Events

Recall of 8 Fr. Bardex Pediatric AllSilicone Foley Catheter

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
    63136
  • Event Risk Class
    Class 2
  • Event Number
    Z-0010-2013
  • Event Initiated Date
    2012-09-07
  • Event Date Posted
    2012-10-04
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-03-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112660
  • 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, urological - Product Code KOD
  • Reason
    The 8 fr. bardex all-silicone foley catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.
  • Action
    An "Urgent: Product Recall Notification" was sent to all customers and distributors in September 2012 via Federal Express. The letter described the product issue and provided recommended actions. Customers can contact Bard at (770) 784-6471 if questions.

Device

8 Fr. Bardex Pediatric AllSilicone Foley Catheter
  • Model / Serial
    Catalog # 165808, Lot # NGWA1111
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide distribution: USA and Puerto Rico
  • Product Description
    8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
  • 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