Fresenius Kabi USA, LLC is recalling 23 Ivenix Infusion System (IIS) Large Volume Pumps with software version 5.9.2 and earlier. The recall is due to software errors that can cause the pump to stop working entirely or deliver fluids at the wrong speed. No injuries have been reported, but these failures can interrupt or delay life-sustaining treatments for patients in hospitals and outpatient care environments.
The pump can become nonfunctional if the 'Pause Audio' option is used 70 or more times during an alarm. Additionally, the software may fail to switch properly to secondary infusions, causing the pump to deliver medication at a previously programmed primary rate, which could lead to over-infusion or under-infusion.
Corrective action for software delivery failure anomalies.
Recall includes software version 5.9.2 and prior.
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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