# FDA recall Z-1052-2024

> **Cardinal Health 200, LLC** · Class I · device recall initiated 2023-12-04.

## Product

Dover" 100% SILICONE FOLEY TRAY, NEEDLELESS, 14 FR (4.7 MM), 5 CC, 2000 ML DRAIN BAG, DRAIN SPOUT; Dover" HYDROGEL COATED LATEX FOLEY CATHETER KIT, 5 CC, 2-WAY, 14 FR (4.7 MM), 10 CC WATER SYRINGE

## Reason for recall

Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.

## Distribution

US and EMEA, Japan, Latin America

## Key facts

- **Recall number:** Z-1052-2024
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-12-04
- **Report date:** 2024-02-28

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Waukegan, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1052-2024

## Citation

> AI Analytics. FDA recall Z-1052-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1052-2024. Source: US FDA. Licensed CC0.

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