Events

Premise Universal Restorative Body Syringe and Unidose, Shade A2 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Kerr 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
    2014-09-12
  • 사례 출판 날짜
    2014-09-12
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20140912.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: kerr premise universal restorative body syringe and unidose, shade a2 medical device manufacturer, kerr corporation, has issued a medical device safety alert concerning its premise universal restorative body syringe and unidose, shade a2, with the following details: product descriptions: a) refill - syringe premise a2; and b) refill - unidose premise a2 part no.: a)32618; b) 32651 serial no.: a) 4941320; 4946443; 4906963; b) 4908202; 4890805; 4890804; 4890806; 4946447 shipped between june 2013 to november 2013 the manufacturer received some complaints that certain units within certain lots of premise a2 composite may be sticky and/or difficult to use. there is no safety issue associated with using the product. affected users should review to determine if they have any of the affected products in their inventory, and users can choose to return the affected product for replacement if not satisfied. according to the local supplier, the affected products were not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 12 sep 2014.

Device

Premise Universal Restorative Body Syringe and Unidose, Shade A2
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Kerr Premise Universal Restorative Body Syringe and Unidose, Shade A2
  • Manufacturer
    Kerr Corporation

Manufacturer

Kerr Corporation