Events

Rappel de BARD Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Bard 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-2016-RN-01075-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-08-12
  • 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-01075-1
  • 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, bard medical division (bmd) has identified that certain product code / lot number combinations may be at risk for having a slit defect on the package which may affect product sterility. use of a potentially non-sterile bard irrigation syringe could introduce microorganisms which may lead to a varying degree of risk including localised and/or systemic infectious complications. in the event this occurred, the patient may require medical intervention. there have been no reports of patient injuries as a result of this issue.
  • Action
    Bard is advising users that if affected product has been used, to monitor the patient for symptoms and signs of localised and/or systemic infection. Users are advised to inspect stock and quarantine any remaining units of the affected batches for return to Bard. This action has been closed-out on 03/03/2017.

Device

BARD Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap
  • Modèle / numéro de série
    BARD Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and CapProduct Code: 0038460Lot Numbers: NGZD0924, NGZD4923, NGZD3989, NGZD3241Expiration dates range between April 30, 2020 and July 31, 2020ARTG Number: 137628
  • Manufacturer
    Bard Australia Pty Ltd

Manufacturer

Bard Australia Pty Ltd