Ministry blocks sale of new U-Mask model, 'health risks'
Il Ministry of Health has ordered the “ban on the marketing and simultaneous recall from the market” of the “U-Mask Model 2.1”, the new version of the well-known masks, which in recent months have been at the center of an investigation by the Milan Public Prosecutor’s Office for fraud in the exercise of trade. The previous model, the “Model 2”, had been the subject of a similar provision by the General Directorate of Medical Devices and Pharmaceutical Service of the Ministry, at the end of February.
The ban on sales and withdrawal from the market was decided, as stated in the provision, "in consideration of the intended use of the product", i.e. as a medical device, "as well as the potentially significant risks to human health resulting from the absence of a regular evaluation process in terms of safety and efficacy and the consequent lack of guarantee on the actual suitability as a tool for preventing infections".
The Carabinieri Command for Health Protection will verify compliance with the provision and the company will be able to appeal to the same Ministry within 30 days or to the TAR within 60 days. At the end of January, among other things, the Carabinieri of the Nas of Trento had seized a laboratory in Bolzano that had carried out certifications on the previous model of masks.
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