Events

Retiro De Equipo (Recall) de Sydney IVF PVP (Used during microinjection techniques for reducing sperm motility to enable easier capture using a pipette)

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-2015-RN-00997-1
  • Clase de Riesgo del Evento
    Class III
  • Fecha de inicio del evento
    2015-10-08
  • 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-2015-RN-00997-1
  • 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
    This batch is being recalled as it was formulated with an excess of water, diluting the product outside the design specification. the batch met all of the release specifications, including mouse embryo assay; however, the effect of this dilution is a loss of viscosity, and creation of a hypo-osmotic environment for the sperm. this may make it difficult for the embryologist to capture the sperm, and may lead to swelling of the sperm tail.
  • Acción
    Cook Medical is advising users to any discard remaining stock. Cook Medical will replace affected stock with a credit or replacement. This action has been closed-out on 04/03/2016.

Device

Sydney IVF PVP (Used during microinjection techniques for reducing sperm motility to enable easie...
  • Modelo / Serial
    Sydney IVF PVP (Used during microinjection techniques for reducing sperm motility to enable easier capture using a pipette) Product Code: K-SIPV-200-5 Bulk batch number M0615061ZLot Numbers: K22948, K22752, K22551, K22825, K22625, K23042 ARTG number 132688
  • Manufacturer
    William A Cook Australia Pty Ltd

Manufacturer

William A Cook Australia Pty Ltd