Events

Retiro De Equipo (Recall) de 9025RHTR ABG Sampling Kit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CareFusion Australia 316 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-01226-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-09-26
  • 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-01226-1
  • 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
    Carefusion have been advised of an issue with a specific lot of 9025rhtr abg sampling kits. these kits should contain a sub-assembly comprised of a 25 gauge needle, with 1ml syringe, and 3.12 international units (iu) of heparin. an error in manufacturing of one lot of the 9025rhtr abg kit(s) has been identified as incorrectly containing a sub-assembly which includes a larger needle (23 gauge needle), larger syringe (3ml), and larger amount of heparin (113iu), than what is intended for the kit.To date, no reports relating to this issue have been receivedin australia, and carefusion is not aware of any report of injury attributed to this defect in australia.
  • Acción
    1. Discontinue use of and segregate the above identified Lot Numbers of Catalogue Number 9025RHTR ABG Sampling Kit with lot number 0001047501. 2. CareFusion is requesting any impacted inventory be set aside for collection. 3. Users are to Complete the supplied Customer Acknowledgement Form to confirm receipt of this notification and return to CareFusion as directed. 4. CareFusion will then arrange for the pick-up of your affected stock and issue a credit.

Device

9025RHTR ABG Sampling Kit

Manufacturer

CareFusion Australia 316 Pty Ltd