BEUDAMED
    FDA Enforcement Class I Ongoing

    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050

    Recall: Z-1930-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1930-2023
    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

    Endotracheal Tube oral/nasal uncuffed/plain - Magill, REF 100380050

    Reason

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

    Code Info

    UDI/DI 14026704340665, Batch Numbers: 18FG05, 18FT26, 18GT27, 18IG06, 18JG20, 18LG03, 18LT24, 19BG30, 19CT50, 19DT17, 19KT21, 19LT51, 20AT26, 20AT41, 20CT43, 20DT13, 20GG27, KME20H2359, KME20K1713, KME20L1811, KME20M2219, KME21A2253, KME21B0984, KME21L0988, KME22D2223, KME22D3339, KME22E0284, KME22F3118, KME22H2816

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    4110 units