Encore™ 26 Inflation Device

Fabricant

  • Société-mère du fabricant (2017)
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DMA

5 dispositifs médicaux avec un nom similaire

En savoir plus sur les données ici

  • Modèle / numéro de série
    UPN : H74904526011, M001151050, M00566670, M0067101140 Multiple Lot numbers of the affected device are provided in the attached file.
  • Description du dispositif
    High pressure inflation device designed to exert pressure for balloon inflation and deflation.
  • Manufacturer
  • Modèle / numéro de série
    Model Number: H74904526011 M001151050 M00566670 M0067101140
  • Description du dispositif
    Medical devices for single use
  • Manufacturer
  • Modèle / numéro de série
  • Description du dispositif
    Boston Scientific Corporation: Encore™ 26 Inflation Device
  • Manufacturer