BEUDAMED
    FDA Enforcement Class I Ongoing

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170055

    Recall: Z-1828-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1828-2023
    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 170055

    Reason

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

    Code Info

    UDI/DI 4026704319541, Batch numbers: 18FG18, 18GG14, 18GG31, 18HG22, 18KG23, 19BG12, 19ET72, 19IT25, 20AT25, 20AT32, 20BT05, 20BT37, 20BT47, 20ET21, KME20G0383, KME20K0936, KME20K2587, KME20L1469, KME20L2378, KME21G0756, KME21M0313, KME21M1832, KME22B0193, KME22D1787, KME22F1665

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    3530 units