Events

Retiro De Equipo (Recall) de National Workplace First Aid Kit & Sports & Outdoors First Aid Kit National Workplace First Aid Kit, Sports & Outdoors First Aid Kit

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por CIP Medical Supplies T/A Caseinpoint 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-00788-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-15
  • 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-00788-1
  • 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
    It has recently come to case in point's attention that some items in the first aid kits you purchased under the first aid factory brand in the last 12 months contain items labelled as being sterile when they are actually not sterile. this occurred due to a manufacturing error. this issue is unlikely to pose any risk to health, however there is a theoretical risk that the use of an un-sterile wound dressing on an immunocompromised patient could result in an infection. there have been no reports of injuries or adverse events related to this issue.
  • Acción
    Case In Point is recalling the affected kits. Customers returning the affected items for replacement are requested to complete the returns form attached and include the returned items in the prepaid post bag provided with the returns form and send to The First Aid Factory within the next 30 days. Customers returning the affected items for are requested to complete the returns form attached and include the complete first aid kit or refill pack, with the returns form in the prepaid post bag provided and send to The First Aid Factory within the next 30 days. This action has been closed-out on 04/08/2016.

Device

National Workplace First Aid Kit & Sports & Outdoors First Aid Kit National Workplace First Aid K...
  • Modelo / Serial
    National Workplace First Aid Kit & Sports & Outdoors First Aid KitNational Workplace First Aid KitBatch number: 20121214D-WP-L Expiry date: 01/2016Sports & Outdoors First Aid Kit Batch number: 20121214C-S&O; Expiry date: 01/2016ARTG number: 172274
  • Manufacturer
    CIP Medical Supplies T/A Caseinpoint Pty Ltd

Manufacturer

CIP Medical Supplies T/A Caseinpoint Pty Ltd
  • Source
    DHTGA