Ivenix Infusion System recall: Software Issue
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Why was Ivenix Infusion System recalled?
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could 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?
UDI-DI: 00811505030122; Software Version 5.9.1 and prior
- Product
- Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 17 units
- Distribution
- US Nationwide.
- Recall date
- October 2, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)