R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(...
FDA Device Recall #Z-1849-2020 — Class II — February 21, 2020
Recall Summary
| Recall Number | Z-1849-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | February 21, 2020 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Epimed International |
| Location | Farmers Branch, TX |
| Product Type | Devices |
| Quantity | 1374 |
Product Description
R-F Injector Cannula. 18gx10cm-STERILE. REF/UDI: 257-1810/(01)00828788021496; REF/UDI: 257-1810D(01)10818788021493 - Product Usage: The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
Reason for Recall
Incorrect expiration date on introduction cannula packaging.
Distribution Pattern
Worldwide distribution - US Nationwide distribution including the states of AL, CA, FL, GA, IL, MD,MI, MS, NJ, NY, OK, TN, TX, WA and WY and the countries of Australia, Chile, United Kingdom.
Lot / Code Information
Catalog #257-1810 Sterile Lot #/Expiration Date/ 1. 14108679/exp. 3-29-23/ 2. 14109199/exp. 1-21-24/ 3. 14108568/exp. 2-4-23/ Catalog #257-1810D Sterile Lot #/Expiration Date/ 1. 14109199/ exp. 1-21-24/ 2. 14109690/exp. 9-26-24/
Other Recalls from Epimed International
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1850-2020 | Class II | R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI... | Feb 21, 2020 |
| Z-2313-2021 | Class II | NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile | Dec 28, 2017 |
| Z-2312-2021 | Class II | NEO-KATH Epidural Catheter Set, REF 200-2430, S... | Dec 28, 2017 |
| Z-0087-2018 | Class II | RX-2 COUDE Epidural Needle, 16g x 3.5in (8.9cm)... | Jul 24, 2017 |
| Z-0089-2018 | Class II | TUOHY Epidural Needle, 20g x 3.5in(8.9cm) TW, 1... | Jul 24, 2017 |
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.