News

Search the news

2021-04-06

Pandemic related product alerts | wk 12 & 13

Pandemic related product alerts | wk 12 & 13
Remarkable

Introduction

What do you need to ask when buying or producing face masks? What legislation is applicable to face masks? What are market surveillance authorities (MSA's) looking for? By analysing the weekly reposrt of Safety Gate we summarise for you what to look for. Products that don't cause hassle, ProductIP helps you! 

Summary



 

Content

The product alerts publsihed here are always published on Safety Gate: the rapid alert system for dangerous non-food products

If you are an economic operator* for these products, product recalls can help you make better products and prevent problems with market surveillance authorities. Due to the reduced number of pandemic related alerts, this week we have cmbined 2 weeks of alerts. 

Particle filter mask(s).

  • The first product alert is for a partile filter mask, sold under the name 'Disposable Mask', of the brand 'YK-MASK. 
    Traceability information: Barcode: YK00202005003 5411504164856
    Type risk: Health risk / other
    The country of origin is China. Link to product alert.

    Reason for the alert:
    The mask is presented as providing a protective function; however these claims are not backed by evidence. This could create a false sense of safety to the wearer of the mask and thus, even if combined with other recommended measures, not protect its user. The product does not comply with the requirements of the General Product Safety Directive (GPSD).

    Measures ordered by public authorities: Withdrawal of the product from the market
    Date of entry into force: 11/03/2021
  • The second product alert is for are a particle filter mask, sold under the name 'N95/FFP2 respirator, N95/FFP2 mask', of the brand 'ELIS SHPK' and 'myfixmask'. 
    Traceability information: Barcode: 3901501930049 and 3901501930018, Type / number of model: 001 and 002. 
    Type risk: Health risk / other
    The country of origin is unknown. Link to product alert

    Reason for the alert:
    The particle/filter retention of the material is insufficient (measured value as low as 49%). Consequently, an excessive amount of particles or microorganisms might pass through the mask, increasing the risk of infection if not combined with additional protective measures. As a result of the labelling, the mask may be worn in areas where hazardous substances are in use or during activities involving asbestos; since the mask fails to offer sufficient protection, this could lead to asbestosis, with fatal consequences. The product does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.

    Measures ordered by public authorities (to: Other): Marking the product with appropriate warnings on the risks. Date of entry into force 01/02/2021
    Measures ordered by public authorities (to: Other): Destruction of the product. Date of entry into force 15/02/2021
    Measures ordered by economic operators (to: Importer): Import rejected at border. Date of entry into force 01/02/2021


Share this post via: