BEUDAMED
    FDA Enforcement Class I Ongoing

    Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170075

    Recall: Z-1832-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1832-2023
    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 170075

    Reason

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

    Code Info

    UDI/DI 4026704319589, Batch numbers: 18FG09, 18FG15, 18FG17, 18FG22, 18FG30, 18FT32, 18GG02, 18GG05, 18GG28, 18GT32, 18HG12, 18HG16, 18HG22, 18HG27, 18HG38, 18IG06, 18IG15, 18IG17, 18IG27, 18JG02, 18JG11, 18JG26, 18KG07, 18KG18, 18KG44, 18LG12, 18LG22, 19AG13, 19AG27, 19AG34, 19AG37, 19BG07, 19CT41, 19CT49, 19CT55, 19FT14, 19FT18, 19FT35, 19GT10, 19GT52, 19GT59, 19GT65, 19HT10, 19HT35, 19HT48, 19IT06, 19IT14, 19IT25, 19IT44, 19JT22, 19JT49, 19JT70, 19KT25, 19LT04, 19LT32, 20AT14, 20AT25, 20AT32, 20AT44, 20AT53, 20BG12, 20BT47, 20CT36, 20CT51, 20DT09, 20DT37, 20ET16, 20ET37, 20FT54, 20FT61, KME20H0977, KME20H0979, KME20J0575, KME20J2715, KME20K1352, KME20L1132, KME20M0033, KME20M0382, KME20M1149, KME20M1225, KME20M1227, KME20M1537, KME20M2881, KME20M2882, KME21A0824, KME21D1785, KME21F1326, KME21F1327, KME21G0544, KME21K1410, KME21L2179, KME21L2346, KME21L2347, KME21M0195, KME21M0869, KME21M0965, KME21M1267

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    38950 units