priuMask
| Alert Number | A12/01580/21 |
| Brand | PRINTEXMedical |
| Category | Protective equipment |
| Risk Type | Health risk / other |
| Notifying Country | Germany |
| Country of Origin | Unknown |
| Model Number | P21H1 |
| Published | 19 November 2021 |
Risk Description
The particle/filter retention of the material is insufficient (measured values: as low as 84%). Furthermore, the mask may lack a nose clip, therefore it cannot be correctly adapted to the user's face. Consequently, the product does not fulfil the health and safety requirements; thus, even if combined with other recommended measures, it may not properly protect. The product does not comply with the Personal Protective Equipment (PPE) Regulation and with the relevant European standard EN 149.
Measures Taken
Type of economic operator to whom the measure(s) were ordered: OtherCategory of measure(s): Ban on the marketing of the product and any accompanying measuresDate of entry into force: 26/08/2021Type of economic operator to whom the measure(s) were ordered: OtherCategory of measure(s): DIN EN 149: Respiratory protective devices – Filtering half-masks to protect against partDate of entry into force: 26/08/2021Type of economic operator taking notified measure(s): ManufacturerCategory of measure(s): Enclose required documentsDate of entry into force: 26/08/2021Type of economic operator taking notified measure(s): ManufacturerCategory of measure(s): Destruction of the productDate of entry into force: 26/08/2021Type of economic operator taking notified measure(s): ManufacturerCategory of measure(s): Withdrawal of the product from the marketDate of entry into force: 26/08/2021
Product Description
5-pack of respiratory face masks branded as FFP2, in a transparent foil packaging.