BEUDAMED
    FDA Enforcement Class I Ongoing

    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120

    Recall: Z-1837-2023 · Reported July 5, 2023

    Enforcement

    Recall Number
    Z-1837-2023
    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

    Slick Set Uncuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170120

    Reason

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

    Code Info

    UDI/DI 14026704644879, Batch Numbers: 18JG23, 18JG26, 18JG34, 18KG26, 18LG05, 19AG18, 19AG21, 19AG24, 19AG37, 19BG01, 19BG04, 19BG07, 19BG12, 19BG16, 19CT58, 19CT71, 19DT06, 19DT20, 19ET77, 19FT14, KME20H0975, KME20H0976, KME20J0324, KME20K0771, KME20K2545, KME20K2568, KME20L0627, KME21A1886, KME21B1671, KME21B2506, KME21C2475, KME21D0447, KME21K1723, KME22A0056, KME22B0179, KME22B0180, KME22B0181, KME22B0464, KME22C2255, KME22C2256, KME22D1638, KME22D1639, KME22D1788, KME22E1489, KME22F1500, KME22F1669, KME22F1670, KME22G3099, KME22H3107, KME22H3275, KME22J2354, KME22J2355, KME22J2356, KME23A2360

    Distribution

    US Nationwide distribution including Puerto Rico.

    Quantity

    14160 units