Z-1048-2026Class II

Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005

Name: Z-1048-2026 Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005
Creator: Fresenius Kabi USA, LLC
Published: 2025-11-21
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2025-11-21 / Open, Classified / root cause: labeling and UDI

FDA source

Fresenius Kabi USA, LLC began a recall of Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005 on 2025-11-21. FDA classified it as Class II and gives the reason as "Emphasizing instructions for LVP duration programming located in the IFU". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1048-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-11-21
Posted: 2026-01-12
Recalling firm: Fresenius Kabi USA, LLC
Product: Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Product code: FRN Pump, Infusion
Reason for recall: Emphasizing instructions for LVP duration programming located in the IFU.
Root cause tag: labeling and UDI
FDA root cause: Use error
Action: An URGENT MEDICAL DEVICE CORRECTION notification dated 11/21/25 was sent to consignees notifying them of this safety alert. The notification reiterates instructions for administering infusions included in the device's IFU. Fresenius Kabi asks consignees to disseminate the notification to all users and any facilities where devices may have been further distributed for their awareness. Consignees with any questions are to contact Customer Support by email at [email protected] or by phone at 1-855-354-6387.
Quantity in commerce: 30 units
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
Product codes and lots: Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1048-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1048-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-21	2026-01-12

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)