Events

Retiro De Equipo (Recall) de 0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare Pty Ltd.

¿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
    RC-2014-RN-01091-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-10-10
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-01091-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notas adicionales en la data
  • Causa
    Investigation of a small number of customer complaints has confirmed a reported problem of solution leaking into the overpouch. it has been identified that the issue was caused by a component used in the manufacture of the lots above, and is confined to these batches. there are no other affected products. this issue potentially impacts the sterility of the irrigation fluid.
  • Acción
    Customers are advised to locate and remove all of the affected products and lot numbers from their facility. The affected product should be returned for credit by contacting Baxter Healthcare Customer Service. Also, customers are advised to bring this matter to the attention of relevant prescribers within their hospital so that any patient who is undergoing infusion, or has very recently received an infusion of this product, can be monitored. This action has been closed-out on 22/08/2016.

Device

0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml
  • Modelo / Serial
    0.9% Sodium Chloride for Irrigation 2000ml and Water for Irrigation 2000ml0.9% Sodium Chloride for Irrigation 2000mlProduct Code: AHB7616Batch Numbers: S77N6 & S77R8 (Expiry Date: July 2016) and S78F1 (Expiry Date: Aug 2016)Water for Irrigation 2000mlProduct Code: AHB7606Batch Numbers: S77N5 (Expiry Date: July 2016) and S78A6 (Expiry Date: Aug 2016)ARTG Number: 155928
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd