* (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"
FDA Recall Z-0165-2010 · Posted 2009-11-10
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Recalling FirmConMed Electrosurgery
Recall StatusTerminated
Product CodeGEI
Date Initiated2009-09-30
Date Terminated2010-03-16
Product Quantity2700 units
Reason for Recall
One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization.
Firm 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.
Root Cause
Process control
Distribution Pattern
US only. CA, FL, GA, ID, IL, IN, KY, LA, MD, MI, MO, MS, NC, NY, OH, OR, PA, SC, SD, TX, VA
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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