Events

Verathon GlideScope GVL and AVL Reusable Video Laryngoscope Blades 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Verathon Medical (Canada) ULC 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
    18653
  • 사례 시작날짜
    2015-06-18
  • 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: Teleflex Medical New Zealand, 12 Victoria Street, Private Bag 31346, Lower Hutt, Wellington 5040
  • 원인
    Verathon, manufacturer of glidescope video laryngoscopes, is revising the operations and maintenance manuals (omm) for certain glidescope gvl and avl reusable laryngoscope blades. the new omms specifically state compatibility limitations of the reusable video laryngoscope validated through simulated use cycles, using certain cleaning and disinfection agents. also, for the purpose of cleaning/disinfecting reusable blades, the following chemicals have been removed from the omms:, · bleach (sodium hypochlorite), · isopropyl alcohol solution, · liquid hydrogen peroxide (7.5%).
  • 조치
    Instructions for use to be updated

Device

Verathon GlideScope GVL and AVL Reusable Video Laryngoscope Blades
  • 모델명 / 제조번호(시리얼번호)
    Model: Models: GVL3, GVL4, GVL5, AVL2, AVL3, AVL4, AVL5, Affected: Selected serial number ranges
  • Manufacturer
    Verathon Medical (Canada) ULC

Manufacturer

Verathon Medical (Canada) ULC