FDA recall Z-1849-2020

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 for recall

Incorrect expiration date on introduction cannula packaging.

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.

Key facts

Status

Terminated

Initiation date

2020-02-21

Report date

2020-05-13

Termination date

2021-01-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Farmers Branch, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1849-2020