Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7F; NV GUIDER CATHETER 90CM ST 7F; NV GUIDER CATHETER 90CM ST 8F 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-2017-RN-01517-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-18
  • 사례 국가
  • 사례 출처
    DHTGA
  • 사례 출처 URL
  • 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 initiated a lot specific product recall on certain lots of guider 7f and 8f product which may be at risk of degrading within their shelf-life period. the root cause of the issue is exposure of components to uv light while in storage between 2014 and october 2017.There have been no reports of injuries associated with this issue.
  • 조치
    Stryker is advising users to inspect stock an quarantine any remaining units of the affected product. Affected stock can be returned to Stryker and replaced with unaffected product.

Device

  • 모델명 / 제조번호(시리얼번호)
    Nv Guider Catheter 90cm NV GUIDER CATHETER 90CM 40° 7FItem Number: 10043 Lot Numbers: 19948645, 18836128, 19545073, 19793264, 19809517, 20024281 NV GUIDER CATHETER 90CM ST 7FItem Number: 10051 Lot Numbers: 18898135, 18898416NV GUIDER CATHETER 90CM ST 8F Item Number: 10052 Lot Numbers: 18643117ARTG Number: 146034
  • Manufacturer

Manufacturer

  • 제조사 모회사 (2017)
  • Source
    DHTGA