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Disposable Flat Fold Respirator

Health risk / other Protective equipment Serious risk

Disposable Flat Fold Respirator was recalled on 16 October 2020 under EU Safety Gate alert A12/01372/20. Health risk / other risk reported by Italy. The particle/filter retention of the material is insufficient (measured value ≤ 50% in the penetration test and ≤ 76% in the exposure test).

Photo of recalled product: Disposable Flat Fold Respirator
Alert NumberA12/01372/20
BrandERA MASKE - BASARAN
CategoryProtective equipment
Risk TypeHealth risk / other
Notifying CountryItaly
Country of OriginTürkiye
Model NumberERA1300 FFP3 NR
Published16 October 2020

Risk Description

The particle/filter retention of the material is insufficient (measured value ≤ 50% in the penetration test and ≤ 76% in the exposure test). 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 with the relevant European standard EN 149.

Measures Taken

Type of economic operator to whom the measure(s) were ordered: OtherCategory of measure(s): Ban on the marketing of the product and any accompanying measuresDate of entry into force: 21/09/2020

Product Description

White transverse face mask, with the model and logo printed on it, claiming to be of the FFP3 type.

🏥 What Should You Do?

This recall involves a health risk / other hazard related to Disposable Flat Fold Respirator.

About this risk

This product poses a health risk that does not fall neatly into a single category. It may involve multiple hazards or an unusual safety concern identified by authorities.

Recommended action

Stop using the product and follow any specific instructions from the recall notice. Contact the manufacturer or your national consumer protection authority for more details.

Who is at risk?

All consumers who have purchased this product.

View on EU Safety Gate →

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