Z-0378-2026Class II

Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004

Name: Z-0378-2026 Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004
Creator: Fresenius Kabi USA, LLC
Published: 2025-09-03
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2025-09-03 / Open, Classified

FDA source

Fresenius Kabi USA, LLC began a recall of Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004 on 2025-09-03. FDA classified it as Class II and gives the reason as "Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-0378-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-09-03
Posted: 2025-10-28
Recalling firm: Fresenius Kabi USA, LLC
Product: Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Product code: FRN Pump, Infusion
Reason for recall: Potential issue that can cause the device to register "phantom" touches in the lower-left corner of the touchscreen during operation.
FDA 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 in commerce: 6 units
Distribution: US Nationwide distribution in the state of Minnesota.
Product codes and lots: Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0378-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0378-2026	Class II	Ongoing	Voluntary: Firm initiated	2025-11-05	2025-10-28

Product code FRN

K183311Class IIIvenix Infusion System (IIS)Ivenix, Inc. / cleared 2019-06-07

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)