Device Recall Atrium Medical Express Dry Seal ATS

  • Model / Serial
    Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)
  • Product Classification
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
  • Product Description
    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.
  • Manufacturer
  • 2 Events

Manufacturer

  • Manufacturer Address
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Manufacturer Parent Company (2017)
  • Source
    USFDA