# FDA recall Z-0116-2024

> **DeRoyal Industries Inc** · Class II · device recall initiated 2023-09-18.

## Product

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

Pennsylvania

## Key facts

- **Recall number:** Z-0116-2024
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-09-18
- **Report date:** 2023-10-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Powell, TN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0116-2024

## Citation

> AI Analytics. FDA recall Z-0116-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0116-2024. Source: US FDA. Licensed CC0.

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