Drug recall
DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
FDA recall event 93078 · Class II · DeRoyal Industries Inc
Key facts
| Event ID | 93078 |
|---|---|
| Recall numbers | Z-0116-2024 |
| Recalling firm | DeRoyal Industries Inc |
| Product type | Devices |
| Products | DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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… |
| Initiation date | Sep 18, 2023 |
| Report date | Oct 25, 2023 |
| City | Powell |
| State | TN |
| Country | United States |
| FEI number | 1043214 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: