BEUDAMED
    FDA Enforcement Class I Ongoing

    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060

    Recall: Z-1923-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1923-2023
    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 100181060

    Reason

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

    Code Info

    UDI/DI 14026704340580, Batch Numbers: 18HG21, 18KG41, 18KG43, 18LG15, 19AG01, 19BG33, 19CT33, 19ET39, 19ET40, 19ET61, 19ET65, 20CT32, KME21M2381, KME22A2300, KME22C2820, KME22D1551, KME22D2353, KME22E1009, KME22E1144, KME22E1407, KME22F2205, KME22F3384

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    8610 units