Recall Z-1785-2014— Convatec Inc.
Class I · Terminated
Class I FDA medical device recall by Convatec Inc., initiated 2014-04-29, terminated 2015-08-28. FDA's recall record names no specific 510(k) clearance for this event. 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.. Reason: 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.
- Recalling firm
- Convatec Inc.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2014-04-29
- Terminated
- 2015-08-28
- Firm location
- Skillman, NJ, United States
Product description
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.
Reason for recall
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.