Events

Beckton Dickinson PrepMate™ Vial Cap 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 manufacturer #1479 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
    19800
  • 사례 시작날짜
    2016-02-24
  • 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
    The prepmate™ vial cap is the spare lid sold separately to re-seal the bd surepath™ collection vial post processing., some prepmate™ vial caps are cracked on the top and have the potential to cause leakage., the concern with any leakage from the vial after specimen collection is that it could cause irritation or inflammation to skin or mucous membranes since there is an increased risk of chemical or biological exposure. cytological specimens may contain infectious agents. if there is contact due to leakage or splashing (preservative fluid contains 24% ethanol and <1% formaldehyde), it can also cause temporary (non-permanent) vision issues.
  • 조치
    Product to be destroyed

Device

Beckton Dickinson PrepMate™ Vial Cap
  • 모델명 / 제조번호(시리얼번호)
    Model: 490505, Affected: Lot Nosd: 5029674 5051867 5083935 5117563 5176869 5202623 5198835
  • Manufacturer
    manufacturer #1479

Manufacturer

manufacturer #1479