Device Recall INSPIRE 8 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir

  • Modèle / numéro de série
    Lot:1709190230, UDI: (01)08033178112369(17)200917(10)1709190230, Exp: 09/17/2020; Lot: 1710260210, UDI: (01)08033178112369(17)201024(10)1710260210, Exp: 10/24/2020
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    US Distribution to the states of : NJ, CA, MN, MO, MA
  • Description du dispositif
    Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 || The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Hollow Fiber Oxygenator: The INSPIRE 8M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. The INSPIRE 8M is intended to be used for 6 hours or less. INSPIRE HVR (Hardshell Venous/Cardiotomy Reservoir): The INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, de-foams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. The INSPIRE HVR is intended to be used for 6 hours or less.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    LivaNova USA, 14401 W 65th Way, Arvada CO 80004-3503
  • Société-mère du fabricant (2017)
  • Source
    USFDA