Device recall
Z-0815-2010: Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX…
FDA device recall · Class I · Thomas Medical Products Inc
Key facts
| Recall number (Z-number) | Z-0815-2010 |
|---|---|
| Recall event | 54525 |
| Product | Transseptal Sheath Introducer Kits (under trade names: HeartSpan, Channel FX, Torflex, Braided Guiding Introducer Kit). The product is shipped 5 per carton. Intended to allow left heart catheterization procedure to occur through the right atrium. |
| Product code | DYB |
| Recalling firm | Thomas Medical Products Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 5, 2011 |
| 510(k) numbers | K040713 |
| 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