Recall Z-0116-2024 ยท LRO General Surgery Tray
DeRoyal Industries Inc
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
| Date | Oct 16, 2023 (initiated Sep 18, 2023) |
| Status | Open, Classified |
| Reason | DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due to damage to the luer tip of the syringe. |
| Root cause | Nonconforming Material/Component |
| Action | DeRoyal issued an URGENT RECALL NOTICE to its sole consignee on 09/18/2023 by email. The notice explained the problem, the risk to health, and requested the return of the product. Distributors were requested to notify their customers. |
| Quantity | 32 kits |
| Distribution | Pennsylvania |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K842648 | GENERAL SURGERY TRAY Deroyal Industries, Inc., Sep 20, 1984 |