Z-1484-2024Class I

LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0

Name: Z-1484-2024 LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0
Creator: Fresenius Kabi USA, LLC
Published: 2024-03-07
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2024-03-07 / Open, Classified / root cause: software

FDA source

Fresenius Kabi USA, LLC began a recall of LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0 on 2024-03-07. FDA classified it as Class I and gives the reason as "Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death". 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-1484-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-03-07
Posted: 2024-04-11
Recalling firm: Fresenius Kabi USA, LLC
Product: LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
Product code: FRN Pump, Infusion
Reason for recall: Software has anomalies that have the potential to cause underdose, overdose, or delay in therapy which could lead to serious patient harm or death.
Root cause tag: software
FDA root cause: Software Design Change
Action: A letter titled URGENT - Medical Device Field Correction, dated 3/7/24, was delivered by hand to consignees or by mail notifying them of this recall event. This notice details eleven software anomalies that could pose a potential risk of serious patient harm or death and the mitigations consignees should perform until software is updated. Consignees are to update their software to LVP software version 5.9.1 by reaching out to their Fresenius Kabi representative at 1-978-775-8100 to schedule installation. Consignees are to complete and return the Customer Reply Form via fax or email. Questions about the recall notice can be directed to Fresenius Kabi by email at [email protected] or by phone at 1-978-775-8100 (Monday through Friday from 8:30 am to 5:00 pm).
Quantity in commerce: 17 units
Distribution: US Distribution: CA, CO, ID, MI, NE, NJ, NV, OK, TX, UT, VA, WA, & WI.
Product codes and lots: Product LVP-SW-0004; UDI-DI 00811505030122.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1484-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1484-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-04-17	2024-04-11

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)