BEUDAMED
    FDA Recall Terminated

    Thoraguard Chest Tube Kit, 20 Fr

    Recall: Z-0105-2022 · Initiated August 31, 2021

    Recall

    Recall Number
    Z-0105-2022
    Event Number
    88616
    Firm
    Centese Inc.
    FEI Number
    3017435705
    Product Code
    GBX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 31, 2021
    Terminated
    August 7, 2023
    Address
    4156 S 52nd St, Omaha, NE, 68117-1324

    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.

    Action

    The impacted consignee was notified via email of the recall on 08/31/2021. The customer has been instructed to immediately cease product use and return all impacted product to the recalling firm.

    Distribution

    Distribution to a single consignee located in California.

    Quantity

    310 kits