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.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting…"
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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