Events

Retiro De Equipo (Recall) de SHER-I-BRONCH ENDOBRONCHIAL TUBE KIT

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por TRUDELL MEDICAL MARKETING LIMITED.

¿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
    137196
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2009-08-14
  • 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
    The tether attaching to the double swivel cap may partially or completely break at the attachent points. the brojen tether may lodge inside the dual swivel tubing or body during shipment to the end user resulting in the potential for the accidental aspiration of the tether into the patient's lungs.

Device

SHER-I-BRONCH ENDOBRONCHIAL TUBE KIT
  • Modelo / Serial
    Model Catalog: 5-16028 (Lot serial: < 10 lot numbers); Model Catalog: 5-15401 (Lot serial: < 10 lot numbers); Model Catalog: 5-15301 (Lot serial: < 10 lot numbers); Model Catalog: 5-15401 (Lot serial: contact manufacturer); Model Catalog: 5-15301 (Lot serial: contact manufacturer); Model Catalog: 5-16141 (Lot serial: contact manufacturer); Model Catalog: 5-16139 (Lot serial: contact manufacturer); Model Catalog: 5-16137 (Lot serial: contact manufacturer); Model Catalog: 5-16135 (Lot serial: contact manufacturer); Model Catalog: 5-16128 (Lot serial: contact manufacturer); Model Catalog: 5-16041 (Lot serial: contact manufacturer); Model Catalog: 5-16039 (Lot serial: contact manufacturer); Model Catalog: 5-16037 (Lot serial: contact manufacturer); Model Catalog: 5-16035 (Lot serial: contact manufacturer); Model Catalog: 5-16028 (Lot serial: contact manufacturer); Model Catalog: 5-16141 (Lot serial: < 10 lot numbers); Model Catalog: 5-16139 (Lot serial: < 10 lot numbers); Model Catalog: 5-16137 (Lot serial: < 10
  • Descripción del producto
    SHER-I-BRONCH
  • Manufacturer
    TRUDELL MEDICAL MARKETING LIMITED

Manufacturer

TRUDELL MEDICAL MARKETING LIMITED