Reported Dec 18, 2013 · Terminated
Aesculap GNI161 Bipolar Foot Control Product Usage: The Aesculap Bipolar Coagulator is intended for use in surgery to…
Aesculap, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Aesculap, Inc. · 3773 Corporate Pkwy · Center Valley, PA · 18034-8217
Is this the product you have?
- Aesculap GNI161
- Bipolar Foot Control Product UsageThe Aesculap 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
- Lot codes and dates
- all GN161's distributed between 4/28/2009 and 5/22/2013.
- Amount recalled
- 85
Where it was sold
- Nationwide
Why it was recalled
Complaints were received for the GN161 Bipolar Foot Control reporting that the bipolar energy did not stop after release of the foot control.
This product could cause temporary or reversible health problems — stop using it.
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