A prospective, phase II, open-label, non-randomized clinical study involving 42 patients from seven U.S. hospitals was performed to evaluate the safety of Flexi-Seal ® FMS. 1 The study found that ...
In April 2014, a Class I recall of ConvaTec's Flexi-Seal CONTROL Fecal Management System Kit was announced. According to the FDA recall release, the company did not file for 510(k) clearance of the ...
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