Fresenius Kabi USA, LLC: Medical Device Recall in 2023 - (Recall #: Z-2635-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1 Part Number: LVP-SW-0004. 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 II

Date Initiated: April 22, 2022

Date Posted: October 4, 2023

Recall Number: Z-2635-2023

Event ID: 92973

Reason for Recall:

Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set

Status: Ongoing

Product Quantity: 1344 pumps

Code Information:

(UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1

Distribution Pattern:

US Nationwide distribution in the states of NJ, WI.

Voluntary or Mandated:

Voluntary: Firm initiated