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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 Recall
Aesculap(R) Bipolar Coagulator/Foot Pedal
see related information
Date Posted February 26, 2013
Recall Status1 Terminated on January 08, 2014
Recall Number Z-0887-2013
Recall Event ID 64407
Premarket Notification
510(K) Number
K952524 
Product Classification Electrosurgical, Cutting & 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, Pennsylvania 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
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = AESCULAP, INC.
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