Fresenius Kabi USA recalled 15,862 Ivenix Infusion Systems on November 3, 2025. The recall affects model LVP-0004 due to downstream occlusion alarms during low flow infusions. Healthcare providers and patients should stop using the device immediately.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Fresenius Kabi USA, LLC or your healthcare provider for instructions. Notification method: E-Mail
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The Ivenix Infusion System is a large volume pump used in healthcare settings for intravenous medication delivery. It is commonly used for administering fluids and medications to patients in various clinical environments.
The device may trigger alarms during low flow infusion, especially when a check valve is added, which can interrupt patient treatment and lead to potential complications.
This recall is not part of a broader industry pattern.
Patients and healthcare providers must stop using the infusion system, which could disrupt medical procedures and require alternative solutions.
The model number and UDI-DI can usually be found on the device label or packaging.
Expect a response within 4-6 weeks regarding your recall inquiry.
Keep records of any communications with the manufacturer, receipts if available, and photographs of the device.
The recalled product is the Ivenix Infusion System (IIS), Large Volume Pump, model number LVP-0004. It was distributed nationwide in states including California, Florida, and Texas. The device is classified as Class II.
Not sure what to do next? Our guide walks you through the process step by step.
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