Events

Rappel de Bard

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 C.R. Bard, Inc..

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
    75492
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0404-2017
  • Date de mise en oeuvre de l'événement
    2016-10-13
  • Statut de l'événement
    Open, Classified
  • Pays de l'événement
    United States
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150499
  • 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
    Stent, ureteral - Product Code FAD
  • Cause
    Labeling: statement was added to the warnings/precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.
  • Action
    Bard Medical sent an Urgent: Medical Device Communication Letter dated October 13, 2016, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Action required: Examine your inventory and identify any product subject to this notification. If you have any remaining inventory, include a copy of this communication with the unit(s) for future use. If you may have further distributed or transferred this product, please identify the respective organizations and notify them at once of this communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter. This notification should be carried out to the user level. This product notification is being made with the knowledge of the Food and Drug administration. We appreciate your cooperation and assistance in dealing with this matter and sincerely apologize for any inconvenience that may result from this action. For further questions, please call (770) 784-6220.

Device

Bard
  • Modèle / numéro de série
    Product Codes: 776400, 776600, 776700, and 776800.
  • Classification du dispositif
    Gastroenterology-Urology Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    U.S. Nationwide.
  • Description du dispositif
    BARD INLAY Ureteral Stent with Suture, Manufacturer: C.R. Bard, Inc., Covington, GA 30014.
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Adresse du fabricant
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA