# FDA recall Z-1203-2026

> **Cardinal Health 200, LLC** · Class II · device recall initiated 2025-12-26.

## Product

Chest Drainage Units and Accessories:    Product Code	Description    1. 8888571562	Cardinal Health Sentinel Seal CDU  2. 8888571513	Cardinal Health Sentinel Seal CDU, Dual Drain  3. 8888571489	Cardinal Health Sentinel Seal CDU, with Easy Change  Connector  4. 8888571370	Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector  5. 8888571299	Cardinal Health Aqua-Seal CDU, Wet Suction  6. 8888571406	Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain  7. 8888571315	Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy  Change Connector  8. 8884713100	Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000  mL  9. 1814713105	OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only)  10. 1180571570	OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL  11. 8884713308	Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL  12. 8884713900	Cardinal Health Thora-Seal Replacement Collection Chamber,  2500 mL

## Reason for recall

The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.

## Distribution

Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.

## Key facts

- **Recall number:** Z-1203-2026
- **Recalling firm:** Cardinal Health 200, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-26
- **Report date:** 2026-02-04

- **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-1203-2026

## Citation

> AI Analytics. FDA recall Z-1203-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1203-2026. Source: US FDA. Licensed CC0.

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