Events

Rappel de Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Gambro 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-2014-RN-01214-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2014-11-13
  • 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-2014-RN-01214-1
  • 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
    Gambro renal products is advising the customers of the possibility of a tear in the individual sterile barrier packaging on some of its polyflux revaclear/ polyflux revaclear max dialysers. the nature of the defect is such that it is isolated to the package only; the dialyser itself is not damaged. the tears are only on the printed white tyvek side of the packaging and are readily visible. a tear in the package is a sterility breach; if the product is then used to treat a patient, there is a remote risk of infection. however, that risk is extremely unlikely. even if the packaging is compromised, the protection caps on the blood ports of the dialyser are protecting the blood fluid path of the device from a potential contamination. gambro has not received any reports of adverse patient events.
  • Action
    Gambro Pty Ltd is requesting the customers to inspect their inventory, discontinue use immediately and quarantine the affected product. Gambro will arrange for the affected stock to be recovered and replacement stock, or a credit note, issued.

Device

Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)
  • Modèle / numéro de série
    Revaclear and Revaclear Max Dialysers (Hollow-fibre haemodialysis dialyser)Product Codes: 110633 & 110634Multiple lot numbers are affectedARTG Number: 194549
  • Manufacturer
    Gambro Pty Ltd

Manufacturer

Gambro Pty Ltd