Device product
R-F Injector Cannula. 20gx10cm-STERILE. REF/UDI: 257-2010/(01)10818788022124; REF/UDI: 257-2010D(01)00818788022127 - Product Usage:The Epimed RF Introduction Cannula is intended for use in radiofrequency (RF) heat lesion procedures for the relief of pain.
Z-1850-2020
Product summary
- Event
- Event 85339
- Status
- Terminated
- Classification
- Class II
- Quantity
- 701
- Official record key
device-enforcement:Z-1850-2020
Official wording
Reason: Incorrect expiration date on introduction cannula packaging.
Code information: Catalog #257-2010 Sterile Lot #/Expiration Date/ 1. 14108680/exp. 3-29-23/ 2. 14108569/exp. 2-4-23/ 3. 14109200/exp. 1-21-24 Catalog #257-2010D Sterile Lot #/Expiration Date/ 1. 14109200/exp. 1-21-24/
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
Incorrect expiration date on introduction cannula packaging.