Question

Which of the following conditions may be expected to lead to a field recall action?

A) Market Withdrawal for correction or removal of distributed devices involving no violation or minor violation of FD&C Act
B) Physical removal of device from point of use to other location for repair, modification, adjustment, relabeling, destruction, or inspection
C) Stock Recovery of a device has not left direct control of manufacturer
D) Routine servicing

Answer 1

Among the given options, typical routine servicing (option D) is not expected to lead to a field recall action, as it is simply the maintenance necessary for a device's continued normal operation.

Step-by-step explanation:

A field recall action in the context of medical devices may be expected under certain conditions. A field recall action specifically indicates a situation where there is a potential for serious adverse health consequences or death. Examples include but are not limited to the discovery of a serious defect or if the device poses an unexpected risk to health.

Therefore, among the provided options, the condition that may lead to a field recall action would not typically include market withdrawals for minor FD&C Act violations (option A), physical removal for routine repair or modification (option B), or stock recovery when the device has not left the manufacturer's control (option C).

In contrast, routine servicing, which is option D, is not expected to lead to a field recall action since this involves regular maintenance required to keep an already distributed device in working order without having identified a risk to health.