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.
This recall has been terminated (originally issued December 27, 2012).
- Company
- Arjo, Inc. Dba Arjohuntleigh
- Recall Initiated
- December 10, 2012
- Posted
- December 27, 2012
- Terminated
- March 30, 2018
- Recall Number
- Z-0615-2013
- Quantity
- 2,859 unts
- Firm Location
- Addison, IL
- Official Source
- View on FDA website ↗
Reason for Recall
The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
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 / Code Info
Model 512003, all serial numbers
Root Cause
No Marketing Application
Action Taken
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.