Events

Retiro De Equipo (Recall) de ProcedurePak (surgical procedure packs)

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-00768-1
  • Clase de Riesgo del Evento
    Class II
  • Fecha de inicio del evento
    2014-07-10
  • 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-00768-1
  • 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
    Molnlycke health care has identified that the sterile tubing supplied in certain procedurepak trays, may not have received an adequate sterilization dosage. this may lead to a compromise in sterility of one of the components in these trays.
  • Acción
    Molnlycke is requesting their customers to identify and isolate all affected unused product at their facility. Molnlycke Health Care will arrange for collection and replacement of the product.

Device

ProcedurePak (surgical procedure packs)
  • Modelo / Serial
    ProcedurePak (surgical procedure packs)Product Codes: 97032966-02, 97032967-01, 97034172-01, 97042192-00 & 97042192-01Multiple batch numbers affectedARTG Numbers: 215992, 215993, 216000 & 216001
  • Manufacturer
    Molnlycke Health Care Pty Ltd

Manufacturer

Molnlycke Health Care Pty Ltd