Events

Arrow International - VPS Rhythm ECG Pack 의 리콜

New Zealand Medicines and Medical Devices Safety Authority에 따르면, 해당 리콜 는 New Zealand 에서 Arrow International 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
    22938
  • 사례 시작날짜
    2018-06-29
  • 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
    The manufacturer has become aware that some individual units may have defective packaging that may not be adequately sealed. in the event the packaging is compromised in this manner, the sterility of the product cannot be guaranteed. if a non-sterile product is used, there is potential for infection to occur., update phase ii, the lubricant is being distributed to heartware field representatives who will apply the lubricant to power source (battery, ac adapter, and dc adapter) connecters. the heartware field representatives will work with healthcare professionals to coordinate bringing patients to the clinic for servicing of their hvad power source components.
  • 조치
    Product to be destroyed

Device

Arrow International - VPS Rhythm ECG Pack
  • 모델명 / 제조번호(시리얼번호)
    Model: , Affected: Multiple product codes
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc