Device product
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.
Z-0743-2014
Product summary
- Event
- Event 66788
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,944 units
- Official record key
device-enforcement:Z-0743-2014
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