Class 2 Device Recall ConMed Pyloric/Colonic Dilator

• Date Initiated by Firm: April 16, 2007
• Date Posted: June 19, 2007
• Recall Status: Terminated on July 30, 2010
• Recall Number: Z-0946-2007
• Recall Event ID: 37905
• 510(K)Number: K033936
• Product Classification: Pyloric/Colonic Dilator - Product Code KNQ
• Product: ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 4cm; product code/end item #000847 and #000857 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
• Code Information: All lots manufactured from May 03, 2006 to December 14, 2006 which includes lot numbers/codes from 0605031 to 0612141. Lot code identification is as follows: For lot #0605031: 06 = year (2006); 05 = month (May); 03 = Day of Month (3rd); 1 = Manufacturing Shift Code (1st shift).
• FEI Number: 1000159712
• Recalling Firm/ Manufacturer: Conmed Endoscopic Technologies, Inc.; 129 Concord Rd Bldg 3; Billerica MA 01821-4600
• Manufacturer Reason for Recall: Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
• FDA Determined Cause: Other
• Action: Notification Letters were sent to domestic consignees on 04/16/07 and to international consignees on 04/17/07. Consignees instructed to discontinue product use, sub recall to accounts sold product, and to contact Stericycle, Inc. at 1-800-668-4391 for instructions on returning product.
• Quantity in Commerce: 152 units (#000847) and 10 units (#000857).
• Distribution: Worldwide-Devices distributed to medical facilities and distributors Nationwide (USA) and to distributors in the following countries: Australia, Belgium, Canada, Croatia, Denmark, Germany, India, Italy, Japan, Mexico, Poland, Spain and Sweden.
• 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 = KNQ