Enforcement Report - Week of January 2, 2013
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-0615-2013 |
| Classification | Class II |
| Code Info | Model 512003, all serial numbers |
| Product Distributed Qty | 2,859 unts |
| Reason For Recall | The Flowtron Trio DVT Pump has been marketed without proper FDA Approval. |
Event Detail
| Event Id | 63857 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Arjo, Inc. dba ArjoHuntleigh |
| City | Addison |
| State | IL | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-10 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | USA (nationwide) including the states of Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Dakota, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin and Wyoming. |
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