Personal Face Mask N95

Health risk / other Protective equipment Serious risk
Photo of recalled product: Personal Face Mask N95
Alert NumberA12/00690/21
BrandPanodyne
CategoryProtective equipment
Risk TypeHealth risk / other
Notifying CountryMalta
Country of OriginUnknown
Model NumberFBN95M-U
Published21 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)

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