Events

Recall of Convatec Inc.

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Convatec 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
    68292
  • Event Risk Class
    Class 1
  • Event Number
    Z-1785-2014
  • Event Initiated Date
    2014-04-29
  • Event Date Posted
    2014-06-13
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127287
  • 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
    Tubes, gastrointestinal (and accessories) - Product Code KNT
  • Reason
    Convatec inc. is recalling flexi-seal fms control kit since it does not have a 510k. in addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that flexi-seal control is not meeting expectations or those of customers. specifically, the auto-valve feature that is unique to the flexi-seal control has not been consistently performing relative.
  • Action
    Convatec Inc. sent an Urgent Voluntary Medical Device Recall letter dated April 29, 2014 via UPS. The letter identified the affected product, problem and actions to be taken. Customers are asked to immediately stop distributing and quarantine all recalled lots. Affected products must be returned to Distributor. Contact your Distributor for shipping instruction. Customers should completed the attached return response form and return it to the address on the response form. Questions can be directed to Gregory Kowzun at (336) 547-3710. Convatec issued a press release on 7/3/2014.

Device

Convatec Inc.
  • Model / Serial
    13-FM-0301  13-FM-0302  13FM0303  13-FM-0303  13FM0309  13VM509948  13VM509949  13VM510046  13VM512473  13VM513636  13VM513642  13VM516733  13VM520039  13VM521731  13VM521733  13VM524363  13VM524364  13VM527149  13VM527150  13VM528992  13VM528994  13VM531214  14FM0301  14VM531935  14VM532098
  • Product Classification
    Gastroenterology-Urology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - USA Nationwide
  • Product Description
    Convatec Flexi Seal Control Fecal Management System Rx Only || REF 411107 || Product Usage:For use to manage fecal incontinence through the collection of liquid to semi-liquid stool and to provide access to administer medications as prescribed by a physician.
  • Manufacturer
    Convatec Inc.

Manufacturer

Convatec Inc.
  • Manufacturer Address
    Convatec Inc., 200 Headquarters Park Dr, Skillman NJ 08558-2600
  • Manufacturer Parent Company (2017)
    Triona Holding Sa
  • Source
    USFDA