BEUDAMED
    FDA Recall Terminated

    Cellfina Prep Pack, Part No. CP1

    Recall: Z-0749-2017 · Initiated November 14, 2016

    Recall

    Recall Number
    Z-0749-2017
    Event Number
    75682
    Firm
    Ulthera Inc
    FEI Number
    3006560326
    Product Code
    OUP
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 14, 2016
    Posted
    December 13, 2016
    Terminated
    September 13, 2017
    Address
    1840 S Stapley Dr, Ste 200, Mesa, AZ, 85204-6681

    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.

    Action

    Ulthera sent an Urgent Medical Device Recall letter dated November 15, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 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. Customers are informed of the actions to be taken. Customers with any technical or logistical questions are instructed to contact technical support at Ulthera, Inc. at (480) 619-4069. The letter informs the customers with questions related to their Cellfina business are instructed to contact Merz North America at 888-751-7546 or at [email protected].

    Distribution

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

    Quantity

    6562 units