Events

Tracoe Twist Tracheostomy TubeSize 06 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Intersurgical 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-2017-RN-01321-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2017-10-20
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-01321-1
  • 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
    Tracoe medical has established at primary packaging, that some obturators of one batch (size 06) can break when inserted into the outer cannula. this may result in the breakage of the obturator whilst in the patient within the tube. if this was to occur, the broken fragments would likely be inhaled into the lower respiratory tract.In the event the breakage of the obturator is not detected, the aspirated fragments may remain in the deep respiratory tract. should the fragments remain there over a longer period of time, in the worst case scenario, an inflammatory reaction in the respiratory tract can occur.
  • 조치
    Intersurgical is advising users to quarantine affected stock. Intersurgical will collect stock from affected customers and provide credit.

Device

Tracoe Twist Tracheostomy TubeSize 06
  • 모델명 / 제조번호(시리얼번호)
    Tracoe Twist Tracheostomy TubeSize 06Reference Number: REF 306-06Batch Numbers: 1000123766, 1000124104, and 1000124346 ARTG Number 128498 (Intersurgical Australia Pty Ltd - Tube, tracheostomy, single use)
  • Manufacturer
    Intersurgical Australia Pty Ltd

Manufacturer

Intersurgical Australia Pty Ltd