BEUDAMED
    FDA Enforcement Class II Terminated

    07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    Recall: Z-1998-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-1998-2014
    Event ID
    68512
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Vascular Technology, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    July 16, 2014
    Initiation Date
    May 28, 2014
    Classification Date
    July 7, 2014
    Termination Date
    February 11, 2016
    Address
    12 Murphy Dr, Nashua, NH, 03062-1903, United States

    Description

    07-150-07 MIZUHO, MAL DISP DOPPLER PROBE BX 4, REF 138200 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    Reason

    Report of the product penetrating the sterile barrier; this could render the product unsterile.

    Code Info

    LOT NUMBER 11798-37631

    Distribution

    Worldwide Distribution - US including California and the countries of Australia, United Kingdom and Taiwan.

    Quantity

    164