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U.S. Department of Health and Human Services

Enforcement Report - Week of July 31, 2013

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Class I Drugs Event

Event ID64018
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jan-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMobius Therapeutics LLC
CitySaint Louis
StateMO
CountryUS
Distribution PatternNationwide and Military and Government Consignees
 

Associated Products

Product DescriptionMitosol (mitomycin for solution), 0.2 mg/vial, Kit for Ophthalmic Use (NDC 49771-002-01), 3 kits per box (NDC 49771-002-03), Rx only, Manufactured for: Mobius Therapeutics, LLC, 4041 Forest Park Avenue, St. Louis, MO 63108 USA.
Code InfoLot #: M086920 and M098260, Exp. 08/2013
ClassificationClass I
Reason for RecallNon-Sterility: one or more components of the kit have been found to be contaminated with yeast.
Product Quantity83 boxes
Recall NumberD-809-2013

Class I Veterinary Event

Event ID64392
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Feb-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmKasel Associates Industries, Inc.
CityDenver
StateCO
CountryUS
Distribution PatternNationwide distribution.
 

Associated Products

Product DescriptionNature's Deli Chicken Jerky Dog Treats, 2.5 lbs. bag, UPC 647263800208, 3 lbs UPC 647263800215, Division of Kasel Industries, Denver, CO 80205. Packaged in a transparent, flexible, plastic bag; the bag is yellow with black and white print writing and a photograph of a golden retriever dog on it.
Code InfoBest By dates of 04202013 DEN to 10032013 DEN excluding Best By 09192013 DEN, which was recalled on 10/03/2012.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity62,336 - 2.5 lbs bags; 88,704 - 3 lbs bags
Recall NumberV-241-2013
Product DescriptionBoots & Barkley Loving your pet from head to tail. Roasted American Pig Ears. Delicious Treat for Dogs, Made in the U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403, net wt 12 oz, 12 count, UPC 647263899158.
Code InfoBest By dates of 20APR2014 DEN to 03OCT2014 DEN, excluding Best By 13SEP2014DEN, which was recalled on 10/17/2012.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity67,200 - 12ct bags
Recall NumberV-242-2013
Product DescriptionBoots & Barkley Loving your pet from head to tail. American Variety Pack Real Beef & Pork. Treats for Dogs. Product of U.S.A. Distributed by TARGET Corporation, Minneapolis, MN 55403, net wt 32 oz. Packaging is white, blue and red with red, black and blue print writing, UPC 490830400086.
Code InfoBest by dates of 20APR2014 DEN to 03OCT2014 DEN, excluding Best By 13SEP2014DEN, which was recalled on 10/17/2012.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity6,720 - 32oz bags
Recall NumberV-243-2013
Product DescriptionBoots & Barkley American Beef Bully Stick, 12 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Pizzles. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043165.
Code InfoBest By dates of 20APR2014 DEN to 03OCT2014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity43,344 bags
Recall NumberV-244-2013
Product DescriptionBoots & Barkley American Smoked Beef Femur Bone 3 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Femur Bone. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239403495.
Code InfoBest By dates of 20APR2014 DEN to 03OCT2014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity46,080 bags
Recall NumberV-245-2013
Product DescriptionBoots & Barkley American Beef Tendon Flossie 6-8 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Tendon. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043103.
Code InfoBest By dates of 20APR2014 DEN to 03OCT2014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity36288 bags
Recall NumberV-246-2013
Product DescriptionBoots & Barkley American Pig Ear Strips 8 oz. Satisfies your dog's instinctive urge to chew. Ingredients: Pig Ears. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239403440.
Code InfoBest By dates of 20APR2014 DEN to 03OCT2014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity36576 bags
Recall NumberV-247-2013
Product DescriptionBoots & Barkley Chicken Stuffed American Beef Femur Bone, 6 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Femur Bone Chicken Breast, Natural Flavorings. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043202.
Code InfoBest By dates of 20APR2014 DEN to 03OCT2014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity42336 bags
Recall NumberV-248-2013
Product DescriptionBoots & Barkley American Braided Beef Bully Stick, 5 inch. Satisfies your dog's instinctive urge to chew. Ingredients: Beef Pizzles. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is transparent with white, blue and red with red, black and blue print writing on the affixed label, UPC 085239043110.
Code InfoBest By dates of 20APR2014 DEN to 03OCT2014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity43632 bags
Recall NumberV-249-2013
Product DescriptionBoots & Barkley American Chicken Jerky, 16 oz UPC 085239043325; 8 oz UPC 085239043400. Satisfies your dog's instinctive urge to chew. Ingredients: Chicken Breast, Natural Flavorings. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Made in U.S.A. Packaging is semi-transparent with white, blue and red with red, black and blue print writing on the affixed label. The labeling also has digital photos of the chicken strips and a picture of a terrier dog.
Code InfoBest By dates of 20APR2014 DEN to 03OCT2014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity22116 - 16oz bags; 24768 - 8oz bags
Recall NumberV-250-2013
Product DescriptionBoots & Barkley American Beef Knuckle, 14 oz. Promotes Plaque and Tartar Reduction. Ingredients: Beef Knuckle. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Packaging is semi-transparent with white, blue and red with red, black and blue print writing on the affixed label. The labeling also has digital photo of a dog. UPC 647263899172.
Code InfoBest By dates of 20APR2014 DEN to 03OCT2014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity48060 bags
Recall NumberV-251-2013
Product DescriptionBoots & Barkley American Pork Femur, 1 bone. Promotes Plaque and Tartar Reduction. Ingredients: Pork Femur. Distributed by TARGET Corporation, Minneapolis, MN 55403, 2012 Target Brands, Inc. Packaging is semi-transparent with white, blue and red with red, black and blue print writing on the affixed label. The labeling also has digital photo of a dog. UPC 647263899165.
Code InfoBest By dates of 20APR2014 DEN to 03OCT2014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity135360 bags
Recall NumberV-252-2013
Product DescriptionBIXBI Skin and Coat Beef Liver Jerky, 5 oz. Packaged in orange semi-transparent flexible plastic packaging, 100% USA Made and Sourced, UPC 091037018021.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity4,750 - 5oz bags
Recall NumberV-253-2013
Product DescriptionBIXBI Skin and Coat Lamb Jerky, 5 oz. Packaged in purple and orange semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018045.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity1,334 - 5 oz bags
Recall NumberV-254-2013
Product DescriptionBIXBI Hip and Joint Pork Jerky, 5 oz. Packaged in yellow and aqua semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018144.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity5,112 - 5oz bags
Recall NumberV-255-2013
Product DescriptionBIXBI Skin and Coat Chicken Breast Jerky Treats, 5 oz. Packaged in orange and green semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018007.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity3,339 - 5oz bags
Recall NumberV-256-2013
Product DescriptionBIXBI Skin and Coat Pork Jerky, 5 oz. Packaged in orange and aqua semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018069.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity4,938 - 5oz bags
Recall NumberV-257-2013
Product DescriptionBIXBI Hip and Joint Lamb Jerky, 5 oz. Packaged in yellow and purple semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018120.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity3,746 - 5oz bags
Recall NumberV-258-2013
Product DescriptionBIXBI Hip and Joint Chicken Breast Jerky, 5 oz. Packaged in yellow and green semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018083.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity6,916 - 5oz bags
Recall NumberV-259-2013
Product DescriptionBIXBI Hip and Joint Beef Liver Jerky, 5 oz. Packaged in yellow and red semi-transparent flexible plastic packaging with black and transparent print writing, 100% USA Made and Sourced, UPC 091037018106.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity5,928 - 5oz bags
Recall NumberV-260-2013
Product DescriptionSam's Club Roasted Pig Ear Dog Treats, 28 oz, UPC 681131857246.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity28,224 - 25ct bags
Recall NumberV-261-2013
Product DescriptionPetco Natural Pig Ears, 25 pk, UPC 800443092903, 12 pk UPC 800443092910, 7 pk UPC 800443092934.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity6,944 - 12ct bags; 6,048 - 7ct bags; 7,992 - 25 ct bags
Recall NumberV-262-2013
Product DescriptionPetco Smoked Pig Ears, 7 pk, UPC 800443092941, 12 pk UPC 800443092927.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity5,376 - 12ct bags; 4,704 - 7ct bags
Recall NumberV-263-2013
Product DescriptionColorado Naturals Chicken Chips, 16 oz, UPC 647263800291, Distributed by Petco/Kasel Ind.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity39,648 - 16oz bags
Recall NumberV-264-2013
Product DescriptionColorado Naturals Salmon Jerky, 4 oz UPC 647263900175. Distributed by Petco/Kasel Industries.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity16,128 - 4oz bags
Recall NumberV-265-2013
Product DescriptionColorado Naturals Chicken Jerky, 4 oz UPC 647263800178, 16 oz UPC 647263800291. Distributed by Petco/Kasel/Menards Industries.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity20,736 - 4oz bags, 31,878 x 16 oz
Recall NumberV-266-2013
Product DescriptionColorado Naturals Lamb Jerky, 4 oz UPC 647263510176, Distributed by Petco/Kasel Industries.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity18,432 - 4oz bags
Recall NumberV-267-2013
Product DescriptionColorado Naturals Pork Jerky, 16 oz UPC 647263700157, Distributed by Petco/Kasel Industries/Menards.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity26,964 - 16oz bags
Recall NumberV-268-2013
Product DescriptionColorado Naturals Beef Jerky, 4 oz UPC 647263801175, Distributed by Petco/Kasel Industries.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity13,824 - 4oz bags
Recall NumberV-269-2013
Product DescriptionTDBBS, Inc/Best Bully Sticks Buffalo Hearts Sliced, 3 lbs, Bulk.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity10 bags
Recall NumberV-270-2013
Product DescriptionTDBBS, Inc/Best Bully Sticks Knee Caps, 25 ct, Bulk.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity10 bags
Recall NumberV-271-2013
Product DescriptionTDBBS, Inc/Best Bully Sticks Pork Jerky Strips, 16 oz.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity100 bags
Recall NumberV-272-2013
Product DescriptionTDBBS, Inc/Best Bully Sticks Chicken Jerky, 16 oz.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity4000 bags
Recall NumberV-273-2013
Product DescriptionTDBBS, Inc/Best Bully Sticks Turkey Cubes, 4.5 oz.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity36 bags
Recall NumberV-274-2013
Product DescriptionTDBBS, Inc/Best Bully Sticks Pig Snouts, 25 ct, Bulk.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity400 bags
Recall NumberV-275-2013
Product DescriptionTDBBS, Inc/Best Bully Sticks Beef Lobster Tails, 1ct, Bulk.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity10,000 bags
Recall NumberV-276-2013
Product DescriptionTDBBS, Inc/Best Bully Sticks Turkey Jerky Sticks, 6 ct.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity200 bags
Recall NumberV-277-2013
Product DescriptionTDBBS, Inc/Best Bully Sticks hearts of Lamb, 4 oz.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity200 bags
Recall NumberV-278-2013
Product DescriptionTDBBS, Inc/Best Bully Sticks Lamb Jerky, 4 oz.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity200 bags
Recall NumberV-279-2013
Product DescriptionNutri-Pet 16oz Natural Filet Strips, UPC 76-0081.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity2016 bags
Recall NumberV-280-2013
Product DescriptionK9 Chicken Joint Jerky 5oz UPC 669125507049; 15oz, UPC 669125507056
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity2000 - 5oz bags; 3600 - 15 oz bags
Recall NumberV-281-2013
Product DescriptionK9 Chicken Coat Jerky 5oz; UPC 669125507063; 15oz, UPC 669125507070
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity2000 - 5oz bags; 3600 - 15 oz bags
Recall NumberV-282-2013
Product DescriptionK9 Chicken Calming Jerky 5oz, UPC 669125507087 ; 15oz , UPC 669125507094
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity2000 - 5 oz bags; 3600 - 15 oz bags
Recall NumberV-283-2013
Product DescriptionK9 Chicken Breath Fresh Jerky 5oz, UPC 669125507100 ; 15oz , UPC 669125507117
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity2000 - 5 oz bags; 3600 - 15 oz bags
Recall NumberV-284-2013
Product DescriptionK9 Chicken Senior Jerky 5oz, UPC 669125507124.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity2000 - 5 oz bags
Recall NumberV-285-2013
Product DescriptionK9 Chicken Digestive Jerky 5oz, UPC 669125507148.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity2000 - 5 oz bags
Recall NumberV-286-2013
Product DescriptionK9 Chicken Healthy Weight Jerky 5oz, UPC 669125507162.
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity2000 - 5 oz bags
Recall NumberV-287-2013
Product DescriptionK9 Chicken Jerky 5oz, UPC 669125507018 ; 8oz , UPC 669125507025; 16oz , UPC 669125507032
Code InfoBest By dates of 04202014 DEN to 10032014 DEN.
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity2000 - 5 oz bags; 2000 - 8 oz bags; 2000 - 16 oz bags
Recall NumberV-288-2013
Product DescriptionK9 Hip & Joint Chicken Strips 8oz, UPC 669125990445
Code InfoBest By dates of 04202014 DEN to 10032014 DEN
ClassificationClass I
Reason for RecallKasel Industries received a 423(a), Notification of Opportunity to Initiate a Voluntary Recall, letter from FDA and is recalling all lots of pet treats manufactured at their facility between April 20, 2012 and September 19, 2012 due to positive Salmonella findings in the firm's products and facility.
Product Quantity1728 bags
Recall NumberV-289-2013

Class I Veterinary Event

Event ID64433
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Feb-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmHonest Kitchen
CitySan Diego
StateCA
CountryUS
Distribution PatternNationwide in the US and in Canada.
 

Associated Products

Product DescriptionVerve, 4lb box, 6 units/case, Item# V4, UPC 183413000 89 5, and 10 lb box, 4 units/case, Item #VR, UPC 183413000 17 8.
Code InfoItem Code: V4 + VR, Lot # 2332A (batches 1-3). Item Code: VR, Lot # 3062A (batches 8 & 9).
ClassificationClass I
Reason for RecallThe Honest Kitchen is recalling five lots of its Verve, Zeal and Thrive pet food products because they have the potential to be contaminated with Salmonella.
Product Quantity2,960 units
Recall NumberV-227-2013
Product DescriptionFree Thrive, 1 oz. sample, 50 units/case, Item#TMC, UPC 183413000 81 9.
Code InfoLot # 2622A (batch 3)
ClassificationClass I
Reason for RecallThe Honest Kitchen is recalling five lots of its Verve, Zeal and Thrive pet food products because they have the potential to be contaminated with Salmonella.
Product Quantity15,650 units
Recall NumberV-228-2013
Product DescriptionZeal, 4lb box, 6 units/case, Item#Z4, UPC 18341300195 3, and 10lb box, 4 units/case, Item# ZR, UPC 18341300191 5.
Code InfoItem Code: Z4 + ZR, Lot # 2272A (batches 1-5). Item Code: ZR, Lot # 2652A (batches 1-4).
ClassificationClass I
Reason for RecallThe Honest Kitchen is recalling five lots of its Verve, Zeal and Thrive pet food products because they have the potential to be contaminated with Salmonella.
Product Quantity4,986 units
Recall NumberV-229-2013

Class I Veterinary Event

Event ID64549
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Feb-13
Initial Firm Notification of Consignee or Public Press Release
Recalling FirmCentral Garden Pet Company
CityPhoenix
StateAZ
CountryUS
Distribution PatternNationwide including Puerto Rico, OUS to include: Canada, China, Indonesia, Japan, Kuwait, Panama, Pakistan, Singapore, South Korea, United Arab Emirates.
 

Associated Products

Product DescriptionKaytee Fiesta Max Canary/Finch, Net Wt. 2 lb., UPC 71859-40410
Code InfoBest Before Code (month/day/year) 9/28/2013 thru 5/7/2014
ClassificationClass I
Reason for RecallKaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.
Product Quantity99,977 eaches total
Recall NumberV-230-2013
Product DescriptionKaytee Honey Treat, Parakeet, Net Wt. 3.5 oz, UPC 71859-00431, 3.5 oz UPC 71859-00434, and 7 oz Value Pack UPC 71859-55027
Code InfoBest Before Code (month/day/year) 12/4/2013 thru 8/2/2014
ClassificationClass I
Reason for RecallKaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.
Product Quantity99,977 eaches total
Recall NumberV-231-2013
Product DescriptionKaytee Fiesta Fruit & Veggie Treat, Parakeet, Net Wt. 3.5 oz, UPC 71859-99885, 9.5 oz UPC 71859-99855,
Code InfoBest Before Code (month/day/year) 12/18/2013 thru 7/31/2014
ClassificationClass I
Reason for RecallKaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.
Product Quantity99,977 eaches total
Recall NumberV-232-2013
Product DescriptionKaytee Forti-Diet Pro Health Honey Treat, Parakeet, Net Wt. 3.5 oz, UPC 71859-94235, 7 oz Value Pack UPC 71859-94236
Code InfoBest Before Code (month/day/year) 12/4/2013 thru 8/1/2014
ClassificationClass I
Reason for RecallKaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.
Product Quantity99,977 eaches total
Recall NumberV-233-2013
Product DescriptionKaytee Forti-Diet Pro Health Munchables Shred-A-Box, Honey Seed Treats, Parakeet, 4 boxes, Net Wt. 2 oz, UPC 71859-94268
Code InfoBest Before Code (month/day/year) 3/7/2014 thru 7/30/2014
ClassificationClass I
Reason for RecallKaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.
Product Quantity99,977 eaches total
Recall NumberV-234-2013
Product DescriptionKaytee Forti-Diet Pro Health Molting & Conditioning, Small Birds, Net Wt. 11 oz, UPC 71859-94264
Code InfoBest Before Code (month/day/year) 12/25/2013 thru 8/5/2014
ClassificationClass I
Reason for RecallKaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.
Product Quantity99,977 eaches total
Recall NumberV-235-2013
Product DescriptionKaytee Fiesta Nutty Papaya Treat, Parakeet & Cockatiel, Net Wt. 2.25 oz, UPC 71859-94368
Code InfoBest Before Code (month/day/year) 12/4/2013 thru 6/25/2014
ClassificationClass I
Reason for RecallKaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.
Product Quantity99,977 eaches total
Recall NumberV-236-2013
Product DescriptionKaytee Fiesta Foraging Treat for Pet Birds, Net Wt. 1.5 oz, UPC 71859-94370
Code InfoBest Before Code (month/day/year) 1/27/2014 thru 5/29/2014
ClassificationClass I
Reason for RecallKaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.
Product Quantity99,977 eaches total
Recall NumberV-237-2013
Product DescriptionGrreat Choice Treat Sticks for Small Birds, Net Wt. 3.2 oz, UPC 37257-27166, 9.6 oz, UPC 37257-27165
Code InfoBest Before Code (month/day/year) 12/10/2013 thru 3/19/2014
ClassificationClass I
Reason for RecallKaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.
Product Quantity99,977 eaches total
Recall NumberV-238-2013
Product DescriptionKaytee Foraging Box O' Fun Treat for Pet Birds, Net Wt. 1.5 oz, UPC 71859-94615
Code InfoBest Before Code (month/day/year) 1/28/2014 thru 7/30/2014
ClassificationClass I
Reason for RecallKaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.
Product Quantity99,977 eaches total
Recall NumberV-239-2013
Product DescriptionKaytee Bird Greens Foraging Treat, Net Wt. 1 oz, UPC 71859-94708
Code InfoBest Before Code (month/day/year) 12/1/2013 thru 5/28/2014
ClassificationClass I
Reason for RecallKaytee Products is recalling several bird treats and greens items due to possible contamination of Salmonella from parsley flake ingredients supplied to Kaytee by Specialty Commodities, Inc.
Product Quantity99,977 eaches total
Recall NumberV-240-2013

Class I Veterinary Event

Event ID64582
StatusOngoing
Product TypeVeterinary
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmJones Natural Chews, Co., Inc.
CityRockford
StateIL
CountryUS
Distribution PatternAZ, CA, CO, PA, VA, and WI
 

Associated Products

Product DescriptionDog treat products as follows: a) Jones Natural Chews Co Woofers (beef patties), bulk 50 count box, Item UPC 741956008169 (may be sold individually at retail) b) Jones Natural Chews Co Woofers (beef patties), 1 pack shrink-wrap, 50 count box, Item UPC 741956008657 c) Jones Natural Chews Co Woofers (beef patties), 1 pack shrink-wrap, 50 count box, Item UPC 741956008183 d) Jones Natural Chews Co Woofers (beef patties) 2 pack shrink-wrap, 25 count box, Item UPC 741956008190
Code Infoa) Lot 2962GPS, Best By 10/22/15, and Lot 2892PAL, Best By 10/15/15 b) Lot 3102, Best By 11/05/15 c) Lot 2892BF, Best By 10/15/15, Lot 2962PWV, Best By 10/22/15, Lot 2962ASC, Best By 10/22/15, and Lot 3032ASL, Best By 10/29/15 d) Lot 2962ASC, Best By 10/22/15, and Lot 3032ASL, Best By 10/29/15.
ClassificationClass I
Reason for RecallThis product is being recalled due to the possible risk of Salmonella.
Product Quantity245 boxes / 12,236 patties
Recall NumberV-226-2013

Class I Food Event

Event ID65545
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBergin Fruit And Nut Co Inc
CitySaint Paul
StateMN
CountryUS
Distribution PatternCA, ID, IL, IN, IA, KS, KY, MI, MN, NV, ND, PA, SD, TN, WI.
 

Associated Products

Product Description601009 ANTIOXIDANT SUPERSTAR MIX 100/2 OZ FLAT PACK, UPC 2052601009 601076 ANTIOXIDANT SUPERSTAR MIX 12/6 OZ BERGIN RED BAG, UPC 2052601076 601051 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL, UPC 2052601051 601051.03 ANTIOXIDANT SUPERSTAR MIX 12/8 OZ CLAMSHELL KOWALSKI, UPC 2052601051 601049.01 ANTIOXIDANT SUPERSTAR MIX 16/6 OZ CLAMSHELL, UPC 1115099870 601049.1 ANTIOXIDANT SUPERSTAR MIX 16/6 OZ CLAMSHELL CUB, IUPAC 601070 ANTIOXIDANT SUPERSTAR MIX 3/5#, UPC 2052601070 601050 ANTIOXIDANT SUPERSTAR MIX 30#, UPC 2052601050 601052 ANTIOXIDANT SUPERSTAR MIX 5#, UPC 2052601052 601069 ANTIOXIDANT SUPERSTAR MIX 8/10 OZ SQ TUB, UPC 2052601069 601069.05 ANTIOXIDANT SUPERSTAR MIX 8/10 OZ SQ TUB FESTIVAL, UPC 2052601069 601054 ANTIOXIDANT SUPERSTAR MX 12/10 OZ BAGLINE, UPC 2052601054 601069.04 ANTIOXIDANT SUPERSTAR MIX 8/10 OZ SQ TUB BOULDER, IUPAC 601048.00 ANTIOXIDANT SUPERSTAR MIX 100/2 OZ FLAT PACK PROMOTIONAL ANTIOXIDANT SUPERSTAR MIX***, UPC 2052601048. 601049.00 ANTIOXIDANT SUPERSTAR MIX 16/6 OZ CLAMSHELL SUPER ANTIOXIDANT MIX***, UPC 2052601049 612150.03 LARGE GIFT BOX KOWALSKIS, UPC 2052612150.
Code InfoBest By 6/22/2013, 10/6/2013, 10/10/2013,10/30/2013, 12/29/2013, 1/8/2014, 1/12/2014, 2/1/14, 2/2/2014, 1/26/2014, 1/28/2014.
ClassificationClass I
Reason for RecallBergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufacturing using pistachios supplied by ARO Pistachio Company. The recall was initiated because Salmonella was found in the environment at the ARO Pistachio Company.
Product Quantity1705.55
Recall NumberF-1734-2013
Product Description601041 HEALTHY HEART MIX 12/14 OZ TRAY, UPC 2052601041 601078 HEALTHY HEART MIX 12/8 OZ CLAMSHELL, UPC 2052601078 601078.03 HEALTHY HEART MIX 12/8 OZ CLAMSHELL KOWALSKI, UPC 2052601078 601089 HEALTHY HEART MIX 16/6 OZ CLAMSHELL, UPC 2052601089 601089.1 HEALTHY HEART MIX 16/6 OZ CLAMSHELL CUB, UPC 1115099868 601125 HEALTHY HEART MIX 8/10 OZ SQ TUB, UPC 2052601125 601125.04 HEALTHY HEART MIX 8/10 OZ SQ TUB BOULDER, UPC 2052601125 601125.05 HEALTHY HEART MIX 8/10 OZ SQ TUB FESTIVAL, UPC 2052601125 601063 HEALTHY HEART NUT MIX 12/16 OZ BAGLINE, UPC 2052601063 601061.05 HEALTHY HEART NUT MIX 12/16 OZ FESTIVAL, UPC 2052601061 601037 HEALTHY HEART NUT MIX 30#, UPC 2052601037 601038 HEALTHY HEART NUT MIX 5#, UPC 2052601038 601089.01 HEALTHY HEART MIX 16/6 OZ CLAMSHELL, UPC 1115099868 602037 HEALTHY HEART NUT MIX 2/5#, UPC 2052602037 601137.00 HEALTHY HEART MIX 12/7 OZ BERGIN CUSTOM ZIPLOCK POUCH DISCONTINUED HEALTHY HEART MIX***, UPC 2052601137
Code InfoBest By: 11/20/2013, 12/11/2013, 11/23/2013, 1/28/2014, 1/11/2014, 1/12/2014, 1/18/2014, 1/21/2014, 1/22/2014, 1/29/2014, 2/2/2014.
ClassificationClass I
Reason for RecallBergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company.
Product Quantity1527.59
Recall NumberF-1735-2013
Product Description604320 LOW GLYCEMIC INSTANT OATMEAL 25#, UPC 2052604320
Code InfoBest By: 12/4/2013
ClassificationClass I
Reason for RecallBergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company.
Product Quantity15
Recall NumberF-1736-2013
Product Description601180 LOW GLYCEMIC SNACK MIX 12/4 OZ BERGIN RED BAG, UPC 2052601180 601082 LOW GLYCEMIC SNACK MIX 12/8 CLAMSHELL, UPC 2052601082 601082.03 LOW GLYCEMIC SNACK MIX 12/8 CLAMSHELL KOWALSKI, UPC 2052601082 601080 LOW GLYCEMIC SNACK MIX 30#, UPC 2052601080 601084 LOW GLYCEMIC SNACK MIX 5#, UPC 2052601084 601083.04 LOW GLYCEMIC SNACK MIX 8/10 OZ SQ TUB, UPC 2052601083 601083 LOW GLYCEMIC SNACK MIX 8/10 OZ SQ TUB, UPC 2052601083
Code Info10/6/2013, 11/27/2013, 12/31/2013, 1/18/2014, 1/27/2014, 1/28/2014.
ClassificationClass I
Reason for RecallBergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company.
Product Quantity93.03
Recall NumberF-1737-2013
Product Description604293 MEGA OMEGA MIX 12/8 OZ SQ TUB, UPC 2052604293 604293.04 MEGA OMEGA MIX 12/8 OZ SQ TUB BOULDER, UPC 2052604293 604293.05 MEGA OMEGA MIX 12/8 OZ SQ TUB FESTIVAL, UPC 2052604293 604290 MEGA OMEGA MIX 15#, UPC 2052604290 604292 MEGA OMEGA MIX 16/7 OZ - CLAMSHELL,UPC 2052604292 604291 MEGA OMEGA MIX 5#, UPC 2052604291
Code Info11/26/13, 1/11/2014, 1/19/2014,1/11/2014, 1/22/2014, 1/28/2014, 1/29/2014.
ClassificationClass I
Reason for RecallBergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company.
Product Quantity331.3
Recall NumberF-1738-2013
Product Description601911 PISTACHIO KERNELS HOT & SPICY 30#, UPC 2052601911 601913 PISTACHIOS HOT AND SPICY 12/5 OZ BERGIN RED BAG, UPC 2052601913
Code Info5/24/2014, 5/28/2014.
ClassificationClass I
Reason for RecallBergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company.
Product Quantity11.27
Recall NumberF-1739-2013
Product Description600943 PISTACHIOS KERNELS RAW 8/11 OZ SQ TUB, UPC 2052600943 601902 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG, UPC 2052601902 601902.09 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG BYERLYS, UPC 2052601902 600899 PISTACHIOS KERNELS RAW 30#, IUPAC 600901 PISTACHIOS KERNELS RAW 5#, UPC 2052600901 600900.05 PISTACHIOS KERNELS RAW 12/16 BAGLINE FESTIVAL, UPC 2052600900. 601902.08 PISTACHIOS KERNELS RAW 10/14 OZ TAPE BAG LUNDS RAW PISTACHIO KERNELS, UPC 2052601902.
Code Info5/31/204, 5/24/2014, 5/28/2014, 12/13/2013, 6/3/2014, 4/2/2014, 1/8/2014.
ClassificationClass I
Reason for RecallBergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company.
Product Quantity401.07
Recall NumberF-1740-2013
Product Description600908.03 PISTACHIOS KERNELS R/S 12/16 OZ TRAY KOWALSKI, UPC 2052600908 600909 PISTACHIOS KERNELS R/S 16/7 OZ CLAMSHELL, UPC 2052600909 600909.03 PISTACHIOS KERNELS R/S 16/7 OZ CLAMSHELL KOWALSKI, IUPAC 600904 PISTACHIOS KERNELS R/S 30#, UPC 2052600904 600905 PISTACHIOS KERNELS R/S 5#, UPC 2052600905 600906 PISTACHIOS KERNELS R/S 12/16 OZ BAGLINE, IUPAC.
Code Info5/30/2014, 4/12/2014, 6/4/2014, 5/7/2014, 1/17/2014.
ClassificationClass I
Reason for RecallBergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company.
Product Quantity159.12
Recall NumberF-1741-2013
Product Description603684 PISTACHIOS S/I/S 12/10 OZ GOLD BAG, UPC 2052603684 600913 PISTACHIOS S/I/S 12/12 OZ BAGLINE, UPC 2052600913 600913.11 PISTACHIOS S/I/S 12/12 OZ BAGLINE AMAZON, UPC 2052600913 600913.07 PISTACHIOS S/I/S 12/12 OZ BAGLINE DISPLAY BOX, UPC 2052600913 600923.05 PISTACHIOS S/I/S 12/12 OZ BAGLINE FESTIVAL, UPC 2052600923 600915 PISTACHIOS S/I/S 12/12 OZ TRAY, UPC 2052600915 603672 PISTACHIOS S/I/S 12/26 OZ TIN HOLIDAY CLOSED SLEEVE, UPC 2052603672 600921 PISTACHIOS S/I/S 12/8 OZ CLAMSHELL, UPC2052600921 603667 PISTACHIOS S/I/S 16/15 OZ TIN HOLIDAY CLOSED SLEEVE, UPC 2052603667 600912 PISTACHIOS S/I/S 25#, UPC 2052600912 600914 PISTACHIOS S/I/S 4/20 OZ TUB, UPC 2052600914 600914.03 PISTACHIOS S/I/S 4/20 OZ TUB KOWALSKI, UPC 2052600914 603677 PISTACHIOS S/I/S 4/36 OZ TIN HOLIDAY CLOSED SLEEVE, UPC 2052603677 603902 PISTACHIOS S/I/S 4/36 OZ TIN HOLIDAY OPEN SLEEVE, UPC2052603902 600911 PISTACHIOS S/I/S 5#, UPC 2052600911 600927.04 PISTACHIOS S/I/S 8/8 OZ SQ TUB BOULDER, UPC 2052600927 600927.05 PISTACHIOS S/I/S 8/8 OZ SQ TUB FESTIVAL, UPC 2052600927 601912 PISTACHIOS S/IS 10/14 OZ TAPE BAG, UPC2052601912 601912.09 PISTACHIOS S/IS 10/14 OZ TAPE BAG BYERLYS, UPC 2052601912 601912.08 PISTACHIOS S/IS 10/14 OZ TAPE BAG LUNDS, UPC 2052601912 603858.00 PISTACHIOS S/I/S 12/26 OZ OPEN SLEEVE IN SHELL PISTACHIOS, UPC 2052603858.
Code Info11/15/2013, 12/13/2013, 5/24/2013, 6/3/2014, 6/5/2014, 5/30/2014, 6/4/204, 5/31/2014,2/25/2014, 3/22/2014, 5/23/2014, 5/7/2014, 3/29/2014, 1/18/2014. 5/28/2014.
ClassificationClass I
Reason for RecallBergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company.
Product Quantity914.05
Recall NumberF-1742-2013
Product Description600910 PISTACHIOS SPLITS RAW 30#, UPC 2052600910
Code Info4/25/2014
ClassificationClass I
Reason for RecallBergin Fruit and Nut Company is initiating a recall on a number of pistachio products manufactured using pistachios supplied by ARO Pistachio Inc. Salmonella was found in the environment at the ARO Pistachio Inc. company.
Product Quantity23
Recall NumberF-1743-2013

