FDAFDA · Food and drugs·Recall number Z-0615-2013
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.
Published January 2, 2013 · Recall initiated: December 10, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Arjo, Inc. dba ArjoHuntleigh
- Distributor
- 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.
- Lot
- Model 512003, all serial numbers
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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