Health product recall

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