BEUDAMED
    FDA Recall 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 · Initiated August 13, 2014

    Recall

    Recall Number
    Z-2688-2014
    Event Number
    69137
    Firm
    Smith & Nephew, Inc.
    FEI Number
    3006760724
    Product Code
    OMP
    Status
    Terminated
    Root Cause
    No Marketing Application
    Initiated
    August 13, 2014
    Posted
    September 23, 2014
    Terminated
    August 6, 2015
    Address
    970 Lake Carillon Dr, Ste 110, Saint Petersburg, FL, 33716-1130

    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.

    Action

    All RENASYS EZ Products will be removed from the field and customers will be transitioned to other product. On August 13, 2014 the firm sent an "Urgent- Medical Device Removal RENASYS EZ" notification via FedEx overnight asking that the use of the RENASYS EZ should be immediately discontinued and the device should be returned to Smith & Nephew. If you have questions, please reach out to your Customer Care representative or call 1-800-876-1261 Monday through Friday, 8:00 AM to 6:00 PM, Eastern Time.

    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