Events

Recall of Device Recall Mammotome Revolve Dual Vacuum Assist Biopsy System

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Devicor Medical Products Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    74297
  • Event Risk Class
    Class 2
  • Event Number
    Z-2211-2016
  • Event Initiated Date
    2016-05-19
  • Event Date Posted
    2016-07-14
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-03
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147103
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Biopsy needle guide kit - Product Code OIJ
  • 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.

Device

Device Recall Mammotome Revolve Dual Vacuum Assist Biopsy System
  • Model / Serial
    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.
  • Product Classification
    Radiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • 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.
  • Product 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.
  • Manufacturer
    Devicor Medical Products Inc

Manufacturer

Devicor Medical Products Inc
  • Manufacturer Address
    Devicor Medical Products Inc, 300 E Business Way Fl 5, Cincinnati OH 45241-2384
  • Source
    USFDA