ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr), length 4cm; product code/end item #000861 and #000867 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
This recall has been terminated (originally issued June 19, 2007).
- Recall Initiated
- April 16, 2007
- Posted
- June 19, 2007
- Terminated
- July 30, 2010
- Recall Number
- Z-0949-2007
- Quantity
- 239 units (#000861) and 12 units (#000867).
- Firm Location
- Billerica, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
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.
Lot / Code Info
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).
Root Cause
Other
Action Taken
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.