Events

Retiro De Equipo (Recall) de MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINISTRATION SET

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por BAYER MEDICAL CARE 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
    55073
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-10-05
  • 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
    In november 2015 during a review of historical intego sas testing it was discovered that documented test evidence related to 85 psi for 35 seconds could not be found. when the necessary testing was recently conducted some failures were found at three year simulated age testing. the failed samples exhibited leaks in the coil bond joint. there was no test failures of the samples at one year accelerated age. product is currently labeled with a 3 year shelf-life and thus needs to be corrected until this shelf-life can be re- established.

Device

MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINISTRATION SET
  • Modelo / Serial
    Model Catalog: INT CSS (Lot serial: More than 10-contact manuf.)
  • Descripción del producto
    MEDRAD INTEGO PET INFUSION SYSTEM - SOURCE ADMINI
  • Manufacturer
    BAYER MEDICAL CARE INC.

Manufacturer

BAYER MEDICAL CARE INC.
  • Dirección del fabricante
    PITTSBURGH
  • Empresa matriz del fabricante (2017)
    Bayer AG
  • Source
    HC