ReSolve Hydophilic Coated Locking Biliary Catheter, REF RBC-10-038, 10F, Sterile EO, Merit Medical Systems, Inc., South
FDA device recall Z-0612-2009 · posted 2009-01-13 · Terminated
Recall details
- Recalling firm
- Merit Medical Systems, Inc.
- Reason for recall
- Biliary drainage catheter tips may separate from the catheter shaft after placement.
- Action taken
- Customers were notified by Merit representatives by phone or visit beginning 11/07/2008. They were to identify and quarantine any unused inventory and complete a Product Retrieval Form. For further information, call 800-356-3748 x 4929.
- Root cause
- Other
- Status
- Terminated
- Product code
- FGE
- Quantity affected
- 528 units
- Distribution
- Nationwide. OUS distribution to Canada, Colombia, France, Germany, Mexico, Ireland, Netherlands, South Korea, and UK.
- Date initiated
- 2008-11-07
- Date posted
- 2009-01-13
- Date terminated
- 2009-08-05
- 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 |
|---|---|---|
| RESOLVE BILIARY DRAINAGE CATHETER (K063733) | Merit Medical Systems, Inc. | 2007-11-14 |