Events

MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Johnson & Johnson Medical Pty 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
    RC-2017-RN-00278-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-02-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00278-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The manufacturer, greatbatch medical has received reports of a pouch seal integrity issue with a specific lot of mobicath bi-directional guiding sheath. one side of the pouch may not be sealed and as a result, may cause the sterile barrier of the pouch to be compromised. the use of a non-sterile product in surgery could potentially result in adverse health consequences, such as infection, which could lead to life threatening events and/or death. greatbatch has received no reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
  • 조치
    JJM is advising users to immediately inspect the device(s) in their possession to determine if their facility has affected product, and then to quarantine the affected product prior to returning it to JJM for replacement.

Device

MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)
  • 모델명 / 제조번호(시리얼번호)
    MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)Product Number: D140010Lot Number: W3338707ARTG Number: 191013
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd