Events

Frazier Suction instrument (used for precision suction in spinal or neurological surgeries) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 ConvaTec 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-00923-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-12
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00923-1
  • 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
    Convatec (australia) pty ltd is issuing an instruction for use (ifu) for their unomedical brand frazier suction instrument which currently is supplied without an ifu. this action is being taken in response to complaints from the users in relation to breaking of the instrument at the junction of the handle and the metal tubing when pressure is applied at the tip. if the issue were to occur, it would result in a loss of suction and loss of visibility in the surgical field. there have been no reports of injuries as a result of this issue.
  • 조치
    The manufacturer has decided to issue an IFU to instruct the users on how to use the product appropriately to avoid any breakage of the instrument. ConvaTec is providing hospitals with the IFU along with the customer letter. This action has been closed-out on 07/02/2017.

Device

Frazier Suction instrument (used for precision suction in spinal or neurological surgeries)
  • 모델명 / 제조번호(시리얼번호)
    Frazier Suction instrument (used for precision suction in spinal or neurological surgeries)Product Codes: 309.02.006, 309.02.008, 309.02.008L, 309.02.010, 309.02.010L, 309.02.012, 309.02.012LAll lots affectedARTG Number: 172620
  • Manufacturer
    ConvaTec Australia Pty Ltd

Manufacturer

ConvaTec Australia Pty Ltd