Events

Retiro De Equipo O Alerta De Seguridad para IV cannula

Según Central Drugs Standard Control Organization, este evento ( retiro de equipo o alerta de seguridad ) involucró a un dispositivo médico en India que fue producido por Wellmed International Industries Pvt. Ltd..

¿Qué es esto?

Las alertas proporcionan información importante y recomendaciones sobre los productos. Aunque se haya emitido una alerta, esto no significa necesariamente que el producto se considera peligroso. Las alertas de seguridad, dirigidas a trabajadores de la salud y a usuarios, pueden incluir retiro de equipos. Pueden ser escritas por los fabricantes, pero también por funcionarios del área de salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall / Safety Alert
  • ID del evento
    29/Misc./3/2014-DC (64)
  • Fecha
    2014-07-17
  • País del evento
    India
  • Fuente del evento
    CDSCO
  • URL de la fuente del evento
    https://web.archive.org/web/20180304060129/http://www.cdsco.nic.in/forms/list.aspx?lid=1862&Id=1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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.