Events

Retiro De Equipo (Recall) de STRYKER 40L HIGH FLOW INSUFFLATOR - TUBING

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

¿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
    144348
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2010-03-23
  • 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
    Stryker endoscopy has become aware that the stryker heated insufflators may have been received with no expiration date printed on the label. additionally it was discovered that no packaging shelf-life testing had been completed for those products during the initial product launch. stryker has also become aware that the above referenced products may have been released for distribution and sold in countries that may have regulations regarding label expiration.

Device

STRYKER 40L HIGH FLOW INSUFFLATOR - TUBING
  • Modelo / Serial
    Model Catalog: 0620-030-407 (Lot serial: >100 NUMBERSCONTACT MFG)
  • Descripción del producto
    STRYKER HEATED INSUFFLATORS
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

STRYKER CANADA LP
  • Dirección del fabricante
    HAMILTON
  • Empresa matriz del fabricante (2017)
    Stryker
  • Source
    HC