Class I Devices Event

Event ID65553
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmLeMaitre Vascular, Inc.
CityBurlington
StateMA
CountryUS
Distribution PatternWorldwide distribution: USA including PA and countries of: BRAZIL, BULGARIA, FRANCE, GEORGIA, GERMANY, GREECE, ITALY, LEBANON, NETHERLAND, POLAND, SPAIN, and TURKEY.
 

Associated Products

Product Description AlboGraft Knitted with Collagen, Bifurcate 14x08 Catalog Number: AMC1408 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity1 unit
Recall NumberZ-1754-2013
Product DescriptionAlboGraft Knitted with Collagen, Straight 15x06 Catalog Number: AMC1506 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity2 units
Recall NumberZ-1755-2013
Product Description Albo Graft Knitted with Collagen, Bifurcate 16x08 Catalog Number: AMC1608 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity7 units
Recall NumberZ-1756-2013
Product DescriptionAlboGraft Knitted with Collagen, Bifurcate 18x09 Catalog Number: AMC1809 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity3 units
Recall NumberZ-1757-2013
Product DescriptionAlboGraft Knitted with Collagen, Bifurcate 18x10 Catalog Number: AMC1810 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity1 unit
Recall NumberZ-1758-2013
Product DescriptionAlboGraft Knitted with Collagen, Bifurcate 20x10Catalog Number: AMC2010 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity3 units
Recall NumberZ-1759-2013
Product DescriptionAlboGraft Knitted with Collagen, Straight 40x07 Catalog Number: AMC4007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity1 unit
Recall NumberZ-1760-2013
Product DescriptionAlboGraft Knitted with Collagen, Straight 40x08 Catalog Number: AMC4008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity3 units
Recall NumberZ-1761-2013
Product DescriptionAlboGraft Knitted with Collagen, Straight 60x06 Catalog Number: AMC6006 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity3 units
Recall NumberZ-1762-2013
Product DescriptionAlboGraft Knitted with Collagen, Straight 60x07 Catalog Number: AMC6007 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity2 untis
Recall NumberZ-1763-2013
Product DescriptionAlboGraft Knitted with Collagen, Straight 60x08 Catalog Number: AMC6008 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity2 units
Recall NumberZ-1764-2013
Product DescriptionAlboGraft Woven with Collagen, Straight 15x26 Catalog Number: ATC1526 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity2 units
Recall NumberZ-1765-2013
Product DescriptionAlboGraft Woven with Collagen, Straight 15x30 Catalog Number: ATC1530 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity2 units
Recall NumberZ-1766-2013
Product DescriptionAlboGraft Woven with Collagen, Straight 30x16 Catalog Number: ATC3016 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity1 unit
Recall NumberZ-1767-2013
Product DescriptionAlboGraft Woven with Collagen, Straight 30x18 Catalog Number: ATC3018 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity1 unit
Recall NumberZ-1768-2013
Product DescriptionAlboGraft Woven with Collagen, Straight 30x24 Catalog Number: ATC3024 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity2 units
Recall NumberZ-1769-2013
Product DescriptionAlboGraft Woven with Collagen, Straight 30x26 Catalog Number: ATC3026 AlboGraft Vascular Grafts are made of synthetic material and designed to replace sections of damaged or malfunctioning arteries.
Code InfoLot number/Expiration Date 56890A 2015-04
ClassificationClass I
Reason for RecallBlood blushing/leaking from the surface of the graft after implantation
Product Quantity3 units
Recall NumberZ-1770-2013

Class I Devices Event

Event ID65579
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGE Healthcare, LLC
CityWaukesha
StateWI
CountryUS
Distribution PatternWorldwide Distribution - US Nationwide including Guam, Puerto Rico and the countries of : Afghanistan, Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, Finland, France, Georgia, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Iran, Ireland, Israel, Italy, Japan, Jordan, Korea (Republic of), Kuwait, Latvia, Lebanon, Lithuania, Malaysia, Malta, Martinique, Mexico, Morocco, Namibia, Netherlands, New Zealand, Norway, Pakistan, Panama, Peru, Philippines, Poland, Portugal, Puerto Rico, Romania, Russia, Saudi Arabia, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, Turkey, Ukraine, United Kingdom, Uruguay, Venezuela, Vietnam.
 

Associated Products

Product DescriptionGE Healthcare Infinia Hawkeye 4 Option For Dual-Head Variable Angle Gamma Camera, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (this includes GE Quasar Nuclear Medicine Systems). Nuclear Medicine Systems Infinia devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications.
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608775INF2, 608775INF3, 608791INF, 609267INF, 609652INF, 609730INF1, 609730INF2, 609835INFINIA, 610278INFINIA, 610327INFINIA, 610402INFINIA, 610402INFINIA2, 610437INFINIA, 610770INFINIA, 610869INF, 610954INFINIA, 613727INFIN, 613761INFINIA, 613969HAWKEYE, 613969INFINIA, 614478INF1, 615284INF1, 615322NM3, 615327VANM1, 615328NM1, 615342INF1, 615349NM1, 615349NM2, 615768SCNM1, 615769NM1, 615781NM1, 615893NM1, 615896NM1, 616267INFINIA, 617243INFINIA, 617296INF, 617313INF1, 618234INF1, 618256INF1, 618395INF, 618544INF, 618942INF, 618993INF, 619229INF, 619482INFINIA, 620225WPI, 620232INF, 623207INF, 623478NM2, 623848NM2, 623882INF, 626359INF1, 626359INF2, 626570INF1, 626573INF1, 626898INF1, 626915INF1, 63009NUC01, 630275INF, 630275INF2, 630312INF, 630545INF, 630786INF, 630801INF, 630856INF, 6502IN1, 6502IN2, 650367IN1, 650725IN, 650725IN2, 650858IN1, 650858IN2, 650858IN3, 651241INF1, 6525011INF1, 661633NM1, 661949NUC1, 661PMCNUC1, 662244INFINIA, 662256INFINIA, 662377INFINIA, 662423INFINIA, 662608NU01, 662772INFRM1, 662772INFRM2, 662772INFRM4, 671USNHINF, 678474INF, 681342INF1, 681342INF2, 681342INF3, 681342INF4, 70027NUC03, 70060NUC12, 701234INF, 701234INF2, 701364INF, 701774NM, 701857NM, 701952NM, 702255INF, 702360CHNM, 702369NM, 702388VNM, 702853NM, 703391INF1, 703391INF2, 703504HAWK1, 703558INF, 703689INF4, 703698INF1, 703858HAWK, 703858INF, 704225INF1, 704225INF2, 704304INF1, 704304INF2, 704316INFI, 704355INF1, 704355INF2, 704384HAWK1, 704384INFI2, 704384INFI4, 704384INFI5, 704384INH1, 704446INF1, 704487INFINIA1, 704660HAWK, 704667INF1, 704739INFI, 704783INFI1, 704783INFI2, 704783INFI3, 704863INF1, 705674HAWKEYE, 705674INFINIA, 705759HAWKEYE, 705759INFINIA2, 706278INF, 706291HINM, 706494HNM, 706651INF, 706651NUC, 706733INF, 707822INFINIA, 707963IN, 708660INF, 708684INF1, 708747INFACQ, 709637INFINIA1, 709651INFINIA, 709651INHE4A, 709737INFINIA, 709737INFINIA2, 709737INFINIA3, 712279INF, 713242INF1, 713242INF2, 713242INF3, 713359INF1, 713456INF, 713722INF, 713785SLINF1, 713785SLINF2, 713785SLINF3, 713794INF, 713794INF2, 713794INF3, 713ACCINF1, 714456INFINIA, 714953INFINIA, 715423INF, 715623INF, 715839INF, 716366INF, 717544INFINIA, 717627INFINIA, 717633INF1, 717633INF2, 717782INF, 718150INF1, 718240INF1, 718240INF2, 718250INF1, 718334INF1, 718334INF2, 718405INF1, 718518INF1, 718584INFINIA, 718616INF, 718630INF1, 718883INF1, 718883INF2, 718948INF, 718963INF1WH, 719333IH, 722050NU01, 724226INF1, 724357INF1, 724450INFINIA, 727461VG, 727521INF, 727581INF, 727843INF1, 727863INF1, 727893INF, 727942INF, 731425INFH1, 731425NMIC1, 731425NMRM, 731644INF, 732292INFINIA, 732321IH4, 732321INFINIA, 732530INFINIA, 732530INFINIA2, 732776INFH4, 732840INFINIA, 732923INFINIA, 732937INFINIA, 734246INF, 734467INF, 734475INF, 734671INF, 740264INF3, 740264INF4, 740356INF1, 740356INF2, 740383INF1, 740623INFINIA, 740922INFINIA, 740944NU01, 757259INF1, 757312INF1, 757312INF2, 757388INF2, 757395INF1, 757398INF1, 757398INF2, 757668INF1, 757722INF1, 757886INF1, 757889INF1, 760241INF1, 760452INF1, 760778INF1, 760873NUC, 763MRCYINFI, 763UNTYINFI, 765456INF, 765552INF, 770219INF, 770229INF, 770382INM, 770400INF, 770535INF1, 770751INF, 77137NUC01, 77139NUC05, 77187NUC01, 77260NUC03, 772LMCNM2, 773665INF1, 773665INF2, 77383NUC03, 773884INF, 773947INF, 773995INF, 774442INF, 775423INF1, 77624NUC01, 77624NUC03, 780489INFINIAH4, 780489INHE4B, 780489INHE4C, 780715INHE4A, 780875INFINIA, 781340INF, 781340INF2, 781340INF3, 781477INF, 781979INF1, 783348NU01, 785462CI, 786308INF1, 786308INF2, 787653INFINIA2, 787758INFINIA2, 787764INFINIA-1, 787848INFINIA, 78NMIH2564713, 801268INF1, 801299INF1, 801314INF1, 801357INF1, 801357INF2, 801387INF1, 801408INF, 801408INF2, 801465INF1, 801479INF, 801479INF2, 801501INF1, 801584INF1, 801584INF2, 801584INF3, 801588INF, 801ALTAINF2, 801IMCCARD, 801IMCINF, 801IMCINF1, 801RHINF, 801SLCINF, 802257INF, 802388INF, 802775INFINIA, 803329HAWK, 803329INFIN1, 804225INF1, 804254INF, 804281INF1, 804323INF1, 804594INF1, 804675INF1, 804957INF1, 804957INF2, 805370INF1, 805489INF1, 805543INF1, 805737INF1, 806354ACINFINIA, 806354NWINF, 806354NWINF2, 806GRACENM, 809758INFINIA, 812265KDINF, 812426INF, 812485INF, 812522INF, 812842INF1, 813788INF1, 813870INF, 813USFINF1, 814333INFINIA1, 814333INFINIA2, 814362INFINIA, 814452INF1, 814467INF, 814533INF, 814534INF1, 814643INF, 814723INF, 814877INFINIA, 814889INFINIA, 815395INF, 815432INF, 815432INFINIA, 815741INF1, 815741INF2, 815756INF, 816271SJINF, 816348INF1, 816380CASSINF, 816392RINF, 816404INF1, 816836CIIN, 817255INF, 817346INF, 817472INF, 817599INF, 817685INF, 817920INF, 818409INF2, 818884INF1, 818907INF1, 819357BINFINIA, 819378INFINIA, 819537INFINIA, 819537INFINIA2, 819563CINFINIA, 819595INFINIA, 828262INFINIA, 828286INFINIA, 828298HAWK1, 828298HAWK2, 828315HWK4, 828586INFINIA, 828696INFINIA1, 828766INFINIA, 828883INFINIA, 831755IN1, 832505NM1, 832522INF, 832522INF2, 832824INF, 843402INF, 843402INF2, 843412INF, 843431IN, 843606INF1, 843674IN1, 843674IN2, 843674IN3, 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905683IN1, 905731INFINIA, 905773INFINIA1, 905813INFINIA, 905813INFINIA2, 905832INFINIA, 905845INFINIA1, 905848INFINIA, 905855INFINIA, 905855INFINIA2, 905855INFINIA3, 905883HAWKEYE, 905895INFINIA1, 905895INFINIA2, 906293INF, 906774INF, 906776INF, 907562NM1, 907562NM2, 908522INFINIA, 908522INFINIA2, 908522INFINIA3, 909825INFINIA, 910323INF1, 912486EGNC, 912691SCNC, 913345INF1, 913541INF1, 913588INF, 913588INF1, 913588INF2, 913676SMIM, 915521HNM1, 915577NM1, 915595GNM1, 916453IN, 916537IN, 916537IN2, 916703IN1, 916703IN2, 916733IN, 916781IN, 916782IN1, 916782IN2, 916983INFN1, 918294INF1, 918307INF1, 918307INF2, 918376INF1, 918494INF1, 918494INF2, 918494INF3, 918502INF1, 918599INF1, 919684INF1, 919684INF2, 919684INF3, 919784INF1, 919934INF, 920288INF, 920288INF2, 920451INF, 920456INF, 920568INF, 920684INF, 920729INF, 920738INF, 920738INF1, 920738INF2, 920794INF, 920849INF, 920907INF, 925370IN, 925779IN, 925785IN, 925INF, 928214INF, 928442INF, 928537INF, 928855INF, 931381NM2, 931403NM1, 931967NM, 937208INF1, 937208INF2, 937268INF1, 937278INF, 937328INF1, 937328INF2, 937374INF1, 937386INF, 937390INF1, 937393INF, 937438INF, 937440INF1, 937440INF2, 937832INF1, 941235INF, 941629INF, 941637INF, 941766INF2, 941VRMCINF, 951672INF1, 951696INF1, 954265INF1, 954735INF1, 954735INF2, 954978INF1, 956350NM1, 956687INF2, 956971NM1, 970350IH, 970945INF, 972394INF, 972498INF, 972540INF, 972596INF, 972969INF, 973579INFINIA, 973625INFINIA, 973676INFINIA, 973831INFINIA, 973877INFINIA, 973971INFINIA, 978521INF, 979241INF, 979532INF1, 980212INF1, 985230INF, 985646INF, 985649INF1, 985649INF2, 985785INF, 989723INF1, 989723INF2, A004NU11, A186363001, A4169304, A4194407, A51043155, A51043187, A5107756, A5107766, A5109126, A5109665, A5109666, A5111127, A5111240, A5112411, A5113627, A5114292, A51149103, A5115111, A51152163, A51152164, A5118056, A5118088, A5120724, A5123523, A5124139, A5127292, A5128755, A5128757, A5129026, A5129959, A5152964, A5153612, A5162248, A5172907, A5172908, A5178021, 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M44827146, M4496943, M5172527, M54606103, M7411101, M7411106, M8572211, M9162716, M9164758, M9319116, M9886832, MA1020NM01, MA1272NM01, MA1439NM01, ME051533, ME208350, ME244391, ME244393, MEX68919, MPP0131, MPX46902, MPX47106, MPX52309, MPX82204, MPX99201, MQ1000MN04, MT1014NM01, MT1014NM02, MVINFNM2, N001NU02, N001NU06, NA1027NM01, NASHNM2, NE209938, NM156449, NM18342, NM18346, NM18356, NM18357, NM18363, NM18365, NM18409, NM18444, NM18451, NM18471, NMCR-17849, NMCR-17980, NMINDTCRL0206, NMINDTCRL0227, NMINDTCRL0311, NMINDTCRL0351, NO1000MN03, NO1000MN06, NO1016MN16, NO1054MN01, NO1068MN07, NO1068MN09, NO1070MN07, NO1088MN09, NO1116MN09, NP739716, NPV15964, NUC5178133HM6, O005NU14, OBNM1, ORMCINFINIA1, ORMCINFINIA2, P4211482, PC1268NU03, PC1818NU03, PC3906NU02, PC3964NU02, PC3970NU02, PC5995NU01, PC8118NU01, PER03520, PER08009, PITTINF4, PITTINF5, PK1001NM01, PK1031NM01, PK1032NM01, PK1180NM03, PK1180NM08, PK1184NM01, PK1278NM01, PK1307NM01, PK1335NM01, PK1336NM01, PK1355NM01, PL1003NM03, PL1143NM03, PL1143NM06, PL1692NM01, PM1633NU03, PMR12506, PPR08202, PPR12213, PPR59030, PPR97306, PPS06907, PRINCEINF, R4211480, RO1224NM01, RU1018NM01, RU1021NM02, RU1085NM02, RU1091NM01, RU1095NM02, RU1152NM02, RU1212NM01, RU1284NM01, RU1294NM01, RU1302NM01, RU2050NM01, RU2199NM01, RU2311NM01, RU2311NM02, RU2526NM01, RU2527NM02, RU2527NM03, RU3143NM02, RU3314NM01, RU3424NM01, RU3448NM01, RU3508NM01, S4160059, S4160079, SA1001MN01, SA2146NM01, SLGHINF, TN1366NM01, UC4109NU02, UC7655NU03, UC7655NU04, UE282633, UE282648, UE720407, UEW19003, UEW19005, UK1110NM01, UK5002NM01, UP285A41, UPW00402, V1471114, V2147210, V2728105, V2728109, V2943412, V2943415, V4198004, V6414104, V7405209, V7406615, V7406617, V8572204, VASINF, VCWESTINF, VVMCINF1, X100611101, X105967809, X105967813, X119197203, X151957601, X2034002, X4211026, X59007307, X61014001, Y004NU08, Y004NU11, YE364413, YE364417, YE626937, YN1196, YN1200, YN1539, YN1540, YN1541, YN1542, YN1543, YN1544, YN1545, YN1546, YN1547, YN1548, YN1549, YN1550, YN1551, YN1552, YN1553, YN1554, YN1555, YN1556, YN1557, YN1558, YN1559, YN1560, YN1561, YN1562, YN1563, YN1564, YN1565, YN1566, YN1567, YN1568, YN1569, YN1570, YN1571, YN1572, YN1573, YN1574, YN1575, YN1577, YN1578, YN1579, YN1580, YN1581, YN1582, YN1583, YN1584, YN1585, YN1586, YN1587, YN1588, YN1589, YN1590, YN1591, YN1592, YN1593, YN1594, YN1595, YN1596, YN1597, YN1598, YN1599, YN1600, YN1601, YN1641, YN1650, YN1730, YN1742, YN1743, YN1744, YN1745, YN1760, YN1802, YN4218, YN4219, YN4220, YN4221, YN4222, YN4223, YN4224, YN4225, YN4226, YN4227, YN4228, YN4229, YN4230, YN4231, YN4232, YN4233, YN4234, YN4235, YN4236, YN4237, YN4238, YN4239, YN4240, YN4241, YN4242, YN4243, YN4244, YN4245, YN4248, YN4249, YN4250, YN4251, YN4252, YN4253, YN4254, YN4255, YN4256, YN4257, YN4258, YN4259, YN4260, YN4261, YN4262, YN4263, YN4264, YN4265, YN4266, YN4267, YN4270, YN4280, YN4288, YN4300, YN4312, YN4818, YN4819, YN4820, YN4821, YN4822, YN4824, YN4825, YN4830, YN4833, YN4900, YN4918, YN4919, YN4920, YN4921, YN4922, YN4923, YN4924, YN4925, YN4926, YN4927, YN4928, YN4929, YN4930, YN4931, YN4932, YN4933, YN4934, YN4935, YN4936, YN4937, YN4938, YN4939, YN4941, YN4942, YN4943, YN4944, YN4945, YN4946, YN4947, YN4948, YN4949, YN4950, YN4951, YN4952, YN4953, YN4954, YN4955, YN4990, YN4992, YN4999, YN5000, YN8001, YN8002, YN8003, Z001NU06, ZA1806NM12, ZA1807NM11, ZA1808NM13, ZA1820NM04, ZA1835NM24, ZA1835NM25, ZA2006NM04, ZA2008NM04, ZA2212NM02, ZA2246NM01, ZA2261NM01, ZTP0133, ZWL0437.
ClassificationClass I
Reason for RecallGE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
Product Quantity2474
Recall NumberZ-1787-2013
Product DescriptionGE Healthcare Varicam/VG and VG Hawkeye devices Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
Code InfoSystem ID: 2998, 6970, 12865, 21414, 38070, 53263, 55461, 56948, 58230, 58378, 58379, 58483, 58510, 58582, 58622, 58630, 58711, 58785, 58797, 58808, 58810, 58871, 58883, 58919, 58958, 58993, 59012, 61061, 63422, 66515, 75074, 79722, 79966, 84636, 92635, 99691, 0850260033, 0850260034, 0850260035, 0850260038, 0850260040, 0850260041, 0850260042, 0850260046, 0850260048, 0850260054, 0850260057, 0850260062, 0853940029, 0853940068, 0853940069, 0853940077, 0853940078, 0853940080, 0853940082, 0856260014, 0856260019, 0910265011, 0910453006, 082426010009, 082426010010, 082426010011, 082426020002, 082426030009, 082426030010, 082426030015, 082426030016, 082426030018, 082426040016, 082426040020, 082426040021, 082426040024, 082426040025, 082426040026, 082426040029, 082426050001, 082426050002, 082426050003, 082426070014, 082426070015, 082426070016, 082426080006, 082426080007, 082426080009, 082426090013, 082426100017, 082426100019, 082426100020, 082426100023, 082426110002, 082426120003, 082426120004, 082426130012, 082426130013, 082426130014, 082426130015, 082426130016, 082426130019, 082426140005, 082426140007, 082426140008, 082426140009, 082426140011, 082426140012, 082426150003, 082426150006, 082426160012, 082426160014, 082426160016, 082426160017, 082426160019, 082426160020, 082426160022, 082426160023, 082426180003, 082426190008, 082426190010, 082426200002, 082426210002, 082426210003, 082426210010, 082426220006, 082426230008, 082426230010, 082426250002, 082426280001, 082426290004, 082426310005, 082426310007, 082426310008, 08302603017002, 08302603135243, 08302606123002, 08302621006334, 083026031062021, 083026242100654, 083026590040004, 083026590040010, 083026598000594, 083026826753913, 0382E00013, 00023NUC06, 0009D, 00132NUC02, 00216NUC09, 00243NUC11, 00243NUC15, 00243NUC17, 00269NUC07, 00323NUC02, 00357NUC02, 00555NUC01, 00584NUC01, 00584NUC04, 0112B, 0277A, 030010NU02, 030028NU01, 030036NU06, 030082NU10, 030151NU05, 030220NU02, 030355NU02, 030388NU01, 0306A, 0343A, 0360A, 06007NUC16, 080041NU01, 082426040029P, 082426050001P, 082426140005P, 0850EL0011, 0850EL0012, 10433NUC01, 110012NU02, 110965NU05, 130083NU07, 13228MILLEN, 16003NUC03, 160070NU01, 190226NU17, 190282NU04, 203694MIL, 203852VG, 203932VG, 204837VG, 205823NMVG, 205933VH, 206288VG, 206598VG, 207795VH, 208529VG, 209334LNVG1, 209526MILVG, 212562VG, 215893VG, 220166NU01, 223410MILVG, 225763MVG, 228818MILLVG, 248828H, 248828VG, 248937VG, 256235OPNM1, 262785VG, 2894872VG2, 2894872VG3, 301896VG, 304256VG, 304487VG, 309662SJVG, 310231VGH1, 310289VG1, 312864VG, 313299VG, 334794MILVG, 361575VG, 402449SJVG, 404605PVGH, 404712VG, 406782SNM, 407277FVG2, 407896FVG1, 407933KVG, 408947VG, 409291HVG, 410605NM1, 410955VG1, 410955VH, 412359VG, 413781VG1, 413781VG2, 414219VG, 414328VG, 414384VG, 414447VG, 414544HEYE, 414544VG, 414777MIL, 414777VG2, 414961VG, 416284VG, 416284VG2, 416290VG, 416444VG, 416469DVH, 416534VG1, 416534VG2, 416586VG, 416656VG, 416747VARICAM, 416747VG, 416756VG, 418404NU01, 418862VARICAM, 419383VG, 440329VG, 443643VG, 450359VG1, 450359VG2, 480981NM1, 501686VG, 508997VG, 509575PYVGH, 510486VG1, 512753VG, 514495VG, 515263LVG, 516256VG, 518271SVG, 519421VG, 520757NM1, 530529VG, 540186NU01, 540596N3, 540953VG, 541276AVG, 559688NM1, 570791HAWK, 580355VGACQ, 589907MVG, 600062NM01, 601426VG, 602406VG, 602870NM1, 605333HAWKEYE, 608263VG, 608364VG, 609267VG, 610954VG, 613548VG, 613548VG2, 615322NM2, 615791VG, 630801VG, 70050NUC06, 705324VG, 705327VARICAM, 705743VG, 706845VG, 707554VG, 708422MIL, 708783VG, 714774VG, 715361VG, 716694VG, 716859VG, 717657VG, 718759VG, 718780GENIEVG, 718780VG, 73240-1, 781278VG, 781744VG2, 781744VH, 786090NU03, 787782VARICAM-1, 804281VG1, 807343BMILLVG, 807343CMILLVG, 809758VARICAM, 812537VG, 813725VG, 813788VG, 815842SJVG, 819563CVG, 819822VG, 828212VG, 828213VG, 843792NUCH, 845437VG, 847695MILMVG, 847842VG, 860343VGOPC, 860344VG, 863494VG, 864573MBVG1, 904202VG, 905472VG, 905527HAWKEYE, 905683VG, 905684VG, 905684VG2, 905845VG, 905848VG, 905855VG, 905883VG, 905895VG, 912691SCVG, 914734VG, 919684VG1, 920459VG, 920729VG, 920887VG, 949760VG1, 956632MVG, 956687HKI, 970491VG1, 973754VG, 978466VG, 978741VG, 979764VGH1, 989269VG, A004NU10, A2846901, A5103321, A5107736, A5111021, A5114718, A5116033, A5128734, A5129932, A5132115, A5177338, A5177340, A5177344, A5177347, A5188524, A5215912, A5236208, A5306504, A5333009, A5353816, A5632411, AH0101NM02, AH0101NM03, AH3701NM04, AH4307NM04, AH4660NM05, ALK0130, ALK0131, APL0236, B4155407, B5119109, B5131812, B5315325, B5365411, B5483426, C5123638, CC0618NU13, CY1088MN04, D007NU07, DE282013, DE619831, DEL26415, DHG0536, DK1026NM05, DLF0237, E001NU09, EE1020MN01, EEF51528, FE416038, FE816127, FEB52048, FHALTVGH1, FHORLVGH1, G001NU07, GEC21815, GEE34020, H1404NUC06, H2103NUC06, H5174NUC02, HBER01NU02, HC2250NU01, HC2250NU02, HC2250NU03, HC3314NU01, HC4387NU01, HC5036NU01, HJJT01NU02, HOR0250, HR4106NM01, HT2106NU02, HT2106NU05, ID9320, IL1020NM01, IL1028NM03, IL1028NM13, IL1059NM01, IL1061NM01, IL1061NM05, IL1062NM01, IL1066NM03, IL1067NM03, IL1072NM01, JHOCVG10464, M001NU10, M001NU14, M2846904, M2881704, M4024091, M4134620, M4143939, M4144609, M4144845, M4145121, M4160707, M4164912, M4211044, M5400305, M5460632, MAYO1VG4, MAYO1VGH1, MAYO4VG3, MC6946NU02, ME260802, ME504345, ME612431, MPX24714, NM10374, NM73049, NM73050, NM81394, NO1012MN04, NO1015MN03, NO1016MN27, PC0173NU06, PC0396NU03, PC2306NU01, PC4178NU01, PER02544, PER10924, PER10925, PL1003NM01, PL1008NM01, PL1143NM01, PMR12503, PPR12206, RADNETNM1724, RU1100NM01, RU1457NM01, RU1591NM01, SK1071NM01, SK1082NM01, U001NU12, UC1129NU01, UC1769NU07, UC4092NU01, UC4109NU01, WH231NM1, YE645816, YE645817, YN0438, YN0440, YN0444, YN0448, YN0450, YN0454, YN0455, YN0468, YN0475, YN0477, YN0479, YN0482, YN0486, YN0493, YN0498, YN0502, YN0506, YN0542, YN0543, YN0544, YN0638, YN0639, YN0640, YN0641, YN0642, YN0643, YN0844, YN0845, YN0846, YN0847, YN0848, YN0849, YN0850, YN0851, YN0852, YN0853, YN0854, YN0907, YN0909, YN0910, YN0911, YN0912, YN0913, YN0914, YN0915, YN0917, YN0918, YN0919, YN0920, YN0921, YN0922, YN0923, YN0924, YN0966, YN0979, YN0980, YN0981, YN0982, YN0983, YN0984, YN0985, YN0986, YN0987, YN0988, YN1000, YN1009, ZA1807NM08, ZWL0431,
ClassificationClass I
Reason for RecallGE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
Product Quantity571
Recall NumberZ-1788-2013
Product DescriptionElscint APEX Helix, dual-head, multi-purpose, Slip-Ring, digital gamma camera Product Usage: The intended use of the Quasar system is to perform general Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition typed and optional imaging features designed to enhance image quality in Oncology, Cardiology, Neurology and other clinical diagnostic imaging applications. The scanning modes include planar (Static, Multi-gated, Dynamic, Whole body scanning) and tomographic (SPECT, Gated SPECT, Whole body SPECT, Camera based PET). Acquisition types include single and multi-isotope/multi-peak frame/list mode single-photon and positron imaging. Optional imaging-enhancement features include assortment of collimators, gating by physiological signals, real-time automatic body contouring, and CT-based attenuation correction and functional anatomic mapping.
Code InfoSystem ID: 57503, 57584, 57588, 57711, 57727, 57734, 57815, 57873, 58826, 0828960002, 082426010006, 082426130005, 082426160008, 00243NUC09, 0090J, 0177A, 0201B, 0252A, 0272B, 0274B, 0279A, 0280A, 0286A, 030038NU04, 030151NU02, 030232NU04, 080019NU03, 210001NU01, 250565NUC2, 416586HELIX, 418589HELIX, 506739HELIX, 519464HELIX, 61420HELIX, A5110123, A5153605, AP2302NM01, B4213128, B5315316, CS1013NM01, FE8161EL18, IL1041NM01, IL1042NM02, IL1062NM02, M4148612, M4392002, MPX247EL09, NE4191EL15, PL1139NM01, SK1042NM01.
ClassificationClass I
Reason for RecallGE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System.
Product Quantity50
Recall NumberZ-1789-2013
Product DescriptionBrivo NM615, is an all-purpose, single detector integrated nuclear imaging system. Product Usage: The Brivo NM 615 is an emission computed tomography system intended to detect the location and distribution of gamma ray photon emitting radionuclides in the body and to produce cross-sectional images through computer reconstruction of the data. The Brivo NM 615 system is intended for General Nuclear Medicine imaging procedures using variety of scanning modes supported by various acquisition types. This generic type of device may include signal analysis and display equipment, patient and equipment supports, and accessories.
Code InfoSystem ID: 030151NU17, 387171NU01, 405456NM615, 406222LN615, 478272NM, 702304NM615, A5635609, HC0541NU03, HC3366NU02, NM24011, NM24015, ZA1819NM04, ZA2446NM01.
ClassificationClass I
Reason for RecallGE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems.
Product Quantity13
Recall NumberZ-1790-2013
Product DescriptionDiscovery NM 630, dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM 630 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and in assessment of organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy. The GE Discovery NM 630 system is a Nuclear Medicine (NM) system, which is intended to yield General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body, using a variety of scanning modes supported by various acquisition types and imaging features designed to enhance image quality. The scanning modes include planar mode (Static, Multi-gated, Dynamic and Whole body scanning) and tomographic mode (SPECT, Gated SPECT, Whole body SPECT). The acquisition types include single and multi-isotope/ multi peak frame/list mode single-photon imaging. The imaging-enhancement features include assortment of collimators, gating by physiological signals, and real-time automatic body contouring. The GE Discovery NM 630 system may include signal analysis and display equipment, patient and equipment supports, components and accessories. The system may be used for patients of all ages.
Code InfoSystem ID: 0850260134, 083026001113611, 00001NUC11, 00052NUC11, 030029NU05, 030151NU15, 030359NU07, 201418D630, 205333D630, 207664NM630, 208455NM630, 217544PH630, 251639D630, 262574D630, 269945D630, 270417D630, 281540D630, 301877D630, 305596D630A, 305596D630B, 317887D630, 318448D630, 318798D630, 319364D630A, 319364D630B, 330386D630, 334287NM630, 34363NUC01, 407431NU01, 409212NM630, 417533D630, 417781D630, 469814NM630, 580531NM630, 585922NM630, 601288D630, 601354D630, 601798D630, 609978D630, 614NCH630, 618443DISC1, 618842DISC1, 618942NM630, 619474D630, 651DSC630, 702388VNM2, 704355D630, 708684D630, 716372NM630, 719587D630, 770751D630, 773282D630, 801714D630, 804675D630A, 808485NM630, 813558D630, 813615D630, 814623D630, 815564D630, 816234D630, 843347D630, 843797TD630, 845454D630, 870939NU01, 870939NU02, 901226D630, 903GSD630, 904276DSC1, 904321DSC1, 905684D630, 913345D630, 918502DIS1, 936NMD630, 937SNHC630, 941LWRNM630, 956523D630, 978354DSV630, 989227D630, A5131865, A5366307, A5384208, A5812287, EG1040NM01, H002NU03, H3001NUC01, HC0863NU02, IE1018MN03, IE1044NM01, JHDSV630NM, M4216453, M4476428, M45052111, NM22073, NO1035MN06, NT3001, NT3002, NT3003, NT3010, NT3020, O009NU09, OSC630, PC3003NU01, PMAB01NU04, POIN630, PRINCE630, RTD0739, RU1136NM01, TP0004NU01.
ClassificationClass I
Reason for RecallGE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems.
Product Quantity108
Recall NumberZ-1791-2013
Product DescriptionDiscovery NM/CT 670 dual detector free-geometry integrated nuclear imaging system. Product Usage: The GE Discovery NM/CT 670 system is a medical tool intended for use by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing of diseases and organ function for the evaluation of diseases, trauma, abnormalities, and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The system output can also be used by the physician for staging and restaging of tumors, planning, guiding, and monitoring therapy.
Code InfoSystem ID: 0828260021, 0828260022, 0850260118, 0850260122, 0850260128, 0850260131, 0850260132, 0853260094, 0853260099, 0856260033, 0856260034, 0856260035, 0910262297, 0910262304, 0910262310, 0910262319, 0910262322, 0910262325, 0910262344, 0910263223, 0910263228, 0910263231, 0910263235, 0910263239, 0910263241, 0910263243, 0910263250, 0910264135, 0910264141, 0910264147, 0910265074, 0910265075, 0910265076, 0920269097, 082426040043, 082426040044, 082426060005, 082426070028, 082426070030, 082426080020, 082426090029, 082426090030, 082426130029, 082426130030, 082426150026, 082426160042, 082426210020, 082426230020, 083026009408410, 083026023683711, 083026201006810, 00001NUC12, 00028NUC01, 00042NUC02, 00046NUC06, 00065NUC08, 00123NUC01, 00149NUC01, 00149NUC03, 00197NUC14, 00199NUC13, 00200NUC07, 00200NUC08, 00234NUC09, 00361NUC08, 00432NUC02, 010120NU19, 030037NU08, 030082NU13, 030133NU13, 030360NU01, 05462NUC05, 06007NUC19, 080041NU04, 100032NU05, 10497NUC20, 110017NU06, 110022NU05, 11018NUC08, 190052NU09, 190163NU04, 190163NU06, 204726D670NM, 210060NU02, 212639NMD670, 250370D670, 260010NU06, 262574D670, 305674D670, 309671SPECT, 403343D670, 403943D670, 403943D670B, 404686NMCT, 410955D670, 410D6701, 415353D670, 416495D670, 418549D670A, 418549D670B, 423495D670, 514281D670, 514338D670, 514842AD670, 514848D670, 514876D670, 519973D670, 529150NU05, 540332D670, 600092NM11, 610402D670NM1, 613548D670, 614NCH670, 615322NM5, 615893MMCT1, 617638DSV670, 630432D670, 720848D670, 803751D670, 819563D670, 819563D670B, 856247D670, 856247NM, 900010NU09, 905472D670, 905684D670A, 905684D670B, 905883D670, 972747NM670, 972935D670, A4169312, A4194844, A51051127, A51142126, A5125139, A5129983, A5196344, B4182011, B5140618, BG4009NM01, D007NU12, DK1029NU14, DK1047NM01, EE1020NM03, FE416061, FI1052MN01, GP1000NM01, HOR0281, IL1020NM36, IL1041NM30, IL1062NM29, M001NU42, M2002713, M251400603, M4134637, M4143630, M4143993, M4144126, M4145158, M4194042, M4198090, M4210246, M4215577, M4476424, M4505290, M5172553, M5400562, M5480777, M9409545, M9886847, MEX68915, NO1018MN06, NO1087MN09, NO1088MN16, NT1001, NT1002, NT1003, NT1004, NT1005, NT1006, NT1007, NT1008, NT1009, NT1010, NT1011, NT1013, NT1015, NT1020, NT2001, NT2002, O005NU27, PC8262NU01, PITT670, RTD0737, RU1095NM03, RU1279NM02, RU1949NM01, RU3451NM01, RU3467NM01, RU3623NM01, RU3637PT01, RU3713NM01, RU3900NM01, RU6340NM01, RU7175NM01, RU7187NM01, RU7505NM01, UX2305NU01, V4144610, V4169306, X102874005, X4144501, XM203402.
ClassificationClass I
Reason for RecallGE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems.
Product Quantity213
Recall NumberZ-1792-2013
Product DescriptionOptima NM/CT 640 Product Usage: The GE Optima NM/CT 640 system is intended for General Nuclear Medicine imaging procedures for detection of radioisotope tracer uptake in the patient body. It includes a general purpose Nuclear Medicine (NM) system using a variety of scanning modes supported by various acquisition types, and a CT component which is intended specifically for enabling attenuation correction and anatomical localization on SPECT studies
Code InfoSystem ID: 0910263253, 0910263256, 00139NUC08, 00162NUC11, 030232NU15, 215728OPT640, 262574O640, 270956NM640, 410543NUC640, 715735OPT1, 717782640NM, 808485NM640, 815564O640, 816234D640, 817250NM640, 847872O640, 901516GO640, 915839NU01, 928214NMCT, A5366308, A5639613, BD003NU01, DK1054NM03, RTD0782, XM203401.
ClassificationClass I
Reason for RecallGE became aware of an incident at a VA Medical Center facility in the US in which a patient died due to injuries sustained while being scanned on an Infinia Hawkeye 4 Nuclear Medicine System. UPDATE: On July 03, 2013 GE notified hospitals that they are recalling several Nuclear Medicine Imaging Systems because serious injuries or deaths could occur due to the failure mode associated with this recall. GE advised hospitals that they cease use of their Nuclear Medicine systems until GE can complete an inspection of the system. In this second notification GE included all Nuclear Medicine Systems.
Product Quantity25
Recall NumberZ-1793-2013

