The US Food and Drug Administration (FDA) has classified ConvaTec’s recently initiated voluntary global recall of Flexi-Seal Control fecal management system (FMS) as a Class I recall.
In April 2014, ConvaTec had recalled all lots of Flexi-Seal Control FMS (Model Number: ICC 411107, SAP codes: 1704335 for US products) and also notified regulatory agencies in all countries where product was distributed.
ConvaTec has recalled the Flexi-Seal Control FMS in the US following the determination that the device should have a 510(k) clearance, rather than the use of the current note to file that was based on existing 510(k) clearance for other Flexi-Seal products.
The company received reports from US healthcare facilities of 13 adverse events, including 12 serious injuries and one death for the period February 2013 through March 2014.
ConvaTec also conducted an analysis following reports that the Auto-Valve feature that is unique to Flexi-Seal Control FMS had not been consistently performing relative to the inflation and deflation of the device’s retention balloon.
According to ConvaTec, the recall does not affect any of the other Flexi-Seal products or Flexi-Seal privacy collection bags, which are sold separately.
Flexi-Seal Control FMS, a temporary containment device, is indicated for use of the management of acute fecal incontinence in patients who are often immobilized and critically ill and have little or no bowel control and liquid or semi-liquid stool.