FDA Enforcement
Class II
Terminated
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.
Recall: Z-1416-2018
·
Reported April 25, 2018
Enforcement
- Recall Number
- Z-1416-2018
- Event ID
- 79652
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Terumo Cardiovascular Systems Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 25, 2018
- Initiation Date
- March 16, 2018
- Classification Date
- April 17, 2018
- Termination Date
- June 10, 2020
- Address
- 6200 Jackson Rd, Ann Arbor, MI, 48103-9586, United States
Description
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.
Reason
Update to cooler-heater cleaning instructions.
Code Info
All Lot Codes
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.
Quantity
2393 this total is for all products