Recall Z-0306-2025
DeRoyal Industries Inc · initiated October 3, 2024
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
DeRoyal C-SECTION TRACEPACK, REF 89-9338-06
Codes / lots: UDI/ DI 00749756927864 (each), 50749756927869 (case): Lot Numbers: 59098305, exp 4/1/2027; 59161271, exp 3/1/2025; 59245221, exp 6/1/2025; 59287659, exp 5/1/2025; 59716337, exp 5/1/2025;59866546, exp 12/1/2025; 59962811, exp 11/1/2025; 59996754, exp 12/1/2025; 60104426, exp 11/1/2025
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.
FDA-determined cause: Under Investigation by firm
Action taken
DeRoyal issued an URGENT! DEROYAL RECALL NOTICE to its consignees on 10/03/2024 via email. The notice explained the issue, potential risk, and requested the return of the affected packs. If the affected product was further distributed, the notice directed the distributor to notify its customers. This may be achieved directly by forwarding the recall notification and notify DeRoyal that you have done so, or the distributor may provide DeRoyal with your customer listing allowing them to contact your customers.
Details
- Recall number
- Z-0306-2025
- Initiated
- October 3, 2024
- Posted by FDA
- November 5, 2024
- Product code
- KDD – Kit, Surgical Instrument, Disposable
- Quantity
- 780 units
- Distribution
- US Nationwide distribution in the state of OH.
- Recalling firm
- DeRoyal Industries Inc, Powell, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0307-2025 Class II | DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke… | 10/03/2024Open, Classified |
| Z-0308-2025 Class II | DeRoyal CHILDREN'S ORTHOPEDIC TRACEPACK, 89-9349-06DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke… | 10/03/2024Open, Classified |
| Z-0309-2025 Class II | DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06DeRoyal is recalling certain lots of surgical procedure pack products that contain a Stryker SafeAir Smoke… | 10/03/2024Open, Classified |