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