Health product recall

3 Ply Medical Mask (2020-06-25)

Starting date:
June 25, 2020
Posting date:
July 10, 2020
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-73519

Last updated: 2020-07-10

Affected Products

3 Ply Medical Mask

Reason

This is a voluntary recall as we submitted the product from this manufacturer (that we imported) for additional against ASTM level 1 testing and the PFE results came in below 95% as well as the breathability was lower than required.

Affected products

3 Ply Medical Mask

Lot or serial number

Not applicable.

Model or catalog number

Not applicable.

Companies
Manufacturer
GANSU NEWSHANYOU MEDICAL INSTRUMENTS CO. LTD.
NO.1FLOOR 4, BUILDING 2, QIJUZHONGCHUANG, INCUBATION PARK, LINXIA
GANSU,
362000
CHINA