Device recall
Z-1226-2011: Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with…
FDA device recall · Class II · Thomas Medical Products Inc
Key facts
| Recall number (Z-number) | Z-1226-2011 |
|---|---|
| Recall event | 57679 |
| Product | Thomas Medical Products, SafeSheath Long, (Tear-Away Sheath Introducer Set with Integral Hemostasis Valve) for use during vascular interventional procedures. Part No. FCL-051-00, Catalog No. HLS2507MCN; and Part No. FCL-051-02, Catalog No. HLS2507MCN. |
| Product code | DYB |
| Recalling firm | Thomas Medical Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Aug 8, 2012 |
| 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