Medical device manufacturer, Terumo Cardiovascular Systems, has issued a medical device safety alert concerning the following:
(Lot Number or Serial Number Range: All; and Dates of Distribution: 2 May 1985 through 10 Jun 2015)
Safety issues regarding water system quality of temperature controllers have been raised by different regulators in recent years. The concern stems from the potential for bacterial growth in the water systems that may be transmitted to patients during surgery and is likely related to the recommended water system cleaning practices and protocols employed. The manufacturer has worked to develop a revised cleaning protocol for the products, but still unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations.
The manufacturer advised that the affected products should no longer be used for clinical procedures and not for resell. Users should dispose of any affected products in their possession.
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 5 May 2021