Device recall
Z-0132-06: HemoSense brand INRatio Prothombin Time Monitoring System, Software Version…
FDA device recall · Class II · HemoSense Inc
Key facts
| Recall number (Z-number) | Z-0132-06 |
|---|---|
| Recall event | 33515 |
| Product | HemoSense brand INRatio Prothombin Time Monitoring System, Software Version 1.25.21; Product is distributed by HemoSense, Inc., 651 River Oaks Pkwy., San Jose, CA 95134 |
| Product code | GJS |
| Recalling firm | HemoSense Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 30, 2006 |
| 510(k) numbers | K020679, K021923 |
| FEI number | 3003038758 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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