KN95 Mask (2021-03-29)

Starting date:

March 29, 2021

Posting date:

April 22, 2021

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-75435

Last updated:
2021-04-22

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  Reason
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  Affected products

Affected Products 

KN95 Mask

Reason

The GB2626 test report is incomplete, only the PFE test is included in this report. The FDA certificate is a FDA registration not an authorization document. The product label states a BFE greater than 95%, but this is an incorrect claim. No quality system information was provided, and no NMPA registration certificate was provided.

Affected products