BEUDAMED
    FDA Enforcement Class II Terminated

    The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.

    Recall: Z-0502-2015 · Reported December 10, 2014

    Enforcement

    Recall Number
    Z-0502-2015
    Event ID
    69600
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 10, 2014
    Initiation Date
    October 24, 2014
    Classification Date
    December 3, 2014
    Termination Date
    May 20, 2015
    Address
    3773 Corporate Pkwy, N/A, Center Valley, PA, 18034-8217, United States

    Description

    The Dual Switch Valve is used for fluid drainage from the ventricles into the peritoneum, in cases of hydrocephalus.

    Reason

    Aesculap Inc. (AIC (USA)) initiated a recall of Miethke Shunt System, Dual Switch Valve, due to incorrect product labeling on three units. The incorrect product labeling was the wrong expiration date, 2024-09, on the inner labeling of the sterile bag. However, the expiration date on the outer box was correct. No patient injuries were reported as a result of this issue.

    Code Info

    Item Number FV129 Lot Number 4506244166 Serial Number A10150

    Distribution

    US Distribution in Kansas only.

    Quantity

    1