ConvaTec, Inc., Flexi-Seal CONTROL Fecal Management System Kit: Class I Recall - Not Cleared for Marketing

[Posted 06/20/2014]

AUDIENCE: Risk Manager, Nursing

ISSUE: A Class I Recall was issued for all Flexi-Seal CONTROL Fecal Management System Kits. No 510k application was submitted to FDA. In addition, ConvaTec received reports from U.S. healthcare facilities of 13 adverse events including twelve serious injuries and one death for the period February 2013 through March 2014. The Auto-Valve feature that is unique to the Flexi-Seal CONTROL Fecal Management System Kit has not consistently performed relative to the inflation and deflation of the device’s retention balloon. Use of this device may lead to: rectal damage (necrosis/ perforation/ulceration or bleeding); expulsion of the device and/or leakage; fecal soiling of bed linen/incontinence pads leading to skin deterioration around the anus, peeling skin, and raw, irritated lesions due to skin contact with fecal matter; and death.

BACKGROUND: This device is used in health care facilities 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.

RECOMMENDATION: On April 29, 2014, ConvaTec Inc. sent an Urgent Voluntary Medical Device Recall letter to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Stop distributing/using the recalled device, and quarantine the devices in your possession.

[06/20/2014 - Recall Notice - FDA]