LVP Software of the Ivenix Infusion System recall: Software Issue
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Why was LVP Software of the Ivenix Infusion System recalled?
Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to 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?
Product LVP-SW-0004; UDI-DI 00811505030122.
- Product
- LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 17 units
- Distribution
- US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
- Recall date
- April 17, 2024
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)