Devices

Device Recall OptiPack Smart Perfusion Pack

  • Modèle / numéro de série
    Lot Numbers: 0924300054, 0924400026, and 0933400046.
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    AZ, CA, FL, MO, NJ, SC, SD, TN, TX, UT, VA and WI.
  • Description du dispositif
    Opti-Pack Smart Perfusion Pack, REF: 086500100, Sterile EO, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004 || Indicated for use in surgical procedures requiring extracorporeal support for periods of up to six hours.
  • Manufacturer
    Sorin Group USA, Inc.
  • 1 Event

Fabricant

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