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SECURITY NOTICE Cross-border falsification of devices
15.03.22    Urgent alert

SECURITY NOTICE Cross-border falsification of devices

Notice of falsification of medical devices manufactured by Fin-ceramica Faenza spa and similar for type to MaioRegen 

Fin-ceramica Faenza spa, as the manufacturer of the medical devices, similar for type to MaioRegen hereby gives notice that a Turkish economic operator has communicated the existence of falsified medical devices in Turkey with falsified packaging and potentially altered contents.
At present, the presence of such falsified medical devices cannot be excluded on the Italian and European territory.
To date, the manufacturer has not been able to analyse the products subject to falsification since they are not available.
They bear the logo no longer in use but similar to the originals of the manufacturer  and  the name “cartilage layer”.
 

As a precautionary measure, we undertake to promptly inform the Ministry of Health, public and private healthcare facilities, economic operators, and the relevant Local Health Authorities (ASL).
Operating instructions for end users: if, in your commercial and healthcare facilities, you receive or find products believed to be falsified, or even if in doubt, these SHOULD NOT BE USED! Therefore, for your safety and for the safety of patients, clearly mark the products and store them safely.
Immediately contact our head office to allow the definitive recognition and collection of the above products by authorized and qualified personnel of the manufacturer.

For further details read the attachement (download pdf)

  
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