Fresenius Kabi USA, LLC LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
UDI-DI 00811505030122 Software versions 5.0.1 and earlier.
Products Sold
UDI-DI 00811505030122 Software versions 5.0.1 and earlier.
Fresenius Kabi USA, LLC is recalling LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004 due to Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an u. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
The issue was resolved through an update of the software to Version 5.2.1, which was installed at customer sites in September 2022. The firm did not issue a customer letter at the time. According to the firm, this issue has been resolved in all fielded product. There have been two subsequent software upgrades since Version 5.2.1 was released. Consignees are now on v 5.8.0.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026