BEUDAMED
    FDA Enforcement Class I Ongoing

    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170150

    Recall: Z-1843-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1843-2023
    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 170150

    Reason

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

    Code Info

    UDI/DI 14026704644930, Batch Numbers: 18JG21, 18KG18, 19AG09, 19AG37, 19CT32, 19DT33, 19ET38, 19ET77, 19GT45, 19IT54, 20DT29, 20ET56, KME20K0157, KME20L1845, KME20L1846, KME21A0892, KME21B1697, KME21J0153, KME22B1390, KME22B2161, KME22C3335, KME22C3453, KME22F1351, KME22F2419

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    2940 units