BEUDAMED
    FDA Enforcement Class I Ongoing

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170065

    Recall: Z-1830-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1830-2023
    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 170065

    Reason

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

    Code Info

    UDI/ID 4026704319565, Batch numbers: 18FG05, 18FG25, 18GG05, 18GG10, 18GG20, 18GT32, 18HG19, 18HG32, 18HG38, 18IG09, 18JG04, 18JG06, 18JG34, 18KG35, 19AG13, 19AG37, 19BG01, 19CT58, 19CT71, 19DT15, 19ET60, 19FT41, 19GT38, 19HT15, 19HT61, 19HT66, 19IT25, 19JT18, 19JT22, 19JT57, 19JT70, 19KT41, 20AT25, 20AT53, 20BT27, 20CT05, 20CT22, 20DT37, 20ET21, 20GT14, KME20H0903, KME20H0904, KME20H2018, KME20J1239, KME20J1240, KME20K0938, KME20K2623, KME20L0487, KME20L1705, KME20M1578, KME20M1751, KME21K1127, KME21K1256, KME21K3029

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    15020