Fresenius Kabi recalls Ivenix infusion pump LVP software for anomalies

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled product

• Product Names: LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0.
• Product Codes: FRN
• Distribution Dates: March 6, 2023 to March 20, 2024
• Devices Recalled in the U.S.: 17
• Date Initiated by Firm: March 7, 2024

Device use
The Ivenix Infusion System is indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids to patients through accepted methods such as intravenous line (IVs), arterial lines, epidurals, and subcutaneous (under the skin) delivery. These fluids include medications, blood products such as red cells or plasma, or other agents needed for treatment of adult and pediatric patients, including neonates and infants.

Reason for recall
Fresenius Kabi USA, LLC. is recalling their Ivenix Infusion System (IIS), LVP Software, an infusion pump software. The recall will take the form of a software update. The reason for the recall is that multiple software anomalies were occurring that have the potential to result in serious patient harm or death.

To remedy this issue, Fresenius Kabi is releasing a new software version (5.9.1) for the Ivenix Large Volume Pump (LVP).

There have been no reports of injuries or deaths associated with this issue.

Who may be affected

• People who are treated in a health-care setting using the Ivenix Infusion System.
• Health care personnel who use Ivenix Infusion Systems to deliver blood and medications to patients in health care settings.

U.S. Food and Drug Administration