Events

Retiro De Equipo (Recall) de NECESSAIRE A INSTALLATION DE SONDE VESICALE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por 8083851 CANADA INC. OPERATING AS PAMA MANUFACTURING.

¿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
    21058
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2011-02-02
  • 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
    Recall initiated following triad group alert regarding potential problem with sterilization that could result in patient infection. all lots manufactured since january 2007.

Device

NECESSAIRE A INSTALLATION DE SONDE VESICALE
  • Modelo / Serial
    Model Catalog: NIS-382 (Lot serial: ); Model Catalog: LG-105 (Lot serial: + 100 LOT NUMBERS); Model Catalog: NIS-001 (Lot serial: ); Model Catalog: PAC-141 (Lot serial: ); Model Catalog: NIS-440 (Lot serial: ); Model Catalog: NIS-088 (Lot serial: ); Model Catalog: NIS-067 (Lot serial: ); Model Catalog: NIS-039 (Lot serial: ); Model Catalog: NIS-090 (Lot serial: ); Model Catalog: NIS-382 (Lot serial: contact manufacturer); Model Catalog: NIS-001 (Lot serial: contact manufacturer); Model Catalog: NIV-001 (Lot serial: contact manufacturer); Model Catalog: NIS-5006 (Lot serial: contact manufacturer); Model Catalog: NIS-278 (Lot serial: contact manufacturer); Model Catalog: NIS-382 (Lot serial: + 100 lot numbers); Model Catalog: NIS-001 (Lot serial: + 100 lot numbers); Model Catalog: NIV-001 (Lot serial: + 100 lot numbers); Model Catalog: NIS-5006 (Lot serial: + 100 lot numbers); Model Catalog: NIS-278 (Lot serial: + 100 lot numbers); Model Catalog: NIV-001 (Lot serial: ); Model Catalog: 10-8472 (Lot serial: cont
  • Descripción del producto
    KIT INSTALLATION SONDE VESICALE-SERINGUE
  • Manufacturer
    8083851 CANADA INC. OPERATING AS PAMA MANUFACTURING

Manufacturer

8083851 CANADA INC. OPERATING AS PAMA MANUFACTURING
  • Dirección del fabricante
    MIRABEL
  • Source
    HC