Fresenius Kabi USA, LLC Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system. Recall
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-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
UDI-DI: 00811505030122, Software Version 5.9.1 and prior
Products Sold
UDI-DI: 00811505030122; Software Version 5.9.1 and prior
Fresenius Kabi USA, LLC is recalling Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion due to The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Recommended Action
Per FDA guidance
An URGENT Medical Device Field Correction Important Safety Update notification letter dated 8/30/24 was sent to customers. Required Actions for Users: 1. Please fill out the Customer Reply Form attached to this letter to acknowledge receipt. 2. If your facility further distributes or transfers products to satellite sites or other locations, please ask these locations to contact the email address on the Customer Reply Form so we can send notice to those satellites directly. 3. Install new software version (5.9.2) for the Ivenix Large Volume Pump (LVP). See details below. How To Obtain and Install Software Version 5.9.2 To request installation, please reach out promptly to your Fresenius Kabi representative (1-855- 354-6387 or Ivenix_support@fresenius-kabi.com). They will push the new software update to your pumps. When the LVP version 5.9.2 software update has been sent to the LVP, the following prompt appears before the LVP is shut down. Customer support - email Ivenix_su pport@fresenius-kabi.com Customer support - phone 1-855-354-6387 Normal business Hours are Monday through Friday 8:30 AM to 5 PM Eastern Time, After Hours Supported with Voicemail Messaging
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