Events

Twin-Pass dual access catheters 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-2016-RN-01234-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-09-21
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01234-1
  • 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
    An investigation of twin-pass units has concluded there is a potential for excess manufacturing material to remain at the tip of the catheter or inside the distal part of the rapid exchange lumen of twin-pass dual access catheters. it is possible that the excess material may separate from the catheter during a procedure which poses a potential risk of an embolism to the patient. there have been no reports of injuries associated with this issue.This action has been undertaken prior to consultation with the therapeutic goods administration (tga).
  • 조치
    Pyramed has advised users to quarantine and return the affected devices. This action has been closed-out on 11/11/2016.

Device

Twin-Pass dual access catheters
  • 모델명 / 제조번호(시리얼번호)
    Twin-Pass dual access cathetersModel Number: 5200Multiple lot numbers affectedSupplied through the Special Access Scheme (SAS)
  • Manufacturer
    Pyramed Pty Ltd

Manufacturer

Pyramed Pty Ltd