Device recall
Z-0626-2010: Sorin / Clearglide EVH Small with Scissor, REF KTV17, Sterile R, Manufactured…
FDA device recall · Class II · Sorin Group USA, Inc.
Key facts
| Recall number (Z-number) | Z-0626-2010 |
|---|---|
| Recall event | 54000 |
| Product | Sorin / Clearglide EVH Small with Scissor, REF KTV17, Sterile R, Manufactured for: Sorin Group USA, Inc., 14401 W.65th Way, Arvada, CO 80004. The device is indicated for endoscopic and open tissue dissection, bipolar coagulation, and transaction of blood vessels. Device is a single patient use… |
| Product code | GEI |
| Recalling firm | Sorin Group USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 4, 2010 |
| 510(k) numbers | K003587 |
| FEI number | 1718850 |
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