FDA-Device2017-02-22Class II
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
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
27 cases (162 units)
Manufactured in
5 Wentworth Dr, N/A, Hudson, NH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1206-2017Don't want to check this manually?
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