Published on: Fri 8 May 2020

Face mask recalls, week 19/2020

During the COVID-19 pandemic is it now becoming sort of a tradition; the publication of new published face mask recalls. The European Commission (EC) has published this week 5 more recalls for face masks (officialy designated as 'surgical mask' or 'respitory mask').

If you are an economic operator* for these products, product recalls can help you make better products and prevent problems with market surveillance authorities.

See also our post of wk 18 here and wk 17 here. This weeks alerts were submitted by the Danish and Spanish market surveillance authorities.

  1. The first product, apProtective respiratory filtration half-face mask of category KN95 (EN 149)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 'Stop of sales (By: Importer)'. The product was imported from China (link to recall on Safety Gate). 
  2. The second product, a Protective respiratory filtration half-face mask according to EN 149, also 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 'Ban on the marketing of the product and any accompanying measures'. The product was imported from China (link to recall on Safety Gate).
  3. The third product concens counterfeit (!); a Protective respiratory filtration half-face mask of category KN95 (EN149). The product also 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 'Ban on the marketing of the product and any accompanying measures'. The product was imported from China (link to recall on Safety Gate). 
  4. The fourth product, a Protective respiratory filtration half-face mask of category KN90 (EN 149), also 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 '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 fifth product is a Respiratory protective half-face filter mask of category KN95 (EN 149 FFP2), folded, with nose clip and elastic bands to secure it behind the ears. The particle/filter retention of the material is insufficient (measured value ≤ 71 %). 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 'Recall of the product from end users'. 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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