Events

Retiro De Equipo (Recall) de OXYARM - OXYMASK MODEL -RTM

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por SOUTHMEDIC 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
    28832
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-02-27
  • 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
    On february 14 southmedic received a customer complaint indicating a potential occlusion of the co2 sampling line on a southmedic capnography mask. inspection of current stock of the lot number in question did not identify any issues however investigation into additional lots manufactured with the same subassembly resulted in identification of occluded co2 sampling lines. subsequently all stock of various product skus manufactured with a co2 sampling line were placed on hold for further inspection.

Device

OXYARM - OXYMASK MODEL -RTM
  • Modelo / Serial
    Model Catalog: OM-2125-8 (Lot serial: W35266); Model Catalog: OP-2125-8 (Lot serial: W35909); Model Catalog: CO2-01-SLM (Lot serial: W35983); Model Catalog: CO2-03-SLM (Lot serial: W35983); Model Catalog: CO2-01-SLM (Lot serial: W35906); Model Catalog: CO2-03-SLM (Lot serial: W35906)
  • Descripción del producto
    OxyArm-OxyMask Model - RTM;OxyArm-OxyPlus;Ophthalmic Capnoxygen Mask
  • Manufacturer
    SOUTHMEDIC INC.

Manufacturer

SOUTHMEDIC INC.