Events

Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Bard Australia 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-2016-RN-00555-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2016-04-28
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00555-1
  • 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
    Bard access systems has received reports involving an incorrect connector colour indicated on the product labelling for specific lots of the replacement connector for groshong nxt picc (for use with groshong nxt, 5 fr. dual-lumen picc). the case label for the specific lot incorrectly identified the connector colour as “white”. the connector is red and is correctly identified by the unit label as “red”.
  • 조치
    Bard is advising users to be aware of the issue. The affected product remains safe to use and there is no requirement to return the affected product. This action has been closed-out on 25/01/2017.

Device

Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter)
  • 모델명 / 제조번호(시리얼번호)
    Groshong NXT PICC Connector (used to repair the damaged external segment of a catheter) Product Code: 7812500 Lot Number: REVH0705ARTG Number: 136492
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd