Events

Retiro De Equipo (Recall) de HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETER SETS

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MCARTHUR MEDICAL SALES 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
    22980
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2015-07-27
  • 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
    Cracks in silicon extension tubing of hemodialysis catheters propagate over time resulting in holes because of inadequate use during the insertion procedure that is the extension line clamp is clamped onto the guidewire. the hole in the extension tubing leaks when the device is being pressurized with a syringe during flushing or during dialysis treatment.

Device

HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETER SETS
  • Modelo / Serial
    Model Catalog: SL15E (Lot serial: ALL); Model Catalog: SL24P (Lot serial: ALL); Model Catalog: SL12P (Lot serial: ALL); Model Catalog: SL18P (Lot serial: ALL); Model Catalog: SL24C (Lot serial: ALL); Model Catalog: SL20C (Lot serial: ALL); Model Catalog: SL15C (Lot serial: ALL); Model Catalog: SL32 (Lot serial: ALL); Model Catalog: SL28 (Lot serial: ALL); Model Catalog: MC101241 (Lot serial: ALL); Model Catalog: SDL138E (Lot serial: ALL); Model Catalog: SDL136E (Lot serial: ALL); Model Catalog: MC101243 (Lot serial: ALL); Model Catalog: MC101242 (Lot serial: ALL); Model Catalog: SDL139E (Lot serial: ALL)
  • Descripción del producto
    HEMO-CATH SILICONE DOUBLE LUMEN TEMPORARY ACCESS CATHETER SETS
  • Manufacturer
    MCARTHUR MEDICAL SALES INC.

Manufacturer

MCARTHUR MEDICAL SALES INC.