BEUDAMED
    FDA Enforcement Class II Terminated

    LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situation and the cannot-intubate-cannot-ventilate situation.

    Recall: Z-1085-2015 · Reported February 18, 2015

    Enforcement

    Recall Number
    Z-1085-2015
    Event ID
    70258
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 18, 2015
    Initiation Date
    January 13, 2015
    Classification Date
    February 10, 2015
    Termination Date
    September 27, 2016
    Address
    2917 Weck Dr, N/A, Research Triangle Park, NC, 27709-0186, United States

    Description

    LMA (Laryngeal Mask Airway) Supreme (New Cuff) Size 5, Sterile, Single use, Product Usage: Achieve and maintain control of airway during routine anaesthesia in fasted patient using either spontaneous or positive pressure ventilation, cardiopulmonary resuscitation, the failed intubation situation and the cannot-intubate-cannot-ventilate situation.

    Reason

    The labelling of units from the affected lot indicates that it contains a size 5 LMA Supreme (New Cuff), but may contain a size 4 LMA Supreme (New Cuff).

    Code Info

    Catalog No(s): 175050, Lot no. HMAUGK

    Distribution

    Worldwide Distribution - U.S Nationwide in the states of: AZ, CA, DE, FL, GA, IL, KY, MO, NY, OK, PA, TX, VA & WA and the country of Canada.

    Quantity

    2640 units