Recall Z-0306-2025— DeRoyal Industries Inc
Class II · Ongoing
Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2024-10-03. FDA's recall record names no specific 510(k) clearance for this event. Product: DeRoyal C-SECTION TRACEPACK, REF 89-9338-06. Reason: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released..
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-10-03
- Firm location
- Powell, TN, United States
Product description
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Reason for recall
DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke Evacuation Pencil. The recall is due to Stryker receiving reports that the pencil is activating without manual input when plugged into a power source or remains active after buttons are released.
Data sourced from openFDA. This site is unofficial and independent of the FDA.