STERRAD Systems 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
    2014-11-27
  • 사례 출판 날짜
    2014-11-27
  • 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 sterrad systems medical device manufacturer, advanced sterilization products, has issued a medical device safety alert concerning its sterrad systems [models: 50, 100s, 200, 100nx and nx]. the manufacturer recently determined, as part of its routine quality programme that the leak indicator on the sterrad system cassettes packaging assembly may not function properly after exposure to hydrogen peroxide. sterrad system cassette packaging assemblies are designed with a leak indicator on the inner package to provide a visual colour indication in the event hydrogen peroxide has leaked from the cassettes. the manufacturer’s recommendations on exercising extra precaution when handling new sterrad system cassettes are as follows: the customer should wear personal protective equipment (e.G. gloves) when handling the cassette. this is a precautionary measure in the event that the customer comes in contact with hydrogen peroxide. in addition to wearing personal protective equipment, the customer should perform a visual inspection of the cassette package to look for signs of liquid leakage prior to opening the package. if a liquid leak is observed, the customer should dispose of the cassette package immediately and contact the local supplier. if customers come into contact with hydrogen peroxide, they should immediately flush the affected area with plenty of water for at least 15 minutes while removing contaminated clothing and shoes. medical attention should be sought promptly if symptoms occur after washing. contaminated clothing should be washed before reuse. 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 27 november 2014.

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Advanced Sterilization Products STERRAD Systems
  • Manufacturer

Manufacturer