Recall Z-1935-2015— Atrium Medical Corporation

Name: FDA recall Z-1935-2015
Creator: U.S. Food and Drug Administration
Published: 2015-05-07

Class II · Terminated

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2015-05-07, terminated 2016-04-26. It names 3 FDA 510(k) clearances: K081718, K043582, K043140. Product: Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000. Reason: Chest drains have a missing o-ring.

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2015-05-07
Terminated: 2016-04-26
Firm location: Hudson, NH, United States

510(k) clearances named in this recall

3 on FDA's record

K081718 — EXPRESS CHEST DRAINAtrium Medical Corp.·cleared 2008-07-25
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

Ocean Water Seal Chest Drain, Single Collection W/AC, P/N: 2002-000

Reason for recall

Chest drains have a missing o-ring

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