Recall Z-1849-2020 ยท GXI Probe, Radiofrequency Lesion
Epimed International
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.
| Date | Apr 16, 2020 (initiated Feb 21, 2020) |
| Status | Terminated |
| Reason | Incorrect expiration date on introduction cannula packaging. |
| Root cause | Labeling design |
| Action | On 02/21/2020, URGENT: MEDICAL DEVICE RECALL letters were sent to customers by way of Standard U.S. Mail services. |
| Quantity | 1374 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041021 | RF INTRODUCTION CANNULA Epimed International, Inc., Sep 16, 2004 |