BEUDAMED
    FDA Enforcement Class II Terminated

    ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

    Recall: Z-2542-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2542-2020
    Event ID
    85734
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    KCI USA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 15, 2020
    Initiation Date
    June 8, 2020
    Classification Date
    July 9, 2020
    Termination Date
    February 7, 2023
    Address
    12930 W Interstate 10, San Antonio, TX, 78249-2248, United States

    Description

    ACTIV.A.C Therapy System; Model Numbers; US: 340000 ACTIV.A.C., NORTH AMERICAN UDI (01)00878237008188 - Product Usage: is an integrated wound management system for use in the acute, extended, and home care settings. When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

    Reason

    The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.

    Code Info

    Products produced from 2007 to 2020 (with software versions up to 3.11) All serial numbers affected for the following model numbers: US: 340000 ACTIV.A.C., NORTH AMERICAN RTMGSM01/US ACTIVAC - RTM, NORTH AMERICAN Outside: 340001 ACTIV.A.C., UNITED KINGDOM 340003 ACTIV.A.C., AUSTRALIAN 340004 ACTIV.A.C., SPANISH 340005 ACTIV.A.C., GERMAN 340006 ACTIV.A.C., FRENCH 340007 ACTIV.A.C., ITALIAN 340008 ACTIV.A.C., DUTCH 340009 ACTIV.A.C., DANISH 340010 ACTIV.A.C., SWEDISH 340012 ACTIV.A.C., JAPAN 340013 ACTIV.A.C., CANADIAN 340015 ACTIV.A.C., TURKEY 340123 ACTIV.A.C., INDIA 340356 ACTIV.A.C., BRAZIL 415311 ACTIV.A.C., CZECH 415312 ACTIV.A.C., HUNGARIAN 415313 ACTIV.A.C., SLOVAKIAN 415314 ACTIV.A.C., CROATIAN 415315 ACTIV.A.C., POLAND 415316 ACTIV.A.C., SLOVENIA 415317 ACTIV.A.C., SOUTH AFRICA 416008 ACTIV.A.C., INDONESIA 416162 ACTIV.A.C., CHINA 416564 ACTIV.A.C., PHILIPPINES 416599 ACTIV.A.C., EUROPEAN UNION

    Distribution

    Worldwide distribution - US Nationwide distribution including in the states of AZ, FL, IL, OH, MD, ND, NV, OK, SC, TN, TX, UT, VA, WA and Puerto Rico. The country of Australia, Austria, Canada, China, France, Germany, Japan, Hong Kong, India, Indonesia, Malaysia, New Zealand, Philippines, South Korea, Sri Lanka, Switzerland, Taiwan, Thailand, United Kingdom and Vietnam.

    Quantity

    5,823 units