Personal Face Mask N95
Personal Face Mask N95 was recalled on 21 May 2021 under EU Safety Gate alert A12/00690/21. Health risk / other risk reported by Malta. The product bears a CE marking but its filtering capacity has not been tested by a relevant competent European conformity assessment body.
| Alert Number | A12/00690/21 |
| Brand | Panodyne |
| Category | Protective equipment |
| Risk Type | Health risk / other |
| Notifying Country | Malta |
| Country of Origin | Unknown |
| Model Number | FBN95M-U |
| Published | 21 May 2021 |
Risk Description
The product bears a CE marking but its filtering capacity has not been tested by a relevant competent European conformity assessment body.Additionally, the particle/filter retention of the material is insufficient (measured values: as low as 39%), the total filtration capacity of the mask is insufficient (measured mean values: as low as 75%).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: 04/05/2021
Product Description
Face masks packed in individual labelled transparent plastic, in boxes of 50 Face masks with ear lugs marked (PM2.5 95 FFP2 Panodyne CE)
🏥 What Should You Do?
This recall involves a health risk / other hazard related to Personal Face Mask N95.
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.