Recall Z-0615-2013— Arjo, Inc. dba ArjoHuntleigh

Name: FDA recall Z-0615-2013
Creator: U.S. Food and Drug Administration
Published: 2012-12-10

Class II · Terminated

Class II FDA medical device recall by Arjo, Inc. dba ArjoHuntleigh, initiated 2012-12-10, terminated 2018-03-30. It names one FDA 510(k) clearance: K010744. Product: 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: The Flowtron Trio DVT Pump has been marketed without proper FDA Approval..

Recalling firm: Arjo, Inc. dba ArjoHuntleigh
Classification: Class II
Status: Terminated
Initiated: 2012-12-10
Terminated: 2018-03-30
Firm location: Addison, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K010744 — FLOWTRON UNIVERSAL, MODEL AC600Huntleigh Healthcare, Inc.·cleared 2002-03-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.