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U.S. Department of Health and Human Services

Class 2 Device Recall Flowtron Trio Pump

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  Class 2 Device Recall Flowtron Trio Pump see related information
Date Initiated by Firm December 10, 2012
Date Posted December 27, 2012
Recall Status1 Open3, Classified
Recall Number Z-0615-2013
Recall Event ID 63857
510(K)Number K010744  
Product Classification Sleeve, limb, compressible - Product Code JOW
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/
Arjo, Inc. dba ArjoHuntleigh
2349 W Lake St
Addison IL 60101-6183
For Additional Information Contact Ms. Brenda Ammonette
Manufacturer Reason
for Recall
The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
FDA Determined
Cause 2
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = JOW and Original Applicant = HUNTLEIGH HEALTHCARE, INC.