BEUDAMED
    FDA Enforcement Class I Ongoing

    Preformed AGT Oral Endotracheal Tube Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080

    Recall: Z-1948-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1948-2023
    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 Murphy Eye, High Volume, Low Pressure Cuff, REF 111780080

    Reason

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

    Code Info

    UDI/DI 14026704341129, Batch Numbers: 18FG33, 18GG23, 18GG34, 18HG30, 18IG11, 18IG18, 18JG21, 18JG35, 18KG19, 18KG41, 19AG15, 19BG04, 19BG19, 19GT65, 19HT68, 19IT15, 19LT21, 20AT26, 20CT12, 20CT13, 20CT32, 20DT35, 20FT19, KME20M3089, KME20M3090, KME21A1299, KME21A2090, KME21B0716, KME21B1783, KME21B1962, KME21B2204, KME21B2676, KME21C0599, KME22B0591, KME22C2317, KME22D0156, KME22D2122, KME22D2752, KME22E1153, KME22G0816, KME22H2094, KME22H2235, KME22H3271, KME22J0148, KME22J0532, KME22J3210, KME22K2844

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    9070 units