BEUDAMED
    FDA Enforcement Class II Terminated

    07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 The Doppler probe is intended for the intraoperative and transcutaneous evaluation of blood flow.

    Recall: Z-2000-2014 · Reported July 16, 2014

    Enforcement

    Recall Number
    Z-2000-2014
    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

    07-150-12 MIZUHO, MINI, SLIM, STERILE, BOX OF 4, REF 138665 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 1516-37698

    Distribution

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

    Quantity

    34