Device 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.

Z-1416-2018

March 16, 2018

Class II

Product summary

Firm: Terumo Cardiovascular Systems Corporation
Event: Event 79652
Status: Terminated
Classification: Class II
Quantity: 2393 this total is for all products
Official record key: device-enforcement:Z-1416-2018

Official wording

Reason: Update to cooler-heater cleaning instructions.

Code information: All Lot Codes

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Update to cooler-heater cleaning instructions.