Events

Retiro De Equipo (Recall) de BURETROL SOLUTION SET

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

¿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
    80103
  • Clase de Riesgo del Evento
    I
  • Fecha de inicio del evento
    2014-07-30
  • 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
    Baxter corporation is issuing a recall for specific lots of buretrol solution set product codes due to complaints for separation between the burette chamber and the drip chamber. the root cause for this issue has been identified and resolved.

Device

BURETROL SOLUTION SET
  • Modelo / Serial
    Model Catalog: JC7564 (Lot serial: DR13E04022); Model Catalog: JC7564 (Lot serial: DR13E03016); Model Catalog: JC7564 (Lot serial: DR13E04014); Model Catalog: 2H8864 (Lot serial: DR14C08043); Model Catalog: 2C7564 (Lot serial: DR13I16028); Model Catalog: 2H8864 (Lot serial: DR14A13013); Model Catalog: 2C8864 (Lot serial: DR14A13013); Model Catalog: 2H8864 (Lot serial: DR13E11019); Model Catalog: 2C8864 (Lot serial: DR13E11019); Model Catalog: 2H8864 (Lot serial: DR13E10011); Model Catalog: 2C8864 (Lot serial: DR13E10011); Model Catalog: 2H8864 (Lot serial: DR14A31049); Model Catalog: 2C8864 (Lot serial: DR14A31049); Model Catalog: 2H8864 (Lot serial: DR14A14011); Model Catalog: 2C8864 (Lot serial: DR14A14011); Model Catalog: 2H8864 (Lot serial: DR13E08023); Model Catalog: 2C8864 (Lot serial: DR13E08023); Model Catalog: 2C7564 (Lot serial: DR13K13022); Model Catalog: 2C7564 (Lot serial: DR13K12024); Model Catalog: 2C7564 (Lot serial: DR13K08022); Model Catalog: 2C7564 (Lot serial: DR13K07024); Model Catalog:
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Descripción del producto
    BURETROL SOLUTION SET WITH INTERLINK(2)
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION