Medset CM Breast Pump Kit 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medela AG 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
    2018-05-09
  • 사례 출판 날짜
    2018-05-09
  • 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: medset cm breast pump kit the medicines and healthcare products regulatory agency (mhra) of united kingdom, has posted a medical device safety alert concerning medset cm breast pump kit, manufactured by medela ag [product code: 001.0112 medset cm; all lots] an internal review performed by the manufacturer found that the labelling documentation for the medset cm breast pump kit is incomplete. additionally, although all product is sterile, the manufacturer cannot demonstrate full compliance with the quality standard for sterilisation. according to the manufacturer, no other sterile breast pump kit is affected by this issue. it can confirm that, to date, there have not been any complaints received which are associated with this issue. however, the manufacturing of this product has been discontinued. a replacement product is immediately available. the affected users are advised to: immediately check their internal inventory and storage areas for subject devices; transfer any subject devices which are found to quarantine area, pending destruction; destroy all subject devices by removing from packaging and disposing in waste in accordance with any local or environmental regulations; and notify the manufacturer immediately of any complaints associated with this issue. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 may 2018.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medset CM Breast Pump Kit
  • Manufacturer

Manufacturer