Events

Catheter, intravascular, general-purpose 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Maquet Cardiopulmonary AG 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
    22941
  • 사례 시작날짜
    2018-05-07
  • 사례 국가
    New Zealand
  • 사례 출처
    NZMMDSA
  • 사례 출처 URL
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 비고 / 경고
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • 데이터 추가 비고
    Recalling Organisation: Getinge Australia Pty Ltd (NZ), 12 G Andromeda Crescent, East Tamaki, Auckland 2013
  • 원인
    The vent plug of the 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., in some cases it has come to the manufacturers attention that the vent plug has broken during the separation from the arterial cannula.
  • 조치
    Product to be returned to supplier

Device

Catheter, intravascular, general-purpose
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: products containing the 3/8" vent plug 70000.8256
  • Manufacturer
    Maquet Cardiopulmonary AG

Manufacturer

Maquet Cardiopulmonary AG