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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Aesculap(R) Bipolar Coagulator/Foot Pedal		see related information
Date Posted February 26, 2013
Recall Number Z-0887-2013
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, Pennsylvania 18034-8217
For Additional Information Contact Kathy A. Racosky
800-258-1946 Ext. 5067
Reason for
Recall		 The bipolar energy did not stop after release of the foot pedal.
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.
 
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