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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
Flowtron Trio Pump		see related information
Date Posted December 27, 2012
Recall Number Z-0615-2013
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.
Code Information Model 512003, all serial numbers
Recalling Firm/
Manufacturer		 Arjo, Inc. dba ArjoHuntleigh
2349 W Lake St
Addison, Illinois 60101-6183
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Ms. Brenda Ammonette
800-323-1245
Reason for
Recall		 The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
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.
 
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