Events

Recall of SENOCOR BIOPSY DEVICE

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
    34549
  • Event Risk Class
    III
  • Event Initiated Date
    2016-04-14
  • 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
    Specific product codes and lot numbers of encor biopsy probes (vertical configuration) may have an incorrect sample trap assembly (lateral configuration). a portion of the affected lots contain units with incorrect sample trap assemblies affixed to the probe inside the product tray. the labeling on the outer product carton and inside packaging tray is correct. the incorrect sample trap assembly contains a shorter vacuum tubing and no clear tray cover.

Device

SENOCOR BIOPSY DEVICE
  • Model / Serial
    Model Catalog: ECP0112GV (Lot serial: >10 LOTS CONTACT MFR); Model Catalog: ECP0110GV (Lot serial: >10 LOTS CONTACT MFR); Model Catalog: ECP017GV (Lot serial: >10 LOTS CONTACT MFR)
  • Product Description
    BARD ENCOR PROBES
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.