# FDA recall Z-1416-2018

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2018-03-16.

## 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

- **Recall number:** Z-1416-2018
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1416-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1416-2018. Source: US FDA. Licensed CC0.

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