Z-1849-2020 Class II Terminated
FDA device recall Z-1849-2020 was initiated by Epimed International on February 21, 2020 and is designated Class II. Reason for recall: Incorrect expiration date on introduction cannula packaging. The recall status is terminated (terminated January 28, 2021). Affected quantity: 1374.
Recall Details
- Product Type
- Devices
- Report Date
- May 13, 2020
- Initiation Date
- February 21, 2020
- Termination Date
- January 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1374
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.
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.
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/