BEUDAMED
    FDA Enforcement Class I Ongoing

    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145

    Recall: Z-1842-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1842-2023
    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

    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170145

    Reason

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

    Code Info

    UDI/DI 14026704644923, Batch Numbers: 18JG14, 18LG15, 19AG24, 19BG12, 19BG16, 19CT49, 19IT25, 20BT05, 20CT12, 20CT51, 20DT29, 20GG41, KME20H2929, KME20K1886, KME20K2586, KME20L1488, KME20L2377, KME21A1891, KME21C0019, KME21C1566, KME21C1974, KME21D0445, KME21J1149, KME21M1818, KME21M2952, KME22D1896, KME22E1744

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    4320 units