Events

Alerta De Seguridad para Medset CM Breast Pump Kit

Según Department of Health, este evento ( alerta de seguridad ) involucró a un dispositivo médico en Hong Kong que fue producido por Medela AG.

¿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
  • Fecha
    2018-05-09
  • Fecha de publicación del evento
    2018-05-09
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20180509b.html
  • Notas / Alertas
    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.
  • Notas adicionales en la data
    Medical Device Safety Alert
  • Causa
    Medical device safety alert: medset cm breast pump kit the medicines and healthcare products regulatory agency (mhra) of united kingdom, has posted a medical device safety alert concerning medset cm breast pump kit, manufactured by medela ag [product code: 001.0112 medset cm; all lots] an internal review performed by the manufacturer found that the labelling documentation for the medset cm breast pump kit is incomplete. additionally, although all product is sterile, the manufacturer cannot demonstrate full compliance with the quality standard for sterilisation. according to the manufacturer, no other sterile breast pump kit is affected by this issue. it can confirm that, to date, there have not been any complaints received which are associated with this issue. however, the manufacturing of this product has been discontinued. a replacement product is immediately available. the affected users are advised to: immediately check their internal inventory and storage areas for subject devices; transfer any subject devices which are found to quarantine area, pending destruction; destroy all subject devices by removing from packaging and disposing in waste in accordance with any local or environmental regulations; and notify the manufacturer immediately of any complaints associated with this issue. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 9 may 2018.

Device

Medset CM Breast Pump Kit
  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Medset CM Breast Pump Kit
  • Manufacturer
    Medela AG

Manufacturer

Medela AG