Events

Transseptal Needle 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-01503-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2017-12-13
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01503-1
  • 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 become aware that certain transseptal needles may be the incorrect length, and is initiating a recall of lot 8181945. potential adverse events may occur by using the nonconforming products, including being unable to perform the transseptal puncture. this could necessitate replacing the device or rescheduling the procedure. in addition, use of the nonconforming products could make the puncture less controlled, which could potentially lead to injury of the heart.
  • 조치
    Cook Medical is advising customers to quarantine affected stock from their inventory for return to the sponsor for a product credit as per the instructions given in the customer letter.

Device

Transseptal Needle
  • 모델명 / 제조번호(시리얼번호)
    Transseptal NeedleLot Number: 8181945Reference Part Number: TSNC-18-71.0Global Part Number: G02364ARTG 155227
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd