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U.S. Department of Health and Human Services

Enforcement Report - Week of January 8, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices The Centricity Laboratory System is intended to be an information system designed to support the clinical and administrative activities associated with the provision and utilization of clinical laboratory services and facilities, e.g., the storing and delivering of analytical results. It is a specially designed data program application (software), which is supplied for installation in existing mainframe or decentralized computers or a computer network. This software system will not be the software directly used to run, steer, or control any specific laboratory analyzer or equipment. It is intended for use in laboratory facilities, including a central laboratory or in a multiple laboratory environment servicing satellite laboratories, reference laboratories, clinics, etc. Centricity Laboratory System is not intended for direct patient contact. The Centricity Laboratory System product is designed to facilitate the general clinical, anatomic pathology and cytology laboratory workflow such as order entry, results entry, instrument interfacing, results reporting and patient record retrieval. It integrates with other Hospital Information Systems (HIS) through HL7 interface by order entering and also report processing. The Centricity Laboratory System is intended to interface with various lab results. Centricity Laboratory System is intended to be used by laboratory technologists, technicians, analyst and other trained/site authorized system users Software Versions: 3.3, 4.0, 4.1 Class II GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instrument Interface (IF) where free-text sent from IM is not being transcribed into free-text in iNET. The instrument may upload results to IF/iNET when order/request is not yet in IF/iNET. In such a situation, test level supporting free-text sent from the instrument is discarded (not captured). GE Healthcare It
Devices Synthes Hand Switch - Electric Pen Drive, Part Number 05.001.012 The Synthes Electric Pen Drive is indicated for screw insertion, pin and wire replacement, cutting of bone and metal, drilling, decorticating, shaping, and smoothing of bones and teeth in a wide variety of surgical procedures, including, but not limited to general orthopaedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngolical, reconstructive, and spine surgery. Part Number 05.001.012, lot number AV18166 Class II Synthes received a complaint from a customer in which the Hand Switch for the Electric Pen Drive was not labeled correctly. The "on" and "lock" labels were interchanged. Synthes USA HQ, Inc.
Food The refrigerated vacuum packed hot smoked oysters, Original flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part "***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***". Pull Dates of AUG 1 2013 to OCT 6 2013 Class II T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Original flavor, is recalled due to the potential contamination with Clostridium botulinum. T And S Oyster Farm
Food The refrigerated vacuum packed hot smoked oysters, Garlic Pepper flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part "***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***". Sticker is placed on the package to identify the "GARLIC PEPPER" flavor. Pull Dates of AUG 1 2013 to OCT 6 2013 Class II T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Garlic Pepper flavor, is recalled due to the potential contamination with Clostridium botulinum. T And S Oyster Farm
Food The refrigerated vacuum packed hot smoked oysters, Teriyaki flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part "***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***". Sticker is placed on the package to identify the "TERIYAKI" flavor. Pull Dates of AUG 1 2013 to OCT 6 2013 Class II T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Teriyaki flavor, is recalled due to the potential contamination with Clostridium botulinum. T And S Oyster Farm
Food The refrigerated vacuum packed hot smoked oysters, Habanero flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part "***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***". Sticker is placed on the package to identify the "HABANERO" flavor. Pull Dates of AUG 1 2013 to OCT 6 2013 Class II T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Habanero flavor, is recalled due to the potential contamination with Clostridium botulinum. T And S Oyster Farm
Food The refrigerated vacuum packed hot smoked oysters, Lemon Pepper flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part "***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***". Sticker is placed on the package to identify the "LEMON PEPPER" flavor. Pull Dates of AUG 1 2013 to OCT 6 2013 Class II T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Lemon Pepper flavor, is recalled due to the potential contamination with Clostridium botulinum. T And S Oyster Farm
Food The refrigerated vacuum packed hot smoked oysters, Peppered flavor, is sold in 2.5 oz. or 4 oz. packages. There is no UPC for this product. The product main label is read in part "***T&S OYSTER FARM NETARTS BAY***SMOKED OYSTERS***NET Net Weight 4 oz (113g) ***PERISHABLE KEEP REFRIGERATED AT OR BELOW 38***Cert. # OR-179-SP 703 Ivy st. Tillamook OR 97141***". Sticker is placed on the package to identify the "PEPPERED" flavor. Pull Dates of AUG 1 2013 to OCT 6 2013 Class II T & S Oyster Farms brand refrigerated vacuum packed hot smoked oysters, Peppered flavor, is recalled due to the potential contamination with Clostridium botulinum. T And S Oyster Farm
Food Nature Science Dym-Sdrol capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Super Drol capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Super DMZ capsules packaged in plastic bottle with 60 capsules per bottle and packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Energize capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Equibolix capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science ADT capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science M1 capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Formex capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Estro Fuze capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Alpha Male capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Bolasterol capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Cyanostane capsules, packed in plastic bottles with 60 capsules per bottle and packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science E-Control capsules packed in plastic bottles with 60 capsules per bottle and packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Decadrol capsules packed in plastic bottles with 90 capsules per bottle and packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Halostane capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Halo capsules packed in plastic bottles with 60 capsules per bottle and packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Sports A-Acid capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Serenity capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Yohimbe capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Male Pill capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Vitalikor capsules packaged in a plastic bottle with 40 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Tendex capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Prematif Male capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science HAM capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science M-Sten capsules packaged in a plastic bottle with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science 4 Andro capsules packaged in a plastic bottle with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science 1 Andro capsules packaged in a plastic bottle with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Methadrol capsules packaged in a plastic bottle with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Science Methadrol capsules packaged in a plastic bottle with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food CoQ10 capsules, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food L-Glutamine capsules, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food L-Serine capsules, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Vitamin C, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food B Complex, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (180 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food L-Carnitine, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (90 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food B-50, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (100 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Mineral Complex, labeled in part as "Healthy Life Chemistry" By Purity First, Est. 1991, packaged in white bottles (200 capsules per bottle) with black font with a Ying & Yang symbol, Manufactured for: Purity First Health Products, Inc. Healthy Life Chemistry 51 Florida Street, Farmingdale, NY 11735 1-800-696-7017. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nisha Male Pill capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nisha Blue Diamond capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nisha Mojo Nights capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nisha Libigrow capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nisha Power Pill capsules packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food New Age Solutions Uri-Flow capsules packaged in a plastic bottle with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Park Labs Reparagen EX capsules packaged in a plastic bottle with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Park Labs Reparagen + Glucosamine capsules packaged in a plastic bottle with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Park Labs Reparagen Pro capsules packaged in a plastic bottle with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Park Labs Vinicol capsules packaged in a plastic bottle with 30 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Swiss Labs Rem Tyme capsules packaged in a plastic bottle with 30 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Nature Bee Bee Pollen capsules packaged in a plastic bottle with containing: 1) 360 capsules per bottle, 2) 180 capsules per bottle and 3) 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Dym-Sdrol capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Super Drol capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Super DMZ capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Energize capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Equibolix capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA ADT capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA M1 capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Formex capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Estro Fuze capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Estro Fuse capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Alpha Male capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Bolasterol capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Cyanostane capsules, packaged in plastic bottles with 60 capsules per bottle and also packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA E-Control capsules, packaged in plastic bottles with 60 capsules per bottle and also packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Decadrol capsules, packaged in plastic bottles with 90 capsules per bottle and also packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Halostane capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Halo capsules, packaged in plastic bottles with 60 capsules per bottle and also packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Sports A-Acid capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Serenity capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Yohimbe capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Male Pill capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Vitalikor capsules, packaged in plastic bottles with 40 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Tendex capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Prematif Male capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA HAM capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA M-Sten capsules, packaged in plastic bottles with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA 4 Andro capsules, packaged in plastic bottles with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA 1 Andro capsules, packaged in plastic bottles with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Methadrol capsules, packaged in plastic bottles with 60 capsules per bottle. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food Biogenix USA Green Coffee Bean capsules, packaged as a bulk product in clear plastic bags. All lots within expiry and distributed prior to August 2013 Class II The dietary supplements have the potential to be contaminated with undeclared steroids, pharmaceutical ingredients and/or chemical additives due to lack of GMPs. Mira Health Products Ltd.
Food XYMOGEN LipiChol (Omega-3 Phospholipid 540 mg) Medical Food Distributed by Xymogen Orlando, Florida. Also sold and distributed under various brands and firms: *1. 4XLipidComplete (Omega-3 Phospholipid 540 mg) Medical Food Distributed by: N2 Health, La Quinta, CA. *2. AL Metabolic P Manufactured for Integrated Medical Center, Mesa AZ. *3. AstaMega-3 Balance Medical Food Distributed by: Lifestyle Research, Cheyenne, WY. *4.Body Balance H.E.M.M.L.A. Manufactured for: Health Masters, Auburndale, FL. *5. Cardio Protect Manufactured for: Shop The Care Group, LLC, Aurora, CO *6. Cardio-Krill Manufactured for: Whole Health Center, Lone Tree, CO. *7. CardiOmega Distributed by: Vail Valley Pharmacy, Edwards, CO. *8. CholeCare Manufactured for: Dr. Christina M. Tondora Scottsdale, AZ. *9. CHOLESTO-BUST Manufactured for: Clear Sky Medical, Centennial, CO. *10. Manufactured for: Arne Chiropractic & Wellness Center PC, Littleton, CO. *11. Dr. Elkin's CardioBlend Manufactured for: Medical Advocated Inc. Whittier, CA. *12. FaB Fats Manufactured for:Bukovina, Auburn, CA. *13. FEM Lipid Support Manufactured for:FEM Centre, Fort Worth, TX. *14.InflmmaChol Distributed By: INNER SCIENCE, Denver, CO. *15. Integrative Bio-Omega Distributed By: Center for Integrative Bio-Energetics, Santa Monica, CA. *16. ItisControl Distributed By: The 2nd Opinion Inc.Chattanooga, OK. *17. Killer Krill Manufactured for: Integrated Medical Care, Littleton, CO. *18. 