Events

Recall of XForce Nephrostomy Balloon Dilation Catheter Kit with Inflation Device

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by C.R. Bard, 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
    75452
  • Event Risk Class
    Class 2
  • Event Number
    Z-0363-2017
  • Event Initiated Date
    2016-10-12
  • Event Status
    Completed
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150405
  • 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
    Catheter, nephrostomy - Product Code LJE
  • Reason
    Contract manufacturer packaged an incorrect sheath with the product. packaged 30fr instead of 24fr.
  • Action
    The firm, Bard Medical, sent an "URGENT: MEDICAL DEVICE PRODUCT RECALL" letter dated 10/13/2016 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to immediately examine their inventory and quarantine product subject to recall; do not use or further distribute any affected product; complete and return the attached Recall & Effectiveness Check Form regardless of whether or not you have any of the affect product by fax to 1-770-784-6469 or email a scanned copy to BMD.FieldAction@crbard.com by October 24, 2016, and if you have further distributed any units of the affected lot, identify your customers and notify them at once of the product recall. If you have any questions, contact BMD Recall Coordinator at 1-800-793-8110.

Device

XForce Nephrostomy Balloon Dilation Catheter Kit with Inflation Device
  • Model / Serial
    Lot BMZCE039, Expiration Date 2018-12-31
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US distribution to: CA, KS, MO, NY, VA, WA, and to countries of: China, Italy, Sweden and United Kingdom.
  • Product Description
    X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081 || The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mounted on the distal tip. It has a radiopaque tip and radiopaque marker beneath the balloon. It is recommended for use in the dilation of the nephrostomy tact and for placement of the working sheath.
  • Manufacturer
    C.R. Bard, Inc.

Manufacturer

C.R. Bard, Inc.
  • Manufacturer Address
    C.R. Bard, Inc., 8195 Industrial Blvd NE, Covington GA 30014-1497
  • Manufacturer Parent Company (2017)
    Becton, Dickinson and Company
  • Source
    USFDA