BEUDAMED
    FDA Enforcement Class II Terminated

    Cellfina Prep Pack, Part No. CP1

    Recall: Z-0749-2017 · Reported December 21, 2016

    Enforcement

    Recall Number
    Z-0749-2017
    Event ID
    75682
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ulthera Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 21, 2016
    Initiation Date
    November 14, 2016
    Classification Date
    December 13, 2016
    Termination Date
    September 13, 2017
    Address
    1840 S Stapley Dr Ste 200, Mesa, AZ, 85204-6681, United States

    Description

    Cellfina Prep Pack, Part No. CP1

    Reason

    It was discovered that a non-sterile vacuum tube is supplied within the pack, although the Instructions for Use (IFU) describe the use of a sterile vacuum tube as part of the procedure setup.

    Code Info

    all

    Distribution

    Worldwide Distribution - US Distribution and to the countries of :Europe (Austria, France, Germany, Italy, Netherlands, Switzerland, Spain, UK)

    Quantity

    6562 units