Health product recall

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

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

KN95 Mask

Lot or serial number

Not applicable. 

Model or catalog number

Not applicable. 

Companies
Manufacturer
ANHUI DELI PROTECTIVE PRODUCTS CO. LTD
93 HEAN ROAD, FUNGANG TOWN, CN-34
TONGCHENG
CHINA