Events

Retiro De Equipo (Recall) de RING AND TANDEM COMBO KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por VARIAN MEDICAL SYSTEMS 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
    82186
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2012-10-01
  • 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
    An anomaly has been identified with the al07289000 rectal retractor stainless steel. the rectal retractors have shown evidence that contaminates or fluids may enter into the center of the rectal retractor paddle through the cross pins or bottom rod areas. the rectal retractor instruments have been identified to potentially have contaminating materials present after clinical use that cannot be removed by the instructed cleaning disinfecting and sterilization method. at this time it appears that the design of the paddle component is allowing for ingress and retention of bodily fluids or cleaning reagents during their clinical use and during their reprocessing for re-use. this issue is an internal finding - therefore no misadministration or serious deterioration in the state of health was reported. there have been no reports of this issue that have occurred in canada or within the eea member states.

Device

RING AND TANDEM COMBO KIT
  • Modelo / Serial
    Model Catalog: AL13016002 (Lot serial: H600346); Model Catalog: AL13015000 (Lot serial: H600346); Model Catalog: AL13016000 (Lot serial: H600346); Model Catalog: AL13016001 (Lot serial: H600346)
  • Descripción del producto
    Ring and Tandem Combo Kit
  • Manufacturer
    VARIAN MEDICAL SYSTEMS INC.

Manufacturer

VARIAN MEDICAL SYSTEMS INC.