NAFY FFPE2 MASKS (2021-04-26)
- Starting date:
- April 26, 2021
- Posting date:
- May 26, 2021
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-75659
Last updated:
2021-05-26
Affected Products
NAFY FFPE2 MASKS
Reason
Health Canada has determined that the NAFY FFP2 respirators imported by Resource Integrated LTD. do not meet the required standards for filtration as indicated on the labelling of the product. As such, the affected products may pose a health and safety risk in settings where a 95% filtration is required (such as health care settings). Users may continue using the product as face masks (not respirators), where a 95% filtration is not needed.
Affected products
NAFY FFPE2 MASKS
Lot or serial number
- Not applicable.
Model or catalog number
- EN 14683 2019
Companies
- Manufacturer
-
GUANDONG NAFEI INDUSTRIAL HOLDING CO. LTD
4TH ROAD
ECOLOGICAL TECHNOLOGY CITY
516411
CHINA