Events

Retiro De Equipo (Recall) de CATARACT PACK

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por CARDINAL HEALTH CANADA 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
    38435
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-11-22
  • 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
    Cardinal health has been informed by beaver visitec of a field safety notice for the beaver xstar safety knives (contained in the cardinal health kits). the knives feature an integrated retractable safety shield to minimize the risk of accidental surgical blade injuries during handling. beaver visitec has received 20 complaints in which the protective shield was retracted thereby exposing the blade. the knives are provided in a tyvek covered tray and customers are advised prior to opening the tyvek tray to visually confirm that the plastic shield is not retracted. if the shield is in the retracted position the knife remains fully functional for its intended use.

Device

CATARACT PACK
  • Modelo / Serial
    Model Catalog: SEY30CTSBG (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SEY30CTCWB (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SEY30CSSJD (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SEY30CASJN (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SEY30CACOL (Lot serial: > 10 NUMBERS CONTACT MFG); Model Catalog: SEY30CSSJB (Lot serial: > 10 NUMBERS CONTACT MFG)
  • Descripción del producto
    CATARACT PACK
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    Cardinal Health
  • Source
    HC