Alerta De Seguridad para Microbore Administration Set and Epidural Administration Set

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

¿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
    2012-06-08
  • Fecha de publicación del evento
    2012-06-08
  • País del evento
  • Fuente del evento
    DH
  • URL de la fuente del evento
  • 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: moog microbore administration set and epidural administration set the united states food and drug administrations (fda) has issued a class i recall concerning non-dehp microbore administration set and epidural administration set (model no: 340-4114, 340-4115, 340-4126, 340-4128, 340-4128-v, 340-4130, 340-4130-v, 340-4137, 340-4144, 340-4165, 340-4166, 340-4173, 340-4133, 340-4176), manufactured by moog medical devices group. the manufacturer became aware via customer complaint, of a reversed pump segment on an administration set. this malfunction could reverse the flow of fluid or medication backwards from what was intended. for details, please refer to fda website http://www.Fda.Gov/safety/recalls/enforcementreports/ucm307229.Htm if you are in possession of the product, please contact your supplier for necessary actions. posted on 8 june 2012.

Device

  • Modelo / Serial
  • Descripción del producto
    Medical Device Safety Alert: Moog Microbore Administration Set and Epidural Administration Set
  • Manufacturer

Manufacturer

  • Empresa matriz del fabricante (2017)
  • Source
    DH