Events

BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 22G 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Becton Dickinson UK 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
    18969
  • 사례 시작날짜
    2015-08-12
  • 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: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • 원인
    Through customer feedback the manufacturer has become aware that some lots of the bd vacutainer eclipse signal blood collection needle with integrated holder have the potential for the integrated holder to become detached from the needle. this detachment can lead to possible sample collection failure and in exceptional circumstances have the potential to cause a needle stick injury.
  • 조치
    Product to be returned to supplier

Device

BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 22G
  • 모델명 / 제조번호(시리얼번호)
    Model: 368836, Affected: 4268488 4302103 4329078 4346062 4346068 5027368 5072462
  • Manufacturer
    Becton Dickinson UK Ltd

Manufacturer

Becton Dickinson UK Ltd