Events

Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Getinge 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-00435-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-05-09
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00435-1
  • 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
    An arterial cannula used for open heart surgery is normally equipped with a vent plug, which facilitates the de-airing of the cannula.The vent plug of our arterial cannula consists of sintered polyethylene, therefore the structure of the vent plug is porous and gas-permeable. after the de-airing process is completed the customer has to separate the vent plug from the cannula to connect the extracorporeal circuit.Getinge has been made aware that in some instances, the vent plug can break during the separation from the arterial cannula.
  • 조치
    Getinge is advising customers to immediately return affected product to their local Getinge representative. Due to the discontinuation of the Surgical Perfusion Catheters/Cannulae product portfolio, Getinge are not providing replacement.

Device

Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256
  • 모델명 / 제조번호(시리얼번호)
    Arterial Cannulae and Customised Tubing Packs including the 3/8” Vent plug 70000.8256Multiple Material NumbersARTG Number: 206768Getinge Australia - Catheter, intravascular, general-purpose
  • Manufacturer
    Getinge Australia Pty Ltd

Manufacturer

Getinge Australia Pty Ltd