Events

Recall of C-LINE ACCU-TEMP HIGH TEMP CAUTERY

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by XOMED 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
    38669
  • Event Risk Class
    III
  • Event Initiated Date
    1999-02-15
  • 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
    Some units have an incomplete seal at the peel-open end of the sterile unit package. (10 units per box).

Device

C-LINE ACCU-TEMP HIGH TEMP CAUTERY
  • Model / Serial
    Model Catalog: (Lot serial: Cat.# 84-44000 lot 16644100); Model Catalog: (Lot serial: Cat.# 84-42000 lot 14507500); Model Catalog: (Lot serial: Cat.# 84-44000 lot 14358100); Model Catalog: (Lot serial: Cat.# 84-44000 lot 16313200)
  • Manufacturer
    XOMED CANADA INC.

Manufacturer

XOMED CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC