BEUDAMED
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    Synchron Phenobarbital (PHE) Reagent, P/N 469785, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. PHE reagent, when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800 System(s) and SYNCHRON Systems Drug Calibrator 1, is intended for quantitative determination of Phenobarbital concentration in human serum or plasma.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DKB·August 11, 2009

    Synchron Phenobarbital (PHE) Drug Calibrator 1, P/N 469600, Classification Product Code: KLT. Subsequent Product Codes: DIP, KLS, LCD, LCQ, LCR, LFN. The Beckman Coulter SYNCHRON Systems DRUG CALIBRATOR 1, when used in conjunction with SYNCHRON reagents, is intended for use on the SYNCHRON Systems for the calibration of Carbamazepine, Phenobarbital, Phenytoin, Theophylline, and Valproic Acid.

    FDA Recall
    Terminated ·Beckman Coulter Inc.·Product code DLZ·August 11, 2009

    Abbott TDx/TDxFLx Gentamicin Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCQ·October 26, 2007

    Abbott TDx/TDxFLx Gentamicin Wedge Reagent - Is a reagent for in vitro diagnostic use. This reagent system is composed of one bottle of gentamicin antiserum, one bottle of gentamicin flourescein tracer and one bottle of pretreatment solution. Abbott Laboratories, Abbott Park, IL 60064

    FDA Recall
    Terminated ·Abbott Diagnostic International, Ltd. Carr # 2 Km 58.0 Cruce Davila·Product code LCQ·October 26, 2007

    Nebulizer Masks Opti-Mist and Opti-Mist Clear Nebulizer masks are intended to spray liquids in aerosol form into gasses that are delivered directly to a patient.

    FDA Recall
    Terminated ·ConvaTec, Inc·Product code LCQ·November 11, 2015

    Advantx 1 LC2 Model 2105657 Angiographic X-ray System

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IZI·March 24, 2004

    Advantx 1 LC2 Model 45562281 Angiographic X-ray System

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IZI·March 24, 2004

    Advantx 1 LC1 Model 45258230 Angiographic X-ray System

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IZI·March 24, 2004

    Advantx 1 LC1 Model 46-279781P1 Angiographic X-ray System

    FDA Recall
    Terminated ·General Electric Med Systems·Product code IZI·March 24, 2004

    Nebulizer (adult elastic strap style aerosol mask 7' tube - 50/cs), Latex Free Salter Labs, Arvin, CA 93203 Intended usage: respiratory therapy.

    FDA Recall
    Terminated ·Salter Laboratories, Division of Regulatory Affairs·Product code CCQ·March 25, 2011

    Broncho Flexible Fiberscope, models: 11001BN1, 11002BD1, 11004BC1, and 11009BC1. " Examination and treatment of the tracheobronchial tree Contraindications for Bronchoscopy " Uncontrolled angina, uncontrolled heart failure, or serious uncontrolled ventricular arrhythmias " Uncontrolled hypertension " Bleeding disorder or use of anticoagulants.

    FDA Recall
    Terminated ·Karl Storz Endoscopy America Inc·Product code ECQ·November 13, 2013

    EZ Breathe Atomizer Model # EZ-100. For the delivery of liquid medications for respiratory usage.

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CCQ·April 30, 2013

    AsthmaNefrin Starter Kit contains ten (10) AsthmaNefrin vials and one (1) EZ Breathe Atomizer. For the delivery of liquid medications for respiratory usage.

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CCQ·April 30, 2013

    EZ Breathe Medication Cup. For the delivery of liquid medications for respiratory usage.

    FDA Recall
    Terminated ·Nephron Pharmaceuticals Corp.·Product code CCQ·April 30, 2013

    FLEXI NOZZLE SHORT Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CCQ·October 27, 2016

    FLEXI NOZZLE LONG, 10 Boxes of 25 units each Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CCQ·October 27, 2016

    LMA MADomizer, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CCQ·October 27, 2016

    LMA MADdy, Rx only, Product Usage: These products are used for the delivery of topical anesthesia via an atomized spray to the oral, nasal, pharyngeal or laryngeal mucosa. Teleflex Medical is recalling these products as they may produce a straight stream instead of a fully atomized plume of medication. It is unlikely that serious adverse health consequences will occur in the event of a failure to deliver an atomized plume; however, this may result in inadequate topical anesthesia which may lead to some discomfort, further attempts to deliver topical anesthesia, or the use of alternative methods of anesthesia.

    FDA Recall
    Terminated ·Teleflex Medical·Product code CCQ·October 27, 2016

    Mucosal Atomization Device (MAD), Intranasal Mucosal Atomization Device with 3mL Syringe and Vial Adapter; Product Code MAD100, MAD100OS MAD110, MAD110OS, MAD130, MAD130OS, MAD140, MAD140OS, MAD300, MAD300B. Manufactured By: Wolfe-Tory Medical, Inc., Teleflex Medical. For atomization of topical solutions across the naso and oropharyngeal mucosal membranes

    FDA Recall
    Terminated ·Teleflex Medical·Product code CCQ·October 27, 2016