Events

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

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par William A Cook Australia Pty Ltd.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    RC-2015-RN-00997-1
  • Classe de risque de l'événement
    Class III
  • Date de mise en oeuvre de l'événement
    2015-10-08
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-00997-1
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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.
  • Action
    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...
  • Modèle / numéro de série
    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