Events

Retiro De Equipo (Recall) de Omrix Pressure Regulator (Surgical air pipeline regulator)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Johnson & Johnson Medical 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-2014-RN-00937-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-08-26
  • 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-2014-RN-00937-1
  • 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
    Omrix biopharmaceuticals has identified that there may be pressure regulators in the field with an incorrect connector type. a nitrous oxide connector has been supplied instead of a carbon dioxide connector (sis-co2 connector). the connector has a different colour (grey and not green-grey, as should be according to the australian standard- as 2896- for medical gas systems ) and in addition, instead of carbon dioxide, it was engraved with “nitrous oxide’’. johnson & johnson medical pty limited (jjm) is recalling omrix pressure regulators. the nitrous oxide inlet connector is not compatible with carbon dioxide source connector and can therefore not connect to omrix pressure regulator.
  • Acción
    Johnson & Johnson Medical Pty Limited is requesting the customers to quarantine the affected pressure regulators. Arrangements will be made for a courier to pick up the affected product and a credit note issued. This action has been closed-out on 22/03/2016.

Device

Omrix Pressure Regulator (Surgical air pipeline regulator)
  • Modelo / Serial
    Omrix Pressure Regulator (Surgical air pipeline regulator)Product Codes: EVRC68 and EVR54CARTG Number: 203072
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd