Recall Z-0165-2010 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
ConMed Electrosurgery
* (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"
| Date | Nov 10, 2009 (initiated Sep 30, 2009) |
| Status | Terminated |
| Reason | One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization. |
| Root cause | 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052104 | ULTRACLEAN HANDCONTROLLED SUCTION COAGULATOR, MODEL 130182, 130183, 130184, 130185; ULTRACLEAN FOOTCONTROLLED SUCTION Conmed Corporation, Oct 21, 2005 |