Events

Receptal 1000 mL liner and canister used with the Laerdal Suction Unit 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Laerdal 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-2013-RN-00440-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-05-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00440-1
  • 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
    Laerdal has advised that the following situations can result in loss of suction:1. the hard canister and the single use liner are not properly seated;2. the liner separates from the canister during use.
  • 조치
    Laerdal are requesting their customers to immediately seek an alternative to the 1000 mL Receptal system. Laerdal recommend to only discontinue use of the suction liners and canister once an alternative is sourced. Once an alternative has been sourced the 1000 mL Receptal liners and canister should be discarded.

Device

Receptal 1000 mL liner and canister used with the Laerdal Suction Unit
  • 모델명 / 제조번호(시리얼번호)
    Receptal 1000 mL liner and canister used with the Laerdal Suction UnitItem code: 78001033ARTG Number: 129688
  • Manufacturer
    Laerdal Pty Ltd

Manufacturer

Laerdal Pty Ltd