Ministry blocks sale of new U-Mask model, 'health risks'
Il Ministry of Health The Ministry of Health has ordered a "market ban and simultaneous recall" of the "U-Mask Model 2.1," the new version of the popular masks, which in recent months have been the subject of an investigation by the Milan Public Prosecutor's Office for commercial fraud. The previous model, "Model 2," had been subject to a similar measure by the Ministry's General Directorate for Medical Devices and Pharmaceutical Services at the end of February.
The ban on its sale and its withdrawal from the market was decided, as stated in the provision, "in consideration of the product's intended use," namely as a medical device, "as well as the potentially significant risks to human health resulting from the lack of a regular evaluation process in terms of safety and efficacy and the consequent lack of guarantees regarding its actual suitability as a tool for preventing infections."
The Carabinieri Health Protection Command will verify compliance with the order, and the company can appeal to the Ministry within 30 days or to the Regional Administrative Court (TAR) within 60 days. At the end of January, among other things, the Carabinieri of the NAS (National Anti-Corruption and Prevention Unit) of Trento seized a laboratory in Bolzano that had performed certifications on the previous model of masks.
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