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U.S. Department of Health and Human Services

Class 2 Device Recall Fixed Tip Electrosurgical Electrode.

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  Class 2 Device Recall Fixed Tip Electrosurgical Electrode. see related information
Date Initiated by Firm June 11, 2004
Date Posted September 22, 2004
Recall Status1 Terminated 3 on November 09, 2004
Recall Number Z-1074-04
Recall Event ID 29430
510(K)Number K912780  
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product AEM Fixed-Tip L-Diamond Electrode, 5mm, Reusable.
Code Information Catalog ES3511B, Lots EKA, FB, FE, FI, FL, GA, GC, GF, GH, GI, GIA, GL, GLA, HC, HCA, HE.
Recalling Firm/
Manufacturer
Encision, Inc.
4828 Sterling Dr
Boulder CO 80301-2350
For Additional Information Contact Ms. Judith V. King
303-444-2600 Ext. 117
Manufacturer Reason
for Recall
Electrosurgical tip may break or come off during use.
FDA Determined
Cause 2
Other
Action Customers were notified beginning 6/15/2004 by phone or visit.
Quantity in Commerce 335 units
Distribution AL, CT, GA, IA, MN, MS, NC, OK, OR, TN, WA. Foreign distribution to Canada and Australia.
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 = ELECTROSCOPE, INC.
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