Events

Disposable Reuter Tip-Deflecting Wire Guide 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 William A Cook 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-01390-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-11-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01390-1
  • 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
    Cook medical has identified that the labels of specific lots of disposable reuter tip-deflecting wire guides do not explicitly state that they are heparin coated. the products are labelled with the correct catalogue identifier, which includes the suffix “bh” that indicates the product is heparin coated. however, users who are not familiar with the “bh” nomenclature may not be aware that the product contains heparin.To date, no adverse events have been reported due to this issue. under rare circumstances, these products could unknowingly be used in a patient with a heparin allergy or a patient with a history of heparin induced thrombocytopenia (hit). either of these situations could potentially result in serious injury or death.
  • 조치
    Cook Medical is advising users to inspect stock and quarantine remaining units for replacement with unaffected stock.

Device

Disposable Reuter Tip-Deflecting Wire Guide
  • 모델명 / 제조번호(시리얼번호)
    Disposable Reuter Tip-Deflecting Wire GuideCatalogue Identifier (Prefix/Suffix): DTDW-/-BHLot Numbers: F4791428, F4791430, NS5562947 and F4791427Supplied under Special Access Scheme (SAS)
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd