Events

Retiro De Equipo (Recall) de Milestone Wand STA Hand Piece model STA-5050-305

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

¿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-2015-RN-00578-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-07-08
  • 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-2015-RN-00578-1
  • 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
    Wand hand piece model wa-2050-305 was packaged (pouched) and boxed as a wand sta hand piece model sta-5050-305. although the function of the hand pieces are identical, these hand pieces are used in two different instruments and they will only attach into the correct instrument.
  • Acción
    Milestone is requesting the customers to inspect the inventory of the Wand Handpieces by looking at the cartridge holder locking tab without opening the sterile pouch. If any mislabelled handpieces are identified, Milestone is requesting the customers to contact Milestone Customer Service to obtain return authorisation and / or replacement of the handpieces. Milestone is also instructing the customers that they can also return the entire quantity of the affected STA Handpieces. This action has been closed-out on 31/08/2016.

Device

Milestone Wand STA Hand Piece model STA-5050-305
  • Modelo / Serial
    Milestone Wand STA Hand Piece model STA-5050-305 Batch or Lot number:140103Expiry date: January 2019ARTG Number: 95633
  • Manufacturer
    Henry Schein Halas

Manufacturer

Henry Schein Halas