BEUDAMED
    FDA Enforcement Class I Ongoing

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170090

    Recall: Z-1835-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1835-2023
    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 170090

    Reason

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

    Code Info

    UDI/DI 4026704319619, Batch Numbers: 18FG09, 18HG27, 18IG12, 18LG18, 19GT52, 19GT65, 19HT35, 20AT25, KME20L0625, KME21E1232, KME22E2491, KME22E2912

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    1460 units