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U.S. Department of Health and Human Services

Class 2 Device Recall AEM Disposable Scissors

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  Class 2 Device Recall AEM Disposable Scissors see related information
Date Initiated by Firm April 07, 2011
Date Posted May 31, 2011
Recall Status1 Terminated 3 on August 09, 2011
Recall Number Z-2400-2011
Recall Event ID 58518
510(K)Number K912780  
Product Classification Electrosurgical, cutting & coagulation & accessories - Product Code GEI
Product ES0102-45, AEM Disposable Curved Scissors, 3/4", 45cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures
Code Information Lot # QDH, QJH, RAB
Recalling Firm/
Manufacturer		 Encision, Inc.
6797 Winchester Cir
Boulder CO 80301-3513
For Additional Information Contact
303-339-6917
Manufacturer Reason
for Recall		 Sterility may be compromised due to holes in packaging.
FDA Determined
Cause 2		 Package design/selection
Action Encision, Inc. sent an Important Safety Notice letter dated April 7, 2011, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to either carefully inspect any remaining pouches for readily visible holes in the Tyvek pouch, or return the affected lots to Encision for inspection. Customers were also asked to fill in and fax back the attached Confirmation to 303-444-2693.
Quantity in Commerce 95 Ten-Count Boxes
Distribution Worldwide Distribution - USA (nationwide) and the countries of Australia 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 = ELECTROSCOPE, INC.
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