Events

Recall of HYDROPHILIC CATHETER - MAGIC3 - MALE

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
    63454
  • Event Risk Class
    II
  • Event Initiated Date
    2017-09-22
  • 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 informing customers that identified product code / lot number combinations of magic3 intermittent catheters may have a sterile barrier breach where the catheter may be caught in the seal or protruding from the seal of the packaging and potentially have the catheter tip cut.

Device

HYDROPHILIC CATHETER - MAGIC3 - MALE
  • Model / Serial
    Model Catalog: 53614 (Lot serial: >10 LOTS CONTACT MFR); Model Catalog: 53612G (Lot serial: >10 LOTS CONTACT MFR); Model Catalog: 50616 (Lot serial: >10 LOTS CONTACT MFR); Model Catalog: 50614 (Lot serial: >10 LOTS CONTACT MFR); Model Catalog: 53616G (Lot serial: >10 LOTS CONTACT MFR); Model Catalog: 53614G (Lot serial: >10 LOTS CONTACT MFR)
  • Product Description
    MAGIC3 INTERMITTENT CATHETERS
  • Manufacturer
    BARD CANADA INC.

Manufacturer

BARD CANADA INC.