The National Authority for Medicines and Health Products (Infarmed) ordered the recall of medical devices manufactured by the company Sterisets Manufacturing after serious incidents associated with the use of a product used in a clinical setting were recorded. The reports included symptoms such as fever, tremors and headaches.
The recall decision covers several medical devices from Sterisets Manufacturing, which were prohibited from being commercialised or used until the situation is resolved.
The inspection carried out by the regulatory authority identified failures in the quality system of the company responsible for manufacturing the devices, which motivated the safety measure imposed.
Infarmed took this decision as a preventive measure to protect patient health, ensuring that the products in question are not continue to be used while their safety and compliance with applicable standards is not confirmed.
