Fresenius Kabi USA, LLC: Medical Device Recall in 2025 - (Recall #: Z-1019-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.

Product Classification:

Class I

Date Initiated: January 10, 2025

Date Posted: February 12, 2025

Recall Number: Z-1019-2025

Event ID: 96085

Reason for Recall:

Large Volume Pump Software, version 5.9.2 and earlier has potential for the following anomalies: 1. The pump may become nonfunctional if during an alarm condition the Pause Audio option is repeated 70 time or more. 2. If a secondary infusion is started at the exact moment a primary infusion completes and VTBI reaches 0, it will switch to primary. The primary infusion will infuse at the previously programed primary rate and continue until the infusion is stopped or the bag is empty.

Status: Ongoing

Product Quantity: 23 systems

Code Information:

UDI-DI: 00811505030122. Software 5.9.2 and prior

Distribution Pattern:

US distribution to CA, CO, GA, ID, MI, MS, NE, NJ, NV, OK, TX, UT, VA, WA, WI.

Voluntary or Mandated:

Voluntary: Firm initiated