BEUDAMED
    FDA Enforcement Class I Ongoing

    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080070

    Recall: Z-1961-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1961-2023
    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 112080070

    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: 18FG19, 18GG19, 18HG28, 18IG06, 18IG19, 18JG13, 18JG17, 18KG13, 18LT07, 19BG19, 19CT26, 19DT20, 19ET12, 19ET36, 19HT26, 19HT69, 19JT21, 19KT14, 19LT31, 19LT51, 20AT22, 20AT58, 20BT13, 20BT42, 20CT13, 20DT10, 20ET12, 20FT11, 20FT19, 20GG40, 20GT38, KME20K2577, KME20L1985, KME20M1771, KME20M1772, KME21F1585, KME21J0644, KME21J1078, KME22A1109, KME22A1781, KME22B0401, KME22F1174, KME22F2171, KME22G1295, KME22G2999

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    17950 units