Convatec Flexi Seal Control Fecal Management System Rx Only REF 411107 Product Usage:For u...
FDA Device Recall #Z-1785-2014 — Class I — April 29, 2014
Recall Summary
| Recall Number | Z-1785-2014 |
| Classification | Class I — Serious risk |
| Date Initiated | April 29, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Convatec Inc. |
| Location | Skillman, NJ |
| Product Type | Devices |
| Quantity | 73,021 units US; 24,866 units OUS |
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
Distribution Pattern
Worldwide Distribution - USA Nationwide
Lot / Code Information
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
Other Recalls from Convatec Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1239-2014 | Class II | JMS, Japan, 3 WAY, 20 FR 10 mL Product Usag... | Feb 7, 2014 |
| Z-1241-2014 | Class II | SLC 3-way standard Lubricious Coated 20Ch/Fr 30... | Feb 7, 2014 |
| Z-1240-2014 | Class II | 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 ... | Feb 7, 2014 |
| Z-1238-2014 | Class II | SLC 2-way standard Lubricious Coated 14ch/FR 5... | Feb 7, 2014 |
| Z-1236-2014 | Class II | Medline Sterile Foley Catheter 14 fr 5 cc 12 p... | Feb 7, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.