Z-0116-2024 Class II Ongoing
FDA device recall Z-0116-2024 was initiated by DeRoyal Industries Inc on September 18, 2023 and is designated Class II. 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 t… The recall status is ongoing. Affected quantity: 32 kits.
Recall Details
- Product Type
- Devices
- Report Date
- October 25, 2023
- Initiation Date
- September 18, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32 kits
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.
Distribution Pattern
Pennsylvania
Code Information
UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027