Regulatory Affairs Certification (RAC) Practice Exam

What type of recall is the return of an expired medical device product categorized as?

1. Normal stock rotation

2. Voluntary market withdrawal

3. Market safety recall

4. Mandatory recall

The correct answer is: Normal stock rotation

A recall that involves the return of an expired medical device product is accurately categorized as a form of normal stock rotation. This process is typically part of inventory management practices that ensure that products are used within their shelf life and reduces the risk of using outdated items that may no longer perform effectively or safely. Normal stock rotation is critical in healthcare to maintain patient safety and product efficacy. It is a proactive approach that manufacturers and distributors should follow to ensure that expired or soon-to-expire products are removed from circulation. In this scenario, returning an expired medical device reflects an organized effort to manage inventory responsibly. The other categories listed, such as voluntary market withdrawal, market safety recall, and mandatory recall, are associated with situations where there is a safety concern or defect identified in the products due to their condition or functionality, which is different from the routine action of managing expired products. Voluntary market withdrawals are initiated by the manufacturer when they choose to remove a product from the market for reasons other than safety concerns. Market safety recalls are often initiated in response to health risks associated with a product, and mandatory recalls involve regulatory authorities enforcing a removal due to severe issues or non-compliance.