Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Ivenix Infusion System (IIS) Recalled by Fresenius Kabi USA, LLC Due to Potential pneumatic valve failure that may cause the...

Date: December 6, 2024
Company: Fresenius Kabi USA, LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Fresenius Kabi USA, LLC directly.

Affected Products

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Quantity: 1,520 units

Why Was This Recalled?

Potential pneumatic valve failure that may cause the LVP to stop an active infusion and/or could prevent the pump from being used.

Where Was This Sold?

This product was distributed to 6 states: ID, MN, NV, TX, VA, WI

Affected (6 states)Not affected

About Fresenius Kabi USA, LLC

Fresenius Kabi USA, LLC has 67 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report