BEUDAMED
    FDA Enforcement Class I Ongoing

    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181050

    Recall: Z-1873-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1873-2023
    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 100181050

    Reason

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

    Code Info

    UDI/DI 14026704340566, Batch Numbers: 18FG31, 18FT35, 18GG23, 18GT32, 18HG17, 18JG19, 18JG21, 18JG37, 18KG18, 18KG19, 18KG21, 18KG38, 18KG39, 18LG14, 19AG01, 19BG02, 19BG18, 19CG01, 19CG02, 19CT28, 19DT05, 19DT30, 19DT35, 19ET36, 19ET39, 19ET40, 19ET61, 19ET69, 19FT01, 20AT26, 20DT18, KME21A2039, KME21B2623, KME21C0543, KME21C1149, KME21C3398, KME21C3399, KME21D1236, KME21F0888, KME21L2303, KME21L2790, KME21M2313, KME21M2314, KME21M2317, KME21M2318, KME21M2380, KME21M2481, KME22A0760, KME22A2297, KME22B0755, KME22B2679, KME22C0412, KME22C2194, KME22C2195, KME22D1145, KME22D2262, KME22D3177, KME22F1334, KME22F2203, KME22F3000, KME22F3239, KME22F3241

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    54469 units