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A12/00418/21

Particle filter mask

ELIS SHPK | myfixmask · N95/FFP2 respirator, N95/FFP2 mask

Protective equipmentHealth risk / other
Notifying country
Germany
Sold online
Yes
Open the alert on the European Commission website ↗

What is the danger

The particle/filter retention of the material is insufficient (measured value as low as 49%). 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. As a result of the labelling, the mask may be worn in areas where hazardous substances are in use or during activities involving asbestos; since the mask fails to offer sufficient protection, this could lead to asbestosis, with fatal consequences.

Risk

Infektion mit Covid 19 ; Reizung, Entzündung oder Verätzung inhalativ Asbestose (Lungenkrebs)

Requirements breached

The product does not comply with the Personal Protective Equipment Regulation and with the relevant European standard EN 149.

Measures taken

  1. Marking the product with appropriate warnings on the risks Compulsory measuresTaken by: OtherIn force from: 1 February 2021
  2. Destruction of the product Compulsory measuresTaken by: OtherIn force from: 15 February 2021
  3. Import rejected at border Voluntary measuresTaken by: ImporterIn force from: 1 February 2021

Product

Description
Protective respiratory filtration half-face mask. Models 001 and 002 cannot be distinguished from each other on the basis of the printed labelling or the barcodes. Furthermore, the masks' labels differ from one mask to another and are not uniform. The product is also sold online.
Packaging
The masks are supplied in boxes of 20 under EAN 3901501930018 and are packed in individual plastic packages with the EAN code 3901501930049.
Brand
ELIS SHPKmyfixmask
Model / type
001002
Barcode
39015019300183901501930049

Original source

Data comes from the official Safety Gate system of the European Commission.

Alert number
A12/00418/21 ↗
Weekly report
Report-2021-12
Published
25 March 2021
Modified
25 March 2021

© European Union, Safety Gate · https://ec.europa.eu/safety-gate-alerts/screen/webReport/alertDetail/10003183

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