Recall Z-1209-2017— Atrium Medical Corporation

Name: FDA recall Z-1209-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-23

Class II · Terminated

Class II FDA medical device recall by Atrium Medical Corporation, initiated 2016-12-23, terminated 2020-11-03. It names one FDA 510(k) clearance: K043582. Product: Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: 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 patients pleural cavity or mediastinal area. Reason: Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed..

Recalling firm: Atrium Medical Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-12-23
Terminated: 2020-11-03
Firm location: Hudson, NH, United States

510(k) clearances named in this recall

1 on FDA's record

K043582 — OCEAN CHEST DRAINAtrium Medical Corp.·cleared 2005-01-21

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

Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: 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 patients pleural cavity or mediastinal area

Reason for recall

Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.

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