Events

Twinfix Quick-T Knot Pusher Suture Cutters 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Smith & Nephew 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-00938-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-07-14
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00938-1
  • 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
    Smith & nephew have identified a packaging issue through internal testing. the twinfix quick-t knot pusher suture cutter could be subject to breaches of its sterile packaging. in the event the device is presented for use and a breach in the sterile barrier is not noticed, a non-sterile device could enter the surgical field. smith & nephew has received no customer complaints indicating a packaging breach or a post-operative infection.
  • 조치
    Smith & Nephew is advising users to discontinue use of affected products and quarantine the device(s). The devices are to be returned to Smith & Nephew.

Device

Twinfix Quick-T Knot Pusher Suture Cutters
  • 모델명 / 제조번호(시리얼번호)
    Twinfix Quick-T Knot Pusher Suture CuttersProduct Number: 7209417Batch Numbers: 50412843, 50477278, 50527184ARTG Number: 112714
  • Manufacturer
    Smith & Nephew Pty Ltd

Manufacturer

Smith & Nephew Pty Ltd