Events

Recall of THERMOPHORE AUTOMATIC MOIST HEAT PACK

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by PERFORMANCE HEALTH 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
    20733
  • Event Risk Class
    II
  • Event Initiated Date
    2012-08-23
  • 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
    Battle creek equipment received a stop sale letter from health canada dated may 8 2012. it was determined that the thermophore automatic moist heat packs are unlicensed class ii medical devices.

Device

THERMOPHORE AUTOMATIC MOIST HEAT PACK
  • Model / Serial
    Model Catalog: N/A (Lot serial: 197); Model Catalog: N/A (Lot serial: 196); Model Catalog: N/A (Lot serial: 195); Model Catalog: N/A (Lot serial: 097); Model Catalog: N/A (Lot serial: 096); Model Catalog: N/A (Lot serial: 095)
  • Product Description
    THERMOPHORE AUTOMATIC MOIST HEAT PACK
  • Manufacturer
    PERFORMANCE HEALTH CANADA INC.

Manufacturer

PERFORMANCE HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Source
    HC