ConvaTec is conducting a Class I recall of its Flexi-Seal CONTROL fecal management system kits, due to a lack of FDA clearance to market the products. Customers should stop using and distributing the devices immediately, the company said.

According to a recall notice posted to the FDA website on June 20, the Skillman, N.J., devicemaker received reports of 13 negative events associated with the device between February 2013 and March of this year. The reports included 12 serious injuries and one death between Feb. 2013 and March 2014, the period during the device was distributed in the U.S.

“However, the firm did not seek FDA clearance to legally market this device through the 510(k) process,” the notice says.

Flexi-Seal CONTROL is intended for the management of fecal incontinence through collection of liquid to semi-liquid stool and the provision of prescription medications. But the device’s auto-valve feature fails to properly inflate and deflate the retention balloon in some instances, ConvaTec says.

Use of the device may lead to rectal damage, expulsion of the device and/or leakage, soiling of bed linen and incontinence pads, which in turn can lead to skin deterioration, peeling skin, raw, irritated lesions and possibly death, the devicemaker says.

ConvaTec sent an Urgent Voluntary Medical Device Recall letter to its customers on April 29, alerting them to stop using the device and quarantine kits in their possession. — Kellen Owings

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