Events

In-Line Blood Set with Filter 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-2018-RN-00783-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2018-06-18
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2018-RN-00783-1
  • 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 have identified the potential for a leak to occur at the tube to cap junction of the in-line blood set with filter (mmc2433). preliminary investigation has shown that this issue is due to the combination of cap dimension variability, especially on lower limit, and insertion depth of the cap into the tube on the lower side.To date, no complaints have been received as a result of this issue.
  • 조치
    Baxter is advising customers to identify and quarantine affected product from their facility. Baxter will arrange return of product from impacted users.

Device

In-Line Blood Set with Filter
  • 모델명 / 제조번호(시리얼번호)
    In-Line Blood Set with FilterProduct Code: MMC2433Multiple Lot NumbersARTG Number: 108533(Baxter Healthcare - Blood transfusion set)
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd