Events

Retiro De Equipo (Recall) de Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Spike Packaged Assy, STERILE340-4166 Non DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assy, STERILE340-4134 Non-DEHP Microbore Admin Set with Non-Vented Spike and Y-Site with Check Valve, Packaged Assy, STERILE

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Fresenius Kabi 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-2018-RN-00053-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2018-01-17
  • 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-2018-RN-00053-1
  • 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
    Fresenius kabi australia has received notice from the manufacturer, moog medical group, that they have initiated a recall in the usa for certain non-filtered moog iv administration sets manufactured between 9th june 2015 and 6th july 2016. the manufacturer received 7 complaints regarding particulate found on the tip of non-filtered moog iv spike sets manufactured between 9th june 2015 and 6th july 2016. during that period, 1,390,720 non-filtered spike administration sets were manufactured. when found, the loose particulate is located on the external edge of the non-vented spike and can potentially enter into the fluid path. introducing foreign material into the body can cause a range of side effects depending on the particle size and the type of line being used. no complaints have been received in australia to date.
  • Acción
    Fresenius Kabi is advising customers to check inventory and quarantine affected stock. Fresenius Kabi will contact affected users to arrange return of stock.

Device

Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Sp...
  • Modelo / Serial
    Moog Infusion System Administration Sets 340-4114 Non DEHP Microbore Admin Set with Non-Vented Spike Packaged Assy, STERILE340-4166 Non DEHP Microbore Administration Set with Non-Vented Spike ASV Packaged Assy, STERILE340-4134 Non-DEHP Microbore Admin Set with Non-Vented Spike and Y-Site with Check Valve, Packaged Assy, STERILEMultiple Affected Part and Lot NumbersARTG Number: 225965 (Fresenius Kabi Australia Pty Limited - Infusion administration set, infusion pump)
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Manufacturer
    Fresenius Kabi Australia Pty Ltd

Manufacturer

Fresenius Kabi Australia Pty Ltd