DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
FDA Recall #Z-0116-2024 — Class II — September 18, 2023
Product Description
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
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.
Recalling Firm
DeRoyal Industries Inc — Powell, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
32 kits
Distribution
Pennsylvania
Code Information
UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated