BEUDAMED
    FDA Enforcement Class I Ongoing

    Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540

    Recall: Z-1857-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1857-2023
    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

    Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506540

    Reason

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

    Code Info

    UDI/DI 4026704547692, Batch Numbers: 18FG05, 18FG13, 18FG22, 18GG17, 18GG28, 18GT32, 18HG16, 18JG02, 18JG17, 18JG32, 18JG34, 18KG29, 18KG35, 18LG02, 18LG12, 18LG18, 18LG28, 19AG21, 19BG21, 19BG40, 19ET38, 19ET60, 19ET72, 19FT01, 19FT18, 19FT35, 19GT05, 19GT28, 19HT15, 19HT40, 19HT80, 19IT39, 19JT57, 19LT04, 19LT17, 20AT09, 20AT32, 20AT53, 20BT23, 20CT12, 20CT22, 20CT36, 20ET49, 20ET56, 20GG45, KME20J2322, KME20K0940, KME20K2247, KME20L0621, KME20L1470, KME20L2029, KME20M2093, KME20M2481, KME21A0670, KME21A2814, KME21B1689, KME21B1692, KME22B1078, KME22C1972, KME22C2370, KME22D0541, KME22D0788, KME22E0224, KME22E1238, KME22F0048, KME22G2817

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    16400 units