Events

Rappel de Bard Soft Mesh 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
    58685
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-2239-2011
  • Date de mise en oeuvre de l'événement
    2011-04-25
  • Date de publication de l'événement
    2011-05-23
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2011-10-28
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=99921
  • 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
    Mislabeling: complaints of product labeled as bard¿ soft mesh 4" x 6" containing bard¿ soft mesh 6" x 6".
  • Action
    Davol issued an URGENT: MEDICAL DEVICE RECALL notification letter to customers dated April 25, 2011, informing them the recall involving a single lot of the BARD Soft Mesh - Lot# HUUF0530. This recall has been initiated because this lot number may contain a different size patch than is indicated. Customers were instructed to immediately examine inventory and quarantine product subject to recall. Customers are asked to identify and notify their customers to whom recalled product may have been further distributed. A Recall Effectiveness Check reply form should be completed and returned to Davol via fax (401-825-8753). For directions on returning product or for questions regarding the recall, contact 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 Soft Mesh patch
  • Modèle / numéro de série
    Lot# HUUF0530
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Nationwide Distribution
  • Description du dispositif
    Bard¿ Soft Mesh 4"x6" (10cm x 15cm) Flat, Product Code: 0117010. || The Bard¿ Soft Mesh patch is a non-absorbable, sterile prosthesis. It has a large pore design and is constructed of knitted polypropylene monofilaments. The device classification name is "Mesh, Surgical, Polymeric".
  • 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