Medical Device Compliance and Postmarketing Activities

Question 1

Class II Recall

Answer 1

A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Question 2

Class III Recall

Answer 2

A situation in which the use of or exposure to a violative product is not likely to cause adverse health consequences.

Question 3

Class I Recall

Answer 3

A situation presenting reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death