BEUDAMED
    FDA Enforcement Class I Ongoing

    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040

    Recall: Z-1871-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1871-2023
    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 100181040

    Reason

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

    Code Info

    UDI/DI 14026704340542, Batch Numbers: 18GG17, 18GG34, 18IG15, 18JG03, 18JG21, 18KG18, 18LG14, 18LG15, 19AG25, 19BG02, 19ET39, 19FT46, 19HT31, 19IT01, 19IT53, 19KT02, 19LT21, 20AT26, 20CT11, 20DT19, 20DT32, KME20J0427, KME20M0303, KME21A2096, KME21A3064, KME21B2620, KME21B2621, KME21C1148, KME21C3436, KME21D0720, KME21D2148, KME21M2369, KME22B0041, KME22B0278, KME22B0588, KME22C0507, KME22D3254, KME22F0607, KME22F2175

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    12852 units