# FDA recall Z-1417-2018

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

## Product

Sarns   TCM, Catalog No. 15747    The Sarns TCM is indicated for controlling and monitoring patient temperature .

## 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-1417-2018
- **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-1417-2018

## Citation

> AI Analytics. FDA recall Z-1417-2018. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/Z-1417-2018. Source: US FDA. Licensed CC0.

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