Health product recall

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