Events

Retiro De Equipo (Recall) de ETCH GEL

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

¿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
    97406
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2011-06-14
  • 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
    Product continues to extrude out of the syringe even after pressure is no longer applied and the affected product actually contains a higher percentage of phosphoric acid than indicated on the label.

Device

ETCH GEL
  • Modelo / Serial
    Model Catalog: T06B (Lot serial: expiry btwn 2011/04-2015/04); Model Catalog: T06A (Lot serial: expiry btwn 2011/04-2015/04); Model Catalog: T06 (Lot serial: expiry btwn 2011/04-2015/04); Model Catalog: N01IB (Lot serial: expiry btwn 2011/04-2015/04); Model Catalog: N01H (Lot serial: expiry btwn 2011/04-2015/04); Model Catalog: T06B (Lot serial: all made since Apr 2007); Model Catalog: T06A (Lot serial: all made since Apr 2007); Model Catalog: T06 (Lot serial: all made since Apr 2007); Model Catalog: N01IB (Lot serial: all made since Apr 2007); Model Catalog: N01H (Lot serial: all made since Apr 2007); Model Catalog: T06B (Lot serial: N06K); Model Catalog: T06A (Lot serial: N06K); Model Catalog: T06 (Lot serial: N06K); Model Catalog: N01IB (Lot serial: N06K); Model Catalog: N01H (Lot serial: N06K); Model Catalog: T06B (Lot serial: N33); Model Catalog: T06A (Lot serial: N33); Model Catalog: T06 (Lot serial: N33); Model Catalog: N01IB (Lot serial: N33); Model Catalog: N01H (Lot serial: N33); Model Catalog: T06
  • Descripción del producto
    37% Phosphoric Acid Etching Gel
  • Manufacturer
    SYNCA MARKETING INC. ALSO OPERATING AS SYNCA

Manufacturer

SYNCA MARKETING INC. ALSO OPERATING AS SYNCA
  • Dirección del fabricante
    LE GARDEUR
  • Empresa matriz del fabricante (2017)
    Synca Marketing Inc
  • Source
    HC