BEUDAMED
    FDA Enforcement Class I Ongoing

    Endotracheal Tube oral/nasal Magill, High Volume, Low Pressure Cuff, REF 112080075

    Recall: Z-1962-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1962-2023
    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 112080075

    Reason

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

    Code Info

    UDI/DI Batch Numbers: 18FT26, 18GG17, 18GG19, 18HG15, 18HG37, 18IG04, 18IG29, 18JG17, 18KG10, 19AT23, 19CT64, 19ET12, 19ET24, 19GT31, 19HT69, 19IT11, 20AT22, 20BT13, 20BT42, 20CT02, 20CT54, 20DT09, 20FT21, 20FT60, 20GT18, KME20H0334, KME21F1534, KME22A2269, KME22B0741, KME22B0896, KME22B1031, KME22C0096, KME22E2348, KME22F2118,

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    13810 units