Events

Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Life Healthcare 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-01497-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-11-16
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01497-1
  • 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 manufacturer has received a report from a user advising that the secondary peel bag of the sterile packaged article was not completely sealed. an incorrect welding process has resulted in the secondary peel bag not being sealed. a non-welded secondary peel bag results in the primary bag becoming no longer sterile and thus a “non-sterile article” can reach the sterile area of the operating room. this presents a potential safety risk for the patient. the manufacturer is not aware of any other incidents, however the affected batch is being recalled as a precaution.
  • 조치
    LifeHealthcare is advising customers to quarantine affected stock and to contact LifeHealthcare to arrange for collection and replacement. This action has been closed-out on 18/05/2017.

Device

Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures)
  • 모델명 / 제조번호(시리얼번호)
    Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures)Product Code: 25-302-10-71Lot Number: 33173390ARTG Number: 202843
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd