BEUDAMED
    FDA Enforcement Class I Ongoing

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060

    Recall: Z-1829-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1829-2023
    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 Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060

    Reason

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

    Code Info

    UDI/DI 4026704319558, Batch numbers: 18GG31, 18HG22, 18HG32, 18HG35, 18IG09, 18IG24, 18IG27, 18JG17, 18LG12, 19AG37, 19BG12, 19CT49, 19DT15, 19DT20, 19ET22, 19ET38, 19ET77, 19FT18, 19IT14, 19IT25, 19JT42, 20DT29, 20ET04, 20FT34, 20FT54, 20GG41, KME20H1653, KME20J1236, KME20J1237, KME20L1487, KME20L2379, KME20M0494, KME21A0384, KME21A1482, KME21C0293, KME21E1411, KME21G0757, KME21G2208, KME21G2209, KME21K0548, KME21K0549, KME21L0444, KME21M1392, KME22A1512, KME22A1513, KME22B1392

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    9400 units