Events

Retiro De Equipo (Recall) de Two and three stage I.V. Poles (used as an optional accessory to a stretcher)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Stryker 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-2015-RN-01123-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2015-11-17
  • 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-01123-1
  • 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
    It has been reported that some i.V. poles were retracting / lowering from an extended position to a low height unexpectedly. the i.V. latch housing has been identified as non-conforming, which has resulted in the suspended i.V. pole retracting.
  • Acción
    Stryker is advising users to identify any of the stretcher models listed on which there may be an affected I.V. pole and place the pole at the lowest position. Stryker are supplying a sticker to be placed on the I.V. pole until the affected poles can be repaired. This action has been closed-out on 05/09/2016.

Device

Two and three stage I.V. Poles (used as an optional accessory to a stretcher)
  • Modelo / Serial
    Two and three stage I.V. Poles (used as an optional accessory to a stretcher)30” I.V. Pole, 2 Stage HE, PRCatalogue Number: 1105035368 Serial Number: 1403030970 26” I.V. Pole, 2 Stage HL Catalogue Number: 1105035638 Serial Number: 1402030027 Used on the following devices:Stretcher models: 1105, 1105E, 1105X, 1105XE, 1115, 1115E, 1115X, 115XE, 1125E, 1125X and 1125XEARTG Number: 167691
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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