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U.S. Department of Health and Human Services

Class 1 Device Recall Convatec Inc.

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  Class 1 Device Recall Convatec Inc. see related information
Date Initiated by Firm April 29, 2014
Date Posted June 13, 2014
Recall Status1 Terminated 3 on August 28, 2015
Recall Number Z-1785-2014
Recall Event ID 68292
Product Classification Tubes, gastrointestinal (and accessories) - Product Code KNT
Product 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.
Code Information 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
Recalling Firm/
Convatec Inc.
200 Headquarters Park Dr
Skillman NJ 08558-2600
For Additional Information Contact Mr. Gregory Kowzun
Manufacturer Reason
for Recall
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
FDA Determined
Cause 2
Device Design
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.
Quantity in Commerce 73,021 units US; 24,866 units OUS
Distribution Worldwide Distribution - USA Nationwide
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.