Endotek Alimaxx-B Uncovered Biliary Stent for Endoscopic Delivery, REF 70129-209, 10 x 60, Sterile EO, Merit Medical Sys
FDA device recall Z-0805-2010 · posted 2010-02-22 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Degradation of the outer portion of the delivery catheter may prevent proper deployment of the biliary stent.
- Action taken
- Merit Medical Systems, Inc initiated customer notification by phone and letter beginning January 28, 2010. Consignees were instructed to immediately contact their affected customers, advise them of the recall activity and to identify and quarantine any unused inventory. A Recall Notification Form is to be completed and signed by the sales rep and by the site representative. Affected product is to returned to the firm. For further information, contact Merit Medical Systems, Inc. at 1-801-208-4228.
- Root cause
- Component change control
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 69 units
- Distribution
- Nationwide Distribution -- AL, CA, CO, FL, IL, KY, NY, MA, MD, ME, MN, MO, PA, TX, UT, VA, WI, VA, TX and WI.
- Date initiated
- 2010-01-28
- Date posted
- 2010-02-22
- Date terminated
- 2010-04-27
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM (K072720) | Alveolus, Inc. | 2008-04-11 |