BEUDAMED
    FDA Enforcement Class II Terminated

    RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

    Recall: Z-2688-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2688-2014
    Event ID
    69137
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2014
    Initiation Date
    August 13, 2014
    Classification Date
    September 23, 2014
    Termination Date
    August 6, 2015
    Address
    970 Lake Carillon Dr, Ste 110, Saint Petersburg, FL, 33716-1130, United States

    Description

    RENASYS EZ Negative Pressure Wound Therapy (NPWT) System (RENASYS EZ) for patients who would benefit from a suction device particulary as the device may promote wound healing.

    Reason

    Modification were made to the RENASYS EZ NPWT Systems without a 510(k) or PreMarket Approval notification.

    Code Info

    Model #'s 66800059, all lots since product launched 01/16/2009

    Distribution

    Worldwide Distribution- US (nationwide) including MA, MN, NY and Puerto Rico; Canada, Mexico, Dubai, Australia, Chile, Colombia, Germany, France, England, Spain, Italy, Norway, Hong Kong, Shanghai, New Zealand, South Africa, Singapore, Japan, Thailand and the Caribbean Islands.

    Quantity

    2,142 units