Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrod...
FDA Device Recall #Z-0500-2013 — Class II — February 9, 2012
Recall Summary
| Recall Number | Z-0500-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 9, 2012 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien LLC dba Uni-Patch |
| Location | Wabasha, MN |
| Product Type | Devices |
| Quantity | 3290 |
Product Description
Performa reusable and self-adhering TENS/NMES/FES stimulating electrodes, A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., electroencephalogram) or to apply electrical stimulation.
Reason for Recall
Covidien is conducting a voluntary recall regarding specific lots of TENS electrodes because it was determined that during the manufacturing process the surface of the wires in these lots may have been exposed to an employee who had a minor cut.
Distribution Pattern
Nationwide Distribution including CA, IL, MA, MN, and SD.
Lot / Code Information
Lot 202406
Other Recalls from Covidien LLC dba Uni-Patch
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0501-2013 | Class II | Empi STIMC RE Self Adhesive electrodes. For us... | Feb 9, 2012 |
| Z-0498-2013 | Class II | Reusable, non-sterile, self-adhering electrodes... | Feb 9, 2012 |
| Z-0499-2013 | Class II | Reusable, Self-Adhering TENS/NMES/FES electrode... | Feb 9, 2012 |
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.