Fresenius Kabi USA, LLC 2024-10-02 Health critical FDA
Health · FDA · Recall #FDA-Z-3153-2024
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and… Recall
Issued October 2, 2024 · Fresenius Kabi USA, LLC
In October 2024, Fresenius Kabi USA, LLC recalled the Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and…, a critical health recall reported by the FDA. Affected owners are eligible for a voluntary. Here is what the hazard is and exactly what to do about it.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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 you should do
- 1 Stop using Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Fresenius Kabi USA, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Fresenius Kabi USA, LLC
- Category
- Health
- Recall date
- October 2, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide.
- Recall number
- FDA-Z-3153-2024
- Made in
- United States
- Issuing agency
- FDA
In context
- Fresenius Kabi USA, LLC has 16 recalls in our database, including 6 rated Critical.
- We're tracking 3,576 Health recalls in our database.
- This is the 737th Health recall we've logged in 2024.