DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
This recall is currently active, issued October 16, 2023. It was issued by Deroyal Industries Inc.
- Company
- Deroyal Industries Inc
- Recall Initiated
- September 18, 2023
- Posted
- October 16, 2023
- Recall Number
- Z-0116-2024
- Quantity
- 32 kits
- Firm Location
- Powell, TN
- Official Source
- View on FDA website ↗
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.
Distribution
Pennsylvania
Lot / Code Info
UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027
Root Cause
Nonconforming Material/Component
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.