Events

Chorion Villus Biopsy Needle Set 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-2018-RN-00835-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2018-06-26
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00835-1
  • 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 the diagram on the product label of the chorion villus biopsy needle set (k-cvns-1821-robinson-et) is incorrect. it shows that the 18ga needle has an echotip, and the 21ga needle does not, whereas the product is designed such that the 21ga needle has the echotip and the 18ga needle does not.The tip of the larger gauge guide needle is likely to be visible on the ultrasound regardless of a non-echogenic tip. in the event that the labelling error resulted in a clinician expecting the echogenic tip to be present on the guide needle, instead of the sampling needle, the clinician may not be able to adequately identify the tip of the inserted access needle.To date, there have been no reports of harm relating to this issue.
  • 조치
    William A Cook is advising customers to inspect stock and return affected product.

Device

Chorion Villus Biopsy Needle Set
  • 모델명 / 제조번호(시리얼번호)
    Chorion Villus Biopsy Needle SetCatalogue Identifier: K-CVNS-1821-ROBINSON-ETOrder Number: G26661All lots manufactured up to 4 June 2018ARTG Number: 138806(William A Cook Australia Pty Ltd - Chorionic Villi Biopsy Needle Set - Needle, biopsy, single use)
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd