Recall Z-0622-2024 ยท LRO General Surgery Tray
DeRoyal Industries Inc
DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572
| Date | Sep 30, 2024 (initiated Nov 22, 2023) |
| Status | Open, Classified |
| Reason | Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences. |
| Root cause | Device Design |
| Action | 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. |
| Quantity | 252 units |
| Distribution | US: Virginia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |