CIDEX Activated Glutaraldehyde Solution 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Advanced Sterilization Products 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
    2015-08-04
  • 사례 출판 날짜
    2015-08-04
  • 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: advanced sterilization products cidex activated glutaraldehyde solution medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its cidex activated glutaraldehyde solution. the manufacturer recently determined, as part of its routine quality program, that it may lack the adequate data to support the entire 24-month shelf life of cidex activated glutaraldehyde solution. the manufacturer determined that data for cidex activated glutaraldehyde solution supports a 12-month shelf life. the cidex activated glutaraldehyde solution is currently labeled for a 24-month shelf life. while the product has a maximum 14-day reuse life, data shows that the ph level of the cidex activated glutaraldehyde solution may be below specification for up to 2 hours after activation. use of cidex activated glutaraldehyde solution after 12 months may result in inadequate medical device reprocessing (disinfection/sterilization) or re-contamination if it is used for reprocessing within the first 2 hours of activation. the manufacturer advises users to check the expiration date on all bottles of cidex activated glutaraldehyde solution currently in inventory. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 04 august 2015.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Advanced Sterilization Products CIDEX Activated Glutaraldehyde Solution
  • Manufacturer

Manufacturer