Events

Retiro De Equipo (Recall) de Inflation bulbs used with Safescope Sigmoidoscopes

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Med-Chem Surgical 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-2013-RN-01237-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2013-12-09
  • 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-2013-RN-01237-1
  • 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
    Med chem is recalling affected bulbs following reports of inflation bulbs not compressing. after physical inspections of the fault by both logikal health and its supplier, it has been determined that this fault is due to a misshaped component within the valve located on the tubing which extends from the bellows.
  • Acción
    Med Chem Surgical is requesting their customers to test any remaining product from the affected batch by applying slight pressure through the packaging. Any bulbs that fail to compress must be returned immediately.

Device

Inflation bulbs used with Safescope Sigmoidoscopes
  • Modelo / Serial
    Inflation bulbs used with Safescope SigmoidoscopesProduct Code: SCU-SS220Batch Number: 061326ARTG Number: 165977
  • Manufacturer
    Med-Chem Surgical Pty Ltd

Manufacturer

Med-Chem Surgical Pty Ltd
  • Source
    DHTGA