Medical Device Remedial Action Recall Procedure

The medical device remedial action recall procedure establishes a process for implementing remedial / recall action on violative products. The document provides instructions on product investigations, actions taken after confirmation of a problem, and the elements of a written action plan complete with required approvals. Specific requirements for effectiveness checks, status reports, and close-out processes are addressed. A Health Hazard Analysis form and forms used for communication with consignees are included. The medical device remedial action recall procedure complies with ISO 13485 and FDA QSR.