Fresenius Kabi USA, LLC 2024-04-17 Health critical FDA
Health · FDA · Recall #FDA-Z-1484-2024
LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. Recall
Issued April 17, 2024 · Fresenius Kabi USA, LLC
In April 2024, Fresenius Kabi USA, LLC recalled the LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0., 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
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 you should do
- 1 Stop using LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0. 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
- April 17, 2024
- Units affected
- Not reported
- Sold at
- US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
- Recall number
- FDA-Z-1484-2024
- 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.