Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
FDA Recall Z-0378-2026 · Posted 2025-10-28
Recalling FirmFresenius Kabi USA, LLC
Recall StatusOpen, Classified
Product CodeFRN
Date Initiated2025-09-03
Product Quantity6 units
Reason for Recall
Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
Firm 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.
Root Cause
Process change control
Distribution Pattern
US Nationwide distribution in the state of Minnesota.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.