Events

Rappel de Volcano TrakBack II Disposable Pullback Device

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Volcano Corporation.

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
    69049
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2636-2014
  • Date de mise en oeuvre de l'événement
    2014-08-13
  • Date de publication de l'événement
    2014-09-12
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-06-30
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129418
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Catheter, intravascular, diagnostic - Product Code DQO
  • Cause
    Internal testing had identified a potential breach to the sterile barrier that may impact the sterility of the product.
  • Action
    Volcano sent an Urgent Product Recall Notification letter dated August 13, 2014, to all customers who received the device in the last 25 months. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately cease use of the affected product and return unused devices to the Volcano distribution center. Customers were asked to prepare the attached inventory log and then contact Volcano Customer Service at 800-228-4728, option 4 to arrange for return of any affected product in their inventory. A credit would be issued for any returned product. Customers with questions were asked to call 800-228-4728. For questions regarding this recall call 978-439-3586.

Device

Volcano TrakBack II Disposable Pullback Device
  • Modèle / numéro de série
    Part number 91003: All Lots
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - USA (nationwide) and Internationally to Korea, Thailand, Canada, Australia, Chili, Mexico, Argentina.
  • Description du dispositif
    Volcano TrakBack II Disposable Pullback Device; || Sterile and nonpyrogenic; Single Use. || TrakBack II is used to move the catheter steadily and precisely, allowing uniform collection of imaging data.
  • Manufacturer
    Volcano Corporation

Manufacturer

Volcano Corporation
  • Adresse du fabricant
    Volcano Corporation, 2870 Kilgore Rd, Rancho Cordova CA 95670-6133
  • Société-mère du fabricant (2017)
    Philips
  • Source
    USFDA