Medical Device Recall Response Verification

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

Inspection Details

• Recall notice identifier recorded
  Record the recall, safety alert, or field correction identifier exactly as received.
• Manufacturer and device family identified
  Document the manufacturer name and affected device family/model.
• Recall classification captured
  Select the recall classification or alert type if provided.

Recall Intake and Triage

• Recall notice received through approved channel
  Verify the notice was received via the designated compliance, biomed, or vendor management channel.
• Date and time of receipt documented
  Capture when the recall notice was first received by the organization.
• Initial triage completed and owner assigned
  Confirm the recall was reviewed, risk assessed, and assigned to a responsible owner for follow-up.
• Affected locations and departments identified
  Select all departments, units, or sites where affected devices may be in service.

Affected Device Identification

• Device model, catalog, or serial range matched to recall notice
  Verify the facility identified the exact affected model, catalog number, lot, or serial range.
• Inventory search completed across all known locations
  Confirm a documented search was performed across storage, point-of-use, loaner, and deployed inventory.
• Quantity of affected devices identified
  Enter the number of affected devices found.
• Unresolved inventory gaps documented
  Confirm any missing or unverified units were documented and escalated for follow-up.

Quarantine and Removal from Service

• Affected devices quarantined or removed from service
  Verify all identified affected devices were physically segregated, tagged, or otherwise removed from clinical use.
• Quarantine location secured and clearly labeled
  Confirm the quarantine area prevents inadvertent use and is clearly marked as hold for recall.
• Device status updated in inventory or CMMS
  Verify the asset record reflects recall hold, out-of-service status, or equivalent control.
• Loaner, rental, or borrowed devices checked for inclusion
  Confirm non-owned devices in use were reviewed against the recall scope.

Notification, Documentation, and Closure

• Clinical and operational stakeholders notified
  Confirm impacted departments, leadership, and service owners were notified of the recall and required actions.
• Manufacturer or FDA response instructions documented
  Verify any required return, correction, replacement, or reporting instructions were recorded.
• Closure evidence retained
  Confirm closure documentation includes search results, quarantine evidence, disposition, and completion status.
• Inspector signature captured
  Signature of the person verifying recall response completion.