BEUDAMED
    FDA Enforcement Class II Terminated

    Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    Recall: Z-1012-2015 · Reported February 4, 2015

    Enforcement

    Recall Number
    Z-1012-2015
    Event ID
    70086
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2015
    Initiation Date
    December 17, 2014
    Classification Date
    January 26, 2015
    Termination Date
    December 13, 2016
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    Miethke Shunt System accessories Product Usage: - The Miethke Shunt System is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    Reason

    Some Miethke Shunt System accessories may have an incorrect MR safety symbol on the shelf box label. The label should have NO symbol but instead is marked with the MR conditional symbol. The product is MR unsafe. This information is only required to be in the Instructions for Use (IFU).

    Code Info

    material numbers: FV400T FV401T FV402T FV403T FV404T FV405T FV406T FV407T FV408T FV409T FV499T FV790T FV791T FV792T FV793T FV794T FV795T FV796T

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    772