Cardinal Health 200, LLC is recalling over 1.1 million Chest Drainage Units (CDUs) and accessories to update the instructions for use. The manufacturer has determined these devices should only be used on adults aged 18 and older, as they may not function as intended when used on infants. The recall covers 12 different product models including Sentinel Seal, Altitude, Aqua-Seal, and Thora-Seal units distributed worldwide.
When used on infants, these units may fail to show expected bubbling or tidaling (fluid movement), which clinicians rely on to assess if the device is working. This can lead to incorrect medical assessments, inappropriate treatment, delays in therapy, and longer hospital stays for infant patients.
All units affected by IFU update.
All units affected by IFU update.
All units affected by IFU update.
All units affected by IFU update.
All units affected by IFU update.
All units affected by IFU update.
All units affected by IFU update.
All units affected by IFU update.
OUS Only. All units affected by IFU update.
OUS Only. All units affected by IFU update.
All units affected by IFU update.
All units affected by IFU update.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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