Device recall
Z-0615-2013: Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein…
FDA device recall · Class II · Arjo, Inc. dba ArjoHuntleigh
Key facts
| Recall number (Z-number) | Z-0615-2013 |
|---|---|
| Recall event | 63857 |
| Product | Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis. |
| Product code | JOW |
| Recalling firm | Arjo, Inc. dba ArjoHuntleigh |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 30, 2018 |
| 510(k) numbers | K010744 |
| FEI number | 1419652 |
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