Events

Retiro De Equipo (Recall) de HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SMITHS MEDICAL CANADA LTD. (SIMS).

¿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
    125032
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-07-10
  • 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
    Smiths medical has become aware of an issue with visible orange/brown particulate on some of hte needles of the 29g hypodermic needle-pro fixed needle insulin syringes. after a comprehensive investigation the particulate was found to consist of inorganic materials. while it is highly unlikely sensitive persons could experience a site reaction to the materials including infection or allergic reaction. smiths medical has received no reports of infection allergic reaction or injury related to this issue.

Device

HYPODERMIC NEEDLE-PRO FIXED NEEDLE INSULIN SYRINGE
  • Modelo / Serial
    Model Catalog: 4429-3 (Lot serial: 2336493); Model Catalog: 4429-5 (Lot serial: 2353094); Model Catalog: 4429-5 (Lot serial: 2357318); Model Catalog: 4429-3 (Lot serial: 2357318); Model Catalog: 4429-5 (Lot serial: 2336493); Model Catalog: 4429-3 (Lot serial: 2348708); Model Catalog: 4429-5 (Lot serial: 2348708); Model Catalog: 4429-3 (Lot serial: 2353094)
  • Descripción del producto
    Hypodermic Needle-Pro Fixed Needle Insulin Syringe 29g
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    HC