Events

Rappel de Bard PerFix Light Plug

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., Subs. 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
    69464
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0191-2015
  • Date de mise en oeuvre de l'événement
    2014-10-08
  • Date de publication de l'événement
    2014-11-07
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2015-12-23
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130721
  • 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
    The patient record peel-off label product code and size did not match the other labeling and actual product in the packaging for the bard small perfix light plug.
  • Action
    Davol Inc. (Subsidiary of C.R. Bard, Inc)sent Customer Notification letters on Friday, October 10, 2014, via FedEx next day delivery with signature confirmation 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 communication. A sample of the product labeling for the lot has been enclosed to assist in product code and lot number identification. The enclosure also depicts the supplied label as well as an image of the label with the correct information. If you have any remaining inventory, a copy of this communication can be kept with the units for future medical record documentation purposes. If you have already used some of the product lot, you may amend any patient record(s) based upon the content of this communication. Please complete and return the accompanying Effectiveness Check Form attached to this letter regardless of whether or not you have any remaining units of the affected product lot. If you may have further distributed or transferred this product, please identify the respective organizations and notify them of this product communication. Your notification to these organizations may be enhanced by including a copy of this product communication letter. This product communication is being made with the knowledge of the Food and Drug Administration. We apologize for any inconvenience this may have caused your organization. Please contact the Davol Customer Service Department at 1-800-556-6275 or C.R. Bard Medical Services & Support Department at 1-800-562-0027 if you have any questions.

Device

Bard PerFix Light Plug
  • Modèle / numéro de série
    Lot# HUYD0176
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    US Distribution including the states of CA, NM, OH, DE, MN, UT, MD and MO.
  • Description du dispositif
    Bard¿ PerFix Light Plug || The Bard¿ PerFix Light Plug is indicated for reinforcement if soft tissue, where weakness exists, in procedures involving soft tissue repair, such as groin hernia defects.
  • Manufacturer
    Davol, Inc., Subs. C. R. Bard, Inc.

Manufacturer

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