Events

Prelude SNAP Splittable Sheath IntroducerVascular Introducer Kit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Merit Medical 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-01511-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-12-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01511-1
  • 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
    Merit medical systems, inc. is conducting a recall of specific lots of prelude snap splittable sheath introducers due to an intermittent failure of the splittable hub. merit medical has received complaints indicating that the wings on certain lots of the prelude snap have broken off the sheath hub during splitting. this will likely result in a minor delay in procedure. although rare, this could also result in a pacing lead/catheter displacement, air embolus, or minor hemorrhage. merit has received no reports of patient harm or injury as a result of this issue.
  • 조치
    Users are advised to check inventory for affected devices and discontinue their use. Affected stock should be returned to Merit Medical.

Device

Prelude SNAP Splittable Sheath IntroducerVascular Introducer Kit
  • 모델명 / 제조번호(시리얼번호)
    Prelude SNAP Splittable Sheath IntroducerVascular Introducer KitMultiple Catalogue and Lot Numbers AffectedARTG 278434
  • Manufacturer
    Merit Medical Australia Pty Ltd

Manufacturer

Merit Medical Australia Pty Ltd