Events

Retiro De Equipo (Recall) de Fischer Cone Biopsy ExcisorSize medium (5/box)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Life 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-2018-RN-00308-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2018-04-13
  • 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-2018-RN-00308-1
  • 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
    Finished product in lot number 212074 was identified to have been incorrectly labelled. the label incorrectly indicates the part number used for large size instead of the medium size excisor. this discrepancy does not meet the product release specifications.
  • Acción
    Customers are asked to isolate these items and place affected units in the supplied plastic bag for collection by LifeHealthcare. Replacement stock will be provided in due course. A copy of the Reply Form attached to the Customer Letter should be returned by fax or email and also be enclosed with the stock to be returned.

Device

Fischer Cone Biopsy ExcisorSize medium (5/box)
  • Modelo / Serial
    Fischer Cone Biopsy ExcisorSize medium (5/box)Part Number: AP-900-151 Lot Number: 212074ARTG Number: 215626(Life Healthcare - Electrode, electrosurgical, active, foot-controlled, single use)
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd