Retiro De Equipo (Recall) de Medcomp Hemo-cath®LT and Hemo-cath®ST Hemodialysis Catheters

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Medcomp Inc.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: AA-Med NZ Ltd, 6 Church Lane, Point Howard, Lower Hutt, Wellington 5013
  • Causa
    Manufacturer notification of potential safety issue affecting medcomp hemo-cath lt and hemo-cath st hemodialysis catheters which may develop holes during use. investiagtion determined that during the insertion procedure engaging the extension line clamp over the guidewire may damage the inside of the tubing. a crack in the tubing on the inside can propagate over time and eventually travel through thickness of the tubing developong into a hole that leaks.
  • Acción
    Manufacturer to issue advice regarding use


  • Modelo / Serial
    Model: LT and ST, Affected: ECS1316 ECS1320 and ECS1324
  • Manufacturer