Health Canada warns against unlicensed PPE firm

Health Canada is urging Canadians to immediately get rid of products from an Ontario-based company selling unauthorized personal protective equipment (PPE) and medical devices online. The company Maskopia, formerly known as Medkem Canada Inc., has been selling masks, gloves, gowns and other PPE without a medical devices establishment licence (MDEL) from Health Canada. The agency requires anyone who sells or imports medical devices to obtain this licence.

PPE sold by Maskopia “may pose serious health risks,” wrote Health Canada in a release Tuesday. “They may not provide the level of protection advertised due to unknown quality and safety.”

Health Canada said Maskopia has falsely advertised and sold non-medical masks as medical masks. While the company didn’t respond to Canada’s National Observer’s request for comment, on its Facebook page, it describes itself as a “manufacturer of disposable medical grade ASTM (American Society for Testing and Materials) surgical masks Level 1-3 Health Canada approved” _ which is completely false, according to Health Canada.

False or misleading claims

Health Canada said it is illegal to sell or advertise health products “that make false or misleading claims.” It has seized many medical products from the company, including N95 masks, gowns and face shields. The company is selling masks for as much as $175 for a 50-pack, according to its website.

Health Canada said it also refused to authorize an application from the company to sell its isolation gowns because they weren’t up to the agency’s requirements for COVID-19 medical devices. Despite the order to stop gown sales, the company has continued to market them to health-care practitioners and consumers, according to Health Canada.

The company’s Facebook page says it manufactures 40,000 disposable isolation gowns per day in Newfoundland. Health Canada recommends that people stop using and dispose of any items purchased from Maskopia and learn more about the risk of buying products with false or misleading advertising. This isn’t the first time companies have sold fraudulent or unauthorized PPE. Health Canada warned people against fake N95 masks in the first wave of the pandemic.

The agency said it has also received reports about plant-based elixirs, Chaga mushroom blends and ultraviolet lamps that have falsely claimed to prevent, treat or cure COVID-19. It has ordered many companies to immediately remove these claims from their websites and advertising materials.