Medical mask with two layers
Medical mask with two layers was recalled on 25 December 2020 under EU Safety Gate alert INFO/00182/20. Health risk / other risk reported by Romania. The product bears a CE marking and claims to meet the requirements of a surgical mask but it has not been certified as such by a relevant European body.
| Alert Number | INFO/00182/20 |
| Brand | PRIMA |
| Category | Protective equipment |
| Risk Type | Health risk / other |
| Notifying Country | Romania |
| Country of Origin | People's Republic of China |
| Published | 25 December 2020 |
Risk Description
The product bears a CE marking and claims to meet the requirements of a surgical mask but it has not been certified as such by a relevant European body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. The product does not comply with the requirements of the Medical Devices Directive and with the relevant European standard EN 14683.
Measures Taken
Type of economic operator to whom the measure(s) were ordered: RetailerCategory of measure(s): Withdrawal of the product from the marketDate of entry into force: 04/11/2020
Product Description
Green medical mask with two layers. Masks are described as Class 1 medical devices, but in the same time, as ,,General purpose face mask suitable for medical, food processing as well as industrial use."
🏥 What Should You Do?
This recall involves a health risk / other hazard related to Medical mask with two layers.
About this risk
This product poses a health risk that does not fall neatly into a single category. It may involve multiple hazards or an unusual safety concern identified by authorities.
Recommended action
Stop using the product and follow any specific instructions from the recall notice. Contact the manufacturer or your national consumer protection authority for more details.
Who is at risk?
All consumers who have purchased this product.