Device Recall Atrium Medical Express Dry Seal ATS

  • Modèle / numéro de série
    Lot number starting with 10883097 and the ending lot number 10913346 (All units in between and including these two numbers)
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Austria, Ireland, Romania, South Africa, Colombia, Lebanon Netherlands, Jordan, Russia, and Taiwan.
  • Description du dispositif
    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

Fabricant

  • Adresse du fabricant
    Atrium Medical Corporation, 5 Wentworth Dr, Hudson NH 03051-4929
  • Société-mère du fabricant (2017)
  • Source
    USFDA