BEUDAMED
    FDA Enforcement Class I Ongoing

    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100180050

    Recall: Z-1865-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1865-2023
    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 100180050

    Reason

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

    Code Info

    UDI/DI 14026704340474, Batch Numbers: 18IG24, 18KG10, 18KG22, 18LG06, 18LG33, 19AG21, 19AG36, 19DT06, 19ET12, 19ET58, 19GT44, 19HT04, 19HT66, 19IT12, 19LT32, 20DT14, 20GG27, KME20J1208, KME21B0077, KME21C0441, KME22D3452, KME22F0736, KME22G0655

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    4146 units