Recall Z-0737-2014— Atrium Medical Corporation

Name: FDA recall Z-0737-2014
Creator: U.S. Food and Drug Administration
Published: 2013-11-19

Class II · Terminated

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2013-11-19, terminated 2015-06-11. It names 2 FDA 510(k) clearances: K043582, K043140. Product: Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.. Reason: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect.

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2013-11-19
Terminated: 2015-06-11
Firm location: Hudson, NH, United States

510(k) clearances named in this recall

2 on FDA's record

K043582 — OCEAN CHEST DRAINAtrium Medical Corp.·cleared 2005-01-21
K043140 — EXPRESS AND OASIS CHEST DRAINAtrium Medical Corp.·cleared 2004-12-08

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock Blood Recovery System; Product Code: 2050-300. To evacuate air and/or fluid from the chest cavity or mediastinum.

Reason for recall

Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Data sourced from openFDA. This site is unofficial and independent of the FDA.