DeRoyal CHILDREN'S GENERAL TRACEPACK, REF 89-9342-06
FDA device recall Z-0307-2025 · posted 2024-11-05 · Open, Classified
Recall details
- Recalling firm
- DeRoyal Industries Inc
- 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.
- 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.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 160 units
- Distribution
- US Nationwide distribution in the state of OH.
- Date initiated
- 2024-10-03
- Date posted
- 2024-11-05
- Location
- Powell, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENERAL SURGERY TRAY (K842648) | Deroyal Industries, Inc. | 1984-09-20 |