FDA Device recall Z-0116-2024
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
- FDA Device
- Class II
- ongoing
- Published 2023-10-25
On 2023-10-25 the FDA classified a Class II recall of DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit by Deroyal Industries, citing 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 steril….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0116-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-09-18 |
| Published | 2023-10-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Deroyal Industries |
| Distribution | PA |
Product
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
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.
Identifiers
| code_info | UDI/DI (GTIN) 74975659085, Lot Codes: 59205650 exp 11/1/2027, 59496207 exp 11/1/2027 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0116-2024%22
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