Pandemic related product alerts, wk 28/2020

Introduction

During the COVID-19 pandemic is it hase become sort of a tradition; the publication of new published recalls related to the Covid-19 pandemic. The European Commission (EC) has published this week recalls for disifectants, particle filter masks and UV sterilsers. Because the UV sterilisers are a relativeky new product, we will dedicate a seperate blog post on this subject. 

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 Hand disinfectant from the brand ON DERMO (Barcode:  8 435060 370367 and Batch number:  0162020294). Link to recall. 
   The product contains an insufficient amount of ethanol and propan-2-ol (measured values: ≤ 50 % and ≤ 6 %, respectively). Consequently, it does not kill bacteria or viruses, which could then reach the user, increasing the risk of infection. Furthermore, the presence of alcohols is not accompanied by the appropriate hazard pictograms and warnings. Users have therefore no information on the toxicity and 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.
   Measures to be taken by economic operators: Recall of the product from end users (By: Distributor). The country of origin of the product is Spain.
2. The second product is another hand disinfectant from the brand FICOMED. Link to recall.
   The product contains an insufficient amount of ethanol (measured value: ≤ 33.5 %). Consequently, it does not kill bacteria or viruses, which could then reach the user, increasing the risk of infection. Furthermore, the presence of alcohol is not accompanied by the corresponding hazard pictograms and warnings. Users have therefore no information on the toxicity and 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.
   Measures to be taken by economic operators: Recall of the product from end users, Withdrawal of the product from the market (By: Distributor). The country of origin of the product is Turkey. 
3. The next product is e a particle filter mask from the brand Elite (link to recall).
   The product bears a CE marking but is not certified as protective equipment by a relevant body. Additionally, the particle/filter retention of the material is insufficient (measured value ≤ 98.5 %). 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 Protective Equipment Regulation and the relevant European standard EN 149.
   Measures to be taken by economic operators: Recall of the product from end users (By: Distributor). The country of origin of the product is Spain. 
4. The fourth product is another particle filter mask. This mask is from the brand Su. (link to alert)
   The particle/filter retention of the material is insufficient (measured value ≤ 88.8 %) 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
5. The fifth product alert is a particle filter mask of the brand Jieyasi with Batch number: 20200323 (link to alert). 
   The particle/filter retention of the material is insufficient (measured value ≤ 78.9 %) 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
6. The next product alert is another particle filter mask. The product is from the brand Health Pro (link to alert). 
   The particle/filter retention of the material is insufficient (measured value ≤ 74.4 %) 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
7. The seventh product alert is of the brand Kemoshi, a particle filter mask (link to alert).
   The particle/filter retention of the material is insufficient (measured value ≤ 83.9 %) 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
8. The eight product alert is of the brand Nine nurse; a particle filer mask with batch number EXP 20220315, L/N 20200301, MFD 20200316 (link to alert). 
   The total filtration capacity of the mask is insufficient (measured mean value ≤ 85.8 %). 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
9. The nineth product is (another) particle filter mask. The brand is unknow, but the name is 'Disposable face mask'. It has Batch number:  EXP: 032022, LOT: 573627, MFD: 032020, Testing Date: 2020.3.23 (link to alert).
   The product bears a CE marking but is not certified as protective equipment by a relevant body. Additionally, the particle/filter retention of the material is insufficient (measured value ≤ 89 %) 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
10. On number ten, a particle filter mask from the brand Manmao. Barcode and batch number are unknown (link to alert). 
    The particle/filter retention of the material is insufficient (measured value ≤ 87 %) 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
11. On number 11, again a particle filter mask, This recall is of the brand Ouleok; Type / number of model: 6212 (link to alert). 
    The product bears a CE marking but is not certified as protective equipment by a relevant body. Additionally, the particle/filter retention of the material is insufficient (measured value ≤ 81.8 %) 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
12. The next product alert is a particle filter mask of the brand Onemix, with barcode 6 941222 431279 (link to alert). 
    The total filtration capacity of the mask is insufficient (measured mean value ≤ 66.3 %). 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.
    Measures to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China.  
13. On number 13 a partilce filter mask of the brand FancyLand. Type / number of model: 3D FFP2, KN95. Barcode: 6 972464 103099 and batch number CY-20200410-01 (link to recall). 
    The product bears a CE marking but is not certified as protective equipment by a relevant body. Additionally, the particle/filter retention of the material is insufficient (measured value ≤ 94.4 %) 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
14. Number 13 is followed by another particle filter mask alert from the brand GYHX (link to alert). 
    The product bears a CE marking but is not certified as protective equipment by a relevant body. Additionally, the particle/filter retention of the material is insufficient (measured value ≤ 86 %) and the mask does not properly adapt to the face leading to an insufficient total filtration capacity (measured value ≤ 80 %) . 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
15. On number 15 is a product alert of the brand Moway. Type / number of model:  95, CE, FFP2, KN95 Certified, Owner/operator number: 10062763 and Barcode: 6 17201 341339 (link to alert). 
    The particle/filter retention of the material is insufficient (measured value ≤ 75.2 %) 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
16. The following alert for a particle filter maks is of the brand Aireco; Type / number of model: AR M01L, KN95 / FFP2 and Batch number:  Production Batch Nº: C0414001, Production date : 2020-04-14 (link to alert).
    The product bears a CE marking but is not certified as protective equipment by a relevant body. Additionally, 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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 
17. On number 17 a partilce filter mask of the brand Daddy Baby.; Type / number of model: CE FFP2, Obstruct Spittle (link to recall). 
    The particle/filter retention of the material is insufficient (measured value ≤ 92.2 %) 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 to be taken by importer: Recall of the product from end users. The country of origin of the product is China. 
18. The last pandemic related alert is of the brand Govek: Barcode: 6 973099 910014 and Batch number: PD: April / 22 / 2020, Production Batch: 2020/04/22 (link to alert).
    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 to be taken by economic operators: Marking the product with appropriate warnings on the risks. The country of origin of the product is China. 

More information

• Learn more on legislation filters masks and respitory devices must comply to by downloading the free ProductIP guide on this subject.
• Learn more on where to certify masks here. 

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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.