Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTF...
FDA Device Recall #Z-1354-2013 — Class II — April 12, 2013
Recall Summary
| Recall Number | Z-1354-2013 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 12, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Progressive Medical Inc |
| Location | Fenton, MO |
| Product Type | Devices |
| Quantity | 20 boxes with 12 units each. |
Product Description
Progressive Medical PTFE Coated Disposable Electrosurgical Electrodes - NON-STICK CAUTERY TIP PTFE Modified Coated Blade 2.50" (6.40cm) Length, Product number P0012M Rx Only. Sterilized by Radiation. Manufactured for Progressive Medical, Inc., St. Louis, MO 63128. Electrodes used in Electrosurgeries
Reason for Recall
Product coatings require 510K approval.
Distribution Pattern
Nationwide Distribution including AR, AZ, CA, CO, FL, ID, IL, IN, KS, KY, LA, MA, MI, MN, MO, NE, OH, OK, OR, TN, TX, WA, and WI.
Lot / Code Information
Lot number 082712-02
Other Recalls from Progressive Medical Inc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1355-2013 | Class II | Progressive Medical PTFE Coated Disposable Elec... | Apr 12, 2013 |
| Z-1357-2013 | Class II | Progressive Medical PTFE Coated Disposable Elec... | Apr 12, 2013 |
| Z-1349-2013 | Class II | Progressive Medical PTFE Coated Disposable Elec... | Apr 12, 2013 |
| Z-1360-2013 | Class II | Progressive Medical PTFE Coated Disposable Ele... | Apr 12, 2013 |
| Z-1364-2013 | Class II | Progressive Medical PTFE Coated Disposable Elec... | Apr 12, 2013 |
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.