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.
FDA Recall Z-1416-2018 · Posted 2018-04-18
Recalling FirmTerumo Cardiovascular Systems Corporation
Recall StatusTerminated
Product CodeDWC
Date Initiated2018-03-16
Date Terminated2020-06-10
Product Quantity2393 this total is for all products
Reason for Recall
Update to cooler-heater cleaning instructions.
Firm 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: [email protected] 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.
Root Cause
Labeling design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.