Events

Rappel de Disposable StrykeFlow Tip(electrosurgical suction tip)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Stryker 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-00484-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2015-06-05
  • 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-00484-1
  • 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
    An internal review concluded that 6 lots of disposable strykeflow tips were shipped with a potentially deformed blister pouch, which could potentially impact the sterility of the product. although to date there have been no reported events of infection to stryker as a result of using potentially affected product, there is a remote possibility for infection due to usage of a non-sterile product.
  • Action
    Customers are asked to check any affected items in their possession and quarantine any affected units immediately. A Stryker Representative will coordinate an inspection of the affected items in quarantine. Any affected items will be removed by the Stryker Representative. This action has been closed-out on 2/06/2016.

Device

Disposable StrykeFlow Tip(electrosurgical suction tip)
  • Modèle / numéro de série
    Disposable StrykeFlow Tip(electrosurgical suction tip)Item Number: 250-070-505Affected Lots: 14021FG2, 13337FG2, 13343FG2, 13347FG2, 14007FG2, 14016FG2ARTG Number: 142786
  • Manufacturer
    Stryker Australia Pty Ltd

Manufacturer

Stryker Australia Pty Ltd
  • Société-mère du fabricant (2017)
    Stryker
  • Source
    DHTGA