Recall Z-0378-2026 ยท FRN Pump, Infusion
Fresenius Kabi USA, LLC
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
| Date | Oct 28, 2025 (initiated Sep 3, 2025) |
| Status | Open, Classified |
| Reason | Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation. |
| Root cause | Process change control |
| Action | 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. |
| Quantity | 6 units |
| Distribution | US Nationwide distribution in the state of Minnesota. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183311 | Ivenix Infusion System (IIS) Ivenix, Inc., Jun 7, 2019 |