BEUDAMED
    FDA Enforcement Class II Terminated

    Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

    Recall: Z-2211-2016 · Reported July 20, 2016

    Enforcement

    Recall Number
    Z-2211-2016
    Event ID
    74297
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Devicor Medical Products Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 20, 2016
    Initiation Date
    May 19, 2016
    Classification Date
    July 14, 2016
    Termination Date
    August 3, 2017
    Address
    300 E Business Way Fl 5, Cincinnati, OH, 45241-2384, United States

    Description

    Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled as sterile. Intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

    Reason

    A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.

    Code Info

    MST1009 - Lot F11537107D1 Exp. Date 9-Sept, 2018; MST0815 Lot F11536423D1 Exp. Date 8-Sept, 2018; and, MST1009 Lot F11537109D1 Exp. Date 10-Sept, 2018.

    Distribution

    Worldwide Distribution -- USA, including the states of AL, AR, CA, CT, DC, FL, GA, IL, KS, KY, LA, MA, MD, ME, MI, MN, MS, NC, NJ, NY, OH, PA, SC, TN, WA and WI; and, the countries of Canada and Japan, Korea, and The Netherlands.

    Quantity

    F11537107D1 = 360; F11536423D1 = 80; F11537109D1 = 360