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Atrium Medical Corporation recalls Maquet Express Dry Seal Suction OCEAN DRAIN, SINGLE W/S Reference: 2002-300 Intended Use: To evacuate air and/or fluid
Recalled February 22, 2017 · FDA recall Z-1209-2017 · Atrium Medical
Hazard
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. · FDA Class II
Units
1 case (6 units)
Sold at
Worldwide Distribution - US (nationwide) and Internationally to Canada and Mexico
Description
Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed.
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
Manufacturer(s)
Atrium Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →