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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo HX2 Temperature Management System

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  Class 2 Device Recall Terumo HX2 Temperature Management System see related information
Date Initiated by Firm February 06, 2015
Date Posted February 13, 2015
Recall Status1 Terminated 3 on October 17, 2016
Recall Number Z-1116-2015
Recall Event ID 70492
510(K)Number K071521  
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
Product Terumo HX2 Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.
Code Information HX2 Temperature Management System, 120V  Catalog # 809810  serial numbers: 00016, 0001  1116  HX2 Temperature Management System, 100V Catalog # 812231  serial numbers: 0001, 1002, PT0003, PT0004   HX2 Temperature Management System, 240V Catalog # 812240  serial numbers: 0001, 0002  HX2 Temperature Management System, Trial Kit Catalog # 809810TK  serial numbers: 1001  1042 
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information Contact Customer Call Center
800-521-2818
Manufacturer Reason
for Recall		 Malfunctioning mixing valve and loss of cooling and/or heating capability. System goes to standby mode and shows error messages EOd (invalid mix valve measured range of motion) or EOE (valve unable to move or complete a motion). Mixing valves need to be replaced at regular intervals.
FDA Determined
Cause 2		 Device Design
Action On 2/6/2015, URGENT MEDICAL DEVICE RECALL notifications were mailed to the affected hospitals. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, call customer service at 1-800-521-2818.
Quantity in Commerce 103 units
Distribution US (nationwide) including the states of AR, CA, CO, CT, FL, IA, IL, KS, KY, MD, MI, MO, MS, NY, OH, PA, TX, UT, WA, and WI and the country of Japan.
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 and Original Applicant = TERUMO CARDIOVASCULAR SYSTEMS CORP.
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