Events

Alerta De Seguridad para Nemschoff Perinatal Bassinet Products (Models: BSNT/01, BSNT/02, BSNT/03, BSNT/04)

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

¿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
    2012-02-16
  • País del evento
    Hong Kong
  • Fuente del evento
    DH
  • URL de la fuente del evento
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20120216.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
    Field safety notice: the nemschoff perinatal bassinet products (models: bsnt/01, bsnt/02, bsnt/03, bsnt/04) the food and drug administration (fda), united states, has issued a class i recall on nemschoff perinatal bassinet products with models number of bsnt/01, bsnt/02, bsnt/03 and bsnt/04. the manufacturer of the device, nemschoff chairs, inc, is correcting issues with casters, door hinges, drawer slides, and the bassinet surround of the affected devices. besides, nemschoff also adds labeling to the product regarding specific instructions for cleaning the bassinet tub and drawer weight limits. according to fda, the affected devices have been distributed in us and canada. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/enforcement reports/ucm292057.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

Nemschoff Perinatal Bassinet Products (Models: BSNT/01, BSNT/02, BSNT/03, BSNT/04)

Manufacturer

Nemschoff