Events

FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Scott Health and Safety 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-2014-RN-01234-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2014-11-27
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-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
    Scott safety has been advised by the supplier, pacsource, of the ‘10 ml normal saline for irrigation’ with batch number 1t2324002 included in the kits may not be sterile after failing the test for sterility undertaken by the tga.
  • 조치
    Scott Safety is recalling all affected First Aid Kits and requesting that these kits should be returned to them immediately. Scott Safety will inspect and replace ‘10 ml Normal Saline for Irrigation’ with alternate component that has already been secured. All new stock will be clearly marked with a QC sticker next to the barcode. This action has been closed-out on 18/03/2016.

Device

FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits
  • 모델명 / 제조번호(시리얼번호)
    FAKWP (Fineline 6100258) and FAKSITE (Fineline 5820595) First Aid Kits All lot NumbersARTG Number: 170275
  • Manufacturer
    Scott Health and Safety

Manufacturer

Scott Health and Safety
  • Source
    DHTGA