BEUDAMED
    FDA Recall Terminated

    Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

    Recall: Z-1136-2017 · Initiated December 28, 2016

    Recall

    Recall Number
    Z-1136-2017
    Event Number
    76130
    Firm
    Medtronic Advanced Energy, LLC
    FEI Number
    1000517638
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    December 28, 2016
    Posted
    February 2, 2017
    Terminated
    May 11, 2017
    Address
    180 International Dr, Portsmouth, NH, 03801-6837

    Description

    Intact Disposable Wands (part of the Intact System) 900-130: 5 Pack 30mm Disposable Product Usage: The Intact Medical disposable wands are intended to provide breast tissue for histologic examination with partial or complete removal of an imaged abnormality and to provide breast tissue for histologic examination with partial removal of a palpable abnormality.

    Reason

    Product sterility compromised due to breach of sterile barrier

    Action

    Medtronic Advanced Energy notified customers by letter on December 27, 2016 via Next Day FEDEX. The communication advises users to immediately stop using the affected Intact Disposable Wands and to quarantine them until they can be returned to Medtronic. Medtronic Sales representatives will arrange for the return of all recalled product.

    Distribution

    Worldwide Distribution - US Nationwide in the countries of China, Greece, Netherlands, Egypt, Turkey, and Switzerland.

    Quantity

    105 units