AFFINITY NT Cardiotomy Venous Reservoirs stand-alone uncoated and coated models.

  • Modèle / numéro de série
    AFFINITY NT Cardiotomy Venous Reservoirs stand-alone uncoated and coated models.AFFINITY NT Cardiotomy Venous Reservoir stand-alone uncoatedCode 540, Model 61399409462All UnexpiredAFFINITY NT Cardiotomy Venous Reservoir stand-alone Trillium coated,Code 540T, Model 95249All UnexpiredARTG: Number: 132278 (Medtronic Australasia Pty Ltd - Reservoir, blood, cardiopulmonary bypass)
  • Manufacturer
  • 1 Event

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA