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U.S. Department of Health and Human Services

Class 2 Device Recall Encision AEM Suction Irrigation Electrode, Needle Tip,

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  Class 2 Device Recall Encision AEM Suction Irrigation Electrode, Needle Tip, see related information
Date Initiated by Firm August 24, 2011
Date Posted August 30, 2011
Recall Status1 Terminated 3 on September 04, 2012
Recall Number Z-3097-2011
Recall Event ID 59781
510(K)Number K100711  
Product Classification Electrosurgical, Cutting; Coagulation; Accessories - Product Code GEI
Product Encision AEM Suction Irrigation Electrode, Needle Tip, REF ES3885, Encision Inc., Boulder, CO 80301.
Code Information Catalog: REF ES3885. Lots: QI and RA.
Recalling Firm/
Manufacturer		 Encision, Inc.
6797 Winchester Cir
Boulder CO 80301-3513
For Additional Information Contact
303-339-6917
Manufacturer Reason
for Recall		 Electrode tips have been reported breaking off during use or cleaning.
FDA Determined
Cause 2		 Device Design
Action Encision Inc. sent out an "Urgent Product Recall" letter dated August 24, 2011 to all affected customers. The letter included: affected product, problem and instructed customers to discontinue use and return all affected electrodes to Encision. An enclosed reply form was to be faxed back to Encision indicating status of firm's inventory. For information on this recall call Encision at (303) 339-6917.
Quantity in Commerce 10 units
Distribution Worldwide Distribution: Nationwide distribution, and the country of New Zealand.
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 and Original Applicant = ENCISION, INC.
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