Retiro De Equipo (Recall) de BD Vacutainer Eclipse Signal Blood Collection Needle with Integrated Holder 22G

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 Becton Dickinson UK 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
    18969
  • Fecha de inicio del evento
    2015-08-12
  • 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: Becton Dickinson Ltd, 14B George Bourke Drive, Mt Wellington, Auckland 1060
  • Causa
    Through customer feedback the manufacturer has become aware that some lots of the bd vacutainer eclipse signal blood collection needle with integrated holder have the potential for the integrated holder to become detached from the needle. this detachment can lead to possible sample collection failure and in exceptional circumstances have the potential to cause a needle stick injury.
  • Acción
    Product to be returned to supplier

Device

  • Modelo / Serial
    Model: 368836, Affected: 4268488 4302103 4329078 4346062 4346068 5027368 5072462
  • Manufacturer

Manufacturer