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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64407
Product Type Devices
Status Ongoing
Recalling Firm Aesculap, Inc.
City Center Valley
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-18
Initial Firm Notification of
Consignee or Public
Distribution Pattern USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226 Product Usage: Aesculaps Bipolar Coagulator is intended for use in surgery to generate electrical power for bipolar instruments. Bipolar coagulators are used in neurosurgery, ENT surgery, urology, laparoscopy, and plastic surgery. Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12 Class II AIC (USA) received a notification from Aesculap, AG (the manufacturer) regarding complaints that the bipolar energy did not stop after release of the foot pedal. 59 Z-0887-2013