Events

Retiro De Equipo (Recall) de American Surgical Company (ASC ) Neuro Sponges Products affected: Americot Blue sponges, Cotton Balls, Ray-Cot sponges, Delicot sponges, Uniqcot sponges and Telfa sponges

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Life Healthcare 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-2016-RN-00433-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2016-04-14
  • 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-00433-1
  • 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
    A failure in the sterile peel pouch has been discovered during a quality control inspection by the manufacturer, asc. this failure may result in a small tear in the pouch of the device leading to a potential compromised sterile barrier. a leak in the sterile barrier may allow contamination of the device increasing the risk of infection. a comprehensive investigation has identified an occurrence rate of less than 0.01% for the affected lots.
  • Acción
    LifeHealthcare is advising users to inspect stock and quarantine any remaining product for return. This action has been closed-out on 30/01/2017.

Device

American Surgical Company (ASC ) Neuro Sponges Products affected: Americot Blue sponges, Cotton B...
  • Modelo / Serial
    American Surgical Company (ASC ) Neuro Sponges Products affected: Americot Blue sponges, Cotton Balls, Ray-Cot sponges, Delicot sponges, Uniqcot sponges and Telfa spongesMultiple item and lot numbers affected (see attached)ARTG Numbers: 265712, 265713 and 146103
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd