Device recall
Z-2595-2010: HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF…
FDA device recall · Class II · Hemostatix Medical Technologies LLC
Key facts
| Recall number (Z-number) | Z-2595-2010 |
|---|---|
| Recall event | 56366 |
| Product | HEMOSTATIX HANDLE, FOR USE WITH MODELS 150 AND 600D HEMOSTATIX CONTROLLERS, REF 7013-5050, QTY (1), STERILE EO, HEMOSTATIX MEDICAL TECHNOLOGIES, LLC, BARTLETT, TN 38133 USA, CE 0473, EU REP : QFI LTD, STRATFORD, LONDON E15 2ST UK The Hemostatix Thermal Scalpel is a surgical instrument designed to… |
| Product code | GEI |
| Recalling firm | Hemostatix Medical Technologies LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 29, 2010 |
| 510(k) numbers | K033089 |
| FEI number | 3006119098 |
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