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

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

A. MASKS WITH BIOMASS GRAPHENE

Lot or serial number

All lots.

Model or catalog number

SMDP20605
SNN200642

Companies

Manufacturer: SHANDONG SHENGQUAN NEW MATERIALS CO., LTD.
DIAOZHEN INDUSTRIAL DEVELOPMENT ZONE
ZHANGQIU
250200
CHINA

B. KN95 MASKS WITH BIOMASS GRAPHENE

Lot or serial number

All lots.

Model or catalog number

SNN70369B
SNN70370B

Companies

Manufacturer: SHANDONG SHENGQUAN NEW MATERIALS CO., LTD.
DIAOZHEN INDUSTRIAL DEVELOPMENT ZONE
ZHANGQIU
250200
CHINA

Date modified:

2021-04-15

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