Official recall notice
FDA DeviceClass IINotable
FDA Recall: Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Numbe
- Recall date
- 2026-03-18
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
Recommended action
What to do
2894 units
Product description
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.