Medline Industries, LP is recalling approximately 2,894 kits containing Cardinal Health Aqua-Seal Chest Drainage Units and accessories. The instructions for use (IFUs) were found to be incorrect regarding the intended patient population. Medline is updating these instructions to clarify that the devices are intended only for adults aged 18 years and older. Consumers should contact their healthcare provider or the manufacturer for further instructions.
Using these chest drainage units on patients under the age of 18 may pose a risk because the device's safety and effectiveness have not been clarified for pediatric populations in the current instructions. No injuries have been reported to date.
UDI-DI listed for both each and case levels.
UDI-DI listed for both each and case levels.
UDI-DI listed for both each and case levels.
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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