Events

Retiro De Equipo (Recall) de Self-Righting Luer Slip Tip Cap, Yellow in the DISCPAC packaging

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Baxter Healthcare 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-2015-RN-00113-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-03-05
  • 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-2015-RN-00113-1
  • 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
    Baxter healthcare identified that the affected products (self-righting luer slip and luer lock tip caps ) were manufactured and shipped with inaccurate single and case labels, missing the latex symbol. the heat shrink tape used on the discpac package is the only product component that contains latex. the instructions for use (ifu) correctly identifies the content of latex. unintended or accidental exposure to latex has the potential to elicit a hypersensitivity reaction, especially in sensitised individuals. symptoms may range from skin irritation to anaphylaxis. baxter has not received any reports of adverse events associated with this issue.
  • Acción
    Baxter is alerting its customers of this labelling issue of missing latex symbol in an effort to prevent unintended exposure to latex. Baxter is updating the labelling of the affected products to include the latex symbol for future batches. This action has been closed-out on 02/03/2016.

Device

Self-Righting Luer Slip Tip Cap, Yellow in the DISCPAC packaging
  • Modelo / Serial
    Self-Righting Luer Slip Tip Cap, Yellow in the DISCPAC packagingProduct Code: H93866025All lot numbers with expiration date 10/2014 to 10/2017ARTG number: 217859
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd