# FDA recall Z-1337-2019

> **Terumo Cardiovascular Systems Corporation** · Class II · device recall initiated 2019-04-18.

## Product

Terumo Advanced Perfusion System 1 Electronic Patient Gas System, Catalog # 801188, UDI 00886799000588    The electronic gas blender provides control and monitoring of the gas flow rate and oxygen content of the gas input to the oxygenator in the perfusion circuit.

## Reason for recall

The gas flow rate output of the EPGS may be inaccurate due to a defect in the internal flowmeter.

## Distribution

Worldwide Distribution: US (nationwide) and countries of: Australia, Belgium, Canada, Chile, Hong Kong, Indonesia, Japan, Mexico, Philippines, Singapore, South Korea, Taiwan, Thailand, and United Arab Emirates.

## Key facts

- **Recall number:** Z-1337-2019
- **Recalling firm:** Terumo Cardiovascular Systems Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-04-18
- **Report date:** 2019-05-22
- **Termination date:** 2020-05-20

- **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-1337-2019

## Citation

> AI Analytics. FDA recall Z-1337-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1337-2019. Source: US FDA. Licensed CC0.

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