BEUDAMED
    FDA Enforcement Class I Ongoing

    Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555

    Recall: Z-1846-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1846-2023
    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 Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504555

    Reason

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

    Code Info

    UDI/DI 4026704547586, Batch Numbers: 18FG20, 18FG22, 18FG25, 18FT32, 18GG14, 18HG12, 18HG27, 18IG06, 18IG24, 18IG27, 18JG02, 18JG14, 18KG07, 18KG23, 18KG35, 18LG31, 19AG27, 19BG04, 19CT55, 19ET72, 19FT30, 19GT05, 19GT10, 19GT20, 19GT38, 19GT59, 19GT65, 19HT61, 19IT25, 19JT29, 19JT42, 19JT49, 19KT30, 19KT41, 19LT04, 19LT50, 20AT09, 20AT44, 20BT05, 20BT13, 20BT27, 20BT37, 20CT05, 20CT12, 20CT36, 20ET21, KME20G0388, KME20J0319, KME20J2321, KME21H1189, KME22A0148, KME22A2939, KME22A2940, KME22A3267, KME22A3268, KME22B1633, KME22B1751, KME22C3207, KME22D0590, KME22D1785, KME22E0619, KME22E0620, KME22F1666, KME22G0225, KME22G2294, KME22H3105, KME22J1458, KME22J1459, KME22J2714, KME22L1104, KME22L1105, KME23C0590

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    42214 units