# FDA recall Z-0622-2024

> **DeRoyal Industries Inc** · Class II · device recall initiated 2023-11-22.

## Product

DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

## Reason for recall

Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.

## Distribution

US:  Virginia

## Key facts

- **Recall number:** Z-0622-2024
- **Recalling firm:** DeRoyal Industries Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-11-22
- **Report date:** 2024-01-03

- **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-0622-2024

## Citation

> AI Analytics. FDA recall Z-0622-2024. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/Z-0622-2024. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*