DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
FDA device recall Z-0622-2024 · posted 2024-09-30 · Open, Classified
Recall details
- Recalling firm
- DeRoyal Industries Inc
- Reason for recall
- Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.
- Action taken
- DeRoyal Industries issued am URGENT FIELD CORRECTIVE ACTION notice to its sole consignee on 11/22/2023 via email. The notice explained the issue and provided instructions on the proper use of the device.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 252 units
- Distribution
- US: Virginia
- Date initiated
- 2023-11-22
- Date posted
- 2024-09-30
- Location
- Powell, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENERAL SURGERY TRAY (K842648) | Deroyal Industries, Inc. | 1984-09-20 |