Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. S... (Fresenius Kabi USA, LLC) – software version 5 (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
Software Versions 5.10.1 and prior, UDI: 00811505030122.
Products Sold
Software Versions 5.10.1 and prior; UDI: 00811505030122.
Fresenius Kabi USA, LLC is recalling Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration o due to Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Recommended Action
Per FDA guidance
Consignees were emailed an "URGENT - Medical Device Field Correction" notice dated 11/14/25. The notice instructs consignees to review and become familiar with the provided notification's risk mitigation actions; the notice is to be forwarded if affected units were further distributed and users are to be notified. Consignees are to facilitate the installation of the new Ivenix Infusion Management System (version 5.2.2) and Large Volume Pump (5.10.2) software versions utilizing the provided instructions. Consignees are to note that the LVP will not be available for use during the update. Completed Customer Reply Forms may be sent via email to fkmd.fieldactions@fresenius-kabi.com. Customer questions can be directed to Customer Support via email at Ivenix_support@fresenius-kabi.com or by phone at 1-855-354-6387.
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 noticeDistribution
As reported by FDA
CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NV, NJ, OK, OR, SC, TX, VA, WA, WI
Page updated: Jan 10, 2026