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Recall Observatory FDA recall evidence

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

November 19, 2013

Class II

Product summary

Firm
Atrium Medical Corporation
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

    reason.no_named_rule · v1.0.0

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