FDA recall Z-1416-2018

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.

Reason for recall

Update to cooler-heater cleaning instructions.

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.

Key facts

Status

Terminated

Initiation date

2018-03-16

Report date

2018-04-25

Termination date

2020-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ann Arbor, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1416-2018