BEUDAMED
    FDA Enforcement Class II Terminated

    Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required.

    Recall: Z-1559-2015 · Reported May 6, 2015

    Enforcement

    Recall Number
    Z-1559-2015
    Event ID
    70899
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 6, 2015
    Initiation Date
    February 19, 2015
    Classification Date
    April 30, 2015
    Termination Date
    October 21, 2015
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834, United States

    Description

    Caviwave Pro Ultrasonic Cleaning System, Product Usage: To wash (remove tissue, blood and other contaminants) or dry laparoscopic and general surgical instruments prior to final disinfection and sterilization as required.

    Reason

    Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power during a processing cycle, the circulation pump may stop functioning. In addition, it is possible that the ultrasonic generator may stop working. The machine does not provide an alert notifying the user of this device malfunction.

    Code Info

    All units distributed between 12/20/2010 and 02/18/2015

    Distribution

    Worldwide Distribution - US Nationwide in the states of: AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, ND, NH,NJ, NM, NV, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, VT, WA, WI & WV and the countries of: Australia, Brazil, Canada, France, Mexico, Saudi Arabia, Spain, Taiwan & United Arab Emirates.

    Quantity

    491 units