PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 22, 2014 Initiated: November 19, 2013 #Z-0740-2014

Product Description

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.

Reason for Recall

Chest Drain tubing of of the ATS Blood recovery may leak or disconnect

Details

Units Affected
42,699 units
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
Location
Hudson, NH

Frequently Asked Questions

What product was recalled?
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.. Recalled by Atrium Medical Corporation. Units affected: 42,699 units.
Why was this product recalled?
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Which agency issued this recall?
This recall was issued by the FDA Devices on January 22, 2014. Severity: Moderate. Recall number: Z-0740-2014.