Events

Softpac C299 (used in preparing dialysate for haemodialysis therapies) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Baxter 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-00815-1
  • 사례 위험등급
    Class II
  • 사례 시작날짜
    2016-06-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00815-1
  • 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
    Two complaints were received from customers that bags labelled as containing softpac c295 were found in boxes labelled as containing softpac c299. after investigation, baxter determined that the bags labelled as containing softpac c295 actually contained softpac c299 solution. the softpac c295 and c299 formulations have the same composition except for the calcium (ca+) and chloride (cl-) content. the labelling error may lead to electrolyte imbalances, under circumstances of repetitive use of mislabelled product. no reports of related adverse events have been received by baxter.
  • 조치
    Baxter is advising users to remove the affected product from use. Affected product will be replaced with unaffected stock. This action has been closed-out on 15/02/2017.

Device

Softpac C299 (used in preparing dialysate for haemodialysis therapies)
  • 모델명 / 제조번호(시리얼번호)
    Softpac C299 (used in preparing dialysate for haemodialysis therapies)Product Code: 114667Lot Number: 755756Expiry Date: 30 April 2017ARTG Number: 146875
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd