Non-medical Foldable Kn95 - Non-sterile Kn95 (2020-12-09)

Recall Summary Non-medical foldable KN95 masks distributed across Canada are being recalled because they are classified as medical devices but were not properly authorized for sale in Canada. The masks do not meet the required standards for medical devices and their protective effectiveness cannot be verified. This recall affects all non-medical foldable KN95 masks of this type sold in Canada.

Reason

COVID - Medical devices

Classification

Class I

Category

drug recall

Country

Canada

Agency

HC-DEVICES

Recall date

2020-12-18

Status

Ongoing

Distribution

Canada-wide

Official recall notice from HC-DEVICES

Recall details on Nibble Recalls: https://trynibble.app/recalls/a55e5065-d43a-4fdd-983c-f311468212d1