BEUDAMED
    FDA Recall Terminated

    DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is used for remote Control in a sterile field.

    Recall: Z-2448-2008 · Initiated August 7, 2008

    Recall

    Recall Number
    Z-2448-2008
    Event Number
    49132
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    August 7, 2008
    Posted
    September 21, 2008
    Terminated
    May 8, 2012
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is used for remote Control in a sterile field.

    Reason

    Integrity of the remote control bag may not be sufficient to prevent tearing or opening of the bag during use.

    Action

    Smith & Nephew Inc. Endoscopy Division contacted each affected user facility via confirmation letter and phone. An Urgent Product Correcetion Notification was sent on August 7, 2008. Users requested to discard the remote control bag form the kit and alternative suggestions provided. For further information please contact Paul Tiwari at 978-749-1397.

    Distribution

    Worldwide Distribution including USA and countries of Canada, Chile, Colombia, Greece, France, Australia, Netherlands, South Africa, United Kingdom, Japan, Dubai, Germany, India, Malaysia, Switzerland, Belgium, Italy, and Puerto Rico.

    Quantity

    11,469 units