Events

Rappel de MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Johnson & Johnson Medical 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-2017-RN-00278-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-02-28
  • 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-2017-RN-00278-1
  • 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, greatbatch medical has received reports of a pouch seal integrity issue with a specific lot of mobicath bi-directional guiding sheath. one side of the pouch may not be sealed and as a result, may cause the sterile barrier of the pouch to be compromised. the use of a non-sterile product in surgery could potentially result in adverse health consequences, such as infection, which could lead to life threatening events and/or death. greatbatch has received no reports of deaths, illnesses, injuries, or other adverse effects associated with this issue.
  • Action
    JJM is advising users to immediately inspect the device(s) in their possession to determine if their facility has affected product, and then to quarantine the affected product prior to returning it to JJM for replacement.

Device

MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)
  • Modèle / numéro de série
    MobiCath Bi-Directional Guiding Sheath, Small Curve(used to introduce cardiovascular catheters)Product Number: D140010Lot Number: W3338707ARTG Number: 191013
  • Manufacturer
    Johnson & Johnson Medical Pty Ltd

Manufacturer

Johnson & Johnson Medical Pty Ltd