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U.S. Department of Health and Human Services

Class 2 Device Recall RF Introduction Cannula

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  Class 2 Device Recall RF Introduction Cannula see related information
Date Initiated by Firm February 21, 2020
Date Posted April 16, 2020
Recall Status1 Terminated 3 on January 28, 2021
Recall Number Z-1850-2020
Recall Event ID 85339
510(K)Number K041021  
Product Classification Probe, radiofrequency lesion - Product Code GXI
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.
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/ 
Recalling Firm/
Manufacturer		 Epimed International
13958 Diplomat Dr
Farmers Branch TX 75234-8805
For Additional Information Contact Bobbi Harrington
518-848-3901 Ext. 1200
Manufacturer Reason
for Recall		 Incorrect expiration date on introduction cannula packaging.
FDA Determined
Cause 2		 Labeling design
Action On 02/21/2020, URGENT: MEDICAL DEVICE RECALL letters were sent to customers by way of Standard U.S. Mail services.
Quantity in Commerce 701
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = GXI and Original Applicant = EPIMED INTERNATIONAL, INC.
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