BEUDAMED
    FDA Enforcement Class II Terminated

    Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region

    Recall: Z-1628-2018 · Reported May 9, 2018

    Enforcement

    Recall Number
    Z-1628-2018
    Event ID
    79643
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical Europe Ltd
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 9, 2018
    Initiation Date
    March 19, 2018
    Classification Date
    May 3, 2018
    Termination Date
    August 27, 2019
    Address
    Ida Business Park, N/A, Athlone, N/A, N/A, Ireland

    Description

    Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region

    Reason

    Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.

    Code Info

    Lot Number 161212

    Distribution

    TX

    Quantity

    25 units