Events

Retiro De Equipo (Recall) de WACA Chorion Villus Biopsy Needle Set

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 William A Cook Australia Pty Ltd.

¿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
    23276
  • Fecha de inicio del evento
    2018-07-02
  • 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: Obex Medical Ltd, 303 Manukau Road, Epsom, AUCKLAND
  • Causa
    The manufacturer is initiating recall of the cook chorion villus biopsy needle set (echo tip) ck-k-cvns-1821-robinson-et. the diagram on the product label is incorrect. it shows that the 18ga needle has an echotip, and the 21ga does not, whereas the product is designed such that the 21ga needle has the echotip and the 18ga needle does not.
  • Acción
    Product to be returned to supplier

Device

WACA Chorion Villus Biopsy Needle Set

Manufacturer

William A Cook Australia Pty Ltd