Events

LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation 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-2014-RN-00153-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-02-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00153-1
  • 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
    Lutonix has confirmed that some devices from specific lots may have been packaged in foil pouches with a defective chevron seal. this is the seal used to open the package containing the sterile balloon catheter. the potential hazard associated with a package having a defective chevron seal is loss of sterility.
  • 조치
    Customers are asked to not use or further distribute any of the affected product. Bard is advising that no special follow-up treatment or clinical care is recommended for patients who have already undergone treatment with the devices affected by this recall.

Device

LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation Catheter
  • 모델명 / 제조번호(시리얼번호)
    LUTONIX 014 and 035 OTW Drug Coated PTA Dilatation CatheterProduct Codes: 9020413500150 and 9020515250040Lot Numbers: GFXJ2800 and GFXK2769Supplied under the Special Access Scheme
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd