Devices

Device Recall Sorin Group Smart Perfusion Pack EPack

  • Modèle / numéro de série
    Lot 1717800062, UDI (01)00803622108075(240)088511400(17)190630(10)1717800082; and Lot 1720800071, UDI (01)00803622108075(240)088511400(17)190731(10)1720800071
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Distribution was made to one consignee in LA.
  • Description du dispositif
    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
  • 1 Event

Fabricant

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