Convatec Flexi Seal Control Fecal Management System recall
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of…
Why was Convatec Flexi Seal Control Fecal Management System recalled?
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 expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control has not been consistently performing relative
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
13-FM-0301 13-FM-0302 13FM0303 13-FM-0303 13FM0309 13VM509948 13VM509949 13VM510046 13VM512473 13VM513636 13VM513642 13VM516733 13VM520039 13VM521731 13VM521733 13VM524363 13VM524364 13VM527149 13VM527150 13VM528992 13VM528994 13VM531214 14FM0301 14VM531935 14VM532098
- Product
- Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal incontinence through the collection of…
- Recalling firm
- Convatec Inc.
- Quantity
- 73,021 units US; 24,866 units OUS
- Distribution
- Worldwide Distribution - USA Nationwide
- Recall date
- June 25, 2014
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)