FDA Medical Device Recalls (openFDA)
Fresenius Kabi USA, LLC: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- Recall number
- Z-2223-2026
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
- Status
- Open, Classified
- Initiated
- 2026-05-06
- Posted
- 2026-06-03
- Terminated
- not on file
- Reason
- 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.
- Root 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
- 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.
- Lot, serial or model codes
- Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
- 510(k) numbers
- ["K183311"]
- PMA numbers
- not on file
- Product code
- FRN
- Firm FEI
- 3014732157
- Firm city
- North Andover
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28