Events

Recall of Device Recall Bard Distaflo Vascular Bypass Graft

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bard Peripheral Vascular Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    73022
  • Event Risk Class
    Class 2
  • Event Number
    Z-0786-2016
  • Event Initiated Date
    2016-01-05
  • Event Date Posted
    2016-02-09
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-03-25
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=143049
  • Notes / Alerts
    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.
  • Extra notes in the data
    Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
  • Reason
    Size mislabeling; the graft is 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
  • Model / Serial
    Product Code: DF8006SC Lot Number: VTZE1783
  • Product Classification
    Cardiovascular Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    Distributed in the states of AL, TX, and CA.
  • Product Description
    Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. || Intended for bypass or reconstruction of peripheral arterial blood vessels.
  • Manufacturer
    Bard Peripheral Vascular Inc

Manufacturer

Bard Peripheral Vascular Inc
  • Manufacturer Address
    Bard Peripheral Vascular Inc, 1625 W 3rd St, Tempe AZ 85281-2438
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA