Events

IV cannula 를 위한 리콜 또는 안전성 경고

Central Drugs Standard Control Organization에 따르면, 해당 리콜 또는 안전성 경고 는 India 에서 Wellmed International Industries Pvt. Ltd. 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
    Recall / Safety Alert
  • 사례 ID
    29/Misc./3/2014-DC (64)
  • 날짜
    2014-07-17
  • 사례 국가
    India
  • 사례 출처
    CDSCO
  • 사례 출처 URL
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • 비고 / 경고
    The data from India is current through 2017. All of the data comes from the Central Drugs Standard Control Organization, 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 recall data from the U.S. and India.
  • 데이터 추가 비고
  • 원인
    Damage of the product (iv cannula) due to fire manufactured by mis wellmed international industries, pvt. ltd, a-176 & 177, sector -63, noida, up for export to bangladesh - reg.
  • 조치
    Please refer to your letter dated 23.06.2014 on the subject cited above. In this connection, the inspection of the incident site was carried out by the officials of COSCO (EZ), Kolkata and State Licensing Authority (SLA), West Bengal. The inspection team observed that material was found stored in damaged conditions and was without legible Batch No., Mfg. & Exp. Date details etc. Further, details of incidence could not be ascertained from Bongaon Municipality. The inspection team concluded that quality and quantity of the material and actual cause of incidence cannot be ascertained. In view of above, you are directed to destroy the material as per your SOP and dispose off the material as per the provisions of Biomedical Waste Management Act and other applicable laws in presence of Drugs Inspector from SLA, WB in coordination with Bongaon Municipality.

Device

IV cannula

Manufacturer

Wellmed International Industries Pvt. Ltd.