BEUDAMED
    FDA Enforcement Class II Terminated

    LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic Intended for the application of topical anesthetics to the oropharynx and upper airway region

    Recall: Z-3212-2017 · Reported October 4, 2017

    Enforcement

    Recall Number
    Z-3212-2017
    Event ID
    77980
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 4, 2017
    Initiation Date
    July 5, 2017
    Classification Date
    September 26, 2017
    Termination Date
    November 20, 2018
    Address
    2917 Weck Dr, N/A, Research Triangle Park, NC, 27709-0186, United States

    Description

    LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 MADgic, (b) MAD700 MADgic, (c) MAD720 MADgic 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 Numbers: (a) MAD600 MADgic: 161217, 161218, 161228 (b) MAD700 MADgic: 161119, 161120, 161121, 161153, 161173, 161212, 161223, 161236 (c) MAD720 MADgic: 161154

    Distribution

    Nationwide distribution

    Quantity

    135,456 units