Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR, Stent Length: 5cm, Disposable-Single use only, Rx Only, W
FDA device recall Z-2331-2008 · posted 2008-09-23 · Terminated
Recall details
- Recalling firm
- Cook Endoscopy
- Reason for recall
- The product packaging label indicates the stent is 5cm, but the actual stent inside the packaging measures 10cm.
- Action taken
- Consignees were notified on/about 07/11/2008 via an Urgent - Product Recall Notice. All medical user consignees were instructed to review the attached list and quarantine any affected product in their possession. They are to return any affected product to Cook Endoscopy. A reply form was attached to verify receipt of notification and quantity product returned. All product returned as part of this recall initiative will be dispositioned to scrap and destroyed.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 20 units
- Distribution
- Worldwide Distribution --- USA including states of MO, NC, NV, TX, and UT and country of India.
- Date initiated
- 2008-07-02
- Date posted
- 2008-09-23
- Date terminated
- 2009-06-04
- 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 |
|---|---|---|
| ZIMMON BILIARY STENT SET (K851962) | Wilson-Cook Medical, Inc. | 1985-12-17 |