MASKS/ KN95 MASKS WITH BIOMASS GRAPHENE (2021-04-08)

Starting date:

April 8, 2021

Posting date:

April 15, 2021

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type II

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

Healthcare Professionals, General Public, Hospitals

Identification number:

RA-75391

Last updated:
2021-04-15

• 
  Reason
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  Affected products

Affected Products 

A. MASKS WITH BIOMASS GRAPHENE

B. KN95 MASKS WITH BIOMASS GRAPHENE

Reason

Health Canada has identified the following class I medical devices from Shandong Shengquan New Materials Co. Ltd, do not meet the manufacturer’s requirements of section 10 to 20 of the Medical Devices Regulations (MDR).

There is a potential that wearers could inhale graphene particles from some masks, which may pose health risks.

Affected products