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U.S. Department of Health and Human Services

Class 2 Device Recall Aesculap(R) Bipolar Coagulator/Foot Pedal

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  Class 2 Device Recall Aesculap(R) Bipolar Coagulator/Foot Pedal see related information
Date Initiated by Firm January 18, 2013
Date Posted February 26, 2013
Recall Status1 Terminated 3 on January 08, 2014
Recall Number Z-0887-2013
Recall Event ID 64407
Product Classification Electrosurgical, cutting and coagulation; accessories - Product Code GEI
Product Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
Code Information Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12
Recalling Firm/
Manufacturer		 Aesculap, Inc.
3773 Corporate Pkwy
Center Valley PA 18034-8217
For Additional Information Contact Customer Support
800-258-1946 Ext. 5067
Manufacturer Reason
for Recall		 The bipolar energy did not stop after release of the foot pedal.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Aesculap AG sent an Important Recall Notification letter dated January 21, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory and return for a replacement product or credit. The letter included an inventory sheet to be completed by the customer and returned to the recalling firm. For question call 610-984-9265 or 610-984-9291.
Quantity in Commerce 59
Distribution USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.
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.
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