BEUDAMED
    FDA Enforcement Class II Terminated

    Thoraguard Chest Tube Kit, 20 Fr

    Recall: Z-0105-2022 · Reported October 20, 2021

    Enforcement

    Recall Number
    Z-0105-2022
    Event ID
    88616
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centese Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 20, 2021
    Initiation Date
    August 31, 2021
    Classification Date
    October 13, 2021
    Termination Date
    August 7, 2023
    Address
    4156 S 52nd St, N/A, Omaha, NE, 68117-1324, United States

    Description

    Thoraguard Chest Tube Kit, 20 Fr

    Reason

    An adhesive joint in the SmartValve component of the device can become compromised resulting in a leak.

    Code Info

    Model: FGS-1126 Catalog Number: TGCT120020 Lot Numbers 20100102, 21031703, and 21053102

    Distribution

    Distribution to a single consignee located in California.

    Quantity

    310 kits