Events

Heater-Cooler Devices 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Terumo Cardiovascular Systems 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
    2016-06-14
  • 사례 출판 날짜
    2016-06-14
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160614.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
    Medical device safety alert: terumo heater-cooler devices medical device manufacturer, terumo cardiovascular systems corporation (terumo cvs), has issued a medical device safety alert concerning its heater-cooler devices. the affected devices are identified as follows:- a) sams tcm ii cooling and heating systems [catalog number: 4416, 164935, 164940] b) sams dual cooler-heaters [catalog number: 4332, 14114, 13460] the manufacturer is notifying all users of its heater-cooler devices that the distributor, intercon chemical company, no longer sells the intechlor sanitizer (product code 205) referenced in its heater-cooler cleaning instructions. however, the identical sanitizer is available from other sources. updated instructions on how to source a sanitizer are provided by the manufacturer. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 14 june 2016.

Device

Heater-Cooler Devices

Manufacturer

Terumo Cardiovascular Systems Corporation