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 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.
The infusion pump may trigger downstream occlusion alarms when a check valve is used in low flow infusion rates. This issue can disrupt patient care and potentially lead to complications.
No specific incidents or injuries have been reported related to this recall. The alarm issue poses a high hazard level but does not currently have documented injuries.
Stop using the Ivenix Infusion System immediately. Contact Fresenius Kabi USA or your healthcare provider for further instructions and follow the recall instructions provided.
To report issues or get more information, contact Fresenius Kabi USA, LLC via email. For more details, visit the FDA recall page.
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