Events

Retiro De Equipo (Recall) de PLASTIC NEEDLE WITH MANDRIN

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por VARIAN MEDICAL SYSTEMS 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
    152416
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-07-29
  • 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
    Previous recall (53838) addressed needle tip may separate from the needle shaft such that the tip may detach in the patient upon withdrawal. recall 66002 supplements and modifies previous noticewhere users are instructed to stop using any plastic needles they may have in inventory with lot numbers c01 to d01 and those with lot numbers which start with h or i. this recall also requires users to return any plastic needles with lot numbers c01 to d01 and those lot numbers which start with h or i to varian brachiotherapy for replacement with plastic needles starting with lot j or higher.

Device

PLASTIC NEEDLE WITH MANDRIN
  • Modelo / Serial
    Model Catalog: GM11007570 (Lot serial: >10 lot numbers.); Model Catalog: GM11007560 (Lot serial: >10 lot numbers.); Model Catalog: GM11007560 (Lot serial: Contact manufacturers.); Model Catalog: GM11007570 (Lot serial: Contact manufacturers.); Model Catalog: GM11007580 (Lot serial: Contact manufacturers.); Model Catalog: GM11007580 (Lot serial: >10 lot numbers.)
  • Descripción del producto
    PLASTIC NEEDLE WITH MANDRIN
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.