BEUDAMED
    FDA Enforcement Class II Terminated

    Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    Recall: Z-0989-2014 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-0989-2014
    Event ID
    67174
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2014
    Initiation Date
    December 23, 2013
    Classification Date
    February 19, 2014
    Termination Date
    October 1, 2014
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Aesculap proSA Adjustment Disc Size Large (L) The Miethke proSA Adjustment shunt system is intended to shut cerebrospinal fluid from the lateral ventricles of the brain into the peritoneum.

    Reason

    The accuracy is out of specification for the Aesculap proSA Adjustment Disc Size L.

    Code Info

    4 lots: 4505268906, 4505336973, 4505408485, 4505238953

    Distribution

    Worldwide Distribution - US Distribution including the states of AZ, MD, MA, WI, MI, MN, DE, KS, and FL., and the countries of Australia, Germany, Great Britain, Norway and Japan.

    Quantity

    79