Device recall
Z-0613-2009: ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038…
FDA device recall · Class II · Merit Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0613-2009 |
|---|---|
| Recall event | 50193 |
| Product | ReSolve Hydrophilic Coated Locking Biliary Catheter, 12F, REF RBC-12-038, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. Used for drainage of bile within the biliary system. |
| Product code | FGE |
| Recalling firm | Merit Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 5, 2009 |
| 510(k) numbers | K063733 |
| FEI number | 1721504 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database