Device recall
Z-0297-06: Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The…
FDA device recall · Class III · Thomas Medical Products Inc
Key facts
| Recall number (Z-number) | Z-0297-06 |
|---|---|
| Recall event | 34028 |
| Product | Bard electrophysiology SSV H. Lee 9.5F split sheath with valve and sideport. The product is packaged in individual pouches and shipped 5 pouches per case. |
| Product code | DYB |
| Recalling firm | Thomas Medical Products Inc |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jun 14, 2006 |
| 510(k) numbers | K934901 |
| FEI number | 3010665433 |
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