Device product
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
Z-0116-2024
Product summary
- Event
- Event 93078
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32 kits
- Official record key
device-enforcement:Z-0116-2024
Official wording
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.
Code information: UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027
Distribution pattern: Pennsylvania
Derived failure modes
-
Unknown
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.