The National Agency for Food and Drug Administration and Control (NAFDAC) received a notification that the European Union’s (EU’s) Rapid Alert System for Dangerous Non-Food Products (RAPEX) has banned the sale and ordered the destruction of Signo FFP2 Non- Reusable Particle Filter Mask produced by a Chinese company, Shenzhen Signo Group Technology Co. Ltd.
According to the EU, the product does not comply with the Personal Protective Equipment (PPE) Regulation nor with the European standard EN 149.
Risk description
The total filtration capacity of the filter mask is insufficient (measured mean values: 32.3%). Consequently, the product does not fulfil the health and safety requirements. Thus, even if combined with other recommended measures, it may not properly protect.
Product details
The details of the product are as follows:
Product Name: FFP2 – Atemschutzmasken (Particle filter mask)
Product Brand: SIGNO
Product Manufacturer: Shenzhen Signo Group Technology Co. Ltd.
Batch No.: 20220112
Barcode No.: 4251924305894
Country of Production: China
Packaging description: White cardboard box (10 pack) with blue lettering; masks are individually wrapped in film with black/green inscription
Product Photo
These products are not available in the NAFDAC database. Importers, distributors, retailers, and consumers are advised to exercise caution and vigilance within the supply chain to avoid the importation, distribution, sale, and use of the above-mentioned products. Members of the public in possession of the product should discontinue the sale or use and submit the stock to the nearest NAFDAC office.
All NAFDAC zonal directors and state coordinators have been instructed to conduct surveillance and remove any unregistered products found within their respective zones and states.
Distributors, retailers, healthcare professionals, and caregivers are advised to exercise caution and vigilance throughout the supply chain to prevent the distribution, sale, and use of the product. It is essential to obtain all medical products from authorized and licensed suppliers. Additionally, the authenticity and physical condition of these products should be thoroughly checked.
Healthcare professionals and consumers are advised to report any suspicion of the sale of substandard and falsified medicines or medical devices to the nearest NAFDAC office, call NAFDAC on 0800-162-3322, or via email: sf.alert@nafdac.gov.ng
Similarly, healthcare professionals and patients are also encouraged to report adverse events or side effects related to the use of medicinal products or devices to the nearest NAFDAC office, or through the use of the E-reporting platforms available on the NAFDAC website www.nafdac.gov.ng, or via the Med- safety application available for download on Android and IOS stores, or via e-mail on pharmacovigilance@nafdac.gov.ng
For complaints, you can call the Reforms Unit on the following lines: 09097630506, 09097630507, or email: reforms@nafdac.gov.ng
Furthermore, note that this notice will be uploaded to the WHO Global Surveillance and Monitoring System (GSMS).
NAFDAC………. Customer-focused, Agency-minded!!!
