon, 805 E. Old 56 Highway, Olathe, KS 66061, UPC 7 64769 92991 9.
Code InfoLot #: a) B26221, Exp 09/18/15; b) B94221, Exp 09/05/15; c) B94221, Exp 09/05/15
ClassificationClass III
Reason for RecallCGMP Deviations: The products were manufactured with raw material which contain unknown particles believed to be water and dirt.
Product Quantitya) 216 cases; b) 75 cases; c) 29 cases
Recall NumberD-056-2013

Class III Devices Event

Event ID63536
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Sep-12
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHoriba Instruments, Inc dba Horiba Medical
CityIrvine
StateCA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionABX PENTRA Creatinine 120 CP, Model Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709. The ABX PENTRA Creatinine 120 CP is an in vitro diagnostic assay for the quantitative determination of creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). It is composed of a 27 ml monoreagent cassette. Reagent is a chemical solution with additives. ABX PENTRA Creatinine 120 CP reagent, with associated calibrator and controls, is a diagnostic reagent for quantitative in vitro determination of Creatinine in human serum, plasma and urine based on a kinetic method using alkaline picrate (Jaffe method). Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes. This reagent is intended for use on the ABX PENTRA 400 Clinical Chemistry Analyzer.
Code InfoModel Number Creatinine Part # A11A01868, Lot Numbers: 203273706, 203273707, 203273808, 203273709.
ClassificationClass III
Reason for RecallThis recall was initiated because some customers were experiencing an alarm during Creatinine calibration "REAG RANGE HIGH". This alarm caused the calibration to fail and prevented the user from using the Creatinine assay.
Product Quantity8,503 units
Recall NumberZ-0289-2013

Class III Biologics Event

Event ID63609
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Oct-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBio-Rad Laboratories
CityRedmond
StateWA
CountryUS
Distribution PatternProduct was distributed nationwide and to Australia and France.
 

Associated Products

Product DescriptionMultispot HIV-1/HIV-2 Rapid Test has a catalog # 25228.
Code InfoExpiration date:April 23, 2013
ClassificationClass III
Reason for RecallBio-Rad Multispot HIV-1/HIV-2 Rapid Test, with reports of decreased reactivity accompanied by a faint speckling appearance on cartridge membrances when using some vials of Conjugate, were distributed.
Product Quantity1 Unit
Recall NumberB-0354-13

Class III Drugs Event

Event ID63659
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Aug-12
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmStat Rx USA
CityGainesville
StateGA
CountryUS
Distribution PatternGA and TN.
 

Associated Products

Product DescriptionVenlafaxine ER 150mg, 30 Tabs bottle, Generic for: Effexor, Packaged and Distributed by: Stat Rx USA, LLC, Gainesville, GA 30501 NDC 42549-684-30
Code InfoLot # A00984 Exp. 01/14
ClassificationClass III
Reason for RecallLabeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Product Quantity5 bottles
Recall NumberD-051-2013

Mixed Classification Biologics Event

Event ID47045
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternTN, CA
 

Associated Products

Product DescriptionRecovered Plasma
Code Info02KH09464
ClassificationClass III
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0032-13
Product DescriptionRed Blood Cells
Code Info02KH09464
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0033-13

Mixed Classification Biologics Event

Event ID50432
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Sep-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican Red Cross Blood Services
CityWichita
StateKS
CountryUS
Distribution PatternKS, CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info02LP19845
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0024-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info02LP19845
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-0025-13
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