Events

Medtronic Navigator Passive Spheres 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Northern Digital Inc 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
    16614
  • 사례 시작날짜
    2014-05-06
  • 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: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • 원인
    A review of the medtronic internal returned goods procedures showed that there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage. this review identfied the sterile part numbers were processed through the returned goods procedures. a risk analysis was subsequently performed showing that, since there have been no complaints related to sterilisation/package damage there was no change in the likeihood of this scenario leading to harm. although there have been no reports of issues related to package sterile barrier damage, manufacturer has elected to issue this safety notice to address this possibility.
  • 조치
    Product to be returned to supplier

Device

Medtronic Navigator Passive Spheres
  • 모델명 / 제조번호(시리얼번호)
    Model: Part Numbers: 8801071 & 8801075, Affected: Lot Numbers: 5 lots & 24 lots respectively
  • Manufacturer
    Northern Digital Inc

Manufacturer

Northern Digital Inc