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U.S. Department of Health and Human Services

Class 2 Device Recall ConMed Suction Coagulator

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 Class 2 Recall
ConMed Suction Coagulator
see related information
Date Posted November 10, 2009
Recall Status1 Terminated on March 16, 2010
Recall Number Z-0165-2010
Recall Event ID 53545
Premarket Notification
510(K) Number
K052104 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product * (Box label) SUCTION COAGULATOR 10FR QTY 25 ***** * (Pouch label) ULTRACLEAN TM FOOT CONTROLLED SUCTION COAGULATOR 10 FR QTY: 1 ** STERILE ***** LOT 09GHL001 July 2014 MADE IN CHINA ** CONMED CORPORATION 525 FRENCH RD, UTICA, NY USA 13502"
Code Information Lot #: 09GHL001
Recalling Firm/
Manufacturer
ConMed Electrosurgery
14603 E Fremont Ave
Centennial, Colorado 80112-4251
Manufacturer Reason
for Recall
One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Recalling firm notified all distributors by phone from 9/30 - 10/1/09. All customers were notified by letter titled "URGENT: DEVICE RECALL" dated 09/30/2009 on 10/2/2009. Customers were instructed to check their inventory for the affected product, complete the reply form and return affected product. For questions, please contact Damaris Velez or Jeff Dickinson of ConMed Electrosurgery at 800-552-0138, ext 5225 or email succoagrecall AT conmed.com.
Quantity in Commerce 2700 units
Distribution US only. CA, FL, GA, ID, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, SD, TX, VA
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = CONMED CORPORATION
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