Events

Retiro De Equipo (Recall) de SYSTEM 1 EXPRESS - QUICK CONNECT KIT

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

¿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
    93011
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2015-12-18
  • 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
    Quick connects provide directed flow of processing fluids (sterilant use dilution and rinse water) into the internal lumens of specifically identified endoscopes via adapters which connect to the endoscope ports. each quick connect contains a flow unit consisting of tubing tethers and adapters for connecting the medical device to the system 1 express processing tray to achieve liquid chemical sterilization. steris has learned that one of the hysteroscope models (karl storz 11264bbu1) listed for processing in two existing quick connects has one inlet port rather than two inlet ports as indicated in the quick connect processing instructions. a user who connects the karl storz 11264bbu1 hysteroscope according to the processing instructions will observe an unused port adapter on the quick connect.

Device

SYSTEM 1 EXPRESS - QUICK CONNECT KIT
  • Modelo / Serial
    Model Catalog: QKC1736INT (Lot serial: all lots); Model Catalog: QKC1737INT (Lot serial: all lots)
  • Descripción del producto
    SYSTEM 1 EXPRESS - QUICK CONNECT KIT
  • Manufacturer
    STERIS CANADA CORPORATION

Manufacturer

STERIS CANADA CORPORATION
  • Dirección del fabricante
    QUEBEC
  • Empresa matriz del fabricante (2017)
    Steris Plc
  • Source
    HC