Recall Z-2223-2026 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
| Date | Jun 3, 2026 (initiated May 6, 2026) |
| Status | Open, Classified |
| 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 a |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |