Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.
Reported: January 22, 2014 Initiated: November 19, 2013 #Z-0735-2014
Product Description
Atrium Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. 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
- Recalling Firm
- Atrium Medical Corporation
- Units Affected
- 10,448 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 Ocean Water Seal Chest Drain ATS (Autotransfusion) Blood Recovery System with stopcock and in-line connectors; Product Code: 2050-000. To evacuate air and/or fluid from the chest cavity or mediastinum.. Recalled by Atrium Medical Corporation. Units affected: 10,448 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-0735-2014.
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