BEUDAMED
    FDA Enforcement Class I Ongoing

    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095

    Recall: Z-1882-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1882-2023
    Event ID
    92373
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    TELEFLEX LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 5, 2023
    Initiation Date
    May 25, 2023
    Classification Date
    June 29, 2023
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080095

    Reason

    Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

    Code Info

    UDI/DI 14026704341266, Batch Numbers: 18IT25, 18JG13, 19CT66, 19HT79, 19KT08, 20BT13, 20DT19, KME22C0673

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    760 units