Events

Recall of UNIVERSAL TUBING SECUREMENT KIT FOR FOLEY CATHETERS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by MEDLINE CANADA CORPORATION.

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
    25944
  • Event Risk Class
    II
  • Event Initiated Date
    2013-07-11
  • 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
    The kit was updated to include an alcohol prep pad that does not have an npn number. the label for the kit pouch does not bear the npn number nor the name and address of the importer (medline canada).

Device

UNIVERSAL TUBING SECUREMENT KIT FOR FOLEY CATHETERS
  • Model / Serial
    Model Catalog: DYND7600FCL (Lot serial: SO-22865)
  • Product Description
    Universal Tubing Securement Kit for Foley Catheters
  • Manufacturer
    MEDLINE CANADA CORPORATION

Manufacturer

MEDLINE CANADA CORPORATION