Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Sa
FDA device recall Z-0520-2007 · posted 2007-02-22 · Terminated
Recall details
- Recalling firm
- Cook Endoscopy
- Reason for recall
- The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
- Action taken
- Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.
- Root cause
- Other
- Status
- Terminated
- Product code
- KNQ
- Quantity affected
- 12 units
- Distribution
- Worldwide, including NY and TX in USA, Australia, Canada and India.
- Date initiated
- 2007-01-24
- Date posted
- 2007-02-22
- Date terminated
- 2012-07-26
- Location
- Winston Salem, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BALLOON DILATION CATHETER (K935094) | Wilson-Cook Medical, Inc. | 1995-01-24 |