Events

Retiro De Equipo (Recall) de Stryker Laparoscopic Manual Instruments and Accessories

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-2014-RN-01264-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-12-04
  • 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-01264-1
  • 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
    Stryker has identified that unacceptable validation reports were in place to support the unwrapped 10 minute, 132° (270°f) gravity steam sterilization cycle as well as the ethylene oxide (eo) sterilization cycle listed in instructions for use. this may give rise to cross infection as viable bacteria/ pathogens could be delivered to the subsequent patient. as a result the instructions for use (ifu) are being modified in a manner that these two sterilisation methods are being deleted and the remaining two options currently given (gravity wrapped & pre-vacuum wrapped methods) will remain in place.
  • Acción
    The Gravity Unwrapped sterilization cycle and the Ethylene Oxide sterilization cycle have both been deleted as sterilisation options from the Instructions for Use (IFU1000-401-070), for Laparoscopic Instruments and Accessories. New instructions for use reflecting this deletion will be circulated to customers.The Gravity Wrapped and Pre-Vacuum Wrapped sterilisation methods will remain unchanged. This ation has been closed-out on 06/07/2016.

Device

Stryker Laparoscopic Manual Instruments and Accessories
  • Modelo / Serial
    Stryker Laparoscopic Manual Instruments and AccessoriesMultiple item numbers/ product descriptionsAll lotsARTG Numbers: 145845, 228398, 141250, 142780, 228395
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

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