BEUDAMED
    FDA Enforcement Class I Ongoing

    Flexi-Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 506525

    Recall: Z-1854-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1854-2023
    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 506525

    Reason

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

    Code Info

    UDI/DI 4026704547661, Batch Numbers: 18FG05, 18FG13, 18GG17, 18GG28, 18HG16, 18HG25, 18HG29, 18HG35, 18HG38, 18IG06, 18IG12, 18IG24, 18IG27, 18JG11, 18JG14, 18JG26, 18JG34, 18KG23, 18LG05, 18LG12, 18LG22, 19AG18, 19AG21, 19AG37, 19CT32, 19CT55, 19ET45, 19GT05, 19GT20, 19GT38, 19GT59, 19HT05, 19HT15, 19HT40, 19HT80, 19IT29, 19KT08, 19KT25, 19KT41, 19KT48, 19LT04, 20AT25, 20AT46, 20BT13, 20BT27, 20CT12, 20CT22, 20CT36, 20CT51, 20DT37, 20ET16, 20ET28, 20FT44, KME20L0615, KME20M2047, KME21A1889, KME21A1890, KME21A2804, KME21B1143, KME21B1672, KME21C0063, KME21C0301, KME21M1833, KME22B0302, KME22B1071, KME22C3357, KME22D0784, KME22D1062, KME22D3648, KME22E1130, KME22F0161, KME22F1501, KME22G0561, KME22G1100, KME22H2626, KME22K0013, KME22K0331, KME22K2365, KME22L0760

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    17551 units