FDAFDA · Food and drugs·Recall number Z-0887-2013
Aesculap Bipolar Generator Foot Pedal, Catalog No. GK226, for electrosurgical cutting and coagulation.
Published March 6, 2013 · Recall initiated: January 18, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The bipolar energy did not stop after release of the foot pedal.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Aesculap, Inc.
- Distributor
- USA Nationwide Distribution including the states of: AR, CA, FL, IN, IA, KS, MD, MN, MO, OR, TN, TX, VA and WA.
- Lot
- Manufacture date on the label on the bottom of the foot pedal - any product with manufactured dates between 45/10 and 31/12
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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