Retiro De Equipo (Recall) de Bard L/L/Med Rad Kit ACVS NZ

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 Bard 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
    22930
  • Fecha de inicio del evento
    2018-05-07
  • País del evento
  • Fuente del evento
    NZMMDSA
  • 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: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, 54 Carbine Road, Mt Wellington, AUCKLAND
  • Causa
    It has been reported that the safety mechanism of the scalpel (component number in1951) of lifemed procedure packs as being not engaged, resulting in an un-sheathed blade that could lead to a cut during handling by health care professionals, especially in circumstances where they are unaware of this anomaly.
  • Acción
    Manufacturer to issue advice regarding use

Device

  • Modelo / Serial
    Model: , Affected: Lot Numbers MYBUL289, MYBVL111, MYBUL289
  • Manufacturer

Manufacturer