Section 42
Recall
ActIn forceProvision 42 of 80
Section 42
(1)
An establishment may recall any defective medical device at any time.
(2)
The establishment shall, on or before undertaking a recall of the medical device, provide information as may be specified by the Authority.
(3)
The establishment shall, as soon as possible after the completion of a recall, report to the Authority the results of the recall and any action taken to prevent a recurrence of the problem.
(4)
Notwithstanding subsection (1), the Authority may order the establishment to recall any medical device at any time due to patient safety and public health.