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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Product Detail

Product Description 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.
Recall Number Z-0887-2013
Classification Class II
Code Info Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12
Product Distributed Qty 59
Reason For Recall 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.

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 Letter
Distribution Pattern 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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