Events

Rappel de Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Life Healthcare 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-2016-RN-01497-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-11-16
  • 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-2016-RN-01497-1
  • 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
    The manufacturer has received a report from a user advising that the secondary peel bag of the sterile packaged article was not completely sealed. an incorrect welding process has resulted in the secondary peel bag not being sealed. a non-welded secondary peel bag results in the primary bag becoming no longer sterile and thus a “non-sterile article” can reach the sterile area of the operating room. this presents a potential safety risk for the patient. the manufacturer is not aware of any other incidents, however the affected batch is being recalled as a precaution.
  • Action
    LifeHealthcare is advising customers to quarantine affected stock and to contact LifeHealthcare to arrange for collection and replacement. This action has been closed-out on 18/05/2017.

Device

Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures)
  • Modèle / numéro de série
    Neuro Flap Fix Kit (used for fixation of cranial bone flaps and fractures)Product Code: 25-302-10-71Lot Number: 33173390ARTG Number: 202843
  • Manufacturer
    Life Healthcare Pty Ltd

Manufacturer

Life Healthcare Pty Ltd