N95/FFP2 respirator, N95/FFP2 mask
| Alert Number | A12/00418/21 |
| Brand | ELIS SHPK, myfixmask |
| Category | Protective equipment |
| Risk Type | Health risk / other |
| Notifying Country | Germany |
| Country of Origin | Unknown |
| Model Number | 001, 002 |
| Published | 26 March 2021 |
Risk Description
The particle/filter retention of the material is insufficient (measured value as low as 49%). Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. As a result of the labelling, the mask may be worn in areas where hazardous substances are in use or during activities involving asbestos; since the mask fails to offer sufficient protection, this could lead to asbestosis, with fatal consequences. The product does not comply with the Personal Protective Equipment 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): Destruction of the productDate of entry into force: 15/02/2021Type of economic operator to whom the measure(s) were ordered: OtherCategory of measure(s): Marking the product with appropriate warnings on the risksDate of entry into force: 01/02/2021Type of economic operator taking notified measure(s): ImporterCategory of measure(s): Import rejected at borderDate of entry into force: 01/02/2021
Product Description
Protective respiratory filtration half-face mask. Models 001 and 002 cannot be distinguished from each other on the basis of the printed labelling or the barcodes. Furthermore, the masks' labels differ from one mask to another and are not uniform. The product is also sold online.