Arjo, Inc. dba ArjoHuntleigh: Medical Device Recall in 2013 - (Recall #: Z-0615-2013)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 10, 2012

Date Posted: January 2, 2013

Recall Number: Z-0615-2013

Event ID: 63857

Reason for Recall:

The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.

Status: Terminated

Product Quantity: 2,859 unts

Code Information:

Model 512003, all serial numbers

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.

Voluntary or Mandated:

Voluntary: Firm initiated