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 Oasis Single Drain as follows: 3600-100 Oasis single Recalled by Atrium Medical Corporation Due to Outer Packaging is not sterile

Date: November 29, 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 Oasis Single Drain as follows: 3600-100 Oasis single drain with in-line connector 3600-150 Oasis single drain with in-line connector and Pre-connected 2550 ATS Bag Product Usage: To evacuate air and/or fluid from the chest cavity or mediastinum.  To help re-establish lung expansion and restore breathing dynamics.  To facilitate postoperative collection and reinfusion of autologous blood from the patient s pleural cavity or mediastinal area.

Quantity: 964,463 cases (US) 521,975 cases (OUS) in total

Why Was This Recalled?

Outer Packaging is not sterile

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

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