Ivenix Infusion System recall
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Why was Ivenix Infusion System recalled?
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
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. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
- Product
- Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 6 units
- Distribution
- US Nationwide distribution in the state of Minnesota.
- Recall date
- November 5, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)