Ivenix Infusion System recall
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Why was Ivenix Infusion System recalled?
Emphasizing instructions for LVP duration programming located in the IFU.
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?
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
- Product
- Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 30 units
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
- Recall date
- January 21, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)