Events

Recall of HYFRECATOR 2000

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CONMED CANADA.

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
    139451
  • Event Risk Class
    II
  • Event Initiated Date
    2017-02-24
  • 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
    A separate accessory package is included in each hyfrecator 2000 electrosurgical unit (esu) carton. this accessory package contains 2 sterile handpiece sheaths p/n 7-796-19. from december 2 2015 to january 3 2017 the accessory packages in the hyfrecator 2000 esu cartons were packaged in error by the manufacturer with non-sterile p/n 7-796-19 handpiece sheaths in pouches that were labeled as "sterile".

Device

HYFRECATOR 2000
  • Model / Serial
    Model Catalog: 7-900-115 (Lot serial: >10 NUMBERS CONTACT MFG)
  • Product Description
    HYFRECATOR 2000
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    CONMED Corp.
  • Source
    HC