Fresenius Kabi USA, LLC has recalled 938 units of the Ivenix Infusion System (IIS) Large Volume Pump (LVP-0004). The recall was initiated because the device may experience mechanical interference on the fluid valve pins, which triggers a 'Pump Problem' alarm and can cause the pump to stop working. This defect can lead to a sudden delay or interruption of critical medical therapy, which could result in serious patient harm or death. These devices were distributed to healthcare facilities in California, Colorado, New Jersey, Utah, and Wisconsin.
A mechanical issue with the fluid valve pins can cause the infusion pump to stop delivering medication or fluids unexpectedly. If a patient is receiving life-sustaining or time-critical therapy, this interruption can lead to a rapid decline in health, serious injury, or death.
Contact your healthcare provider or the manufacturer for further instructions.
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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