ConMed Eliminator Pyloric/Colonic PET Balloon Dilator; Outer Diameter (OD) size 8mm (24 Fr), length 4cm; product code/en
FDA device recall Z-0944-2007 · posted 2007-06-19 · Terminated
Recall details
- Recalling firm
- Conmed Endoscopic Technologies, Inc.
- 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.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNQ
- Quantity affected
- 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, Ital
- Date initiated
- 2007-04-16
- Date posted
- 2007-06-19
- Date terminated
- 2010-07-30
- Location
- Billerica, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD ELIMINATOR PET BALLOON DILATORS (K033936) | C.R. Bard, Inc. | 2004-01-14 |