Events

Retiro De Equipo (Recall) de Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra-Raz Ligature Carrier

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook 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-2017-RN-00539-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-05-08
  • 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-2017-RN-00539-1
  • 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 reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection and sterilisation of these products. preliminary investigation indicates that validation data related to the reprocessing of these devices do not meet the current guidance.There have been no reports of adverse reactions related to inadequate cleaning, disinfection, or sterilisation associated with these devices.
  • Acción
    Users are requested to: 1. Review the list provided in the customer letter and examine inventory immediately to identify; and quarantine any affected products. 2. Complete and return the Acknowledgement and Receipt form provided as soon as possible. Users are further advised that supply of these products will be discontinued in Australia.

Device

Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra...
  • Modelo / Serial
    Cook Pereyra-Raz Ligature Carrier, Stamey Needle and Clarke-Reich Laparoscopic Knot PusherPereyra-Raz Ligature Carrier Catalogue Identifier: 090002All LotsStamey NeedleCatalogue Identifier: 095030, 095015 and 095000All LotsClarke-Reich Laparoscopic Knot PusherCatalogue Identifier: J-CRKP-042900All LotsARTG Numbers: 212233 and 166926
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd