Z-0615-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- January 2, 2013
- Initiation Date
- December 10, 2012
- Termination Date
- March 30, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,859 unts
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.
Reason for Recall
The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
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.
Code Information
Model 512003, all serial numbers