Class 2 Device Recall Terumo HX2 Temperature Management System

• Date Initiated by Firm: June 11, 2010
• Create Date: June 26, 2015
• Recall Status: Terminated on April 13, 2011
• Recall Number: Z-2060-2010
• Recall Event ID: 55224
• 510(K)Number: K071521
• Product Classification: controller, temperature, cardiopulmonary bypass - Product Code DWC
• Product: Terumo HX2 Temperature Management System 120V, 50/60 Hz catalog number 809810, Terumo Cardiovascular Systems Corp., Ann Arbor MI. The Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly control the temperature of the patients blood and cardioplegia solution during cardiovascular bypass surgery. The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels.
• Code Information: Serial numbers 0001-0003, 1001-1084 and 1101-1116.
• Recalling Firm/ Manufacturer: Terumo Cardiovascular Systems Corporation; 6200 Jackson Road; Ann Arbor MI 48103-9586
• For Additional Information Contact: 734-741-6173
• Manufacturer Reason for Recall: The HX2 Temperature Management System mixing valve may fail resulting in an unusable water channel and then the machine would go into standby mode.
• FDA Determined Cause: Device Design
• Action: The firm, TERUMO Cardiovascular Systems, sent an "URGENT MEDICAL DEVICE CORRECTION" letter dated June 11, 2010, to the consignees. The letter describes the product, reason for correction, what to do in the event of failure, potential hazard, correction, affected population and action to be taken by the customers. The customers are instructed to review the correction notice, assure that all users are aware of this notice, and complete, sign and fax the attached Customer Response Form to Terumo CVS Customer Service at 800-292-6551. The Terumo CVS Customer Service Dept. will contact you upon receipt of the Customer Response Form to schedule the replacement. The firm plans to inspect and correct all units in the field within 5 months. We encourage you to contact Terumo CVS Customer Service at 1-800-521-2818, Monday-Friday, 8 AM-6 PM EST, with any questions or concerns.
• Quantity in Commerce: 100
• Distribution: Nationwide Distribution: AR, CA, CO, CT, FL, HI, IA, IL, KS, LA, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA and WI.
• 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 = DWC