Events

Rappel de Device Recall Davol

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
    38634
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-1271-2007
  • Date de mise en oeuvre de l'événement
    2007-07-16
  • Date de publication de l'événement
    2007-09-27
  • Statut de l'événement
    Completed
  • 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=54069
  • 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
    Laproscopic 38cm Sterile Implant Cartridge 60 - Product Code GDW
  • Cause
    Malformed constructs (straight shots) may form causing injury to user/patient.
  • Action
    Davol issued recall letter notification on 7/16/07 via Federal Express. Sales of the disposable cartridges ceased July 31, 2007. Cartridges will not be requested to be returned to Davol. Customer requests to return cartridges will be managed on an account-by-account basis. A reminder Second Letter issued July 23,2007 as a follow-up to the letter of July 16, 2007. The second stage will be a series of three letters to customers following the cessation of disposable cartridge sales and to recall the re-usable handles. A Stock Status form will be provided to customers to inventory the product which they are returning. The Stock Status form will be used to document the handles being returned. In the event that the customer cannot locate one or more handles. All handles will be returned to Cranston and will be dispositioned. Account verification for the number of handles returned from the account will be performed. No verification testing will be performed on returned handles unless a formal complaint has been registered for a handle.

Device

Device Recall Davol
  • Modèle / numéro de série
    All lots
  • Classification du dispositif
    General and Plastic Surgery Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide-USA and Canada, Austria, Switzerland, Spain, Sweden, United Kingdom, Italy,Portugal, Greece,Holland, South Africa, Israel, Japan, Belgium, Denmark, Finland, France, and Germany
  • Description du dispositif
    Davol Salute Short 18cm Sterile Implant Cartridge - 30 Q-ring;5/Box, Item Number: 0113061
  • 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 Sockanossett Crossroad, Cranston RI 02920
  • Source
    USFDA