Events

Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Pyramed 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-2013-RN-00615-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2013-06-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00615-1
  • 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 has identified that there is a potential problem with the loosening of the y connector on the hub of the delivery sheath which is outside the patient's body during delivery of the stent.The outer sheath and y connector should be adjoined each other using glue as well as screw compression, however the gluing process was skipped in some cases with the affected lot number during manufacturing.
  • 조치
    Pyramed is asking customers to return the affected stock for replacement with unaffected stock.

Device

Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm
  • 모델명 / 제조번호(시리얼번호)
    Niti-S Biliary Covered Stent (Flare-Type) Nagi/Pseudocyst 10mm x 3cm Model number: BS1003FWLot number: 13D1394D3EB780 Expiry date: 2016-04ARTG number: 130531
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd