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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Class I Food Event

Event ID61892
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCaribe Produce
CitySan Juan
StateTX
CountryUS
Distribution PatternNJ and NC
 

Associated Products

Product DescriptionCaribena Brand papayas packed in 35 lb. cartons marked with the brand "Caribena" and "Product of Mexico" stamped on the side. Each papaya bears a label which states "3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO www.grandeproduce.com" Papayas are packed in boxes of 8-12 papayas per box
Code InfoEach papaya bears a label which states "3112 CARIBENA Papaya MARADOL PRODUCT OF MEXICO www.grandeproduce.com". Lot # 115123
ClassificationClass I
Reason for RecallProduct has the potential to be contaminated with salmonella.
Product Quantity1,152 cartons each with 35 lbs. of product
Recall NumberF-1643-2013

Class I Food Event

Event ID63209
StatusOngoing
Product TypeFood
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 FirmFood Source, Inc
CityEdinburg
StateTX
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionTomorrow's Tropicals Mangos Distributed by FoodSource A C.H. Robinson Company Edinburg, Texas 78539
Code InfoAll product sourced by Agricola Daniella, produced 7/16/12-9/14/12.
ClassificationClass I
Reason for RecallOut of an abundance of caution, the firm is voluntarily recalling mangoes that have been sourced from Agricola Daniella. The recall was initiated after the FDA warning to consumers not to eat any mangoes from Agricola Daniella was issued.
Product Quantity610,780
Recall NumberF-1596-2013

Class I Food Event

Event ID63233
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Sep-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmGHSW, LLC
CityHouston
StateTX
CountryUS
Distribution PatternFL, LA, and TX
 

Associated Products

Product DescriptionGarden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated Island Medley Net Wt. 1 lb (454g) Renaissance Food Group LLC Rancho Cordova, CA 95670 www.gardenhighway.com Ingredients: Pineapple, Mango, Papaya Packed in its own juice, UPC Code: 826766201044
Code InfoBest if Sold By 9/8/12, 9/13/12. and 9/15/12
ClassificationClass I
Reason for RecallThe product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.
Product Quantity1741 lb. total for recall
Recall NumberF-1605-2013
Product DescriptionFruit Burst, ingredients: Cantaloupe, Pineapple, Honeydew, Watermelon, Red Grapes, Mango, Strawberries, Blueberries: 1) Garden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated, Net Wts 1 lb, UPC 826766241071 and 1.5 lbs., UPC 826766241279; 2) Fruit Burst Net Wt. 1 lb Renaissance Food Group LLC Rancho Cordova, CA 95670 www.gardenhighway.com. Packed in its own juice., UPC 826766241279; 2) Winn-Dixie, Jacksonville, FL 32254 Perishable, Keep Refrigerated Net Wts 1 lb (454g) UPC 021140017017, and 1.5 lb (680g), UPC 021140017079
Code Info1) 1 lb. and 1.5 lb., Best if Sold By: 9/8/12, 9/13/12, and 9/15/12 2) 1 lb Containers: , Best if Sold By: 9/7/12, 9/8/12, 9/10/12, 9/11/12, 9/12/12, and 9/15/12. 1.5 lb Containers: Best if Sold By: 9/7/12, 9/8/12, 9/10/12, 9/11/12, 9/12/12, 9/14/12, and 9/15/12
ClassificationClass I
Reason for RecallThe product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.
Product Quantity1741 lb. total for recall
Recall NumberF-1606-2013
Product DescriptionGarden Highway Fresh Fruit No Preservatives Perishable Keep Refrigerated Mango Medley Net Wt. 10 oz (284g) Renaissance Food Group LLC, Rancho Cordova, CA 95670, UPC: 826766214334 www.gardenhighway.com Ingredients: Cantaloupe, Pineapple, Mango, Red Grapes Packed in its own juice
Code InfoBest if Sold By: 9/8/12, 9/9/12, 9/11/12, 9/13/12
ClassificationClass I
Reason for RecallThe product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.
Product Quantity1741 lb. total for recall
Recall NumberF-1607-2013
Product DescriptionMango Spears: 1) Garden Highway Fresh Fruit Perishable Keep Refrigerated Mango Spears Net Wt 1 LB (454g) Renaissance Food Group LLC ,Rancho Cordova, CA 95670 www.gardenhighway.com Ingredients: Mango Packed in its own juice; UPC: 826766268498 2) Mango Spears 1 lb (454g) Ingredients: Mango Packed in its own juice. Distributed By: Winn-Dixie Stores, Inc. Jacksonville, FL 32254 Perishable Keep Refrigerated, UPC: 021140016942
Code Info1) Best if Sold By: 9/8/12, 9/11/12, and 9/13/12 2) Best if Sold By: 9/7/12, 9/8/12, 9/10/12, 9/11/12, 9/12/12, 9/14/12, and 9/15/12
ClassificationClass I
Reason for RecallThe product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.
Product Quantity1741 lb. total for recall
Recall NumberF-1608-2013
Product DescriptionSignature CAFE Fruit Basket Medley Perishable Keep Refrigerated NET WT 30 oz (1 LB 14 OZ) 850g Ingredients: Red Grapes, Pineapple, Cantaloupe, Mango, Watermelon, Apples (Apples, Calcium Ascorbate [a blend of calcium and vitamins to maintain color] Distributed By Lucerne Foods, Inc. P.O. Box 99, Pleasanton, CA 94566-0009, UPC 021130069187
Code InfoUse By: SEP 7 12, SEP 10 12, and SEP 12 12
ClassificationClass I
Reason for RecallThe product has the potential to be contaminated with Salmonella. Contains mangoes sourced from Agricola Daniella.
Product Quantity1741 lb. total for recall
Recall NumberF-1609-2013

Class I Food Event

Event ID63234
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-12
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmDel Monte Fresh Produce North America, Inc
CityDallas
StateTX
CountryUS
Distribution PatternProduct was distributed directly to the states of Florida, Georgia, Missouri, North Carolina, Ohio, and Texas. Product was then shipped further from the firm's direct accounts.
 

Associated Products

Product DescriptionMango (Fresh Cut): Del Monte brand slices, 32 oz., UPC 7-62357-07532-1, 32 oz., UPC 7-17524 72503-5; 16 oz., UPC 7-17524-71902-7, 8 oz., UPC 7-17524-72506-7, UPC 7-17524-72506-6; Del Monte brand chunks, 7 oz., 7 Eleven brand chunks, 6 oz., UPC 0-52548-52070-0
Code InfoDel Monte, 32 oz., best by 9/26/12, 9/27/12 and 9/28/12; 16 oz., best by 9/26/12 and 9/27/12; 8 oz., best by 9/26/12; chunks 7 oz., Lot 05262101 7 Eleven chunks, 6 oz., best by 9/28/12 and 9/29/12
ClassificationClass I
Reason for RecallIn cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.
Product Quantity3071 unit total
Recall NumberF-1610-2013
Product DescriptionDel Monte brand Tropical Fruit Medley, 16 oz., UPC 7-17524-77649-5
Code Infobest by 9/26/12
ClassificationClass I
Reason for RecallIn cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.
Product Quantity3071 units total
Recall NumberF-1611-2013
Product DescriptionDel Monte brand Tropical Fruit Bowl, 28 oz., UPC 7-17524-77651-8; 64 oz., UPC 7-17524-77834-5
Code Infoboth sizes, best by 9/26/12
ClassificationClass I
Reason for RecallIn cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.
Product Quantity3071 units total
Recall NumberF-1612-2013
Product DescriptionDel Monte brand Tropical Blend, 7 oz., Lot number 05262101; 16 oz., UPC 7-17524-77868-7
Code Infoboth sizes, best by 9/27/12
ClassificationClass I
Reason for RecallIn cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.
Product Quantity3071 units total
Recall NumberF-1613-2013
Product DescriptionSeasonal Blend: Del Monte brand, 32 oz., UPC 7-17524-77604-4; 7 Eleven brand, 6 oz., UPC 7-17524-77647-1; 16 oz., UPC 7-17524-77647-1; Wal-Mart, 10 oz., UPC 7-17524-77815-4; 16 oz., UPC 7-17524-77603-7; 32 oz., UPC 7-17524-77604-4
Code InfoDel Monte, best by 9/27/12; 7 Eleven, 6 oz., best by 9/29/12, 16 oz., best by 9/27/12 and 9/29/12; Wal-Mart, all sizes, best by 9/26/12
ClassificationClass I
Reason for RecallIn cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.
Product Quantity3071 units total
Recall NumberF-1614-2013
Product Description7 Eleven brand Pineapple/Mango/Grape, 6 oz., UPC 0-52548-51986-5
Code Info6 oz., best by 9/28/12 and 9/29/12
ClassificationClass I
Reason for RecallIn cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.
Product Quantity3071 units total
Recall NumberF-1615-2013
Product Description7 Eleven brand Strawberry/Kiwi/Mango, 6 oz., UPC 0-52548-51979-7
Code Info6 oz., best by 9/28/12 and 9/29/12
ClassificationClass I
Reason for RecallIn cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.
Product Quantity3071 units total
Recall NumberF-1616-2013
Product DescriptionApple Blend, generic, 16 oz., sold at Wal-Mart, UPC 7-17524-77626-6
Code Infobest by 9/26/12
ClassificationClass I
Reason for RecallIn cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.
Product Quantity3071 units total
Recall NumberF-1617-2013
Product DescriptionFruit Bowl, generic, 48 oz., sold at Wal-Mart, UPC 7-17524-77687-7
Code Infobest by 9/26/12
ClassificationClass I
Reason for RecallIn cooperation with the FDA's warning to not consume mangoes from Agricola Daniella in Mexico, Del Monte Fresh Produce N.A., Inc, is initiating a voluntary recall of 1,600 bowls of fresh-cut mangoes distributed to retail outlets due to the potential risk that the mangoes may contain Salmonella. Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. This recall is associated with FoodSource's (Edinburg, TX) recall of mangoes sourced from Agricola Daniella in Mexico.
Product Quantity3071 units total
Recall NumberF-1618-2013

Class I Food Event

Event ID65373
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmCreole & Company, LLC
Citynew orleans
StateLA
CountryUS
Distribution PatternLA
 

Associated Products

Product DescriptionCreole & Company Creole Bisque, NET WEIGHT 3.47 oz (98g), manufacture for: Creole & Company, 145 Robert E. Lee Blvd. Penthouse Suite, New Orleans, LA 70124, UPC: 811773014869
Code InfoNone, the product is not lot coded
ClassificationClass I
Reason for RecallProduct which contains milk, soy, and wheat was distributed without an ingredient statement which declares their presence.
Product Quantity22 cases of 20 units
Recall NumberF-1645-2013

Class I Food Event

Event ID65375
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmARO Pistachios, Inc.
CityTerra Bella
StateCA
CountryUS
Distribution PatternCA, TX, MN, OR, NY, MI, UT, IA, AL, VA, NJ,AZ, GA, PA. and FL, IL, SC, OH, MA, NE, KY, UT, CT, LA, IN, DC, KS, OK, NH,, RI,, NC, MD, AK,
 

Associated Products

Product DescriptionARO Pistachios, Pistachios raw kernel - no salt; Sold in 9 oz. raw kernel, no salt airtight jar; 2.5 lb raw Kernel, no salt, air tight jar; 30 lb Bulk raw kernel, no salt.
Code Infoall codes in 2012 crop year.
ClassificationClass I
Reason for RecallEpidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm.
Product Quantity~550,000 pounds 2012 crop year.
Recall NumberF-1632-2013
Product DescriptionARO Pistachios, Inc., Pistachios roasted/salted, in shell; sold in 6 oz. in shell R/S Poly Resealable bag; 1 lb. in shell R/S Poly Resealable bag; 2 lb. R/S airtight Jar 5 lb. in shell R/S Poly Resealable bag 25 lb bulk in shell R/S
Code InfoAll codes from 2012 crop year.
ClassificationClass I
Reason for RecallEpidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm.
Product Quantity~550,000 lbs total crop year.
Recall NumberF-1633-2013
Product DescriptionARO Pistachios, Inc., Pistachios roasted inshell - no salt; 25 lb bulk .
Code InfoAll codes from 2012 crop year.
ClassificationClass I
Reason for RecallEpidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm.
Product Quantity~550,000 lbs total crop year.
Recall NumberF-1634-2013
Product DescriptionARO Pistachios, Inc., Pistachios inshell - raw; 25 lb bulk .
Code InfoAll codes from 2012 crop year.
ClassificationClass I
Reason for RecallEpidemiological evidence in Salmonella Senftenberg outbreak points to product produced at firm.
Product Quantity~550,000 lbs. total crop year.
Recall NumberF-1635-2013

Class I Food Event

Event ID65392
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLipari Foods, Inc.
CityWarren
StateMI
CountryUS
Distribution PatternOhio, Michigan, West Virginia, Kentucky, Tennessee, Pennsylvania, Wisconsin, Illinois, and Indiana.
 

Associated Products

Product DescriptionItem Number: 101643 Item Description: TUB CHOC DD PEANUTS Case Pack: 12 Package Size: 8 OZ 2-Piece Clear Tub (Zoppity Label on Top, Nutritional Label on Bottom) UPC Number: 094776095575
Code InfoLot Number: 22201304 Best By Date: 4/22/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity33 cases
Recall NumberF-1659-2013
Product DescriptionItem Number: 192772 Item Description: BAG CLR SUNFLOWER R/SEA SALT Case Pack: 12 Package Size: 11 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207018849
Code InfoLot Number: 23201305 Best By Date: 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity193 cases
Recall NumberF-1660-2013
Product DescriptionItem Number: 192806 Item Description: BAG CLR PUMPKIN SD R/SEA SALT Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207018832
Code InfoLot Number: 23201305 Best By Date: 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity107 cases
Recall NumberF-1661-2013
Product DescriptionItem Number: 192874 Item Description: BAG CLR SUNFLOWER MEAT W/SLT Case Pack: 12 Package Size: 7 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000424
Code InfoLot Number: 15201304 Best By Date: 4/15/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity127 cases
Recall NumberF-1662-2013
Product DescriptionItem Number: 192959 Item Description: BAGS SM PEPITA SEEDS R/S Case Pack: 12 Package Size: 2.75 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207022501
Code InfoLot Number: 23201305 Best By Date: 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity115 cases
Recall NumberF-1663-2013
Product DescriptionItem Number: 192976 Item Description: BAG CLR SUNFLOWER MEAT RAW PP Case Pack: 12 Package Size: 7 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000202
Code InfoLot Numbers: 08201304, 15201304, 23201305, 03201306, 06201306 Best By Dates: 4/8/2014, 4/15/2014, 5/23/2014, 6/3/2014, 6/6/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity109 cases
Recall NumberF-1664-2013
Product DescriptionItem Number: 192993 Item Description: BAG CLR SESAME STX OAT BRAN PP Case Pack: 12 Package Size: 4.75 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000011
Code InfoLot Number: 23201305 Best By Date: 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity78 cases
Recall NumberF-1665-2013
Product DescriptionItem Number: 193010 Item Description: BAGS SM CASHEW JUMBO R/S Case Pack: 12 Package Size: 1 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207022068
Code InfoLot Number: 23201305 Best By Date: 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity94 cases
Recall NumberF-1666-2013
Product DescriptionItem Number: 193044 Item Description: BAGS LG PECAN PIECES Case Pack: 12 Package Size: 4 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207016227
Code InfoLot Number: 08201304 Best By Date: 4/8/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity122 cases
Recall NumberF-1667-2013
Product DescriptionItem Number: 193061 Item Description: BAG CLR ALMOND SLICED RAW PP Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000110
Code InfoLot Numbers: 08201304, 23201305, 03201306 Best By Dates: 4/8/2014, 5/23/2014, 6/3/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity85 cases
Recall NumberF-1668-2013
Product DescriptionItem Number: 193078 Item Description: BAGS SM SUNFLOWER SHELLED R/S Case Pack: 12 Package Size: 4 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207029029
Code InfoLot Number: 23201305 Best By Date: 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity87 cases
Recall NumberF-1669-2013
Product DescriptionItem Number: 193095 Item Description: BAGS LG SESAME STIX HONEY Case Pack: 12 Package Size: 4.5 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207004484
Code InfoLot Numbers: 15201304, 23201305 Best By Dates: 4/15/2014, 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity200 cases
Recall NumberF-1670-2013
Product DescriptionItem Number: 193129 Item Description: BAGS LG CASHEW JUMBO R/S Case Pack: 12 Package Size: 6 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207022853
Code InfoLot Numbers: 15201304, 23201305 Best By Dates: 4/15/2014, 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity255 cases
Recall NumberF-1671-2013
Product DescriptionItem Number: 193282 Item Description: BAG CLR CASHEW JUMBO N/SALT PP Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000288
Code InfoLot Number: 06201306 Best By Date: 6/6/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity54 cases
Recall NumberF-1672-2013
Product DescriptionItem Number: 193333 Item Description: BAGS LG WALNUT HALVES & PIECES Case Pack: 12 Package Size: 6.5 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207015206
Code InfoLot Numbers: 08201304, 06201306 Best By Dates: 4/8/2014, 6/6/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity48 cases
Recall NumberF-1673-2013
Product DescriptionItem Number: 193435 Item Description: BAGS LG PUMPKIN SEEDS I/S R/S Case Pack: 12 Package Size: 7 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207025151
Code InfoLot Number: 23201305 Best By Date: 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity136 cases
Recall NumberF-1674-2013
Product DescriptionItem Number: 193673 Item Description: BAGS SM PEPITA SEEDS R/S Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207025106
Code InfoLot Number: 23201305 Best By Date: 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity67 cases
Recall NumberF-1675-2013
Product DescriptionItem Number: 193775 Item Description: BAGS SM ALMOND SLIVERED Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207018412
Code InfoLot Numbers: 08201304, 23201305 Best By Dates: 4/8/2014, 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity104 cases
Recall NumberF-1676-2013
Product DescriptionItem Number: 193843 Item Description: BAGS SM ALMONDS SLICED RAW Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207018351
Code InfoLot Numbers: 08201304, 03201306, 06201306 Best By Dates: 4/8/2014, 6/3/2014, 6/6/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity100 cases
Recall NumberF-1677-2013
Product DescriptionItem Number: 193894 Item Description: BAGS SM ALMONDS WHOLE RAW Case Pack: 12 Package Size: 1.75 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207018405
Code InfoLot Number: 06201306 Best By Date: 6/6/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity114 cases
Recall NumberF-1678-2013
Product DescriptionItem Number: 196274 Item Description: BAGS LG ALMOND SLICED Case Pack: 12 Package Size: 3.25 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207018207
Code InfoLot Numbers: 08201304, 23201305 Best By Dates: 4/8/2014, 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity89 cases
Recall NumberF-1679-2013
Product DescriptionItem Number: 196291 Item Description: BAGS SM WALNUT HALVES & PIECES Case Pack: 12 Package Size: 1 OZ Fully Preprinted Old Style Pic-A-Nut Bag UPC Number: 070207015121
Code InfoLot Number: 08201304 Best By Date: 4/8/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity52 cases
Recall NumberF-1680-2013
Product DescriptionItem Number: 196325 Item Description: BAG CLR ALMOND SLIVERED Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 070207000127
Code InfoLot Number: 06201306 Best By Date: 6/6/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity73 cases
Recall NumberF-1681-2013
Product DescriptionItem Number: 201612 Item Description: BAGS SM PISTACHIO SHELLED R/S Case Pack: 12 Package Size: 0.75 OZ Fully Preprinted New Style Pic-A-Nut Bag UPC Number: 070207020217
Code InfoLot Numbers: 15201304, 23201305 Best By Dates: 4/15/2014, 5/23/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity144 cases
Recall NumberF-1682-2013
Product DescriptionItem Number: 204128 Item Description: TUB PAN MD ALMOND ROASTED N/S Case Pack: 12 Package Size: 11 OZ 2-Piece Clear Plastic Tub (Pic-A-Nut Label on Top, Nutritional Label on Bottom) UPC Number: 070207005030
Code InfoLot Number: 30201305 Best By Date: 05/30/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity172 cases
Recall NumberF-1683-2013
Product DescriptionItem Number: 204145 Item Description: TUB PAN MD CASHEW JUMBO N/S Case Pack: 12 Package Size: 10 OZ 2-Piece Clear Plastic Tub (Pic-A-Nut Label on Top, Nutritional Label on Bottom) UPC Number: 070207005061
Code InfoLot Number: 30201305 Best By Date: 05/30/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity147 cases
Recall NumberF-1684-2013
Product DescriptionItem Number: 208903 Item Description: TUB SM PEPITA ROASTED W/SALT Case Pack: 12 Package Size: 8 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208113017
Code InfoLot Number: 09201305 Best By Date: 5/9/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity32 cases
Recall NumberF-1685-2013
Product DescriptionItem Number: 224411 Item Description: MIX CHERRY BERRY DELITE Case Pack: 1 Package Size: 25# Cardboard Box with Plastic Liner UPC: 094776121793
Code InfoLot Number: 15201304 Best By Date: 04/15/14
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity53 units
Recall NumberF-1686-2013
Product DescriptionItem Number: 333803 Item Description: TUB SM PISTACHIO MEAT RAW Case Pack: 12 Package Size: 9 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208123818
Code InfoLot Numbers: 23201305, 24201305 Best By Dates: 05/23/2014, 05/24/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity144 cases
Recall NumberF-1687-2013
Product DescriptionItem Number: 357642 Item Description: TUB SM ALMOND WHOLE RAW Case Pack: 12 Package Size: 10 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208107450
Code InfoLot Numbers: 23201305, 24201305 Best By Dates: 05/23/2014, 05/24/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity186 cases
Recall NumberF-1688-2013
Product DescriptionItem Number: 364761 Item Description: BAGS SUNFLOWER KERNEL RAW PP Case Pack: 12 Package Size: 12 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110452
Code InfoLot Numbers: 08201304, 30201304, 05201306 Best By Dates: 4/8/2014, 4/30/2014, 6/5/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity50 cases
Recall NumberF-1689-2013
Product DescriptionItem Number: 364773 Item Description: BAGS PUMPKIN SEEDS NATURAL PP Case Pack: 12 Package Size: 9 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110353
Code InfoLot Number: 05201306 Best By Date: 6/5/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity49 cases
Recall NumberF-1690-2013
Product DescriptionItem Number: 364926 Item Description: BAGS PEAS WASABI PP Case Pack: 12 Package Size: 10 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110582
Code InfoLot Number: 08201304 Best By Date: 4/8/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity78 cases
Recall NumberF-1691-2013
Product DescriptionItem Number: 364932 Item Description: BAGS PRETZELS YOGURT PP Case Pack: 12 Package Size: 10 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110599
Code InfoLot Number: 08201304 Best By Date: 4/8/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity122 cases
Recall NumberF-1692-2013
Product DescriptionItem Number: 365163 Item Description: BAGS BANANA CHIPS PP Case Pack: 12 Package Size: 10 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110186
Code InfoLot Numbers: 08201304, 30201304 Best By Dates: 4/8/2014, 4/30/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity177 cases
Recall NumberF-1693-2013
Product DescriptionItem Number: 365172 Item Description: BAGS MIX CHERRY BERRY DELIGHT PP Case Pack: 12 Package Size: 9.5 OZ Clear Plastic Bag (Black Label on Front, Nutritional Label on Back) UPC Number: 094776110209
Code InfoLot Numbers: 08201304, 30201304 Best By Dates: 4/8/2014, 4/30/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity63 cases
Recall NumberF-1694-2013
Product DescriptionItem Number: 366568 Item Description: TUB LG MIX DIET DELIGHT Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081769
Code InfoLot Numbers: 09201304, 20201305 Best By Dates: 4/9/2014, 05/20/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity203 cases
Recall NumberF-1695-2013
Product DescriptionItem Number: 368712 Item Description: TUB MD GOOD & PLENTY Case Pack: 12 Package Size: 16 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776110032
Code InfoLot Number: 30201305 Best By Date: 05/30/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity75 cases
Recall NumberF-1696-2013
Product DescriptionItem Number: 368729 Item Description: TUB MD HAZELNUT/FILBERT RAW Case Pack: 12 Package Size: 9 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776110049
Code InfoLot Number: 30201305 Best By Date: 05/30/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity86 cases
Recall NumberF-1697-2013
Product DescriptionItem Number: 368768 Item Description: TUB LG SUNFLOWER MEAT R/NS Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081752
Code InfoLot Numbers: 09201304, 24201304, 20201305, 30201305 Best By Dates: 4/9/2014, 04/24/2014, 05/20/2014, 05/30/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity462 cases
Recall NumberF-1698-2013
Product DescriptionItem Number: 373703 Item Description: TUB LG ALMOND ROASTED N/SLT Case Pack: 12 Package Size: 15 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776076116
Code InfoLot Number: 01201305 Best By Date: 05/01/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity125 cases
Recall NumberF-1699-2013
Product DescriptionItem Number: 374103 Item Description: TUB LG ALMOND WHOLE RAW Case Pack: 12 Package Size: 15 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081820
Code InfoLot Number: 09201304 Best By Date: 4/9/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity302 cases
Recall NumberF-1700-2013
Product DescriptionItem Number: 374903 Item Description: TUB LG MIXED NUTS DELUXE W/S Case Pack: 12 Package Size: 13 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 094776081707
Code InfoLot Number: 24201304 Best By Date: 04/24/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity161 cases
Recall NumberF-1701-2013
Product DescriptionItem Number: 379235 Item Description: BAG CLEAR PINE NUTS Case Pack: 12 Package Size: 3 OZ Clear Plastic Bag (Pic-A-Nut Label on Front, Nutritional Label on Back) UPC Number: 094776110087
Code InfoLot Number: 03201306 Best By Date: 6/3/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity23 cases
Recall NumberF-1702-2013
Product DescriptionItem Number: 392103 Item Description: TUB LG CASHEW RAW WHOLE 320 Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No Label on Top, Nutritional Label on Bottom) UPC Number: 760208124983
Code InfoLot Number: 09201304 Best By Date: 4/9/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity162 cases
Recall NumberF-1703-2013
Product DescriptionItem Number: 395203 Item Description: TUB LG SUNFLOWER MEAT RAW Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (No label on Top, Nutritional Label on Bottom) UPC Number: 094776081738
Code InfoLot Numbers: 09201304, 24201304, 01201305, 20201305, 30201305 Best By Dates: 4/9/2014, 4/24/2014, 5/1/2014, 5/20/2014, 5/30/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity121 cases
Recall NumberF-1704-2013
Product DescriptionItem Number: 461564 Item Description: TUB PL LG SUNFLOWER SEED RAW Case Pack: 12 Package Size: 14 OZ 2-Piece Clear Plastic Tub (Private Label on Top, Nutritional Label on Bottom) UPC Number: 094776081738
Code InfoLot Numbers: 09201304, 24201304, 01201305, 20201305, 30201305 Best By Dates: 4/9/2014, 4/24/2014, 5/1/2014, 5/20/2014, 5/30/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity64 cases
Recall NumberF-1705-2013
Product DescriptionItem Number: 423622 Item Description: TUB MD MIX CHERRY BERRY Case Pack: 12 Package Size: 12 OZ 2-Piece Clear Plastic Tub ('Cherry' Label on Top, Nutritional Label on Bottom) UPC Number: 094776111404
Code InfoLot Number: 16201305 Best By Date: 5/16/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity0
Recall NumberF-1706-2013
Product DescriptionItem Number: 545303 Item Description: NATURAL GINGER CRYSTALLIZED Case Pack: 12 Package Size: 7 OZ 2-Piece Clear Plastic Tub (Alex's Natural Label on Top, Nutritional Label on Bottom) UPC Number: 094776082940
Code InfoLot Number: 09201305 Best By Date: 5/9/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity90 cases
Recall NumberF-1707-2013
Product DescriptionItem Number: 545603 Item Description: NATURAL ALMONDS DARK CHOC Case Pack: 12 Package Size: 11 OZ 2-Piece Clear Plastic Tub (Alex's Natural Label on Top, Nutritional Label on Bottom) UPC Number: 094776082971
Code InfoLot Number: 08201304 Best By Date: 4/8/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity207 cases
Recall NumberF-1708-2013
Product DescriptionItem Number: 545803 Item Description: NATURAL SUNFLOWER KERNEL Case Pack: 12 Package Size: 9 OZ 2-Piece Clear Plastic Tub (Alex's Natural Label on Top, Nutritional Label on Bottom) UPC Number: 094776082995
Code InfoLot Numbers: 08201304, 22201304, 08201305, 09201305, 23201305, 24201305 Best By Dates: 4/8/2014, 4/22/2014, 5/8/2014, 5/9/2014, 5/23/2014, 5/24/2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity139 cases
Recall NumberF-1709-2013
Product DescriptionItem Number: 631215 Item Description: SUNFLOWER SEED KERNELS RAW Case Pack: 1 Package Size: 50# Brown Bag UPC Number: 079348999086
Code Info50# Lot Numbers: PRO-1346, PRO-1349 Best By Date: April 2014
ClassificationClass I
Reason for RecallContamination with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.
Product Quantity1295 (50# bag)
Recall NumberF-1710-2013

Class I Food Event

Event ID65419
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPalmer Candy Co
CitySioux City
StateIA
CountryUS
Distribution PatternDistribution made to TN, ND, NE, IL, SD and MO. No foreign or military/government distribution made.
 

Associated Products

Product DescriptionEagle Premium, Snack Shoppe, Pistachios, in-shell pistachios, packaged in 2-oz (UPC 4262500705) and 5.25-oz (UPC 42625000604) bags. Distributed by: Genco Marketing, Omaha, NE.
Code Info2-oz packages - Best Before: 10/16/13; 10/17/13; 10/18/13; 10/30/13; 11/14/13; 12/15/13; 02/20/14; 03/04/14; 03/18/14; 03/26/14; 04/04/14; 04/16/14; 04/23/14 and 05/16/14 5.25-oz packages - Best Before: 10/16/13; 04/14/14 and 04/24/14
ClassificationClass I
Reason for RecallThe product may be contaminated with Salmonella.
Product Quantity112/12/5.25-oz bag/cases and 4,264/8/2.0-oz bag/cases
Recall NumberF-1637-2013

Class I Devices Event

Event ID65430
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic MiniMed
CityNorthridge
StateCA
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) distribution: Algeria, Argentina, Australia, Bahamas, Bahrain, Bermuda, Boliva, Bosnia and Herzegovina, Brazil, Canada, Chile, China, Columbia, Costa Rica, Croatia, Cyprus, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Finland, France, French Southern Territories, Germany, Great Britain, Greece, Guatemala, Hong Kong, India, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kuwait, Latvia, Lebanon, Macedonia, Malaysia, Mexico, Morocco, Netherlands, Norway, New Zealand, Oman, Panama, Paraguay, Peru, Poland, Province of China, Taiwan, Qatar, Republic of Korea, Romania, Russia Federation, Saint Lucia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Thailand, Trinidad and Tobago, Turkey, Ukraine, United Arab Emirates, Uruguay, and Venezuela.
 

Associated Products

Product DescriptionMedtronic MiniMed Paradigm Insulin Infusion Sets The Paradigm infusion sets are intended for use with Paradigm insulin infusion pumps.
Code InfoThis field correction involves models: MMT-317, MMT-318, MMT-324, MMT-325, MMT-312S, MMT-312L, MMT-386, MMT-387, MMT-394, MMT-396, MMT-397, MMT-398, MMT-399, MMT-377, MMT-378, MMT-381, MMT-382, MMT-383, MMT-384, MMT-368, MMT-862, MMT-864, MMT-866, MMT-874, MMT-876, MMT-884, MMT-886, MMT-921, MMT-923, MMT-925, MMT-941, MMT-943, MMT-945, MMT-961, MMT-963, MMT-965, & MMT-975 Paradigm Infusion sets.
ClassificationClass I
Reason for RecallMedtronic is recalling the Medtronic MiniMed Paradigm Insulin Infusion sets because of a potential safety issue that can occur if insulin or other fluids come in contact with the inside of Medtronic Paradigm infusion sets. Under certain conditions, the infusion set may malfunction and deliver an incorrect volume of insulin
Product Quantity11,000,000 units
Recall NumberZ-1668-2013

Class I Food Event

Event ID65448
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHines Nut Co
CityDallas
StateTX
CountryUS
Distribution PatternAR, MN, PA, and TX
 

Associated Products

Product DescriptionRoasted and Salted In Shell Pistachio Nuts, repackaged into 48 ounce red topped gift jars labeled "Orchard Fresh HINES"; 16 ounce trays labeled "Natural Pistachios, Roasted and Salted"; and 16 ounce bags labeled "Hines Natural Pistachios".
Code InfoNo lot number appears on the gift jars; the trays and 1 pound bags have a Hines Nut Company lot number "04396" or "4396".
ClassificationClass I
Reason for RecallThe product recall is being initiated because the product has the potential to be contaminated with Salmonella.
Product Quantity4,000 lbs
Recall NumberF-1658-2013

Class I Devices Event

Event ID65449
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBryan Medical Inc
CityCincinnati
StateOH
CountryUS
Distribution PatternDistributed in KY and AL.
 

Associated Products

Product DescriptionTracoe Mini 3.0mm Tube, for pediatric use. Pediatric tracheostomy tube used to provide safe airway access.
Code InfoThe following product/catalog number and lot number was affects: Ref #350-3.0, lot #000-1000071752
ClassificationClass I
Reason for RecallThe pediatric tracheostomy tubes were mislabeled as the smaller infant tracheostomy tubes.
Product Quantity5 units
Recall NumberZ-1667-2013

Class I Food Event

Event ID65480
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWestern Mixers Produce & Nuts, Inc.
CityLos Angeles
StateCA
CountryUS
Distribution PatternCA, OH, UT, FL, WA, NV, OR, AZ, TX
 

Associated Products

Product DescriptionTreasured Harvest-Roasted & Salted Pistachios, 5lbs, 12oz, 6oz
Code InfoLot Codes: 6 oz. size: 123050, 123140, 123320, 123450, 123360, 130150, 130240, 130350; 12 oz. size: 130290; 5 lb. Size: 123550, 130020
ClassificationClass I
Reason for RecallPistachios may be contaminated with Salmonella.
Product Quantity10,612 lbs total
Recall NumberF-1653-2013
Product DescriptionTreasured Harvest-Assorted Nut Trays, 28 oz, 6 per carton
Code InfoLot Codes: 123100, 122960, 123040
ClassificationClass I
Reason for RecallPistachios may be contaminated with Salmonella.
Product Quantity10,612 lbs total
Recall NumberF-1654-2013
Product DescriptionTreasured Harvest-Raw, Shelled Pistachios, 5lbs & 1lb, 1 per carton
Code InfoLot Codes: 1lb size: 131540; 5lbs size: 131160, 131200, 131230, 131300, 131400;
ClassificationClass I
Reason for RecallPistachios may be contaminated with Salmonella.
Product Quantity10,612 lbs total
Recall NumberF-1655-2013

Class I Food Event

Event ID65509
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmGranna's, LLC
CityBessie
StateOK
CountryUS
Distribution PatternAll product was distributed in Oklahoma.
 

Associated Products

Product DescriptionGranna's 412 Main, Bessie, Oklahoma 705 Tuna Mac, Italian Blend Vegetables & Spiced Apple Rings
Code InfoBest By dates of 06/20/2013 to 06/20/2014.
ClassificationClass I
Reason for RecallThe product was recalled due to undeclared egg.
Product Quantity26,740 packages
Recall NumberF-1595-2013

Class I Food Event

Event ID65570
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmTorn & Glasser Inc.
CityEast Rancho Dominguez
StateCA
CountryUS
Distribution PatternCA, AZ, and HI.
 

Associated Products

Product DescriptionTorn and Glasser Brand Roasted & Salted Natural Pistachios, 8 oz. 24/8oz Case. Labeling reads in part:"TORN & GLASSER***ROASTED & SALTED NATURAL PISTACHIOS***NET WT. 8 OZ***Packed by:Torn & Glasser, Los Angeles, CA***"
Code InfoBest By date:12/05/2012, Julian date 3402 UPC: 0 72488 15002 7
ClassificationClass I
Reason for RecallPistachios have the potential to be contaminated with Salmonella.
Product Quantity3 cases
Recall NumberF-1656-2013
Product DescriptionRoasted and Salted Pistachios packed under the following brand names and packaging: Sprouts Brand Roasted & Salted Pistachios, various weights. into 12 individual plastic bags with various weights per unit, then packaged into 10 lbs cardboard box. . Sun Harvest Brand Roasted & Salted Pistachios, 12 oz., packaged in plastic bag then packed into cardboard case. 24/12oz. Hilo Brand Roasted & Salted Pistachios, 16 oz., plastic bags, packed into 12/1lb case. Individual 1 lb plastic bag labeling. Outer case #H460-084; 12/1 LB (454g).
Code InfoSprouts - Best By dates:02/20/2013, 02/25/13; Julian Dates:0513 and 0563; UPC code changes for each package of Sprouts product as it has the price coded, 2 06620 xxxxx x. Sun Harvest - Best By Dates:04/11/2013 & 04/23/2013; Julian Dates:1003 and 1133. Hilo - Best By Date:04/02/2013; Julian Date:0923
ClassificationClass I
Reason for RecallPistachios have the potential to be contaminated with Salmonella.
Product Quantity328 cases
Recall NumberF-1657-2013

Class II Biologics Event

Event ID39169
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Feb-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmAmerican National Red Cross (The)
CityTucson
StateAZ
CountryUS
Distribution PatternArizona
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info007FN52555
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to a malaria endemic area, was distributed.
Product Quantity1
Recall NumberB-1709-13

Class II Biologics Event

Event ID39191
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-May-07
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSouthern California Permanente Medical Group Blood Bank
CitySan Diego
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoFJ62759
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1782-13
Product DescriptionFresh Frozen Plasma
Code InfoFJ62759
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1783-13

Class II Biologics Event

Event ID40132
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-May-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthern California Permanente Medical Group Blood Donor Ctr
CityDowney
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionPlatelets Pheresis
Code InfoGP13388A; GP13388B; GP13276; GP13234
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity4 units
Recall NumberB-1676-13

Class II Biologics Event

Event ID40191
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-May-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank of San Bernardino and Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCalifornia, Washington DC, Switzerland
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoGQ24012; GQ16732; GL53069
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the medication Purinethol, were distributed.
Product Quantity3 units
Recall NumberB-1784-13
Product DescriptionFresh Frozen Plasma
Code InfoGQ24012; GL53069
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the medication Purinethol, were distributed.
Product Quantity2 units
Recall NumberB-1785-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGQ46933; GQ42775
ClassificationClass II
Reason for RecallBlood products, collected from a donor taking the medication Purinethol, were distributed.
Product Quantity2 units
Recall NumberB-1786-13

Class II Biologics Event

Event ID40489
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Aug-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHemaCare Corporation
CitySherman Oaks
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionFresh Frozen Plasma
Code Info40225560
ClassificationClass II
Reason for RecallBlood products, labeled with an incorrect ABO type, were distributed.
Product Quantity1 unit
Recall NumberB-1794-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info 4025560
ClassificationClass II
Reason for RecallBlood products, labeled with an incorrect ABO type, were distributed.
Product Quantity1 unit
Recall NumberB-1795-13

Class II Biologics Event

Event ID41094
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Sep-05
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthern California Permanente Medical Group Blood Bank
CityIrvine
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoFJ62632
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1801-13
Product DescriptionFresh Frozen Plasma
Code InfoFJ62632
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1802-13

Class II Biologics Event

Event ID41826
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe American National Red Cross South Carolina Region
CityColumbia
StateSC
CountryUS
Distribution PatternSC
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info36LE12634 Part 1, 36LE12634 Part 2
ClassificationClass II
Reason for RecallBlood products, which did not meet the acceptable product specifications, were distributed.
Product Quantity2 units
Recall NumberB-1710-13

Class II Biologics Event

Event ID42335
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmBloodNetUSA, Inc.
CityLakeland
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info6647950 and 6608685.
ClassificationClass II
Reason for RecallBlood products, collected from a donor who had traveled to a malarial endemic area, were distributed.
Product Quantity2
Recall NumberB-1674-13

Class II Biologics Event

Event ID42386
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-May-06
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternIllinois, New York
 

Associated Products

Product DescriptionPlatelets
Code Info01KH99185; 01KK22409; 01KK22422; 01KK22414; 01W28412; 01W28416; 01FW27321; 01KH99018; 01KH99164; 01KH99173; 01KK22425; 01Y68661; 01Y68675 01Y68678; 01Y68681; 01Y68689; 01Y68693; 01Y68695
ClassificationClass II
Reason for RecallBlood products, collected from donors who traveled to potential malaria endemic areas, were distributed.
Product Quantity18
Recall NumberB-1715-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01KK22409; 01KK22414; 01KM36647; 01KM36670;
ClassificationClass II
Reason for RecallBlood products, collected from donors who traveled to potential malaria endemic areas, were distributed.
Product Quantity4
Recall NumberB-1716-13
Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info01KH99018
ClassificationClass II
Reason for RecallBlood products, collected from donors who traveled to potential malaria endemic areas, were distributed.
Product Quantity1
Recall NumberB-1717-13

Class II Biologics Event

Event ID44539
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Apr-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHemaCare Corporation
CitySherman Oaks
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code Info0726836; 0726836; 0726836
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-1788-13

Class II Biologics Event

Event ID46569
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Nov-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthern California Permanente Medical Group Blood Bank
CitySan Diego
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoFV87754
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-1803-13

Class II Biologics Event

Event ID48246
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Mar-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe American National Red Cross South Carolina Region
CityColumbia
StateSC
CountryUS
Distribution PatternSC
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info36L92853
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1711-13
Product DescriptionPlasma Frozen
Code Info36L92853
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1712-13

Class II Biologics Event

Event ID48483
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Mar-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2545079
ClassificationClass II
Reason for RecallBlood product, identified unsuitable due to a donor screening deviation, was distributed.
Product Quantity1 unit
Recall NumberB-1631-13

Class II Biologics Event

Event ID49317
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Aug-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthern California Permanente Medical Group Blood Donor Center
CityIrvine
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW071808005080
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1 unit
Recall NumberB-1790-13

Class II Biologics Event

Event ID49698
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Aug-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank of San Bernardino and Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGN91057
ClassificationClass II
Reason for RecallBlood product, collected from a donor with a history of Hepatitis A, was distributed.
Product Quantity1 unit
Recall NumberB-1806-13

Class II Biologics Event

Event ID49812
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Sep-08
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthern California Permanente Medical Group Blood Donor Center
CityIrvine
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW07180800087
ClassificationClass II
Reason for RecallBlood product, which did not meet the acceptable product specifications for release, was distributed.
Product Quantity1 unit
Recall NumberB-1791-13

Class II Biologics Event

Event ID50623
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Oct-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross (The)
CityWest Henrietta
StateNY
CountryUS
Distribution PatternNY
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info01KX94084
ClassificationClass II
Reason for RecallBlood products, in which routine testing interpreted or documented incorrectly, were distributed.
Product Quantity1 unit
Recall NumberB-1627-13
Product DescriptionPlatelets Leukocytes Reduced
Code Info01Q20922
ClassificationClass II
Reason for RecallBlood products, in which routine testing interpreted or documented incorrectly, were distributed.
Product Quantity1 unit
Recall NumberB-1628-13

Class II Biologics Event

Event ID50630
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Nov-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCSL Plasma Inc
CityTempe
StateAZ
CountryUS
Distribution PatternIL, CA, Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info0481140752, 0481144544, 0481143405, 0481139746, 0481136797, 0481135692, 0481133547, 0481131926, 0481130470, 0481128779, 0481127338, 0481124821, 0481123835, 0481121841 0481120824, 0481118127, 0481117175, 0481114690, 0481112748, 0481110630, 0481108999, 0481107026, 0481106141, 0481102517, 0481100805, 0481098555, 0481097037, 0481095951, 0481092615, 0481092031, 0481088182, 0481087379, 0481084331, 0481081938, 0481078834, 0481077362, 0481075084, 0481070832, 0481070128, 0481068129, 0481066918, 0481066257, 0481064907, 0481064382, 0481063187, 0481062597, 0481061449, 0481060853, 0481059667, 0481059086, 0481057965, 0481057416, 0481056188, 0481055571, 0481054514, 0481053946,
ClassificationClass II
Reason for RecallBlood products, collected from donors whose scheduled physical examinations were incomplete, were distributed.
Product Quantity56 units
Recall NumberB-1673-13

Class II Biologics Event

Event ID55636
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Feb-10
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross
CityBoise
StateID
CountryUS
Distribution PatternNC, ID , UT ,OR, MT, WY, CA, AZ
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info020LE28771, 020LE28776, 020LE28796, 020LE28802, 020LE29112, 020LE29116, 020LE29155, 020LE29169, 020LE29183, 020LP96569, 020LP96576, 020LP96605, 020LQ28067, 020LQ28078, 020LQ28224, 020LQ28248, 020LQ28298.
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity17 units
Recall NumberB-1696-13
Product DescriptionPlasma Frozen within 24 hours (FP24)
Code Info020LE28771, 020LE28776 , 020LE28802 , 020LE29112 , 020LE29122, 020LE29126, 020LE29142, 020LQ28072, 020LQ28078, 020LQ28224, 020LQ28259.
ClassificationClass II
Reason for RecallBlood products, which were collected in a manner that may have compromised the sterility of the collection system, were distributed.
Product Quantity11 units
Recall NumberB-1697-13

Class II Biologics Event

Event ID58357
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jan-11
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (the)
CityCharlotte
StateNC
CountryUS
Distribution PatternNC
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info012LV66398, 012LV66403, 012LV66405, 012LV66408, 012LV66409, 012LV66410, 012LV66413, 012LV66414, 012LV66417, 012LV66418, 012LV66419, 012LV66421, 012LV66422, 012LV66424, 012LV66425, 012LC66429
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity16 units
Recall NumberB-1713-13
Product DescriptionFresh Frozen Plasma
Code Info012LV66409, 012LV66410, 012LV66417, 012LV66418, 012LV66422, 012LV66425
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity6 units
Recall NumberB-1714-13

Class II Food Event

Event ID62716
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-12
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmChristian Cheese, LLC
CityKingfisher
StateOK
CountryUS
Distribution PatternCO and OK
 

