Medical Devices Recalls

Definitions

Hazard Classification

The numerical designation, i.e., Type I, II or III, assigned by Health Products and Food Branch (HPFB or the Branch) to a particular product to indicate the relative degree of health hazard presented by the product, as follows:

• Type I: a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death.
• Type II: a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote, or
• Type III: a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences.

Type I and II include situations where a product which does not have generally recognized or scientifically supported therapeutic value is promoted in such a way that avoidance of recognized therapy occurs and where such avoidance could lead to injury or death.