Events

Rappel de Device Recall Bard Distaflo Vascular Bypass Graft

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 Bard Peripheral Vascular 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
    73022
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0785-2016
  • Date de mise en oeuvre de l'événement
    2016-01-05
  • Date de publication de l'événement
    2016-02-09
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2016-03-25
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142774
  • 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
    Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
  • Cause
    Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
  • Action
    Customer notification letters were sent on 01/05/2016. Customers were asked to not use the affected product, or further distribute it. Customers were asked to check all inventory locations for the affected product code, lot number combination listed. If customers further distributed any of the product they are requested to contact that location, advise them of the recall, and forward the listed instructions. The letter states to remove all identified product from the shelves. If no affected product is going to be returned the firm states to complete and return the attached form stating so. If customers have product it is requested that they also complete the attached form, and state the quantities and lot numbers in stock. The letter requests that customers call the firm's Recall Coordinator, Raye Seisinger, at 1-800-321-4254, option #2 ext. 2501 (M-F 6am to 3pm MST) or email raye.seisinger@crbard.com. Once all information has been verified the customer will be issued a Return Authorization or Consignment Recall Number to facilitate the expedient return of the product. The firm will provide replace product for returned product. Fax the attached form to the firm at 1-800-994-6772. If the customer cannot fax the firm they request that the Recall Coordinator be contact and provided the information verbally. The letter states a mailing label is enclosed to return the affected product. Customers are requested to amek the package as "recalled product" and include the XC or XH number. All products should be returned to the following shipping address: Bard Peripheral Vascular, Inc. 1415 W. 3rd St. Tempe, AZ 85281

Device

Device Recall Bard Distaflo Vascular Bypass Graft
  • Modèle / numéro de série
    Product Code: DF6006SC Lot Number: VTZE1782
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    Yes
  • Distribution
    Distributed in the states of AL, TX, and CA.
  • Description du dispositif
    Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. || Intended for bypass or reconstruction of peripheral arterial blood vessels.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Adresse du fabricant
    Bard Peripheral Vascular Inc, 1625 W 3rd St, Tempe AZ 85281-2438
  • Société-mère du fabricant (2017)
    Becton, Dickinson and Company
  • Source
    USFDA