Events

Cook Inc (Urology) Holmium Laser Fibres (Multi Use) (HLF-M) 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Cook Incorporated 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
    21403
  • 사례 시작날짜
    2017-05-05
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • 원인
    The manfacturer has identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products. the manufacturer preliminary investigation indicates that the validation data related to the reprocessing of these devices do not meet the current guidance.
  • 조치
    Product to be returned to supplier

Device

Cook Inc (Urology) Holmium Laser Fibres (Multi Use) (HLF-M)
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Catalogue number G48611 HLF-M273-CN, G48613 HLF-M365-CNV, G48615 HLF-M550-CNV All Lots
  • Manufacturer
    Cook Incorporated

Manufacturer

Cook Incorporated