Class II — Potential Health Hazard

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

Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended Recalled by Atrium Medical Corporation Due to Trocar Catheters are packaged with a label containing...

Date: October 26, 2016
Company: Atrium Medical Corporation
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 Atrium Medical Corporation directly.

Affected Products

Atrium Medical 16 Fr Trocar catheter Model Number: 8416 Intended to facilitate the evacuation of air and/or fluid from the chest cavity or mediastinum.

Quantity: 2172 cases (10/cs)

Why Was This Recalled?

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Where Was This Sold?

Worldwide Distribution -- USA, Australia, Austria, Belgium, Canada, Costa Rica, Dominican Republic, Ecuador, Finland, France, Germany, Honduras, Hong Kong, Ireland, Jamaica, Kuwait, Mexico, Netherlands, New Zealand, Panama, Peru, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, South Africa, Spain, Sweden, Switzerland, and Venezuela.

About Atrium Medical Corporation

Atrium Medical Corporation has 150 total recalls tracked by RecallDetector.

Related Recalls

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