BEUDAMED
    FDA Enforcement Class III Terminated

    Hidrex USA DP450

    Recall: Z-1236-2017 · Reported March 1, 2017

    Enforcement

    Recall Number
    Z-1236-2017
    Event ID
    76362
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Hidrex GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 1, 2017
    Initiation Date
    January 30, 2017
    Classification Date
    February 22, 2017
    Termination Date
    August 4, 2017
    Address
    Otto-Hahn-Str. 12, N/A, Heiligenhaus, N/A, N/A, Germany

    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.

    Code Info

    SN# 16-3.7091 to 16-3.7134, 17-3.7001 to 17-3.7020

    Distribution

    Nationwide throughout the US

    Quantity

    64 units