News

Search the news

2021-03-10

Pandemic related product alerts | wk 10

Pandemic related product alerts | wk 10
Regulatory

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. 

Particle filter mask(s).

  • The first product alert is for a partile filter mask, sold under the name 'FFP2 NR Filtering Half Mask', of the brand 'JIA YUAN'. 
    Traceability information: Barcode: unknown, Batch number: 20210120, Type / number of model: JY-KN95
    Type risk: Health risk / other
    The country of origin is Turkey. Link to product alert.

    Reason for the alert:
    The product advertises a protective potential against particles but its filtering capacity has not been tested by a relevant competent European conformity assessment body, and it misuses the CE marking and the model name of a different product from the same manufacturer, which is certified. The packaging of the two being identical, there is no possibility for the consumer to see that it is not the certified product. In addition, the product has a complete different shape and size than the certified product, and due to its small size, it does not cover the mouth and nose entirely. Consequently, it is not proven that the product fulfils 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 Regulation and with the relevant European standard EN 149.

    Measures ordered by public authorities: Import rejected at border
    Date of entry into force: 26/02/2021
  • The second product alert is for are masks labelled as KN95 and FFP2, 10 masks per pack. It was marketed under the brand name 'Brüder Mannesmann'. 
    Traceability information: Barcode: 4003315846734, Batch number: unknown, Type / number of model: M40210
    Type risk: Health risk / other
    The country of origin is Germany. Link to product alert

    Reason for the alert:
    The particle/filter retention of the material is insufficient (measured value as low as 83%). 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 economic operators (to: Retailer): Ban on the marketing of the product and any accompanying measures (Date of entry into force 20/01/2021)
    Measures ordered by economic operators (to: Retailer): Recall of the product from end users (Date of entry into force 10/02/202

  • The last product alert is for a particle filter mask of the brand 'Shenzhen Medical Equipment'. 
    Traceability information: Batchnumber: 202006054520. Other traceability information not known.
    Type risk: Health risk / other
    The country of origin is China. Link to product alert

    Reason for the alert:

    The particle/filter retention of the material is insufficient (measured values as low as 90%). 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 economic operators (to: Retailer): Ban on the marketing of the product and any accompanying measures
    Measures ordered by economic operators (to: Retailer): Recall of the product from end users
    Date of entry into force 20/01/2021


Share this post via: