Device product
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.
Z-0735-2014
Product summary
- Event
- Event 66788
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10,448 units
- Official record key
device-enforcement:Z-0735-2014
Official wording
Reason: Chest Drain tubing of of the ATS Blood recovery may leak or disconnect
Code information: Lot number starting with 10883097 and the ending lot number 10913346. (All units in between and including these two numbers)
Distribution pattern: Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
Derived failure modes
-
Unknown
Chest Drain tubing of of the ATS Blood recovery may leak or disconnect