Atrium Medical Corporation recalls Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 Intended Use: To evacuate air and/or fl…

Recall date

December 23, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1206-2017

FDA classification

Class II

Brand / firm

Atrium Medical Corporation

Sold / distributed

Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Maquet Ocean Water Seal Chest Drain, Single Collection w/AC Reference: 2002-100 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