Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 Recall
Issued October 12, 2022 · Fresenius Kabi USA, LLC
In October 2022, Fresenius Kabi USA, LLC recalled the Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0, 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
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
What you should do
- 1 Stop using Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0 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.
Recall details
- Brand
- Fresenius Kabi USA, LLC
- Category
- Health
- Recall date
- October 12, 2022
- Units affected
- Not reported
- Sold at
- Domestic distribution to NJ and WI.
- Recall number
- FDA-Z-0002-2023
- 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 870th Health recall we've logged in 2022.