Device recall
Z-0678-06: Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React, Pulmonic Valve…
FDA device recall · Class II · Shelhigh, Inc.
Key facts
| Recall number (Z-number) | Z-0678-06 |
|---|---|
| Recall event | 34692 |
| Product | Shelhigh No-React Pulmonic Valve Conduit. **'Shelhigh No-React, Pulmonic Valve Conduit, NR4000-PA-C'** **'Shelhigh, Inc., 650 Liberty Ave., Union, NJ 07083 USA'** **'Shelhigh Porcine Pulmonic Valve Conduit Prosthesis Model NR-4000 Series with 'No-React' treatment*, INSTRUCTIONS FOR USE'**. |
| Product code | MWH |
| Recalling firm | Shelhigh, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 23, 2007 |
| FEI number | 1000081147 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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