Events

Retiro De Equipo (Recall) de Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin Liners

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Molnlycke Health Care 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-01082-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-10-08
  • 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-01082-1
  • 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
    Mölnlycke health care has received a recall notification from ecolab-microtek medical regarding basin liners which are contained within procedurepak products. the supplier has identified that very low number of basin liners have small holes or cracks which if present may compromise sterility.
  • Acción
    Molnlycke Healthcare is requesting their customers to isolate any product from the affected batches. Mölnlycke Health Care will arrange for the collection and replacement of the product. This action has been closed-out on 06/06/2016. This action has been closed-out on 06/06/2016.

Device

Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin Liners
  • Modelo / Serial
    Multiple ProcedurePak Trays with Ecolab-Microtek Medical Basin LinersProcedurePak Trays:Maxillo Facial Pack Rev4, Cairns Base Maxillo Facial Pack Rev4, Cairns Base Limb Rev6SKU: 97006791-05, 97006791-07, 97008210-07Batch ID: 12073320, 12080223, 12168637Basin Liner Product Codes: 2302362-00 & 2309247-00ARTG Numbers: 213220 & 133564
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd