BEUDAMED
    FDA Enforcement Class I Ongoing

    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180030

    Recall: Z-1861-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1861-2023
    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 100180030

    Reason

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

    Code Info

    UDI/DI 14026704340436, Batch Numbers: 18GG26, 18GT26, 18JG14, 19AG21, 19CG07, 19CT69, 19DT42, 19ET34, 19FT29, 19HT04, 19IT43, 19KT17, 19LT08, 20DT15, 20DT24, 20ET56, KME20K1810, KME20M0946, KME20M2783, KME21A2389, KME21B0075, KME21B1923, KME22D1514, KME22F2666, KME22G0172, KME22G1751

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    3100 units