Personal protective equipment sold by Maskopia (formerly Medkem Canada Inc.) may pose serious health risks

Starting date:
December 22, 2020
Type of communication:
Advisory
Subcategory:
Medical Device
Source of recall:
Health Canada
Issue:
Unauthorized products, Medical Devices
Audience:
General Public, Healthcare Professionals, Hospitals
Identification number:
RA-74613

Last updated:

Summary

  • Product: Various isolation gowns, face masks, gloves and other personal protective equipment (PPE) sold by Maskopia (formally known as Medkem Canada Inc.)
  • Issue: Health Canada is warning Canadians that the company Maskopia (formerly known as Medkem Canada Inc.) in Brampton, Ontario, has been selling medical devices, via social media and websites such as Kijiji, without the required Medical Device Establishment Licence (MDEL) from Health Canada.
  • What to do: Immediately stop using and dispose of these gowns, masks, gloves and other PPE. They may not provide the level of protection advertised.

Issue

Health Canada is warning Canadians that the company Maskopia (formerly known as Medkem Canada Inc.) in Brampton, Ontario, has been selling personal protective equipment (PPE), including gowns, masks and gloves, via social media and websites such as Kijiji without the required Medical Device Establishment Licence (MDEL) from Health Canada. Canadians are advised to immediately stop using these products and to dispose of them as they may not provide the level of protection advertised due to unknown quality and safety.

This company does not hold a MDEL, which is required to import or sell medical devices (including PPE) in Canada. Health Canada also refused an application from the company for authorization to sell its gowns under the Interim Order Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19 because they did not meet all of the requirements.

Despite Health Canada’s direction to stop sale, the company continued to sell its isolation gowns to various health care practitioners and consumers. Maskopia has also falsely advertised and sold non-medical masks as medical masks.

Health Canada has seized the following products from the company:

  • N95 masks
  • K95 masks
  • Isolation gowns
  • Face shields
  • CPR face shields
  • Cloth masks advertised as surgical masks
  • Disposable surgical masks
  • Latex and vinyl gloves

For more information about medical gowns, PPE and the Health Canada authorization process, please visit: COVID-19 personal protective equipment (PPE).

What you should do

Media enquiries

Health Canada
(613) 957-2983
hc.media.sc@canada.ca

Public enquiries

613-957-2991
1-866-225-0709
hcinfo.infosc@canada.ca