BEUDAMED
    FDA Enforcement Class I Ongoing

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170085

    Recall: Z-1834-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1834-2023
    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 170085

    Reason

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

    Code Info

    UDI/DI 4026704319602, Batch Numbers: 18FG09, 18GG20, 18GG28, 18HG07, 18JG11, 18KG18, 19AG37, 19CT32, 19DT02, 19ET38, 19ET60, 19HT61, 19HT66, 19IT44, 19KT21, 19KT55, 19LT32, 20AT32, 20BT05, 20BT23, 20CT51, 20GG36, KME20L0398, KME20L2376, KME20M3247, KME21C0298, KME21E1296, KME21K1876, KME21L0573, KME22F0484

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    4370 units