Events

Retiro De Equipo (Recall) de Rite Aid Mini Digital Temple Touch Thermometer

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ToLife Technologies 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-00195-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-03-06
  • 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-00195-1
  • 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
    The battery compartment on the thermometer is not adequately secured, allowing unintentional access to the button battery inside.In the event a young child gains access to the button batteries themselves and ingests them, they may suffer internal burns injuries, which can result in serious illness and, without appropriate medical treatment, may even result in death or permanent injury. furthermore, access to these batteries may pose a choking hazard to young children.
  • Acción
    ToLife Technologies is requesting Consumers immediately stop using the thermometer and return it to the below reply-paid address for an exchange: ToLife Technologies Reply Paid 36 PO Box 36 Welshpool, WA 6986

Device

Rite Aid Mini Digital Temple Touch Thermometer
  • Modelo / Serial
    Rite Aid Mini Digital Temple Touch ThermometerLot Number: 5216ARTG Number: 171947
  • Manufacturer
    ToLife Technologies Pty Ltd

Manufacturer

ToLife Technologies Pty Ltd
  • Source
    DHTGA