BEUDAMED
    FDA Enforcement Class I Ongoing

    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080050

    Recall: Z-1958-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1958-2023
    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 112080050

    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: 18FG07, 18JG33, 18JG36, 18LT16, 19CT26, 19KT38, 19LT07, 20AT41, 20CT13, 20ET17, KME20K1512, KME22B0593, KME22E2347, KME22H1178, KME22H3021

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    1750 units