Fresenius Kabi USA, LLC 2023-12-27 Health critical FDA
Health · FDA · Recall #FDA-Z-0549-2024
Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 Recall
Issued December 27, 2023 · Fresenius Kabi USA, LLC
In December 2023, Fresenius Kabi USA, LLC recalled the Ivenix Infusion System (IIS), Large Volume Pump LVP-0004, 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 device may experience mechanical interference on the Fluid Valve pins, which will trigger a Pump Problem alarm. The issue may lead to delay or interruption of therapy. Depending on the therapy and duration of delay/interruption, the issue may lead to serious harm or death.
What you should do
- 1 Stop using Ivenix Infusion System (IIS), Large Volume Pump LVP-0004 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
- December 27, 2023
- Units affected
- Not reported
- Sold at
- US distribution to states of: CA, CO, NJ, UT, and WI.
- Recall number
- FDA-Z-0549-2024
- 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 903rd Health recall we've logged in 2023.