Class 2 Device Recall Monopolar Laparoscopic Electrode

• Date Initiated by Firm: January 15, 2003
• Date Posted: January 30, 2003
• Recall Status: Terminated on April 14, 2003
• Recall Number: Z-0470-03
• Recall Event ID: 25368
• 510(K)Number: K912780
• Product Classification: Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
• Product: AEM Fixed-Tip Needle Electrode - 5mm, Reusable REF/CAT ES3521B
• Code Information: Catalog # ES3521B. Lots FI, GC, GH, GL, HH, HI.
• Recalling Firm/ Manufacturer: Encision, Inc.; 4828 Sterling Drive; Boulder CO 80301
• Manufacturer Reason for Recall: Reports of needle fixed-tip electrodes becoming loose or breaking off.
• FDA Determined Cause: Other
• Action: All consignees will be notified by phone or visit beginning 01/15/2003.
• Quantity in Commerce: 58 devices.
• Distribution: Domestic distribution to LA, MA, MN, OR, UT and WA.
• 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 = GEI