Events

Retiro De Equipo (Recall) de Sorbsan Calcium Alignate Dressings (Flat, Ribbon, Packing, Plus and Border) and Sorbsan Silver Calcium Alignate Dressing (Flat)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Bosco Medical Australia.

¿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-00727-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-06-01
  • 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-00727-1
  • 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
    Bosco medical australia has become aware of an issue related to the application of an incorrect expiry date to a number of sorbsan dressings. product has been labelled incorrectly with a 5 year expiry date instead of a 3 year expiry date. product effectiveness may be impacted if used past a three year shelf life, and may result in the need to change the dressing more often.
  • Acción
    Bosco Medical is advising customers to inspect stock and quarantine any remaining units of affected stock, for return to Bosco.

Device

Sorbsan Calcium Alignate Dressings (Flat, Ribbon, Packing, Plus and Border) and Sorbsan Silver Ca...
  • Modelo / Serial
    Sorbsan Calcium Alignate Dressings (Flat, Ribbon, Packing, Plus and Border) and Sorbsan Silver Calcium Alignate Dressing (Flat)Product Codes: 1400, 1410, 1411, 1412, 1415, 1420SA, 1421, 1421C, 1423, 1423C, 1425Multiple Lot Numbers affectedARTG Number: 168684
  • Manufacturer
    Bosco Medical Australia

Manufacturer

Bosco Medical Australia