Events

Retiro De Equipo (Recall) de INFINITI PLUS DISPOSABLE NEEDLE GUIDE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CIVCO MEDICAL INSTRUMENTS CO. INC. DBA CIVCO.

¿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
    90154
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-02-16
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Civco has recently discovered a quality issue with infiniti bracket. the affected brackets were included in the kits identified and manufactured between 11/2009 through 12/2017. description of problem: if the length of the mount may be longer than specified it can allow the needle guide insert to puncture the cover which is applied between the mount and needle guide assembly. this does not prevent the assembly from functioning as intended to keep the biopsy needle in the ultrasound scanning plane.

Device

INFINITI PLUS DISPOSABLE NEEDLE GUIDE
  • Modelo / Serial
    Model Catalog: 698-009 (Lot serial: M419650); Model Catalog: 698-009 (Lot serial: M427370); Model Catalog: 698-009 (Lot serial: M388690); Model Catalog: 698-009 (Lot serial: M220960)
  • Descripción del producto
    INFINITI BRACKET (SOLD AS PART OF CIVCO BRAND BIOPSY STARTER KITS AND BIOPSY BRACKET)
  • Manufacturer
    CIVCO MEDICAL INSTRUMENTS CO. INC. DBA CIVCO

Manufacturer

CIVCO MEDICAL INSTRUMENTS CO. INC. DBA CIVCO