Events

Retiro De Equipo (Recall) de Baxter 15l Cycler Drainage Bag

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Baxter Healthcare 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
    15568
  • Fecha de inicio del evento
    2013-10-25
  • País del evento
    New Zealand
  • Fuente del evento
    NZMMDSA
  • URL de la fuente del evento
    https://medsafe.govt.nz/hot/Recalls/RecallSearch.asp
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Baxter Healthcare Ltd, 33 Vestey Drive, Mt Wellington, AUCKLAND
  • Causa
    Baxter has received an increased number of leakage complaints for the 15l cycler drainage bag (r5c4145p) after the mold was changed for the large clamp on the drain tube. if leakage occurs and the patient/caregiver comes in contact with the fluid there is a potential risk of contamination or infection, and the possibility of a slipping hazard if there is a fluid spill on a floor.
  • Acción
    Manufacturer to issue advice regarding use

Device

Baxter 15l Cycler Drainage Bag

Manufacturer

Baxter Healthcare Corporation