Events

Retiro De Equipo (Recall) de Baxter MiniCap with Povidone-Iodine Solution

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 SA.

¿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
    18002
  • Fecha de inicio del evento
    2015-02-11
  • 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 received complaints indicating that the sponge of the minicap was fully separated from the cap, partially protruding from the cap, or missing. use of minicaps with sponges fully separated or missing from the caps may compromise the ability of the minicap to provide a sterile barrier protection at the end of the transfer when the transfer set is not connected to the patient line of the automated peritoneal dialysis (apd) cassette or continuous ambulatory peritoneal dialysis (capd) twin bag set-ups. this may increase the risk of peritonitis.
  • Acción
    Manufacturer to issue advice regarding use

Device

Baxter MiniCap with Povidone-Iodine Solution

Manufacturer

Baxter Healthcare Corporation SA