BEUDAMED
    FDA Enforcement Class I Ongoing

    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055

    Recall: Z-1922-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1922-2023
    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

    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055

    Reason

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

    Code Info

    UDI/DI 14026704340573, Batch Numbers: 18FT35, 18GG18, 18GG23, 18GT32, 18IG16, 18JG35, 18KG01, 18KG39, 18LG15, 18LG18, 18LG39, 19AG01, 19AG25, 19CG02, 19CT33, 19DT05, 19DT35, 19ET36, 19ET61, 19ET65, 19KT02, 20AT26, 20CT11, 20DT19, KME21A2087, KME21B1774, KME21B2624, KME21B2710, KME21B2711, KME21C0549, KME22A0758, KME22A2298, KME22A2299, KME22B1465, KME22B1666, KME22B2680, KME22C2315, KME22C2316, KME22D1671, KME22D2352, KME22E1006, KME22E1007, KME22E1406, KME22E1930, KME22F2204, KME22F2482

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    24752 units