Devices

Device Recall Sorin Group

  • Modelo / Serial
    All Lots.
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution
  • Descripción del producto
    PTS Heart/Lung Perfusion Pack Labeling Sterile EO, Product is manufactured by Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004 (utilizing oxygenators manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy.) || Intended for use in small-adult or adult surgical procedures requiring extracorporeal gas exchange support and blood temperature control for periods up to 6 hours.
  • Manufacturer
    Sorin Group USA, Inc.
  • 1 Event

Fabricante

Sorin Group USA, Inc.
  • Dirección del fabricante
    Sorin Group USA, Inc., 14401 W 65th Way, Arvada CO 80004
  • Empresa matriz del fabricante (2017)
    LivaNova PLC
  • Source
    USFDA

Dispositivo con un nombre similar

Más información acerca de la data acá

Device Recall Sorin Group Smart Perfusion Pack EPack
  • Modelo / Serial
    Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
  • Clasificación del producto
    Cardiovascular Devices
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Distribution was made to one consignee in LA.
  • Descripción del producto
    Sorin Group Smart Perfusion Pack E-Pack, REF 088511400, Rev: L, Single Use, Sterile, Rx. The firm name on the label is Sorin Group USA, Inc., Arvada, CO.
  • Manufacturer
    LivaNova USA