KN95 Respirators (2020-10-16)
- Starting date:
- October 16, 2020
- Posting date:
- November 27, 2020
- 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-74417
Last updated:
2020-11-27
Affected Products
KN95 Respirators
Reason
The KN95's from this manufacturer may not provide consistent and adequate respiratory protection to healthcare personnel exposed to Covid-19 based on additional filtration performance testing conducted by the National Institute for Occupational Safety and Health (NIOSH) - National Personal Protective Technology Laboratory (NPPTL) of the Centers for Disease Control and Prevention (CDC).
Affected products
KN95 Respirators
Lot or serial number
Not applicable.
Model or catalog number
RESPIRATOR
Companies
- Manufacturer
-
Guangdong Zhizhen Biological Medicine Co., Ltd.
5 South Street, Datian First Team, Minzhu Village, Tanbu Town, Huadu District, Guangzhou
Guangdong
510820
CHINA