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U.S. Department of Health and Human Services

Class 2 Device Recall AEM Disposable Electrodes

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  Class 2 Device Recall AEM Disposable Electrodes see related information
Date Initiated by Firm June 15, 2012
Date Posted July 06, 2012
Recall Status1 Terminated 3 on August 07, 2012
Recall Number Z-1951-2012
Recall Event ID 61529
510(K)Number K091074  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product AEM Disposable Electrodes, Device, Electrosurgical, Cutting and Coagulation and Accessories. AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators. The device is model FC03XX series.

AEM Disposable Electrodes used as electrosurgical accessories intended for ablation, removal, resection and coagulation of soft tissue in open, endoscopic and laparoscopic surgical procedures channeling monopolar high-frequency electrical current from compatible electrosurgical generators.
Code Information RDB, RJB, RJE, RJH, RLG, RLI, RLJ, RLK, RLO, RLP, RLR, RLQ, SBF, SBJ.
Recalling Firm/
Manufacturer		 Encision, Inc.
6797 Winchester Cir
Boulder CO 80301-3513
For Additional Information Contact Mr. James Lewis
303-339-6917
Manufacturer Reason
for Recall		 Encision is performing a field correction to their AEM Disposable Electrodes due to two consumer complaints reporting unanticipated alarms from the AEM monitor while using the device. This issue could result delays or complications during surgical procedures.
FDA Determined
Cause 2		 Device Design
Action Encision sent an Urgent Medical Device Recall letter dated June 13, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to lubricate the contact on the instrument cord with a conductive gel (to be supplied by Encision) prior to making the connection of the cord to the instrument. Instructions for applying the gel were attached. This corrective action was temporary; allowing customers to use their inventory of devices and for new product in the short term, until a design correction can resolve the problem. Customers would be contacted by their Encision Sales Representative to review this information for their specific situation and train their staff on its correction. For questions customers should call 303-339-6917 or Customer Service at 800-998-0986. For questions regarding this recall call 303-339-6917.
Quantity in Commerce 48 boxes
Distribution Worldwide Distribution - USA including CA, TX, GA, NY, NC, OH), and 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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