Associated Products

Product DescriptionChristian Cheese Ranch Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, and Ranch Dressing. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.
Code InfoNo codes are used at the facility. All product made approximately on June 7, 2012.
ClassificationClass II
Reason for RecallUndeclared Soy lecithin
Product QuantityApproximately 15-16 units
Recall NumberF-1647-2013
Product DescriptionChristian Cheese Vegetable Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, Onion, Garlic, Basil, Red Bell Pepper, Black Pepper, Tomato, Vinegar, Parsley, Ginger, and Rosemary. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.
Code InfoNo codes are used at the facility. All product made approximately on June 7, 2012.
ClassificationClass II
Reason for RecallUndeclared Soy lecithin and Soybean Oil
Product QuantityApproximately 15-16 units
Recall NumberF-1648-2013
Product DescriptionChristian Cheese Ranch Bacon Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Rennet, Salt, Ranch Dressing and Bacon Bits. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.
Code InfoNo codes are used at the facility. All product made approximately on June 7, 2012.
ClassificationClass II
Reason for Recallundeclared Soy lecithin, Soybean Oil, and sulfites
Product QuantityApproximately 15-16 units
Recall NumberF-1649-2013
Product DescriptionChristian Cheese Sun-Dried tomato Cheddar Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Sun-Dried Tomato and Salt. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.
Code InfoNo codes are used at the facility. All product made approximately on June 7, 2012.
ClassificationClass II
Reason for RecallUndeclared Sulfites
Product QuantityApproximately 15-16 units
Recall NumberF-1650-2013
Product DescriptionChristian Cheese Blackberry Wine Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Salt, Blackberry Wine. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.
Code InfoNo codes are used at the facility. All product made approximately on June 7, 2012.
ClassificationClass II
Reason for RecallUndeclared sulfites
Product Quantity
Recall NumberF-1651-2013
Product DescriptionChristian Cheese Horseradish Cheddar Cheese Made in Kingfisher, Oklahoma (405-375-6711) Ingredients: Pasteurized Milk, Culture, Vegetable Rennet, Salt, and Horseradish. 1 unit weighing approximately 0.6 lbs and plastic vacuum packed in plastic. 1 case is approximately 32 units weighing approximately 0.60 lbs each.
Code InfoNo codes are used at the facility. All product made approximately on June 7, 2012.
ClassificationClass II
Reason for RecallUndeclared Soy lecithin and Soybean Oil
Product Quantity
Recall NumberF-1652-2013

Class II Biologics Event

Event ID64866
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Feb-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCoastal Bend Blood Center
CityCorpus Christi
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW230813809663; W230813809663;
ClassificationClass II
Reason for RecallBlood products, labeled leukoreduced without the assurance they met the criteria for leukoreduced products, were distributed.
Product Quantity2
Recall NumberB-1613-13

Class II Biologics Event

Event ID64873
StatusCompleted
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmArc Blood Services, New England Region
CityDedham
StateMA
CountryUS
Distribution PatternTennessee; New Hampshire; Vermont; Massachusetts; Maryland; Maine; New York
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code Info004LN27612; 004LS39882
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity2 units
Recall NumberB-1839-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info004FM18651; 004FM18653; 004FW12875; 004FW12880; 004FW12920P1; 004FW12920P2; 004FW13213; 004GH23026; 004GH24503; 004GH25651; 004GH26351; 004GH26455; 004GH26464; 004GH26469; 004GH26474; 004GQ14814; 004GQ14822; 004KF92568; 004LH16537; 004LH18502; 004LH18814; 004LH19273; 004LH19285; 004LN29942; 004LN29944; 004LS40757
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity26 units
Recall NumberB-1840-13

Class II Devices Event

Event ID65049
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmToshiba American Medical Systems Inc
CityTustin
StateCA
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionTOSHIBA Kalare Diagnostic X-Ray System K110785
Code InfoDREX-KL80 NO. SERIAL# LAST FOUR . MANUFACTURE DATE 1 99C1042292 2292 APRIL 2010 2 99C1162353 2353 JUNE 2011 3 99C1062307 2307 JUNE 2010 4 99C1072311 2311 JULY 2010 5 99C0972246 2246 JULY 2009 6 99C09Z2273 2273 DECEMBER 2009 7 99C1212372 2372 JANUARY 2012 8 99C0932234 2234 MARCH 2009 9 99C09X2262 2262 OCTOBER 2009 10 99C1182359 2359 AUGUST 2011 11 99C1022285 2285 FEBRUARY 2010 12 99C10Y2329 2329 NOVEMBER 2010 13 99C1092316 2316 SEPTEMBER 2010 14 99C1262385 2385 JUNE 2012 15 99C09Y2265 2265 NOVEMBER 2009 16 99C1122344 2344 FEBRUARY 2011 17 99C0982248 2248 AUGUST 2009 18 99C09Z2276 2276 DECEMBER 2009 19 99C1282389 2389 AUGUST 2012 20 99C1072309 2309 JULY 2010 21 99C0912228 2228 JANUARY 2009 22 99C1062303 2303 JUNE 2010 23 99C1212374 2374 JANUARY 2012 24 99C11Y2369 2369 NOVEMBER 2011 25 99C09X2260 2260 OCTOBER 2009 26 99C1042297 2297 APRIL2010 27 Jll1293530 3530 SEPTEMBER 2012 28 99C1012278 2278 JANUARY 2010 29 99C10Y2328 2328 NOVEMBER 2010 30 99C1052299 2299 MAY 2010 31 99C0982250 2250 AUGUST 2008 32 99C1242381 2381 APRIL 2012 33 J1H08Z3448 3448 DECEMBER 2008 34 99C1252383 2383 MAY 2012 35 99C1022287 2287 FEBRUARY 2010 36 99C1072308 2308 JULY 2010 37 99C1042291 2291 APRIL2010 38 99C1042290 2290 APRIL2010 39 99C09X2258 2258 OCTOBER 2009 40 99B0892210 2210 SEPTEMBER 2008 41 99C1162355 2355 JUNE 2011 42 99C11X2364 2364 OCTOBER 2011 43 99C1162352 2352 JUNE 2011 44 99B08Y2216 2216 NOVEMBER 2008 45 99C11X2367 2367 OCTOBER 2011 46 99C12Y2396 2396 NOVEMBER 2012 47 99C1162354 2354 JUNE 2011 48 99C1012282 2282 JANUARY 2010 49 99C1042294 2294 APRIL 2010 50 99C0912227 2227 JANUARY 2009 51 99C12X2393 2393 OCTOBER 2012 52 99C0982251 2251 AUGUST2009 53 99C1182358 2358 AUGUST2011 54 99B08X2213 2213 OCTOBER 2008 55 99C1012279 2279 JANUARY 2010 NO. SERIAL# LAST FOUR MANUFACTURE DATE 56 99C1062305 2305 JUNE 2010 57 99D0962239 2239 JUNE 2009 58 99C0922230 2230 FEBRUARY 2009 59 99C0992255 2255 SEPTEMBER 2009 60 99C09Z2271 2271 DECEMBER 2009 61 99C1092317 2317 SEPTEMBER 2010 62 99C1212371 2371 JANUARY 2012 63 99C1052302 2302 MAY2010 64 99C1012284 2284 JANUARY 2010 65 99C1152349 2349 MAY2011 66 99C1082315 2315 AUGUST2010 67 99C10Y2327 2327 NOVEMBER 2010 68 99C1272387 2387 JULY 2012 69 99C0972243 2243 JULY 2009 70 99C1062304 2304 JUNE 2010 71 99C10X2324 2324 OCTOBER 2010 72 99C09X2263 2263 OCTOBER 2009 73 99C0992256 2256 SEPTEMBER 2009 74 J1109X3472 3472 OCTOBER 2009 75 99C09X2261 2261 OCTOBER 2009 76 99B08Y2219 2219 NOVEMBER 2008 77 99B08X2214 2214 OCTOBER 2008 78 99C09Y2268 2268 NOVEMBER 2009 79 99C1132346 2346 MARCH 2011 80 99C1012281 2281 OCTOBER 2010 81 99C1122341 2341 FEBRUARY 2011 82 99C1122342 2342 FEBRUARY 2011 83 99C12X2394 2394 OCTOBER 2012 84 99C12X2392 2392 OCTOBER 2012 85 99C0962241 2241 JUNE 2009 86 99C11X2365 2365 OCTOBER 2011 87 99C0952238 2238 MAY2009 88 99C0992257 2257 SEPTEMBER 2009 89 99C1152350 2350 MAY2011 90 J1H0973467 33467 JULY 2009 91 99C1012277 2277 JANUARY 2010 92 99C09Y2264 2264 NOVEMBER 2009 93 99C10Z2337 2337 DECEMBER 2010 94 J1H0953463 3463 MAY 2009 95 99B08Y2217 2217 NOVEMBER 2008 96 99C1222376 2376 FEBRUARY 2012 97 99C10X2325 2325 SEPTEMBER 2010 98 99C1032289 2289 MARCH 2010 99 J1109Y3476 3476 NOVEMBER 2009 100 99C1052300 2300 MAY 2010 101 99C1252384 2384 MAY 2012 102 99C1072312 2312 JULY 2010 203 99C1022286 2286 FEBRUARY 2010 104 99C0952237 2237 MAY 2009 105 99C0972245 2245 JULY 2009 106 99C10X2326 2326 OCTOBER 2010 107 99C1282388 2388 AUGUST 2012 108 99C1182360 2360 AUGUST 2011 109 99C08Z2221 2221 DECEMBER 2008 110 J111023482 3482 FBRUARY 2010 NO. SERIAL# . LASTFOUR .· MANUFACTURE DATE 111 99B08Y221S 221S NOVEMBER 2008 112 99C1092319 2319 SEPTEMBER 2010 113 99C1112340 2340 JANUARY 2011 114 99C093223S 223S MARCH 2009 115 99C0962240 2240 JUNE 2009 116 99B08X2211 2211 OCTOBER 2008 117 99C0922233 2233 FEBRUARY 2009 118 99C1092321 2321 SEPTEMBER 2010 119 99C0922229 2229 FEBRUARY 2009 120 99C11S23S1 23S1 MAY 2011 121 J1H08X3442 3442 OCTOBER 2008 122 99C1072310 2310 JULY 2010 123 99B08Y2218 2218 NOVEMBER 2008 124 99C11623S6 23S6 JUNE 2011 125 99C09Y2266 2266 NOVEMBER 2009 126 99C1142348 2348 APRIL 2011 127 J1110X3S04 3S04 OCTOBER 2010 128 Jli12S3S29 3S29 MAY2012 129 99C08Z2222 2222 DECEMBER 2008 130 99C0972242 2242 JULY 2009 131 99C091222S 222S SEPTEMBER 2012 132 99C09Y2267 2267 NOVEMBER 2009 133 99C0972247 2247 JULY 2009 134 99B08X2212 2212 OCTOBER 2008 135 99C1112339 2339 JANUARY 2011 136 99C1072313 2313 JULY 2010 137 99C09922S4 22S4 SEPTEMBER 2009 138 99C1092320 2320 SEPTEMBER 2010 139 99C0972244 2244 JULY 2009 140 99C10S2298 2298 MAY 2010 141 99C09Z2274 2274 DECEMBER 2009 142 99C104229S 229S APRIL2010 143 99C09Z2272 2272 DECEMBER 2009 144 99C11X2368 2368 OCTOBER 2011 145 99C1212373 2373 JANUARY 2012 146 99C10X2323 2323 OCTOBER 2010 147 99C1012283 2283 JANUARY 2010 148 99B0892209 2209 SEPTEMBER 2008 149 99C08Z2220 2220 DECEMBER 2008 150 99C08Z2223 2223 DECEMBER 2008 151 99C1142347 2347 APRIL 2011 152 99B0892207 2207 SEPTEMBER 2008 153 99C09Z227S 227S DECEMBER 2008
ClassificationClass II
Reason for RecallFirm initiated recall because when radiographic conditions with the small focus are set and the radiography ready switch is held down, the large focus is also heated after a few seconds or more. This occurs when the Automatic Exposure Function (AEC) function is used. As a result, a radiographic tube current exceeding the set value flows and a brighter image than expected is acquired.
Product Quantity153 units
Recall NumberZ-1598-2013

Class II Biologics Event

Event ID65087
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmUniversity Of Miami Miller School of Medicine Tissue Bank
CityMiami
StateFL
CountryUS
Distribution PatternGreece
 

Associated Products

Product DescriptionFascia
Code Info0087040077
ClassificationClass II
Reason for RecallHuman tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed.
Product Quantity1 allograft
Recall NumberB-1747-13

Class II Devices Event

Event ID65090
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFresenius Medical Care Holdings, Inc.
CityWaltham
StateMA
CountryUS
Distribution PatternNationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.
 

Associated Products

Product DescriptionFresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
Code InfoPart Number: 640919
ClassificationClass II
Reason for RecallIncorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
Product Quantity725 units
Recall NumberZ-1693-2013

Class II Devices Event

Event ID65148
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-May-08
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmSagaTech Electronics, Inc.
CityCalgary
StateAB
CountryCA
Distribution PatternWorldwide Distribution:US (nationwide) and countries of:Canada and Mexico.
 

Associated Products

Product DescriptionFinger Sensor for Remmers Recorder (Formerly SnoreSat Sleep recorder) To be used to gather heart rate and blood oxygen data during a sleep study.
Code InfoModel: 1.1 Lot numbers: 13367 and 13710
ClassificationClass II
Reason for RecallThe outer jacket is receding away from the black sensor prematurely.
Product Quantity152 units 77 devices from lot 13367 and 75 devices from lot 13710
Recall NumberZ-1725-2013

Class II Biologics Event

Event ID65157
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Feb-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmUniversity Of Miami Miller School of Medicine Tissue Bank
CityMiami
StateFL
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionBone
Code Info0093440125
ClassificationClass II
Reason for RecallHuman tissue allograft, processed in a manner that could cause contamination or cross-contamination during processing, as well as the introduction, transmission, or spread of communicable disease through the use of the HCT/P, was distributed.
Product Quantity1 allograft
Recall NumberB-1882-13

Class II Devices Event

Event ID65183
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBaxter Healthcare Corp.
CityDeerfield
StateIL
CountryUS
Distribution PatternUS Nationwide Distribution
 

Associated Products

Product DescriptionFour Lead TUR irrigation Set, for use with UROMATIC Plastic Containers, Product Code 2C4013 - Approximate Length 85" (2.2. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.
Code InfoUR175554 UR176743 UR182030 UR188144 UR192047 UR192096 UR192260 UR194951 UR202044 UR204032 UR211698 UR214312 UR216069 UR222471 UR225334 UR229294 UR233569 UR233700 UR238915 UR243022 UR246009 UR249383 UR255802 UR260273 UR262980 UR263004 UR265918 UR283580 UR287284 UR288746 UR298216 UR304246 UR307249 UR314328 UR318063 UR321000 UR325464 UR334151 UR339317 UR344234 UR352484 UR352567 UR360255 UR363432 UR366161 UR375857 UR383794 UR385534 UR07J19029 UR07K29059 UR07L21039 UR08B21053 UR08C25151 UR08E15157 UR08G22167 UR08I12065 UR08K13086 UR08L18158 UR09A21211 UR09D02157 UR09E14084 UR09G17125 UR09H26140 UR09J30040 UR09J30065 UR09J30107 UR09L01146 UR10C25033 UR10D09142 UR10E21037 UR10G28129 UR10I28034 UR10L03024 UR10L22024 UR11A14022 UR11B24086 UR11B25125 UR11C25032 UR11F01028 UR11G08088 UR11H08011 UR11H09019 UR11I08043 UR11I23026 UR12A25043 UR12E18502 UR12H03011 UR12H17045 UR12I05030 UR12I06053 UR12I21052 UR12J18040 UR12J26019 UR12L12023 UR13B08053 UR13B15041 UR13C08036
ClassificationClass II
Reason for RecallA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
Product Quantity356,728 units
Recall NumberZ-1682-2013
Product DescriptionTwo Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4030 - Approximate Length 98" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.
Code InfoR06K01067 R06K01075 R06K01083 R07B02013 R07C14065 R07C22035 R07D19088 R07E07015 R07E20935 R07E29050 R07F02063 R07F05025 R07I22065 R07J01019 R07J28012 R07L05073 R08A14027 R08A28019 R08B04026 R08B05031 R08C18040 R08C24022 R08D12066 R08D15085 R08F28075 R08G19122 R08G21029 R08G21037 R08H21019 R08H27065 R08I20076 R08J10175 R08K04010 R08L05205 R09A17060 R09A28109 R09B16086 R09C16100 R09C30119 R09D14012 R09E19026 R09E25122 R09F10148 R09F16087 R09G14072 R09G27025 R09H27080 R09I28094 R09J13103 R09K11154 R09K30014 R09L09032 R09L16227 R10A08264 R10A19188 R10A21630 R10B13122 R10B16158 R10C10118 R10C13096 R10C24044 R10C27179 R10D05041 R10D26047 R10E11087 R10F05152 R10F19054 R10G27014 R10H17211 R10H31212 R10I01106 R10I07129 R10I27036 R10J19024 R10J19149 R10J23067 R10K02226 R10K13066 R10K25029 R10L04071 R10L23048 R11A11010 R11A15078 R11A31224 R11B07172 R11C01223 R11C15157 R11C22294 R11D04167 R11D16062 R11E12159 R11E21077 R11F24103 R11G18020 R11G18103 R11G19077 R11J24189 R11K22140 R11L22114 R12A04113 R12A11134 R12A23113 R12A31124 R12B15117 R12B27070 R12C08144 R12E17116 R12E18056 R12F07057 R12F09087 R12F11067
ClassificationClass II
Reason for RecallA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
Product Quantity530,488 units
Recall NumberZ-1683-2013
Product Description Four Lead Arthroscopic Irrigation Set, for use with ARTHROMATIC Plastic Containers, Product Code 2C4031 -Approximate Length 99" (2.5. m) Usage: Baxter irrigation sets are intended for the delivery of irrigating solutions from the fluid container to the irrigation site during bladder irrigation or endoscopic procedures including cytoscopy, transurethral resection and arthroscopic procedures. the sets are intended for use with Baxter irrigating solutions in Uromatic or Arthromatic plastic containers.
Code InfoR08D28039 R08D28047 R08D28054 R08H20094 R08H22124 R08H25010 R08H28113 R08I06083 R08I08097 R08I09087 R08J06124 R08J13088 R08K21139 R08K29074 R08L08092 R08L12110 R09A16013 R09A27101 R09A31079 R09B17043 R09B26010 R09C02084 R09C15029 R09D13089 R09E12120 R09E19133 R09F13068 R09F22028 R09G13108 R09H05037 R09H06134 R09H19111 R09I08096 R09I27013 R09J08038 R09J14010 R09J27103 R09J28119 R09K12129 R09L04017 R09L22035 R10A06011 R10A08165 R10A19113 R10A21655 R10B17024 R10C11033 R10C11116 R10C15026 R10D15081 R10D16063 R10D16154 R10D24067 R10E03035 R10G21108 R10G27089 R10H21064 R10H23110 R10I02138 R10I04068 R10I25071 R10J19123 R10J25096 R10K17984 R10K25094 R10L03065 R10L06019 R10L21174 R11B16165 R11B23161 R11C15165 R11C22229 R11D04084 R11D12038 R11E04115 R11E13066 R11E28072 R11E30086 R11F08171 R11H05041 R11H16071 R11H22053 R11I06039 R11I16095 R11I28249 R11J12093 R11J13158 R11J14081 R11K19054 R11K21183 R12A09070 R12A09112 R12B25058 R12C28142 R12E19070 R12E21076 R12E31125 R12F11109 R12F12081
ClassificationClass II
Reason for RecallA firm's internal investigation led to the discovery of pinholes in the packaging of the products. The pinholes are not likely to be detected by the end user prior to use and could compromise the sterile barrier properties of the packaging.
Product Quantity249,576 units
Recall NumberZ-1684-2013

Class II Food Event

Event ID65204
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmEco-Cuisine
Cityboulder
StateCO
CountryUS
Distribution PatternNation wide distribution and Canada.
 

Associated Products

Product DescriptionEco-Cuisine Betty Brownie Mix with Vanilla, Pack size 1.09 lb bag, 10 bags per case or 25 lbs bulk, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
Code InfoItem number T3333 all lots.
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity1,010 lbs
Recall NumberF-1620-2013
Product DescriptionEco-Cuisine Chocolate Brownie Mix, SKU: AA01BRWN, Pack size 1 lb bag, 10 bags per case, and SKU: AA25BRWN 25 lbs bulk bag, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
Code InfoItem number T3314 all lots.
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity5,050 lbs
Recall NumberF-1621-2013
Product DescriptionEco-Cuisine Reduced Sodium "Ground Beef Style" Quick Mix, SKU: AA10GBQM, Pack size 10 lb bag, 1 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO; and TV10GBQM 10 lb bag distributed by Eco-Cuisine and manufactured by TOVA, Louisville, KY.
Code InfoSKU: AA10GBQM, item number T3388 all lots, SKU: TV10GBQM, lot 26122481A.
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity6,971 lbs
Recall NumberF-1622-2013
Product DescriptionEco-Cuisine Reduced Sodium "Sausage Style" Quick Mix, SKU: AA10SGQM, Pack size 10 lb bag, 1 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
Code InfoItem number T3394 all lots.
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity1,911 lbs
Recall NumberF-1623-2013
Product DescriptionEco-Cuisine Chocolate Chip Cookie Mix, SKU: AA01COOK-CC, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
Code InfoItem number T3416 all lots.
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity1,005 lbs
Recall NumberF-1624-2013
Product DescriptionEco-Cuisine Lemon Muffin Mix, SKU: AA01MUFF-LM, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
Code InfoItem number T3417 all lots.
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity1,005 lbs
Recall NumberF-1625-2013
Product DescriptionEco-Cuisine English Scone Mix, SKU: AA01SCON, Pack size 1 lb bag, 10 bags per case, Distributed by Eco-Cuisine and manufactured by All American Seasonings, Denver, CO.
Code InfoItem number T3418 all lots.
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity1,005 lbs
Recall NumberF-1626-2013
Product DescriptionEco-Cuisine Basic English Scone Mix, SKU: CM25SCONE, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling.
Code InfoItem number CM25SCONE all lots.
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity1,250 lbs
Recall NumberF-1627-2013
Product DescriptionEco-Cuisine Cookie Mix, SKU: CM25COOK, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling.
Code InfoItem number CM25COOK all lots.
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity2,450 lbs
Recall NumberF-1628-2013
Product DescriptionEco-Cuisine Muffin Mix, SKU: CM25MUFF, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by Central Milling.
Code InfoItem number CM25MUFF all lots.
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity2,500 lbs
Recall NumberF-1629-2013
Product DescriptionEco-Cuisine Basic Pancake Mix, SKU: TV25PANC, Pack size 25 lb bag, Distributed by Eco-Cuisine and manufactured by TOVA, Louisville, KY.
Code InfoItem number TV25PANC, lot 001122331A
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity1,000 lbs
Recall NumberF-1630-2013
Product DescriptionEco-Cuisine "Chicken Style" Quick Mix, SKU: RM10CKQM, Pack size 10 lb bag, Distributed by Eco-Cuisine and manufactured by Rocy Mountain Spice, and SKU: TV10CKQM, package size 10 lb bag, distributed by Eco-Cuisine and manufactured by TOVA.
Code InfoItem number RM10CKQM lots E3112, G0312, G2412, H1612, J0912, B0813.
ClassificationClass II
Reason for RecallEco-Cuisine is recalling certain spice/baking mixes due to potential contamination with salmonella as reported by their raw materials supplier.
Product Quantity7.570 lbs
Recall NumberF-1631-2013

Class II Drugs Event

Event ID65226
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionGentamicin Sulfate Injection USP 80 mg/2mL(40 mg/mL as Gentamicin), 2 mL Single-dose Fliptop Vial, (NDC 0409-1207-13), Rx only, Manufactured by Hospira, Inc, Lake Forest, IL 60046 USA.
Code InfoLot 07-067-DK Exp. 07/13
ClassificationClass II
Reason for RecallPresence of Particulate Matter: Confirmed customer report where visible particles were identified floating in the primary container.
Product Quantity168,300 vals
Recall NumberD-686-2013

Class II Biologics Event

Event ID65252
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Apr-06
Initial Firm Notification of Consignee or Public FAX
Recalling FirmOneBlood / dba CBCF
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2182124; 1799950
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity2 units
Recall NumberB-1943-13
Product DescriptionFresh Frozen Plasma
Code Info2182124
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, were distributed.
Product Quantity1 unit
Recall NumberB-1944-13

Class II Food Event

Event ID65262
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmMother Earth International LLC
CityAmes
StateIA
CountryUS
Distribution PatternDistribution was nationwide through internet sales. No foriegn or military distribution was made.
 

Associated Products

Product DescriptionMother Earth Products, Veggie Burger, Textured Vegetable Protein, packaged in 2-cup mylar bags, 1-quart mylar bags, 1-quart plastic jar, 1-gallon mylar bags, 5-lb mylar bags, 15-lb bulk bag, 25-lb bulk box and TVP Variety Sample Pack.
Code InfoThey use a manufacture date code. 712 means July 2012. Their customer letter states product manufactured July 1, 2012 to present.
ClassificationClass II
Reason for RecallThe product was manufactured with a Soy Protein Isolate manufactured by CHS, Inc and may be contaminated with Salmonella.
Product Quantity210
Recall NumberF-1590-2013

Class II Devices Event

Event ID65290
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-13
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 PatternNationwide Distribution including IL and MO.
 

Associated Products

Product DescriptionBigliani/Flatow® The Complete Shoulder Solution, Humeral Stem Provisional 12mm x 170mm This reusable trial device is used in orthopaedic joint replacement and is specific to the replaced joint (e.g. hip, knee, shoulder, ankle, elbow). It can be made of metal or plastic.
Code InfoItem 00-4301-012-17; lot 62283991
ClassificationClass II
Reason for RecallThe firm is initiating a removal of one lot of the Bigliani/Flatow Humeral Provisional Stem (00-4301-012-17, lot 62283991) as the stems manufactured under the lot are 14mm x 170mm devices incorrectly etched and packaged as 12mm x 170mm devices.
Product Quantity1
Recall NumberZ-1676-2013

Class II Devices Event

Event ID65292
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAbbott Medical Optics, Inc.
CityMilpitas
StateCA
CountryUS
Distribution PatternWorldwide Distribution, including Nationwide (US) and countries in Latin America, EMEA, and APAC.
 

Associated Products

Product DescriptionSovereign® Compact Phacoemulsification System, v 5.3, Part Number: CMP680300. The system is used for cataract surgery.
Code InfoProduct Name: Sovereign® Compact Console Universal, Part Number: CMP680300. The Sovereign® Compact console is identified with a unique, sequentially assigned 3 digit number identified below as XXX. For Sovereign® Compact systems manufactured at the Third Party Manufacturer, Sanmina-SCI Corporation, the serial number format is YYYY35XXX where Y is for the year manufactured and "35" designates manufacturing at Sanmina-SCI Corporation. The Sanmina-SCI Corporation started manufacturing the Sovereign® Compact v 5.3 systems in February 2012. For Sovereign® Compact systems manufactured at the AMO Manufacturing USA, LLC facility in Milpitas, CA the serial number format is YYYY80XXX where Y is for the year manufactured and "80" designates manufacturing at Milpitas. The Milpitas facility started manufacturing the v 5.3 systems in February 2013. The serial number is contained in the Product Identification Label (part number Z352548) that is attached to the rear of the console for systems manufactured.
ClassificationClass II
Reason for RecallAbbott Medical Optics Inc. (AMO) initiated this Urgent Notice of Medical Device Correction and Advisory Notice to all customers who use the AMO Sovereign® Compact Phacoemulsification System, Version 5.3, because it has the potential to lose the vacuum tone mode during surgery.
Product Quantity534 systems
Recall NumberZ-1670-2013

Class II Devices Event

Event ID65317
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBoston Scientific Corporation
CityMarlborough
StateMA
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) including states of: NJ, NY, OH, IL, MI, MD, MA and countries of: Denmark, Great Britain, and Spain.
 

Associated Products

Product DescriptionNephroMax high Pressure Nephrostomy Balloon Catheter. Material Number/Catalog Number: M0062101400/210-140, M062101440/210144 Dilation of the nephrostomy tract.
Code InfoLot Number: 15875861, 15875860, 15875299, 15872797, 15872799, 15872798
ClassificationClass II
Reason for RecallIncorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Product Quantity27
Recall NumberZ-1672-2013
Product DescriptionNephroMax high Pressure nephrostomy Balloon Catheter Kit. Material Number/Catalog Number: M0062101600/210-160, M0062101640/210-164 Dilation of the nephrostomy tract.
Code InfoLot Number: 15982017, 15963887, 16034014
ClassificationClass II
Reason for RecallIncorrect sized renal sheath was packaged with the NephroMax high pressure nephrostomy Balloon Catheter.
Product Quantity15 units
Recall NumberZ-1673-2013

Class II Devices Event

Event ID65320
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLinvatec Corp. dba ConMed Linvatec
CityLargo
StateFL
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AR, CA, FL, GA, IL, IN, KS, MO, NC, NJ, NM, NY, OH, OK, PA, TN, TX, UT, VA, and WI, and the countries of Austria; Belgium, Canada, China, Czech Republic, Finland, France, Great Britain, Italy, and Japan.
 

Associated Products

Product Description***REF C7120***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Code InfoC7120 Lot's #: 1301184, 1301214, 1301254, 1301284, 1301294, 1302014, 1302044, 1302054, 1302064, 1302074, 13020124, 1302134, 1302144, 1302194, 1302204, 1302214, 1302224, 1302254, 1302264, 1303014, 1303054, 1303064, 1303074, 1303114, 1303124, 1303204, 1303214, 1303264, 1303274, 1303284, 1304014, 1304034, 1304054, 1304154, 1304294, 1304304, and 1305014.
ClassificationClass II
Reason for RecallConmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site.
Product Quantity4,691 Units total of each
Recall NumberZ-1680-2013
Product Description***REF C7122***QTY 1***APEX Arthroscopy Tubing Set. Intended for use for joint irrigation and dissention during arthroscopic procedures.
Code InfoC7122 Lots #'s: 1301224, 1301234, 1301244, 1301304, 1301314, 1302114, 1302154, 1302274, 1302284, 1303144, 1303254, 1304044, 1304234, 1304244, and 1305024
ClassificationClass II
Reason for RecallConmed Linvatec received complaints that their products C7120 APEX Arthroscopy Tubing Set, One Connection and C7122 APEX Arthroscopy Tubing Set, Two Connection, contained a scratch/grooved area on the inside diameter of the pressure fitting that may cause the APEX Irrigation (pump) Console to sense a pressure drop and increase fluid flow to the surgical site.
Product Quantity4,691 units, total of each
Recall NumberZ-1681-2013

Class II Food Event

Event ID65327
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmABCO Laboratories, Inc.
CityFairfield
StateCA
CountryUS
Distribution PatternCA and PA.
 

Associated Products

Product DescriptionSoy Protein Isolate; 79 bulk raw material lots and 52 finished product lots. Soy Protein Isolate was sold in bulk to two customers, both sausage manufacturers not under FDA jurisdiction. Also sold 48 bags of 34.875 bags to a third sausage manufacturer. Finished product was made for Nurti-Cology - Allergy Research Group of Alameda, CA and Vinco Inc. of Evans City PA, both of whom will be conducting their own recalls.
Code Info All Lots 03-25-11 t0 05-21-13
ClassificationClass II
Reason for RecallABCO products are being recalled as part of a larger recall from their supplier of certain soy based products produced in its Ashdod, Israel production facility.
Product Quantity52 lots of finished products, 70 bulk raw material lots.
Recall NumberF-1585-2013

Class II Devices Event

Event ID65332
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFresenius Medical Care Holdings, Inc.
CityWaltham
StateMA
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionFresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
Code InfoLot 11PR08083
ClassificationClass II
Reason for RecallCassette may leak during set up or during peritoneal dialysis treatment
Product Quantity5480 units
Recall NumberZ-1674-2013

Class II Food Event

Event ID65396
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAllergy Research Group
CityAlameda
StateCA
CountryUS
Distribution PatternDistributors, Wholesalers, healthcare providers and retail customers in the USA. Nutrilink in England and DeltaStar in the Netherlands are distributors in Europe.
 

Associated Products

Product DescriptionWholly Immune Powder, Total Immune Nutrient Support; 300 gram (10.6 oz) and 900 gram ( 31.7 oz.) containers. Also packaged as Complete Immune Powder and packed in 300 and 900 gram containers. Suggested use: As a dietary supplement, 1 level scoop one or two times daily, mixed with desired liquid or as directed by a healthcare practitioner. California Proposition 65 warning: this product contains lead, a chemical known to the State of California to cause birth defects or other reproductive harm. UCP 13947-73560 and 13947 73820 formulated exclusively for Allergy Research Group, Alameda, CA 94502.
Code InfoProduct number 73560, 53560 - 300 gr. Lot numbers: 11030685, Exp 6/1/13; 11030686, Exp 6/1/13; 11100829, Exp 11/1/13; 11100835, Exp 11/1/13; 12010362, Exp 4/1/14; 12061214, Exp 8/1/14; 12061217, Exp 8/1/14; 13010635, Exp. 2/1/15. Product number 73820, 53820 - 900 gr. Lot numbers: 11030676, Exp Jun 2013; 11030686, Exp 6/1/13; 11100836, Exp 11/1/13; 12010363, Exp 4/25/14; 12061215, Exp 8/1/14; 12061218, Exp 8/1/14; 13010636, Exp 2/1/15;
ClassificationClass II
Reason for RecallAllergy Research Group received word from their contract manufacturer, ABCO Laboratories, that two of their products have been manufactured with soy based products from CHS Inc. at it Ashdod, Israel facility.
Product Quantity3000 units of 300 gr powder bottles' 1869 units of 900 gr bottles
Recall NumberF-1636-2013

Class II Devices Event

Event ID65439
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAngiodynamics, INC
CityManchester
StateGA
CountryUS
Distribution PatternWorldwide Distribution, including the US, Austria, China, Italy, Russia and the UK.
 

Associated Products

Product DescriptionAngioDynamics RITA Main Cable, 9 Pin to 14 Pin, REF 700-101892. RITA Main Cables are indicated for use with the RITA RF Generators and RITA electrosurgical devices.
Code InfoCatalog #700-101892, Lot number: 30.12
ClassificationClass II
Reason for RecallThe RITA Main Cable product contains the incorrect Instructions for Use.
Product Quantity13 units
Recall NumberZ-1675-2013

Class II Devices Event

Event ID65459
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBiomet, Inc.
CityWarsaw
StateIN
CountryUS
Distribution PatternWorldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.
 

Associated Products

Product DescriptionREF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM619730 , M480920, M656920, M938460, M444630
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity26
Recall NumberZ-1695-2013
Product DescriptionREF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM619740, M492940, M444640, M656930, M938470
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity22
Recall NumberZ-1696-2013
Product DescriptionREF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code Info M879630 , M584360, M492950, M444650, M656940, M938480
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity28
Recall NumberZ-1697-2013
Product DescriptionREF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code Info M879640, M375460, M444660, M886350, M938490
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity30
Recall NumberZ-1698-2013
Product DescriptionREF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code Info M375470, M444680 , M886360, M938500
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity22
Recall NumberZ-1699-2013
Product DescriptionREF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM561220 M584370 M151880 , M444690, M886370 , M956050,
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity25
Recall NumberZ-1700-2013
Product DescriptionREF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM619750 ; M375480; M886380, M956060 , M444700
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity24
Recall NumberZ-1701-2013
Product DescriptionREF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM561290, M956070, M444710 6, M136780, M886390
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity23
Recall NumberZ-1702-2013
Product DescriptionREF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code Info M375490, M444720 , M886400, M956080
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity22
Recall NumberZ-1703-2013
Product DescriptionREF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM375500 ,M886410, M444760, M956090
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity22
Recall NumberZ-1704-2013
Product DescriptionREF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code Info M321570, M894590,M619770, M480930, M656950 M444780, M969100
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity32
Recall NumberZ-1705-2013
Product DescriptionREF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM321580 , M619780, M492960, M656960, M969120 , M444790 6
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity30
Recall NumberZ-1706-2013
Product DescriptionREF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM539400, M619790, M987360 , M444800, M969130, M151150, M987360
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity23
Recall NumberZ-1707-2013
Product DescriptionREF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM492970, M598310, M598310, M656980, M969150
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity24
Recall NumberZ-1708-2013
Product DescriptionREF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM584380, M754830, M969160, M444820, M987510
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity20
Recall NumberZ-1709-2013
Product DescriptionREF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM987290, M035670, 987410, M444830, M920680, M754840
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity29
Recall NumberZ-1710-2013
Product DescriptionREF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM598320, M480940, M987300, M444840, M656990
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity37
Recall NumberZ-1711-2013
Product DescriptionREF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM300790, M632920, M539410, M444850, M987620, M987310
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity46
Recall NumberZ-1712-2013
Product DescriptionREF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM632930 , M539420 , M444860 , M657010, M987630 , M987320
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity26
Recall NumberZ-1713-2013
Product DescriptionREF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM619800 , M106200, M444870 , M657020 , M987640 , M987330 , M987640
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity26
Recall NumberZ-1714-2013
Product DescriptionREF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM619800 , M106200, M444870 , M657020 , M987640 , M987330 , M987640
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity25
Recall NumberZ-1715-2013
Product DescriptionREF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM561240, M632960 , M136950 M657040 , M722420 , M444890
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity25
Recall NumberZ-1716-2013
Product DescriptionREF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM480950 , M657050, M444900 , M030220
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity25
Recall NumberZ-1717-2013
Product DescriptionREF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code Info M321600, M539430, M444910, M657070,M722440, M136980, M444910
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity28
Recall NumberZ-1718-2013
Product DescriptionREF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM921180, M539440, M444920, M722450, M136990, M657080
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity31
Recall NumberZ-1719-2013
Product DescriptionREF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM632970 , M539450 , M920610 , M657090 , M017520 , M166860 , M886420
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity26
Recall NumberZ-1720-2013
Product DescriptionREF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM632980 , M539460 , M657100 , M017530 , M166870 , M920620 , M886430
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity25
Recall NumberZ-1721-2013
Product DescriptionREF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM561250, M657110, M017540, M166880, M920640, M886440
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity23
Recall NumberZ-1722-2013
Product DescriptionREF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM480960, M657120, M886450, M166890, M920650
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity25
Recall NumberZ-1723-2013
Product DescriptionREF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.
Code InfoM492980, M657130, M920670, M886460, M166900
ClassificationClass II
Reason for RecallBiomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.
Product Quantity24
Recall NumberZ-1724-2013

Class II Devices Event

Event ID65462
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCardio Medical Products
CityRockaway
StateNJ
CountryUS
Distribution PatternNationwide Distribution
 

Associated Products

Product DescriptionCardio Medical Products, Inc. Defibrillation/Cardioversion/Monophasic or Biphasic Pacing/ECG Electrode Rx Only Single Patient Use Only Manufactured for Cardio Medical Products 385 Franklin Avenue, Suite L Rockaway, New Jersey 07866 www.cardiomedicalproducts.com (800) 227-3633 (973) 586-9624 FAX Defibrillator
Code Info510 K K103159 Part number O101 Lot numbers Y111412-2 Y111912-17 Y020613-03
ClassificationClass II
Reason for RecallCovidien received customer reports of Arcing/Sparking on the defibrillation electrode leadwire which may affect Cardio Medical Products Inc. defibrillator electrodes Model Number O101.
Product Quantity657 units
Recall NumberZ-1669-2013

Class II Devices Event

Event ID65487
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternUnited States Nationwide Distribution in the states of ND, OH and SC.
 

Associated Products

Product DescriptionSiemens Mammomat Inspiration - full-field digital mammography Product Usage: Mammography
Code InfoModel number 10140000, serial numbers 3118, 3243 and 3309
ClassificationClass II
Reason for RecallFirm became aware of an unintended behavior when using the Mammomat Inspiration. The possibility exists that a malfunction may occur during Stereo or Tomo acquisitions if the tomo clutch was incorrectly adjusted. Although the possibility is rare, the system could move while a patient's breast is compressed resulting in a possible bruise. Firm released Update Instructions XP031/12/S for this issue, and a Siemens Service Engineer has inspected the units and made any adjustments necessary.
Product Quantity3
Recall NumberZ-1694-2013

Class II Drugs Event

Event ID65501
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSun Pharmaceutical Industries Inc.
CityCranbury
StateNJ
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionNimodipine Capsules 30 mg, Rx Only, For Institutional Use Only, a) 30-count unit dose Capsules (5x6 blister cards per carton), NDC 57664-135-64, b) 100-count unit dose Capsules (25x4 blister cards per carton), NDC 57664-135-65, Distributed by: Caraco Pharmaceutical Laboratories, Ltd. Detroit, MI 48202 Affiliate of Sun Pharmaceutical Industries, Inc.
Code InfoLot #s: a) 3305.036B, 3305.037B, Exp Jun-13; 3505.041B, Exp Sep-13; 3305.043B, Exp Nov-13; 3305.044B, Exp Dec-13; 3305.045B Mar-14. Lot #s: b) 3305.036A, 3305.037A, Exp Jun-13; 3305.038A, Exp Jul-13; 3305.040A, 3505.041A Exp Sep-13; 3305.042A, 3305.043A, Exp Nov-13; 3305.044A Dec-13.
ClassificationClass II
Reason for RecallCrystallization; crystallized nimopdipine
Product Quantity46387 Cartons
Recall NumberD-687-2013

Class II Devices Event

Event ID65503
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Feb-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmIntegra LifeSciences Corp.
CityPlainsboro
StateNJ
CountryUS
Distribution PatternWorldwide Distribution-USA (nationwide) including the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, PA, RI, SC, TN, TX, UT, VA, and WA and the countries of Canada, Austria, Belgium, Switzerland, Czech Republic, Germany, Denmark, Spain, Finland, France, Ireland, Israel, Italy, Lebanon, Luxembourg, Netherlands, Norway, Portugal, Russia, Saudi Arabia, Sweden, United Arab Republic, United Kingdom, and South Africa.
 

Associated Products

Product DescriptionIntegra Hallu-Fix cannulated screw driver (model number P/N 129733ND) and cannulated screwdriver tip (model number P/N 129735ND). Indicated for use in fixation of fractures, osteotomies and arthrodesis of the first metatarso-phalangeal joint.
Code InfoThe following lots of the cannulated screw driver (model number P/N 129733ND) were affected: D2ZG, D32L, D3HV, D3PG and E0U3. The following lots of the cannulated screwdriver tip (model number P/N 129735ND) were affected: D2ZQ and D3EC.
ClassificationClass II
Reason for RecallThe firm has received numerous complaints of the cannulated screw driver tip breaking during surgery.
Product Quantity154 screwdrivers were distributed; 67 screwdriver tips were distributed.
Recall NumberZ-1685-2013

Class II Food Event

Event ID65508
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmGarden-Fresh Foods, Inc.
CityMilwaukee
StateWI
CountryUS
Distribution PatternIA, FL, TX
 

Associated Products

Product DescriptionLID: Archer Fames, Smoked Salmon dip, NET WT 11 OZ (312g). TUB: Archer Farms, Bacon Parmesan dip, NET WT 11 OZ (312g). UPC: 0 85239 99017 9 Distributed by Target corp., Minneapolis, MN.
Code InfoLot code: 28 / JUN / 2013 / 01 Best By Date: 28 / JUN / 2013 / 01
ClassificationClass II
Reason for RecallGarden Fresh Foods Inc. is voluntarily recalling a limited number of packages of Archer Farms Smoked Salmon Dip that may contain undeclared allergens, fish and egg. Some of Archer Farms Smoked Salmon Dip may have inadvertently been filled in a limited amount of Bacon Parmesan dip containers.
Product Quantity126 cases ( 6 containers / case) for a total of 756 contaienrs
Recall NumberF-1646-2013

Class II Devices Event

Event ID65554
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmDeRoyal Industries Inc
CityPowell
StateTN
CountryUS
Distribution PatternUSA Nationwide Distribution in the state of PA
 

Associated Products

Product DescriptionGEO-MED ORTHO TOTAL JOINT TRACECART(R), REF 53-1831.07, Rx Only, NON-STERILE Product Usage: general surgical
Code InfoSerial Numbers: 25405311, 25405485, 25556398, 25866038, 25920479, 25969803, 26040887, 26092011, 26092089, 26109451, 26198457, 26262324, 26330892, 26394079, 26568438, 26637085, 26695568, 26938574, 26942371, 26946478, 27751648, 27860730, 27905871, 27915366
ClassificationClass II
Reason for RecallDeRoyal recalled kits that contained Stryker togas which were recalled for a potential problem with sterilization.
Product Quantity87 units
Recall NumberZ-1692-2013

Class II Devices Event

Event ID65577
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jul-09
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBaxter Healthcare Corp.
CityDeerfield
StateIL
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide), Puerto Rico and Internationally to Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Columbia, Czech Republic, Denmark (including Faroe Islands), Ecuador, Finland, France (including Martinique and Reunion Islands), Germany, Greece, Iceland, India, Ireland, Isreal, Italy, Luxemburg, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Spain, Sweded, Switzerland, Thailand, Turkey, United Arab Emirates, and United Kingdom.
 

Associated Products

Product DescriptionBaxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.
Code Info*** 1) Product Code: 2C1008KP; Lots: 08M036, 08N041, 09A030, 09B044, 09C053, 09D018, 09E019, 09F005; *** 2) Product Code: 2C1009KP; Lots: 08M016, 08M035, 08M066, 09A010, 09A052, 09A065, 09A080, 09B038, 09B048, 09B060, 09B074, 09C03, 09C016, 09C044, 09C060, 09D011, 09D042, 09D049, 09D054, 09E021, 09E043, 09F002; *** 3) Product Code: 2C1063KP; Lots: 08K078, 08M014, 08M060, 08N022, 08N053, 08N074, 09A032, 09A057, 09B006, 09B014, 09C007, 09C017, 09C054, 09C077, 09D015, 09D041, 09E012,09E018, 09E022, 09E044; *** 4) Product Code: 2C1087KP; Lots: 08K074, 08M050, 08N051, 09A053, 09B063, 09C041, 09D044, 09E073; *** 5) Product Code: 2C1156KP; Lots: 08M063, 09C042
ClassificationClass II
Reason for RecallThere are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage were contained within the storage pouch provided and observed prior to patient use.
Product QuantityCode 2C1008KP: 56,400 units; Code 2C1009KP: 180,004 units; Code 2C1063KP: 154,937 units; Code 2C1087KP: 43,521 units; Code 2C1156KP: 7,908 units
Recall NumberZ-1677-2013
Product DescriptionBaxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.
Code Info*** 1) Product Code: 2C1700KP; Lots: 09C013, 09D023; *** 2) Product Code: 2C1702KP; Lots: 08M005, 08M056, 08N055, 09A029, 09B008, 09B061, 09C015, 09D013, 09D043, 09D081, 09E041, 09E070
ClassificationClass II
Reason for RecallThere are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage were contained within the storage pouch provided and observed prior to patient use.
Product QuantityCode 2C1700KP: 7,128 units; Code 2C1702KP: 105,732 units
Recall NumberZ-1678-2013
Product DescriptionBaxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days. They are designed for medication therapies requiring continuous infusion. The infusion pumps can be utilized for slow, continuous delivery through clinically acceptable routes of administration such as intravenous (IV), intra-arterial (IA), and subcutaneous or epidural infusion of medications directly into an intraoperative site or subcutaneously for post-operative pain management.
Code Info*** 1) Product Code: 2C4700K; Lot: 09A014
ClassificationClass II
Reason for RecallThere are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage were contained within the storage pouch provided and observed prior to patient use. *** Note: This product was not sold in the United States.
Product QuantityCode 2C4700K: 4,128 units
Recall NumberZ-1679-2013

Class II Drugs Event

Event ID65588
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFresenius Kabi USA, LLC
CityLake Zurich
StateIL
CountryUS
Distribution PatternNationwide & Puerto Rico
 

Associated Products

Product DescriptionBenztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx only, labeled as a) Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-970-02; and b) Manufactured in the USA for Nexus Pharmaceuticals Inc., Vernon Hills, IL 60061, NDC 14789-300-02
Code Infoa) Lot: 111412, Exp: 11/2014 b) Lots: 030712, Exp: 03/2014; 071212, Exp: 07/2014; 090512, Exp: 09/2014;
ClassificationClass II
Reason for RecallPresence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination observed in reserve sample vials
Product Quantity65110 vials
Recall NumberD-685-2013

Class II Devices Event

Event ID65590
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmIntuitive Surgical, Inc.
CitySunnyvale
StateCA
CountryUS
Distribution PatternWorldwide Distribution - USA including UT, CA, AZ, CO, FL, HI. MT, NY,TX and WA and one customer in Russia.
 

Associated Products

Product Descriptionda Vinci Si Surgeon Side Cart, model number SS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
Code InfoPart number 380610-15: Serial numbers: 323936 323937 325082 325143 325175 325178 325355 325290 325352 325669 325672 325692 325444 325446 325447 325583 325585 325587 325634 325671 325684 325720 325724 325719 325888 325465 325549 325266 325268 323875 324092 324098 324100 324190 324258 324260 324265 324370 324425 324426 324528 324585 324586 324638 324649 324847 324848 324849 325076
ClassificationClass II
Reason for RecallFactory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.
Product Quantity30 total, all devices
Recall NumberZ-1686-2013
Product Descriptionda Vinci Si Vision System Cart, model number VS3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
Code InfoPart number 380990-11: Serial numbers: 324350 325289 325301 325858 325872 325686 325700 325639 325646 324537 324566 324087 324577 324772 324784 324948 325126 325279 325138 325621 325441 325453 325564 323865 323870 323977 324010 324014 324334.
ClassificationClass II
Reason for RecallFactory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.
Product Quantity30 total, all devices
Recall NumberZ-1687-2013
Product Descriptionda Vinci Dual Camera Controller, model number DC3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
Code InfoPart number 372019-01: Serial numbers: 323943 323895 323882 323945 323994 323804 323979 323987 324042 324086.
ClassificationClass II
Reason for RecallFactory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.
Product Quantity30 total, all devices
Recall NumberZ-1688-2013
Product Descriptionda Vinci Instrument Control Box, model number ICB3000; Manufactured by Intuitive Surgical, Sunnyvale, CA 94086. Intuitive Surgical endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic instruments. It is intended for adult and pediatric use.
Code InfoPart number 372012-96: Serial numbers: 323986 324198.
ClassificationClass II
Reason for RecallFactory testing on da Vinci Si Surgical Systems may not be in compliance with UL Standards as one of the testing devices was found to be working incorrectly.
Product Quantity30 total, all devices
Recall NumberZ-1689-2013

Class II Food Event

Event ID65615
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmGKI Foods, LLC
CityBrighton
StateMI
CountryUS
Distribution PatternTraverse City, MI. One customer.
 

Associated Products

Product DescriptionShoreline Fruit Dark Chocolate Covered Dried Balaton Cherries Net Wt. 25 lbs Product of USA Traverse City, MI 49684
Code InfoLot 02513
ClassificationClass II
Reason for RecallGKI is recalling Dark Chocolate Cherries produced on Jan 25, 2013 because dark chocolate strawberries are mixed with dark chocolate cherries. The strawberries contain sufites which are not declared on the label.
Product Quantity259-25lb cases
Recall NumberF-1642-2013

Class II Food Event

Event ID65628
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLos Milagros Tortilleria, LLC
CityTucson
StateAZ
CountryUS
Distribution PatternAZ
 

Associated Products

Product DescriptionMilagros Green Corn Tamales, packaged in plastic in quantities of one dozen
Code InfoNo lot/production codes on the products
ClassificationClass II
Reason for RecallLos Milagros Tortilleria is recalling Milagros Tortillas Green Corn Tamales because they did not list the sub-ingredient for Monterey Jack Cheese which contains the milk allergen.
Product Quantity95 units
Recall NumberF-1619-2013

Class III Biologics Event

Event ID39170
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date29-Mar-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityTucson
StateAZ
CountryUS
Distribution PatternAZ
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code Info007GG15294 Part 1;007GG15294 Part 2
ClassificationClass III
Reason for RecallBlood products, in which extra amount of red cell preservative solution was added, were distributed.
Product Quantity2
Recall NumberB-1708-13

Class III Biologics Event

Event ID39175
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Apr-07
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSouthern California Permanente Medical Group Blood Donor Center
CityIrvine
StateCA
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoKK15215; KK15213; KK15186
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity3 units
Recall NumberB-1680-13
Product DescriptionPlasma Frozen
Code InfoKK15215; KK15186; KK13926; KK13907; KK13906; KK13867; KK13868; KJ42191; KK13869
ClassificationClass III
Reason for RecallBlood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity9 units
Recall NumberB-1681-13

Class III Biologics Event

Event ID49844
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-Jul-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmThe American National Red Cross South Carolina Region
CityColumbia
StateSC
CountryUS
Distribution PatternSC
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info036KC23040, 036KC23041, 036KC23042, 036KC23043, 036KC23044, 036KC23045, 036KC23046, 036KC23047, 036KC23049, 036KC23050, 036KC23051, 036KC23052, 036KC23053, 036KC23054, 036KC23055, 036KC23056
ClassificationClass III
Reason for RecallBlood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
Product Quantity16 units
Recall NumberB-1718-13
Product DescriptionPlasma Frozen
Code Info36KC23043, 036KC23053, 036KC23054
ClassificationClass III
Reason for RecallBlood products, lacking assurance of having been maintained at an acceptable temperature during shipping, were distributed.
Product Quantity3 units
Recall NumberB-1719-13

Class III Biologics Event

Event ID52144
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Dec-08
Initial Firm Notification of Consignee or Public Other
Recalling FirmDepartment of the Navy
CityCamp Lejeune
StateNC
CountryUS
Distribution PatternNJ
 

Associated Products

Product DescriptionRed Blood Cells
Code InfoW020408003424, W020408003428, W020408003445, W020408003447, W020408003436, W020408003443, W020408003432, W020408003427, W020408003230, W020408003426, W020408003450, W020408003444, W020408003440, W020408003439, W020408003437, W020408003435, W020408003434, W020408003433, W020408003429, W202408003431, W020408003425
ClassificationClass III
Reason for RecallBlood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
Product Quantity21 units
Recall NumberB-1793-13

Class III Biologics Event

Event ID56197
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jun-10
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCommunity Blood Center Of Gtr KC
CityKansas City
StateMO
CountryUS
Distribution PatternMO; KS; IL
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW045009005846; W045009005849; W045009005855; W045009006140; W045009055966; W045009055994; W045009060785; W045009064974; W045009068435; W045009069882; W045009070592; W045009074872; W045009077325; W045009079051; W045009080374; W045009081796; W045009081796; W045009082500; W045009084700; W045009084708; W045009084878; W045009084880; W045009085097; W045009085097; W045009085694; W045009085881; W045009086095; W045009086662; W045009086662; W045009087089; W045009087238; W045009087846; W045009089462; W045009090898; W045009091113; W045009091309; W045009092210; W045009094625; W045009096808; W045009096869; W045009096871; W045009097845; W045009097995; W045009099542; W045009100893; W045009101833; W045009102557; W045009102568; W045009102764; W045009102823; W045009103442; W045009103444; W045009103445; W045009104453; W045009108732; W045009111096; W045009111100; W045009111447; W045009111542; W045009111949; W045009111969; W045009115093; W045009115475; W045009122559; W045009122563; W045009122974; W045009123069; W045009124084; W045009129978; W045009129983; W045010000261; W045010000264; W045010001369; W045010001915; W045010001915; W045010001985; W045010002995; W045010003314; W045010004049; W045010004325; W045010004346; W045010004537; W045010004930; W045010005064; W045010005235; W045010005770; W045010005795; W045010005885; W045010006153; W045010010483; W045010014563; W045010016561; W045010016668; W045010017981; W045010020241; W045010020244; W045010020321; W045010020790; W045010021005; W045010021205; W045010021675; W045010022905; W045010023749; W045010023826; W045010025015; W045010027716; W045010029688; W045010030344; W045010030415; W045010031076; W045010032479; W045010032481; W045010032589; W045010032859; W045010033666; W045010034479; W045010035118; W045010035243; W045010035436; W045010035608; W045010036037; W045010036319; W045010036349; W045010036790; W045010039499; W045010041000; W045010041234; W045010041452; W045010041890; W045010044402; W045010046501; W045010046504; W045010046630; W045010047534; W045010047832; W045010047867; W045010047903; W045010047909; W045010049353; W045010051395; W045010052855; W045010053836; W045010053908; W045010053910; W045010057376; W045010057920; W045010900993
ClassificationClass III
Reason for RecallBlood products, which may have been exposed to unacceptable temperatures during storage, were distributed.
Product Quantity147 Units
Recall NumberB-1575-13

Class III Drugs Event

Event ID64643
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionErrin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58
Code InfoLot #s: 33801773A, Exp 7/14; 33801774A, Exp 8/14; 33801775A, 33801776A, Exp 9/14; 33802427A, 33802428A, 33802429A, 33802430A, Exp 12/14; 33802925A, 33802926A, Exp 3/15; 33803383A, 33803384A, 33803385A, 33803387A, 33803685A, Exp 6/15.
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Product Quantity154,536 cartons
Recall NumberD-689-2013
Product DescriptionCamila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58
Code InfoLot #s: 33802107A, 33802108A, Exp 9/13; 33802109A, 33802110A, 33802111A, 33802112A, Exp10/13; 33802560A, Exp 1/14.
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Product Quantity59,240 Cartons
Recall NumberD-690-2013

Class III Drugs Event

Event ID64644
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTeva Pharmaceuticals USA, Inc.
CitySellersville
StatePA
CountryUS
Distribution PatternNationwide distribution. No foreign or government accounts.
 

Associated Products

Product DescriptionLessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67
Code InfoNDC 0555-9014-67, Lot numbers 33802921A, exp 8/2013; 33803173A, exp 10/2013; 33803695A, exp 2/2014; and 33803942A, exp 3/2014.
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Product Quantity148,785 blister packs
Recall NumberD-681-2013
Product DescriptionJunel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58
Code InfoNDC 0555-9028-58, Lot numbers 33802123A, exp 4/2013; 33802202A, exp 5/2013; 33802203A, exp 5/2013; and 33802204A, exp 5/2013.
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Product Quantity47,200 blister packs
Recall NumberD-682-2013
Product DescriptionJolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66
Code InfoNDC 0555-9123-66, Lot numbers 33802986A, exp 9/2013; 33802991A, exp 7/2013; and 33803270A, exp 10/2013.
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Product Quantity54,412 blister packs
Recall NumberD-683-2013
Product DescriptionBalziva(TM) (norethindrone and ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 28 day regimen, Rx only, Barr Laboratories, Inc., Pomona, NY --- NDC 0555-9034-58
Code InfoNDC 0555-9034-58, Lot numbers 33802100A, exp 3/2013; 33802266A, exp 3/2013; and 33802832A, exp 8/2013.
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing
Product Quantity36,708 blister packs
Recall NumberD-684-2013

Class III Drugs Event

Event ID65213
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFresenius Kabi USA, LLC
CityLake Zurich
StateIL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionFolic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx only, APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-184-11
Code InfoLot #: 6103883, Exp 10/2013
ClassificationClass III
Reason for RecallFailed Impurities/Degradation Specification
Product Quantity80,480 vials
Recall NumberD-688-2013

Class III Drugs Event

Event ID65287
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWest-ward Pharmaceutical Corp.
CityEatontown
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionNicardipine Hydrochloride Injection 25 mg/10 mL (2.5 mg/mL), 10 mL single-use vials, Rx Only, Mfd. by Exela Pharma Sciences, LLC, Lenoir, NC, Dist. by: West-ward Pharmaceutical Corp., Eatontown, NJ --- NDC 0143-9689-10
Code InfoLot PLNJ1201 APRIL 2014 Lot PLNJ1202 MAY 2014
ClassificationClass III
Reason for RecallFailed Impurity/Degradation Specifications; out of specification value for impurity Nitrophenylpuridine Derivative (NPP-D)
Product QuantityLot PLNJ1201 -16,880 vials ; Lot PLNJ1202 - 16,960 vials
Recall NumberD-691-2013

Class III Devices Event

Event ID65347
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBoston Scientific Corporation
CityMarlborough
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including the state of NY, NE, MD, OH, TX, PA, VA, PR, CA, NJ, NY, CA and the countries of: AT, FR, DE, GB, IL, IT, LB, NL, ES, SE, TN, Argentina, and Japan.
 

Associated Products

Product DescriptionRigiflexTM 11 Single-Use Achalasia Balloon Dilator, Material Number (UPN) M00554510 Product Usage: The Boston Scientific Corporation RigiflexTM II Single- Use Achalasia Balloon Dilator is indicated for dilatation of the cardia in patients with achalasia.
Code InfoLot/Batch Number: 091541
ClassificationClass III
Reason for RecallProduct labeled with incorrect expiration date.
Product Quantity91
Recall NumberZ-1671-2013

Class III Food Event

Event ID65575
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Apr-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmR.L. SCHREIBER INC - LEBANON
CityLebanon
StateKY
CountryUS
Distribution PatternThe affected product was distributed to the following states:AZ, CA, CO, FL, ID, IL, MA, MI, MO, NC, NJ, NV, OH, OR, PA, TN, and WA.
 

Associated Products

Product DescriptionR.L. Schreiber Batter Mix, 2.5 lb packaged in white flexible plastic bag, 12 bags per case.
Code InfoProduct Code  CFBATTEB, 1464; Lot Code  3-066-133872
ClassificationClass III
Reason for RecallProduct contains undeclared Red 40. Product does not meet quality specifications for color.
Product Quantity823 units
Recall NumberF-1644-2013

Mixed Classification Food Event

Event ID65227
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmChs Inc
CityInver Grove Heights
StateMN
CountryUS
Distribution PatternNationwide. Product was shipped from the Israel facility to the following countries. This product did not come into the U.S. before shipment to the following countries: Canada, Australia, Belgium, Brazil, Bulgaria, Chile, Columbia, Costa Rica, Czech Republic, Denmark, Finland, France, Germany, Greece, Guatemala, Hungary, India, Israel, Italy, Japan, Lithuania, Mauritius, Mexico, Netherlands, New Zealand, Panama, Poland, Portugal, Romania, Russia, Serbia, Slovakia, Slovenia, South Africa, South Korea, Spain, Taiwan, Thailand, United Kingdom, Uruguay, and Vietnam
 

Associated Products

Product DescriptionSolbar Q Soy Protein Isolates. Item No. / Item Description: 22843 / Solbar Q 843 GMO, 22910 / Solbar Q 910 GMO, 22942 / Solbar Q 842 GMO, 22943 / Solbar Q 842 NGMO, 3323912 / Solbar Q 910, 3323920 / Solbar Q 920, 3323932 / Solbar Q 842, and 3323973 / Solbar Q 842 IP
Code InfoItem No.22843, Batch Code: PDSP843040712 Item No. 22910, Batch Codes: SP910031212, SP910071212, SP910090812, SP910201112, SP910260612, SP910270412, SP910270612, SP910300712. Item No. 22942, Batch Codes: sp842010113, SP842010512, SP842010712, SP842030812, SP842040212, SP842040812, SP842041111, SP842050812, SP842071111, SP842090212, SP842090712, SP842100212, SP842100712, SP842140212, SP842141112, SP842160112, SP842160212, SP842170112, SP842180112, SP842190712, SP842200212, SP842200712, SP842201111, SP842220712, SP842220912, SP842230612, SP842230912, SP842260112, SP842270112, SP842270412, SP842280112, SP842290112, SP842290412, SP842300412. Item No. 22943, Batch Codes: NSP842080412, NSP842280312, NSP842280312/1, NSP842280312/2. Item No. 3323912, Batch Codes: SP910241012/2, SP910251112, SP910271212, SP910281212.SP910311212. Item No. 3323920, Batch Codes: SP920090812, SP920200313, SP920211012/1, SP920220512, SP920221012, SP920290512. Item No. 3323932, Batch Codes: SP842010113, SP842010113/1, SP842010313, SP842030213/1, SP842030812, SP842031112, SP842040212/R, SP842040213, SP842040213/1, SP842041112, SP842061112/1, SP842070213, SP842071111/2, SP842071112, SP842071112/1, SP842080213, SP842080413/2, SP842081112/1, SP842090213, SP842090413/2, SP842090413/3, SP842091112, SP842091112/1, SP842101112, SP842110213, SP842110213/1, SP842120213, SP842120213/1, SP842121112, SP842130213, SP842131112, SP842131112/1, SP842140213, SP842141112, SP842141112/3, SP842150213, SP842160213, SP842161112, SP842170213, SP842171112, SP842171112/1, SP842200912, SP842240113, SP842250612, SP842260213, SP842270213, SP842270213/1, SP842280113/1, SP842280213, SP842280213/1, SP842280213/2, SP842290113, SP842290113/2, SP842290113/3, SP842290113/4, SP842290113/5, SP842311212/1, SP842311212/2. Item No. 3323973, Batch Codes: NSP842120113, NSP842120113/1, NSP842120113/2, NSP842130113, NSP842140113, NSP842140113/1, NSP842170113/1, NSP842190113.
ClassificationClass I
Reason for RecallCertain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella
Product Quantity1,671,960 kilograms
Recall NumberF-1638-2013
Product DescriptionSolcon Soy Protein Concentrates. Item No. / Item Description: 12110 / Solcon F GMO, 3112030 / Solcon F Soy Protein Concentrate, 12100 / Solcon GMO, and 3112002 / Solcon GMO Soy Protein Concentrate
Code InfoItem No. 12110, Batch Codes: SF011111, SF040811, SF121111, SF130112, SF131111, SF131212, SF140112, SF180712, SF190612, SF210512, SF240112, SF251011, SF251112, , SF310511. Item No. 3112030, Batch Codes: SF190911, SF200313, SF251112, SF270113, SF270711/1. Item No. 12100, Batch Codes: S010812, S020612, S020712, S020812, S021211, S030412, S030612, S040412, S050112, S050712, S060212, S060612, S061211, S080512, S080812, S090812, S100312, S110312, S120812, S120912, S130912, S140811, S150112, S150512, S150912, S151211, S160112, S160512, S160812, S161012, S170512, S180612, S181012, S200512, S200612, S210512, S210612, S220312, S220712, S230712, S240412, S240612, S240712, S250512, S250612, S250712, S260412, S260612, S270312, S270412, S270612, S280512, S280612, S281012, S300312, S300712, S310512. Item No. 3112002, Batch Codes: S011112, S041112, S050213, S051112, S051112/1, S060213, S061112, S061212, S061212/1, S070213, S071112/1, S071212, S101112, S111012, S111212, S111212/1, S121012, S121112, S130912/1, S131112, S151112, S151112/1, S161112, S191212, S200512, S201012, S201212, S201212/1, S221012, S230113, S230113/1, S231012, S231012/1, S241012, S241112, S251012, S251112, S261012, S261112, S281012/1, S291112, S300113, S301112.
ClassificationClass II
Reason for RecallCertain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella
Product Quantity2,536,725 kilograms
Recall NumberF-1639-2013
Product DescriptionSolcon S Functional Soy Protein Concentrates. Item No. / Item Description: 3232212 / Solcon S 110 GMO, and 32211 / Solcon S110 GMO
Code InfoItem No. 3232212, Batch Codes: SS110010113, SS110030113, SS110111212/1, SS110271212. Item No. 32211, Batch Codes: SS110150812, SS110160712, SS110170712, SS110180712, SS110210612, SS110220612, SS110280812.
ClassificationClass II
Reason for RecallCertain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella
Product Quantity161,400 killograms
Recall NumberF-1640-2013
Product DescriptionContex - Textured Soy Protein Concentrates Item No. / Item Description: 3411112 / Contex 120 Textured Soy Protein, 3411124 / Contex 25 Textured Soy Protein, 3411129 / Contex 31 CL Textured Soy Protein, 3411142 / Contex 120CL IP Textured Soy Protein, 3411144 / Contex 240 Textured Soy Protein, 3411161 / Contex 25 CLH, 51026 / Contex 25 Textured NGMO Soy Protein, 52031 / Contex 31 GMO Textured Soy Protein, 52032 / Contex 31 CL GMO Textured Soy Protein, 52034 / Contex 31PV GMO Textured Soy Protein, 52035 / Contex 31NP GMO Textured Soy Protein, 52121 / Contex 120CL IP Textured Soy Protein, and 52248 / Contex 240CL GMO Textured Soy Protein.
Code InfoItem No. 3411112, Batch Codes: C120031012, C120080413, C120080911, C120110213, C120110213/1, C120161111/1, C120171111, C120180412, C120190112, C120221012, C120240811, C120270612, C120280612, C120300512, C120310512. Item No. 3411124 , Batch Code: C25190911 Item No. 3411129 , Batch Codes: C31CL051212, C31CL150113/1 Item No. 3411142, Batch Code NC120CL230611 Item No. 3411144, Batch Codes: C240060512, C240220512, C240261112 Item No. 3411161 Batch Code PDC25CLH240512 Item No. 51026, Batch Codes: NC25070911, NC2522061, NC25251212. Item No. 52031, Batch Codes: 7100712, C31081111, C31090212, C31120112, C31170111, C31200512, C31200911, C31210611, C31240712, C31250911, C31251112, C31270911. Item No. 52032, Batch Code: C31CL271112 Item No. 52034, Batch Codes: C31PV050511, C31PV140611, C31PV150611, C31PV160611. Item No. 52035, Batch Codes: C31NP030511, C31NP110511, C31NP160611, C31NP180711, C31NP220511, C31NP220511/C31NP110511. Item No. 52121, Batch Codes: NC120CL160212, NC120CL170511, NC120CL200612, NC120CL230611. Item No. 52248, Batch Code: C240CL070212, C240CL070512, C240CL240512, C240CL260712, C240CL261112, C240CL281012.
ClassificationClass II
Reason for RecallCertain Soy-based products produced at the Ashdod Israel production facility have the potential to be contaminated with Salmonella
Product Quantity651,225 kilograms
Recall NumberF-1641-2013

Mixed Classification Food Event

Event ID65304
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmSalmolux (A Pacific Seafood Group Company)
CityFederal Way
StateWA
CountryUS
Distribution PatternProducts were distributed in Arkansas, Arizona, California, Idaho, Michigan, Nevada, New York, Ohio, Texas, and Washington.
 

Associated Products

Product Description"***JENSEN'S SEATTLE STYLE SMOKED WILD PACIFIC SALMON ***JENSEN'S SMOKEHOUSE, INC.***10520 GREENWOOD AVE N***SEATTLE, WA 98133*** (206) 364-5569** SOCKEYE LOX Net Wt. 4 oz***".
Code InfoProduction Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.
ClassificationClass I
Reason for RecallCold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.
Product Quantitytotal 4930 lbs.
Recall NumberF-1597-2013
Product DescriptionSOCKEYE SALMON: 1) "***SMOKED WILD SOCKEYE SALMON (NOVA LOX)***INGREDIENTS: Wild Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. CONTAINS: SOCKEYE SALMON (FISH)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***". 2) "***SOCKEYE SMOKED SALMON TRIM***NET WT: 2 lbs (908g)***INGREDIENTS: Wild Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. (No Preservatives or Artificial Colors)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***". 3) "***SMOKED SOCKEYE SALMON (NOVA LOX)***Net Wt. 4 oz (113g)***INGREDIENTS: Alaskan Sockeye Salmon, Salt, Sugar, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 16468 44900 8***".
Code InfoProduction Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.
ClassificationClass II
Reason for RecallCold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.
Product Quantity
Recall NumberF-1598-2013
Product DescriptionATLANTIC SALMON: 1) "***Raley's***NOVA LOX***NET WT 4 OZ (113 g)***INGREDIENTS: ATLANTIC SALMON (FARM RAISED-COLOR ADDED), SALT, SUGAR, SODIUM NITRITE, NATURAL WOOD SMOKE. CONTAINS: SALMON (FISH)***READY TO EAT***REFRIGERATED BELOW 38F***Proudly Distributed By: Raley's, 500 West Capitol Avenue, West Sacramento, CA 95605***0 46567 50029 4***". 2) "***LOX TRIM*** NET WT: 2 lbs (908g)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodium Nitrite, Natural Wood Smoke. CONTAINS: ATLANTIC SALMON (FISH)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***". 3) "***SMOKED SALMON NOVA LOX (Pre-Sliced)***NET WT: 3 lbs ( 1 .36kg)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodium Nitrite, Natural Wood Smoke***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***0 16468 42072 4***".
Code InfoProduction Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.
ClassificationClass II
Reason for RecallCold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.
Product Quantity
Recall NumberF-1599-2013
Product DescriptionKETA SALMON: 1) "***ALASKAN SMOKED SALMON (NOVA LOX)***Net WT. 16 oz (454g)***INGREDIENTS: Wild Keta Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6 & Red #40, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 16468 44294 8***". 2) "***WILD KETA SMOKED SALMON (NOVA LOX) TRIM***NET WT: 2 lbs (908g)***INGREDIENTS. Wild Keta Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6 & Red #40. Natural Wood Smoke. CONTAINS: WILD KETA SALMON (FISH)***Produced By: SALMOLUX, 34100 9th Avenue S. Federal Way. WA 98003***". 3) "***SMOKED SALMON (NOVA LOX)***Net Wt. 4 oz (113g)***INGREDIENTS: Wild Keta Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6 & Red #40, Natural Wood Smoke. CONTAINS: KETA SALMON (FISH)***0 16468 44305 1***".
Code InfoProduction Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.
ClassificationClass II
Reason for RecallCold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.
Product Quantity
Recall NumberF-1600-2013
Product Description"***WILD ALASKAN NOVA LOX SMOKED SALMON***Sea Passion***INGREDIENTS: Wild Alaskan Salmon, Salt, Sugar, Sodium Nitrite, FD&C Yellow #6, FD&C Red #40 (color enhancers), Natural Wood Smoke. CONTAINS: FISH (SALMON)*** Salmolux Federal Way, WA 98003***0 16468 44543 7***".
Code InfoProduction Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.
ClassificationClass II
Reason for RecallCold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.
Product Quantity
Recall NumberF-1601-2013
Product Description"***NORWEGIAN SMOKED SALMON (NOVA LOX)***Net Wt. 8 oz (227g)***INGREDIENTS: Atlantic Salmon (Farm Raised-Color Added), Salt, Sugar, Sodium Nitrite, Natural Wood Smoke. CONTAINS: FISH (SALMON)***0 16468 44328 0***".
Code InfoProduction Lot 10803. The code is breaking down as: 1 and 3 are the year 2013. 080 is the Julian date, the 80th of the year (or March 21st). Retail stores issue the best-by date based on when they thaw the product.
ClassificationClass II
Reason for RecallCold Smoked Salmon products are recalled due to the potential contamination with Listeria monocytogenes.
Product Quantity
Recall NumberF-1602-2013

Mixed Classification Food Event

Event ID65326
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date31-May-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFinger Lakes Farmstead Cheese Company Llc
CityTrumansburg
StateNY
CountryUS
Distribution Pattern1 firm in NY State.
 

Associated Products

Product DescriptionFinger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schuyler County, SCHUYLER Gouda aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES FARMSTEAD CHEESE CO. 5491 BERGEN ROAD TRUMANBURG, NY 14886. Ingredients: raw milk, rennet, calcium chloride, culures, salt
Code Infounder investigation
ClassificationClass I
Reason for RecallListeria monocytogenes contamination.
Product Quantity5 wheels
Recall NumberF-1603-2013
Product DescriptionFinger Lakes FARMSTEAD CHEESE Mecklenburg, NY Schyler County, BIER MECK Gouda, aged at least 60 days, Net Wt. 8 lbs wheels. FINGER LAKES FARMSTEAD CHEESE CO. 5491 BERGENT ROAD TRUMANBURG, NY Ingredients: raw milk, rennet, calcium chrloride, cultures, beer, salt
Code Infounder investigation
ClassificationClass II
Reason for RecallListeria monocytogenes contamination.
Product Quantity7 wheels
Recall NumberF-1604-2013

Mixed Classification Biologics Event

Event ID47073
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jan-08
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBlood Bank of San Bernardino and Riverside Counties
CitySan Bernardino
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoGZ21115
ClassificationClass III
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1804-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGZ21115
ClassificationClass II
Reason for RecallBlood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1805-13

Mixed Classification Biologics Event

Event ID65189
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTissueTech, Inc. dba Bio-Tissue, Inc.
CityMiami
StateFL
CountryUS
Distribution PatternNevada; Illinois; New Mexico; Arizona; Alabama; Oregon; Ohio; Florida; California; Washington; Louisiana; Texas
 

Associated Products

Product DescriptionAmniotic membrane
Code Info12NX10252500519, 12NX10252500520
ClassificationClass III
Reason for RecallAmniotic membrane allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.
Product Quantity2
Recall NumberB-1846-13
Product DescriptionAmniotic membrane
Code Info2012AG1510F06969, 2012AG1510F06970, 2012AG1510F06974, 2012AG1510F06976, 2012AG1510F06977, 2012AG1510F06979, 2012AG1510F06980, 2012AG1510F06981, 2012AG1510F06984, 2012AG1510F06988, 2012AG1510F06991, 2012AG1510F06992, 2012AG1510F06994, 2012AG1510F07000, 2012AG1510F07001, 2012AG1510F07002, 2012AG1510F07005, 2012AG1510F07007, 2012AG1510F07008, 2012AG1510F07010, 2012AG1510F07011, 2012AG1510F07012, 2012AG1510F07019, 2012AG1510F07020, 2012AG1510F07021, 2012AG1510F07025, 2012AG1510F07026, 13NX10252500019, 2012AG1510F06978, 2012AG1510F06993, 2012AG1510F07003, 2012AG1510F07004, 2012AG1510F07014, 2012AG1510F07015, 2012AG1510F07016, 2012AG1510F07017, 2012AG1510F07018, 2012AG1510F06971, 2012AG1510F06972, 2012AG1510F06973, 2012AG1510F06975, 2012AG1510F06982, 2012AG1510F06983, 2012AG1510F06985, 2012AG1510F06986, 2012AG1510F06987, 2012AG1510F06989, 2012AG1510F06990, 2012AG1510F06995, 2012AG1510F06997, 2012AG1510F06998, 2012AG1510F06999, 2012AG1510F07006, 2012AG1510F07009, 2012AG1510F07013, 2012AG1510F07022, 2012AG1510F07023, 2012AG1510F07024
ClassificationClass II
Reason for RecallAmniotic membrane allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.
Product Quantity58
Recall NumberB-1847-13

Mixed Classification Biologics Event

Event ID65277
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLake Worth
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info1741752; W036813022451; W036812642595; 1484265;
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, was distributed.
Product Quantity4 units
Recall NumberB-1951-13
Product DescriptionCryoprecipitated AHF, Pooled
Code InfoW036813801696
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, was distributed.
Product Quantity1 unit
Recall NumberB-1952-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW036812852142
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, was distributed.
Product Quantity1 unit
Recall NumberB-1953-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW036812642595
ClassificationClass III
Reason for RecallBlood products, collected from an ineligible donor, was distributed.
Product Quantity1 unit
Recall NumberB-1954-13
Product DescriptionCryoprecipitated AHF
Code Info1741752
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, was distributed.
Product Quantity1 unit
Recall NumberB-1955-13
Product DescriptionFresh Frozen Plasma
Code Info1484265
ClassificationClass II
Reason for RecallBlood products, collected from an ineligible donor, was distributed.
Product Quantity1 unit
Recall NumberB-1956-13
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