BEUDAMED
    FDA Enforcement Class I Ongoing

    Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181045

    Recall: Z-1872-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1872-2023
    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 100181045

    Reason

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

    Code Info

    UDI/DI 14026704340559, Batch Numbers: 18FG31, 18FT35, 18GG17, 18GG25, 18GG34, 18HG17, 18IG14, 18JG16, 18JG35, 18JG37, 18KG17, 18KG36, 18KG41, 18LG14, 18LG39, 19AG25, 19BG02, 19BG32, 19CG01, 19CG02, 19CT26, 19CT53, 19CT56, 19CT57, 19DT03, 19DT34, 19DT42, 19ET61, 19GT13, 19GT16, 19GT60, 19HT59, 19LT36, 20AT26, 20CT05, 20CT32, KME21C1880, KME21D0722, KME21D1235, KME21D2149, KME21D2150, KME21L2312, KME21M0208, KME21M0957, KME21M0958, KME21M0959, KME21M2377, KME21M2379, KME22B0281, KME22B1307, KME22B1308, KME22B1464, KME22C0411, KME22C2193, KME22D1004, KME22D1005, KME22E1405, KME22E1503, KME22E2767, KME22F0777, KME22F1313, KME22F2624, KME22G0321, KME22G1706, KME22G2273, KME22H0491, KME22H1075, KME22H1324, KME22J0385

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    53216 units