Events

Medline Custom Procedure Kits 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Medline Assembly 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
    18514
  • 사례 시작날짜
    2015-05-14
  • 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: REM Systems Limited, 69 Elizabeth Knox Place, Glen Innes, AUCKLAND
  • 원인
    Medline is recalling certain lots of procedure packs which contain covidien devon light gloves. these light gloves may contain splits and pin holes. if a clinician touches the handle unaware that the light glove is split and or contains pin holes, micro-organisms from the light handle could be transferred to the clinician and thus patient, resulting in risk of surgical site infection. medline is recommending that a light cover is discarded at the time of the surgical procedure.
  • 조치
    Manufacturer to issue advice regarding use

Device

Medline Custom Procedure Kits

Manufacturer

Medline Assembly Australia Pty Ltd