Events

Retiro De Equipo (Recall) de ONE LINK NON-DEHP MICROBORE CATHETER EXTENSION SET BONDED NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT POWER INJECTABLE

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
    73374
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-11-26
  • 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 notifying customers of an incompatible product that should not be used with specific one-link devices. customers have reported no-flow and restricted flow situations when attempting to connect the microclave device to the male luer lock adapter of the one-link catheter extension set in product code 7n8371. baxter's investigation has determined that the microclave dimensions are not compatible with the iso-compliant male luer lock adapter dimensions of the affected one-link product codes. under-infusion or interruption of therapy could result.

Device

ONE LINK NON-DEHP MICROBORE CATHETER EXTENSION SET BONDED NEEDLE-FREE IV CONNECTOR WITH NEUTRAL F...
  • Modelo / Serial
    Model Catalog: 7N8390 (Lot serial: ALL LOTS); Model Catalog: 7N8300 (Lot serial: ALL LOTS); Model Catalog: 7N8371 (Lot serial: ALL LOTS)
  • Descripción del producto
    BONDED ONE-LINK NON-DEHP MICROBORE SETS
  • Manufacturer
    BAXTER CORPORATION

Manufacturer

BAXTER CORPORATION