Reported Jun 25, 2014 · Terminated
Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For use to manage fecal…
Convatec Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Convatec Inc. · 200 Headquarters Park Dr · Skillman, NJ · 08558-2600
Is this the product you have?
- Convatec Flexi Seal Control Fecal Management
- System Rx Only REF 411107 Product UsageFor 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
- Lot codes and dates
13-FM-030113-FM-030213FM030313-FM-030313FM030913VM50994813VM50994913VM51004613VM51247313VM51363613VM51364213VM51673313VM52003913VM52173113VM52173313VM52436313VM52436413VM52714913VM52715013VM52899213VM52899413VM53121414FM030114VM53193514VM532098
- Amount recalled
- 73,021 units US; 24,866 units OUS
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
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
Using this product could cause serious injury, illness or death — stop using it now.
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