Class I Food Event

Event ID65687
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-13
Initial Firm Notification of Consignee or Public Other
Recalling FirmPriester Pecan Company, Inc.
CityFort Deposit
StateAL
CountryUS
Distribution PatternNationwide and Puerto Rico
 

Associated Products

Product DescriptionPRIESTER'S PECANS brand brand ROASTED SALTED PISTACHIOS, item #18010, Net Wt. 1 lb (454g), UPC 720056180104; item #15502, Net Wt. 8 oz (226.8g), UPC 001001155027; Stock No. 189, Net Wt. 2 lb (907g)
Code InfoThe product is not coded.
ClassificationClass I
Reason for RecallPistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella.
Product Quantity701.5 pounds
Recall NumberF-1730-2013
Product DescriptionPRIESTER'S PECANS brand NUTTY FAVORITES ASST, Stock No. 79, Net Wt 1 lb 10 oz (737g)
Code InfoThe product is not coded.
ClassificationClass I
Reason for RecallPistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella.
Product Quantity777 units (4 oz)
Recall NumberF-1731-2013
Product DescriptionPRIESTER'S PECANS brand FANCY ROASTED NUTS, Stock No. 7, Net Wt 12 oz (454g)
Code InfoThe product is not coded.
ClassificationClass I
Reason for RecallPistachios, which were supplied by ARO and subsequently recalled, have the potential to be contaminated with Salmonella.
Product Quantity268 units of 3 oz
Recall NumberF-1732-2013

Class I Food Event

Event ID65720
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jul-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmHigh Quality Organics, Inc.
CityReno
StateNV
CountryUS
Distribution PatternCA, FL, NY
 

Associated Products

Product DescriptionDried Oregano, cut and sifted; Organic; Product of Turkey, sold in 25 lb boxes High Quality Organics, Reno, NV
Code InfoLOT OREO-3305638A-CS-102AB
ClassificationClass I
Reason for RecallHigh Quality Organics was notified by a customer who received a lot of oregano in October 2012, recently tested last box of the shipment and found to be positive for Salmonella.
Product Quantity3,125 plbs
Recall NumberF-1744-2013

Class I Food Event

Event ID65729
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHearthside Food Solutions LLC
CityWillmar
StateMN
CountryUS
Distribution PatternNationwide, no OUS distribution
 

Associated Products

Product DescriptionPistachios, Salted in the Shell packaged in the following configurations: 1. Gurley's Golden Recipe Natural Pistachios in 2 oz., 2.25 oz., 12 oz., 3 lb., and 25 lb; 2. Mountain Country Natural Pistachios, in 2. 25 oz., and 3.5 oz.; 3. Rachael's Natural Pistachios in 2 oz.
Code InfoBest by dates between 02-26-14 to 06-03-14
ClassificationClass I
Reason for RecallOne of our vendors, ARO Pistachio Inc., is issuing an FDA Class 2 Voluntary Recall on certain shipments of pistachios.
Product Quantity17,538 lbs
Recall NumberF-1733-2013

Class II Biologics Event

Event ID39177
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-May-07
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
Code InfoGP92319
ClassificationClass II
Reason for RecallBlood product, possibly contaminated with air, was distributed.
Product Quantity1 unit
Recall NumberB-1789-13

Class II Biologics Event

Event ID39199
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBioLife Plasma Services L.P.
CityVan Nuys
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionSource Plasma
Code Info 5497515,5493852 ,5490646 ,5435494 ,03ATXD8952 , 03ATXD8350 ,030WID5154 ,03ATXD7245 ,030WID4563 , 03ATXD6718 ,92426047 ,03ATXD3475 ,03ATXD2073 , 81844791 ,90023088 ,82899691 ,95029559 ,85507142 , 82896096 ,85505056 ,85500884 ,85498747 ,85486683 , 85485266 ,85481107 ,85479753 ,03HWVA3474 ,03HWVA3195 , 03HWVA2891 ,86233026 ,91312808 ,86228411 ,82430757 , 84098917 ,82429966 ,03PWVA2307 ,03TOHA2187 , 86219440 ,86220002 ,82426606 ,82425036 ,82420130 , 03DOHA1086 ,92648463 ,03TOHA1911 ,86214001 , 03PWVA1959 ,03GNCA2128 ,03DOHA0820 ,92645622 , 03TOHA1495 ,86204644 ,03GNCA1686 ,84087836 , 03TOHA1246 ,92406469 ,86199322 ,03DOHA0556 , 03DOHA0550 ,92641945 ,03TOHA0874 ,03RMIA0654 , 03DOHA0316 ,86186377 ,03DOHA0140 ,03TOHA0491 , 03RMIA0283 ,86177009 ,03RMIA0029 ,03TOHA0119 , 86175647 ,86166454 ,86165099 ,80447573D ,78336018 , 83706882D ,86155540 ,85432956D ,80442387 ,78333659 , 83703348D ,86150835 ,02DOHA3331 ,80438250D , 78331532 ,02DOHA3186 ,86141208 ,80433217D , 78440258D ,86136051D ,02LKYB2845 ,02LKYB2784 , 84811394D ,84811417D ,78438170T ,02DIAD2181 , 02RVAB6902 ,78436657T ,84805331D ,84805355D , 02LKYB2562 ,02GMIG0005 ,02MWII0872 ,02RVAB6689 , 02LKYB2536 ,02MWII0572 ,02RVAB6486 ,84795588D , 84792952D ,84789907 ,84788535D ,91056498 , 02RVAB6064 ,85408876D ,70551013D ,02LKYB1703 , 02LKYB1587 ,80392118D ,02FNDH0949 ,02HHIC0478 , 02HHIC0177 ,02LKYB1337 ,02HHIC0044 ,020NEA2959 , 020NEA2931 ,02BVAA6836 ,02HHIB9703 ,02BVAA6692 , 020NEA2804 ,68262181D ,68262754D ,91269874 , 020NEA2697 ,71336855D ,68262167D ,02BVAA6395 , 91227164 ,68260965D ,68260293D ,020NEA2582 , 68259877D ,83308802D ,71334868D ,68259303D , 020NEA2586 ,02BVAA6300 ,68257927D ,83307744D , 77683762D ,77684066D ,68258269 ,77682123D , 1330631D ,02BVAA6027 ,71328522D ,68253257D , 02BVAA5920 ,77690296D ,66915546 ,91007322 , 71323985D ,02BVAA5695 ,90436505D ,020NEA2729 , 02BVAA5468 ,02BVAA5367 ,90432507D ,81078882D , 02BVAA5240 ,90200380 ,81073832D ,67978755D , 66903741 ,02BVAA5104 ,67977055D ,02BVAA5019 , 02BVAA4969 ,81064540D ,02BVAA4876 ,69045165D , 66898252 ,02BVAA4692 ,78119178D ,02BVAA4628 , 02BVAA4570 ,78115538D ,70515428D ,02BVAA4531 , 80318767D ,02BVAA4342 ,78108844 ,80315599D , 78106499 ,70512298D ,90084973 ,78976757T , 78976344T ,90082351 ,02BVAA3966 ,77976543D , 78973367T ,78972377T ,78863408 ,77899798 , 02LKYB0451 ,77896940 ,78861435 ,02RMIA8056 , 78970311T ,02RMIA7895 ,77891143 ,70037081D , 77328847 ,77867476 ,79916813D ,70031980D , 78967007D ,80275343 ,70026634D ,77325211 , 80272328D ,79907736D ,77322890 ,81226528D , 02GNCA7174 ,74021680D ,80266624D ,70017588D , 79902946D ,66505969D ,77321657 ,70012835D , 81221325D ,79899161D ,66502142D ,81216024D , 66497936D ,77320247 ,81211418D ,77318718 , 02GNCA5866 ,78993907T ,81206643D ,02GNCA5693 , 77316936 ,77315496 ,02RVAA5459 ,02RVAA5130 , 02RVAA4842 ,76731297D ,02RVAA4667 ,02RVAA4250 , 02RVAA4209 ,02RVAA4017 ,02RVAA4030 ,6010210821 , 80857105D ,75384067 ,020NEA0135 ,75940010 , 75937270 ,75930646 ,75379285 ,75371470 , 74858248 ,76559648 ,ZR083538 ,63020052D , 63015331D
ClassificationClass II
Reason for RecallBlood products, which were not quarantined subsequent to receiving information regarding a post donation information related to vCJD risk, were distributed.
Product Quantity269 units
Recall NumberB-1932-13

Class II Biologics Event

Event ID40181
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jun-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-Counties Blood Bank dba UBS- Central Coast
CityPhoenix
StateAZ
CountryUS
Distribution PatternAZ, CA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLF32303
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity1 unit
Recall NumberB-1826-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoLF33971; LF32872; LF32576; LF34288
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity4 units
Recall NumberB-1827-13

Class II Biologics Event

Event ID40807
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Aug-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-counties Blood Bank
CitySan Luis Obispo
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoGW70580
ClassificationClass II
Reason for RecallBlood product, positive for the c-antigen but labeled as c-antigen negative, was distributed.
Product Quantity1 unit
Recall NumberB-1833-13

Class II Biologics Event

Event ID41089
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Nov-05
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTri-counties Blood Bank
CityPhoenix
StateAZ
CountryUS
Distribution PatternCA
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoLG82166; GX06220
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2 units
Recall NumberB-1834-13

Class II Biologics Event

Event ID41111
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Nov-05
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionPlatelets
Code Info1761509
ClassificationClass II
Reason for RecallBlood products, that were possibly contaminated with Enterococcus Faecalis, were distributed.
Product Quantity1 unit
Recall NumberB-1986-13
Product DescriptionFresh Frozen Plasma
Code Info1761509
ClassificationClass II
Reason for RecallBlood products, that were possibly contaminated with Enterococcus Faecalis, were distributed.
Product Quantity1 unit
Recall NumberB-1987-13

Class II Biologics Event

Event ID42466
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Jun-06
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmFlorida Blood Services, Inc.
CitySt Petersburg
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info 4590944
ClassificationClass II
Reason for RecallBlood product, which was positive for E antigen was distributed to a recipient who was identified with an E antibody.
Product Quantity1
Recall NumberB-1933-13

Class II Biologics Event

Event ID46986
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-Nov-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityPomona
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info06GP73413
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1967-13
Product DescriptionFresh Frozen Plasma
Code Info06GP73413
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1968-13

Class II Biologics Event

Event ID47732
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 PatternNew York and Florida.
 

Associated Products

Product DescriptionRed Blood Cells
Code Info2648780
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1822-13
Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code Info2648780
ClassificationClass II
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1823-13

Class II Biologics Event

Event ID47946
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Mar-08
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Centers of South Florida, Inc.
CityLauderhill
StateFL
CountryUS
Distribution PatternNew York
 

Associated Products

Product DescriptionPlatelets Pooled Leukocytes Reduced
Code Info2929086
ClassificationClass II
Reason for RecallBlood product, manufactured from a unit of whole blood with incorrect volume was distributed.
Product Quantity1
Recall NumberB-1934-13

Class II Biologics Event

Event ID62882
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDelta Blood Bank
CityStockton
StateCA
CountryUS
Distribution PatternAustria
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW128710072059
ClassificationClass II
Reason for RecallBlood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
Product Quantity1 unit
Recall NumberB-1574-13

Class II Devices Event

Event ID63947
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSt. Jude Medical
CityPlano
StateTX
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide including Puerto Rico and countries of: Austria, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, India, Ireland, Israel, Italy, Japan, Luxembourg, Martinique, Mexico, Netherlands, Poland, Russian Federal, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Turkey and United Kingdom.
 

Associated Products

Product DescriptionEon and Eon Mini charging system, model numbers Eon -3701 (Wall Charger), 3711 (Portable Charger) and Eon Mini -3721 (Charger); This is a continuation of the firm's July 2012 recall. Product Usage: The Eon Wall Charger (3701) provides the capability to recharge the IPG Battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The Eon Portable Charger (3711) provides the capability to recharge the IPG battery. The charger transmits RF energy through the antenna to the IPG battery to recharge it. The patient can be mobile during the recharging process with a portable charger. The Eon Mini Charger (3721) provides the capability to recharge the IPG battery while stimulation is either on or off. The charger transmits RF energy through the antenna to the IPG battery to recharge it.
Code InfoAll serial numbers manufactured
ClassificationClass II
Reason for RecallThere is issues of warmth or heating at the implant site during charging for the Eon Mini implantable pulse generators (IPGs). In the July 2012 letter St. Jude Medical informed customers that they would be implementing design improvements to the charger to address possible increased energy dissipation when the charger is misaligned with the IPG or the IPG is implanted too near the surface of the skin. This field action is to announce the availability of the newly designed Eon Mini Charger Model 3722 to mitigate excessive heating while charging.
Product Quantity75,663
Recall NumberZ-1785-2013

Class II Food Event

Event ID64926
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmWhole Foods Market
CityAustin
StateTX
CountryUS
Distribution PatternNationwide
 

Associated Products

Product Description365 Organic 100% Apple Juice from concentrate with Vitamin C and Calcium in 6.75 fl oz (UPC 0 99482 42095 6) and 64 fl oz. (UPC 0 99482 42096 3) Distributed by: Whole Foods Market, Austin, TX 78703; 8 units peer shipping case
Code Info6.75 fl oz (UPC 0 99482 42095 6) - Expiration dates 2/14/2014 & 02/15/2014; 64 oz (UPC 0 99482 42096 3) - Expiration dates 1/15/2014, 1/29/2014, 2/12/2014, 2/18/2014, 2/27/2014, 3/11/2014, and 3/25/2014.
ClassificationClass II
Reason for RecallElevated patulin levels.
Product Quantity39,056 of the 64 oz and 23,576 of the 4pk/6.75 oz
Recall NumberF-1725-2013

Class II Food Event

Event ID65057
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGreen Mountain Coffee Roasters
CityWaterbury
StateVT
CountryUS
Distribution PatternTX, LA, MD, IN, IL, NE, NC, MN, WI, FL, AL
 

Associated Products

Product DescriptionMaster Cases, Product Code #8534 (6-12 count retail boxes) Label of master case bears the name: Donut House K -Cup Packs. 12-Count Retail Boxes, Product Code #8934, Donut House Decaffeinated K-Cup Packs
Code InfoBest By: 15NOV2013 PL113 3049
ClassificationClass II
Reason for RecallRegular (caffeinated) Coffee individual K-cup packs were packaged inside multi unit retail boxes labeled Decaffeinated Coffee.
Product Quantity288,144 kcups/4,002 master cases (6 retail boxes per case)/ 24,012 retail boxes
Recall NumberF-1584-2013

Class II Biologics Event

Event ID65065
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHoxworth Blood Center UC Medical Center
CityCincinnati
StateOH
CountryUS
Distribution PatternOhio
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW037711145273 Part 1; W037711145273 Part 2;
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor who traveled to a malarial endemic area, were distributed.
Product Quantity2
Recall NumberB-1752-13

Class II Biologics Event

Event ID65066
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmFlorida's Blood Centers - Lake Park
CityPalm Beach Gardens
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038112346434;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-1753-13

Class II Biologics Event

Event ID65076
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBiotest Pharmaceuticals Corporation
CityAugusta
StateGA
CountryUS
Distribution PatternKorea, Republic Of(South)
 

Associated Products

Product DescriptionSource Plasma
Code Info0380099025; 0380098497; 0380098106;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who did not have a complete physical examination, were distributed.
Product Quantity3
Recall NumberB-1809-13

Class II Biologics Event

Event ID65086
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Mar-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmNorthern California Community Blood Bank
CityEureka
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced Irradiated
Code InfoW149513934421Part 1 ; W149513934421Part 2;
ClassificationClass II
Reason for RecallBlood products, which were labeled as leukoreduced, but were not tested to verify the White Blood Cell count, were distributed
Product Quantity2
Recall NumberB-1810-13

Class II Drugs Event

Event ID65092
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Nov-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAlkermes, Inc.
CityWaltham
StateMA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionVIVITROL (naltrexone for extended-release injectable suspension) a) 380 mg vial NDC 65757-303-02, b) 380 mg vial in kit NDC 65757-300-01, Rx Only Manufactured and marketed by Alkermes, Inc., Waltham, MA 02451,
Code InfoIndividual vial lot 402-3683AA, EXP 10/13; kit vial lot 2011-003, EXP 08/13
ClassificationClass II
Reason for RecallLack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.
Product Quantity3,325 vials
Recall NumberD-819-2013

Class II Biologics Event

Event ID65100
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmBlood Systems, Inc
CityBillings
StateMT
CountryUS
Distribution PatternMontana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW042313005162D;
ClassificationClass II
Reason for RecallBlood products, which were not manufactured in accordance to acceptable product specifications, were distributed.
Product Quantity1
Recall NumberB-1811-13

Class II Biologics Event

Event ID65102
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOneBlood, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038112371216;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity1
Recall NumberB-1855-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW038112986694;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity1
Recall NumberB-1856-13

Class II Biologics Event

Event ID65104
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date17-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmNorthern Illinois Blood Bank dba Rock River Valley BC
CityRockford
StateIL
CountryUS
Distribution PatternIndiana
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW044412606060;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who traveled to an area considered endemic for malaria, was distributed.
Product Quantity1
Recall NumberB-1858-13

Class II Biologics Event

Event ID65105
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmCommunity Blood Center of Carolinas
CityCharlotte
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW227013003230;
ClassificationClass II
Reason for RecallBlood product, which was collected from a donor who traveled to a malarial endemic area, was distributed.
Product Quantity1
Recall NumberB-1859-13

Class II Devices Event

Event ID65141
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEthicon Endo-Surgery Inc
CityCincinnati
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA Nationwide to all fifty (50) states, and internationally including the following countries: ARGENTINA, ARGENTINA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, ECUADOR, EGYPT, EL SALVADOR, GREECE, HONDURAS, INDIA, INDONESIA, ISRAEL, JAMAICA, JAPAN, JORDAN, KOREA, REPUBLIC OF, KUWAIT, LEBANON, MEXICO, NETHERLANDS ANTILLES, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, QATAR, RUSSIAN FEDERATION, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, PROVINCE OF CHINA, THAILAND, TRINIDAD AND TOBAGO, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA and YEMEN.
 

Associated Products

Product DescriptionLIGACLIP® Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH® surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360° in either direction. The rotating knob is located to allow for a one-handed technique.
Code InfoH44Z7W, 37ER320, 01/03/12 to 11/15/16; J4A016, 37ER320, 01/05/12 to 12/15/16; J4A11G, 37ER320, 01/10/12 to 12/15/16; J4A124, 37ER320, 01/10/12 to 12/15/16; J4A145 37ER320, 01/11/12 to 12/15/16 J4A182, 37ER320, 01/13/12 to 12/15/16; J4A21T, 37ER320, 01/27/12 to 12/15/16; J4A28D, 37ER320, 01/19/12 to 12/15/16; J4A28U, 37ER320, 01/19/12 to 12/15/16; J4A335, 37ER320, 01/23/12 to 12/15/16; J4A38L, 37ER320, 01/25/12 to 12/15/16; J4A39D, 37ER320, 01/26/12 to 12/15/16; J4A406, 37ER320, 01/26/12 to 12/15/16; J4A40P, 37ER320, 02/07/12 to 12/15/16; J4A45T, 37ER320, 01/29/12 to 12/15/16; J4A461, 37ER320, 01/30/12 to 12/15/16; J4A46T, 37ER320, 01/30/12 to 12/15/16; J4A48U,), 37ER320, 02/02/12 to 12/15/16; J4A49L, 37ER320, 02/01/12 to 12/15/16; J4A525, 37ER320, 02/02/12 to 12/15/16; J4A535, 37ER320, 02/02/12 to 12/15/16; J4A559, 41XBB48B 02/02/12 to 07/15/16; J4A60K, 37ER320, 02/08/12 to 01/15/17; J4A60W, 37ER320, 02/08/12 to 01/15/17; J4A61Z, 37ER320, 02/08/12 to 01/15/17; J4A62E, 37ER320, 02/08/12 to 01/15/17; J4A62U, 37ER320, 02/09/12 to 01/15/17; J4A71W, 37ER320, 02/15/12 to 01/15/17; J4A729, 37ER320, 02/15/12 to 01/15/17; J4A73H, 37ER320, 02/15/12 to 01/15/17; J4A743, 37ER320, 02/16/12 to 01/15/17; J4A74T, 37ER320, 02/16/12 to 01/15/17; J4A755, 37ER320, 02/16/12 to 01/15/17; J4A75P, 37ER320, 02/16/12 to 01/15/17; J4A86E, 37ER320, 02/24/12 to 01/15/17; J4A871, 37ER320, 02/25/12 to 01/15/17; J4A87L, 37ER320, 02/25/12 to 01/15/17; J4A889, 37ER320, 02/25/12 to 01/15/17; J4A92X, 41XBB48B 02/28/12 to 08/15/16; J4A97H, 37ER320, 03/02/12 to 01/15/17; J4A98T, 37ER320, 03/02/12 to 01/15/17; J4A997, 37ER320, 03/03/12 to 01/15/17; J4A99V, 37ER320, 03/03/12 to 02/15/17; J4AAOM, 37ER320, 03/03/12 to 02/15/17; J4AA1H, 37ER320, 03/05/12 to 02/15/17; J4AA71, 37ER320, 03/07/12 to 02/15/17; J4AA7V, 37ER320, 03/08/12 to 02/15/17; J4AA84, 37ER320, 03/08/12 to 02/15/17; J4AA9D, 37ER320, 03/08/12 to 02/15/17; J4AC2X, 37ER320, 03/10/12 to 02/15/17; J4AD09, 37ER320, 03/15/12 to 02/15/17; J4AD1A, 37ER320, 03/15/12 to 02/15/17; J4AD2G, 37ER320, 03/16/12 to 02/15/17; J4AE3W, 37ER320, 03/22/12 to 02/15/17; J4AE49, 37ER320, 03/22/12 to 02/15/17; J4AE57, 37ER320, 03/23/12 to 02/15/17; J4AE63, 37ER320, 03/23/12 to 02/15/17; J4AE6R, 37ER320, 04/13/12 to 02/15/17; J4AE7E, 37ER320, 04/11/12 to 02/15/17; J4AE86, 37ER320, 03/24/12 to 02/15/17; J4AE8L, 37ER320, 03/24/12 to 02/15/17; J4AF09, 41XBB48B, 03/27/12 to 10/15/16 84; J4AF15, 37ER320, 03/28/12 to 02/15/17; J4AF1N, 37ER320, 03/28/12 to 02/15/17; J4AF2G, 37ER320, 03/28/12 to 02/15/17; J4AF3K, 37ER320, 03/28/12" 02/15/17; J4AF48, 37ER320, 03/29/12 to 02/15/17; J4AF4J, 37ER320, 03/29/12 to 02/15/17; J4AGOV, 37ER320, 04/03/12 to 02/15/17; J4AG4V, 37ER320, 04/05/12 to 03/15/17; J4AG91, 37ER320, 04/11/12 to 03/15/17; J4AG9G, 37ER320, 04/18/12 to 03/15/17; J4AHOV, 37ER320, 04/12/12 to 03/15/17; J4AH8N, 37ER320, 04/15/12 to 03/15/17; J4AH96, 37ER320, 04/16/12 to 03/15/17; J4AH9C, 37ER320, 04/16/12 to 03/15/17; J4AH9R, 37ER320, 04/16/12 to 03/15/17; J4AJ3A, 37ER320, 04/18/12 to 03/15/17; J4AJ3T, 37ER320, 04/18/12 to 03/15/17; J4AJ6P, 37ER320, 04/20/12 to 03/15/17; J4AJ7M, 37ER320, 04/20/12 to 03/15/17; J4AKOP, 37ER320, 04/21/12 to 03/15/17; J4AK14, 37ER320, 04/22/12 to 03/15/17; J4AK1H, 37ER320, 04/23/12 to 03/15/17; J4AK1R, 37ER320, 04/23/12 to 03/15/17; J4AK2V, 37ER320, 04/24/12 to 03/15/17; J4AK35, 37ER320, 04/24/12 to 03/15/17; J4AK40, 37ER320, 04/24/12 to 03/15/17; J4AK5U, 37ER320, 04/25/12 to 03/15/17; J4AK67, 37ER320, 04/25/12 to 03/15/17; 2136; J4AK7D, 37ER320, 04/26/12 to 03/15/17; J4AK8C, 37ER320, 04/26/12 to 03/15/17; 1152; 4AK9R, 37ER320, 04/28/12 to 03/15/17; J4ALOU, 37ER320, 04/27/12 to 03/15/17; J4AL65, 37ER320, 05/02/12 to 03/15/17; J4AL6P, 37ER320, 05/02/12 to 03/15/17; 2172; J4AL87, 37ER320, 05/11/12 to 03/15/17; 2244; J4AL90, 37ER320, 05/03/12 to 04/15/17; J4AL9H, 37ER320, 05/03/12 to 04/15/17; J4AM11, 37ER320, 05/03/12 to 04/15/17; J4AM1K, 37ER320, 05/04/12 to 04/15/17; J4AM2E, 37ER320, 05/04/12 to 04/15/17; J4AM32, 37ER320, 05/04/12 to 04/15/17; J4AM3G, 37ER320, 05/05/12 to 04/15/17; J4AM45, 37ER320, 05/05/12 to 04/15/17; J4AM7R, 37ER320, 05/08/12 to 04/15/17; J4AM7W, 37ER320, 05/08/12 to 04/15/17; J4AM8H, 37ER320, 05/09/12 to 04/15/17; J4AM9J, 37ER320, 05/09/12 to 04/15/17; J4ANOC, 37ER320, 05/09/12 to 04/15/17; J4AN14, 37ER320, 05/09/12 to 04/15/17; J4AN1P, 37ER320, 05/10/12 to 04/15/17; J4AN1X, 37ER320, 05/10/12 to 04/15/17; J4AN2K, 37ER320, 05/10/12 to 04/15/17; J4AN35, 37ER320, 05/10/12 to 04/15/17; J4AR7E, 41XBB48B 05/24/12 to 01/15/17; J4AT2G, 37ER320, 06/02/12 to 04/15/17; 1152; J4AT2H, 37ER320, 05/31/12 to 04/15/17; J4AUOH, 37ER320, 06/04/12 to 04/15/17; J4AU23, 37ER320, 06/04/12 to 04/15/17; J4AU29, 37ER320, 06/05/12 to 05/15/17; J4AU2V, 37ER320, 06/05/12 to 05/15/17; J4AV5J, 37ER320, 06/12/12 to 05/15/17; J4AV5T, 37ER320, 06/12/12 to 05/15/17; J4AW02, 37ER320, 06/13/12 to 05/15/17; J4AWOG, 37ER320, 06/14/12 to 05/15/17; J4AW7D, 37ER320, 06/18/12 to 05/15/17; J4AW7N, 37ER320, 06/18/12 to 05/15/17; J4AW86, 37ER320, 06/19/12 to 05/15/17; J4AX78, 37ER320, 06/23/12 to 05/15/17; J4AX7M, 37ER320, 06/23/12 to 05/15/17; J4AX84, 37ER320, 06/24/12 to 05/15/17; J4AX8M, 37ER320, 06/24/12 to 05/15/17; J4AY22, 37ER320, 06/26/12 to 05/15/17; J4AY23, 37ER320, 06/27/12 to 05/15/17; J4AY24, 37ER320, 06/27/12 to 05/15/17; J4AY26, 37ER320, 06/27/12 to 05/15/17; J4AY7E, 37ER320, 06/29/12 to 05/15/17; J4AY8R, 37ER320, 06/29/12 to 05/15/17; J4AY9D, 37ER320, 07/09/12 to 05/15/17; J4AZOL, 37ER320, 07/02/12 to 05/15/17; J4AZ1X, 37ER320, 07/11/12 to 05/15/17; J4AZ2H, 37ER320, 07/03/12 to 06/15/17; J4AZ6R, 37ER320, 07/06/12 to 06/15/17; J4AZ7K, 37ER320, 07/06/12 to 06/15/17; J4C04N, 37ER320, 07/11/12 to 06/15/17; J4C059, 37ER320, 07/12/12 to 06/15/17; J4C08U, 37ER320, 07/13/12 to 06/15/17; J4C09E, 37ER320, 07/14/12 to 06/15/17; J4C12Y, 37ER320, 07/16/12 to 06/15/17; J4C14F, 37ER320, 07/18/12 to 06/15/17; J4C16V, 37ER320, 07/18/12 to 06/15/17; J4C216, 37ER320, 07/23/12 to 06/15/17; J4C21H, 37ER320, 07/24/12 to 06/15/17; J4C21N, 37ER320, 07/24/12 to 06/15/17; J4C22M, 37ER320, 07/24/12 to 06/15/17; J4C30T, 37ER320, 07/27/12 to 06/15/17; J4C31J, 37ER320, 07/28/12 to 06/15/17; J4C32M, 37ER320, 08/21/12 to 06/15/17; J4C332, 37ER320, 07/30/12 to 06/15/17; J4C399, 37ER320, 08/03/12 to 06/15/17; J4C41U, 37ER320, 08/06/12 to 07/15/17; J4C42C, 37ER320, 08/04/12 to 07/15/17; J4C42X, 37ER320, 08/03/12 to 07/15/17; J4C45J, 37ER320, 08/07/12 to 07/15/17; J4C46Y, 37ER320, 08/07/12 to 07/15/17; J4C47A, 37ER320, 08/07/12 to 07/15/17; J4C489, 37ER320, 08/08/12 to 07/15/17; J4C49Y, 37ER320, 08/08/12 to 07/15/17; J4C508, 37ER320, 08/09/12 to 07/15/17; J4C510, 37ER320, 08/09/12 to 07/15/17; J4C57X, 37ER320, 08/14/12 to 07/15/17; J4C59E, 37ER320, 08/14/12 to 07/15/17; J4C606, 37ER320, 08/15/12 to 07/15/17; J4C65Z, 37ER320, 08/18/12 to 07/15/17; J4C66P, 37ER320, 08/20/12 to 07/15/17; J4C678, 37ER320, 08/21/12 to 07/15/17; J4C67K, 37ER320, 08/21/12 to 07/15/17; J4C762, 37ER320, 08/24/12 to 07/15/17; J4C765, 37ER320, 08/24/12 to 07/15/17; J4C76T, 37ER320, 08/24/12 to 07/15/17; J4C84K, 37ER320, 08/30/12 to 07/15/17; J4C84Z, 37ER320, 08/30/12 to 07/15/17; J4C90P, 37ER320, 09/05/12 to 07/15/17; J4C91H, 37ER320, 09/02/12 to 07/15/17; J4C91W, 37ER320, 09/05/12 to 07/15/17; J4C92P, 37ER320, 09/05/12 to 07/15/17; J4C96L, 37ER320, 09/06/12 to 08/15/17; J4C97D, 37ER320, 09/06/12 to 08/15/17; J4C97Z, 37ER320, 09/07/12 to 08/15/17; J4C98X, 37ER320, 09/07/12 to 08/15/17; J4CA3A, 37ER320, 09/11/12 to 08/15/17; J4CA4L, 37ER320, 09/11/12 to 08/15/17; J4CA62, 37ER320, 09/12/12 to 08/15/17; J4CA6K, 37ER320, 09/12/12 to 08/15/17; J4CA7F, 37ER320, 09/13/12 to 08/15/17; J4CA7J, 37ER320, 09/13/12 to 08/15/17; J4CA96, 37ER320, 09/13/12 to 08/15/17; J4CA9V, 37ER320, 09/13/12 to 08/15/17; J4CC63, 37ER320, 09/19/12 to 08/15/17; J4CD25, 42XBB48B 09/21/12 to 02/15/17; J4CD4R, 37ER320, 09/21/12 to 08/15/17; J4CD5H, 37ER320, 09/22/12 to 08/15/17; J4CD6D, 42XBB48B 09/25/12 to 02/15/17; J4CD6R, 37ER320, 09/25/12 to 08/15/17; J4CD8F, 42XBB48B 09/27/12 to 02/15/17; J4CE05, 37ER320, 09/26/12 to 08/15/17; J4CEOA, 37ER320, 09/26/12 to 08/15/17; J4CE1U, 37ER320, 09/26/12 to 08/15/17; J4CF6M, 37ER320, 10/05/12 to 09/15/17; J4CF6P, 37ER320, 10/05/12 to 09/15/17; J4CF7E, 37ER320, 10/05/12 to 09/15/17; J4CF7R, 37ER320, 10/06/12 to 09/15/17; J4CF80, 37ER320, 10/06/12 to 09/15/17; J4CF8X, 37ER320, 10/08/12 to 09/15/17; J4CGOP, 37ER320, 10/09/12 to 09/15/17; J4CG17, 37ER320, 10/10/12 to 09/15/17; J4CG1U, 37ER320, 10/10/12 to 09/15/17; J4CG2U, 37ER320, 10/10/12 to 09/15/17; J4CG37, 37ER320, 10/10/12 to 09/15/17; J4CG4L, 37ER320, 10/11/12 to 09/15/17; J4CG66, 37ER320, 10/11/12 to 09/15/17; J4CG8R, 37ER320, 10/16/12 to 09/15/17; J4CG8X, 37ER320, 10/16/12 to 09/15/17; J4CH10, 37ER320, 10/15/12 to 09/15/17; J4CH4U, 37ER320, 10/17;/12 to 09/15/17; J4CH4V, 37ER320, 11/16/12 to 09/15/17; J4CH97, 37ER320, 10/20/12 to 09/15/17; J4CH9R, 37ER320, 10/20/12 to 09/15/17; J4CJ17, 37ER320, 10/20/12 to 09/15/17; J4CJ61, 37ER320, 10/25/12 to 09/15/17; J4CJ6L, 37ER320, 10/25/12 to 09/15/17; J4CKOV, 37ER320, 10/27/12 to 09/15/17; J4CK16, 37ER320, 10/29/12 to 09/15/17; J4CK3L, 37ER320, 10/30/12 to 09/15/17; J4CK9D, 37ER320, 11/02/12 to 09/15/17; J4CK9J, 37ER320, 11/02/12 to 09/15/17; J4CL23, 37ER320, 11/03/12 to 10/15/17; J4CL3F, 37ER320, 11/06/12 to 10/15/17; J4CL3U, 37ER320, 11/06/12 to 10/15/17; J4CL49, 37ER320, 11/06/12 to 10/15/17; J4CL8D, 37ER320, 11/08/12 to 10/15/17; J4CL9A, 37ER320, 11/08/12 to 10/15/17; J4CL9Z, 37ER320, 11/17;/12 to 10/15/17; J4CN1C, 37ER320, 11/15/12 to 10/15/17; J4CN9T, 37ER320, 11/20/12 to 10/15/17; J4CP1P, 37ER320, 11/27/12 to 10/15/17; J4CP1Y, 37ER320, 11/27/12 to 10/15/17; J4CP4C, 37ER320, 11/27/12 to 10/15/17; J4CP4L, 37ER320, 11/27/12 to 10/15/17; J4CP8U, 37ER320, 11/29/12 to 10/15/17; J4CR1C, 37ER320, 11/30/12 to 10/15/17; J4CR3L, 37ER320, 12/04/12 to 10/15/17; J4CR44, 37ER320, 12/04/12 to 10/15/17; J4CR6Y, 37ER320, 12/04/12 to 11/15/17; J4CR7X, 37ER320, 12/07/12 to 11/15/17; J4CT1U, 37ER320, 12/07/12 to 11/15/17; J4CT27, 37ER320, 12/09/12 to 11/15/17; J4CTSR, 37ER320, 12/11/12 to 11/15/17; J4CU1U, 37ER320, 12/12/12 to 11/15/17; J4CU27, 37ER320, 12/12/12 to 11/15/17; J4CU3K, 37ER320, 12/14/12 to 11/15/17; J4CU68, 37ER320, 12/15/12 to 11/15/17; J4CV2F, 37ER320, 12/20/12 to 11/15/17; J4CV48, 37ER320, 12/20/12 to 11/15/17; J4CV4J, 37ER320, 12/21/12 to 11/15/17; J4CV4U, 37ER320, 12/21/12 to 11/15/17; J4CV58, 37ER320, 12/21/12 to 11/15/17; J9002K, 41XCB57S 01/03/12 to 12/15/16; J9002L, 41XCD52S 01/03/12 to 12/15/16; J9003P, 02CK017 01/05/12 to 12/31/99; J90058, 41XCC51S 01/06/12 to 12/15/16; J90078, 41XCDS15 01/05/12 to 12/15/16; J9012T, 41KNC61XL 01/06/12 to 12/15/16; J9012U, 41XCD50S 01/06/12 to 12/15/16; J9012V, 41FNC42XL, 01/06/12 to 12/15/16; J90143, 41XCB52S 01/09/12 to 12/15/16; J90145, 41XCB57S 01/09/12 to 12/15/16; J90146, 41FNC41XL 01/09/12 to 12/15/16; J9014N, 02CK017 01/06/12 to 12/31/99; J9016G, 41XCB52S 01/09/12 to 12/15/16; J9016H, 41FNC43XL 01/09/12 to 12/15/16; J9016J 41TNC49XL 01/10/12 to 12/15/16; J9016K 41KNC60XL 01/10/12 to 12/15/16; J9020X 41XCD51S 01/10/12 to 12/15/16; J9022W 02CK017 01/10/12 to 12/31/99; J90249 41KBC17XL 01/12/12 to 12/15/16; J9026C 41XCD51S 01/11/12 to 12/15/16; J9026D 41XCC51S 01/12/12 to 12/15/16; J9026H 02CK017 01/11/12 to 12/31/99; J9028G 41XCB57S 01/13/12 to 12/15/16; J9032A 41XCD50S 01/13/12 to 12/15/16; J9032D 41KBC17XL 01/13/12 to 12/15/16; J9033P 02CK017 01/13/12 to 12/31/99; J90379 41XCC51S 01/16/12 to 12/15/16; J9037A 41FNC42XL, 01/16/12 to 12/15/16; J9038A 41KBC17XL 01/17;/12 to 12/15/16; J90390 41KNC61XL 01/17;/12 to 12/15/16; J9042C 02CK017 01/17;/12 to 12/31/99; J9044R 41XCD51S 01/18/12 to 12/15/16; J9044T 41FNC42XL, 01/18/12 to 12/15/16; J9047G 41XCD51S 01/19/12 to 12/15/16; J9047H 41FNC41XL 01/19/12 to 12/15/16; J9051P 41XCD51S 01/20/12 to 12/15/16; J9051R 41XCC51S 01/20/12 to 12/15/16; J9051T 41XCC50S 01/20/12 to 12/15/16; J9051U 41FNC41XLD 01/20/12 to 12/15/16; J90574, 41XCB57S 01/23/12 to 12/15/16; J90575, 41TNC49XL 01/24/12 to 12/15/16; J90598, 41FNC42XL, 01/24/12 to 12/15/16; J9059A, 41XCD51S 01/25/12 to 12/15/16; J90643, 41XCD52S 01/26/12 to 12/15/16; J90644, 41KNC61XL 01/26/12 to 12/15/16; J90646, 41XCC53S 01/27/12 to 12/15/16; J9066Z, 41XCD51S 01/27/12 to 12/15/16; J90671, 41KNC60XL 01/27/12 to 12/15/16; J9068K, 02CK017 01/26/12 to 12/31/99; J90743, 41XCD51S 01/30/12 to 12/15/16; J9074T, 41TNC69XL 01/31/12 to 12/15/16; J9074X, 41FNC41XL 02/01/12 to 12/15/16; J90771, 41XCB52S, 01/31/12 to 12/15/16; J9080P, 41XCD51S, 02/01/12 to 12/15/16; J9080R, 41FNC42XL, 02/01/12 to 12/15/16; J90823, 41XCD52S, 02/01/12 to 12/15/16; J90824, 41XCC51S, 02/01/12 to 12/15/16; J90825, 41XCB57S, 02/01/12 to 12/15/16; J9082G, 02CK017, 02/01/12 to 12/31/99; J9084F, 41FNC43XL, 02/02/12 to 12/15/16; J90867, 41FNC41XL, 02/03/12 to 12/15/16; J90881, 41KNC09XL, 02/03/12 to 12/15/16; J90883, 41KNC60XL, 02/03/12 to 12/15/16; J9090A, 41XCD50S, 02/03/12 to 12/15/16; J9091Z, 02CK017, 02/03/12 to 12/31/99; J90931, 41XCD51S, 02/07/12 to 01/15/17; J90948, 41XCC53S, 02/07/12 to 01/15/17; J90949, 41TNC49XL, 02/07/12 to 01/15/17; J90968, 41FNC41XLD, 02/08/12 to 01/15/17; J90969, 41KNC07XL, 02/09/12 to 01/15/17; J9098C, 41TNC36XL, 02/09/12 to 01/15/17; J90993, 02CK017, 02/08/12 to 12/31/99; J90C1W, 41XCC51S, 02/14/12 to 01/15/17; J90C1X, 41XCD51S, 02/14/12 to 01/15/17; J90C1Y, 41XCD52S, 02/14/12 to 01/15/17; J90C1Z, 41XCC50S, 02/14/12 to 01/15/17; J90C67, 41XCD51S, 02/15/12 to 01/15/17; J90C8C, 02CK017, 02/15/12 to 12/31/99; J90DOL, 41XCD51S, 02/16/12 to 01/15/17; J9003N, 02CK017, 02/17/12 to 12/31/99; J9004Z, 41FNC43XL, 02/17/12 to 01/15/17; J90050, 41XCC51S, 02/17/12 to 01/15/17; J90051, 41FNC41XL, 02/17/12 to 01/15/17; J9007A, 41XCD51S, 02/17/12 to 01/15/17; J9008J, 41XCD51S, 02/21/12 to 01/15/17; J9008K, 41TNC36XL, 02/21/12 to 01/15/17; J9008L, 41KNC60XL, 02/21/12 to 01/15/17; J9009H, 41FNC41XLD, 02/20/12 to 01/15/17; J9009K, 02CK017, 02/20/12 to 12/31/99; J90E2R, 41XCD51S, 02/21/12 to 01/15/17; J90E2T, 41XCB57S, 02/21/12 to 01/15/17; J90E40, 41FNC42XL, 02/22/12 to 01/15/17; J90E5P, 41XCD51S, 02/22/12 to 01/15/17; J90E5T, 41XCB52S, 02/22/12 to 01/15/17; J90E7G, 41XCC53S, 02/22/12 to 01/15/17; J90E7R, 02CK017, 02/22/12 to 12/31/99; J90F03, 41XCD51S, 02/23/12 to 01/15/17; J90F06, 41XCD50S, 02/23/12 to 01/15/17; J90F2P, 41XCD515, 02/24/12 to 01/15/17; J90F2R, 41KBC17XL, 02/24/12 to 01/15/17; J90F2T, 41TNC69XL, 02/24/12 to 01/15/17; J90F2U, 41XCD525, 02/27/12 to 01/15/17; J90F4T, 41XCC515, 02/27/12 to 01/15/17; J90F68, 41XCD515, 02/27/12 to 01/15/17; J90F6A, 41KNC07XL, 02/27/12 to 01/15/17; J90F6C, 41FNC42XL, 02/27/12 to 01/15/17; J90F6U, 41FNC41XL, 02/27/12 to 01/15/17; J90F90, 41FNC41XLD, 02/28/12 to 01/15/17; J90F91, 41XCD515, 02/28/12 to 01/15/17; J90F9Z, 41KNC60XL, 02/28/12 to 01/15/17; J90GOO, 41KNC61XL, 02/28/12 to 01/15/17; J90GOF, 02CK017, 02/28/12 to 12/31/99; J90G23, 41XCD515, 02/29/12 to 01/15/17; J90G25, 41TNC36XL, 02/29/12 to 01/15/17; J90G26, 41XCC515, 02/29/12 to 01/15/17; J90G3A, 41KNC60XL, 02/29/12 to 01/15/17; J90G5F, 41XCD515, 03/01/12 to 01/15/17; J90G5H, 41FNC42XL, 03/01/12 to 01/15/17; J90G5J, 41XCD525, 03/01/12 to 01/15/17; J90G9G, 41XCB515, 03/02/12 to 01/15/17; J90G9H, 41KBC17XL, 03/02/12 to 01/15/17; J90G9J, 41XCC515, 03/02/12 to 01/15/17; J90G9K, 41TNC36XL, 03/02/12 to 01/15/17; J90HOP, 41TNC69XL, 03/05/12 to 01/15/17; J90H1R, 41XCD51S, 03/05/12 to 02/15/17; J90H6E, 41FNC42XL, 03/07/12 to 02/15/17; J90H6K, 41FNC41XL, 03/07/12 to 02/15/17; J90H6L, 41KBC17XL, 03/07/12 to 02/15/17; J90H7J, 41KNC09XL, 03/07/12 to 02/15/17; J90H7K, 41XCD525, 03/07/12 to 02/15/17; J90H7L, 41XCB575, 03/07/12 to 02/15/17; J90J1A, 02CK017, 03/07/12 to 12/31/99; J90J36, 41XCD51S, 03/09/12 to 02/15/17; J90J7X, 41XCC515, 03/09/12 to 02/15/17; J90J7Y, 41XCD525, 03/09/12 to 02/15/17; J90J7Z, 41FNC42XL, 03/09/12 to 02/15/17; J90J8P, 41FNC43XL, 03/12/12 to 02/15/17; J90KOH, 41XCD515, 03/12/12 to 02/15/17; J90KOJ, 41TNC20XL, 03/12/12 to 02/15/17; J90KOK, 41XCB575, 03/12/12 to 02/15/17; J90K1V, 41KNC60XL, 03/13/12 to 02/15/17; J90K4E, 41XCC505, 03/13/12 to 02/15/17; J90K4G, 41FNC41XL, 03/13/12 to 02/15/17; J90K4H, 41TNC49XL, 03/13/12 to 02/15/17; J90K4J, 41KNC07XL, 03/13/12 to 02/15/17; J90K5E, 41KNC61XL, 03/13/12 to 02/15/17; J90K5F, 41KNC09XL, 03/13/12 to 02/15/17; J90K6K, 02CK017, 03/13/12 to 12/31/99; J90K7N, 41FNC41XLD, 04/13/12 to 02/15/17; J90K7P, 41KNC09XL, 03/14/12 to 02/15/17; J90K7R, 41TNC49XL, 03/14/12 to 02/15/17; J90K7T, 41KNC07XL, 03/14/12 to 02/15/17; J90K9D, 41XCC51S, 03/14/12 to 02/15/17; J90L1A, 41FNC42XL, 03/15/12 to 02/15/17; J90L1D, 41XCD50S, 03/15/12 to 02/15/17; J90L1E, 41XCD52S, 03/15/12 to 02/15/17; J90L2L, 41FNC41XL, 03/15/12 to 02/15/17; J90L4E, 41KNC03XL, 03/16/12 to 02/15/17; J90L4F, 41KNC60XL, 03/16/12 to 02/15/17; J90L62, 41FNC43XL, 03/16/12 to 02/15/17; J90L6G, 02CK017, 03/16/12 to 12/31/99; J90M16, 02CK017, 03/19/12 to 12/31/99; J90M1T, 41FNC43XLD, 03/20/12 to 02/15/17; J90M1U, 41XCC51S, 03/20/12 to 02/15/17; J90M3G, 41FNC41XLD, 03/21/12 to 02/15/17; J90M3H, 41KNC19XL, 03/22/12 to 02/15/17; J90M3K, 41FNC42XL, 03/22/12 to 02/15/17; J90M4H, 41FNC41XL, 03/23/12 to 02/15/17; J90M4J, 41KNC60XL, 03/23/12 to 02/15/17; J90M50, 02CK017, 03/20/12 to 12/31/99; J90NOJ, 41KNC03XL, 03/23/12 to 02/15/17; J90NOK, 41FNC42XL, 03/23/12 to 02/15/17; J90N33, 41XCC51S 03/22/12 to 02/15/17; J90N4Y, 41XCC51S 03/27/12 to 02/15/17; J90P15, 41XCD51S 03/27/12 to 02/15/17; J90P16, 41FNC43XLD 03/27/12 to 02/15/17; J90P44, 41XCC51S 03/28/12 to 02/15/17; J90P5U, 02CK017 03/27/12 to 12/31/99; J90P6G, 02CK017 03/28/12 to 12/31/99; J90P7T, 41FNC42XL, 03/28/12 to 02/15/17; J90R22, 41KNC60XL 03/29/12 to 02/15/17; J90R23, 41FNC43XL 03/29/12 to 02/15/17; J90R24, 41XCC51S 03/29/12 to 02/15/17; J90R25, 41XCB52S 03/29/12 to 02/15/17; J90R3H, 41KNC07XL 03/29/12 to 02/15/17; J90R3J, 41FNC41XL 03/29/12 to 02/15/17; J90R45, 02CK017 03/29/12 to 12/31/99; J90T34, 41XCC51S 04/02/12 to 02/15/17; J90T35, 41KNC61XL 04/03/12 to 02/15/17; J90T3Z, 41XCB57S 04/02/12 to 02/15/17; J90T5D, 41XCC51S 04/04/12 to 03/15/17; J90T5E, 41XCB57S 04/04/12 to 03/15/17; J90T5F, 41FNC42XL, 04/04/12 to 03/15/17; J90T5G, 41FNC41XL 04/04/12 to 03/15/17; J90T90, 41KNC07XL 04/09/12 to 03/15/17; J90T91, 41XCB52S 04/09/12 to 03/15/17; J90T92, 41FNC43XL 04/09/12 to 03/15/17; J90T93, 41KNC61XL 04/09/12 to 03/15/17; J90UOT, 02CK017 04/04/12 to 12/31/99; J90U41, 41FNC41XLD 04/10/12 to 03/15/17; J90U50, 41FNC42XL, 04/10/12 to 03/15/17; J90U51, 41XCC51S 04/10/12 to 03/15/17; J90U52, 41KNC07XL 04/10/12 to 03/15/17; J90U53, 41FNC43XL 04/10/12 to 03/15/17; J90U54, 41TNC20XL 04/10/12 to 03/15/17; J90W98, 02CK017 04/10/12 to 12/31/99; J90X3A, 02CK017 04/11/12 to 12/31/99; J90X6K, 02CK017 04/12/12 to 12/31/99; J90X6X, 41FNC42XL, 04/12/12 to 03/15/17; J90X6Y, 41XCC51S 04/12/12 to 03/15/17; J90X7D, 41FNC41XL 04/12/12 to 03/15/17; J90X7K, 41KNC07XL 04/13/12 to 03/15/17; J90X9A, 41FNC43XL 04/13/12 to 03/15/17; J90VOO, 02CK017 04/13/12 to 12/31/99; J90V2U, 41XCD51S 04/17;/12 to 03/15/17; J90V41, 02CK017 04/16/12 to 12/31/99; J90V82, to 02CK017 04/17;/12 to 12/31/99; J90Z32, 41FNC42XL, 04/18/12 to 03/15/17; J90Z33, 41XCC51S 04/18/12 to 03/15/17; J90Z43, 41KBC17XL 04/19/12 to 03/15/17; J90Z44, 41XCD52S 04/18/12 to 03/15/17; J90Z5Z, 41FNC41XL, 04/19/12 to 03/15/17; J91005, 02CK017, 04/20/12 to 12/31/99; J9107X, 41FNC42XL, 04/24/12 to 03/15/17; J9110D, 41XCC51S, 04/25/12 to 03/15/17; J9110E, 41KBC17XL, 04/25/12 to 03/15/17; J9112K, 02CK017, 04/25/12 to 12/31/99; J91167, 41TNC49XL, 04/27/12 to 03/15/17; J91168, 41FNC41XL, 04/27/12 to 03/15/17; J91179, 02CK017, 04/26/12 to 12/31/99; J91195, 41XCD52S, 04/27/12 to 03/15/17; J9125D, 02CK017, 04/28/12 to 12/31/99; J9128G, 41FNC42XL, 05/02/12 to 03/15/17; J9128H, 41XCC51S, 05/02/12 to 03/15/17; J91306, 02CK017, 05/02/12 to 12/31/99; J9133G, 02CK017, 05/03/12 to 12/31/99; J9140G, 02CK017, 05/07/12 to 12/31/99; J91484, 02CK017, 05/09/12 to 12/31/99; J9167F, 02CK017, 05/17;/12 to 12/31/99; J91685, 41FNC41XL, 05/17/12 to 04/15/17; J9171F, 02CK017, 05/18/12 to 12/31/99; J9175D, 41XCC51S, 05/21/12 to 04/15/17; J9175F, 41KBC17XL, 05/21/12 to 04/15/17; J9180F, 41FNC42XL, 05/23/12 to 04/15/17; J9180G, 41KNC07XL, 05/23/12 to 04/15/17; J9181K, 02CK017, 05/22/12 to 12/31/99; J9183T, 41XCB52S, 05/23/12 to 04/15/17; J9183U, 41FNC43XL, 05/23/12 to 04/15/17; J9184V, 02CK017, 05/23/12 to 12/31/99; J9187R, 41KNC60XL, 05/25/12 to 04/15/17; J9196V, 41FNC43XLD, 05/28/12 to 04/15/17; J9196W, 41XCC51S, 06/15/12 to 04/15/17; J9196X, 41KNC07XL, 05/28/12 to 04/15/17; J9199X, 02CK017, 05/28/12 to 12/31/99; J91A1C, 41KBC17XL, 05/30/12 to 04/15/17; J91A1D, 41FNC42XL, 05/30/12 to 04/15/17; J91A1E, 41FNC43XL, 05/29/12 to 04/15/17; J91A47, 41FNC41XL, 05/30/12 to 04/15/17; J91A57, 41XCB52S, 05/30/12 to 04/15/17; J91A58, 41FNC41XLD, 05/30/12 to 04/15/17; J91A59, 41XCB57S, 05/30/12 to 04/15/17; J91A62, 41XCD52S, 05/30/12 -04/15/17; J91A63, 41TNC49XL, 05/31/12 to 04/15/17; J91A6V, 02CK017, 05/30/12 to 12/31/99; J91A9P, 02CK017, 05/31/12 to 12/31/99; J91C2H, 41KNC07XL, 06/01/12 to 04/15/17; J91C2Z, 41XCC51S, 06/04/12 to 04/15/17; J91C30, 41XCC51S, 06/01/12 to 04/15/17; J91C31, 41FNC42XL, 06/01/12 to 04/15/17; J91C3J, 41FNC43XL, 06/04/12 to 04/15/17; J91C3K, 41KBC17XL, 06/04/12 to 04/15/17; J91C60, 41FNC41XL, 06/05/12 to 04/15/17; J91C6Z, 02CK017, 06/04/12 to 12/31/99; J91D05, 41XCD51S, 06/05/12 to 05/15/17; J91D1D, 02CK017, , 06/05/12 to 12/31/99; J91D3V, 41KNC07XL, 06/06/12 to 05/15/17; J91D7X, 41XCB57S, 06/07/12 to 05/15/17; J91D7Y, 41FNC42XL, 06/07/12 to 05/15/17; J91D7Z, 41KNC07XL, 06/07/12 to 05/15/17; J91D8H, 41XCC51S, 06/08/12 to 05/15/17; J91D8J, 41TNC69XL, 06/07/12 to 05/15/17; J91E4M, 41XCD51S, 06/12/12 to 05/15/17; J91E4N, 41FNC41XLD, 06/12/12 to 05/15/17; J91E9R, 41FNC43XL, 06/13/12 to 05/15/17; J91E9T, 41FNC42XL, 06/12/12 to 05/15/17; J91E9V, 41KNC07XL, 06/13/12 to 05/15/17; J91F23, 02CK017, , 06/12/12 to 12/31/99; J91F45, 41XCB52S, 06/14/12 to 05/15/17; J91F47, 41TNC49XL, 06/14/12 to 05/15/17; J91F77, 41XBB79S, 06/14/12 to 05/15/17; J91F9F, 02CK017, , 06/14/12 to 12/31/99; J91G24, 41XCD51S, 06/14/12 to 05/15/17; J91G2D, 41KNC61XL, 06/20/12 to 05/15/17; J91G2Z, 02CK017, , 06/15/12 to 12/31/99; J91G5K, 41XCD51S, 06/15/12 to 05/15/17; J91G70, 41XCC51S, 06/18/12 to 05/15/17; J91H03, 41FNC42XL, 06/19/12 to 05/15/17; J91H04, 41KNC07XL, 06/21/12 to 05/15/17; J91H05, 41KBC17XL, 06/22/12 to 05/15/17; J91H15, 02CK017, , 06/19/12 to 12/31/99; J91H35, 41FNC41XL, 06/19/12 to 05/15/17; J91H36, 41XCD51S, 06/21/12 to 05/15/17; J91H9N, 02CK017, , 06/21/12 to 12/31/99; J91J39, 41KNC60XL, 06/22/12 to 05/15/17; J91K3F, 41XBB79S, 06/26/12 to 05/15/17; J91K5G, 41XBB79S, 06/26/12 to 05/15/17; J91K6V, 41XCC51S, 06/28/12 to 05/15/17; J91K6Z, 41KNC61XL, 07/04/12 to 05/15/17; J91K71, 41FNC42XL, 06/28/12 to 05/15/17; J91K73, 41XCC50S, 06/28/12 to 05/15/17; J91K75, 41KBC17XL, 06/29/12 to 05/15/17; J91L08, 41KNC61XL, 06/29/12 to 05/15/17; J91L09, 41FNC41XL, 06/29/12 to 05/15/17; J91LOA, 41XCB52S, 06/29/12 to 05/15/17; J91LOD, 41FNC43XL, 07/04/12 to 05/15/17; J91L68, 02CK017, , 06/29/12 to 12/31/99; J91MOH, 02CK017, , 07/04/12 to 12/31/99; J91M5Z, 41XBB79S, 07/05/12 to 06/15/17; J91M62, 41FNC43XLD, 07/05/12 to 06/15/17; J91M63, 41KBC17XL, 07/05/12 to 06/15/17; J91M6U, 02CK017, , 07/05/12 to 12/31/99; J91M9U, 41TNC49XL, 07/06/12 to 06/15/17; J91M9W, 41FNC41XL, 07/06/12 to 06/15/17; J91N3A, 41FNC41XLD, 07/09/12 to 06/15/17; J91N3C, 41XCB57S, 07/09/12 to 06/15/17; J91N3D, 41XCD52S, 07/09/12 to 06/15/17; J91N4K, 02CK017, , 07/09/12 to 12/31/99; J91N9L, 41FNC43XL, 07/10/12 to 06/15/17; J91N9M, 41XCB52S, 07/10/12 to 06/15/17;J91N9N, 41XCD51S, 07/10/12 to 06/15/17; J91P1K, 02CK017, , 07/10/12 to 12/31/99; J91P2X, 41KBC17Xl, 07/11/12 to 06/15/17; J91P2Y, 41XCC50S, 07/11/12 to 06/15/17; J91P2Z, 41XCC51S, 07/12/12 to 06/15/17; J91P47, 02CK017, , 07/11/12 to 12/31/99; J91P79, 41XCB52S, 07/12/12 to 06/15/17; J91P7A, 41FNC41Xl, 07/12/12 to 06/15/17; J91ROH, 41TNC36Xl, 07/13/12 to 06/15/17; J91ROK, 41FNC42Xl, 07/13/12 to 06/15/17; J91R4P, 41XCC53S, 07/17;/12 to 06/15/17; J91R4R, 41XCD51S, 07/17;/12 to 06/15/17; J91R9C, 41TNC49Xl, 07/17;/12 to 06/15/17; J91R9D, 41XCB57S, 07/18/12 to 06/15/17; J91R9F, 41FNC41Xl, 07/17;/12 to 06/15/17; J91T22, to 02CK017, , 07/17;/12 to 12/31/99; J91T42, 41XCD52S, 07/18/12 to 06/15/17; J91T67, 02CK017, , 07/18/12 to 12/31/99; J91T98, 41XCD50S, 07/19/12 to 06/15/17; J91T99, 41FNC42Xl, 07/19/12 to 06/15/17; J91T9A, 41XCC51S, 07/19/12 to 06/15/17; J91U23, 41XCD51S, 07/19/12 to 06/15/17; J91U36, 41KNC60Xl, 07/23/12 to 06/15/17; J91U37, 41KBC17Xl, 07/20/12 to 06/15/17; J91U38, 41XCC51S, 07/23/12 to 06/15/17; J91U46, 41TNC36Xl, 07/20/12 to 06/15/17; J91U7U, 41KNC09Xl, 07/24/12 to 06/15/17; J91U7V, 41XCC53S, 07/24/12 to 06/15/17; J91V2E, 41KNC03Xl, 07/25/12 to 06/15/17; J91V2F, 41XCD51S, 07/25/12 to 06/15/17; J91V30, 02CK017, , 07/24/12 to 12/31/99; J91V60, 41KBC17Xl, 07/25/12 to 06/15/17; J91V6U, 41XCC51S, 07/25/12 to 06/15/17; J91V6Z, 02CK017, , 07/25/12 to 12/31/99; J91W06, 41XCD51S, 07/26/12 to 06/15/17; J91W07, 41KNC60Xl, 07/27/12 to 06/15/17; J91W42, 41FNC43Xl, 07/27/12 to 06/15/17; J91W43, 41FNC41Xl, 07/27/12 to 06/15/17; J91W44, 41XCD52S, 07/27/12 to 06/15/17; J91W45, 41XCD51S, 07/27/12 to 06/15/17; J91W7J, 41XCC51S, 07/31/12 to 06/15/17; J91W7l, 41KBC17Xl, 07/30/12 to 06/15/17; J91W7M, 41KNC03Xl, 08/01/12 to 06/15/17; J91X1l, 02CK017, , 07/31/12 to 12/31/99; J91X3U, 41FNC42Xl, 08/01/12 to 06/15/17; J91X3V, 41FNC43XL, 08/01/12 to 06/15/17; J91X3W, 41FNC41XL, 08/02/12 to 06/15/17; J91X3X, 41FNC41XLD, 08/02/12 to 06/15/17; J91X7K, 41KNC60XL, 08/02/12 to 06/15/17; J91Y10, 41XCD51S, 08/03/12 to 07/15/17; J91Y11, 41XCC50S, 08/06/12 to 07/15/17; J91Y49, 41XCD51S, 08/06/12 to 07/15/17; J91Y5G, 02CK017, , 08/06/12 to 12/31/99; J91Y8A, 41TNC49XL, 08/07/12 to 07/15/17; J91Y8C, 41FNC42XL, 08/07/12 to 07/15/17; J91Y9C, 02CK017, , 08/08/12 to 12/31/99; J91Z1H, 41XCB57S, 08/08/12 to 07/15/17; J91Z1J, 41FNC41XL, 08/08/12 to 07/15/17; J91Z26, 41KBC17XL, 08/08/12 to 07/15/17; J91Z5J, 41FNC43XL, 08/09/12 to 07/15/17; J91Z9E, 41XCD51S, 08/13/12 to 07/15/17; J91Z9F, 41XCC51S, 08/14/12 to 07/15/17; J9206A, 41XCD51S, 08/15/12 to 07/15/17; J92079, 41XCD51S, 08/15/12 to 07/15/17; J9208E, 02CK017, , 08/15/12 to 12/31/99; J9210Y, 41XCC50S, 08/16/12 to 07/15/17; J9210Z, 41XCD50S, 08/16/12 to 07/15/17; J92110, 41XCD51S, 08/16/12 to 07/15/17; J9214G, 41XCC51S, 08/17;/12 to 07/15/17; J9214H, 41FNC41XL, 08/17;/12 to 07/15/17; J9214J, 41FNC42XL, 08/17;/12 to 07/15/17; J9214K, 41XCD51S, 08/17;/12 to 07/15/17; J9219P, 41FNC41XLD, 08/20/12 to 07/15/17; J92239, 41FNC43XL, 08/21/12 to 07/15/17; J9223A, 41KBC17XL, 08/21/12 to 07/15/17; J9223C, 41FNC43XLD, 08/21/12 to 07/15/17; J9223D, 41XCB52S, 08/21/12 to 07/15/17; J92245, 02CK017, , 08/21/12 to 12/31/99; J92273, 41XCD51S, 08/23/12 to 07/15/17; J92274, 41XCC51S, 08/22/12 to 07/15/17; J92275, 41FNC42XL, 08/23/12 to 07/15/17; J9230G, 41XCD51S, 08/24/12 to 07/15/17; J9231U, 02CK017, , 08/23/12 to 12/31/99; J9236P, 02CK017, , 08/24/12 to 12/31/99; J9237F, 41XCD51S, 08/27/12 to 07/15/17; J9243Y, 41FNC43XL, 08/28/12 to 07/15/17; J9243Z, 41FNC41XL, 08/28/12 to 07/15/17; J92440, 41XCC51S, 08/28/12 to 07/15/17; J92441, 41FNC41XLD, 08/28/12 to 07/15/17; J9244Y, 02CK017, , 08/28/12 to 12/31/99; J9247V, 41XCB55S, 08/29/12 to 07/15/17; J9247W, 41KBC17XL, 08/29/12 to 07/15/17; J9247X, 41XCC51S, 08/29/12 to 07/15/17; J9247Y, 41FNC41XL, 08/29/12 to 07/15/17; J9247Z, 41FNC43XL, 08/29/12 to 07/15/17; J9248W, 02CK017, , 08/30/12 to 12/31/99; J92578, 02CK017, , 08/31/12 to 12/31/99; J9260L, 02CK017, , 09/03/12 to 12/31/99; J9262H, 41FNC41XLD, 09/05/12 to 08/15/17; J9262J, 41XCC53S, 09/05/12 to 08/15/17; J9262K, 41FNC42XL, 09/04/12 to 08/15/17; J92639, 41XCC51S, 09/05/12 to 08/15/17; J9263A, 41XCB57S, 09/04/12 to 08/15/17; J92700, 41KBC17XL, 09/06/12 to 08/15/17; J92701, 41FNC43XL, 09/06/12 to 08/15/17; J92702, 41FNC42XL, 09/06/12 to 08/15/17; J9276X, 02CK017, , 09/07/12 to 12/31/99; J9277T, 41XCC51S, 09/10/12 to 08/15/17; J9277V, 41FNC43XL, 09/10/12 to 08/15/17; J9284L, 02CK017, , 09/11/12 to 12/31/99; J9284M, 41KNC60XL, 09/11/12 to 08/15/17; J92866, 41XCC50S, 09/12/12 to 08/15/17; J92868, 41FNC41XL, 09/12/12 to 08/15/17; J9289Y, 41TNC49XL, 09/13/12 to 08/15/17; J9289Z, 41FNC42XL, 09/13/12 to 08/15/17; J92900, 41FNC43XL, 09/13/12 to 08/15/17; J92902, 41XCC51S, 09/14/12 to 08/15/17; J9297F, 41XCC51S, 09/18/12 to 08/15/17; J9297H, 41XCB52S, 09/18/12 to 08/15/17; J92A2C, 41FNC41XL, 09/19/12 to 08/15/17; J92A2D, 41XCB52S, 09/19/12 to 08/15/17; J92A2E, 41XCC51S, 09/19/12 to 08/15/17; J92A2N, 02CK017, , 09/19/12 to 12/31/99; J92A50, 41FNC43XL, 09/20/12 to 08/15/17; J92A51, 41XCC53S, 09/20/12 to 08/15/17; J92A52, 41FNC42XL, 09/20/12 to 08/15/17; J92A53, 41FNC41XLD, 09/20/12 to 08/15/17; J92A7N, 02CK017, , 09/20/12 to 12/31/99; J92C1E, 02CK017, , 09/21/12 to 12/31/99; J92C5E, 41FNC43XLD, 09/27/12 to 08/15/17; J92C75, 02CK017, , 09/25/12 to 12/31/99; J92D7A, 41XCD52S, 09/28/12 to 08/15/17; J92EOO, 02CK017, , 09/28/12 to 12/31/99; J92E15, 41KBC17XL, 10/01/12 to 08/15/17; J92E42, to 02CK017, , 10/01/12 to 12/31/99; J92E5N, 41KNC60XL, 10/02/12 to 08/15/17; J92E5P, 41KNC61XL, 10/02/12 to 08/15/17; J92E5R, 41XCD51S, 10/02/12 to 08/15/17; J92E7J, 02CK017, , 10/02/12 to 12/31/99; J92F04, 41XCB57S, 10/04/12 to 09/15/17; J92F05, 41FNC43XL, 10/03/12 to 09/15/17; J92F06, 41FNC42XL, 10/04/12 to 09/15/17; J92F3G, 41KNC09XL, 10/04/12 to 09/15/17; J92F3H, 41FNC41XLD, 10/04/12 to 09/15/17; J92F73, 41FNC40XL, 10/08/12 to 09/15/17; J92F74, 41XCB57S, 10/08/12 to 09/15/17; J92F76, 41XCD51S, 10/08/12 to 09/15/17; J92GOO, 02CK017, , 10/05/12 to 12/31/99; J92G48, 02CK017, , 10/08/12 to 12/31/99; J92G5T, 41XCC50S, 10/09/12 to 09/15/17; J92G6G, 41KNC60XL, 10/09/12 to 09/15/17; J92G90, 41XCD51S, 10/12/12 to 09/15/17; J92G92, 41TNC49XL, 10/10/12 to 09/15/17; J92H03, 41FNC43XLD, 10/11/12 to 09/15/17; J92H20, 02CK017, , 10/10/12 to 12/31/99; J92H3C, 41XCD52S, 10/10/12 to 09/15/17; J92H3E, 41XCD50S, 10/12/12 to 09/15/17; J92H4E, 42KNC07XL, 10/11/12 to 09/15/17; J92H4Z, 42KNC35XL, 10/11/12 to 09/15/17; J92H50, 42XCB55S, 11/05/12 to 09/15/17; J92H6E, 02CK017, , 10/11/12 to 12/31/99; J92H6L, 41XCD50S, 10/11/12 to 09/15/17; J92H8J, 42XCB51S, 10/15/12 to 09/15/17; J92H8N, 41KBC17XL, 10/15/12 to 09/15/17; J92H8P, 41FNC41XL, 10/12/12 to 09/15/17; J92H8R, 41FNC42XL, 10/15/12 to 09/15/17; J92J2D, 41FNC41XLD, 10/16/12 to 09/15/17; J92J2F, 41TNC49XL, 10/16/12 to 09/15/17; J92J2H, 41FNC43XLD, 10/16/12 to 09/15/17; J92J32, 42KNC03XL, 10/16/12 to 09/15/17; J92J6N, 41XCD50S, 10/16/12 to 09/15/17; J92J6P, 41FNC41XL, 10/17;/12 to 09/15/17; J92J8W, 02CK017, , 10/16/12 to 12/31/99; J92K9A, 42KNC07XL, 11/05/12 to 09/15/17; J92K9C, 42XCB55S, 11/05/12 to 09/15/17; J92L9N, 02CK017, , 10/23/12 to 12/31/99; J92M19, 41XCC53S, 10/25/12 to 09/15/17; J92M4E, 02CK017, , 10/24/12 to 12/31/99; J92M6C, 41FNC41XLD, 10/25/12 to 09/15/17; J92M8K, 02CK017, , 10/25/12 to 12/31/99; J92N4R, 41FNC43XL, 10/30/12 to 09/15/17; J92N7Y, 42KNC35XL, 11/02/12 to 09/15/17; J92N7Z, 42KNC03XL, 11/05/12 to 09/15/17; J92N8Z, 02CK017, , 10/30/12 to 12/31/99; J92R3Y, 02CK017, , 11/02/12 to 12/31/99; J92T1A, 41FNC42XL, 11/06/12 to 10/15/17; J92T1C, 41KBC17XL, 11/06/12 to 10/15/17; J92T1D, 42KNC35XL, 11/06/12 to 10/15/17; J92T3A, 02CK017, , 11/06/12 to 12/31/99; J92T4G, 42KNC07XL, 11/07/12 to 10/15/17; J92T6M, 02CK017, , 11/07/12 to 12/31/99; J92T7E, 41XCC51S, 11/08/12 to 10/15/17; J92T7F, 41XCD52S, 11/08/12 to 10/15/17; J92T7G, 41XCB57S, 11/08/12 to 10/15/17; J92U06, 43TNC20XL, 11/12/12 to 10/15/17; J92U07, 43TNC69XL, 11/12/12 to 10/15/17; J92U26, 41KNC61XL, 11/14/12 to 10/15/17; J92U62, 42XCB55S, 11/14/12 to 10/15/17; J92U63, 42KNC03XL, 11/14/12 to 10/15/17; J92U88, 41KNC60XL, 11/14/12 to 10/15/17; J92V5U, 02CK017, , 11/14/12 to 12/31/99; J92V63, 41XCC51S, 11/15/12 to 10/15/17; J92V64, 41FNC41XLD, 11/15/12 to 10/15/17; J92V7H, 41FNC43XL, 11/14/12 to 10/15/17; J92V7K, 42XCB51S, 11/15/12 to 10/15/17; J92V8M, 43TNC20XL, 11/15/12 to 10/15/17; J92V8N, 43TNC69XL, 11/16/12 to 10/15/17; J92WOT, 02CK017, , 11/15/12 to 12/31/99; J92W2E, 43TNC69XL, 11/21/12 to 10/15/17; J92W2F, 43TNC20XL, 11/16/12 to 10/15/17; J92W2G, 43KNC03XL, 11/16/12 to 10/15/17; J92X07, 42KNC07XL, 11/21/12 to 10/15/17; J92XOA, 41FNC41XL, 11/22/12 to 10/15/17; J92XOC, 41XCC50S, 11/22/12 to 10/15/17; J92XOZ, 41FNC41XL, 11/21/12 to 10/15/17; J92X3P, 02CK017, , 11/22/12 to 12/31/99; J92X8C, 02CK017, , 11/24/12 to 12/31/99; J92X8D, 42KNC35XL, 11/23/12 to 10/15/17; J92X8E, 42XCB55S, 11/23/12 to 10/15/17; J92X9R, 41FNC43XL, 11/23/12 to 10/15/17; J92X9T, 41FNC42XL, 11/23/12 to 10/15/17; J92Y2P, 41KBC17XL, 11/26/12 to 10/15/17; J92Y2R, 41XCC50S, 11/26/12 to 10/15/17; J92Y2T, 41KNC61XL, 11/26/12 to 10/15/17; J92Y2U, 41XCC51S, 11/26/12 to 10/15/17; J92Y6R, 41XCD51S, 11/27/12 to 10/15/17; J92Y71, 41XCC51S, 11/28/12 to 10/15/17; J92ZOJ, 41FNC43XLD, 11/28/12 to 10/15/17; J92ZOK, 41KNC09XL, 11/28/12 to 10/15/17; J92Z14, 41XCD52S, 11/28/12 to 10/15/17; J92Z3Z, 02CK017, , 11/28/12 to 12/31/99; J92Z4R, 41XCB57S, 11/29/12 to 10/15/17; J92Z4T, 42XCB55S, 11/29/12 to 10/15/17; J92Z4U, 41XCC53S, 11/29/12 to 10/15/17; J92Z92, 41FNC41XL, 11/30/12 to 10/15/17; J92Z93, 41XCD51S, 12/01/12 to 10/15/17; J9302F, 41FNC42XL, 12/03/12 to 10/15/17; J9302G, 41KBC17XL, 12/03/12 to 10/15/17; J9302H, 41FNC43XL, 12/03/12 to 10/15/17; J9303L, 41XCC50S, 12/03/12 to 10/15/17; J93105, 41XCD51S, 12/05/12 to 11/15/17; J9313T, 41XCD52S, 12/05/12 to 11/15/17; J9313Z, 41XCC51S, 12/05/12 to 11/15/17; J93140, 41XCD50S, 12/07/12 to 11/15/17; J93168, 41XCD51S, 12/07/12 to 11/15/17; J9316C, 41FNC43XL, 12/10/12 to 11/15/17; J9316D, 41FNC42XL, 12/10/12 to 11/15/17; J9318Z, 02CK017, , 12/07/12 to 12/31/99; J93231, 02CK017, , 12/10/12 to 12/31/99; J9324T, 41KBC17XL, 12/10/12 to 11/15/17; J9324U, 41FNC40XL, 12/10/12 to 11/15/17; J9324V, 41XCC50S, 12/11/12 to 11/15/17; J9325M, 41FNC41XL, 12/11/12 to 11/15/17; K4C03G, 37ER320, 01/04/13 12/15/17; K4C03N, 37ER320, 01/04/13 12/15/17; K4C07P, 37ER320, 01/08/13 12/15/17; K4C09V, 37ER320, 01/09/13 12/15/17; K4C136, 37ER320, 01/10/13 12/15/17; K4C15P, 37ER320, 01/12/13 12/15/17; K4C16E, 37ER320, 01/12/13 12/15/17; K4C185, 37ER320, 01/13/13 12/15/17; K4C18P, 37ER320, 01/14/13 12/15/17; K4C18Y, 37ER320, 01/13/13 12/15/17; K4C19W, 37ER320, 01/15/13 12/15/17; K4C206, 37ER320, 01/16/13 12/15/17; K4C22M, 37ER320, 01/17;/13 12/15/17; K4C26W, 37ER320, 01/18/13 12/15/17; K4C27N, 37ER320, 01/21/13 12/15/17; K4C28T, 37ER320, 01/22/13 12/15/17; K4C293, 37ER320, 01/22/13 12/15/17; K4C31W, 37ER320, 01/22/13 12/15/17; K4C37N, 37ER320, 01/26/13 12/15/17; K4C384, 37ER320, 01/26/13 12/15/17; K4C39J, 37ER320, 01/25/13 12/15/17; K4C412, 37ER320, 01/26/13 12/15/17; K4C41Z, 37ER320, 01/26/13 12/15/17; K4C42N, 37ER320, 01/26/13 12/15/17; K4C504, 37ER320, 02/01/13 12/15/17; K4C51A, 37ER320, 02/02/13 12/15/17; K4C523, 37ER320, 02/02/13 12/15/17; K4C573, 37ER320, 02/06/13 01/15/18; K4C57K, 37ER320, 02/05/13 01/15/18; K4C581, 37ER320, 02/06/13 01/15/18; K4C58G, 37ER320, 02/06/13 01/15/18; K4C591, 37ER320, 02/06/13 01/15/18; K4C63E, 37ER320, 02/08/13 01/15/18; K4C645, 37ER320, 02/09/13 01/15/18; K4C64P, 37ER320, 02/12/13 01/15/18; K4C69N, 37ER320, 02/13/13 01/15/18; K4C709, 37ER320, 02/13/13 01/15/18; K4C71H, 37ER320, 02/13/13 01/15/18; K4C74T, 37ER320, 02/15/13 01/15/18; K4C791, 37ER320, 02/19/13 01/15/18; K4C82W, 37ER320, 02/20/13 01/15/18; K4C833, 37ER320, 02/20/13 01/15/18; K4C848, 37ER320, 02/21/13 01/15/18; K4C88J, 37ER320, 02/23/13 01/15/18; K4C88Y, 37ER320, 02/24/13 01/15/18; K4C89U, 37ER320, 02/24/13 01/15/18; K4C98D, 37ER320, 03/02/13 01/15/18; K4C98K, 37ER320, 03/01/13 01/15/18; K4CA38, 37ER320, 03/11/13 01/15/18; K4CA3V, 37ER320, 03/08/13 02/15/18; K4CC3F, 37ER320, 03/08/13 02/15/18; K4CC3H, 37ER320, 03/09/13 02/15/18; K4CC4R, 37ER320, 03/09/13 02/15/18; K4CC5J, 37ER320, 03/09/13 02/15/18; K4CC5K, 37ER320, 03/11/13 02/15/18; K4CD16, 37ER320, 03/13/13 02/15/18; K4CD1Y, 37ER320, 03/14/13 02/15/18; K4CD24, 37ER320, 03/14/13 02/15/18; K4CD2M, 37ER320, 03/14/13 02/15/18; K4CD3F, 37ER320, 03/15/13 02/15/18; K4CD3Y, 37ER320, 03/15/13 02/15/18; K4CD45, 37ER320, 03/15/13 02/15/18; K4CD7W, 37ER320, 03/18/13 02/15/18; K4CEOW, 37ER320, 03/20/13 02/15/18; K4CE2N, 37ER320, 03/20/13 02/15/18; K4CE9K, 37ER320, 03/23/13 02/15/18; K4CF07, 37ER320, 03/23/13 02/15/18; K4CFOJ, 37ER320, 03/26/13 02/15/18; K4CF43, 37ER320, 03/27/13 02/15/18; K4CF49, 37ER320, 03/27/13 02/15/18; K4CF60, 37ER320, 03/28/13 02/15/18; K4CF72, 37ER320, 03/28/13 02/15/18; K4CF7R, 37ER320, 03/28/13 02/15/18; K4CF8Z, 37ER320, 04/03/13 02/15/18; K4CG2H, 37ER320, 04/04/13 03/15/18; K4CG3H, 37ER320, 04/04/13 03/15/18; K90393, 41TNC49XL, 01/17;/13 12/15/17; K90394, 41FNC43XLD, 01/17;/13 12/15/17; K90395, 41FNC43XL, 01/17;/13 12/15/17; K9042A, 02CK017, , 01/18/13 12/31/99; K90441, 41FNC41XL, 01/21/13 12/15/17; K90442, 41KBC17XL, 01/21/13 12/15/17; K90443, 41FNC41XLD, 01/21/13 12/15/17; K90486, 41XCC51S, 01/22/13 12/15/17; K90487, 41XCD51S, 01/23/13 12/15/17; K90488, 41XCD52S, 01/23/13 12/15/17; K90489, 41XCB57S, 01/23/13 12/15/17; K90519, 02CK017, , 01/23/13 12/31/99; K9057D, 41TNC49XL, 02/01/13 12/15/17; K9059K, 02CK017, , 01/24/13 12/31/99; K9063J, 41FNC41XLD, 01/28/13 12/15/17; K9063K, 41FNC41XL, 01/28/13 12/15/17; K9083C, 41FNC43XL, 02/05/13 12/15/17; K9083D, 41XCC51S, 02/05/13 12/15/17; K9083E, 02CK017, , 02/01/13 12/31/99; K9084H, 41FNC42XL, 02/05/13 12/15/17; K9084L, 41XCB57S, 02/06/13 12/15/17; K9088P, 41FNC40XL 02/05/13 01/15/18; K9088R 41XCD52S 02/06/13 01/15/18; K90894 41XCB52S 02/06/13 01/15/18; K90895 41KBC17XL 02/06/13 01/15/18; K9093F 41XCD51S 02/07/13 01/15/18; K90947 43TNC69XL 02/08/13 01/15/18; K9094P 41FNC43XLD 02/11/13 01/15/18; K9097G 41XCD50S 02/12/13 01/15/18; K9097H 41XCD51S 02/11/13 01/15/18; K90A5Z, 43TNC69XL 02/13/13 01/15/18; K90A9V, 41FNC41XLD 02/13/13 01/15/18; K90A9W, 41FNC41XL, 02/13/13 01/15/18; K90A9X, 41XCC51S, 02/13/13 01/15/18; K90C2J, 02CK017, , 02/14/13 12/31/99; K90C3A, 41FNC43XL, 02/13/13 01/15/18; K90C3K, 41XCB57S, 02/14/13 01/15/18; K90C5C, 41XCD51S, 02/15/13 01/15/18; K90C89, 41XCD51S, 02/16/13 01/15/18; K90C8L, 41FNC43XLD, 02/15/13 01/15/18; K90C8N, 41XCD52S, 02/18/13 01/15/18; K90C9W, 02CK017, , 02/15/13 12/31/99; K90D1X, 41FNC42XL, 02/19/13 01/15/18; K90D1Y, 41KBC17XL, 02/19/13 01/15/18; K90D4U, 02CK01,7 02/18/13 12/31/99; K90D7N, 41XCC50S, 02/19/13 01/15/18; K90E1A, 41XCB57S, 02/20/13 01/15/18; K90E1D, 43TNC69XL, 02/20/13 01/15/18; K90E29, 41XCD50S, 02/20/13 01/15/18; K90E2A, 41XCB52S, 02/20/13 01/15/18; K90E4G, 02CK017, , 02/20/13 12/31/99; K90E5Y, 41XCD51S, 02/21/13 01/15/18; K90F02, 41FNC43XL, 02/22/13 01/15/18; K90F04, 41XCC51S, 02/22/13 01/15/18; K90F30, 02CK017, 02/23/13 to 12/31/99; K90F3X, 41XCD51S 02/22/13 01/15/18; K90F4E, 41XCD51S 02/25/13 01/15/18; K90F4H, 41FNC42XL, 02/25/13 01/15/18; K90F90 41FNC43XL 02/26/13 01/15/18; K90F91 41XCC51S 02/26/13 01/15/18; K90G1G 02CK017, 02/26/13 12/31/99; K90G2V 41FNC43XL 02/27/13 01/15/18; K90G2W 41FNC42XL, 02/27/13 01/15/18; K90G2X 41XCC51S 02/27/13 01/15/18; K90G4X 02CK017, 02/27/13 12/31/99; K90H1P 41KBC17XL 03/04/13 01/15/18; K90H1R 41XCD52S 03/04/13 01/15/18; K90H1T 41XCD51S 03/01/13 01/15/18; K90H5V 41FNC41XLD 03/04/13 01/15/18; K90JOZ 41KNC60XL 03/11/13 02/15/18; K90J10 41KNC61XL 03/07/13 02/15/18; K90J11 41TNC36XL 03/07/13 02/15/18; K90J93, 41XCC53S 03/07/13 02/15/18; K90K3, A 02CK017, 03/08/13 12/31/99; K90K55, 41KNC09XL 03/13/13 02/15/18; K90K56, 41FNC43XLD 03/12/13 02/15/18; K90K57, 41XCD51S 03/12/13 02/15/18; K90L08, 41FNC43XL 03/14/13 02/15/18; K90L09, 41KNC60XL 03/14/13 02/15/18; K90L17, 41FNC41XL 03/13/13 02/15/18; K90L1V, 02CK017, 03/12/13 12/31/99; K90L5A, 41KBC17XL 03/14/13 02/15/18; K90M20, 41XCD51S 03/14/13 02/15/18; K90M22, 41XCC53S 03/22/13 02/15/18; K90M3N, 41XCC50S 03/15/13 02/15/18; K90M3P, 41XCD50S 03/15/13 02/15/18; K90M6M, 41XCC51S 03/18/13 02/15/18; K90M6N, 41FNC43XL 03/18/13 02/15/18; K90M6P, 41XCD51S 03/18/13 02/15/18; K90N1Z, 41TNC49XL 03/19/13 02/15/18; K90N6A, 41XCB52S 03/20/13 02/15/18; K90N6C, 41FNC41XL 03/20/13 02/15/18; K90N9F, 41XCC51S 03/21/13 02/15/18; K90N9G, 41FNC43XL 03/21/13 02/15/18; K90N9H, 41FNC42XL, 03/21/13 02/15/18; K90P3G, 41TNC49XL 03/22/13 02/15/18; K90P3H, 41FNC41XLD 03/22/13 02/15/18; K90P4F, 41KNC61XL 03/22/13 02/15/18; K90R2P, 02CK017, 03/26/13 12/31/99; K90R8R, 41KBC17XL 04/01/13 02/15/18; K90R8T, 41FNC41XLD 04/01/13 02/15/18; K90U1H, 41TNC36XL 04/04/13 03/15/18; and K90U1J, 41KNC09XL 04/04/13 03/15/18.
ClassificationClass II
Reason for RecallEthicon Endo-Surgery is initiating a voluntary recall for LIGACLIP® 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
Product Quantity738,356
Recall NumberZ-1775-2013
Product DescriptionLIGACLIP® Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Trays), 10mm M/L Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a sterile, single patient use instrument designed to provide a means of ligation through ENDOPATH® surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360° in either direction. The rotating knob is located to allow for a one-handed technique.
Code InfoFNC40XL, 41, 2017-09 to 2018-01; FNC41XL, 41, 2016-12 to 2018-02; FNC41XLD, 41, 2016-12 to 2018-02; FNC42XL, 41, 2016-12 to 2018-02; FNC43XL, 41, 2016-12 to 2018-02; FNC43XLD, 41, 2017-02 to 2018-02; KBC17XL, 41, 2016-12 to 2018-2; KNC03XL, 41, 2017-02 to 2017-06; KNC03XL, 42, 2017-09 to 2017-10; KNC03XL, 43, 2017-10; KNC07XL, 41, 2017-01 to 017-05; KNC07XL, 42, 2017-09 to 2017-10; KNC09XL, 41, 2016-12 to 2018-03; KNC19XL, 41, 2017-02; KNC60XL, 41, 2016-2 2018-02; KNC61XL, 41, 2016-12 to 2018-02; TNC20XL, 41, 2017-02 to 2017-03; TNC20XL, 43, 2017-10; TNC36XL, 41, 2017-01 to 2018-03; TNC49XL, 41, 2016-12 to 2018-02; TNC69XL, 41, 2016-12 to 2017-05; TNC69XL, 43, 2017-10 to 2018-1; XCB51S, 41, 2017-01; XCB51S, 42, 2017-09 to 2017-10; XCB52S, 41, 2016-12 to 2018-02; XCB55S, 41, 2017-07; XCB55S, 42, 2017-09 to 2017-10; XCB57S, 41, 2016-12 to 2018-01; XCC50S, 41, 2016-12 to 2018-02; XCC51S, 41, 2016-12 to 2018-02; XCC53S, 41, 2016-12 to 2018-02; XCD50S, 41, 2016-12 to 2018-02; XCD51S, 41, 2016-12 to 2018-02; XCD52S, 41, 2016-12 to 2018-01; KNC35XL, 42, 2017-09 to 2017-10; XBB48B, 41, 2016-07 to 2017-01; XBB48B, 42, 2017-02 and XBB79S, 41, 2017-05 to 2017-06.
ClassificationClass II
Reason for RecallEthicon Endo-Surgery is initiating a voluntary recall for LIGACLIP® 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
Product Quantity49,357
Recall NumberZ-1776-2013
Product DescriptionLIGACLIP® Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endoscopic Rotating Multiple Clip Applier is a single patient use instrument designed to provide a means of ligation through ENDOPATH® surgical trocars. The instrument delivers 20 titanium clips that individually advance after each firing. The shaft is made of a low glare material that minimizes reflective distortion. It is designed to rotate 360° in either direction. The rotating knob is located to allow for a one-handed technique.
Code InfoCK017, 02, 2016-11 to 2018-03
ClassificationClass II
Reason for RecallEthicon Endo-Surgery is initiating a voluntary recall for LIGACLIP® 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure
Product Quantity10,488
Recall NumberZ-1777-2013

