LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 Recall
Issued March 20, 2024 · Fresenius Kabi USA, LLC
In March 2024, Fresenius Kabi USA, LLC recalled the LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004, a serious 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
Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm. This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.
What you should do
- 1 Stop using LVP software of the Ivenix Infusion System (IIS), LVP-SW-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.
Recall details
- Brand
- Fresenius Kabi USA, LLC
- Category
- Health
- Recall date
- March 20, 2024
- Units affected
- Not reported
- Sold at
- US Nationwide distribution in the states of WI and NJ.
- Recall number
- FDA-Z-1282-2024
- 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.