Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
FDA Recall Z-0885-2026 · Posted 2025-12-16
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Recalling FirmFresenius Kabi USA, LLC
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2025-11-14
Product Quantity30 units
Reason for Recall
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Firm Action
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 [email protected].
Customer questions can be directed to Customer Support via email at [email protected] or by phone at 1-855-354-6387.
Root Cause
Software design
Distribution Pattern
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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