BEUDAMED
    FDA Recall Terminated

    PRE2055: Prevena Customizable Dressing 5-Pack 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-1140-2014 · Initiated January 30, 2014

    Recall

    Recall Number
    Z-1140-2014
    Event Number
    67454
    Firm
    KCI USA, INC.
    FEI Number
    3009897021
    Product Code
    OMP
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 30, 2014
    Posted
    March 5, 2014
    Terminated
    April 6, 2015
    Address
    12930 IH 10, West San Antonio, TX, 78249

    Description

    PRE2055: Prevena Customizable Dressing 5-Pack 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

    Action

    KCL sent an Urgent Voluntary Medical Device Correction letter dated February 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to locate, quarantine and return the affected device. For a replacement of the affected product and questions customers were instructed to contact KCL Customer Technical Support at 1-800-275-4524. A Product Reconciliation Form is attached to be completed and returned.

    Distribution

    USA Nationwide Distribution

    Quantity

    20,850 units total