Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinenc

FDA device recall Z-1785-2014 · posted 2014-06-13 · Terminated

Recall details

Recalling firm

Convatec Inc.

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

Action taken

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.

Root cause

Device Design

Status

Terminated

Product code

KNT

Quantity affected

73,021 units US; 24,866 units OUS

Distribution

Worldwide Distribution - USA Nationwide

Date initiated

2014-04-29

Date posted

2014-06-13

Date terminated

2015-08-28

Location

Skillman, NJ