Events

Retiro De Equipo (Recall) de MICROFIL COMPOSITE INSTRUMENT- GOLD

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por ALMORE INTERNATIONAL INC..

¿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
    21174
  • Clase de Riesgo del Evento
    III
  • Fecha de inicio del evento
    2017-05-16
  • 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
    Almore international inc. is voluntarily recalling the following microfil composite instruments that were shipped between january 1 2017 and march 17 2017. microfil composite instruments in these shipments contained the sterile symbol on their packaging label insertsindicating that the products are sold as sterile devices. these products are not sterile. these devices are intended to be sterile prior to use but they were distributed in packaging with a sterile symbol. we are concerned customers could misinterpret this labeling and assume this device is sterile.

Device

MICROFIL COMPOSITE INSTRUMENT- GOLD
  • Modelo / Serial
    Model Catalog: 96041 (Lot serial: 201609); Model Catalog: 96041 (Lot serial: 082015); Model Catalog: 96041 (Lot serial: 12983); Model Catalog: 96041 (Lot serial: NOT APPLICABLE); Model Catalog: 96041 (Lot serial: 01012017); Model Catalog: 96044 (Lot serial: NOT APPLICABLE); Model Catalog: 96044 (Lot serial: 12983); Model Catalog: 96044 (Lot serial: 082015); Model Catalog: 96044 (Lot serial: 201609); Model Catalog: 96044 (Lot serial: 01012017); Model Catalog: 96042 (Lot serial: 201609); Model Catalog: 96042 (Lot serial: 01012017); Model Catalog: 96042 (Lot serial: 12983); Model Catalog: 96042 (Lot serial: 082015); Model Catalog: 96042 (Lot serial: NOT APPLICABLE)
  • Descripción del producto
    #96041- Gold Microfil;#96044- SET OF 3 MICROFIL (GOLD GREEN BLUE);#96042- GREEN MICROFIL;MICROFIL COMPOSITE INSTRUMENT- GOLD;MICROFIL COMPOSITE INSTRUMENT- GOLD GREEN BLUE;MICROFIL COMPOSITE INSTRUMENT- GREEN
  • Manufacturer
    ALMORE INTERNATIONAL INC.

Manufacturer

ALMORE INTERNATIONAL INC.