Events

Encore 26 Advantage Kit & Encore 26 Advantage Kit, 5 pack (Used to perform general intravascular procedures) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Boston Scientific Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2012-RN-01053-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2012-10-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2012-RN-01053-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • 데이터 추가 비고
  • 원인
    Users of the encore 26 advantage kits which were manufactured between august 3 2012 and september 18 2012 may experience difficulty in passing guidewires through the insertion tool which is included in the encore 26 advantage kits. the difficulty to pass guidewires, especially j tipped guidewires, through the insertion tool is caused by lack of smoothness within the hub/hypo tube transition in some devices.
  • 조치
    The sponsor is provided work around instructions for users to follow.

Device

Encore 26 Advantage Kit & Encore 26 Advantage Kit, 5 pack (Used to perform general intravascular ...
  • 모델명 / 제조번호(시리얼번호)
    Encore 26 Advantage Kit & Encore 26 Advantage Kit, 5 pack (Used to perform general intravascular procedures)Encore 26 Advantage KitMaterial Number: H74904527011Catalogue Number: 04527-01Encore 26 Advantage Kit (5 pack)Material Number: H74904527052Catalogue Number: 04527-05Multiple Lot NumbersExpiration dates between 13 August 2014 & 30 September 2014Manufactured between 3 August 2012 & 18 September 2012ARTG Number: 159833
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 제조사 모회사 (2017)
    Boston Scientific
  • 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
    DHTGA