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Recall Observatory FDA recall evidence

Device 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.

Z-1849-2020

February 21, 2020

Class II

Product summary

Firm
Epimed International
Event
Event 85339
Status
Terminated
Classification
Class II
Quantity
1374
Official record key
device-enforcement:Z-1849-2020

Official wording

Reason: Incorrect expiration date on introduction cannula packaging.

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/

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Incorrect expiration date on introduction cannula packaging.