BEUDAMED
    FDA Enforcement Class II Terminated

    ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.

    Recall: Z-0600-2016 · Reported January 13, 2016

    Enforcement

    Recall Number
    Z-0600-2016
    Event ID
    72753
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    KCI USA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 13, 2016
    Initiation Date
    November 25, 2015
    Classification Date
    January 6, 2016
    Termination Date
    November 17, 2016
    Address
    12930 W Interstate 10, N/A, San Antonio, TX, 78249-2248, United States

    Description

    ActiV.A.C. 300ml Canister (with Gel) for ActiV.A.C. Therapy System for the application of V.A.C. Therapy in the acute extended and home care settings. The software-controlled therapy unit applies negative pressure wound therapy. The dressing, to which the therapy unit is connected, enables distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister.

    Reason

    There is potential for small holes, the size of a pin, to develop in the pouches of the ActiV.A.C. Sterile Canisters.

    Code Info

    Models M8275058-JP/5 and M8275059/5. manufactured between October 5, 2014 and May 29, 2015. Labeled with a 23 month shelf life from the date of manufacture.

    Distribution

    Japan and Australia

    Quantity

    12,728 units