The FDA issued a Class I recall status, its most serious, to medical device maker ConvaTec for its fecal management system that is blamed for one death and a dozen injuries. The company began its own recall of the system, which was not cleared for marketing by the FDA, in April.
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| The Flexi-Seal CONTROL Fecal Management System--Courtesy of ConvaTec |
The Flexi-Seal CONTROL Fecal Management System contains an Auto-Valve feature that hasn't consistently performed relative to the inflation and deflation of the device's retention balloon. The device is designed 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, the FDA said in a release.
In issuing the Class I recall, the regulatory agency said the device was manufactured between January 2013 and April 2014, and the company began distribution in February 2013 up until a few months ago in April. However, ConvaTec did not seek FDA clearance to legally market this device through the 510(k) process.
Class I recalls involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Earlier this year, the Luxembourg-based company shuttered its Skillman, NJ, office and let go of 118 employees from its sales, marketing and human resources division. Originally Bristol-Myers Squibb's ($BMY) wound-care unit, ConvaTec was sold to Nordic Capital and Avista Capital Partners in 2008 for $4.1 billion.
- see the FDA announcement