Recall Z-1849-2020— Epimed International

Name: FDA recall Z-1849-2020
Creator: U.S. Food and Drug Administration
Published: 2020-02-21

Class II · Terminated

Class II FDA medical device recall by Epimed International, initiated 2020-02-21, terminated 2021-01-28. It names one FDA 510(k) clearance: K041021. Product: 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: Incorrect expiration date on introduction cannula packaging..

Recalling firm: Epimed International
Classification: Class II
Status: Terminated
Initiated: 2020-02-21
Terminated: 2021-01-28
Firm location: Farmers Branch, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K041021 — RF INTRODUCTION CANNULAEpimed International, Inc.·cleared 2004-09-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.