Ivenix Infusion System (Fresenius Kabi) – Touchscreen Error (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
Products Sold
Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.
Fresenius Kabi USA, LLC is recalling Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004. due to Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026