BEUDAMED
    FDA Recall Terminated

    Hidrex USA DP450

    Recall: Z-1236-2017 · Initiated January 30, 2017

    Recall

    Recall Number
    Z-1236-2017
    Event Number
    76362
    Firm
    Hidrex GmbH Otto-Hahn-Str. 12 Heiligenhaus Germany
    FEI Number
    3008642982
    Product Code
    EGJ
    Status
    Terminated
    Root Cause
    Error in labeling
    Initiated
    January 30, 2017
    Posted
    February 22, 2017
    Terminated
    August 4, 2017

    Description

    Hidrex USA DP450

    Reason

    The device was reclassified from a class III device to a class II device and there are new documentation requirements.

    Action

    Distributor sent recall notification letter to affected dealers and end users on 2/10/17. Notification letter will include a copy of the addendum to the user manual. The device is not instructed to be returned.

    Distribution

    Nationwide throughout the US

    Quantity

    64 units