Recall Z-0941-2007
Conmed Endoscopic Technologies, Inc. · initiated April 16, 2007
Product
ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 18mm (54 Fr), length 8cm; product code/end item #000345 and #000736 (5 pack); Single Use, Non-Sterile; distributed by ConMed Endoscopic Technologies, Billerica, MA 01821.
Codes / lots: 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).
Reason for recall
Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of dilator.
FDA-determined 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.
Details
- Recall number
- Z-0941-2007
- Initiated
- April 16, 2007
- Posted by FDA
- June 19, 2007
- Terminated
- July 30, 2010
- Product code
- KNQ – Dilator, Esophageal
- Quantity
- 3,826 units (#000345) and 41 units (#000736).
- 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.
- Recalling firm
- Conmed Endoscopic Technologies, Inc., Billerica, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0937-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | 04/16/2007Terminated |
| Z-0938-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 10mm (30 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | 04/16/2007Terminated |
| Z-0939-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 12mm (36 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | 04/16/2007Terminated |
| Z-0940-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 15mm (45 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | 04/16/2007Terminated |
| Z-0942-2007 | ConMed Eliminator Esophageal PET Balloon Dilator; Outer Diameter (OD) size 20mm (60 Fr)…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | 04/16/2007Terminated |
| Z-0943-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 6mm (18…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | 04/16/2007Terminated |
| Z-0944-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 8mm (24…Complaints received regarding PET Balloon Dilators for a variety of labeling errors, including: incorrect… | 04/16/2007Terminated |
| Z-0945-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 10mm (30…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | 04/16/2007Terminated |
| Z-0946-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 12mm (36…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | 04/16/2007Terminated |
| Z-0947-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 15mm (45…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | 04/16/2007Terminated |
| Z-0948-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 18mm (54…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | 04/16/2007Terminated |
| Z-0949-2007 | ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 20mm (60…Mislabeling issues including; incorrect balloon diameters, lot number discrepancies, and incorrect type of… | 04/16/2007Terminated |