BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0381-2017 · Reported December 28, 2016

    Enforcement

    Recall Number
    Z-0381-2017
    Event ID
    75554
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 28, 2016
    Initiation Date
    October 27, 2016
    Classification Date
    December 22, 2016
    Termination Date
    September 25, 2020
    Address
    2917 Weck Dr, N/A, Research Triangle Park, NC, 27709-0186, United States

    Description

    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.

    Reason

    Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

    Code Info

    Product Code: MAD500, Lot # 160127, 160314, 160441, 160508, 160632 and 160805; Product Code: MAD510, Lot# 160109, 160115, 160206, 160220, 160227, 160303, 160315, 160323, 160328, 160401, 160426, 160501, 160519, 160603, 160612, 160622, 160633, 160702, 160719 and 160808.

    Distribution

    Worldwide distribution. U.S. (Nationwide) and Internationally to Canada, Belgium, Singapore and Thailand.

    Quantity

    2,674,650 units in total