Baxter Healthcare Corporation is recalling 75 Exactamix Pro 1200 and 2400 compounding devices due to a software error in versions 2.0.8 and 2.1.8. This specific software flaw occurs when using the "Use Some Overfill" feature, which can cause the device to deliver redundant amounts of ingredients. The recall affects 8 units of the Pro 1200 model and 67 units of the Pro 2400 model distributed across 22 states. Because these devices are used to prepare clinical nutrition and medications, an over-delivery of ingredients could lead to serious patient harm.
A software bug triggers the delivery of double the requested overfill volume, leading to potentially dangerous concentrations of ingredients in a patient's prescription. Over-delivery of potent ingredients can cause metabolic imbalances or toxicities, particularly in sensitive patient populations.
Manufacturer mitigation for software error
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 ยท 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.