Events

Recall of SENOMARK BREAST TISSUE MARKER FOR ENCOR

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD CANADA 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
    12957
  • Event Risk Class
    III
  • Event Initiated Date
    2016-10-14
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Bard has confirmed that specific product code / lot number combinations of senomark ultracor mri breast tissue markers may have incorrect instructions for use (ifu) containing a table in the description section misidentifying the wireform shape and material. the label on the outside of the box contains the correct information.

Device

SENOMARK BREAST TISSUE MARKER FOR ENCOR
  • Model / Serial
    Model Catalog: SMUCMRI14GT (Lot serial: >10 NUMBERS (CONTACT MFR)); Model Catalog: SMUCMRI14GSS (Lot serial: >10 NUMBERS (CONTACT MFR))
  • Product Description
    SENOMARK ULTRACOR BREAST TISSUE MARKERS
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.