Events

Retiro De Equipo (Recall) de Arrow Teleflex Intra-Aortic Balloon Pump Catheter Kits and Percutaneous Insertion Kits

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 Arrow International Inc.

¿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
    19818
  • Fecha de inicio del evento
    2016-03-04
  • 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: InterMed Medical Ltd, 71 Apollo Drive, Albany, AUCKLAND 1311
  • Causa
    The arrow intra-aortic balloon catheter kits and percutaneous insertion kits contain a percutaneous sheath introducer. the percutaneous sheath introducer is used by some clinicians in the intra-aortic balloon catheter insertion procedure. the issue pertains to the sheath introducer in the insertion kit only. the other components of the kits are unaffected., this notice is required following notification by the manufacturer of the possibility that the percutaneous sheath introducer body may become separated from the sheath hub. if the separation occurs, there is a potential for bleeding from the device. if bleeding is not addressed with prompt intervention, it may result in loss of significant blood volume or exsanguination. in addition, delay of treatment, interruption of treatment, or loss of iab therapy can occur.
  • Acción
    Product to be returned to supplier

Device

Arrow Teleflex Intra-Aortic Balloon Pump Catheter Kits and Percutaneous Insertion Kits
  • Modelo / Serial
    Model: IAB-05830-LWS IAB-05830-U IAB-05840-LWS IAB-05840-U IAB-06830-U IAB-06840-U and IAK-06845 (Percutaneous Insertion Kit), Affected: Multiple
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    Arrow International Inc

Manufacturer

Arrow International Inc