Events

Retiro De Equipo (Recall) de ACM W/FEM NOZZLE/PRESS (PK6) and INRPLS HP W/HIGH FLOW TIP

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-2018-RN-00131-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2018-02-20
  • 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-00131-1
  • 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
    During routine testing, it was found that bioburden levels of the manufacturing process were higher than internal acceptable rates and as such the sterility of the products cannot be confirmed. to date there have been no reports of any adverse events or serious injuries.
  • Acción
    Stryker is advising customers immediately quarantine the product and return it back to Stryker. A Stryker representative can help facilitate this return where necessary.

Device

ACM W/FEM NOZZLE/PRESS (PK6) and INRPLS HP W/HIGH FLOW TIP
  • Modelo / Serial
    ACM W/FEM NOZZLE/PRESS (PK6) and INRPLS HP W/HIGH FLOW TIPItem Numbers: 0306573000, 0210114100Affected Lot Numbers: 17282012, 17283012 ARTG Numbers: 139627, 141176
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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