FDA-Device2017-02-22Class II
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 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.
Atrium Medical Corporation
Hazard
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
Sold states
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
Affected count
245 cases (1470 units)
Manufactured in
5 Wentworth Dr, N/A, Hudson, NH, United States
Products
Maquet Ocean Water Seal Chest Drain, Single Collection WAC Reference: 2002-000 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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1205-2017Don't want to check this manually?
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