Baxter Healthcare Corporation is recalling approximately 339,936 Amia Automated Peritoneal Dialysis (APD) Cycler Sets because of an increase in reports that the devices are triggering failure alarms during the 'Wet Cassette Integrity Test.' This test is a critical safety check performed by the machine before dialysis treatment begins. If the test fails and the alarm sounds, it may prevent the user from starting or completing their necessary dialysis therapy.
A failure during the integrity test and the resulting alarms can lead to delays or interruptions in life-sustaining peritoneal dialysis treatment. While no specific injuries were mentioned in the initial report, such delays can cause serious health complications for patients who rely on regular dialysis cycles to filter waste from their blood.
healthcare provider or manufacturer consultation.
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
openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.