|
Class 2 Device Recall ConMed Suction Coagulator |
|
Date Initiated by Firm |
September 30, 2009 |
Date Posted |
November 10, 2009 |
Recall Status1 |
Terminated 3 on March 16, 2010 |
Recall Number |
Z-0165-2010 |
Recall Event ID |
53545 |
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 CO 80112-4251
|
For Additional Information Contact |
800-699-9854
|
Manufacturer Reason for Recall |
One production lot of Suction Coagulators received ETO sterilization instead of gamma radiation sterilization.
|
FDA Determined Cause 2 |
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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
510(K) Database |
510(K)s with Product Code = GEI and Original Applicant = CONMED CORPORATION
|
|
|
|