Ivenix Infusion System recallZ-0378-2026 · Fresenius Kabi USA, LLC · initiated Sep 3, 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
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
FDA root cause category: Process change control
What the company is doing
Fresenius Kabi notified the consignee on 09/03/2025 via email. The consignee was instructed to review the list of affected units and identify any on hand for return, remove all affected units from circulation pending repair and isolate them to avoid use, notify customers/personnel if the units were further distributed or transferred, and ensure all relevant personnel are aware. A Fresenius Kabi service representative will contact the consignee arrange for the return of affected units for repair.
Recall details
- Recall number
- Z-0378-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 3, 2025
- Posted by the FDA
- Oct 28, 2025
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 6 units
- Product code
- FRN
- FDA submissions
- K183311
- Distribution
- US Nationwide distribution in the state of Minnesota.
Product description
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Code information (models, lots, serial numbers)
Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Ivenix Infusion System LVP-0004Fresenius Kabi AG · Pump, Infusion7 recalls2 deaths4,328 reports
Product lines
Other devices under the same FDA submission
3 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 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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