FDA-Device2014-01-22Class II
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
Atrium Medical Corporation
Hazard
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Sold states
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
Affected count
1,944 units
Manufactured in
5 Wentworth Dr, Hudson, NH, United States
Products
Atrium Express Dry Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with Prefilled Air Leak Monitor; Product Code: 4050-100P. To evacuate air and/or fluid from the chest cavity or mediastinum.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0743-2014Don't want to check this manually?
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