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FDA Class I recall issued for ConvaTec fecal management system
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An FDA Class I recall was initiated on April 29 for all ConvaTec Flexi-Seal Control Fecal Management System Kits, according to an administration press release.
The global medical products and technologies firm released an urgent voluntary medical device recall letter after US health care facilities reported 13 adverse events, including 12 serious injuries and one death from February 2013 through March 2014. According to the FDA, ConvaTec failed to seek FDA clearance to legally market the product through the 510(k) process.
The kit is used to manage fecal incontinence and provide access to administer medications. The product’s auto-valve feature “has not consistently performed relative to the inflation and deflation of the device’s retention balloon,” which is “one of the reasons a 510(k) application should have been submitted,” the FDA said.
Device failures include the auto-valve failing to limit inflation to 45 mL, the balloon being unable to fully inflate or deflate, and the valve leaking at the inflation port. These failures may result in rectal damage, device expulsion and/or leakage, skin deterioration associated with soiling of bed linens, and death.
Health care professionals and consumers are urged to report adverse reactions or problems they experienced using this device to the FDA MedWatch program.