Events

Retiro De Equipo (Recall) de Dimetapp Saline Nasal Drops for Infants

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Pfizer 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-2014-RN-01036-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-15
  • 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-01036-1
  • 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
    Pfizer is recalling dimetapp saline nasal drops for infants following a complaint received by tga. the nature of the complaint involved the nozzle of the product becoming dislodged and subsequent flowing of the saline fluid onto a baby’s face.
  • Acción
    Retailers and wholesalers are requested to inspect their stock and quarantine all units from the affected batches (21320 and 21465). Retailers are also requested to retain any units returned by consumers and provide a refund or replacement. This action has been closed-out on 18/07/2016.

Device

Dimetapp Saline Nasal Drops for Infants
  • Modelo / Serial
    Dimetapp Saline Nasal Drops for InfantsBatch numbers: 21320 & 21465ARTG Number: 167019
  • Manufacturer
    Pfizer Australia Pty Ltd

Manufacturer

Pfizer Australia Pty Ltd
  • Empresa matriz del fabricante (2017)
    Pfizer
  • Source
    DHTGA