DeRoyal Industries Inc Recall 95509
Description: DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06
DeRoyal Industries Inc Recall 95509 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0309-2025 |
| Event ID | 95509 |
| Event Description | DeRoyal CHILDREN'S LAPTRACEPACK, 89-9362.06 |
| Product Type | Devices |
| Distribution | US Nationwide distribution in the state of OH. |
| Quantity | 95 units |
| Recall 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. |
| Device Classification | 20241113 |
| Device Code Info | UDI/ DI 00749756913393 (each), 50749756913398 (case): Lot Numbers: lot 59244907 exp 10/1/2025 |
| Center Classification Date | 20241105 |
| Recall Initiation Date | 20241003 |
| Recalling Firm | DeRoyal Industries Inc |
| Initial Notification | |
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