KIMGUARD Container Filters 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Kimberly-Clark Corporation 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
    2013-03-18
  • 사례 출판 날짜
    2013-03-18
  • 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: kimberly-clark kimguard container filters medical device manufacturer, kimberly-clark corporation issued a medical device safety alert concerning 9in. x 9in. (23cm x 23cm) square sized kimguard container filters. the affected product code is 68509 and the affected lot numbers are mf1279xxx, mf1287xxx, mf1288xxx. according to the manufacturer, some individual container filter units from the above product lots might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier. complaints received so far involved defects that were identified prior to use of possibly affected instruments or supplies on patients. kimberly-clark stressed that standard practice involves inspecting the sterilization container and filter for sterility breaches prior to use. if the defect is not detected upon standard inspection, contamination of surgical instruments and supplies within the container could be resulted. kimberly-clark asia pacific health care confirmed that the affected products have been distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 march 2013.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Kimberly-Clark KIMGUARD Container Filters
  • Manufacturer

Manufacturer