Z-0615-2013Class II

Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB...

Name: Z-0615-2013 Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB...
Creator: Arjo, Inc. dba ArjoHuntleigh
Published: 2012-12-10
License: https://open.fda.gov/license/

Arjo, Inc. / initiated 2012-12-10 / Terminated

FDA source

Arjo, Inc. dba ArjoHuntleigh began a recall of Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive... on 2012-12-10. FDA classified it as Class II and gives the reason as "The Flowtron Trio DVT Pump has been marketed without proper FDA Approval". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0615-2013
Classification: Class II
Status: Terminated
Initiated: 2012-12-10
Posted: 2012-12-27
Terminated: 2018-03-30
Recalling firm: Arjo, Inc.
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.
Product code: JOW Sleeve, Limb, Compressible
Reason for recall: The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
FDA root cause: No Marketing Application
Action: ArjoHuntleigh sent an Urgent Field Correction Recall letters dated December 10, 2012, to all affected customers, informing the accounts that the pumps were marketed without proper FDA approval, and that ArjoHuntleigh is removing the pumps from the market and replacing them with a suitable alternative. The accounts were requested to disseminate the information to all organizations where the devices may have been transferred, and to complete the Customer Response Form and return it to ArjoHuntleigh by mail, fax or e-mail. Questions were directed to the ArjoHuntleigh at 1-800-323-1245, ext 57985.
Quantity in commerce: 2,859 unts
Distribution: 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 codes and lots: Model 512003, all serial numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0615-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0615-2013	Class II	Terminated	Voluntary: Firm initiated	2013-01-02	2012-12-27

Product code JOW

K010744Class IIFlowtron Universal, Model Ac600Huntleigh Healthcare, Inc. / cleared 2002-03-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)