BEUDAMED
    FDA Enforcement Class II Terminated

    PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    Recall: Z-1135-2014 · Reported March 12, 2014

    Enforcement

    Recall Number
    Z-1135-2014
    Event ID
    67454
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    KCI USA, INC.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    March 12, 2014
    Initiation Date
    January 30, 2014
    Classification Date
    March 4, 2014
    Termination Date
    April 6, 2015
    Address
    12930 IH 10 West, San Antonio, TX, 78249, United States

    Description

    PRE1001: Prevena Peel and Place System Kit Product Usage: The Prevena Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

    Reason

    Prevena Incisional Management System Kit/Dressing Connector - the male connector on the tubing is difficult to connect to the female connector on the Prevena canister tubing

    Code Info

    Kit Lot #'s 2363893, 2367890, 2368876, 2368877, 2379870, 2382869, 2389874, 2397884, 2406889, 2410933, 2411866, 2417879, 2423890

    Distribution

    USA Nationwide Distribution

    Quantity

    20,850 units total