Z-2223-2026Class I

LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005

Name: Z-2223-2026 LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005
Creator: Fresenius Kabi USA, LLC
Published: 2026-05-06
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2026-05-06 / Open, Classified / root cause: software

FDA source

Fresenius Kabi USA, LLC began a recall of LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005 on 2026-05-06. FDA classified it as Class I and gives the reason as "Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as software.

Recall record

Recall number: Z-2223-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-05-06
Posted: 2026-06-03
Recalling firm: Fresenius Kabi USA, LLC
Product: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Product code: FRN Pump, Infusion
Reason for recall: Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
Root cause tag: software
FDA root cause: Software design (manufacturing process)
Action: Consignees were notified on about 05/06/2026 via letter. Consignees were informed of the issue, risk associated, and instructed to keep the Ivenix pump plugged in at all times rather than rely on battery and if a "Battery Extremely Low" alarm occurs while on battery, immediately connect the pump to AC. For any transport of a patient on an affected pump, have a plan for AC access. For patients receiving critical or short half-life infusion therapies, ensure an RN accompanies the patient during transport. Consignees were also instructed to notify other users if applicable, notify customers if affected units were transferred or distributed, and post the provided Safety Tip Sheet, Battery Health Software Anomaly in the Ivenix Large Volume Pump (LVP) notice alongside this letter in all areas where affected pumps are stored and used. consignees were asked to complete and return the provided Customer Reply Form.
Quantity in commerce: 32 systems
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Product codes and lots: Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2223-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2223-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-06-10	2026-06-03

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)