Events

Retiro De Equipo (Recall) de Medcom Hemo-Cath LT 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
    Recall
  • ID del evento
    18735
  • Fecha de inicio del evento
    2015-06-30
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • 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: New Zealand Medical & Scientific Ltd, 2A Fisher Crescent, Mt Wellington, AUCKLAND 1060
  • Causa
    The manufacturer has updated the instructions for use (ifu) to include an instruction for the catheter not to be clamped. clamping the catheter can cause holes in the catheter causing leaks potentially leading to blood loss, air emboli, infection, delays in treatment, and a surgical procedure to remove and replace the device prior to continuing the dialysis treatment.
  • Acción
    Instructions for use to be updated

Device

Medcom Hemo-Cath LT Hemodialysis Catheters
  • Modelo / Serial
    Model: All models, Affected: All lot numbers
  • Manufacturer
    Medcomp Inc

Manufacturer

Medcomp Inc