Official recall record
Chest Drainage Units and Accessories: Product Code Description 1. 8888571562 Cardinal Health Sentinel Seal CDU 2. 8888571513 Cardinal
- Issuing authority
- US FDA — Medical Devices
- Recall initiated by firm
- 2025-12-26
- Country of alert
- United States
- Alert level
- Class II
- Alert type
- recall
- Brand on record
- Cardinal Health 200, LLC
What the authority reported
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.
What to do
Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.
Record last checked against the registry on 2026-05-31.
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All 31 official recall notices naming Cardinal Health 200, LLC on this site →