Events

Askina Gel 15g 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 B Braun 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-2018-RN-00364-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2018-05-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00364-1
  • 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
    B.Braun's manufacturing site it has determined that the irradiation dose qualified for sterilisation of specific products was too low. in consequence, the germ reduction through gamma irradiation may not have reached the requested sterility assurance level of 0.000001.To date, there have been no reports of any adverse patient outcome as a result of this issue.
  • 조치
    B.Braun is advising customers to identify quarantine and return affected stock as per the instructions given in the Customer letter.

Device

Askina Gel 15g
  • 모델명 / 제조번호(시리얼번호)
    Askina Gel 15g Item Code: 001419NAll BatchesARTG Number: 177492(B Braun Australia Pty Ltd - Dressing, hydrogel)Irradiation Dose Qualified for Sterilisation
  • Manufacturer
    B Braun Australia Pty Ltd

Manufacturer

B Braun Australia Pty Ltd