Fresenius Kabi USA recalled 30 units of the Ivenix Infusion System LVP Software on November 21, 2025. The recall addresses concerns related to programming instructions for LVP duration. Patients and healthcare providers must stop using the device immediately.
Emphasizing instructions for LVP duration programming located in the IFU.
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: Letter
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The Ivenix Infusion System is used in healthcare settings for administering intravenous medications and fluids. Healthcare providers rely on it for accurate dosing and patient care.
The software issue affects the programming of LVP duration, which is critical for proper infusion management. Incorrect programming could lead to under- or over-infusion of medications.
This recall is not part of a broader industry pattern.
This recall poses a significant risk to patient safety, requiring immediate action from healthcare providers to prevent potential harm.
Check the product packaging or the device itself for labels indicating the product code and software version.
Expect a refund or replacement timeline of approximately 4-6 weeks after following recall instructions.
Keep records of any correspondence with the manufacturer or healthcare provider regarding the recall.
The recalled product is the Ivenix Infusion System LVP Software, model LVP-SW-0005. It is distributed nationwide in states including California, Florida, and Texas. This software is classified as a Class II medical device.
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