Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Ivenix Infusion System (IIS) Recalled by Ivenix, Inc. Due to Downstream occlusion alarm is sometimes immediately followed by...

Date: April 22, 2022
Company: Ivenix, Inc.
Status: Terminated
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 Ivenix, Inc. directly.

Affected Products

Ivenix Infusion System (IIS)

Quantity: 1335 devices

Why Was This Recalled?

Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Ivenix, Inc.

Ivenix, Inc. has 1 total recall tracked by RecallDetector.

Related Recalls

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