Events

Alerta De Seguridad para Steam Indicator Tape 1322

Según National Institute of Drugs and Food Surveillance (INVIMA), este evento ( alerta de seguridad ) involucró a un dispositivo médico en Colombia que fue producido por 3M Canada Company || 3M Health Care.

¿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
    Safety alert
  • ID del evento
    R1705-195
  • Número del evento
    2007DM-0001180
  • Fecha
    2017-05-30
  • País del evento
    Colombia
  • Fuente del evento
    INVIMA
  • URL de la fuente del evento
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=85
  • Notas / Alertas
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Notas adicionales en la data
  • Causa
    The manufacturer reports that it has detected as a result of internal tests that some rolls of tape do not adequately develop the correct standard visual color once the process of steam sterilization is completed, which can be interpreted as a failure in the sterilization process, leading to that they must be repeat the sterilization processes on the loads.

Device

Steam Indicator Tape 1322
  • Modelo / Serial
  • Descripción del producto
    Use the steam indicator tape to demonstrate that the packages taken to steam sterilization processes have been exposed to the process and to distinguish between processed and unprocessed packaging.
  • Manufacturer
    3M Canada Company || 3M Health Care

Manufacturer

3M Canada Company || 3M Health Care
  • Empresa matriz del fabricante (2017)
    3m Company
  • Source
    NIDFSINVIMA