Events

Recall of Device Recall BardiaComplete Foley Kit

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
    28310
  • Event Risk Class
    Class 3
  • Event Number
    Z-0562-04
  • Event Initiated Date
    2004-02-10
  • Event Date Posted
    2004-02-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2004-07-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=31575
  • 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 foley trays contain a 16 french catheter instead of an 18 french catheter as specified by the product insert/labeling.
  • Action
    Consignees were notified by certified mail on 02/10/2004.

Device

Device Recall BardiaComplete Foley Kit
  • Model / Serial
    Catalog Number: 800518, Lot Number: 76IN0317
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    AL, CA, CO, FL, GA, IL, IN, KY, MO, MS, NJ, NY, OH, PA, TX and WA.
  • Product Description
    Bardia¿Complete Foley Kit, Single use only, Do not resterilize, For urological use only, Reorder: 800518, 18 Fr., Lot 76IN0317, Inflate with 10ml sterile water, Contents: ¿5cc Silicone Elastomer-Coated Foley Catheter, ¿Waterproof underpad, ¿Synthetic Vinyl Gloves (2), ¿ Lubricant, ¿10cc Syringe (prefilled with sterile water to inflate Foley catheter), ¿Povidone-Iodine swabs (3), ¿CSR Wrap, ¿Plastic Tray. CR.Bard, Inc., Covington,GA 30014, 222.;bardmedical.com.
  • 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