| Class 2 Device Recall AEM Disposable Scissors | |
Date Initiated by Firm | April 07, 2011 |
Date Posted | May 31, 2011 |
Recall Status1 |
Terminated 3 on August 09, 2011 |
Recall Number | Z-2399-2011 |
Recall Event ID |
58518 |
510(K)Number | K912780 |
Product Classification |
Electrosurgical, cutting & coagulation & accessories - Product Code GEI
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Product | ES0101-45, AEM Disposable Curved Scissors, 1/2", 45cm, Sterile R, Encision Inc., Boulder, CO 80301
Cutting tissue during electrosurgical procedures |
Code Information |
Lot # QDI, QJJ, RAF |
Recalling Firm/ Manufacturer |
Encision, Inc. 6797 Winchester Cir Boulder CO 80301-3513
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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 | 44 Ten-Count Boxes |
Distribution | Worldwide Distribution - USA (nationwide) and the countries of Australia and New Zealand |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = GEI
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