360 Medicine Krill Pills Manufactured for: Russ Canfield, MD Santa Fe, NM. *19. Krill Supreme Manufactured for: Health Bridge, Great Neck, NY. *20. Krill-Xanthin Manufactured for: Envita Lifestyle, Scottsdale, AZ. *21. " Li-Chol Manufactured for: Pierce Integrative Medical Center, West Bloomfield, MI. *22. Antarctic Omega Cholesterol Free Distributed By: Villa Park Medical , Villa Park, CA. *23.Lipechol Manufactured For: Women's View Medical Group Holistic Center for Integrated Family Health Care, Upland, CA. *24. Lipical Manufactured For: Ruben Ruiz, M.D.,Montebello, CA. *25. Lipicare Manufactured For: Center for Optimum Health, Los Angeles, CA. *26. Lipichol Krill Mfd for: Longevity Orthopedic Center Inc., Mission Viejo, CA. *27. Lipicontrol Distributed By: Dr. Robert Derryberry, D.C., Paso Robles, CA. *28. " Lipid Complete 360 More than a Fish Oil Distributed By: Pure Biotics, LLC, Tustin, CA. *29. Lipid Balance Food Formulated for: Uzzi Reiss, M.D., Beverly Hills, CA. *30. Lipid Complete Distributed By: Advanced Integrative Medicine, Park Meadows Drive, CO. *31. Lipid Support Distributed By: Rehabilitation Chiropractic Care, Mesa, AZ. *32.Lipid ProtX Manufactured For: Inspire, San Diego, CA. *33. LipiKol Manufactured For: Karima Hirani, M.D., MPH, Hirani Wellness Medical Center, Inc. Culver City, CA. *34. LipiKrill Distributed By: Advance Body Dynamics, Centennial, CO. *35. LipidControl Distributed By: Center for Integrative Medicine, Valley Springs, CA. *36. LipidChol Distributed By: Body Hormone Balance, Texarkana, TX. *37. Lipid ProtX Manufactured For: Premier Health and Wellness Screven Edgerton, M.D., Austin, TX. *38. Marine Lipids EPA-DHA Manufactured For: Dr. Cochrans's Nutraceuticals, Tucson, AZ. *39. Omega Antarctica Manufactured For: Mohammed Ali, M.D. Health & Wellness Center, Inc., Lake Forest, CA. *40. Omega Antarctica Manufactured For: Mohammed Ali, M.D. Health & Wellness Center, Inc., San Clemenete, CA. *41. Lipochol Manufactured For: Phillips Clinic, Las Vegas, NV. *42. LipiKrill Manufactured For: Quest for Wellness, Payson, AZ. *43. LipiXanthin-EX Manufactured For: Health Tools LLC, Clarksville, TN. *44. OmegaPhos Distributed By: Therapeutic Lifestyle Center, Idyllwild, CA. *45. Omega Strength Distributed By: Healthy Cells Wellness, Windermere, FL. *46. OmegaPhos Manufactured For: Dr. Chris Fiorentino, Santa Ana, CA. *47. Omega Supreme Krill Manufactured For: NutriMedical Inc., Vista, CA. *48. OmegaXan Krill Oil Distributed By: True Wellness LLC, Austin, TX. *49. Phospholopid EPA-DHA Manufactured For: MOHRDAR Institute of Homeopathy & Integrated Medicine, Riverside, CA. *50. Phospholopid Pro Manufactured For: Renovare Wellness Clinic, Peoria, AZ. *51. " RevChol Distributed By: Revolution Health & Wellness Clinic, Tulsa OK. *52. RotoCor Formulated by Michael Hirt, M.D. Distributed By: The Center For Integrative Medicine, Tarzana, CA. *53. Star LipiChol Manufactured For: Star Energetics, Scottsdale, AZ. *54. SuperKrill Manufactured For: Armonk Integrative Medicine PLLC, Armonk, NY. *55. The Lipid Remedy Manufactured For: The Remedy Pahrmacy, Torrence, CA. *56. Ultimate Krill Manufactured For: The Focus, Boerne, TX. *57. Ultra Krill Distributed By: The Hills Medical Group, West Lake Hills, TX. *58. Ultra Lipid Distributed By: Pursuit Nutraceuticals, Irvine, CA. *59. Vessel Krill Distributed By: Vesel Health LLC, Albuquerque, NM. *60. VitaChol Manufactured For: Vitality Medical & Wellness Center, Las Vegas, NV. *61. Vitality Total Omega (Omega-3 Phospholipid 540mg) Medical Food Manufactured For: Vitality Medical & Wellness Center, Las Vegas, NV. UPC # 8 71149 00375 3 and UPC # 8 71149 00891 8 Lot # 50001784 exp. 09/2014, lot # 50001783 exp. 09/2014, lot # 50002588 exp 11/2015, and lot # 50002587 exp. 11/2015 Class III Product was labeled as a medical food as opposed to a dietary supplement. Atlantic Pro Nutrients, Inc. dba XYMOGEN
Food LipiChol 540 (Omega-3 Phospholipid) Medical Food Dispense by Prescription Distributed by: PharmaceutiX Orlando, Florida UPC # N3 53731-001-06 9 Lot # 50001784 exp. 09/2014, lot # 50001783 exp. 09/2014, lot # 50002588 exp 11/2015, and lot # 50002587 exp. 11/2015 Class III Product was labeled as a medical food as opposed to a dietary supplement. Atlantic Pro Nutrients, Inc. dba XYMOGEN
Food Gold Label Shrimp Dip in 7 oz plastic containers, Manufactured by Adelphia Seafood, ingredients: cream cheese (pasteurized milk & cream, cheese culture, salt, stabilizers (carob bean and/or xanthan gums), water, shrimp, surimi (fish protein (pollock, cod and/or pacific whiting), water, wheat/corn starch, natural crab extract, soy oil), shrimp base (shrimp, salt, monosodium glutamate, spices), contains 2% or less of the following: spices, natural preservative (inactive dry yeast, lactic acid, cultured dextrose, maltodextrin, sodium diacetate, egg white lysozyme, nisin preparation) Allergens: milk, fish, crustacean shellfish, egg, wheat, soy. Use by 11/04/13 Class III Red #40 color additive in shrimp raw ingredient undeclared on finished product label of various shrimp dips and salads. Hahn, Harry O Seafood Inc
Food Adelphia Seafood Shrimp Salad, in 5 lb. plastic tubs, Adelphia Seafood, West Lawn, PA, Ingredients: shrimp, celery, mayonnaise, onion, green pepper, relish, sweet pickle, chili sauce (sugar, water, picked red chili, vinegar, garlic, salt, stabilizer, xanthan gum), gum cellulose. Allergens: Soybeans, egg, shellfish, wheat. Use by: 9/19/13 Class III Red #40 color additive in shrimp raw ingredient undeclared on finished product label of various shrimp dips and salads. Hahn, Harry O Seafood Inc
Food Adelphia Seafood Shrimp & Scallop Rotini, in 5 lb. plastic tubs, Adelphia Seafood, West Lawn, PA. Ingredients: pasta, oil (soybean and olive), cider vinegar, water, shrimp, scallops, red & green peppers, red onion, food starch, salt, spices, natural preservatives. Allergens: soybeans, shellfish, wheat Use by 9/21/13 Class III Red #40 color additive in shrimp raw ingredient undeclared on finished product label of various shrimp dips and salads. Hahn, Harry O Seafood Inc
Food Adelphia Seafood Mermaid Salad in a 5 lb. plastic tub. Ingredients: surimi (alaska pollock, water, wheat flour, soybean oil, natural and artificial flavor), shrimp, pasta shell, mayonnaise (vegetable oil (soybean, canola), egg yolk, water, corn syrup, vinegar), lemon juice, spices, peppers, (diced green), natural and artificial flavors, natural preservatives. Allergens: Soybeans, milk, egg, fish, shellfish, wheat Adelphia Seafood, West Lawn, PA Use by: 9/17/13 Class III Red #40 color additive in shrimp raw ingredient undeclared on finished product label of various shrimp dips and salads. Hahn, Harry O Seafood Inc
Drugs G & W Fluocinolone Acetonide Cream USP 0.025%, a) 15 gm (NDC 0713-0222-15), b) 60 gm (NDC 0713-0222-60 ), Rx Only, Manufactured by: G&W Laboratories, Inc. 111 Coolidge Street, South Plainfield, NJ 07080 15 gm Lot #: 022211002, 022212001- 022212008, 022212010-022212012, 022212017, 022213001, 022213005, 022213008 60 gm Lot #: 022211002, 022212001- 022212007, 022212009, 022212010, 022212012-022212016, 022212018, 022212019, 022213002. Class III Failed Content Uniformity Specifications; at the 18 month time point. G & W Laboratories Inc
Devices Secure II Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components. Models: 3002 EX, 3002 KCI, 3002 CUSTOM, 3002 ZOOM, 3002000000, and 3002 ZX-SB. And Serial Numbers: 060215711 , 060215712 , 060215713 , 060215714 , 060215715 , 060215716 , 060215717 , 060215718 , 060215719 , 060215720 , 060215721 , 060215722 , 060215723 , 060215724 , 060215725 , 060215726 , 060215727 ,  ...
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Class II Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header. Stryker Medical Division of Stryker Corporation
Devices S3 Med/Surg Bed Secure II and the 3002 S3 are the beds typically found in the Med-Surg units of the hospitals. The bed is designed for a 15 year expected service life under normal use conditions, and with appropriate periodic maintenance as described in the maintenance manual for each device. There are minimal differences between the functionality of the two models, each of which function as a highly complex system of a large number of individual components. Models: 3002 S3 EX, 3002 S3 PATRIOT, 3002 S3 CUSTOM, 3002 S3 ZOOM, and 3002 S3 SIGNATURE. And Serial Numbers:080615942, 080715062, 080916706, 080916707, 080916708, 080916709, 080916710, 080916711, 080916712, 080916713, 080916714, 080916715, 080916716, 080916717, 090415690, 100215206, 100215207, 100215208, 100215209, 100215210, 100215211, 100215212, 100215213, 100215214, 100215215, 100215216, 100215217, 100215218, 100215219, 100215220, 100215221,  ...
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Class II Stryker Medical has identified a potential issue associated with Secure II and S3 Med/Surg beds built between April 2nd, 2005 and July 26th, 2011. The affected beds have the potential to experience damage to the Foot End Cover and/or Power Coil Cable due to reduced clearance between the Foot End Cover and Foot End Lift Header. Stryker Medical Division of Stryker Corporation
Devices FEM COND BUTTRESS PLT, RT. Item #'s: 00-2347-001-12 00-2347-001-14 00-2347-001-16 00-2347-001-18 Lot #s: All lots with an expiration date prior to July 24, 2023 Class II Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. Zimmer, Inc.
Devices TIBIO FEM/FEM NAIL. Item Numbers 32-8553-311-11 32-8553-311-13 32-8553-311-15 32-8553-311-17 All lots with an expiration date prior to July 24, 2023 Class II Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. Zimmer, Inc.
Devices DIST LAT FEM LOCK PLT, LT Item Number: 47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023 Class II Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. Zimmer, Inc.
Devices DIST LAT FEM LOCK PLT, RT Item Numbers: 47-2357-101-14 47-2357-101-18 47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023 Class II Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. Zimmer, Inc.
Devices ITST THREADED GUIDE PIN Item Numbers: 47-2258-067-00 All Lots with an expiration date prior to July 24, 2023 Class II Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. Zimmer, Inc.
Devices NGK Stem Ext 24 x 245mm Item Numbers: 32-5988-012-24 All lots with an expiration date prior to July 24, 2023 Class II Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. Zimmer, Inc.
Devices FEM COND BUTTRESS PLT, LT Item #'s: 00-2347-002-12 00-2347-002-14 00-2347-002-16 00-2347-002-18 Lot #s: All lots with an expiration date prior to July 24, 2023 Class II Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. Zimmer, Inc.
Devices TIB NAIL Item #'s: 32-8553-311-59 32-8553-311-61 32-8553-311-63 32-8553-311-65 Lot #s: All lots with an expiration date prior to July 24, 2023 Class II Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed. Zimmer, Inc.
Drugs Fosinopril Sodium and Hydrochlorothiazide Tablets, 10 mg/12.5 mg, Rx Only, 100 Tablets, Sandoz Inc. Princeton, NJ 08540 ---NDC 0185-0341-01, Lot CU0856 Class II Subpotent; Hydrochlorothiazide at the 9 month time point. Sandoz Inc
Drugs Daunorubicin Hydrochloride Injection, 20 mg/4 mL (5 mg/mL), 4 mL Single Dose Vial, Rx ONLY, For IV Use Only, Manufactured By: Teva parenteral Medicines, Inc., Irvine, CA NOVAPlus® labels. NDC 0703-5233-13 (carton), NDC 0703-5233-11 (vial) or NDC 0703-5233-93 (carton), NDC 0703-5233-91 (vial) Lot number EXP 31314801B, 2/2014; 31314990B, 2/2014; 31314991B, 2/2014; 31315014B, 2/2014; 31315155B, 6/2014; 31315279B, 6/2014; 31315837B, 10/2014; 31315921B, 10/2014; 31316029D, 12/2014; and 31316029C, 12/2014 Class II Presence of Precipitate; precipitation of drug product Teva Pharmaceuticals USA
Food Chewable EnZym-Complete/DPPIV with Isogest, Kirkman brand. Item # 0934-090. Lot 54112001 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol Kirkman Group Inc.
Food Chewable Maximum Spectrum EnZym-Complete/DPPIV with Isogest, Kirkmand brand. Item # 0893-090 Lot number: 54255000 Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol Kirkman Group Inc.
Food EnZym-Complete/DPP-IV II with Isogest, Kirkman brand. Item numbers: 0851A-090, 0851A-180, 0931-090, 0931-180, 5851A-090, 5931-090. Lot numbers: 52939039, 52939040, 52939042, 52939043, 53852011, 53852012, 53852013, 53852015, 53852016, Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol Kirkman Group Inc.
