Events

1.5 mm HYDRO LeMaitre Valvulotome, 40 cm(intended for the treatment of vascular disorders and particularly for excising or disrupting venous valves) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Emergo Asia Pacific Pty Ltd T/a Emergo Australia 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-01046-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-08-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01046-1
  • 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 centering hoops keep the head of the hydro lemaitre valvulotome centered in the vessel and prevents the valve-cutting blades from damaging the vessel wall. there have been reported issues of hoops failing to close when the device was actuated. in some cases, this issue has been discovered in-use. while no adverse events have been reported, there is the possibility that a malfunctioning device could damage the vessel upon withdrawal.
  • 조치
    Emergo is advising users to locate, quarantine and return all affected product. Returned devices will be replaced with unaffected devices. This action has been closed-out on 02/03/2017.

Device

1.5 mm HYDRO LeMaitre Valvulotome, 40 cm(intended for the treatment of vascular disorders and par...
  • 모델명 / 제조번호(시리얼번호)
    1.5 mm HYDRO LeMaitre Valvulotome, 40 cm(intended for the treatment of vascular disorders and particularly for excising or disrupting venous valves)Reference number: 1010-00Lot numbers: ELVH1089V, ELVH1091VExpiry date : 2021-03Lot numbers: ELVH1099VExpiry date : 2021-05ARTG number: 218706
  • Manufacturer
    Emergo Asia Pacific Pty Ltd T/a Emergo Australia

Manufacturer

Emergo Asia Pacific Pty Ltd T/a Emergo Australia