Events

Retiro De Equipo (Recall) de SERATRONICS DIALYZER PREPARATION SYSTEM

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

¿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
    66314
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-01-13
  • 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
    Conmed received five complaints of some devices which had broken through the seal of the sterile pouch: the initial complaint was received on november 30 2012. conmed has confirmed instances where the pouch seal was compromised on the affected products. in no instance has it been reported to conmed corporation that a compromise in the sterile barrier has resulted in illness or injury. the compromised seals were discovered prior to use.

Device

SERATRONICS DIALYZER PREPARATION SYSTEM
  • Modelo / Serial
    Model Catalog: 130343 (Lot serial: 120628X - 120917X); Model Catalog: 138025 (Lot serial: 120628X - 120917X); Model Catalog: 137668 (Lot serial: 120628X - 120917X); Model Catalog: 139105EXT (Lot serial: 120628X - 120917X); Model Catalog: 139104EXT (Lot serial: 120628X - 120917X); Model Catalog: 139102 (Lot serial: 120628X - 120917X); Model Catalog: 139112 (Lot serial: 120628X - 120917X); Model Catalog: 7-100-8BX (Lot serial: 120628X - 120917X); Model Catalog: 7-101-8BX (Lot serial: 120628X - 120917X); Model Catalog: 139107 (Lot serial: 120628X - 120917X)
  • Descripción del producto
    Single Use ABC Nozzle Sterile (For use with 130500 Reusable ABC Handpiece)
  • Manufacturer
    CONMED CANADA

Manufacturer

CONMED CANADA
  • Dirección del fabricante
    MISSISSAUGA
  • Empresa matriz del fabricante (2017)
    CONMED Corp.
  • Source
    HC