Events

Rappel de Bard Ventralex" ST Medium Circle with Strap Hernia Patch

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 Davol, Inc., Sub. 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
    60057
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0144-2012
  • Date de mise en oeuvre de l'événement
    2011-10-04
  • Date de publication de l'événement
    2011-11-01
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2013-09-20
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104352
  • 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
    Mesh, surgical, polymeric - Product Code FTL
  • Cause
    Mislabeled: bard¿ ventralex" st medium circle was packaged in a pre-printed carton identified for a bard¿ ventralex" st large circle.
  • Action
    Davol Inc. issued an Urgent; Medical Device Recall letter on 10/4/11 for the mislabeled Bard Ventralex ST Medium Circle. The letter identified the affected product and explained the reason for recall. Customers are to immediately examine their inventory and quarantine any affected product. In addition, if any product was further distributed then those customers should be notified of the recall as well. Accounts are to contact Davol Customer Service at 1-800-556-6275 for instructions on how to return product to Davol. The attached recall effectiveness check form should be completed and returned. Questions should be directed towards Davol Customer Service Department at 1-800-556-6275 or C. R. Bard's Medical Services & Support Department at 1-800-562-0027.

Device

Bard Ventralex" ST Medium Circle with Strap Hernia Patch
  • Modèle / numéro de série
    Lot number: HUVD1253.
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Bard¿ Ventralex" ST Medium Circle with Strap Hernia Patch Diameter 6.4cm /2.5", Catalog Number: 5950008. || Intended for use in the reconstruction of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair hernias and deficiencies caused by trocars.
  • Manufacturer
    Davol, Inc., Sub. C. R. Bard, Inc.

Manufacturer

Davol, Inc., Sub. C. R. Bard, Inc.
  • Adresse du fabricant
    Davol, Inc., Sub. C. R. Bard, Inc., 100 Crossings Blvd, Warwick RI 02886-2850
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA