Events

SAM XT Extremity Tourniquets (SAM XT) - Military (SAM-XT M) and Civilian (SAM-XT-C) Products 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Ferno 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-00434-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00434-1
  • 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
    Based on internal testing, ferno have identified a possible failure of the stitches securing the buckle to the nylon belt could occur, posing a potential risk when used on a human patient to stop arterial blood flow. an affected tourniquet will not have the “box x stitch” icon on the upper right of the folded instructions for use (ifu) insert. tourniquets not affected will display the “box x stitch” icon on the upper right of the folded ifu.To date, no reports of adverse health consequences have been received.
  • 조치
    Ferno is advising customers to inspect inventory and quarantine affected units to prevent further use. Users should contact their Ferno Australia representative for return and replacement details.

Device

SAM XT Extremity Tourniquets (SAM XT) - Military (SAM-XT M) and Civilian (SAM-XT-C) Products
  • 모델명 / 제조번호(시리얼번호)
    SAM XT Extremity Tourniquets (SAM XT) - Military (SAM-XT M) and Civilian (SAM-XT-C) Products Batch Numbers: XT1748 and XT1802 Impacted stock distributed between March 2017 - April 2018ARTG Number: 293915(Ferno Australia - Tourniquet strap)
  • Manufacturer
    Ferno Australia Pty Ltd

Manufacturer

Ferno Australia Pty Ltd