Events

Stryker Neurovascular Excelsior SL-10/Excelsior 1018 Microcatheters 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Stryker Australia 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-2015-RN-00485-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2015-06-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00485-1
  • 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
    Stryker has become aware that certain lots of the above excelsior sl-10/excelsior 1018 microcatheters have incorrect product expiry dates printed on the packaging. the earliest expiration date of the affected products is may 2016. in the event these products remain in the market after the labelled expiry date, there is a potential hazard that patients exposed to this product may experience severe health consequences.
  • 조치
    Stryker is requesting their customers to quarantine any affected lots on hand. Any affected items will be removed by the Stryker Representative and customers will be provided with unaffected replacement stock. This action has been closed-out on 18/08/2016.

Device

Stryker Neurovascular Excelsior SL-10/Excelsior 1018 Microcatheters
  • 모델명 / 제조번호(시리얼번호)
    Stryker Neurovascular Excelsior SL-10/Excelsior 1018 MicrocathetersExcelsior SL-10 150CM 2 TIPExcelsior 1018 Pre-shaped 45 150CMExcelsior SL-10 Pre-shaped 45 150CMExcelsior SL-10 Pre-shaped 90 150CMExcelsior SL-10 Pre-shaped J 150CMCatalogue Numbers: 168189, 144190, 168190, 168191, 168192Lot Numbers: 17026669, 17013156, 17013021,17026849, 17030892, 17045869, 17045959, 17046094, 17046274, 17046229ARTG Numbers: 177031, 149440, 147430
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • 제조사 모회사 (2017)
    Stryker
  • Source
    DHTGA