Events

Retiro De Equipo (Recall) de 70mL Centrifuge Bowl

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Haemonetics Australia 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-2017-RN-01006-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-08-07
  • 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-2017-RN-01006-1
  • 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
    Haemonetics has received isolated reports that in some cases the 70ml centrifuge bowl may leak during cell salvage processing. a leaking bowl may potentially expose the operator to blood. in addition, because some amount of autologous blood intended to be returned to the patient would not be available for return, an allogenic blood transfusion may be required.
  • Acción
    Haemonetics is requesting customers: 1. Discontinue use of the affected products; and 2. Return any unused product to Haemonetics Contact your local customer service representative to coordinate the return, shipment and credit receipt of unused product.

Device

70mL Centrifuge Bowl
  • Modelo / Serial
    70mL Centrifuge BowlCell Saver 5/5+ Bowl Set - 70mLProduct ID: 0291E-00Cell Saver Elite Processing Set - 70mLProduct ID: CSE-P-70Cell saver 5/5+ Bowl Set - 70mLProduct ID: 0291A-00ARTG Number: 123999
  • Manufacturer
    Haemonetics Australia Pty Ltd

Manufacturer

Haemonetics Australia Pty Ltd