Device recall
Z-2187-2014: Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories…
FDA device recall · Class II · Codman & Shurtleff, Inc.
Key facts
| Recall number (Z-number) | Z-2187-2014 |
|---|---|
| Recall event | 68837 |
| Product | Codman Certas - In line Valve with Unitized BACTISEAL Catheter and Accessories; Product Code: 82-8803 The Codman Certas Programmable valve is an implantable device that provides constant intraventricular pressure and drainage of CSF (cerebrospinal fluid) for the management of hydrocephalus. |
| Product code | JXG |
| Recalling firm | Codman & Shurtleff, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 30, 2017 |
| 510(k) numbers | K112156, K113526 |
| FEI number | 3002947440 |
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