Convatec Inc.: Medical Device Recall in 2014 - (Recall #: Z-1785-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: April 29, 2014

Date Posted: June 25, 2014

Recall Number: Z-1785-2014

Event ID: 68292

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

Status: Terminated

Product Quantity: 73,021 units US; 24,866 units OUS

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

Distribution Pattern:

Worldwide Distribution - USA Nationwide

Voluntary or Mandated:

Voluntary: Firm initiated