Health product recall

N95 Particulate Respirator (2021-09-15)

Starting date:
September 15, 2021
Posting date:
October 8, 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-76617



Last updated:
2021-10-08

Affected Products

N95 Particulate Respirator

Reason

Health Canada has cancelled the interim order authorization for N95 particulate respirators model DTC3Z and interim order for exceptional import for models DTC3Z, DTC3B, DTC3W, DTC3M-1 following the revocation of niosh certification on August 13 2021, for Shanghai Dasheng health products manufacture co. Ltd.   Health Canada is recommending discontinuing use of these devices in settings requiring NIOSH certification.

 

Affected products

N95 Particulate Respirator

Lot or serial number

Not applicable.

Model or catalog number
  • DTC3Z
  • DTC3X
  • DTC3W
  • DTC3M-1
  • DTC3B
Companies
Manufacturer

SHANGHAI DASHENG HEALTH PRODUCTS MANUFACTURE CO., LTD.

228 SHIHUI ROAD, ZHONGSHAN STREET,

SONGJIANG DISTRICT

CHINA