Events

Retiro De Equipo (Recall) de CADD ADMINISTRATION SET

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

¿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
    149856
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2018-03-05
  • 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
    A detailed investigation points to a unique use case involving a single canadian customer using non-approved smiths medical pouches with the cadd? blue-striped administration set. use of non-approved accessories as indicated in labeling may adversely affect pump operation. smiths medical has decided to proceed with sending communication to notify all canadian customers who have purchased the cadd blue-striped administration set. the content of the fsn provides more information to the customer / user when using the administration set. fsn emphasizes the correct use of the product and how to avoid strain relief which in turn prevents leakage.

Device

CADD ADMINISTRATION SET
  • Modelo / Serial
    Model Catalog: 21-7036-01 (Lot serial: >1000 numbers contact mfg)
  • Descripción del producto
    CADD Blue-Striped Administration Set
  • Manufacturer
    SMITHS MEDICAL CANADA LTD. (SIMS)

Manufacturer

SMITHS MEDICAL CANADA LTD. (SIMS)
  • Dirección del fabricante
    MARKHAM
  • Empresa matriz del fabricante (2017)
    Smiths Group Plc
  • Source
    HC