BEUDAMED
    FDA Enforcement Class I Ongoing

    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080065

    Recall: Z-1960-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1960-2023
    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 112080065

    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: 18GT07, 18HG20, 18IG16, 18IG22, 18JG13, 19AT23, 19CT64, 19ET12, 19ET31, 19HT69, 19LT47, 20AT41, 20BT13, 20DT40, 20GT05, KME22A2193, KME22A2546, KME22B2739, KME22C2271, KME22E0189

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    6710 units