Events

Recall of Device Recall Bard UroForce

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

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
    34037
  • Event Risk Class
    Class 2
  • Event Number
    Z-0268-06
  • Event Initiated Date
    2005-11-03
  • Event Date Posted
    2005-12-03
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-01-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=42967
  • 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
    Dilator, Catheter, Ureteral - Product Code EZN
  • Reason
    There is a potential for the lumen to collapse and prevent passage over a guidewire.
  • Action
    Consignees were notified via overnight courier on 11/7&8/2005

Device

Device Recall Bard UroForce
  • Model / Serial
    Catalog #887504, Lot #GFPG2394; Catalog #887510, Lot #GFPG2399; Catalog #887604, GFPG2401, GFPG2402, GFPG2403, GFPG2404, GFPG2405, GFPG2424; Catalog #887610, Lot #GFPF3439, GFPG2406; Catalog #888404, Lot #GFPG2409, Catalog #888604, Lot #GFPG2411, GFPH1415; Catalog #888510, Lot #GFPG2415, GFPH2024; Catalog #888604, Lot #GFPG2417, GFPG2418; Catalog #888610, Lot #GFPF3451.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Belgium, Canada
  • Product Description
    Bard UroForce¿ Balloon Dilation Catheter with Glissando¿ Coating * BARD * C.R. Bard, Inc. Covington, Georgia 30014 * 1-800-526-4455 * Sterile/EO
  • Manufacturer
    C.R. Bard, Inc., Urological Division

Manufacturer

C.R. Bard, Inc., Urological Division
  • Manufacturer Address
    C.R. Bard, Inc., Urological Division, 8195 Industrial Blvd Ne, Covington GA 30014-1497
  • Source
    USFDA