Convatec Recalls Flexi-Seal Fecal Management System for Regulatory and Performance Issues
Convatec Inc. is recalling the Flexi-Seal Fecal Management System because it lacks FDA 510(k) clearance and its Auto-Valve feature is not performing consistently.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class I, which is defined as unlikely to cause adverse health consequences. The issues cited are regulatory (lack of 510(k)) and performance-related (inconsistent valve function) without reports of injury or death.
Plain-English summary
Convatec Inc. is recalling the Flexi-Seal Fecal Management System (FMS) Control Kit. The product is an Rx-only medical device used to manage fecal incontinence by collecting liquid to semi-liquid stool and providing access for administering medications as prescribed by a physician.
The recall was initiated because the product does not have FDA 510(k) clearance. Additionally, an internal assessment of product performance, which included a review of customer feedback, confirmed that the Flexi-Seal Control is not meeting expectations or customer requirements. Specifically, the Auto-Valve feature, which is unique to this system, has not been performing consistently.
The recall affects 73,021 units distributed in the US and 24,866 units distributed outside the US. The product was distributed nationwide in the US and worldwide. Consumers and healthcare providers should stop using the affected units and contact Convatec Inc. for further instructions.
The recalled product
- Product
- Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use 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.
- Manufacturer
- Convatec Inc.
Distribution
Distributed nationwide across the United States.
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