Events

Safety Alert for Heater-Cooler Devices

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Terumo Cardiovascular Systems Corporation.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2016-06-14
  • Event Date Posted
    2016-06-14
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160614.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • Extra notes in the data
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: terumo heater-cooler devices medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs), has issued a medical device safety alert concerning its heater-cooler devices. the affected devices are identified as follows:- a) sams tcm ii cooling and heating systems [catalog number: 4416, 164935, 164940] b) sams dual cooler-heaters [catalog number: 4332, 14114, 13460] the manufacturer is notifying all users of its heater-cooler devices that the distributor, intercon chemical company, no longer sells the intechlor sanitizer (product code 205) referenced in its heater-cooler cleaning instructions. however, the identical sanitizer is available from other sources. updated instructions on how to source a sanitizer are provided by the manufacturer. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 june 2016.

Device

Heater-Cooler Devices

Manufacturer

Terumo Cardiovascular Systems Corporation