BEUDAMED
    FDA Enforcement Class I Ongoing

    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180040

    Recall: Z-1863-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1863-2023
    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

    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180040

    Reason

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

    Code Info

    UDI/DI 14026704340450, Batch Numbers: 18GT26, 18KG10, 18LG33, 19AG21, 19BG12, 19CT36, 19DT42, 19FT29, 19FT49, 20DT24, KME20L2493, KME20M0278, KME21A0061, KME21B1925, KME21M1736, KME22C0700, KME22F0734, KME22G0184, KME22H0033, KME22H3078, KME22J0843

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    5120 units