Events

Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347) 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Sorin 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
    2011-11-15
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20111115d.html
  • 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
    Health canada type ii recall: sorincrm isoline 2cr6 defibrillation leads (serial no. s2cr605346 and s2cr605347) it has come to our attention that the health canada has issued a type ii recall regarding the sorincrm isoline 2cr6 defibrillation leads (serial no. s2cr605346 and s2cr605347). as stated in the report, a batch of isoline defibrillation leads was labelled with an incorrect use before date (ubd), which was greater than the maximum of 36 months shelf life. the date printed on the labels was 5 may 2013, while the correct ubd is 21 september 2012. according to the supplier, the affected product with serial no. s2cr605346 and s2cr605347 have never been distributed or supplied in hong kong. for details, please refer to the health canada website: http://www.Hc-sc.Gc.Ca/dhp-mps/compli-conform/recall-retrait/_list/rec-ret_md-im_date_oct-dec_2011-eng.Php if you are in possession of the affected product, please contact your supplier for necessary actions.

Device

Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Sorin CRM Isoline 2CR6 Defibrillation Leads (Serial No. S2CR605346 and S2CR605347)
  • Manufacturer
    Sorin

Manufacturer

Sorin