BEUDAMED
    FDA Enforcement Class II Terminated

    CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    Recall: Z-3378-2018 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-3378-2018
    Event ID
    80811
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    B. Braun Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    July 20, 2018
    Classification Date
    October 1, 2018
    Termination Date
    May 13, 2020
    Address
    901 Marcon Blvd, Allentown, PA, 18109-9512, United States

    Description

    CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a catheter for delivery of anesthetics. The connector is used in conjunction with the catheter for continuous administration of anesthetic fluids.

    Reason

    The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.

    Code Info

    Batch: 61597444, 61603111, 61618684

    Distribution

    Worldwide Distribution: US (nationwide) and countries of: Australia, Canada, Guatemala and Kuwait.

    Quantity

    2070