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Terminated

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.

FDA Recall Z-1849-2020 · Posted 2020-04-16

Recalling FirmEpimed International
Recall StatusTerminated
Product CodeGXI
Date Initiated2020-02-21
Date Terminated2021-01-28
Product Quantity1374

Reason for Recall

Incorrect expiration date on introduction cannula packaging.

Firm Action

On 02/21/2020, URGENT: MEDICAL DEVICE RECALL letters were sent to customers by way of Standard U.S. Mail services.

Root Cause

Labeling design

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K041021RF INTRODUCTION CANNULAEpimed International, Inc. · 2004-09-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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