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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013

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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
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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model 512003, all serial numbers Class II The Flowtron Trio DVT Pump has been marketed without proper FDA Approval. 2,859 unts Z-0615-2013