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U.S. Department of Health and Human Services

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.