Published on: Mon 8 June 2020

Pandemic related recalls, wk 23/2020

During the COVID-19 pandemic is it hase become sort of a tradition; the publication of new published face mask recalls. The European Commission (EC) has published this week 7 more recalls for face masks (officialy designated as 'surgical mask' or 'respitory mask'). This week the recalls were alerted by (again) the supervisory aythorities of Malta, Belgium and Poland. 

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. The first alert of this week concerns a Protective respiratory filtration half-face mask of category KN95; Barcode:  2054 6625.
    The product bears a CE marking but is not certified as protective equipment by the relevant body.
    Consequently, the product might not fulfil the health and safety requirements and properly protect when combined with additional measures. The product does not comply with the Personal Protective Equipment Regulation.
    - The result is 'Recall of the product from end users (By: Importer)'. The product was imported from China (link to recall on Safety Gate). 
  2. The second product is also a Protective respiratory filtration half-face mask of category KN95. Similarly, the product bears a CE marking but is not certified as protective equipment by the relevant body. Consequently, the product might not fulfil the health and safety requirements and properly protect when combined with additional measures. The product does not comply with the Personal Protective Equipment Regulation.
    - The results is 'Import rejected at border (By: Importer)'. The product was imported from China (link to recall on Safety Gate).
  3. The third product is another Protective respiratory filtration half-face mask of category KN95. Barcode:  8 033109 030595. Likewise, the product bears a CE marking but is not certified as protective equipment by the relevant body. Consequently, the product might not fulfil the health and safety requirements and properly protect when combined with additional measures. The product does not comply with the Personal Protective Equipment Regulation.
    - The results is 'Import rejected at border (By: Importer)'. The product was imported from China (link to recall on Safety Gate). 
  4. The fourth products is also a Respiratory protective half-face mask of category KN95. The particle/filter retention of the material is insufficient (measured value ≤ 67 %) and the mask does not properly adapt to the face.
    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.
    - The result is 'Ban on the marketing of the product and any accompanying measures'. The product was imported from China (link to recall on Safety Gate). 
  5. The next product is 'a Protective respiratory filtration half-face mask according to EN 149'. The particle/filter retention of the material is insufficient (measured value ≤ 69.3 %).
    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 the relevant European standard EN 149.
    - The result is 'Ban on the marketing of the product and any accompanying measure'. The product was imported from China (link to recall on Safety Gate). 
  6. The second last product of this week is also a 'Protective respiratory filtration half-face mask according to EN 149'. The particle/filter retention of the material is insufficient (measured value ≤ 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 Protective Equipment Regulation and the relevant European standard EN 149.
    - The result is 'Ban on the marketing of the product and any accompanying measure'. The product was imported from China (link to recall on Safety Gate).
  7. The last published EU product recall of this week is 'Protective respiratory filtration half-face mask of category KN95 (corresponding to FFP2 according to EN 149)'. The particle/filter retention of the material is insufficient (measured mode value ≤ 92.7 %) and the mask might not properly adapt to the face.
    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 the relevant European standard EN 149.
    - The result is 'Ban on the marketing of the product and any accompanying measure'. The product was imported from China (link to recall on Safety Gate). 

More information

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* Economic operator means the manufacturer, the authorised representative, the importer, the distributor, the fulfilment service provider or any other natural or legal person who is subject to obligations in relation to the manufacture of products, making them available on the market or putting them into service in accordance with the relevant Union harmonisation legislation.

 


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