Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
- Company
- Fresenius Kabi Usa, Llc
- Recall Initiated
- September 3, 2025
- Posted
- October 28, 2025
- Recall Number
- Z-0378-2026
- Quantity
- 6 units
- Firm Location
- North Andover, MA
Reason for Recall
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Distribution
US Nationwide distribution in the state of Minnesota.
Lot / Code Info
Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
Root Cause
Process change control
Action Taken
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.