Ivenix, Inc. recallZ-0002-2023 · Fresenius Kabi USA, LLC · initiated Sep 8, 2022
Terminated
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
The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.
FDA root cause category: Software design
What the company is doing
On September 8, 2022, the company notified affected customers via phone call and emailed letter. Customers were instructed to do the following: 1. If a high priority Pump Problem alarm occurs, the LVP should be powered down by holding the power button for 10 seconds then releasing the power button so that the screen goes dark, then pressing the power button again to re-start the pump. Alternatively, if you have another LVP available, you may use it to resume infusion. 2. Inform potential users of the product within your organization of this notification. If your facility further distributes or transfers products amongst satellite sites or other locations, please disseminate this information accordingly. Fresenius Kabi has updated the software to rectify the condition. The updated software is currently available. Please schedule a service call at your earliest convenience to have it installed. Customer support: [email protected]; 1-978-775-8100
Recall details
- Recall number
- Z-0002-2023
- Status
- Terminated
- Initiated by the company
- Sep 8, 2022
- Posted by the FDA
- Oct 6, 2022
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 4 instances
- Product code
- PHC
- FDA submissions
- K183311
- Distribution
- Domestic distribution to NJ and WI.
Product description
Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004 version 5.2.0
Code information (models, lots, serial numbers)
UDI-DI: 00811505030122 version 5.2.0
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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