Medical Device Recall Response Verification

Verifies intake of a medical device recall notice, identification of affected devices, quarantine actions, and closure documentation.

Recall Notice Intake

• Recall notice received and logged
  Confirm the recall notice was received, date/time stamped, and entered into the tracking log or ticketing system.
• Source of recall notice identified
  Record the source of the notice, such as FDA, manufacturer, distributor, or internal safety team.
• Recall identifier recorded
  Capture the recall number, alert number, lot number, serial number range, or other manufacturer reference used to identify the action.
• Affected device model and UDI identified
  Verify the device model, catalog number, and UDI or equivalent identifier are documented for the recall.
• Recall classification and urgency reviewed
  Document whether the recall is urgent, high risk, or routine, and whether immediate action is required.

Affected Device Identification

• Inventory search completed for affected devices
  Confirm a search was performed across inventory, storage, in-use locations, loaners, and offsite areas for all affected devices.
• In-service devices identified
  Record the number of affected devices currently in service or available for patient use.
• Devices in inventory identified
  Record the number of affected devices located in storage, receiving, or spare inventory.
• Serial numbers or lot numbers matched to recall scope
  Verify each located device was matched against the recall scope using serial number, lot number, or other applicable identifier.
• Unresolved device count documented
  Record any affected devices that could not be located or verified and explain the gap.

Quarantine and Removal Actions

• Affected devices removed from service
  Verify all identified affected devices were taken out of clinical use or removed from availability.
• Quarantine area established and labeled
  Confirm quarantined devices are segregated, clearly labeled, and protected from accidental use.
• Quarantine date and responsible person recorded
  Document when quarantine occurred and who completed the action.
• Manufacturer return, repair, or disposal instructions reviewed
  Verify the recall instructions for return, repair, replacement, or disposal were reviewed and followed.
• Patient care impact assessed
  Document whether the recall created any interruption to patient care, replacement need, or temporary workaround.

Notifications and Escalation

• Clinical leadership notified
  Confirm the appropriate clinical manager, department leader, or service line owner was notified.
• Risk management or compliance notified
  Confirm risk management, compliance, or quality leadership was notified when required by policy.
• Manufacturer or distributor contacted for disposition guidance
  Document whether follow-up contact was made to clarify return, replacement, or disposition requirements.
• Escalation required for unresolved devices
  Indicate whether unresolved devices were escalated to leadership for further search or containment.
• Escalation notes
  Provide a concise summary of any escalations, including who was notified and what action was requested.

Closure Documentation

• Recall response summary completed
  Confirm the final response summary includes devices identified, devices quarantined, and disposition status.
• Supporting records attached
  Verify supporting evidence is attached, such as recall notice, inventory list, quarantine log, and correspondence.
• Closure date recorded
  Document the date the recall response was closed or submitted for final review.
• Open actions remain
  Indicate whether any open actions remain after closure review.
• Final reviewer signature
  Signature of the person approving the recall response verification.