Device Recall Cardinal BI Stat Biological Test Pack with Instant Readout Integrator

  • Modèle / numéro de série
    Affected Biological Indicator Lot No.:130401
  • Classification du dispositif
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide distribution: US (Nationwide) and countries of: Argentina, Australia, Canada, British Virgin Island, Czech Republic, Italy, and Turkey.
  • Description du dispositif
    Cardinal BI Stat Biological Test Pack with Instant Readout Integrator, SteriTec Product Code PL 160/A, Distributor Product Code T40311PE || SteriTec Steam Biological Test Packs with Instant Readout Integrator Card: The Steam Biological Test Pack with Instant Readout Integrator is a steam sterilization monitor designed specifically for biological testing of pre-vacuum steam sterilizers operating at 132¿C (270¿F) for 3 minutes or longer. The Instant Readout Integrator Card gives the operator a prediction of the biological test outcome.
  • Manufacturer
  • 1 Event

Fabricant

  • Adresse du fabricant
    Steritec Products Mfc. Co., Inc., 74 Inverness Drive East, Englewood CO 80112-5114
  • Société-mère du fabricant (2017)
  • Source
    USFDA