Ivenix Infusion System recall: Software Issue
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Why was Ivenix Infusion System recalled?
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Software Versions 5.10.1 and prior; UDI: 00811505030122.
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 30 units
- Distribution
- US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
- Recall date
- December 24, 2025
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)