Events

Potassium 10mmol in 0.225% Sodium Chloride and 10% Glucose (500ml) 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-2014-RN-00421-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2014-04-08
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00421-1
  • 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
    Baxter healthcare is issuing a recall as a result of a complaint received indicating that the labelling of this product contains an error. underneath the “potassium 10 mmol” type on the main label, there is bracketed text that states “potassium chloride 0.075%”. the figure of 0.075% is incorrect. the correct figure should be 0.15%.
  • 조치
    Hospitals are requested to remove all units from affected lots. The affected product should be returned by contacting Baxter Healthcare Customer Service. Baxter is requesting prescribers to monitor patients infused with the affected product for any irregularity in electrolyte levels.

Device

Potassium 10mmol in 0.225% Sodium Chloride and 10% Glucose (500ml)
  • 모델명 / 제조번호(시리얼번호)
    Potassium 10mmol in 0.225% Sodium Chloride and 10% Glucose (500ml)Product Code: AHK6021Batch numbers: S60P3 & S67P2Exempt from registration in the ARTG under Schedule 5A of the Regulations.
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd