BEUDAMED
    FDA Recall Terminated

    Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy

    Recall: Z-2609-2010 · Initiated July 9, 2010

    Recall

    Recall Number
    Z-2609-2010
    Event Number
    56160
    Firm
    Convatec Inc.
    FEI Number
    3011987967
    Product Code
    OMP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    July 9, 2010
    Posted
    September 28, 2010
    Terminated
    June 7, 2011
    Address
    200 Headquarters Park Drive, Skillman, NJ, 08558-2600

    Description

    Engenex Non Acute Care Suction Pump for use with Engenex Negative Pressure Wound Therapy

    Reason

    Reduced vacuum capacity has been reported with a small number of units caused by electrostatic discharge (ESD) or static electricity.

    Action

    Recall notification letters were sent to 46 customers, acute care facilities and durable medical device distributors on July 9, 2010, by Federal Express.

    Distribution

    Nationwide distribution.

    Quantity

    1190 units