Events

Retiro De Equipo (Recall) de LASEREDGE

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por VALEANT CANADA LP/VALEANT CANADA S.E.C.

¿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
    45466
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2017-03-03
  • 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 company choose to initiate this recall due to higher than nornmal complaints of the laseredge product having a dull knife edge. some of the lots of laseredge knives have not been as sharp as previous lots of this product.

Device

LASEREDGE
  • Modelo / Serial
    Model Catalog: E7759A (Lot serial: MAVZ170); Model Catalog: E7550AG (Lot serial: MBFG600); Model Catalog: E7594 (Lot serial: >10lots contact mfg); Model Catalog: E7593 (Lot serial: >10lots contact mfg); Model Catalog: E7592 (Lot serial: >10lots contact mfg); Model Catalog: E7561A (Lot serial: >10lots contact mfg); Model Catalog: E7560A (Lot serial: >10lots contact mfg); Model Catalog: E7559A (Lot serial: >10lots contact mfg); Model Catalog: E7557A (Lot serial: >10lots contact mfg); Model Catalog: E7556A (Lot serial: >10lots contact mfg); Model Catalog: E7552ADB (Lot serial: >10lots contact mfg); Model Catalog: E7551ADB (Lot serial: >10lots contact mfg); Model Catalog: E7551A (Lot serial: >10lots contact mfg); Model Catalog: E7550A (Lot serial: >10lots contact mfg); Model Catalog: E7549ADB (Lot serial: >10lots contact mfg); Model Catalog: E7548ADB (Lot serial: >10lots contact mfg); Model Catalog: E7530 (Lot serial: >10lots contact mfg); Model Catalog: E7527 (Lot serial: >10lots contact mfg); Model Catalog: E7
  • Descripción del producto
    LASEREDGE;GUARDED LASEREDGE MICROSURGICAL KNIVES;LASEREDGE MICROSURGICAL KNIVES
  • Manufacturer
    VALEANT CANADA LP/VALEANT CANADA S.E.C

Manufacturer

VALEANT CANADA LP/VALEANT CANADA S.E.C