Events

Rappel de VASCU-GUARD Peripheral Vascular Patch, 0.8 x 8cm

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Baxter 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-00879-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2016-07-01
  • 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-00879-1
  • 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
    Baxter healthcare is issuing a recall notice in response to post-marketing reports overseas received for the vascu-guard peripheral vascular patch. to date, baxter has received four post-marketing reports for the vascu-guard product for intraoperative or post-operative bleeding episodes, which required additional clinical intervention. at this point, it is unknown whether there is any causal relationship between vascu-guard and the reported events. in the interim, baxter is requesting that customers immediately discontinue the use of the identified product lots until the investigation has concluded.
  • Action
    Baxter is advising users to discontinue use, and return all affected stock.

Device

VASCU-GUARD Peripheral Vascular Patch, 0.8 x 8cm
  • Modèle / numéro de série
    VASCU-GUARD Peripheral Vascular Patch, 0.8 x 8cmProduct Code: VG0108NLot Number: SP16B05-1119217Supplied under the Special Access Scheme (SAS)
  • Classification du dispositif
    Cardiovascular Devices
  • Manufacturer
    Baxter Healthcare Pty Ltd

Manufacturer

Baxter Healthcare Pty Ltd