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
    37221
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-05-04
  • 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
    Smiths is notifying users of cadd administration sets with flow stop that these listed sets may affect flow rate when used with a variety of cadd ambulatory infusion pumps. this may result in under-delivery of medication by an average additional 5.2% beyond the labeled system delivery accuracy claim of +/- 6.0%. if drug under-delivery occurs patients may not receive their full volume of medicinal product in the prescribed timeframe.

Device

CADD ADMINISTRATION SET
  • Modelo / Serial
    Model Catalog: 21-7324-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7333-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7323-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7322-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7322-01 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7321-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7321-01 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7383-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7383-01 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7395-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7394-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7394-01 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7391-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7391-01 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-7390-24 (Lot serial: EXPIRY ON/BEFORE MAR 2021); Model Catalog: 21-
  • Descripción del producto
    CADD ADMINISTRATION SETS WITH FLOW STOP
  • 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