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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 Systemsee related information
Date Initiated by FirmApril 16, 2021
Create DateJune 04, 2021
Recall Status1 Terminated 3 on November 29, 2023
Recall NumberZ-1789-2021
Recall Event ID 87834
510(K)NumberK071521 
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
ProductThe 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. 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 (Left and Right). The system has the capacity to circulate water at a rate of up to 6.5 gal./min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels. Device Name / Model Number: HX2 Temperature Management System (P/N 809810) Catalog Number: 809810
Code Information All lot numbers distributed from 05/02/1985 thru 06/10/2015
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
For Additional Information ContactMary Swift
734-741-6056
Manufacturer Reason
for Recall		Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.
FDA Determined
Cause 2		Device Design
ActionOn 04/30/2021, Terumo issued an Urgent Medical Device Removal notice to customer via letter notifying users to discontinue the use of and dispose of HX2, TCM I and TCM II devices. Customers were instructed to confirm receipt of this communication by completing and returning the attached Customer Response Form as indicated on the form. For questions contact Terumo CVS Customer Service: 1-800-521-2818.
Quantity in Commerce75 devices
DistributionDomestic: Foreign: Australia, Belgium, Canada, Chile, China, Colombia, Dominican Republic, England, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), Vietnam
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DWC
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