Fresenius Kabi USA, LLC: Medical Device Recall in 2024 - (Recall #: Z-3153-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004, Software Version 5.9.1 and prior. Infusion pump software for infusion management system.

Product Classification:

Class I

Date Initiated: August 30, 2024

Date Posted: October 2, 2024

Recall Number: Z-3153-2024

Event ID: 95240

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.

Status: Ongoing

Product Quantity: 17 units

Code Information:

UDI-DI: 00811505030122; Software Version 5.9.1 and prior

Distribution Pattern:

US Nationwide.

Voluntary or Mandated:

Voluntary: Firm initiated