BEUDAMED
    FDA Recall 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 · Initiated December 17, 2014

    Recall

    Recall Number
    Z-1012-2015
    Event Number
    70086
    Firm
    Aesculap, Inc.
    FEI Number
    2916714
    Product Code
    JXG
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    December 17, 2014
    Posted
    January 26, 2015
    Terminated
    December 13, 2016
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    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).

    Action

    Aesculap sent an Important Correction and Removal and Field Safety Notification letter, dated December 17, 2014, to all affected customers. The letter identiifed the affected product, problem, and actions to be taken. Customers were requested to remove from inventory and contact Aesculap regarding return of the affected devices and acknowledgement form.

    Distribution

    Worldwide Distribution - US Nationwide

    Quantity

    772