Events

Retiro De Equipo (Recall) de Biopsy gun, side-notch

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 Peripheral Vascular 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
    22025
  • Fecha de inicio del evento
    2017-09-26
  • 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: Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics, 54 Carbine Road, Mt Wellington, AUCKLAND
  • Causa
    The manufacturer has identified that the biopsy gun dispos maxcore may be at risk of having issues related to proper functioning of the device. this includes difficulty with priming and firing, failure to obtain tissue sample, and in some instances self-activating after priming.
  • Acción
    Product to be returned to supplier

Device

Biopsy gun, side-notch
  • Modelo / Serial
    Model: , Affected: Biopsy Gun Dispos MaxCore 14gx10cm Lot numbers REBN2123, REBP1199, REBP1807, Biopsy Gun Dispos MaxCore 16gx16cm Lot numbers REBP1420, Biopsy Gun Dispos MaxCore 18gx16cm Lot numbers REBN0342,Biopsy Gun Dispos MaxCore 18gx20cm Lot numbers REBQ1014
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc