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/ Manufacturer |
Convatec Inc. 200 Headquarters Park Dr Skillman NJ 08558-2600
|
For Additional Information Contact |
Mr. Gregory Kowzun 336-547-3710
|
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.
|