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What is a Section 64 recall?

Section 64 of the MDR requires importers and manufacturers to report all recalls to Health Canada, including recalls unlikely to cause any adverse health consequences (Type III recalls).

What are the 3 types of recalls?

While both the FDA and USDA have their own definitions of product recall classes, they follow the same general rule 1= most serious / dangerous, 2= potentially dangerous and 3 = least dangerous.

What is a recall on a medical device?

Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. A medical device recall does not always mean that you must stop using the product or return it to the company.

What is compulsory recall?

Compulsory product recall orders The Minister can issue a compulsory product recall order to a supplier if the supplier has not recalled goods or taken satisfactory action to recall goods, and the goods: are likely to cause injury to any person.

What is meant by product recall?

A product recall is the process of retrieving defective and/or potentially unsafe goods from consumers while providing those consumers with compensation. Recalls often occur as a result of safety concerns over a manufacturing defect in a product that may harm its user.