Class II — Potential Health Hazard

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

Custom Fluid Management Set Recalled by Merit Medical Systems, Inc. Due to Merit Medical Systems, Inc. announces a voluntary field...

Date: August 12, 2016
Company: Merit Medical Systems, 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 Merit Medical Systems, Inc. directly.

Affected Products

Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer contrast media and saline from a container to a patients vascular system.

Quantity: 107,341 total devices

Why Was This Recalled?

Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Merit Medical Systems, Inc.

Merit Medical Systems, Inc. has 135 total recalls tracked by RecallDetector.

Related Recalls

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