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