DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
FDA device recall Z-0116-2024 · posted 2023-10-16 · Open, Classified
Recall details
- Recalling firm
- DeRoyal Industries Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 32 kits
- Distribution
- Pennsylvania
- Date initiated
- 2023-09-18
- Date posted
- 2023-10-16
- Location
- Powell, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENERAL SURGERY TRAY (K842648) | Deroyal Industries, Inc. | 1984-09-20 |