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Class 2 Device Recall ConMed Pyloric/Colonic Dilator |
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Date Initiated by Firm |
April 16, 2007 |
Date Posted |
June 19, 2007 |
Recall Status1 |
Terminated 3 on July 30, 2010 |
Recall Number |
Z-0944-2007 |
Recall Event ID |
37905 |
510(K)Number |
K033936
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Product Classification |
Pyloric/Colonic Dilator - Product Code KNQ
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Product |
ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 4cm; product code/end item #000845; 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
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Manufacturer Reason for Recall |
Complaints received regarding PET Balloon Dilators for a variety of labeling errors, including: incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
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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 |
172 units. |
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
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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.
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510(K) Database |
510(K)s with Product Code = KNQ and Original Applicant = C.R. BARD, INC.
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