Class 1 Device Recall LVP software of the Ivenix Infusion System (IIS)

• Date Initiated by Firm: May 06, 2026
• Date Posted: June 03, 2026
• Recall Status: Open, Classified
• Recall Number: Z-2223-2026
• Recall Event ID: 98929
• 510(K)Number: K183311
• Product Classification: Pump, infusion - Product Code FRN
• Product: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
• Code Information: Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
• FEI Number: 3014732157
• Recalling Firm/ Manufacturer: Fresenius Kabi USA, LLC; 50 High St Ste 50; North Andover MA 01845-2620
• For Additional Information Contact: Rebecca McCandless; 978-775-8050
• Manufacturer Reason for Recall: Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
• FDA Determined Cause: Software design (manufacturing process)
• Action: Consignees were notified on about 05/06/2026 via letter. Consignees were informed of the issue, risk associated, and instructed to keep the Ivenix pump plugged in at all times rather than rely on battery and if a "Battery Extremely Low" alarm occurs while on battery, immediately connect the pump to AC. For any transport of a patient on an affected pump, have a plan for AC access. For patients receiving critical or short half-life infusion therapies, ensure an RN accompanies the patient during transport. Consignees were also instructed to notify other users if applicable, notify customers if affected units were transferred or distributed, and post the provided Safety Tip Sheet, Battery Health Software Anomaly in the Ivenix Large Volume Pump (LVP) notice alongside this letter in all areas where affected pumps are stored and used. consignees were asked to complete and return the provided Customer Reply Form.
• Quantity in Commerce: 32 systems
• Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, 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