Class 1 Device Recall Ivenix Infusion System

• Date Initiated by Firm: November 14, 2025
• Date Posted: December 16, 2025
• Recall Status: Open, Classified
• Recall Number: Z-0885-2026
• Recall Event ID: 98009
• 510(K)Number: K183311
• Product Classification: Pump, infusion - Product Code FRN
• Product: Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
• Code Information: Software Versions 5.10.1 and prior; UDI: 00811505030122.
• Recalling Firm/ Manufacturer: Fresenius Kabi USA, LLC; 50 High St Ste 50; North Andover MA 01845-2620
• For Additional Information Contact: Rebecca McCandless; 847-393-5451
• Manufacturer Reason for Recall: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
• FDA Determined Cause: Software design
• 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 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.
• Quantity in Commerce: 30 units
• Distribution: US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = FRN