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2020-12-29

Pandemic related product alerts | wk 52

Pandemic related product alerts | wk 52
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. 

1. Product alerts on UV-C lights.

  • The first product is a 'UV Steriliser' of the brand 'ProMedix'. It was sold with the name 'Disinfection UV-C O3 Lamp Room Steriliser PR-210'. Barcode:  5902211116998. The country of origin is China. Link to product alert. 
    Risk type: Damage to sight. The product has a risk of exceeding the exposure limit for the eye or skin if used incorrectly. A user may inadvertently expose its eyes or skin to UV-C light which would leads to an eye injury or burns. The product does not comply with the requirements of the Low Voltage Directive and of the relevant European standard EN 62471.
    Measures taken by economic operators: Recall of the product from end users, Removal of this product listing by the online marketplace (By: Other, Retailer)
  • The second UV-C related product is a 'Portable UV Steriliser', of the brand 'Rosa Rugosa'. It was sold with the name ' Security Knight Q3'. No traceability information is available. The country of origin is China. Link to product alert. 
    The product may not fully sanitise a contaminated item. Consequently, it might not kill bacteria or viruses, which could then reach the user, increasing the risk of infection. The product does not comply with the requirements of the Low Voltage Directive and of the relevant European standard EN 62471.
    Measures taken by economic operators: Removal of this product listing by the online marketplace (By: Other)
    Measures ordered by public authorities (to: Retailer): Recall of the product from end users

2. A list of particle filter masks:

  • The first article is a particle filter mask of the brand 'Welooo' (Barcode: 6973109940017, Batch number: 20200417). The country of origin is China. Link to product alert. 
    The particle/filter retention of the material is insufficient (measured value 44,1%). 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. The product does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.
    Measures taken by economic operators: Destruction of the product, Recall of the product from end users (By: Importer, Retailer)
  • The second article is a particle filter mask of the brand 'purvigor' (Barcode: 6973129750016 (single), 6973129750023 (10-items pack), Batch number: 20200328). The country of origin is China. Link to product alert.
    The particle/filter retention of the material is insufficient (measured value 64,6%). 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. 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: Importer): Recall of the product from end users
  • The next particle filter mask is of unknown brand, unknown barcode and batchnumber. The country of origin is China. Link to product alert.  
    The particle/filter retention of the material is insufficient (measured value as low as 37%). 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. The product does not comply with the Personal Preotective Equipment Regulation.
    Measures taken by economic operators: Withdrawal of the product from the market (By: Other)
  • The next particle filter mask is of unknown brand, unknown barcode and batchnumber. The country of origin is China. Link to product alert.
    The particle/filter retention of the material is insufficient (measured value as low as 67,6%). 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. The product does not comply with the Personal Preotective Equipment Regulation.
    Measures taken by economic operators: Withdrawal of the product from the market (By: Other)
  • The next particle filter mask is of unknown brand, unknown barcode and batchnumber. The country of origin is China. Link to product alert.
    The particle/filter retention of the material is insufficient (measured value as low as 31,5%). 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. The product does not comply with the Personal Preotective Equipment Regulation.
    Measures taken by economic operators: Withdrawal of the product from the market (By: Other)
  • The following particle filter mask is of the brand 'Ouleok', Barcode: 789849136593. The country of origin is China. Link to product alert. 
    The product bears a CE marking but is not certified as protective equipment by a relevant body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. / 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: Distributor): Ban on the marketing of the product and any accompanying measures
  • The next particle filter mask of (also) of unknown brand. Traceability information is also not available. The country of origin is China. Link to product alert. 
    The product bears a CE marking and claims to meet the requirements of a surgical mask but it has not been certified as such by a relevant European body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. The product does not comply with the requirements of the Medical Devices Directive and of the relevant European standard EN 14683.
    Measures ordered by public authorities (to: Importer): Withdrawal of the product from the market
  • The following particle filter mask is marketed with the name 'Disposable Protective Mask', Barcode: 6973215750012. The country of origin is China. Link to product alert. 
    The product bears the CE marking but it is certified by a relevant body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. The product does not comply with the Personal Protective Equipment Regulation.
    Measures ordered by public authorities (to: Retailer): Withdrawal of the product from the market
  • The last particle filter mask alert was sold with the name 'Medical mask with two layers'. Barcode: 6422125003911, Batch number: LHP – 1283 02/2028. The country of origin is China. Link tot product alert. 
    The product bears a CE marking and claims to meet the requirements of a surgical mask but it has not been certified as such by a relevant European body. Consequently, the product might not fulfil the health and safety requirements and thus not properly protect if not combined with additional measures. The product does not comply with the requirements of the Medical Devices Directive and with the relevant European standard EN 14683.
    Measures ordered by public authorities (to: Retailer): Withdrawal of the product from the market
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