Class 2 Device Recall Flowtron Trio Pump

• Date Initiated by Firm: December 10, 2012
• Date Posted: December 27, 2012
• Recall Status: Terminated on March 30, 2018
• 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
• FEI Number: 1419652
• Recalling Firm/ Manufacturer: Arjo, Inc. dba ArjoHuntleigh; 2349 W Lake St; Addison IL 60101-6183
• For Additional Information Contact: Ms. Brenda Ammonette; 800-323-1245
• Manufacturer Reason for Recall: The Flowtron Trio DVT Pump has been marketed without proper FDA Approval.
• FDA Determined 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.
• 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = JOW