Events

Recall of FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM

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

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
    18091
  • Event Risk Class
    I
  • Event Initiated Date
    2014-05-01
  • 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
    Flexi-seal control fms is not meeting convatec expectations. specifically the auto-valve which is unique to this product has not been consistently performing relative to the inflation and deflation of the retention balloon.

Device

FLEXI-SEAL SIGNAL FECAL MANAGEMENT SYSTEM
  • Model / Serial
    Model Catalog: 411107 (Lot serial: 13VM520039 13VM521733); Model Catalog: 411107 (Lot serial: 13VM510046 13VM512473); Model Catalog: 411107 (Lot serial: 13-FM-0303 13FM0309); Model Catalog: 411107 (Lot serial: 13VM528994 14VM531935); Model Catalog: 411107 (Lot serial: 13VM513636 13VM516733)
  • Product Classification
    Gastroenterology-Urology Devices
  • Product Description
    Flexi-Seal Control Fecal Management
  • Manufacturer
    CONVATEC CANADA LTD.

Manufacturer

CONVATEC CANADA LTD.