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 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.
The recall emphasizes the need for clear instructions regarding LVP duration programming found in the Instructions for Use (IFU). Failure to adhere to these instructions could lead to serious patient safety risks.
There have been no reported injuries or incidents directly linked to this software recall. However, the high hazard classification indicates a potential risk to patient safety.
Stop using the Ivenix Infusion System immediately. Follow the recall instructions from Fresenius Kabi USA and contact your healthcare provider for further guidance.
For more information, contact Fresenius Kabi USA at their customer service line. Further details can be found on the FDA's recall page.
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