Events

Arrow Teleflex Intra-Aortic Balloon Pump Catheter Kits and Percutaneous Insertion Kits 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
    19818
  • 사례 시작날짜
    2016-03-04
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • 원인
    The arrow intra-aortic balloon catheter kits and percutaneous insertion kits contain a percutaneous sheath introducer. the percutaneous sheath introducer is used by some clinicians in the intra-aortic balloon catheter insertion procedure. the issue pertains to the sheath introducer in the insertion kit only. the other components of the kits are unaffected., this notice is required following notification by the manufacturer of the possibility that the percutaneous sheath introducer body may become separated from the sheath hub. if the separation occurs, there is a potential for bleeding from the device. if bleeding is not addressed with prompt intervention, it may result in loss of significant blood volume or exsanguination. in addition, delay of treatment, interruption of treatment, or loss of iab therapy can occur.
  • 조치
    Product to be returned to supplier

Device

Arrow Teleflex Intra-Aortic Balloon Pump Catheter Kits and Percutaneous Insertion Kits
  • 모델명 / 제조번호(시리얼번호)
    Model: IAB-05830-LWS IAB-05830-U IAB-05840-LWS IAB-05840-U IAB-06830-U IAB-06840-U and IAK-06845 (Percutaneous Insertion Kit), Affected: Multiple
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc