Events

Retiro De Equipo (Recall) de Aerowound Combine Dressing ACD2040S, size 20cm x 40cm

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

¿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-00283-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2017-02-27
  • 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-00283-1
  • 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
    The aerowound combine dressing is comprised of an absorbent pad enclosed in a polyester/viscose over bag. each sterile dressing is sealed in an individual pouch. it was discovered that one of the pouch edges has a weak sealing strength which could compromise the sterility of the device.
  • Acción
    Aero Healthcare is advising customers to quarantine all affected stock within their control. Distributors are advised to forward the recall notice to retailers to whom they have sold affected products and to accept the affected stock returned to them. Distributors are further requested to contact Aero Healthcare to organise their return.

Device

Aerowound Combine Dressing ACD2040S, size 20cm x 40cm
  • Modelo / Serial
    Aerowound Combine Dressing ACD2040S, size 20cm x 40cmBatch Number: 17110Expiry Date: 31 August 2021ARTG Number: 159437
  • Manufacturer
    Aero Healthcare

Manufacturer

Aero Healthcare