Events

Retiro De Equipo (Recall) de Various Safeset and Transpac Blood Pressure Transducer Sets

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por ICU Medical 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-01237-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-10-09
  • 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-01237-1
  • 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
    Icu medical has identified a potential for detachment or separation of pressure tubing/luer bonded connections on specific blood pressure tranducer sets. icu medical has received reports due to this issue and there is the potential for serious injury. as a precaution, icu medical is recalling the affected devices.
  • Acción
    ICU Medical is advising users to inspect stock and quarantine all affected units. Any remaining affected stock will be returned and replaced or a credit note issued.

Device

Various Safeset and Transpac Blood Pressure Transducer Sets
  • Modelo / Serial
    Various Safeset and Transpac Blood Pressure Transducer SetsMultiple Products, Item and Lot Numbers affectedARTG Number: 195624
  • Manufacturer
    ICU Medical Australia Pty Ltd

Manufacturer

ICU Medical Australia Pty Ltd
  • Source
    DHTGA