Unsafe Particle Filter Masks Recalled in the EU

The European Union (EU) has recently recalled several particle
filter masks for non-compliance via its Rapid Alert System for dangerous
non-food products (RAPEX).

Market surveillance performed by EU Member States has found that these
masks failed to conform to requirements in:

  • Regulation (EU)
    2016/425 – Personal Protective Equipment (PPE)
  • EN 149 – harmonized standard for respiratory protective devices

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Non-conformities included:

  • Insufficient particle filter retention to match claims
  • Uncertified products bearing the CE mark
  • Face masks claimed to protect against viral particles, but their
    filtering capacity was uncertified and their use as biocidal products was
    unauthorized

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Filtering facepieces (FFP or face masks) should protect the wearer
from inhaling airborne liquid and solid particles.

Non-conforming products should be:

  • Rejected for importation
  • Withdrawn from the market and recalls
  • Temporarily banned
  • Marked with appropriate warnings
  • Banned from being marketed in the EU

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RAPEX provides EU citizens and businesses with information about products
that pose a serious risk to their health and which fail to meet EU legislative
requirements.

SGS
Medical PPE Services

SGS offers a
full range of services to help manufacturers and suppliers of medical PPE
deliver high quality, safe, and compliant products to markets around the world.
Learn more about SGS
Medical PPE
Services
.

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RAPEX Recall Particle Filter Masks from Markets
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For further information contact:

Louann Spirito

Consumer and Retail — Softlines

US & Canada Softlines Business Head

Tel: +1 973 461 7919

Email: crs.media@sgs.com

Website: www.sgs.com/softlines

LinkedIn: sgs-consumer-goods-&-retail

About SGS

SGS is the world’s leading inspection, verification, testing and
certification company. SGS is recognized as the global benchmark for quality
and integrity. With more than 89,000 employees, SGS operates a network of over
2,600 offices and laboratories around the world.

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