Ivenix Infusion System recall
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Why was Ivenix Infusion System recalled?
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
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?
Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:
- Product
- Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 18,444
- Distribution
- Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
- Recall date
- June 10, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)