Flowtron Trio DVT Pump — Class II medical device recall Z-0615-2013
Terminated recall by Arjo, Inc. dba ArjoHuntleigh, reported 2013-01-02, distributed nationwide. The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
| Recall number | Z-0615-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Arjo, Inc. dba ArjoHuntleigh, Addison, IL, United States |
| Recall initiated | 2012-12-10 |
| Classified | 2012-12-27 |
| Reported by FDA | 2013-01-02 |
| Terminated | 2018-03-30 |
| Distributed | Nationwide (US) |
| Quantity | 2,859 unts |
| Model numbers | 512003 |
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 for recall
The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0615-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.