The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning SEDASYS Computer-Assisted Personalized Sedation System [Product code: SEDPRU01], manufactured by Ethicon Endo-Surgery Inc.
The manufacturer has found that disinfecting methods not specified in the Instructions For Use (IFU) have led to the degradation of the plastic material of the SEDASYS System Control Unit.
According to the local supplier, the affected products are not distributed in Hong Kong.
For details, please refer to the FDA website:
http://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?action=select&recall_number=Z-2374-2015&w=09022015&lang=eng
If you are in possession of the affected products, please contact your supplier for necessary actions
Posted on 7 September 2015