Published on: Mon 1 June 2020

Pandemic related recalls, week 22/2020

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 6 more recalls for face masks (officialy designated as 'surgical mask' or 'respitory mask'). This week the recalls were alerted by (again) the Belgian and Polish authorities. 

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

This weeks alerts were submitted by the Belgian and Polish market surveillance authorities.

  1. The first alert of this week concerns a Hand disinfectant; 60 ml of transparent hydro-alcoholic disinfectant hand gel. Batch number:  CSM 100220, EXP: 10.02.2023, PRD: 10.02.2020. The product is manufactured in different perfumes.
    The product contains an insufficient amount of ethanol (measured value: ≤ 42 %). Consequently, it might not kill bacteria or viruses, which could then reach the user, increasing the risk of infection.
    Additionally, the presence of ethanol is not accompanied by the corresponding hazard pictograms and warnings. Users have therefore no information on the flammability of the product, which in the presence of an ignition source, could lead to a fire. The product does not comply with the Biocidal Products and the Classification, Labelling and Packaging (CLP) Regulations.
    - The result is 'Recall of the product from end users (By: Distributor)'. The product was imported from Turkey (link to recall on Safety Gate). 
  2. The second product is a Respiratory protective filtration half-face mask category KN95, Type / number of model:  HBV202002005, KN 95. The particle/filter retention of the material is insufficient (measured value ≤ 78 %). 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 measures'. The origin of the product is not mentioned (link to recall on Safety Gate). 
  3. The third alert is a Protective respiratory filtration half-face mask of category KN95 from the brand 'HUABIWEI', Type / number of model:  MC 950V. The particle/filter retention of the material is insufficient (measured value ≤ 57 %). 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 measures' (link to recall on Safety Gate). 
  4. The 4th product is a 'Protective respiratory filtration half-face mask according to EN 149' from the brand MOCUE, Batch number:  Lot no. 20200418, Production date: 2020/04/18. The total filtration capacity of the mask is insufficient (measured mean value ≤ 88 %). 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 measures' (link to recall on Safety Gate). 
  5. The next product is a 'Protective respiratory filtration half-face mask according to EN 149' from the brand 'MASK', Lot no. 20200418, Production date: 2020/04/18.
    The total filtration capacity of the mask is insufficient (measured mean value ≤ 88 %). 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 measures'. The product was imported from China (link to recall on Safety Gate). 
  6. The following productrecall is also a 'Respiratory protective mask of category KN95' from the brand Yubei. (Batch number: 48200401, Expiration Date: 1 April 2022, Production date: 2 April 2020). 
    The particle/filter retention of the material is insufficient (measured value ≤ 93 %) 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). 
  7. The seventh product recall concerns a 'Respiratory protective mask of category KN95 and FFP2', EXP.:March, 2023, SD2020M01. 
    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 imoprted from China (link to recall on Safety Gate). 
  8. Nr 8 is a 'Respiratory protective filtration half-face mask of category KN95', Type / number of model:  KN95, ref. PON002. 
    The particle/filter retention of the material is insufficient (measured value ≤ 47 %). 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 ordered measure is 'Ban on the marketing of the product and any accompanying measures'. The product was imported from China (link to recall on Safety Gate). 
  9. The 9th product recall is again a 'Respiratory protective filtration half-face mask of category KN95', Type / number of model:  EGM-KN95L. 
    The particle/filter retention of the material is insufficient (measured value ≤ 68 %). 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 ordered measure is 'Ban on the marketing of the product and any accompanying measures'. The product was imported from China (link to recall on Safety Gate). 
  10. Nr 9 is a Respiratory protective filtration half-face mask of category KN95 and FFP2, according to EN 149'.
    The total filtration capacity of the mask is insufficient (measured mean value ≤ 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. The product does not comply with the Personal Protective Equipment Regulation and the relevant European standard EN 149.
    - The ordered measure is 'Ban on the marketing of the product and any accompanying measures'. The product was imported from China (link to recall on Safety Gate). 
  11. The next product recall is a Respiratory protective filtration half-face mask of category KN95 from the brand HUABIWEI.
    The particle/filter retention of the material is insufficient (measured value ≤ 89 %). 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 ordered measure is 'Ban on the marketing of the product and any accompanying measures' (link to recall on Safety Gate). 
  12. The following product recall is another Respiratory protective filtration half-face mask of category KN95 from the brand AMO. 
    The particle/filter retention of the material is insufficient (measured value ≤ 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. The product does not comply with the Personal Protective Equipment Regulation and the relevant European standard EN 149.
    - The ordered measure is 'Ban on the marketing of the product and any accompanying measures' (link to recall on Safety Gate). 
  13. Nr 13, a Respiratory protective filtration half-face mask category KN95 from the brand Foshan.
    The particle/filter retention of the material is insufficient (measured value ≤ 78 %). 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 ordered measure is 'Ban on the marketing of the product and any accompanying measures' (link to recall on Safety Gate). 
  14. Nr. 14, a Respiratory protective mask of category KN95, Barcode:  6 970730 050030, 6 970730 050306 from the brand Teyouda. 
    The total filtration capacity of the mask is insufficient (measured value ≤ 74 %) 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.
    - Measures ordered by public authorities (to: Importer): Ban on the marketing of the product and any accompanying measures. The product was imported from China (link to recall on Safety Gate). 
  15. The 15th product recall is another Respiratory protective mask of category KN95 from the brand Yicheng Yi Liao. The particle/filter retention of the material is insufficient (measured value ≤ 90 %) 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.
    - Measures ordered by public authorities (to: Importer): Ban on the marketing of the product and any accompanying measures. The product was imported from China (link to recall on Safety Gate).
  16. The last product is a 'Disposable single use mouth protective mask' from the brand Protekcia (Type / number of model:  Registry number: 1673C2017 SSA , CVE: CUP01, Hindernis.mx). 
    The total filtration capacity of the mask is insufficient (measured value ≤ 31 %) 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.
    - Measures ordered by public authorities (to: Importer): Ban on the marketing of the product and any accompanying measures. The product was imported from Mexico (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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