FDA-Device2014-01-22Class II

Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. 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
42,699 units
Manufactured in
5 Wentworth Dr, Hudson, NH, United States
Products
Atrium Oasis Dry Suction Water Seal ATS (Autotransfusion) Blood Recovery System Chest Drain with in-line connectors Product Code: 3650-100. 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-0740-2014

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