BEUDAMED
    FDA Recall 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 · Initiated June 8, 2020

    Recall

    Recall Number
    Z-2542-2020
    Event Number
    85734
    Firm
    KCI USA, INC.
    FEI Number
    3009897021
    Product Code
    OMP
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    June 8, 2020
    Terminated
    February 7, 2023
    Address
    12930 W Interstate 10, San Antonio, TX, 78249-2248

    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.

    Action

    For Customer Owned units, KCI plans to notify customers via customer letters delivered by common carriers or via email communication that the ACTIV.A.C." Therapy Unit may shut down without notification to the user. The customer letter notification or email communication will inform customers to coordinate the product software change. The recalling firm sent an URGENT - MEDICAL DEVICE RECALL letter to the affected customers on 06/08/2020. The completed Customer Response Form is to be returned to [email protected]

    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