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U.S. Department of Health and Human Services

Class 2 Device Recall ConMed Esophageal Dilator

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  Class 2 Device Recall ConMed Esophageal Dilator see related information
Date Initiated by Firm April 16, 2007
Date Posted June 19, 2007
Recall Status1 Terminated 3 on July 30, 2010
Recall Number Z-0939-2007
Recall Event ID 37905
510(K)Number K033936  
Product Classification Esophageal Dilator - Product Code KNQ
Product ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr), length 8cm; product code/end item #000343 and #000443 (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).
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 2		 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 384 units (#000343) and 12 units (#000443).
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 and Original Applicant = C.R. BARD, INC.
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