Ivenix, Inc. recallZ-1019-2025 · Fresenius Kabi USA, LLC · initiated Jan 10, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Fresenius Kabi USA, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.
FDA root cause category: Software Design Change
What the company is doing
Fresenius Kabi began notifying consignees on 01/10/2024 via emailed letter. Consignees were instructed to check if your device contains the affected software, review and become familiar with the temporary Risk Mitigation actions for each anomaly outlined in the letter and notify customers/personnel if the product was transferred or further distributed. Additionally, to facilitate the installation of the pump software, LVP SW 5.10, your facility must install the new Ivenix Infusion Management System (IMS) software version (5.2) on your IMS server and install the new software version (5.10) for the Ivenix Large Volume Pump (LVP). Please post this letter in areas that affected devices are stored and used such that users of this device are aware of the issues and recommended risk mitigation measures. Lastly, consignees were requested to complete and return the Customer Reply Form.
Recall details
- Recall number
- Z-1019-2025
- Status
- Open, Classified
- Initiated by the company
- Jan 10, 2025
- Posted by the FDA
- Feb 4, 2025
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 23 systems
- Product code
- FRN
- FDA submissions
- K183311
- Distribution
- US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.
Product description
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.
Code information (models, lots, serial numbers)
UDI-DI: 00811505030122. Software 5.9.2 and prior
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ivenix, Inc. 2.0Fresenius Kabi AG · Pump, Infusion10 recalls0 reports
Product lines
Other devices under the same FDA submission
4 devices cleared under K183311 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- Ivenix Infusion System LVP-0004Fresenius Kabi AG · Pump, Infusion7 recalls2 deaths4,328 reports
- Ivenix Infusion System 030-0028-08Fresenius Kabi AG · Pump, Infusion7 reports
- Ivenix Infusion System 030-0027-06Fresenius Kabi AG · Infusion Safety Management Software3 reports
- Ivenix Infusion System 030-0028-07Fresenius Kabi AG · Pump, Infusion2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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