Events

Recall of BARDEX I.C. ANTI-INFECTIVE FOLEY CATHETER WITH BARD HYDROGEL AND BACTI-GUARD SILVER ALLOY COATING

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by BARD CANADA 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
    19633
  • Event Risk Class
    II
  • Event Initiated Date
    2015-12-23
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Bard is notifying cusyomers that the instructions for use (ifu) included with the named bardex i.C. 2-way foley catheters and 2-way council tip foley catheters distributed by the manufacturer from june 2013 to june 2015 provide the incorrect inflation volume. the inflation volume provided on the catheter's valve cap does state the correct inflation volume.

Device

BARDEX I.C. ANTI-INFECTIVE FOLEY CATHETER WITH BARD HYDROGEL AND BACTI-GUARD SILVER ALLOY COATING
  • Model / Serial
    Model Catalog: 0196SI18 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0196SI16 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI30 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI28 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI08 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI24 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI22 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI20 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI18 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI16 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI14 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI12 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI10 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0196SI20 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0196SI22 (Lot serial: >100 NUMBERS CONTACT MFR); Model Catalog: 0165SI26 (Lot serial: >100 NUMBERS CONTACT MFR)
  • Product Description
    BARDEX I.C. 2-WAY FOLEY CATHETERS
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.