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U.S. Department of Health and Human Services

Class 2 Device Recall HX2" Temperature Management Systems

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  Class 2 Device Recall HX2" Temperature Management Systems see related information
Date Initiated by Firm June 08, 2016
Date Posted July 14, 2016
Recall Status1 Terminated 3 on August 04, 2017
Recall Number Z-2207-2016
Recall Event ID 74389
510(K)Number K071521  
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
Product HX2" Temperature Management Systems;

The 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.

Product Usage:
HX2 Temperature Management Systems is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
Code Information HX2" Temperature Management Systems, P/N 809810, Catalog Number 809810
Recalling Firm/
Manufacturer		 Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103
For Additional Information Contact Terumo CVS Technical Support
800-441-3220 Ext. 6932
Manufacturer Reason
for Recall		 Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Terumo Cardiovascular Systems (Terumo CVS) initiated a voluntary recall on 06/08/2016, by mailing certifed letters to customers. Terumo CVS is notifying all users of its heater-cooler devices that the distributor, Intercon Chemical Company, no longer sells the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions. However, the identical sanitizer is available from other sources. This notice applies to the following Terumo CVS heater-cooler devices: ¿ Sarns" TCM and TCM II Cooling and Heating Systems ¿ Sarns" Dual Cooler-Heaters ¿ HX2" Temperature Management Systems Terumo CVS will provide users with updated user instructions regarding the 10% Sodium Hypochlorite sanitization solution. Instructions will be provided under separate cover, when available; updated manual and cleaning guide will be completed in December 2016. Customers are asked to do the following: Review this notice and ensure that all users receive notice of this issue. 2. Return the attached Customer Response Form acknowledging receipt of this notice. 3. Source a replacement for the Interchlor sanitizer. See information above or call Terumo CVS Technical Support for assistance. If you have questions about this notification, please contact your Terumo representative or Terumo CVS Technical Support: 800.441.3220, extension 6932 Technical Support Hours: Monday  Friday 8 a.m.  6 p.m. ET (24/7 Emergency Hours)
Quantity in Commerce 6412 units
Distribution Domestic: AK, AL, AR, AZ, CA , CO, CT, DC , DE , FL, GA, HI, IA, ID, IL, IN, KS, KY,LA , MA, MD, ME, MI , MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV , NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, England, Finland, France, Germany Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel, Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Malaysia Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates , Uruguay , Venezuela, Vietnam
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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