Events

Dual Luer Lock Caps 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Baxter 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
    2013-09-23
  • 사례 출판 날짜
    2013-09-23
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130923.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: baxter dual luer lock caps the u.S. food and drug administration (fda) have posted a press release issued by baxter concerning its dual luer lock caps with the followings: product code: 2c6250 lot number: 10043 and 10044 affected lots were distributed to customers between 19 jun 2013 and 20 aug 2013. there is the presence of loose particulate matter found in the packaging of the affected products. particulate matter entering the fluid path from the luer lock caps may result in thrombotic and embolic events, including pulmonary embolism, myocardial infarction and stroke. there have been no reported complaints associated with this issue. according to the manufacturer, customers should not use product from the two recalled lots and should locate and remove all affected product from their facility. affected lots should be returned to baxter. according to the local supplier, the affected products were not distributed in hong kong. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/ucm369253.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 23 september 2013.

Device

Dual Luer Lock Caps
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Baxter Dual Luer Lock Caps
  • Manufacturer
    Baxter

Manufacturer

Baxter