U-Mask 2.1, stop at the sale of the new mask model – Corriere.it

The Ministry of Health has ordered the prohibition of commercialization and the simultaneous provision of withdrawal from the market of the 2.1 U-mask model, the new version of the well-known masks, which in recent months ended up at the center of an investigation by the Milan Prosecutor’s Office for fraud in the exercise of commerce.

Withdrawal from the market

The prohibition of sale and withdrawal from the market It has been decided, as indicated in the provision, taking into account the intended use of the product, i.e. as a medical deviceas well as the potential significant health risks arising fromabsence of a regular evaluation process in terms of safety and efficacy and the consequent absence of guarantee on the actual suitability as an infection prevention tool (here the podcast: Effective or just elegant? The case of the anti-Covid U-Mask).

Filtration capabilities

Regarding the new model of the U-Mask, on the market for a few weeks, the ministry also pointed out that the results of the tests that the manufacturer has made available as an annex to the technical file do not provide scientific evidence on the ability to maintain filter performance unchanged for up to 200 hours of use. As stated in the provision, in fact, there are no test reports available proving that the characteristics of bacterial filtration efficiency, breathability and splash resistance They are held. The product was then removed from the medical device database.

The previous kidnapping in Bolzano

At the end of January, among other things, the Nas de Trento carabinieri had seized a laboratory in Bolzano that had carried out certifications on the previous model of the masks.(Here is the deepening on how much the masks protect, model by model).