Class II Biologics Event

Event ID65169
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmTacoma Pierce County Blood Bank
CityTacoma
StateWA
CountryUS
Distribution PatternWashington
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced Irradiated
Code InfoW127813300875;
ClassificationClass II
Reason for RecallBlood product, which was irradiated but labeled with incorrect irradiation status and expiration date, was distributed.
Product Quantity1
Recall NumberB-1928-13

Class II Biologics Event

Event ID65170
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date13-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmOneBlood, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW038112210948; W038112124166;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity2
Recall NumberB-1929-13
Product DescriptionPlatelets Pooled Leukocytes Reduced
Code InfoW038112985393; W038112982318;
ClassificationClass II
Reason for RecallBlood products, collected from a donor who traveled to an area considered endemic for malaria, were distributed.
Product Quantity2
Recall NumberB-1930-13

Class II Biologics Event

Event ID65177
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Apr-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmOneBlood, Inc.
CityOrlando
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW038111360397;
ClassificationClass II
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1
Recall NumberB-1931-13

Class II Biologics Event

Event ID65178
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Feb-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmAmerican National Red Cross The
CityPomona
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info006LJ61025
ClassificationClass II
Reason for RecallBlood product, collected from an ineligible donor, was distributed.
Product Quantity1 unit
Recall NumberB-1940-13
Product DescriptionBlood and Blood Products for Reprocessing
Code Info006LJ61025
ClassificationClass II
Reason for RecallBlood product, collected from an ineligible donor, was distributed.
Product Quantity1 unit
Recall NumberB-1941-13

Class II Biologics Event

Event ID65198
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-Apr-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmLifeServe Blood Center
CityDes Moines
StateIA
CountryUS
Distribution PatternNew Jersey
 

Associated Products

Product DescriptionPlatelets Pheresis Leukocytes Reduced
Code InfoW037913559084(Part A); W037913559084(Part B)
ClassificationClass II
Reason for RecallBlood products, in which quality control and distribution of products did not meet specifications, were distributed.
Product Quantity2 units
Recall NumberB-1999-13

Class II Biologics Event

Event ID65199
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmCarter BloodCare/ WE & Lela I Stewart Blood Center, Inc
CityTyler
StateTX
CountryUS
Distribution PatternTexas
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis) Leukocytes Reduced
Code InfoW035212218081F(Part A); W035212218081F(Part B)
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-2000-13

Class II Devices Event

Event ID65259
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHill-Rom, Inc.
CityBatesville
StateIN
CountryUS
Distribution PatternWorldwide distribution: USA (nationwide) and countries of: Canada, Columbia, Nigeria, Kuwait and Saudi Arabia.
 

Associated Products

Product DescriptionTotalCare Bed used with AccuMax Quantum VPC mattress AccuMax Quantum Complete mattress, and AccuMax Quantum Convertible mattress The TotalCare Bed System is intended to provide a patient support ideally suited to be used in health care environments. The TotalCare Bed System may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (PACU), and sections of the emergency department (ED). The TotalCare Bed System is capable of being used with a broad patient population as determined appropriate by the caregiver or institution.
Code InfoBed model numbers: PAU001010784, PAU005010784, P1900, PAK169N10184, PAK169N10384, PA8171210184, PA8175210184, PA8175210384, PA8171210384, PA8171310384, and PA8173210384. The AccuMax Quantum VPC, Complete and Convertible mattresses are not serialized, but were distributed between September 2005 and April 2013
ClassificationClass II
Reason for RecallHill-Rom is initiating this recall due to a potential issue with TotalCare® Beds equipped with AccuMax Quantum" mattresses. If the bed is put into the chair egress position, the magnets on the mattress may not hold the bottom of the mattress flat to the bed frame. If this happens, the foot section of the mattress will extend away from the bed at about a 30° angle (as shown in the photo). A patient attempting to get back into the bed may assume that the mattress is against the bed and attempt to sit, but may miss the seat and sit on the foot section instead. This can result in the patient sliding down to the floor, with possible injury. If the patient falls, the result may be major critical muscular/skeletal injury.
Product Quantity4,121 Units
Recall NumberZ-1794-2013

Class II Devices Event

Event ID65391
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Mar-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAdvanced Orthogonal Equipment, Incorporated
CitySaint Petersburg
StateFL
CountryUS
Distribution PatternNationwide distribution: US including states of: AL, CA, CO, FL, GA, ID, KY, MD, NC, NJ, NY, OH, PA, TN, VA, and WA.
 

Associated Products

Product DescriptionAdvanced Orthogonal Percussion Adjusting Instrument Indicated for use by a licensed Chiropractor to assist in making Chiropractic adjustments to the Atlas vertebra.
Code InfoSerial numbers: 001, 002, 008, 007, 006, 0010, 009, 011, 016, 015, 014, 023, 017, 018, 019, 020, 021, 024, 025, 022, 027, 026, 028, 029, 030, 031, 032, 033, 034, 035, 036, 038, 039, 037, 041, 042, 040, 043, 044, 045, 046, 048, 049, 050, 052, 053, 055, 056, 060, 058, 059, and 061
ClassificationClass II
Reason for RecallUnapproved medical device
Product Quantity54
Recall NumberZ-1809-2013

Class II Devices Event

Event ID65399
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmInstrumentation Laboratory Co.
CityBedford
StateMA
CountryUS
Distribution PatternWorldwide Distribution- US (nationwide) including states of: MA, ME, CT, NJ, NY, PA, MD, VA, NC, SC, GA, FL, AL, TN, MS, KY, OH, IN, MI, IA, WI, MN, SD, MT, IL, MO, KS, NE, LA, AR, OK, TX, CO, ID, AZ, CA, OR, WA, AK, RI, VT and the countries of: Angola, Argentina, Australia, Austria, Belgium, Bermuda, Brazil, Bulgaria, Canada, Caribbean, Chile, Colombia, Costa Rica, Czech, Denmark, Dubai, Ecuador, Egypt, France, Germany, Gibraltar, Great Britain, Greece, Guatemala, Hungary, India, Indonesia, Iran, Israel, Italy, Jamaica, Jordan, Korea, Kossovo, Kuwait, Lebanon, Lithuania, Malaysia, Malta, Mexico, Morocco, Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Romania, Russia, Saudi Arabia, Serbia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Syria, Taiwan, Thailand, Trinidad, Turkey, Ukraine, Uruguay, Vietnam, and Japan.
 

Associated Products

Product DescriptionHemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Anticoagulant Therapy.
Code InfoPart Number applies to all: 0020002950 - all product lots. Lot Numbers: 1) N0716706 Exp. Date 5/31/2013, 2) N0817321 Exp. Date 5/31/2013, 3) E0917396 Exp. Date 9/30/2013, 4)) N0917378 Exp. Date 9/30/2013, 5) N1118029 Exp. Date 10/31/2013, 6) N0128669 Exp. Date 1/31/2014, 7) N0329291 Exp. Date 2/28/2014, 8) N0429596 Exp. Date 3/31/2014, 9) N0520056 Exp. Date 5/31/2014,10) E0720822 Exp. Date 7/31/2014, 11) N0821174 Exp. Date 8/31/2014, 12) N091388 Exp. Date 9/30/2014, 13) N0921522 Exp. Date 9/30/2014, 14) N0132676 Exp. Date 1/31/2015 and 15) N1222567 Exp. Date 1/31/2015.
ClassificationClass II
Reason for RecallInstrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.
Product QuantityKits per product:1)11080, 2)11603, 3)11487, 4)11483, 5)11290, 6)11562, 7)11535, 8)11577, 9)11505, 10)11708,11)11579,12)11580, 13&14) not distributed
Recall NumberZ-1784-2013

Class II Devices Event

Event ID65401
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEtac Supply Center Ab
CityAnderstorp
State
CountrySE
Distribution PatternInternational distribution: Austria, Australia, Belgium, Brazil, Canada, Czech Republic, Denmark, Esonia, Finland, France, Great Britain, Germany, Greece, Hong Kong, Ireland, Isreal, Iceland, Italy, Kingdom of Bahrain, Kuwait, Lithuania, Netherlands, Norge, New Zealand, Spain, Switzerland, Sweden, and United Arab Emirates.
 

Associated Products

Product DescriptionSwift Mobil shower chair, Swift Mobil 160 shower chair, and Swift Mobil Tilt shower chair. Height adjustable four wheeled shower chairs for persons of various weights.
Code InfoAffected Serial numbers: 3829 to 11028 (same series for all Swift Mobil products)
ClassificationClass II
Reason for RecallEtac is voluntarily conducting a field correction of the Etac Swift Mobil shower chair. If the Swift Mobil shower chair loses a caster and thus becomes instantly unstable, there is potiential risk for harm or injury.
Product Quantity7200 internationally
Recall NumberZ-1807-2013

Class II Drugs Event

Event ID65445
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date16-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWest-Ward Pharmaceutical Corp.
CityEatontown
StateNJ
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionWest-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10), b) 5000-count bottle (NDC 0143-1140-51), Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724
Code InfoLot # 69098A, 69098B, 69100A; Exp 8/15
ClassificationClass II
Reason for RecallPresence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.
Product Quantity14,503 bottles
Recall NumberD-824-2013
Product DescriptionWest-ward Belladonna Alkaloids with Phenobarbital Tablets, a) 1000-count bottle (NDC 0143-1140-10),Rx only, Manufactured by West-ward Pharmacuetical Corp., Eatontown, N.J., 07724
Code InfoLot# 67331A, Exp 10/14
ClassificationClass II
Reason for RecallCross contamination with other products: Belladonna Alkaloids with Phenobarbital Tablets contained a trace amount of Methocarbamol.
Product Quantity7,324 bottles
Recall NumberD-825-2013

Class II Food Event

Event ID65447
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date25-Feb-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican Importing Co, Inc
CityMinneapolis
StateMN
CountryUS
Distribution PatternIL, IN, IA, KS, MN, NJ, NY, NC, OH, SC, TX, VT.
 

Associated Products

Product DescriptionVanilla almond granola, Net WT 16 oz(454g), UPC 0 71725 71239 4, Distributed by American Importing Co., Inc, Minneapolis, MN 55414. Vanilla Almond Granola, Net Wt 16 oz (454g), UPC 7 25439 20038 7, Distributed by DZA Brands LLC, Salisbury,NC 28147. Hy-Vee Granola Vanilla Almond, 24 oz, UPC 71725 71239 Amport, Granola, Vanilla Almond, 22 oz, UPC 71725 72512
Code Info8/10/13 223X218 9/13/13 257X218 4/16/13 1072O3 5/14/13 1352O2 7/12/13 1942P2 or 1942O2 8/10/13 223X218 9/13/13 257X218 11/4/2013 353385819 12/12/13 0722D1 1/24/2013 1142-362329 1/23/2013 1142-362331 1/24/2013 1152-363511 2/1/2013 1222-364253 2/7/2013 1282-364381 2/24/2013 1452-366291 3/7/2013 1592-366870 6/7/2013 2512-374976 6/13/2013 2572-374410 6/13/2013 2572-375613 7/1/2013 2752-376949 7/7/2013 2912-376014 7/17/2013 2912-378591 7/17/2013 2912-378591 8/5/2013 3102-379574 8/6/2013 3112-379952 9/12/2013 3472-382323 9/13/2013 3472-382969 4/16/13 1072O3 5/14/13 1352O2 8/10/13 223X218 9/13/13 257X218 1/22/14 022X318 5/14/13 1352O2 8/10/13 223X218 9/13/13 257X218 1/22/14 022X318 4/16/13 1072O3 8/10/13 223x218 9/13/13 257x218 8/15/13 320X246 4/16/13 1072O3 8/10/13 233X218 9/13/13 257X218 1/22/14 022X318 5/14/13 1352O2 7/12/13 1942P2 or 1942O2 8/10/13 223X218 9/13/18 257X218 4/16/13 1072O3 3/6/13 0662O2 4/16/13 1072P3 5/14/13 1352OO1 6/6/13 1582I1 8/1/13 214X218 8/10/13 233X218 9/13/13 257X218 10/8/13 282X218 10/30/13 304X218 11/15/13 320X218 1/24/2013 1142-362329 1/24/2013 1152-363511 2/1/2013 1222-363918 3/7/2013 1592-366870 6/13/2013 2572-374410 6/13/2013 2572-375613 7/17/2013 2912-376014 8/6/2012 3112-379952 1/23/2013 1142-362331 1/24/2013 1142-362329 2/1/2013 1222-363918 2/7/2013 1282-364381 3/7/2013 1592-366870 6/7/2013 2512-372839 6/13/2013 2572-374410 6/13/2013 2572-375613 7/1/2013 2752-376665 7/17/2013 2912-376014 7/17/2013 2912-378591 8/5/2013 3102-379574 8/6/2013 3112-379952 9/13/2013 3472-382969 11/4/2013 0353-385819 5/14/13 1352N2 6/7/2013 2512-372839 6/13/2013 2572-374410 7/1/2013 2752-376665 7/1/2013 2752-376949 7/17/2013 2912-376014 9/13/2013 3472-382969 9/13/13 257X218
ClassificationClass II
Reason for RecallAmerican Importing Co., d/b/a Amport Foods is voluntarily recalling a limited number of packages of its Amport Foods 16 oz Vanilla Almond Granola because they may contain pliable metal wire mesh fragments from a defective flour sifter from a 3rd party vendor.
Product Quantity16,884 cases (8/case) and 1500 bags.
Recall NumberF-1727-2013
Product DescriptionOrchard Reserve, Fiber Health Blend, Net WT 6.5 oz , UPC 0 71725 74211 7, Distributed by Amport Foods, Minneapolis, MN 55414.
Code InfoBest By 1/28/14 Lot #:30X322
ClassificationClass II
Reason for RecallAmerican Importing Co., d/b/a Amport Foods is voluntarily recalling a limited number of packages of its Amport Foods 16 oz Vanilla Almond Granola because they may contain pliable metal wire mesh fragments from a defective flour sifter from a 3rd party vendor.
Product Quantity910 cases (12/case)
Recall NumberF-1728-2013
Product DescriptionSmart Sense Fruit & Granola Trail Mix, Net WT 4.0 oz , UPC 8 83967 29091 8, Distributed by Kmart corporation, Hoffman Estates, Il 60179, Minneapolis, MN 55414.
Code InfoLot # Best By Date 9/10/2012 7/10/2013 10/16/2012 8/16/2013 10/23/2012 8/23/2013 11/5/2012 9/5/2013 12/3/2012 10/3/2013 1/3/2013 11/3/2013 1/4/2013 11/4/2013 1/22/2013 11/22/2013
ClassificationClass II
Reason for RecallAmerican Importing Co., d/b/a Amport Foods is voluntarily recalling a limited number of packages of its Amport Foods 16 oz Vanilla Almond Granola because they may contain pliable metal wire mesh fragments from a defective flour sifter from a 3rd party vendor.
Product Quantity1462 cases (12/case)
Recall NumberF-1729-2013

Class II Biologics Event

Event ID65463
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-May-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmBlood Bank Computer Systems, Inc
CityAuburn
StateWA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionBlood Bank software Primary Application with Model numbers 5.4.0.2 and 5.4.1.
Code InfoBBCS Primary Application 5.4.0.2, 5.4.1
ClassificationClass II
Reason for RecallBlood Bank software Primary Application (Model Numbers 5.4.0.2 and 5.4.1), with a defect or glitch, was distributed.
Product Quantity2 Devices
Recall NumberB-2148-13

Class II Biologics Event

Event ID65466
StatusOngoing
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBD Biosciences, Systems & Reagents
CitySan Jose
StateCA
CountryUS
Distribution PatternWorldwide distribution.
 

Associated Products

Product DescriptionBDTM Stem Cell Control Kit; BD Biosciences 2350 Qume Drive, San Jose, CA 95131
Code InfoCatalog number: 340991 Lot numbers: BC053, expires 06/02/13 and BC063, expires 07/02/13.
ClassificationClass II
Reason for RecallBD Stem cells controls, not functioning as intended, were distributed.
Product Quantity2 Units
Recall NumberB-2098-13

Class II Devices Event

Event ID65468
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternWorldwide Distribution - USA (nationwide) and countries of: AFGHANISTAN ALBANIA ARGENTINA ARUBA AUSTRALIA AUSTRIA AZERBAIJAN BAHRAIN BANGLADESH BELGIUM BOLIVIA BOSNIA AND HERZEGOWINA BRAZIL BRUNEI DARUSSALAM BULGARIA CAMBODIA CHILE CHINA COLOMBIA COSTA RICA CROATIA (local name: Hrvatska) CYPRUS CZECH REPUBLIC DENMARK ECUADOR EGYPT EL SALVADOR ESTONIA ETHIOPIA FINLAND FRANCE GERMANY GREECE GUADELOUPE HONG KONG ICELAND INDIA INDONESIA IRAQ IRELAND ISRAEL ITALY JAPAN JORDAN KAZAKHSTAN KENYA KOREA, REPUBLIC OF KUWAIT LAOS LATVIA LEBANON LIBYAN ARAB JAMAHIRIYA LITHUANIA LUXEMBOURG MACAU MACEDONIA MALAYSIA MALTA MEXICO MONGOLIA MOROCCO NAMIBIA NEPAL NETHERLANDS NETHERLANDS ANTILLES NEW CALEDONIA NEW ZEALAND NICARAGUA NIGERIA NORWAY OMAN PAKISTAN PALESTINE PANAMA PAPUA NEW GUINEA PARAGUAY PERU PHILIPPINES POLAND PORTUGAL PUERTO RICO QATAR REUNION ROMANIA RUSSIAN FEDERATION SAUDI ARABIA SERBIA SINGAPORE SLOVENIA SOUTH AFRICA SPAIN SRI LANKA SWEDEN SWITZERLAND TAIWAN, PROVINCE OF CHINA TANZANIA, UNITED REPUBLIC OF THAILAND TRINIDAD AND TOBAGO TUNISIA TURKEY UGANDA UKRAINE UNITED ARAB EMIRATES UNITED KINGDOM UZBEKISTAN VENEZUELA VIET NAM and YEMEN.
 

Associated Products

Product DescriptionPhilips HeartStart MRx Monitor/Defibrillator, Model numbers M3535A, M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician
Code InfoSerial numbers ranging from: US00100100 to US00567299 (serial numbers of the HeartStart MRx monitor/defibrillator are printed on the primary label on the back of the MRx in battery bay B)
ClassificationClass II
Reason for RecallThe MRx may deliver a non-synchronized cardioversion shock resulting in the delivery of incorrect therapy, which may induce ventricular fibrillation.
Product Quantity66,150 units
Recall NumberZ-1797-2013

Class II Drugs Event

Event ID65496
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAstellas Pharma US Inc
CityNorthbrook
StateIL
CountryUS
Distribution PatternNationwide and Canada
 

Associated Products

Product DescriptionAmBisome (amphotericin B) liposome for injection, 50mg vial, single use vial, For Intravenous Infusion Only, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc, San Dimas, CA 91773, NDC: 0469-3051-30.
Code InfoLot #: 042267AA, Exp July 2015, 042287AA, 042289AA, 042291AA, Exp Aug 2015. Lot Numbers and Expiry Dates (for Canada distribution). LOT 042269AA, EXP 07/2015, LOT 0422C1AA, EXP 11/2015.
ClassificationClass II
Reason for RecallLack of Assurance of Sterility; Astellas Pharma US, Inc. is performing a voluntary recall on certain lots of AmBisome because the manufacturer has notified Astellas that during a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in the media fills.
Product Quantity133,550 Vials
Recall NumberD-820-2013

Class II Devices Event

Event ID65504
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmEthicon Endo-Surgery Inc
CityCincinnati
StateOH
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) including states of: AK, AL, AR, AZ, CA, CO, CT, FL, GA, lA, ID, IL, IN, KS, KY, LA, MA, MD, ME, Ml, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, & WY and countries of: Canada, Argentina, Australia, Austria, Bahrain, Belgium, Brazil, Canada, Chile, China, Columbia, Czech Republic, Dominican Republic, Ecuador, Egypt, India, Indonesia, Israel, Italy, Jamaica, Japan, Korea, Kuwait, Libya, Malaysia, Mexico, Pakistan, Panama, Philippines, Poland, Puerto Rico, Russia, Singapore, Slovenia, South Africa, Spain, Saudi Arabia, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, & Venezuela.
 

Associated Products

Product DescriptionEndopath Electrosurgery Probe Plus II, twelve (12) different devices, including hooks, spatulas, right angles, curved dissectors, suction/irrigation devices, accessory ports, pool/sump devices and stone retrieval cannula, packaged and sterilized individually in a transparent flexible blister sealed to a Tyvek lid. 6 flexible packages are placed into a sales unit carton, with 4 cartons per corrugated shipper. The Endopath Electrosurgery Probe Plus II system has application in minimally invasive procedures to facilitate tissue dissection, coagulation, irrigation, and fluid evacuation through a common trocar sleeve.
Code InfoProduct Code: EPS01, Exp. Date: 2015 09 through 2018 03; Product Code: EPS02, Exp. Date: 2015 09 through 2018 03; Product Code: EPS03, Exp. Date: 2015 09 through 2018 03; Product Code: EPS04, Exp. Date: 2015 09 through 2018 03; Product Code: EPS05, Exp. Date: 2015 09 through 2018 03; Product Code: EPS06, Exp. Date: 2015 09 through 2018 03; Product Code: EPS07, Exp. Date: 2015 09 through 2018 03; Product Code: EPS08, Exp. Date: 2015 09 through 2018 03; Product Code: EPS10, Exp. Date: 2013 04 through 2018 03; Product Code: EPS11, Exp. Date: 2013 04 through 2018 03; Product Code: EPS12, Exp. Date: 2013 04 through 2018 03 & Product Code: EPS13, Exp. Date: 2013 04 through 2018 03.
ClassificationClass II
Reason for RecallThe firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in the Tyvek packaging may affect the sterility of the device.
Product Quantity327,648 instruments
Recall NumberZ-1772-2013

Class II Drugs Event

Event ID65541
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date22-Mar-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmWatson Laboratories, Inc.-(Actavis) - Florida
CityDavie
StateFL
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionDiclofenac Sodium and Misoprostol Delayed-Release Tablets, 75mg/0.2mg, 60-count bottle, Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60
Code InfoLot 635098A, Exp 10/14
ClassificationClass II
Reason for RecallFailed Tablet/Capsule Specifications: Broken tablets
Product Quantity392,400 tablets
Recall NumberD-817-2013

Class II Devices Event

Event ID65542
StatusCompleted
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-13
Initial Firm Notification of Consignee or Public Visit
Recalling FirmMyoscience Inc
CityRedwood City
StateCA
CountryUS
Distribution PatternUS distribution including CA and ID.
 

Associated Products

Product DescriptionMyoscience brand iovera Smart Tip, Myoscience Cryo-Touch IV, a Cryogenic Surgical device, REF Catalog Number: STA0311-10. Product Usage: The Myoscience Cryo-Touch IV (a.k.a. iovera) is used to destroy tissue during surgical procedures by applying freezing cold. It can also be used to produce lesions in peripheral nervous tissue by the application of cold to the selected site for the blocking of pain. The Cryo-Touch IV (a.k.a. iovera) is not indicated for treatment of central nervous system tissue.
Code InfoSerial Numbers: 100100, 100101, 100103
ClassificationClass II
Reason for RecallThe outer box label of the product was labeled with a down revision label which did not include the US labeling requirements, specifically the symbol descriptors and also the "Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician." This product was previously labeled for EU distribution only.
Product Quantity3 units
Recall NumberZ-1781-2013

Class II Drugs Event

Event ID65555
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmGilead Sciences, Inc.
CityFoster City
StateCA
CountryUS
Distribution PatternForeign distribution only to France, Italy, Switzerland, Portugal, Denmark,Turkey, Ireland, Norway, Malta, UK, Greece, Belgium, Austria, Germany, India, Hong Kong, Israel, Saudi Arabia, Thailand, UAE, Singapore, Ecuador, Oman, El Salvador, MCF Holland, MSF, France, Ethiopia, Egypt, Argentina, Chile, Brazil, Spain, Finland, Sweden.
 

Associated Products

Product DescriptionAmBisome (amphotericin B) liposome for Injection, 50 mg, For Intravenous Infusion Only, Single-Use Vial, Rx Only, Marketed by: Astellas Pharma US, Inc., Northbrook, IL 60062, Manufactured by: Gilead Sciences, Inc., San Dimas, CA 91773, NDC 0469-3051-30.
Code InfoLot #: 042262AD, 042262AD1, 042263AD, 042263AD1, 042264AD, 042265AD, 042265AD1, 042265AD2, Exp 06/2015; 42269AK, 042270AD, 042270AD1, 042270AD3, 042270AD4, 042273AD, Exp 07/2015 and 07/2016 (Germany only); 042285AD, Exp 08/2015 and 8/2016 (UK only); 042293AA, 042293AE, 042293AK, 042298AD, Exp 09/2015; 0422A6AD, Exp 10/15 (for Finland, Greece, Turkey) and Exp10/2016 (for Sweden, UK, Lebanon), 0422B0AD, Exp 10/2015 (for Turkey, Netherland, France), and Exp 10/2016 (for Poland), 0422B0AD1, Exp 10/2015, 0422C1AA, 042304AD, Exp 01/2016 (Spain), and Exp 01/2017 (for Germany, Switzerland), 042304AD1, 042311AD, Exp 01/2016, and Exp 01/2017 (France, UK).
ClassificationClass II
Reason for RecallLack of Sterility Assurance; During a routine simulation of the manufacturing of AmBisome, a bacterial contamination was detected in some media fill units. No contaminated batches have actually been identified in the finished product, but there is a possibility of contamination.
Product Quantity478,352 vials
Recall NumberD-821-2013

Class II Food Event

Event ID65557
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date21-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmPrice Chopper Golub Corperisable Warehouse
CitySchenectady
StateNY
CountryUS
Distribution PatternPrice Chopper stores in NY, NH, MA, VT, PA and CT.
 

Associated Products

Product DescriptionJacqueline's GOURMET COOKIES Almond Bursts COOKIES, Net Wt. 11 oz (8 units total) packed in clear plastic with white labeling----Shelf life is 12 months frozen and 7 days after baked.
Code InfoStore Item No: 3552153, UPC: 4173522011 Lot numbers: PB18353-12, PB19036-1, PB19036-2, PB19036-3, PB19036-4, PB19036-5, PB19036-6, PB17576-6, PB18257-10, PB18257-8, PB18777-1, PB18777-2, PB18777-3
ClassificationClass II
Reason for RecallUndeclared Milk allergen
Product Quantity103,032 cookies packed into 12,879 11 oz packages (10,368 cookies held in stock @ Jacqueline's Gourmet)
Recall NumberF-1747-2013
Product DescriptionJacqueline's GOURMET COOKIES Brownie Burst Cookies, Net Wt. 11 oz (8 units in total) packed in clear plastic with white labeling--Shelf life is 12 months frozen and 7 days after baked.
Code InfoStore Item No: 3552273, UPC: 4173522010 Lot numbers: PB18906-10, PB18906-11, PB18906-12, PB18906-9, PB18906-3, PB18906-4, PB18906-5, PB18906-6, PB18905-10, PB18905-11, PB18905-12, PB18905-2, PB18905-3, PB20908-5, PB20908-6
ClassificationClass II
Reason for RecallUndeclared Milk allergen
Product Quantity112,320 cookes packaged into 14,040 11 oz packages
Recall NumberF-1748-2013
Product DescriptionJacqueline's GOURMET COOKIES Raspberry Burst Cookies, Net Wt. 11 oz (8 units in total) packed in clear plastic with white labeling---Shelf life is 12 months frozen and 7 days after baked.
Code InfoStore Item Code: 3552393, UPC:4173522009 Lot Numbers: PB18363-4, PB18363-5, PB18363-6, PB18363-7, PB18363-8, PB18363-9, PB18363-15, PB18363-16, PB17833-3, PB18325-3, PB20781-3, PB20781-4, PB20781-5, PB20781-6
ClassificationClass II
Reason for RecallUndeclared Milk allergen
Product Quantity112, 536 cookies packaged into 14,067 11 oz packages
Recall NumberF-1749-2013

Class II Devices Event

Event ID65565
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date12-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhysio Control, Inc.
CityRedmond
StateWA
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) including states of: IL, MA, NC, ND, NY, PA, RI, TX, WA, and WI; and country of: Canada.
 

Associated Products

Product DescriptionThe LIFEPAK 500 Automated External Defibrillator is a semi-automatic defibrillator that uses a patented Shock Advisory System. This software algorithm analyzes the patient's electrocardiographic (ECG) rhythm and indicates whether or not it detects a shockable rhythm. The LIFEPAK 500 AED is intended for use by personnel who are authorized by a physician/medical director and is intended for use in the pre-hospital and workplace and community environments.
Code InfoPART NUMBERS: 3011790-001568, 3011790-001574, 3011790-001627, 3011790-001634, and 3011790-001650. SERIAL NUMBERS OUTSIDE the US: 41232265, 41232267, 41232269, 41232270, 41232271, 41232272, 41238207, 41238208, 41301145, 41301370, 41301371, 41301372, 41301373, and 41301374. SERIAL NUMBERS IN THE US: 41134905, 41134906, 41134907, 41135982, 41135983, 41135984, 41135991, 41135992, 41135993, 41135994, 41135995, 41135996, 41135997, 41135998, 41135999, 41136000, 41136001, 41136002, 41136003, 41136004, 41136005, 41136006, 41136007, 41136008, 41136009, 41136010, 41136011, 41136012, 41136013, 41136014, 41136015, 41136016, 41136017, 41136018, 41136019, 41136020, 41136021, 41136022, 41136023, 41136024, 41136025, 41136026, 41136027, 41136028, 41136029, 41136030, 41136031, 41136033, 41136034, 41136035, 41136036, 41136037, 41136038, 41136039, 41136040, 41136060, 41136061, 41136062, 41136063, 41136064, 41136065, 41136066, 41136067, 41136068, 41136069, 41136070, 41136071, 41136072, 41136073, 41136074, 41136075, 41136076, 41136077, 41136078, 41136079, 41136092, 41136093, 41136094, 41142873, 41145359, 41145360, 41145361, 41145362, 41145363, 41145364, 41145365, 41145366, 41145367, 41145368, 41145369, 41145370, 41145371, 41145372, 41145373, 41145374, 41145375, 41145376, 41145377, 41145378, 41164115, 41232002, 41232003, 41232004, 41232005, 41232249, 41232250, 41232251, 41232252, 41232253, 41232254, 41232255, 41232256, 41232257, 41232258, 41232259, 41232260, 41232554, 41239182, 41239183, 41239184, 41239185, 41239186, 41239187, 41239188, and 41239189.
ClassificationClass II
Reason for RecallThe LIFEPAK 500 Automated External Defibrillator (AED) could be susceptible to malfunction due to an assembly error. If affected, the malfunction would be the result of internal shorting on a printed circuit board assembly and could render the device inoperable.
Product Quantity139 total (125 units in the US and 14 units outside US)
Recall NumberZ-1773-2013

Class II Devices Event

Event ID65573
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-May-13
Initial Firm Notification of Consignee or Public Visit
Recalling FirmSteris Corporation
CityMentor
StateOH
CountryUS
Distribution PatternUSA Nationwide Distribution in the states of CO, KY, LA, VA, and WI. The affected product was also distributed to Canada.
 

Associated Products

Product DescriptionSTERIS Fine Traction Device, one unit per box Product Usage: The Fine Traction Device is used to provide traction and enable fine adjustments to traction and orientation of the leg during orthopedic procedures.
Code InfoThe following serial/lot numbers are affected by this recall: 0404913150, 0404913151, 0404913152, 0404913153, 0408713001, 0408713002, 0408713003, 0408713004, 0408713005, 0408713006, 0409813097, 0409813098, 0409813099, 0409813100, 0410113001, 0410113002, 0410713024, 0410713025, 0410713026, 0410713027, 0410713028, and 0410713029.
ClassificationClass II
Reason for RecallA bearing used in the assembly of the Fine Traction Device did not perform successfully in pre-release reliability testing; a replacement bushing passed reliability testing and was substituted per a change order. The change order authorized use of the substitute bushing in assembly of the Fine Traction Accessory; however, inadvertently the new part was not implemented. During complaint evaluation of a Fine Traction Device returned by a Customer it was determined that the original part, the bearing, was used in Fine Traction Devices distributed to Customers.
Product Quantity16 units
Recall NumberZ-1786-2013

Class II Devices Event

Event ID65600
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmMedtronic Neurosurgery
CityGoleta
StateCA
CountryUS
Distribution PatternNationwide Distribution in the US.
 

Associated Products

Product DescriptionMedtronic Preimplantation Test Kit, Catalog No. 21047. The kit is indicated for use with Medtronic CSF-Flow Control Valves and Delta Valves, when a simple preimplantation test is desired to verify that the valve conforms to labeled product specifications.
Code InfoC22929 C40543 C56465 C80034 D16291 C25329 C42910 C57924 C80787 D16693 C25475 C43115 C62128 D00052 D20967 C25662 C43512 C65929 D01033 D22544 C28396 C45615 C66120 D07250 D25802 C29229 C46351 C68906 D07373 D30597 C33946 C46583 C69701 D07507 C36893 C49439 C71003 D10462 C36904 C49706 C73622 D11409 C38718 C51418 C76639 D13208 C39484 C52417 C78186 D14099 C40150 C53058 C79051 D16157
ClassificationClass II
Reason for RecallMedtronic Neurosurgery is recalling the Medtronic Preimplantation Test Kit because the outer carton had expiration dates that were incorrect. The date on the outer carton is later than the expiration date for one or more of the individually packaged sterile components in the kit.
Product Quantity915 units
Recall NumberZ-1810-2013

Class II Devices Event

Event ID65604
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide Distribution.
 

Associated Products

Product DescriptionAxiom Aristos MX Solid State Flat Panel Digital Imager, Model number 5895003. The device is used for diagnostic X-ray imaging.
Code InfoModel Number 5895003 with serial numbers 1052 through 2500.
ClassificationClass II
Reason for RecallSiemens issued a Field Safety Notice about the potential hazard to patients or operators when using the function "table top float" of the AXIOM Aristos MX. When repositioning a patient lying on the table top and releasing the table top, it is possible that the fingers of the patient or operator are between the table top and the detector tray and if the table top is moved, the fingers can be squeezed.
Product Quantity401
Recall NumberZ-1795-2013

Class II Devices Event

Event ID65614
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date06-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmBecton Dickinson & Co.
CitySparks
StateMD
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) and countries of:Belgium, Canada, Columbia, Mexico, Singapore, and Taiwan.
 

Associated Products

Product DescriptionBD BBL Vancomycin Screen Agar, carton of 10 plates, catalog # 222204, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
Code InfoLot 3081136 Exp June 18, 2013 Lot 3073114 Exp June 12, 2013
ClassificationClass II
Reason for RecallMicrobiological identification media may exhibit reduced levels of Vancomycin.
Product Quantity911 cartons
Recall NumberZ-1798-2013
Product DescriptionBD BBL Schaedler K-V Agar with 5% Sheep Blood, carton of 20 plates, catalog # 221555, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Vancomycin Screen Agar is used to test entercocci for resistance to vancomycin and to predict the synergistic activity of this antimicrobial with an aminoglycoside antimicrobial.
Code InfoLot 3078263 Exp 5/16/13
ClassificationClass II
Reason for RecallMicrobiological identification media may exhibit reduced levels of Vancomycin.
Product Quantity92 cartons
Recall NumberZ-1799-2013
Product DescriptionBD BBL CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin (KV), packaged in cartons of 100 plates, Catalog # 221736, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** CDC Anaerobe 5% Sheep Blood Agar with Kanamycin and Vancomycin is used for the selective isolation of fastidious and slow-growing, obligately anaerobic gram-negative bacteria from a variety of clinical and nonclinical materials.
Code InfoLot 3080083 Exp 6/4/13 Lot 3073075 Exp 5/29/13
ClassificationClass II
Reason for RecallMicrobiological identification media may exhibit reduced levels of Vancomycin.
Product Quantity45 cartons
Recall NumberZ-1800-2013
Product DescriptionBD BBL Anaerobe CNA Agar with 5% Sheep Blood // Anaerobe Laked Sheep Blood KV Agar, packaged in cartons of 20 plates, Catalog # 297041, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Anaerobe Laked Sheep Blood KV Agar is used in a qualitative procedure for isolation of gram-negative anaerobic bacilli.
Code InfoLot 3080366 Exp 5/31/13 Lot 3071134 Exp 5/28/13 Lot 3081061 Exp 6/4/13
ClassificationClass II
Reason for RecallMicrobiological identification media may exhibit reduced levels of Vancomycin.
Product Quantity106 cartons
Recall NumberZ-1801-2013
Product DescriptionBD BBL BBE // CDC Anaerobe Laked Sheep Blood Agar with KV, packaged in cartons of 100 plates, Catalog # 297260, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Bacteroides Bile Esculin Agar (BBE) is recommended as a primary isolation medium for the selection and presumptive identification of the B. fragilis group.
Code InfoLot 3071112 Exp 5/28/13
ClassificationClass II
Reason for RecallMicrobiological identification media may exhibit reduced levels of Vancomycin.
Product Quantity42 cartons
Recall NumberZ-1802-2013
Product DescriptionBBL Brucella Laked Blood Agar with Kanamycin and Vancomycin (KV), Catalog # 297840, packaged in cartons of 20 plates, labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** Brucella Laked Blood with KV is used for the selective isolation of fastidious and slow growing, obligately anaerobic bacteria from the same specimen.
Code InfoLot 3078280 Exp 6/27/13
ClassificationClass II
Reason for RecallMicrobiological identification media may exhibit reduced levels of Vancomycin.
Product Quantity92 cartons
Recall NumberZ-1803-2013
Product DescriptionBD BBL BCYE Selective Agar with PAV, Catalog # 297880, packaged in cartons of 10 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.
Code InfoLot 3078348 Exp 6/27/13
ClassificationClass II
Reason for RecallMicrobiological identification media may exhibit reduced levels of Vancomycin.
Product Quantity163 cartons
Recall NumberZ-1804-2013
Product DescriptionBBL Campylobacter CSM Agar (Charcoal-Based Selective Medium), Catalog # 299614, packaged in cartons of 20 plates, and labeled in part ***Becton, Dickinson and Company 7 Loveton Circle Sparks, MD 21152 USA 800-638-8663 www.bd.com/ds*** BCYE Selective with PAV is used in qualitative procedures for isolation of Legionella species from clinical specimen and nonclinical (environmental) samples. It is similar to the Edelstein formula, except that the concentration of polymyxin B is reduced by half, and vancomycin is substituted for cefamandole.
Code InfoLot 3078430 Exp 5/30/13
ClassificationClass II
Reason for RecallMicrobiological identification media may exhibit reduced levels of Vancomycin.
Product Quantity293 cartons
Recall NumberZ-1805-2013

Class II Drugs Event

Event ID65621
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Dec-12
Initial Firm Notification of Consignee or Public Visit
Recalling FirmOklahoma Respiratory Care Inc
CityNorman
StateOK
CountryUS
Distribution PatternOklahoma
 

Associated Products

Product DescriptionOxygen, Compressed USP UN1072 Medical Gas supplied in a) 682 litres and b)165 litres cylinders, Rx only, Oklahoma Respiratory Care 800.262.9857, Norman, OK 73071
Code InfoLot numbers: 03141201, 03211201, 05021201, 06271201, and 11081201.
ClassificationClass II
Reason for RecallFailed impurities/degradation specifications: Purity readings for oxygen were out of specification.
Product Quantity94 cylinders
Recall NumberD-818-2013

Class II Devices Event

Event ID65622
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPhilips Healthcare Inc.
CityAndover
StateMA
CountryUS
Distribution PatternUSA Nationwide Distribution
 

Associated Products

Product DescriptionRadiohead Access Point 1.4 GHz Radiohead Access Point Firmware versions: C.00.04 & C.00.05 Part Number: 989803171211 Product Usage: IntelliVue Smart-hopping 1.4 GHz Access Point provides wireless connectivity between IntelliVue devices (listed below) and the Philips IntelliVue Information Center. MX40 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. Intended for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults and pediatrics in hospital environments and during transport inside hospitals. The MX4O is to be used primarily as a traditional telemetry medical device. It connects to the IntelliVue Information Center by way of a wireless network.
Code InfoSerial numbers ranging from: US12700465 to US20823366
ClassificationClass II
Reason for RecallIntelliVue Smart-hopping 1.4 GHz Access Point may experience unexpected signal loss of several minutes impacting wireless connectivity
Product Quantity20105 units
Recall NumberZ-1780-2013

Class II Devices Event

Event ID65630
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date07-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmDel Mar Reynolds Medical, Ltd.
CityHertford
State
CountryGB
Distribution PatternWorldwide Distribution - USA including South Carolina and internationally to Canada and Great Britian.
 

Associated Products

Product DescriptionSpacelabs ARKON Anesthesia Workstation. Spacelabs ARKON Anesthesia Workstation may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer.
Code InfoARKN-000001, ARKN-000005, ARKN-000010, ARKN-000015, ARKN-000016, ARKN-000017, ARKN-000018, ARKN-000020, ARKN-000021.
ClassificationClass II
Reason for RecallSpacelabs ARKON Anesthesia System is recalled due to software defect. The System Status Computer may incorrectly determine that a communication error has occurred. If this situation occurs, a buzzer will activate and a yellow triangle will be displayed on the System Status Computer screen that alerts the user of this error.
Product Quantity9 units (4 in the US and 5 outside US)
Recall NumberZ-1771-2013

Class II Devices Event

Event ID65635
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date20-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHaemonetics Corporation
CityBraintree
StateMA
CountryUS
Distribution PatternUS Nationwide
 

Associated Products

Product DescriptionTEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In Vitro Coagulation Studies
Code InfoPer recall strategy.
ClassificationClass II
Reason for RecallResearch Use Only (RUO) parameters were included in TEG 5000 User Manual.
Product Quantity1590 devices
Recall NumberZ-1796-2013

Class II Food Event

Event ID65640
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date03-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNOW Foods
CityBloomingdale
StateIL
CountryUS
Distribution PatternUS: Nationwide; Foreign: United Kingdom
 

Associated Products

Product DescriptionWhite plastic bottle with blue cap containing 90 capsules; Ashwagandha Extract; 450 mg; CODE 4603; Manufactured by NOW FOODS; 395 S. Glen Ellyn Rd., Bloomingdale, IL 60108, USA
Code InfoUPC: 7 33739 04603 1; Product Code: 4603; Lot: 1599135; Best By: May 2015
ClassificationClass II
Reason for RecallIt has been determined that this product contains an undeclared ingredient, licorice extract, which contains glycyrrhizin derived from licorice root.
Product Quantity2,571 bottles
Recall NumberF-1726-2013

Class II Devices Event

Event ID65651
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmSiemens Medical Solutions USA, Inc
CityMalvern
StatePA
CountryUS
Distribution PatternNationwide Distribution and Puerto Rico
 

Associated Products

Product DescriptionARTIS zee and zeego x-ray, angiographic system with Software Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. Angiographic x-ray system
Code InfoModel numbers: 10094137, 10094139, 10094141, 10280959
ClassificationClass II
Reason for RecallSiemens issued a customer safety advisory notice and field safety corrective action for a potential issue on Artis systems with Artis VC20x/VC21A that have Patch 7 and a 3D and DSA license installed. The issue affects-DSA rotational acquisition. The restriction is related to any rotational 3D-acquisition program with real-time subtraction (e.g. 3D DSA). During the fill phase of the rotational aquisition, the subtraction is not correctly displayed on the live monitor in the control room. As subtracted images are not displayed correctly, this may lead the user to abort or redo the 3D protocol, potentially resulting in the application of an additional dose or contrast agent. 3D data are saved however, and available on the system.
Product Quantity29
Recall NumberZ-1782-2013

Class II Devices Event

Event ID65654
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmStryker Neurovascular
CityFremont
StateCA
CountryUS
Distribution PatternInternational Distribution including Austria, China, and Germany.
 

Associated Products

Product DescriptionStryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, CA and distributed by Stryker Neurovascular, Fremont, CA The Neuroform Microdelivery Stent System is intended for use with embolic coils for the treatment of wide neck, intracranial, saccular aneurysms arising from a parent vessel with a diameter of greater than equal to 2 mm and greater than equal to 4.5 mm that are not amenable to treatment with surgical clipping.
Code InfoCode: M003450200, Lot 15391019, Expiration Date: 2015-07
ClassificationClass II
Reason for RecallThe device is labeled incorrectly, in that, the device Model Number on the outer carton and inner pouch labels did not match, although both referenced the same lot number. The Model Number on the outer box states UPN M003E345020 (4.5mm x 20 mm Neuroform 3 Stent) while the pouch label states UPN M003E3450300 (4.5mm x 30 mm Neuroform 3 Stent).
Product Quantity23 units
Recall NumberZ-1808-2013

Class II Devices Event

Event ID65679
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date10-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPemco Inc
CityIndependence
StateOH
CountryUS
Distribution PatternWorldwide Distribution - USA including AL, CA, CT, FL, GA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, NJ, NM, NV, OK, PA, TN, TX, UT, VA & WA. Internationally to Czech Republic, Italy, Japan, Korea & Singapore.
 

Associated Products

Product DescriptionRultract Retractor Ratchet Cover Plate Distributed by Pemco, Inc., Cleveland, OH 44131 Surgical retractor used to lift the incision site
Code InfoM/N 4100-IMR-6: S/N's: 4829-4839, 4845-4851, 4857-4871, 4874-4884, 4894-4908 & 4916-4923; M/N 4100-IMR-41: S/N's: 4840-4844, 4852-4856, 4888-4893, 4913-4915 & 4926-4927.
ClassificationClass II
Reason for RecallThe firm became aware of the problem when a ratchet cover plate on a device was returned for repair showed signs of corrosion.
Product Quantity87 units
Recall NumberZ-1783-2013

Class II Devices Event

Event ID65686
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date11-Jun-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmChurch & Dwight Inc
CityPrinceton
StateNJ
CountryUS
Distribution PatternNationwide Distribution including IL, PA, IN, OH, MI, TN, TX, MN, MO, NJ, KY,and MD.
 

Associated Products

Product DescriptionSodium Bicarbonate, USP Provided bulk as raw material - label not applicable according to firm Dialysis Grade 1.5 Dialysis Grade 2 As an API or excipient in the manufacture of Medical Devices and Drugs
Code InfoLots and sizes- 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015437 SBC DIALYSIS 1.5 GRADE 2500 LB SACK 20015443 SBC DIALYSIS 2 GRADE 50 LB BAG
ClassificationClass II
Reason for RecallChurch and Dwight Co., Inc. has initiated a recall for Sodium Bicarbonate, USP produced by the Old Fort, OH Sodium Bicarbonate Production facility due to metal and other contamination.
Product Quantity234 sacks at 2500 lbs. each of Dialysis Grade 1.5 ; 880 bags at 50 lbs. each of Dialysis Grade 2
Recall NumberZ-1811-2013

Class II Devices Event

Event ID65688
StatusTerminated
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Mar-12
Initial Firm Notification of Consignee or Public Letter
Recalling FirmTopcon Medical Laser Systems, Inc
CitySanta Clara
StateCA
CountryUS
Distribution PatternWorldwide Distribution-USA and the countries of China, Hong Kong, Brazil, France, Japan, Netherlands, Pakistan, Malaysia, United Kingdom, South Korea, Thailand, Dubai, and South Africa.
 

Associated Products

Product DescriptionPASCAL and PASCAL Streamline (532 nm.577 nm); Treats the patient's eye.
Code InfoPASCAL Standard 2R/G System v2.x.x and PASCAL Streamline 2R/G Software v2.x.x Serial numbers: United States 33057910 33060410 33063610 66078611 66084911 66085111 66085511 Out of United States OMC-179 11138509 11141209 11147209 11147809 11148910 11149010 11149210 11149710 . 11149810 11150110 11150210 11150410 11150610 11150810 11150910 11151010 1 151110 11151211 33054310 33059310 33059510 33062810" 66075211' 66076711 66077111 66078011 66079911 6608391'1 66084611 66084811 66085011 66085211
ClassificationClass II
Reason for RecallWhen using the "Favorites" function for saved settings, there is potential for a mismatch between displayed power and the actual power output. This may result in over or under treatment.
Product Quantity7 US, 33 foreign
Recall NumberZ-1774-2013

Class II Devices Event

Event ID65703
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jun-13
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmAesculap, Inc.
CityCenter Valley
StatePA
CountryUS
Distribution PatternUS Distribution including the states of NV and MI
 

Associated Products

Product DescriptionProSpace Peek Implant 5 degree x 8.5 x 22 mm The device is intended for vertebral body replacement or intervertebral body fusion to aid in the surgical correction or stabilization of the spine. The Aesculap PEEK Spinal Implant System is indicated for use in the thoracolumbar spine (T1 to L5) for partial or total replacement of a collapsed, damaged, or unstable vertebral body due to tumor or trauma to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.
Code InfoPart no. SN038P, batch number 51915765
ClassificationClass II
Reason for RecallAesculap Implant Systems, LLC initiated a recall of the Aesculap Prospace PEEK 5 degree Implant - 8 x 8.5 x 22 mm (SN038P) because the device is incorrectly etched with an 8 degree lordosis instead of a 5 degree lordosis. The device is labeled correctly, only the etching of the implant may be incorrect.
Product Quantity9
Recall NumberZ-1806-2013

Class II Drugs Event

Event ID65731
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmHospira Inc.
CityLake Forest
StateIL
CountryUS
Distribution PatternNationwide and Guam
 

Associated Products

Product DescriptionSodium Chloride Injection, USP, 0.9%, 20 mL Single-dose Fliptop Plastic Vial, packaged in 25 vial Units per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-4888-20.
Code InfoLot #: 15-058-DK*, Exp 1MAR2014; note the * may be followed by 01
ClassificationClass II
Reason for RecallPresence of Particulate Matter: Confirmed customer report of visible particulate in the form of an orange or rust colored ring embedded in between the plastic layers of the plastic vial.
Product Quantity268,700 vials
Recall NumberD-813-2013

Class III Biologics Event

Event ID39071
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date15-May-07
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 (Apheresis)
Code Info2302264(Part A), 2302264(Part B)
ClassificationClass III
Reason for RecallBlood products, for which RBC volume QC. failed, were distributed.
Product Quantity2 units
Recall NumberB-1368-13

Class III Biologics Event

Event ID44361
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date02-Feb-07
Initial Firm Notification of Consignee or Public FAX
Recalling FirmONEBLOOD, Inc.
CitySt Petersburg
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells
Code Info7971994
ClassificationClass III
Reason for RecallBlood product, collected from a deferred donor who was improperly re-entered, was distributed.
Product Quantity1
Recall NumberB-1969-13

Class III Biologics Event

Event ID49911
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date26-Aug-08
Initial Firm Notification of Consignee or Public FAX
Recalling FirmFlorida Blood Services, Inc.
CitySt Petersburg
StateFL
CountryUS
Distribution PatternFlorida
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info W03940851263400
ClassificationClass III
Reason for RecallBlood product, collected from a donor, whose suitability to donate was not adequately determined, was distributed.
Product Quantity1
Recall NumberB-1707-13

Class III Biologics Event

Event ID54959
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-Feb-10
Initial Firm Notification of Consignee or Public E-Mail
Recalling FirmCSL Plasma, Inc.
CityFort Worth
StateTX
CountryUS
Distribution PatternIL, Germany, Switzerland
 

Associated Products

Product DescriptionSource Plasma
Code Info4190070246;4190069532;4190069192;4190027129;4190026840;4190026121;4190025997;4190025272;4190024519;4190024119;4190023368;4190023222;4190017364;4190016544;4190016270;4190015917;4190015709;4190015318;4190015102;4190014641;4190014263;4190014099;4190013711;4190013478;4190013121;4190012934;4190012550;4190012358;4190081815;4190080585;4190080216;4190079168;4190078417;4190077735;4190077089;4190076142;4190075613;4190074971;4190074511;4190073983;4190072666;4190072341;4190071308;4190069854;4190069408;4190068507;4190068082;4190067326;4190066902;4190066244;4190065743;4190064942;4190064667;4190063980;4190063661;4190062560;4190062010;4190061360;4190060923;4190060380;4190059961;4190059491;4190059058;4190058581;4190058157;4190057508;4190057160;4190056551;4190056074;4190055667;4190055221;4190054530;4190053927;4190053665;4190052787;4190052555
ClassificationClass III
Reason for RecallBlood products, collected from donors who were permanently deferred, were distributed.
Product Quantity76 units
Recall NumberB-1560-13

Class III Biologics Event

Event ID59414
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date05-Jul-11
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources, Inc.
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info3960123216; 39601223330 ; 3960121814; 3960121011; 3960120309; 3960119657; 3960118638; 3960118139; 3960117309; 3960116824; 3960116024; 3960115424; 3960114675; 3960114100; 3960113325; 3960112818; 3960111726; 3960111298; 3960110490; 3960110001; 3960109024; 3960108623 3960107840 ; 3960107405 3960106731; 3960106364; 3960105290; 3960104517; 3960103998 3960102975;3960102538;3960101812;3960101424;3960100773;3960100260;3960098952;3960098445;3960097648;3960097126;3960096356;3960095962;3960095108;3960094706;3960093927;3960093398;3960092616;3960092134;3960091377;3960090872;3960090173;3960089676;3960088833;3960088441;3960087651;3960087225;3960080644;3960080277;3960079574;3960079152;3960078711;3960078203;3960077670;3960077255;3960076712;3960076267;3960075531;3960075322;3960074558;3960074350;3960073705;3960073499;3960066335;3960065987
ClassificationClass III
Reason for RecallBlood products, collected from donors whose suitability to donate were not adequately determined, were distributed.
Product Quantity73 units
Recall NumberB-1561-13

Class III Biologics Event

Event ID65103
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date28-Mar-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmTalecris Plasma Resources Inc
CityResearch Triangle Park
StateNC
CountryUS
Distribution PatternNorth Carolina
 

Associated Products

Product DescriptionSource Plasma
Code Info3790262030; 3790281497; 3790260795; 3790260536; 3790260073; 3790259619; 3790259388; 3790258872; 3790258627; 3790257457; 3790256939; 3790258833; 3790256107; 3790255821; 3790255343; 3790255075; 3790254093; 3790253834; 3790253273; 3790252998; 3790252179; 3790251046; 3790250913; 3790250293; 3790249853; 3790249353; 3790248961; 3790248519; 3790248074; 3790247204; 3790248896; 3790248294; 3790245959; 3790245385; 3790245071; 3790244522; 3790244236; 3790243660; 3790262852;
ClassificationClass III
Reason for RecallBlood products, collected from donors, whose suitability to donate was not adequately determined, were distributed.
Product Quantity39
Recall NumberB-1857-13

Class III Biologics Event

Event ID65197
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date23-Apr-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmMississippi Blood Services Inc.
CityFlowood
StateMS
CountryUS
Distribution PatternTennessee
 

Associated Products

Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW069111115072
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity1 unit
Recall NumberB-1998-13

Class III Biologics Event

Event ID65231
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date01-May-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmCommunity Blood Center
CityDayton
StateOH
CountryUS
Distribution PatternIndiana
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW035413009699
ClassificationClass III
Reason for RecallBlood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob Disease (vCJD), was distributed.
Product Quantity1 unit
Recall NumberB-2001-13

Class III Drugs Event

Event ID65244
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date30-May-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmPharmalucence, Inc.
CityBillerica
StateMA
CountryUS
Distribution PatternNationwide & Bahamas, Barbados, Bermuda, Japan
 

Associated Products

Product DescriptionPharmalucence Kit for the Preparation of Technetium Tc 99m Sestamibi Injection for Mycardial and Breast Imaging. For Intravenous Use and Reconstitution. a) Five vials kits: NDC# 45567-0555-1, b) Thirty vials kits: NDC# 45567-0555-2, Rx Only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821
Code InfoLot 280011, Exp 08/13
ClassificationClass III
Reason for RecallPresence of Particulates; particulate found in retain sample
Product Quantity17,260 vials
Recall NumberD-808-2013

Class III Devices Event

Event ID65488
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date09-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNational Biological Corp
CityBeachwood
StateOH
CountryUS
Distribution PatternWorldwide distribution: US (nationwide) including states of: AL, CA, CO, CT, FL, GA, IA, ID, IL, LA, MA, MN, MO, MS, NE, NJ, NY, OH, PA, SC, TN, TX, VA, WA, and WI; and countries of: Canada, Brazil, Malaysia, and Mexico.
 

Associated Products

Product DescriptionDermalight 80 Model Number UVB-080, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
Code InfoThe following batch numbers and serial numbers are affected by this recall: Batches 7839 and 7951, Serial numbers D80-12748 to D80-12871.
ClassificationClass III
Reason for RecallThe incorrect manual may have been packaged with this product. UVB-080 devices may have included the manual for a UVA-083 device.
Product Quantity124 units
Recall NumberZ-1778-2013

Class III Devices Event

Event ID65494
StatusOngoing
Product TypeDevices
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date08-Apr-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmNational Biological Corp
CityBeachwood
StateOH
CountryUS
Distribution PatternUS distribution including the states of: AL, CA, MN, and NC.
 

Associated Products

Product DescriptionDermalight 80 Model Number UVB-083, one unit per box. The Dermalight 80 is a Phototherapy light unit that provides ultraviolet radiation therapy for diagnosed skin disorders such as Psoriasis and Vitiligo.
Code InfoThe following batch and serial numbers are affected by the recall: Batch 007778, Serial numbers D83-30016 to D83-30021.
ClassificationClass III
Reason for RecallThe incorrect manual may have been packaged with this product. UVB-083 devices may have included the manual for a UVA-080 device.
Product Quantity6 units
Recall NumberZ-1779-2013

Class III Drugs Event

Event ID65629
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jun-13
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recalling FirmMax Huber Research Labs, Inc.
CityNew York
StateNY
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionLA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade LIGHT 02, UPC 7 47930 00481 3, MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
Code Infoall lots currently in the market shipped before June 2013
ClassificationClass III
Reason for RecallSubpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Product Quantity49,845 tubes (total for all products)
Recall NumberD-814-2013
Product DescriptionLA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade MEDIUM 03, UPC 7 47930 00482 0 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
Code Infoall lots currently in the market shipped before June 2013
ClassificationClass III
Reason for RecallSubpotent Drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Product Quantity49,845 tubes (total for all products)
Recall NumberD-815-2013
Product DescriptionLA MER the spf 18 fluid tint , broad spectrum spf 18, 1.7 fl.oz. liq./50 ml, Shade DARK 04, UPC 7 47930 00483 7 --- MAX HUBER RESEARCH LABS INC., DIST. NEW YORK, N.Y. 10022 -- MADE IN BELGIUM
Code Infoall lots currently in the market shipped before June 2013
ClassificationClass III
Reason for RecallSubpotent drug: Avobenzone 3%, one of the active sunscreen ingredients may be subpotent and sunscreen effectiveness may be less than labeled
Product Quantity49,845 tubes (total for all products)
Recall NumberD-816-2013

Class III Food Event

Event ID65656
StatusOngoing
Product TypeFood
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date27-Jun-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmC Pacific Food
CityNorwalk
StateCA
CountryUS
Distribution PatternTX
 

Associated Products

Product DescriptionCanned Mushroom Sliced 6 cans, 53oz
Code InfoCarton Code: CONF#4402 Can Code: PRO.03/30/2013 EXP.03/30/2013 3502/01080 805 1 PRO.03/39/2013 EXP.03/29/2016 3502/01080 388 Bar Code: 076215131037
ClassificationClass III
Reason for RecallC. Pacific Foods is recalling canned mushroom sliced because it contains pesticide levels that are not approved for canned mushroom.
Product Quantity159 cartons (954 units)
Recall NumberF-1750-2013

Class III Drugs Event

Event ID65747
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmWatson Laboratories Inc
CityCorona
StateCA
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionOxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bottle (NDC 0591-0737-05), Rx only, Manufactured by Watson Laboratories, Inc., Corona, CA92880.
Code InfoLot # a) 444971A, Exp 8/13; b) 444973A, Exp 8/13
ClassificationClass III
Reason for RecallSubpotent drug: Two lots of Oxycodone and Acetaminophen Capsules, USP 5/500 mg are being recalled due to low out of specification (OOS) assay result obtained at expiry (24 months) for the oxycodone portion of the product.
Product Quantity1,260 bottles
Recall NumberD-823-2013

Class III Drugs Event

Event ID65761
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date18-Jul-13
Initial Firm Notification of Consignee or Public Letter
Recalling FirmVi-Jon, Inc.
CitySmyrna
StateTN
CountryUS
Distribution PatternNationwide
 

Associated Products

Product DescriptionALCOHOL FREE ANTISEPTIC (cetylpyridinium chloride) Mouth Rinse, 0.07%, mint, 33.8 FL OZ (1 L) bottle, Distributed By The Kroger Co., Cincinnati, OH 45202, UPC 0 41260 33606 5.
Code InfoLot #: 0185828, Exp 12/14
ClassificationClass III
Reason for RecallMicrobial Contamination of Non-Sterile Products: This product is being recalled because a stability sample was found to be contaminated with Burkholderia contaminans.
Product Quantity18,408 bottles
Recall NumberD-812-2013

Mixed Classification Drugs Event

Event ID64640
StatusOngoing
Product TypeDrugs
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date14-Mar-13
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmMed Prep Consulting, Inc.
CityTinton Falls
StateNJ
CountryUS
Distribution PatternPress States Nationwide. Distribution List indicates the following: DE, FL, IL, IN, ME, MI, NJ, PA, TX, and VA
 

Associated Products

Product DescriptionMagnesium Sulfate 2 grams in Dextrose 5% for Injection, in 50 mL Plastic Infusion Bags, Med Prep Consulting Inc., Tinton Falls, NJ 07712
Code InfoAll lots
ClassificationClass I
Reason for RecallNon-Sterility; mold contamination
Product Quantity403883 bags
Recall NumberD-810-2013
Product DescriptionAll Compounded Products, packaged in plastic infusion bags, devices, syringes and glass vials, Med Prep Consulting Inc., Tinton Falls, NJ 07712
Code InfoAll lots
ClassificationClass II
Reason for RecallLack of Assurance of Sterility; potential for mold contamination
Product Quantity
Recall NumberD-811-2013

Mixed Classification Biologics Event

Event ID45171
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date24-Aug-07
Initial Firm Notification of Consignee or Public Letter
Recalling FirmAmerican National Red Cross (The)
CityTucson
StateAZ
CountryUS
Distribution PatternArizona, California
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info007FC25436
ClassificationClass III
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1812-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info007FC25436
ClassificationClass II
Reason for RecallBlood products, collected from a donor in whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1813-13

Mixed Classification Biologics Event

Event ID46557
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date19-Nov-07
Initial Firm Notification of Consignee or Public Telephone
Recalling FirmAmerican National Red Cross (The)
CityPomona
StateCA
CountryUS
Distribution PatternCalifornia
 

Associated Products

Product DescriptionBlood and Blood Products for Reprocessing
Code Info06GG78505;06GV43156
ClassificationClass III
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1820-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code Info06GG78505;06GV43156
ClassificationClass II
Reason for RecallBlood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1821-13

Mixed Classification Biologics Event

Event ID65055
StatusTerminated
Product TypeBiologics
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date04-Jan-13
Initial Firm Notification of Consignee or Public FAX
Recalling FirmHCSC-Blood Center
CityBethlehem
StatePA
CountryUS
Distribution PatternPennsylvania; Korea,
 

Associated Products

Product DescriptionRed Blood Cells (Apheresis)
Code InfoW050912005453;
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1814-13
Product DescriptionFresh Frozen Plasma (Apheresis)
Code InfoW050912005453;
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1815-13
Product DescriptionRed Blood Cells Irradiated
Code InfoW050912008713;
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity1
Recall NumberB-1816-13
Product DescriptionRed Blood Cells
Code Info W050912002027; W050912009851;
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity2 units
Recall NumberB-1817-13
Product DescriptionRed Blood Cells Leukocytes Reduced
Code InfoW050912009111; W050912000741;
ClassificationClass II
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity2
Recall NumberB-1818-13
Product DescriptionBlood and Blood Products for Reprocessing
Code InfoW050912009111; W050912002027; W05091009851; W050912000741;
ClassificationClass III
Reason for RecallBlood products, collected from donors for whom donor suitability was not adequately determined, were distributed.
Product Quantity4
Recall NumberB-1819-13
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