BEUDAMED
    FDA Recall Terminated

    DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number: 7211005

    Recall: Z-2077-2009 · Initiated May 27, 2009

    Recall

    Recall Number
    Z-2077-2009
    Event Number
    52211
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    FEI Number
    3003604053
    Product Code
    HRX
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    May 27, 2009
    Posted
    September 21, 2009
    Terminated
    May 8, 2012
    Address
    150 Minuteman Drive, Andover, MA, 01810-1031

    Description

    DYONICS 25 Fluid Management System Disposable Inflow/Outflow Tubeset With Single Suction Catalog Number: 7211005

    Reason

    The sterility of the device cannot be assured

    Action

    Smith & Nephew notified direct accounts by letter dated May 27, 2009 . International accounts notified by Smith & Nephew Inc. Endoscopy Division to each affected Outside United States (OUS) country or distributor by electronic communication, with telephone follow-up as required. The distributor is expected to notify each of their customers that has been confirmed to have product included in this recall.

    Distribution

    Worldwide Distribution -- USA, Korea, Australia, Hong Kong, India, Mexico, New Zealand, United Kingdom, Spain, Singapore, Austria, Poland, Russia, Finland, Denmark, Japan, Switzerland, China, Italy, Puerto Rico, France, Asia Pacific, Belgium, Canada, Norway, Thailand, The Netherlands, Malaysia, Brazil, Argentina, Chile, Colombia, Costa Rica, Venezuela, Turkey, Israel, Germany, UAE, Greece, and South Africa.

    Quantity

    67,697 units