Fasken was retained by a major global manufacturer with various aspects relating to a Type II recall by Health Canada of its medical device (in Canada and the U.S.).
As a result of Fasken’s guidance, the company was able to continue to commercialize their medical devices throughout the recall process in Canada and no additional enforcement measures or penalties were imposed. Fasken also coordinated with US counsel to assess any regulatory and reputational risk across borders and to prevent any material impact in the United States.
With the support of Fasken, the manufacturer and the importer were able to recall hundreds of products in Canada, while promptly and successfully addressing all regulatory compliance issues raised by Health Canada without further damages to the company.
Fasken team was composed of Mathieu Gagné, Jean-Raphaël Champagne and Dara Jospé.