BEUDAMED
    FDA Enforcement Class I Ongoing

    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140

    Recall: Z-1841-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1841-2023
    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 Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170140

    Reason

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

    Code Info

    UDI/DI 14026704647047, Batch Numbers: 18JG17, 18JG32, 18JG34, 18KG29, 18LG02, 18LG15, 18LG18, 19AG09, 19AG21, 19BG12, 19CT32, 19DT06, 19DT20, 19ET38, 19ET72, 19ET77, 19FT24, 19JT29, 20BG16, 20CT36, 20DT37, 20ET28, 20GG45, 20GT14, KME20H2017, KME20K0772, KME20K2549, KME20K2584, KME20L1491, KME20L2402, KME21A1159, KME21A1900, KME21A2810, KME21B0572, KME21B1688, KME21C0024, KME21C0493, KME21C2999, KME21L1921, KME21L1922, KME22B1077, KME22C2262, KME22C3452, KME22E1239, KME22F0049, KME22F1951, KME22H0913, KME22H0967, KME22H2910

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    10650 units