Z-3153-2024Class I

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump...

Name: Z-3153-2024 Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump...
Creator: Fresenius Kabi USA, LLC
Published: 2024-08-30
License: https://open.fda.gov/license/

Fresenius Kabi USA, LLC / initiated 2024-08-30 / Open, Classified / root cause: software

FDA source

Fresenius Kabi USA, LLC began a recall of Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system on 2024-08-30. FDA classified it as Class I and gives the reason as "The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause 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-3153-2024
Classification: Class I
Status: Open, Classified
Initiated: 2024-08-30
Posted: 2024-09-26
Recalling firm: Fresenius Kabi USA, LLC
Product: Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.
Product code: FRN Pump, Infusion
Reason for recall: The software has anomalies that have the potential to cause alarms, nonfunctioning pump, or unresponsive screen while continuing therapy. These could cause serious patient harm or death.
Root cause tag: software
FDA root cause: Software design
Action: An URGENT Medical Device Field Correction Important Safety Update notification letter dated 8/30/24 was sent to customers. Required Actions for Users: 1. Please fill out the Customer Reply Form attached to this letter to acknowledge receipt. 2. If your facility further distributes or transfers products to satellite sites or other locations, please ask these locations to contact the email address on the Customer Reply Form so we can send notice to those satellites directly. 3. Install new software version (5.9.2) for the Ivenix Large Volume Pump (LVP). See details below. How To Obtain and Install Software Version 5.9.2 To request installation, please reach out promptly to your Fresenius Kabi representative (1-855- 354-6387 or [email protected]). They will push the new software update to your pumps. When the LVP version 5.9.2 software update has been sent to the LVP, the following prompt appears before the LVP is shut down. Customer support - email Ivenix_su [email protected] Customer support - phone 1-855-354-6387 Normal business Hours are Monday through Friday 8:30 AM to 5 PM Eastern Time, After Hours Supported with Voicemail Messaging
Quantity in commerce: 17 units
Distribution: US Nationwide.
Product codes and lots: UDI-DI: 00811505030122; Software Version 5.9.1 and prior

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3153-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3153-2024	Class I	Ongoing	Voluntary: Firm initiated	2024-10-02	2024-09-26

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)