BEUDAMED
    FDA Enforcement Class I Ongoing

    Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506550

    Recall: Z-1859-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1859-2023
    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 506550

    Reason

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

    Code Info

    UDI/DI 4026704547715, Batch Numbers: 18FG01, 18FG05, 18FG13, 18GG17, 18GG31, 18HG12, 18HG19, 18JG21, 18JG32, 18KG41, 18LG18, 18LG28, 19AG21, 19DT25, 19DT33, 19ET54, 19ET77, 19FT24, 19GT59, 19GT65, 19HT24, 19HT61, 19IT29, 19JT42, 19JT49, 19JT57, 19KT25, 20AT14, 20AT25, 20AT44, 20BT05, 20BT27, 20BT37, 20BT51, 20CT05, 20CT12, 20CT36, 20DT09, 20ET56, 20GT06, 20GT38, KME20H1790, KME20J2114, KME20J3032, KME20K1344, KME20L1842, KME20L1843, KME20L2299, KME20M2094, KME20M2483, KME21A2812, KME21B1693, KME21C0020, KME22B1976, KME22H3204

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    10600 units