Events

Recall of Device Recall BARDEX

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
    72922
  • Event Risk Class
    Class 2
  • Event Number
    Z-1357-2016
  • Event Initiated Date
    2015-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-06-29
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=142505
  • 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 (antimicrobial) and accessories - Product Code MJC
  • Reason
    Labeling error: catalog contains instructions for use (ifu) error; incorrect inflation volume.
  • Action
    C. R. Bard, Inc. sent a "NOTIFICATION OF MISLABELING" letter, dated 12/18/2015 to all affected consignees. The letter identifies the product, problem, and actions to be taken by the customers.

Device

Device Recall BARDEX
  • Model / Serial
    Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed US (nationwide) and the countries of Canada and Australia.
  • Product Description
    BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.
  • 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