Events

Retiro De Equipo (Recall) de Micro-Injection Pipettes for IVF procedures

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por William A Cook Australia 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-00679-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2014-06-26
  • 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-00679-1
  • 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 listed devices are being recalled due to incorrect labelling of the product. specifically, micro-injection pipettes k-mpip-3135 have been placed into a shelf box identified as model k-mpip-3330. in addition, micro-injection pipettes k-mpip-3330 have been placed into a shelf box identified as model k-mpip-3135.
  • Acción
    Cook Medical is requesting their customers to return any remaining affected product.

Device

Micro-Injection Pipettes for IVF procedures
  • Modelo / Serial
    Micro-Injection Pipettes for IVF proceduresProduct Number: K-MPIP-3135Lot Number: N118880Product Number: K-MPIP-3330Lot Number: N118800ARTG Number: 174653
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd