Events

Retiro De Equipo (Recall) de Polyurethane Nasogastric Feeding Tube

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por REM Systems 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-00561-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-05-22
  • 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-00561-1
  • 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 manufacturer, pacific hospital supply company, has determined that in certain lot numbers, after a number of times where routine folding of the tube occurs, the folding site has split which has resulted in leakage from the tube. the stretching during folding can produce a tensile (pulling) force which breaks the bonding between the two surfaces.
  • Acción
    Users are asked to immediately check their facility’s inventory for the affected lot numbers and quarantine any of the affected products. Await instructions from REM SYSTEMS Pty Ltd for the return and replacement of the affected product. This action has been closed-out on 02/02/2016.

Device

Polyurethane Nasogastric Feeding Tube
  • Modelo / Serial
    Polyurethane Nasogastric Feeding TubeItem Numbers: PH-05100PU, PH-06100PU, PH-06125PU, PH-08100PU PH-08125PU Lot Numbers : 14004121, 13022911, 14004123, 13022912, 14004125, 13022915, 14004130, 13022913, 14004132 and 13022916 ARTG Number: 204612
  • Manufacturer
    REM Systems Pty Ltd

Manufacturer

REM Systems Pty Ltd