Food Enzym-Complete/DPP-IV, Kirkman brand. Item numbers 0234-060, 0234-120, 0234-200, 5234-200 LOT numbers: 52587047, 52587048, 52587049, 52587050, 52588047, 52588048, 52588049, 52588050, 53853006, 53853007, 53853008, 53853009, 53853010, 54956000, 52588051, Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol Kirkman Group Inc.
Food Maximum Spectrum EnZym-Complete/DPP-IV Fruit Free w/Isogest, Kirkman brand, Item # 0869A-120 and 0932-120. LOT number: 53854008, 53854010, 53854012, 53854014, Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol Kirkman Group Inc.
Food Phenol Assist, Kirkman brand, Item # 0835-090 LOT numbers: 52640015, 53855003, 53855004. Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol Kirkman Group Inc.
Food Biofilm Defense, Kirkman brand, Item # 0881-060 and 5881-060 Biofilm Defense, Pure Compounding brand, Item # 1881-060. LOT numbers: 53666006, 53666007, 53666008, 53666009, Class II Firm is recalling dietary supplements containing a raw material which may contain >0.3 ppb chloramphenicol Kirkman Group Inc.
Food Wegman's Brand New England Clam Chowder (refrigerated at 38F or below) in a 16 oz plastic cup. Lot: 10313-8J UPC 77890 27864 Use By Date: 01/08/2014 Class II May contain undeclared shellfish (crab). Blount Fine Foods Corporation
Cosmetics Labeled to be Antiseptic Skin Freshener, packaged in one gallon containers. The product is shipped in boxes containing 4 one gallon containers. Firm name on the label is La Palm Products, Wichita, KS. 061115Gcr Class II Labels on the recalled product do not match the product. Millenium Productions, LLC
Cosmetics Labeled to be Antibacterial Sea Spa Tablet, packaged in five gallon buckets. Firm name on the label is La Palm Products, Wichita, KS. 8121Gcr Class II Labels on the recalled product do not match the product. Millenium Productions, LLC
Cosmetics Labeled to be Antibacterial Ocean Fresh Super Dark Green Antiseptic, packaged in one gallon containers. The product is shipped in cases containing 4 one gallon containers. Firm name on the label is La Palm Products, Wichita, KS. 7251GCR Class II Labels on the recalled product do not match the product. Millenium Productions, LLC
Devices Asante Comfort Infusion Set with 60cm tubing & 13mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5123-4) Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark Asante Catalog number: FG-4123-5 FG-4123T Unomedical Item number: 87-060-2562; Lot numbers: 0230118 0230122 5036994 Class II Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. Asante Solutions, Inc.
Devices Asante Comfort Infusion Set with 60cm tubing & 17mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5127-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark Asante Catalog number: FG-4127-5, FG-4127T Unomedical Item number: 87-060-2662 Lot numbers: 0230119 0230123 5023420 5031106 Class II Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. Asante Solutions, Inc.
Devices Asante Comfort Infusion Set with 110cm tubing & 13mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5143-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical Lejre, Denmark Asante Catalog number: FG-4143-5, FG-4143T. Unomedical Item number: 87-110-2562 Lot numbers: 0230120; 0230124 5031108. Class II Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. Asante Solutions, Inc.
Devices Asante Comfort Infusion Set with 110cm tubing & 17mm cannula packaged in 5-packs, singles, or inside a Combination Kit (FG-5147-4). Manufactured for: Asante Solutions Sunnyvale, CA; Manufactured by: Unomedical, Lejre, Denmark Asante Catalog number:FG-4147-5, FG-4147T Unomedical Item number:87-110-2662; Lot numbers: 0230121 0230125 5025227. Class II Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. Asante Solutions, Inc.
Devices Asante Conset Infusion Set with 60cm tubing & 6mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5226-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark. Asante Catalog number: FG-4226-5, G-4147T; Unomedical Item number:43-060-5266; Lot numbers: 0230126 5005801 5030167. Class II Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. Asante Solutions, Inc.
Devices Asante Conset Infusion Set with 60cm tubing & 9mm cannula packaged in 5-packs,singles, or inside a Combination Kit (FG-5229-4); Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark. Asante Catalog number:FG-4229-5 FG-4229T; Unomedical Item number:43-060-5269; Lot numbers: 0230127 5005802 5038313. Class II Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. Asante Solutions, Inc.
Devices Asante Conset Infusion Set with 110cm tubing & 6mm cannula packaged in 5-packs, singles,or inside a Combination Kit (FG-5246-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark. Asante Catalog number:FG-4246-5, FG-4246T; Unomedical Item number:43-110-5266; Lot numbers: 0230128 5005803 5030168. Class II Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. Asante Solutions, Inc.
Devices Asante Conset Infusion Set with tubing & 9mm cannula packaged in 5-packs,singles,or inside a Combination Kit (FG-5249-4) Distributed by Asante Solutions, Sunnyvale, CA; Manufactured by Convatec; Lejre, Denmark. Asante Catalog number:FG-4249-5, FG-4249T; Unomedical Item number: 43-110-5269; Lot numbers: 0230129 5005804 5040412. Class II Reports of the infusion tubing disconnecting from the connector, resulting in leakage of insulin from the infusion set and providing patient with less insulin than intended. Asante Solutions, Inc.
Devices RTC 25-C Inline Aerosol Tee Adapter. Intended to be used to adapt an aerosolized medication delivery system having an elliptical mouthpiece to a ventilator circuit. multiple lots shipped between 10/7/13 and 11/6/13: P1002913, P1004413, P1005713, P1007713, P1009813, P1014213, P1014813, and P1102013. Class II Some packages of the RTC 25-C may have been shipped to customers with incomplete Installation and Usage Directions due to a printing error. Instrumentation Industries Inc
Drugs Niacin Extended Release Tablets, USP, 500 mg, 90 count bottle, Rx Only, Teva Pharmaceuticals USA, Inc., Sellersville, PA, 18960, NDC 0093-7392-98 Lot#: 32900349B, Exp: 12/2014 Class II Failed Tablet/Capsule Specifications: There is a potential for broken tablets. Teva Pharmaceuticals USA
Devices CPT Hip System, Parts 00-8114-002-10 and 00-8011-004-00 Hip joint metal/polymer semi-constrained cemented prosthesis. The CPT Hip System is indicated for cemented use in: Patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head, and nonunion of previous fractures of the femur. Patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis. Patients suffering from disability due to previous fusion. Patients with previously failed endoprostheses and/or total hip components in the affected extremity. Patients with acute femoral neck fractures. 510(k) K960658 Part 00-8114-002-10, Lot 62424414 Part 00-8011-004-00, Lot 62406423 Class II Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct. Zimmer, Inc.
Devices Trabecular Metal (TM) Reverse Glenosphere 36mm Part 00-4349-036-11 The reverse shoulder system is used in the treatment of the following: severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; un-united humeral head fractures of long duration; irreducible 3 and 4-part proximal humeral fractures; avascular necrosis of the humeral head, or other difficult clinical management problems (such as a failed total shoulder arthropolastey or grossly rotator cuff deficient joint) where arthrodesis or resectional arthroplasty is not acceptable. 510(k) K130661 Part 00-4349-036-11, Lot 62393502 Class II Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct. Zimmer, Inc.
Devices Versys Build-Up Block The VerSys CRC Hip System is indicated for total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by defi ciencies of the femoral head, neck, or portions of the proximal femur. Arthroplasty should be performed only when more conservative methods of treatment have failed to provide symptomatic relief and when there is progressive disability. Part 00-7871-001-10 Lot 62359872 Class II Zimmer is initiating a lot specific recall of the CPT Hip Stem, Versys Build-Up Block, and Trabecular Metal Reverse Glenosphere medical devices due to reports of the products being packaged in the incorrect outer carton. Product labels and patient labels are correct. Zimmer, Inc.
Devices IntelliFill i.v. Pharmacy Compounding Device (PCD). Intended to fill syringes from 0.5mL up to 11.5mL using mixing instructions from its formulary to fill the orders. Lot # 123, 125R, 127, 129, 145, 146R, 147R, 148, 215R, 500, 501, 502, 503, 504, 505, 506, 508, 510, 511R, 512, 514, 515, 516R, 517, 518, 519, and 520. Class II Following a retrospective review for Baxter Daytona Complaint CR-954, it was identified that the IntelliFill i.v. Pharmacy Compounding Device (PCD) (product code: IFIV) has the potential to continue to run and fill syringes with the HEPA filtration disabled. Baxter Healthcare Corp.
Devices STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. Batch/Lot No. 14913706 15013706 15413706 15413106 15513706 15613706 15713706 15913706 16113706 16113106 16213706 16413706 16413806 16613706 16813706 16813806 16913706 17113706 17213706 17513706 17613706 17713706 17813706 17913706 18013706 18313706 18413706 18913706 19013706 19113706 19213706 19313706 19613706 19713706 19813706 19913706 20013706 20113706 20313706 20413706 20613706 20713706 20813706 21113706 21213706 21313706 21413706 21513706 21513806 21713706 21813706 21913706 22013706 22113706 22213706 22413706 22513706 22613706 22713706 22813706 22913706 23113706 23113806 23213706 23313706 23413706 23513706 23813706 23913706 24013706 24113706 24513706 24813106 24913706 25313106 25613106 26113106 26613106 26813106 27313106 27513106 28713106 28913106 29513106 30113106 Class II Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator. Advanced Sterilization Products
Devices SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. Model #6500 & 7500 Class II Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts. Steris Corporation
Food Organic Forbidden RICE RAMEN; Gluten Free/Vegan, Black Rice Noodles Ready in 4 minutes; Net Wt. 10 oz; (283 g) 4 ramen per bag USDA Organic; Lotus Foods, Richmond, CA. Lot # 07.31.2015; UPC# 7 08953 60201 1 Class II Customer complaint of mold on Lotus Foods Ramen. Lotus Foods Inc
Food Organic Jade Pearl RICE RAMEN; Gluten Free/Vegan, Infused Noodles Ready in 4 minutes; Net Wt. 10 oz; (283 g) ramen per bag USDA Organic; Lotus Foods, Richmond, CA. Lot # 07.31.2015 UPC# 7 08953 60202 8 Class II Customer complaint of mold on Lotus Foods Ramen. Lotus Foods Inc
Food Organic Millet & Brown RICE RAMEN; Gluten Free/Vegan Ready in 4 minutes; Net Wt. 10 oz; (283g) 4 ramen per bag USDA Organic; Lotus Foods, Richmond, CA. Lot # 07.31.2015 UPC# 7 08953 60203 5 Class II Customer complaint of mold on Lotus Foods Ramen. Lotus Foods Inc
Food Forbidden RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g) 1 Ramen per bag USDA Organic; Lotus Foods, Richmond, CA. Lot # 07.31.2015 UPC# 7 08953 60101 4 Class II Customer complaint of mold on Lotus Foods Ramen. Lotus Foods Inc
Food Jade Pearl RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g) 1 Ramen per bag USDA Organic; Lotus Foods, Richmond, CA. Lot # 07.31.2015 UPC# 7 08953 60102 1 Class II Customer complaint of mold on Lotus Foods Ramen. Lotus Foods Inc
Food Millet & Brown RICE RAMEN with miso soup Gluten Free/Reduced Sodium; made with organic rice Ready in 4 minutes; Net Wt.2.8 oz. (80 g) 1 Ramen per bag USDA Organic; Lotus Foods, Richmond, CA. Lot # 07.31.2015 UPC# 7 08953 60103 8 Class II Customer complaint of mold on Lotus Foods Ramen. Lotus Foods Inc
Devices Philips Essenta DR, a Stationary x-ray system, X-ray system Model: 712070 The Essenta DR is a multifunctional stationary X-ray system, in which the swivel arm rotation, the vertical movement of the swivel arm and the SID adjustment are motorized. It is designed for radiographic examination of the recumbent, standing or seated patient and also for lateral exposures. It enables the operator to quickly and safely move the unit to all the pre-programmed basic positions at the press of a button, using the autopositioning feature. Fine positioning of the tube/collimator and detector on the patient is easy to carry out using the command. All Essenta DR x-ray Systems Class II X-ray system C-arm casting may loosen and fall Philips Medical Systems, Inc.
