Sterile Water for Irrigation 1000ml 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Baxter Healthcare Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2012-08-20
  • 사례 출판 날짜
    2012-08-20
  • 사례 국가
  • 사례 출처
    DH
  • 사례 출처 URL
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: baxter sterile water for irrigation 1000ml the medicines and healthcare products regulatory agency (mhra), united kingdom issued a medical device alert concerning sterile water for irrigation 1000ml manufactured by baxter healthcare ltd. the affected product code is ukf7114, lot no 12d10b26. this lot was supplied by baxter from 1 may 2012 to 22 may 2012 inclusive. there is a risk of contamination of this batch as there has been a report in france that bottles within this batch were contaminated with aspergillus. this case is still under investigation and the affected batch is being independently tested. meanwhile, customers are advised to quarantine bottles in the affected batch and liaise with baxter regarding availability of supplies and for updates. the mhra is liaising with baxter and will provide further updates as necessary. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/medicaldevicealerts /index.Htm if you are in possession of the affected product, please contact your supplier for necessary actions. posted on 20 august 2012.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Baxter Sterile Water for Irrigation 1000ml
  • Manufacturer

Manufacturer