FDA Medical Device Recalls (openFDA)
Arjo, Inc. dba ArjoHuntleigh: 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
- Recalling firm
- Arjo, Inc. dba ArjoHuntleigh
- 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.
- Status
- Terminated
- Initiated
- 2012-12-10
- Posted
- 2012-12-27
- Terminated
- 2018-03-30
- Reason
- The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
- 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
- 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.
- Lot, serial or model codes
- Model 512003, all serial numbers
- 510(k) numbers
- ["K010744"]
- PMA numbers
- not on file
- Product code
- JOW
- Firm FEI
- 1419652
- Firm city
- Addison
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28