Food Diet Coke, 2L, 67.6 FL OZ (2 QT 3.6 FL OZ), UPC 4900005011 FEB1714GBA2 with time stamps: 1830 through 1908 Class II One lot of Diet Coke, 2L, may contain regular Cherry Coke which contains sugar. Coca Cola Bottling Company United-East, LLC
Food Joseph's Gourmet Pasta and Sauces- Asiago and Garlic Tortelloni (par cooked). Sold Frozen in 5 lb. plastic bags for food service Item Number: 22273 (G11008331) UPC Code: 00048769222738 Lot Codes: 13311, 13315, 13316 Class II Potential for foreign material Nestle Prepared Foods Company
Devices Philips HeartStart MRx Monitor/Defibrillator Models: M3536A, M3536J, M3536M, M3536MC, M3536M2, M3536M4, M3536M5, M3536M6 The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. 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 Serial numbers ranging: From US00100100 to US00210461 Class II Device Operating on Battery Power May Shutdown without Warning if exposed to elevated levels of electromagnetic interference from other radio frequency (RF) energy sources and Philips Medical Systems, Inc.
Devices VERIFY® Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes. Lot #131004 Model #'s: S3060, S3061, S3065, S3069, LCB006 & LCB007. Class II STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved. Steris Corporation
Drugs 0.5% Bupivacaine HCl and Epinephrine 1:200,000 Inj., 50 mL, Multiple-dose Fliptop Vial, Rx only, Hospira, Inc., Lake Forest, IL 60045. NDC #0409-9046-01. Lot #32-484-EV, 32-485-EV Exp: 2/2015. Class II Lack of assurance of sterility; equipment failure led to potential breach in asceptic process. Hospira Inc.
Devices Philips HeartStart MRx Monitor/Defibrillator Models: M3536A Options A20 - A27, HeartStart MRx ALS Monitor (Grey) The HeartStart MRx is for use for the termination of ventricular tachycardia and ventricular fibrillation. 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 Serial numbers: US00558442 - US00558461 US00561519 US00558531 - US00558532 US00561578 US00558615 US00562454 US00558758 - US00558759 US00562504 - US00562527 US00560165 - US00560166 US00562640 - US00562641 US00560738 - US00560739 US00562832 US00560740 - US00560745 US00563125 US00560872 US00563231 - US00563243 US00560909 US00564032 US00561068 US00564177 US00561209 US00564409 US00561447 - US00561452 US00564793 Class II Error in the printing of the therapy energy setting labels on Philips HeartStart M3536A MRx Monitor/Defibrillators. The first energy setting is labeled 10 when it should be labeled1-10 Philips Medical Systems, Inc.
Devices Terumo Cardiovascular Custom Cardiovascular Procedure Kits containing an Overpressure Safety Valve, LN130B, in the Arterial Recirculation Line N/A Class II Over-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit. Terumo Cardiovascular Systems Corporation
Devices AdvanDx Gram-Negative QuickFISH BC. In-Vitro Diagnostic for the identification of Enterobacteriacae Catalog Number: QFGNRBC1-25 Gram-Negative QuickFISH BC provides rapid identification of Escherichia coli, and/or Pseudomonas aeruginosa, and/or Klebsiella pneumoniae directly from GNR-positive blood cultures Lot codes US: 04813C, 7413, 08113 exp. 2013-12 Lot codes OUS: 03113A 04213A 04813B Class III Kits incompatible with certain fluorescence microscope light sources AdvanDx, Inc.
Food Antonina's Artisan Bakery brand, Gluten Free, Blueberry Mini Muffins, 12 pieces per package. Net wt. 12.6 oz. The UPC Code is 8 18703 01102 1. Lot Code - 051114; Expiration Date: 5/11/14 (if kept frozen) Class I Antonina's Artisan Bakery Gluten Free Blueberry Mini Muffins are recalled due to undeclared walnuts. Pin Hsiao & Associates
Food Stuffed Foods Asiago Risotto Bites; UPC 850821-00301 Best By Dates: November 7, 2014, November 13, 2014, November 14, 2014, November 20, 2014, November 22, 2014 Class II Supplier informed manufacturer that cheese used in asiago risotto bites may contain small pieces of plastic. Stuffed Foods LLC
Devices Integra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or Temperature are measured at the Catheter tip, eliminating the need for external transducers, fluid, pressure tubing, and flush devices. The Camino displays intracranial pressure (ICP), intracranial temperature (ICT), and calculates cerebral perfusion pressure (CPP) (CPP = mean arterial pressure - mean intracranial pressure). The Camino provides a continuous display of the ICP waveform, as well as mean ICP, CPP, ICT, or systolic and diastolic waveform values. A continuous record of mean pressure and CPP values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 12 or 24 hour period. Outputs for ICP and ICT are available for use with patient bedside monitors. An isolated analogue output provides a continuous ICP waveform for hard copy documentation or data acquisition. An input to receive mean arterial pressure from a compatible patient bedside monitor is available for use when it is desired to have a CPP reading. The mean arterial pressure cannot be acquired from a non-invasive blood pressure cuff. Although the Camino is intended to be a stand-alone system, it also conveniently connects to hospital bedside monitoring systems. MEK1200104 MEK1200204 MEK1200304 MEK1200404 MEK1200504 MEK1200604 MEK1200704 MEK1200804 MEK1200904 MEK1201004 MEK1201104 MEK1201204 MEK1201304 MEK1201404 MEK1201504 MEK1201604 MEK1201704 MEK1201804 MEK1201904 MEK1202004 MEL1200104 MEL1200204 MEL1200304 MEL1200404 MEL1200504 MEL1200604 MEL1200704 MEL1200804 MEL1200904 MEL1201004 MEL1201104 MEL1201204 MEL1201304 MEL1201404 MEL1201504 MEL1201604 MEL1201704 MEL1201804 MEL1201904 MEL1202004 MEL1202104 MEL1202204 MEL1202304 MEL1202404 MEL1202504 MEL1202604 MEL1202704 MEL1202804 MEL1202904 MEL1203004 MEL1203104 MEL1203204 MEL1203304 MEL1203404 MEL1203504 MEL1203604 MEL1203704 MEL1203804 MEL1203904 MEL1204004 MEL1204104 MEL1204204 MEL1204304 MEL1204404 MEL1204504 MEL1204604 MEL1204704 MEL1204804 MEL1204904 MEL1205004 MEM1200104 MEM1200204 MEM1200304 MEM1200404 MEM1200504 MEM1200604 MEM1200704 MEM1200804 MEM1200904 MEM1201004 MEM1201104 MEM1201204 MEM1201304 MEM1201404 MEM1201504 MEM1201604 MEM1201704 MEM1201804 MEM1201904 MEM1202004 MEM1202104 MEM1202204 MEM1202304 MEM1202404 MEM1202504 MEM1202604 MEM1202704 MEM1202804 MEM1202904 MEM1203004 MEM1203104 MEM1203204 MEM1203304 MEM1203404 MEM1203504 MEM1203604 MEM1203704 MEM1203804 MEM1203904 MEM1204004 MEA1300104 MEA1300204 MEA1300304 MEA1300404 MEA1300504 MEA1300604 MEA1300704 MEA1300804 MEA1300904 MEA1301004 MEA1301104 MEA1301204 MEA1301304 MEA1301404 MEA1301504 MEA1301604 MEA1301704 MEA1301804 MEC1300104 MEC1300204 MEC1300304 MEC1300404 MEC1300504 MEC1300604 MEC1300704 MEC1300804 MEC1300904 MEC1301004 MEC1301104 MEC1301204 MEC1301404 MEC1301504 MEC1301604 MEC1301704 MEC1301804 MEC1301904 MEC1302004 MED1300104 MED1300204 MED1300304 MED1300404 MED1300504 MED1300604 MED1300704 MED1300804 MED1300904 MED1301004 MED1301104 MED1301204 MED1301304 MED1301404 MED1301504 MED1301604 MED1301704 MED1301804 MED1301904 MED1302004 MEE1300104 MEE1300204 MEE1300304 MEE1300404 MEE1300504 MEE1300604 MEE1300704 MEE1300804 MEE1300904 MEE1301004 MEE1301104 MEE1301204 MEE1301304 MEE1301404 MEE1301504 MEE1301604 MEE1301704 MEE1301804 MEE1301904 MEE1302004 MEE1302104 MEE1302204 MEE1302304 MEE1302404 MEE1302504 MEE1302604 MEE1302704 MEE1302804 MEE1302904 MEE1303004 MEE1303104 MEE1303204 MEF1300104 MEF1300204 MEF1300304 MEF1300404 MEF1300504 MEF1300604 MEF1300704 MEF1300804 MEF1300904 MEF1301104 MEF1301204 MEF1301304 MEF1301404 MEF1301504 MEF1301604 MEF1301704 MEF1301804 MEF1301904 MEF1302004 MEF1302104 MEF1302204 MEF1302304 MEF1302404 MEF1302504 MEF1302604 MEF1302704 MEF1302804 MEF1302904 MEF1303004 MEF1303104 MEF1303204 MEF1303304 MEF1303404 MEF1303504 MEF1303604 MEF1303704 MEF1303804 MEF1303904 MEF1304004 MEF1304104 MEF1304204 MEF1304304 MEF1304404 MEF1304504 MEF1304604 MEF1304704 MEF1304804 MEF1304904 MEF1305004 MEF1305104 MEF1305204 MEF1305304 MEF1305404 MEG1300104 MEG1300204 MEG1300304 MEG1300404 MEG1300504 MEG1300604 MEG1300704 MEG1300804 MEG1300904 MEG1301004 MEG1301304 MEG1301404 MEG1301504 MEG1301604 MEG1301704 MEG1301804 MEG1301904 MEG1302004 MEG1302104 MEG1302204 MEH1300104 MEH1300204 MEH1300304 Class II Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed. But, if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly. Integra LifeSciences Corp.
Drugs Cetirizine Hydrochloride Syrup (Cetirizine Hydrochloride Oral Solution, USP) 1 mg/mL, 120 mL and 480 mL bottles, Rx only. Mfg. for: Qualitest Pharmaceuticals, Huntsville, AL 35811. NDC 0603-9063-54 (120 mL), NDC 0603-9063-58 (480 mL). Lot Numbers: NDC 0603-9063-54 (120 mL): L081K12A, exp. 4/14; L082K12A, exp. 4/14; L062M12A, exp. 6/14; L063M12A, exp. 6/14; L064M12A, exp. 6/14; L054A13A, exp. 7/14; L055A13A, exp. 7/14; L057A13A, exp. 7/14; L058A13A, exp. 7/14; L075B13A, exp. 8/14; L076B13A, exp 8/14; L003C13A, exp. 8/14; L004C13A, exp. 8/14; and L005C13A, exp. 8/14 NDC 0603-9063-58  ...
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Class III Failed impurities/degradation specifications; out of specification for the known impurity 4-chlorobenzophenone. Qualitest Pharmaceuticals
Food Down Unders Cookie Mobile Meal sold under brand Down Unders, approximately 6.75 oz. (189 gram). No codes Class II Down Unders Cookie Mobile Meal is recalled because the coconut is declared in the ingredient statement but the label also lists NO NUTS. Cuisine Med. Catering
Devices Catheter, Continuous Flush The Merit Microcatheter is intended for general intravascular use, including peripheral and coronary vasculature. Once the subselective region has been accessed, the microcatheter can be used for the controlled and selective infusion of diagnostic, embolic or therapeutic materials into vessels. Catalog Numbers: 28MC24110ST with Lot Number: H548211, and Catalog Number: 28MC24130SN with Lot Numbers: H549598, or H553237 Class II Merit Medical Systems, Inc. is conducting a recall for 3 lots of Maestro Microcatheters with a graphic discrepancy on the carton/box label end panel. The catheter graphic on the front of the carton box (correct) and the graphic on the end panel (incorrect) do not match. Merit Medical Systems, Inc.
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