FDA Device recall Z-0615-2013
Flowtron Trio DVT Pump
- FDA Device
- Class II
- terminated
- Published 2013-01-02
On 2013-01-02 the FDA classified a Class II recall of Flowtron Trio DVT Pump by Arjo, citing the Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0615-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-10 |
| Published | 2013-01-02 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Arjo |
| Distribution | US |
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.
Reason
The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
Identifiers
| code_info | Model 512003, all serial numbers |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0615-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.