BEUDAMED
    FDA Enforcement Class I Ongoing

    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382040

    Recall: Z-1935-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1935-2023
    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 - Murphy, REF 100382040

    Reason

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

    Code Info

    UDI/DI 14026704340818, Batch Numbers: 18FG31, 18FG33, 18FT13, 18GG15, 18HG08, 18HG10, 18HG25, 18IG13, 18JG08, 18KG09, 18KG33, 18LG01, 19BG12, 19BG35, 19ET09, 19FT12, 19GT05, 19IT11, 19KT20, 19KT38, 20AT37, 20CT12, 20CT53, 20DT04, 20ET56, 20FT21, 20FT43, 20GT18, KME20G0126, KME20H0286, KME20H1091, KME20H2041, KME20J2613, KME20K0326, KME20K0601, KME20M0209, KME20M1518, KME21B1133, KME21B1830, KME21C1573, KME21C1675, KME21C2245, KME21C3124, KME21D0525, KME21J0629, KME21K0797, KME21L2516, KME21L2526, KME21M0868, KME22C2637, KME22D0032, KME22D0811, KME22D0943, KME22D1009, KME22E0606, KME22E1274, KME22E2288

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    17102 units