BEUDAMED
    FDA Recall 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 · Initiated May 19, 2016

    Recall

    Recall Number
    Z-2211-2016
    Event Number
    74297
    Firm
    Devicor Medical Products Inc
    FEI Number
    3008492462
    Product Code
    OIJ
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    May 19, 2016
    Posted
    July 14, 2016
    Terminated
    August 3, 2017
    Address
    300 E Business Way, Fl 5, Cincinnati, OH, 45241-2384

    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.

    Action

    An Urgent: Medical Device Recall of Mammotome Revolve Dual Vacuum Assist Biopsy Probe due to Potential Product Code Mislabel communication was sent to the customers via 1st class USPS on June 6, 2016. The labeling and the Customer response form was also attached. Customers were asked to examine their inventory and quarantine the affected product. If the product was further distributed, those customers are to be identified and notified. The letter stated that the assigned sales rep would be in contact to support the identification, inspection and replacement of the recalled products. Customers are to complete and return the enclosed response form. Questions are to be directed to Mammatome Customer Service 1-877-926-2666.

    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