Particle filter mask PRINTEXMedical “priuMask” — risk: health risk / other

Product

Particle filter mask — PRINTEXMedical

Brand

PRINTEXMedical

Name / model

priuMask · P21H1

Batch number(s)

21.12.2020

Category

Protective equipment

• 5-pack of respiratory face masks branded as FFP2, in a transparent foil packaging.
• Recall information: https://ffp.productions/wp-content/uploads/2021/08/Kundenhinweis.pdf

What is the risk?

• The particle/filter retention of the material is insufficient (measured values: as low as 84%). Furthermore, the mask may lack a nose clip, therefore it cannot be correctly adapted to the user's face. 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): Ban on the marketing of the product and any accompanying measures
• Date of entry into force: 26/08/2021
• Type of economic operator to whom the measure(s) were ordered: OtherCategory of measure(s): DIN EN 149: Respiratory protective devices – Filtering half-masks to protect against part
• Date of entry into force: 26/08/2021
• Type of economic operator taking notified measure(s): ManufacturerCategory of measure(s): Enclose required documents
• Date of entry into force: 26/08/2021
• Type of economic operator taking notified measure(s): ManufacturerCategory of measure(s): Destruction of the product
• Date of entry into force: 26/08/2021
• Type of economic operator taking notified measure(s): ManufacturerCategory of measure(s): Withdrawal of the product from the market
• Date of entry into force: 26/08/2021

Photos