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| Alert Number | A12/01064/21 |
| Brand | Univent medical |
| Category | Protective equipment |
| Risk Type | Health risk / other |
| Notifying Country | Germany |
| Country of Origin | Germany |
| Published | 23 July 2021 |
Risk Description
The total filtration capacity of the mask and the particle/filter retention of the material are insufficient (measured mean values as low as 78%, and measured filter penetration values as low as 89%, respectively). 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): Recall of the product from end usersDate of entry into force: UnknownType of economic operator taking notified measure(s): ManufacturerCategory of measure(s): Stop of salesDate of entry into force: Unknown
Product Description
White respiratory face mask with ear loops. The product was sold online, in particular via Amazon.