Encore™ 26 Inflation Device

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    MHSIDCCCDMIS

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    UPN : H74904526011, M001151050, M00566670, M0067101140 Multiple Lot numbers of the affected device are provided in the attached file.
  • 제품 설명
    High pressure inflation device designed to exert pressure for balloon inflation and deflation.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Boston Scientific Corporation: Encore™ 26 Inflation Device
  • Manufacturer