BEUDAMED
    FDA Enforcement Class I Ongoing

    Endotracheal Tube oral/nasal uncuffed/plain - Murphy, REF 100382030

    Recall: Z-1874-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1874-2023
    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 100382030

    Reason

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

    Code Info

    UDI/DI 14026704340795, Batch Numbers: 18FT13, 18GT32, 18HG08, 18HG25, 18IG29, 18JG35, 18KG08, 18LG23, 19AG08, 19AG23, 19AG38, 19BG12, 19BG35, 19CT37, 19CT42, 19DT36, 19ET51, 19FT08, 19GT05, 19GT35, 19IT11, 19IT56, 19KT13, 19LT27, 20AT05, 20BT43, 20CT07, 20DT22, 20ET30, 20FT43, 20FT55, 20GT18, KME20K0276, KME20M3220, KME21A0764, KME21C0890, KME21C1020, KME21C1033, KME21C1572, KME21C2686, KME21D1293, KME21D1448, KME21D1743, KME21D1913, KME21F0962, KME22A2454, KME22C1763, KME22D2425, KME22D2823, KME22E0291, KME22E0560, KME22E2506, KME22E2684, KME22E2925, KME22F1606, KME22J1478, KME22K0878, KME22L2920, KME22M0084, KME22M0213

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    25160 units