KN95 Face Mask (2020-05-20)
- Starting date:
- May 20, 2020
- Posting date:
- June 12, 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-73311
Last updated: 2020-06-15
Affected Products
KN95 Face Mask
Reason
Product does not meet 95% filtration as per CDC/NIOSH testing of the product. Certain filtering facepiece respirators may not provide consistent and adequate respiratory protection to healthcare personnel exposed to COVID-19 based on the 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 Face Mask
Lot or serial number
All lots.
Model or catalog number
Not applicable.
Companies
- Manufacturer
-
DONGGUAN XIANDA MEDICAL EQUIPMENT CO., LTD
ROOM 301, BUILDING 7, NO. 40 LONGYAN ROAD, SHIJIE TOWN
Donguan
523300
CHINA