Events

Retiro De Equipo (Recall) de SUCTION IRRIGATOR REUSABLE TIPS

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
    131866
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-04-09
  • 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 initiated a voluntary product field correction for the instructions for use (ifu) for the suction irrigator reusable tips. the pre-vacuum steam sterilization (wrapped method) temperature in the instructions for use (ifu part # 1000-400-100 rev. k) incorrectly listed 121 - 123c instead of the correct 132 - 133c.

Device

SUCTION IRRIGATOR REUSABLE TIPS
  • Modelo / Serial
    Model Catalog: 250070484 (Lot serial: 2006/11/16-2012/11/16); Model Catalog: 250070483 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070484 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070487 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070488 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070473 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070472 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070471 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070437 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070411 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070409 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070408 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070407 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070404 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070403 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070402 (Lot serial: MANUFACTURED BETWEEN); Model Catalog: 250070491 (Lot serial: 2006/11/
  • Descripción del producto
    INSTRUCTIONS FOR USE FOR THE SUCTION IRRIGATOR REUSABLE TIPS
  • Manufacturer
    STRYKER CANADA LP

Manufacturer

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