Events

Retiro De Equipo (Recall) de Cook Beacon Tip Angiography Catheters Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal Flush Plus High-Flow Catheters, Beacon Tip Catheters, Shuttle Select Slip-Cath, 4 FR Shuttle System Compatible

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-2016-RN-00021-2
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-01-06
  • 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-2016-RN-00021-2
  • 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
    Cook medical is initiating a recall of all lots in distribution following reports of catheter tip splits and/or separation. potential adverse events that may occur as a result of catheter tip splitting and or separation may include the loss of device function, medical intervention to retrieve the separated segment, or complications resulting from the separated tip occluding blood flow to end organs.
  • Acción
    Cook Medical is advising users to inspect and quarantine any affected lots for return to Cook Medical.

Device

Cook Beacon Tip Angiography Catheters Beacon Tip Torcon NB Advantage Catheters, Beacon Tip Royal ...
  • Modelo / Serial
    Cook Beacon Tip Angiography CathetersBeacon Tip Torcon NB Advantage CathetersCatalogue Prefix: HNBR4.0, HNBR4.1 and only HNBR5.0 w/RUC SuffixBeacon Tip Royal Flush Plus High-Flow CathetersCatalogue Prefix: HNR4.0Slip-Cath Beacon Tip CathetersCatalogue Prefix: SCBR4.0, SCBR4.1, and only SCBR5.0 w/RUC SuffixShuttle Select Slip-Cath, 4 FR Shuttle System CompatibleCatalogue Prefix: SCBR4.5All Lot Numbers affectedARTG Numbers: 137861, 154909, 154911, 137865
  • Clasificación del producto
    Cardiovascular Devices
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd