BEUDAMED
    FDA Enforcement Class I Ongoing

    Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 504585

    Recall: Z-1852-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1852-2023
    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 504585

    Reason

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

    Code Info

    UDI/DI 4026704547647, Batch Numbers: 18FG13, 18FG15, 18FG25, 18GG20, 18GG28, 18HG12, 18HG19, 18IG06, 18IG27, 18JG02, 18JG23, 18JG26, 18KG18, 18KG23, 19AG05, 19AG31, 19AG37, 19CT17, 19CT58, 19CT71, 19DT02, 19ET32, 19ET45, 19FT14, 19FT24, 19GT52, 19HT61, 19HT80, 19IT39, 19KT17, 19KT48, 19LT50, 20AT32, 20AT53, 20BT05, 20CT12, 20CT44, 20DT09, 20DT37, 20GG27, 20GG45, 20GT38, KME20H0532, KME20J2404, KME20J2405, KME20K2625, KME20L0624, KME20L1482, KME20L2303, KME20L2832, KME21E1295, KME21K1874, KME21M1728, KME21M2447, KME21M2519, KME22B0987, KME22B1754, KME22B2155, KME22C0679, KME22C0866, KME22C2001, KME22C2381, KME22D0823, KME22F1553, KME22F2230, KME22H0145, KME22J0252, KME22J0259, KME22J0470, KME22J2352, KME22L2186, KME22L2295, KME22L2804

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    56640 units