BEUDAMED
    FDA Enforcement Class I Ongoing

    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180045

    Recall: Z-1864-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1864-2023
    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 100180045

    Reason

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

    Code Info

    UDI/DI 14026704340467, Batch Numbers: 18GT26, 18KG10, 18LG06, 19AG11, 19AG21, 19CT69, 19DT06, 19FT29, 19FT49, 19GT43, 19HT66, 19JT55, 19KT17, 19LT08, 19LT32, 20AT49, 20BT53, 20DT15, 20ET04, 20GG27, KME20H2636, KME20K1812, KME20K2573, KME21L2619, KME21M1773, KME22E2900, KME22G0347, KME22J3224, KME22K0489

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    4155 units