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U.S. Department of Health and Human Services

Class 2 Device Recall Terumo HX2 Temperature Management System, Catalog No. 809810

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  Class 2 Device Recall Terumo HX2 Temperature Management System, Catalog No. 809810 see related information
Date Initiated by Firm March 16, 2018
Date Posted April 18, 2018
Recall Status1 Terminated 3 on June 10, 2020
Recall Number Z-1416-2018
Recall Event ID 79652
510(K)Number K071521  
Product Classification Controller, temperature, cardiopulmonary bypass - Product Code DWC
Product Terumo HX2 Temperature Management System, Catalog No. 809810

The Terumo HX2 Temperature Management System is indicated for use to supply temperature regulated water to heat exchangers during open heart surgery.
Code Information All Lot Codes
Recalling Firm/
Terumo Cardiovascular Systems Corporation
6200 Jackson Rd
Ann Arbor MI 48103-9586
Manufacturer Reason
for Recall
Update to cooler-heater cleaning instructions.
FDA Determined
Cause 2
Labeling design
Action The firm,Terumo Cardiovascular Systems Corporation, mailed customers an "Urgent Medical Device Correction" letter dated 2/16/18. The letter described the product, problem and actions to be taken. The Customers were instructed to do the following: 1) discard the current Sarns TCM, TCM II Cooling and Heating, or tHX2 Temperature Management Systems cleaning guides; 2) Review the notice and updated cleaning guides, and ensure all users receive notice of the updated cleaning guides and; 3) Return the Customer Response Form acknowledging receipt of the notice via Terumo Recall Email: tcvs.recall@terumomedical.com or Terumo Recall Fax: 734-741-6149. The letter also includes a list of the updates to the cleaning guides. Customers with questions may contact Terumo CVS Customer Service (800) 521-2818, Monday-Friday, 8am-6pm ET or Fax (734)741-6149.
Quantity in Commerce 2393 this total is for all products
Distribution Worldwide Distribution: US (Nationwide), Australia, Belgium, Canada, Chile, China. Colombia, Dominican Republic, England, Finland, France, Germany, Greece, HK, India, Indonesia, Iran. Israel, Italy, Japan, Korea, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates,and 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.